Effective Implementation of Quality Management Systems (0857090011)

Effective implementation of
quality management systems
Effective implementation of
quality management systems
B. Purushothama
WOODHEAD PUBLISHING INDIA PVT LTD

New Delhi
Cambridge
Oxford
Published by Woodhead Publishing India Pvt. Ltd.

Woodhead Publishing India Pvt. Ltd., G-2, Vardaan House, 7/28, Ansari Road
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First published 2010, Woodhead Publishing India Pvt. Ltd.
Woodhead Publishing India Pvt. Ltd., 2010
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Contents
Preface
vii
1.
Sustaining business
1.1
1.2
1.3
1.4
1.5
1.6
1.7
Introduction
Recession
Business sustainability
Evolution of QMS
Definition of quality
Imperatives of quality
Quality from a larger perspective
2.
Understanding and implementation of

ISO 9001:2008
14
2.1
2.2
2.3
2.4
2.5
Introduction
Fifty Steps for implementation
Undergo audits
Post-certification audits
Points to remember
14
17
46
47
48
3.
Roles and responsibilities of management

representative
49
3.1
3.2
3.3
Who should be the management representative?

Jobs expected from management representative
Tips for management representative
49
51
55
4.
Internal quality audits: A strong tool for

quality management
56
4.1
4.2
4.3
4.4
4.5
Need for audits

Internal quality audits
Quality control versus quality audits
Product audit versus system audit
Top management review versus quality audits
56
58
58
60
60
1
2
4
4
6
8
11
vi
Contents
4.6
4.7
4.8
4.9
4.10
4.11
4.12
Types of internal quality audits

Pre-requirements of an auditor
What is to be verified?
Can we discontinue quality control investigation?
Process audits
Imperatives of effective audit
Linking exercises a strong tool for quality auditing
61
62
64
79
80
83
85
5.
Measuring maturity in QMS implementation
95
5.1
5.2
5.3
5.4
Need for measurement

Measuring maturity by linking to the principles
Measuring maturity by considering the clauses
Guidelines for assessing maturity in QMS implementation
95
96
97
98
6.
Welcome the complaints
6.1
6.2
6.3
6.4
Who is interested in complaining?

When customer complains?
When customer does not complain?
Customer a free consultant
7.
Face the audits
7.1
7.2
7.3
7.4
7.5
7.6
7.7
Why to face audits?

Basic human nature
What shall be audited?
Preparing for the audit
Face the audits
Role of a guide
Understand the non-conformities and observations
133
133
134
135
136
138
138
140
140
141
142
143
143
Appendix 1: Departmental objectives and expectations
146
References
157
Index
158
Preface
To survive on this earth, it is necessary to keep ourselves fit. It might be

an individual or an organization. One need to follow certain disciplines to
keep his body fit; similarly, an organization also has to follow certain basic
disciplines. The concepts of ISO 9001 give guidelines for helping an
organization to remain fit all the time. What is needed is to implement it
whole heartedly. Remember, one has to do his exercises and follow the
diet to remain fit. This cannot be delegated to others.
It is unfortunate that the need for implementation of ISO 9001 was
understood in a wrong way by majority of the people, and they consider it
as a mere certification process to get entry to world markets. The
concentration is on getting the certificate. The organizations somehow
manage to convince the certifying body and get certificate with out even
understanding the basic concepts. As the number of ISO 9001 certified
organizations are increasing, the respect for the systems is coming down.
When all are ISO 9001, there is no value for the same. There is a need to
measure the level of implementation or the maturity of implementation.
In my experience of implementing ISO 9001 for last 18 years, I have
seen different types of managements and the people. There are very few,
who have understood the real essence of the systems and implementing
them by heart. They are building a good foundation for their organization
to remain stable for long. However, majority of the companies I visited
are concentrating mainly on getting the certificate, somehow manage the
audits and keep auditors happy. The managements are not taking interest
and getting themselves involved in the internal quality audits. They blame
that ISO is increasing their work, adding the paper work and bureaucracy
and not helping improvement. People quote different quality systems like
6 Sigma, Kaizen, Quality Circles etc., but do not understand that no system
can remain or give results unless one has the basic discipline of planning
and establishing the systems, implementing them through out the
organization, monitoring and measuring the performance, correct the
viii
Preface
deviations and take preventive actions with the involvement of people and
a committed management. The real implementation actually reduces the
work, as you will be auditing, identifying the non-conformities and taking
corrective and preventive actions, and go on improving your systems on a
continual basis. As the activities are customer-focused, the sale is
guaranteed.
In this book, I have tried to explain the real need for implementing the
systems, the steps in implanting, the roles and responsibilities of
management representative, making effective internal quality audits by
linking exercises, assessing the level of implementation of ISO 9001,
inviting complaints and treating customer as a free consultant, and freely
facing the audits. I hope this book will drive out some of the misconcepts
and help the organizations to become strong and competitive.
B. Purushothama
Sustaining business
1
Sustaining business
.
Introduction
In earlier days, normally, the trade was a family business. People used to
stick to their family trade, irrespective of the profitability. They were
respecting what their ancestors did. A carpenters son used to become a
carpenter and a soldiers son used to become a soldier. The community
was recognised by the trade they did, and it was even used as surname.
People were not entering in the trade of others, and an act of doing others
trade was even punishable. There was no competition as the productions
were less and the demand was certain.
The increase in demands and the desire to earn more and more led to
development of technology and ultimately to the industrial revolution.
Gradually as the concepts of management was developed, the concepts of
high speed production to reduce the cost of manufacturing pierced in the
minds of the industrialists and technicians. Organized industries started
replacing the earlier cottage industries or craftsmen business. The earlier
craftsmen were compelled to join the organized industries as labourers as
they were not able to compete with the industry by their craftsman skills.
Rapid technological developments and system developments were seen in
20th century as a by-product of the world wars. There were social reforms
also, and the barriers for others in the trade that was being managed by
particular family or community no longer exist. Now a son of a farmer can
become a doctor, and a teachers son can become an agriculturist. The
education is open to all and anyone can enter the business. The labourers
children no longer wish to work as a labourer as the earnings are much
less compared to other trades. It is now very difficult to get servants to do
petty jobs, where as earlier that was the main job of illiterate poor people.
Now people are able to make their own assessment and try to enter into
that trade where the earnings are more. A number of new industries are
being started because of the financial supports given by governments and
public. This very act led to the competition between units of the same
industry and also between industries.
Effective implementation of quality management systems
The recent developments of free trade and globalization opened the

markets that lead to the competition between countries. In earlier days,
the trade was restricted within certain regions. The local manufacturers
were protected by banning imports and the traders were able to sustain
their business depending on the countries and their policies. To protect
themselves, regional trade associations were started and certain trade
barriers were put to prevent others entering in their segment.
The 21st century started with fierce competition and a number of
organizations boasting to be world leaders started collapsing, as they could
not beat the competition. The world is changing very fast. The thinking,
ideologies, and the expectations are all changing. We can see rising
expectations worldwide and open-market economies are forcing people
to compete with each other, more often on the basis of quality. It holds
good for all, even to industry and business, and all have a number of players.
1.2
Recession
As the technology progressed, the speeds of production increased. The

latest high speed machines can produce more than 34 times compared to
the machines that were running two decades back. Further, the
developments in engineering aspects assured good quality product even
at the high speed. Therefore, the industries preferred replacing their old
machines with latest state of the art machines to get higher production and
better quality.
Along with the growth of technology, the cost of living also started
increasing. People demanded higher and higher remunerations as the speed
of production increased. As people preferred to work where salaries are
high, a scarcity was developed for skilled human workers, those could
work at a lower wage. The latest technologies, therefore, concentrated on
reducing the human dependency in the activities by automating wherever
possible. The term rationalization of employment came to restrict the
component of employee cost in the total cost of manufacture. Voluntary
retirement scheme (VRS) was introduced in the industries as well as service
organizations including government establishments to reduce the number
of employees.
As the technology was developed, old machinery was removed and new
high speed machines were put. The skilled people in a number of industries
opted for VRS and started their own small units by purchasing the old
machines on which they were working earlier as an employee. The
governments supported small scale industries by giving them tax benefits
and soft loans. These small industries became competitors for large
industries because of the cheapness of their products. Also, the eruption
Sustaining business
of small industries added to total products available in the market, and the
supply exceeded the demands.
Adapting high speed machines and increasing productions were
preached as an easy way of reducing the contribution of overheads per
unit production and increasing profitability by the costing and management
experts. The calculations were simple. The manufacturing industries started
expanding and increasing their productions in volumes to reduce the cost
of manufacture of unit piece. They were able to achieve this, but
unfortunately were not able to sell their products, as the total demands
remained same or started reducing because of the improved quality products
that were durable.
It is observed that the recession is a cyclic phenomenon. It is repeating
every 1012 years. As the technology developed, new machineries are
installed and the production is increased. This led to competition and surplus
material in the market leading to recession. The weak performers have to
shut their operations, and even the good performers make loss during the
recessions and reduce their productions. After some time, reduction in
production leads to short of materials and the demand starts. This is called
as a boom period. Recession is cyclic so also the boom period. When the
boom period comes, everyone invests and expands, leading to recession
again (Fig 1.1). Companies with good forward thinking does not simply
expand, but also try to bring innovative products to the markets and will
always be first to introduce new products and capture the market.
Performance
Boom period
Time years
Recession
Recessi
1.1 Cycle of recession.
The recession affects the organizations and the economy as a whole.

The planned projects cannot take off and people lose confidence among
themselves. Numbers of hasty decisions are taken during recession leading
to further worsening of the situation.
1.3
Business sustainability
One cannot keep quite just because recession is cyclic. The recession is
cyclic only for those who survive in a recession. One should have strategies
and action plans to face the recession and survive. Any organization should
first sustain before thinking of anything. Sustained success is more
important than making profit in some years and expanding, and making
losses later and retrenching the people. A long-term approach is essential
for sustaining the business. Dr. Ali AL-Zubaidi (1) explains sustained
success as a result of the ability of an organization to achieve and maintain
its objectives in the long term under dynamic organizations environment.
He explains organizations environment as a combination of internal and
external factors and conditions that can affect the achievement of an
organizations objectives, and its behaviour towards its interested parties.
Everyone wants to be a winner as only a winner can survive (2). The
technology and systems adopted have a wide variation from man to man,
organization to organization and depends much on the culture developed
over a period of time, the community and the economic systems. There is
nothing like monopoly in any field and the competition is very high.
Patenting, to some extent, protects the inventors of technology, but no one
can prevent copying and adopting of good and effective systems developed
elsewhere. Surviving has become difficult if one is not competitive.
Everyone tries to adopt a system best suited for his environment, so as to
achieve the best possible results, which is often called as Management
System. The systems designed are trying to address the activities needed
to achieve the required results right at the first time, with least expense.
One who implements and succeeds in sustaining the benefits of the strategic
decisions taken is called a good manager or a winner, and the organization
becomes a winning organization.
1.4
Evolution of QMS
The Quality Management Systems (QMS) was developed in response to

the challenges of increasing market globalization (3). The concepts of ISO
9000 series of standards are widely accepted world over as the basic
guidelines for implementing a system that can help the organization to
sustain in the changing environment. These standards are viewed as
powerful tools for effective management not only for products and services,
but also for business operations irrespective of their sector.
The present concepts of documented quality management system was
developed during the second world war and were maintained as military
secret till 1976, when British Standard Institute came out with BS 5750.
The same was adopted in total as ISO 9000 standards in 1987 by ISO, the
Sustaining business
International Organization for Standardization at Geneva. These standards

went through amendments in 1994, 2000 and 2008.
The guidelines given by ISO are the minimum requirements for
implementation of a quality management system and it is expected for the
organizations to move further by keeping this as a base. A number of quality
management systems were developed by different trade groups, corporate
offices, consultants, state award committees, etc., all with a view to help
the industry sustain in the changing scenario. However, the base of ISO
9000 holds good for all the quality management systems.
The International Organization for Standardization (ISO) defines quality
management system as:
The organisational structure, responsibilities, procedures, processes and
resources for implementing quality management. ISO 8042 (ISO, 1986)
The QMS provides a structure to ensure that process is carried out in
formal and systematic way (7). The ISO 9001:2000 guidelines insists that
implementing a quality management system within an organization needs
to be a decision by top management. (8)
Pradeep Kumar Mathur (4) defines the term quality management system
as The process of management of the systems of an organization, with
regard to its quality related activities, for meeting and enhancing customer
satisfaction and also taking care of all other interested parties such as
legislative and regulatory bodies, shareholders, suppliers, employees, etc.
Navin Shamji Dedhia (5) defines Quality Systems as a series of functions
or activities (sub processes, stages, etc.) within an organization that work
together for the aim of the organization. It comprises the processes in an
organization intended to yield consistency or improvement to the enterprise
of the corporation.
The definition for quality systems by the author in his book Guidelines
for Process Management in Textiles (6) was An un-interrupted follow up
of procedures for doing a work, which are written after judicious studies
in order to achieve the best possible results and A system designed to
achieve reliability and performance is quality system.
The Engineers International (9) observes that the design and
implementation of a quality management system vary depending on the
type, size and products of the organization. Each company will have its
own objective; however, most companys objective is to increase
profitability. A quality management system will assist by managing costs
and risks, increasing effectiveness and productivity, identifying
improvement opportunities and increasing customer satisfaction. A wellmanaged quality system will have an impact on customer loyalty and repeat
business, market share, operational efficiencies, flexibility and ability to
respond to market opportunities, effective and efficient use of resources,
cost reductions, competitive advantages, participation and motivation of

human resources, industry reputation and control on all processes.
From all the above definitions we can understand that strategically
planned and well-designed quality management systems enable us in
achieving our company objectives, which is mainly to help sustenance by
achieving customer and stakeholder satisfaction while maintaining the
operations rationally and economically.
1.5
Definition of quality
Quality is defined by number of people in different ways (10). Joseph Juran

and Frank Gryna define Quality as Fitness for use. The ISO 9000 defines
it as The totality of characteristics of an entity that bear on its ability to
satisfy stated or implied needs. Armand Feigenbaum explains Quality as
A customer determination based upon a customers actual experience
with a product or service, measured against his or her requirements stated
or unstated, conscious or merely sensed, technically operational or entirely
subjective and always representing a moving target in a competitive
market. American Society for Quality (ASQ) opines that quality denotes
an excellence in goods and services, especially to the degree they conform
to requirements and satisfy customers. Peter Senge et al, in their book The
Fifth Discipline Field Book, explains Quality is a transformation in the
way we think and work together, in what we value and reward, and in the
way we measure success. All of us collaborate to design and operate a
seamless value-adding system that incorporates quality control, customer
service, process improvement, supplier relationships, and good relations
with the communities we serve and in which we operate all optimizing
for a common purpose. Daves definition is Quality is a really, really
boring definition that has no real meaning to most humans on this planet
unless you are a millionaire consultant writing a new book or a quality
coordinator applying for some Quality award or certification so you can
quit and become a millionaire consultant who writes books and produces
infomercials from his private island in the Caribbean.
The definitions given by most are centred on meeting customer
requirements effectively. It includes providing right quality goods and
services at the affordable prices and at the committed time. Let us discuss
on this in detail.
Dreaded smuggler late Veerappan was cutting sandal wood trees and
smuggling out of the forests in southern Karnataka and Tamil Nadu. He
was also killing wild tuskers for the ivory. Why he was cutting sandal
wood only and not other trees? His customers demanded sandal wood, so
he was cutting sandal wood. Why he was killing elephants? He had to kill
them because elephants were not giving ivory if he asked. The elephants
Sustaining business
were wild and they could have killed him if he tried to take ivory without
killing them. He stayed in the forests where there were no houses, no luxury,
no facilities and no protection. He had to spend day and night in forests
along with wild animals. The police were after him, so he had to fight
with them and kill the police. He had very good communication systems
in those forest areas that never used mobile phones or satellite services.
He was able to get the information about the movement of police precisely,
where as police were finding very difficult to access he area in spite of
having electronic gadgets, mobile phones, wireless, etc. From the point of
definitions discussed above, i.e. fitness for purpose, working for customer
satisfactions, totality of characteristics of an entity that bear on its ability
to satisfy stated or implied needs of a customer, etc., we must honour him
as the Best Quality Person. We are not ready to sacrifice our life or family
for the sake of customers, but Veerappan did it. Why are we not recognizing
such quality persons and rewarding them?
Take the examples of terrorists. They plan well and attack. They do
their work right at first time for the sake of their customers, who are looking
after their families and community. Can we call them as quality persons?
Certainly we do not accept smugglers, poachers, thieves, robbers,
terrorists as quality people. Then what is missing in the definition of
Quality?
Take some more examples.
A garment company is producing good quality garments at a very low
price and their customers are very happy. The deliveries are given in time
as agreed in the contracts. They boast themselves as having the lowest
lead time. To achieve this, the employees, who come from poor families,
toil in a bad working condition. They are paid less and kept almost as
bonded labour much away from their families. The supervisors and
workers work extra hours without getting the overtime wages as per the
rules. The ladies are not looked after well. No facility of crche is provided
for the babies. The company makes profit, and worlds best brands get
their garments stitched from them. The buyers agents who come for doing
compliance audit give a clean chit to that factory, because, if they disqualify
that factory, then they need to pay more and purchase from others. They
shall become uncompetitive. The certifying bodies also give certificates
of ISO 9001, SA 8000, etc, as their business depends on giving more
certificates to the organizations. If they do not give certificate, they will
loose the business and some one will give the certificate. Can you call that
company as a good Quality Company? They are meeting the requirements
of their customers. The actions taken by the management are fit for the
purpose, i.e. providing the quality goods to the customers at lowest possible
price and at lowest lead time. It meets the definition given by Armand
Feigenbaum that Quality as a customer determination based upon a

customers actual experience with a product or service, measured against
his or her requirements stated or unstated, conscious or merely sensed,
technically operational or entirely subjective and always representing a
moving target in a competitive market.
Another profit-making company was producing good quality and
meeting the complete requirements of customers, but
The company is polluting the environment.

Employees are harassed.
Suppliers are not paid in time.
Taxes are not paid to government as should have been paid by making
some intelligent manipulations.
Roads are frequently blocked because of the parking of heavy trucks.
Roads are frequently getting spoiled because of the movement of
heavy vehicles.
Strikes and agitations disturbing the normal life of public.
Can we call this as a quality company? The definition of quality has

gone much beyond the product requirements to the customer requirements
and the International Quality Standards cover a bigger sphere. The quality
does not restrict itself to fulfilling the customer requirements, but it should
also consider the ethical and society needs and regulatory requirements.
Understanding society needs and requirements and developing the systems
and strategies to help community is essentially a part of quality. Any act
that does not address human values is not a quality. The quality can thus
be defined as Achieving the customer and stakeholder satisfactions while
adhering to business ethics, human values and the statutory, legal and
regulatory requirements.
1.6
Imperatives of quality
The quality should consider the following requirements:
Customer Product features and tolerances, the delivery in time,

reasonable price and quick and prompt service. The technology and
systems adopted should be appropriate to the quality requirements.
The training should be adequate for the people to produce the quality.
The plant should have the capacity to produce the required quantity
to deliver in time, and the management should have planned the
resources and provided them in time to help delivering the goods in
time.
International standards Measuring systems adapted should be inline
with internationally recognized systems. Similarly, the labelling and
Sustaining business
marking should meet the statutory and regulatory requirements. They

should not mislead or confuse the customers and ultimate users. They
should be user friendly.
Regulatory requirements Safety of product as well as users is the
main concern of any regulation. The general interests of the
community and environment are taken into consideration while
developing the regulatory standards. It is essential for any
organization to adhere to legal, statutory and regulatory requirements.
Ethical requirements The ethical requirements consider human
values, business ethics and social obligations. One can make a shortterm profit by not adhering to ethics, but the affected people shall be
waiting for an opportunity to over throw such establishments.
Supplier Timely payment for the materials supplied is the main
expectation of suppliers. Suppliers cannot survive if their payments
are not made in time, and hence the organization cannot expect the
quality products and services from them. It affects the performance
in terms of quality and productivity.
Employees Employees are the backbone of any organization. Unless
the employees are involved in the activities by heart, it is not possible
to get the required performance in terms of quality, productivity, cost,
customer satisfaction, reputation, etc. Remunerations for the work
and security of job and self are the main requirements of the
employees, and it is the duty of the management to provide this. The
scope to grow, the social security and the welfare activities are the
secondary requirements. They are also very important.
Community The community supports an industry as it gives
employment to the people either directly or indirectly. The community
around us has to survive if our organization wants to survive. Providing
a pollution free environment is one of the prime responsibilities of
any organization.
Legal and regulatory requirements should consider
No violation of the law of the land like minimum wages,

working hours, overtime, minimum age for employment,
providing crche facilities where women employees are
working, safety regulations, bonus, PF and other welfare
measures.
When the activities are outsourced, it is the responsibility of

the organization to ensure that the people are paid the minimum
wages as per the Act, and the number of hours worked does no
exceed the limits for both regular working and for overtime.
The employees need to be insured for their safety and health.
All safety aspects are to be maintained as per the law of the

country
10
The training of the employees is the responsibility of the

organization, as they are committing the quality to the
customers.
Regulatory requirements relating to product safety and the

safety of the consumer include number of factors, for e.g., in
a garment industry.
Use of metal free buttons and other accessories in garments.
Avoiding carcinogenic azonic dyes.
Preventing metal pieces like broken needle parts and staple

pins in the garments.
The washing instructions are to be given with the

internationally accepted symbols.
The product safety requirements depend on the nature of the product,
the culture and the conditions in which the users live and use the
products. It depends upon the basic objective of the product.
General regulatory requirements consider
The quantity despatched should match exactly the invoice and

the delivery challan.
The product features mentioned should match the actual

product features.
The packages should have the details of manufacturer, the

period of manufacture and the country of manufacture.
Specifying expiry date is very essential for perishable products.
Specifying maximum retail price (MRP) is essential for

commodity products.
Business ethics include
The product shown in the catalogue to match with the final

material delivered.
Performance according to the promises given to the buyer,

either personally or as claimed in the advertisements.
The product quality to match the samples shown while taking

orders.
Proper documentation as agreed during negotiations.
High quality label and instructions clearly describing the

products and explaining their method of use and the precautions
to be taken.
Timely delivery of material is as important as its quality and

price.
Making in-time payment to suppliers, contractors, service

provides and the government.
Trade regulations requirements
Apart from the International Standards, it is necessary to refer
Sustaining business
1.7
11
to the trade practices and the regulations prevailing in the

country to which the exports are made.
It might include the ban on certain chemicals, packing materials,

packing systems, permissible limits for the traces of heavy metals,
pesticides, etc., depending on the product and the end use.
Societal safety factors emphasize that
Products do not create problem to the user because of its

constituents and finishes.
No loss is made to society or environment because of the processes.
The industry should follow ethical standards and consider the

community requirements.
There should not be any disturbance to the community, like the

noise disturbing the sleep of people, frequent traffic jams because
of the movement or parking of heavy and long trucks in narrow
lanes adjacent to the factory, frequent strikes and lockouts
because of unhealthy industrial relation approaches, etc.
Quality from a larger perspective
The discussions made above indicate that the quality is not a simple word,
but has a large perspective.
The quality not only addresses the basic product requirements, but
also other requirements of customers as well as of society.
We need to work towards achieving both in order to survive in the
competitive international market.
We need to have appropriate procedures to address the requirements,
implement the systems, verify the results and compare with the
competitors and reengineer the systems to achieve improved results.
Adherence to quality systems and ethics should be developed as a
culture, and not for getting certified by third party.
The certificates might give a confidence for new customers for
entering into business with a supplier, but the actual quality and
services, the ethics in dealing and the transparency are the real factors
considered by the customers to stay in business.
The basic need is to adhere to Agreed Quality Standards. Quality

standards must be recognized and agreed by all levels of management. In
the absence of such agreement the operative does not know what is
expected of him or her, becomes frustrated, and leaves, with the ensuing
needlessly high labour-turnover and training costs of new labour.
The next step is to identify the unspecified needs of the customers and
address them. The unspecified needs are very important, as they are the
deciding factors for continuation of a business.
12

Customer Requirements
Specified
Expectations are clear.

Suppliers are clear.
Customers are clear.
Process is designed and monitored.
Unspecified
Customer has no time to sit and list out

all requirements.
Customer feels the requirement when a
problem arises.
Customer feels the requirement when
some one else has got it.
Customer knows the needs but does
not effectively express.
Customer expects the supplier to know.
1.2 Customer requirements.
Once the needs are clear, then we can design the processes to ensure
that the quality is achieved.
How quality is ensured?
By devising correct work methods,

Providing correct materials in time,
Engaging competent personnel and training them adequately,
Proactively inspecting the machines and maintaining them properly,
Checking the material in process and the process itself,
Reviewing the systems periodically for their continued suitability,
By inspecting the material produced,
Checking the documents produced,
Getting the services of an external inspection agency,
Rejecting the nonconforming materials,
Visiting customer place to study the working of our materials and
taking corrective actions and
Getting customer feedback and taking measures to correct the situation.
All the points above can be implemented by taking guidance of

International Standards of ISO 9000. One can take more benefits by adapting
the guidelines given in these standards in the daily affairs rather than
concentrating only on getting a certificate. Please remember that a certificate
can impress a customer before starting the real business. Once the business
is started, it is the consistency in the quality of products and services, the
prompt and ethical dealings and your proactive efforts to address the concerns
of the customers help in keeping the business continuous. Therefore, for
surviving in the business, a whole-hearted implementation of quality
management systems is very important rather than getting a certificate.
Sustaining business
13
Getting certified for ISO 9001 is not the end, but it is the starting point.
It gives confidence to the customers that you are on the right track. Unless
you move, you cannot reach the destination.
ISO 9001 explains the minimum requirements that are given as
guidelines for us to design a quality management system and it is not the
end. We need to improve our systems on a continuous basis taking the
help of guidelines given in the standards.
Goal
Organization
ISO 9000
1.3 ISO 9000 does not allow the organization to slip.
The true implementation of ISO 9000 guidelines does not allow your
company to slip down from what you have already achieved. It shall prevent
you from making mistakes as you shall be following a procedure designed
by you to achieve the results expected by you and you are continuously
monitoring whether you are adhering to your systems and are taking
suitable corrective and preventive actions in time or not.
If you are not adhering to the requirements of the systems and just boast
of having a certificate, you shall be hanged by your customers similar to
as you are hanging your certificate.
IS O 900 1C ertifica te
x xx
If you r ISO certifica te is m ea nt o nly for

ha ng in g in yo ur o ffice, y ou r o rgan izatio n w ill
be ha ng ed by y ou r cu sto m ers
14
Understanding
and implementation
ISO 9001:2008
Effective implementation
of quality of
management
systems
2
Understanding and implementation of
ISO 9001:2008
2.1
Introduction
ISO 9000 series of standards, popularly known, as Documented Quality

Management Systems were amended and new guidelines for
implementation of Quality Management Systems were released in
November 2008, with slight changes from ISO 9001:2000. All the certified
companies and the companies to be certified a fresh, need to adopt the
amended guidelines. Let us discuss the steps involved in implementing
the new system.
The standards have 8 clauses as follows:
1.
2.
3.
4.
5.
6.
7.
8.
Scope
Normative reference
Terms and definitions
Quality management system
Management responsibility
Resource management
Product realization
Measurement, analysis and improvement.
The scope of the standard specifies the requirements of quality

management systems, where an organization needs to demonstrate its
ability to consistently provide the product and services that meets the
customers and applicable statutory, legal and regulatory requirements, and
aims to enhance customer satisfaction through the effective application of
the system. This includes processes for continual improvement and
assurance of conformity to customer and applicable regulatory
requirements. When we talk of the scope of the application for ISO 9000,
we talk about the sections of the organization, which shall be offering
them for third party audits to get themselves certified. When we write the
Quality Manual, it is essential to specify the scope of the application, and
also mention if any sub-clauses from Clause No. 7 are not applicable to
us. This shall depend on the nature of activity. For e.g., Clause No. 7.5.4
viz. Customer Property might not be applicable to a factory or organization
where they are not doing any job work, nor getting any materials from the
"
Understanding and implementation of ISO 9001:2008
15
customers to be incorporated in the final product. One needs to really see

in detail to decide on the clause that could be excluded, as the exclusion
of the clause should not come in the way of meeting customer requirements
and also applicable statutory, legal and regulatory requirements.
The clause on normative references specifies that the organization should
refer the latest version of applicable procedures, standards and norms.
There are standards developed by ISO for writing quality manual, vendor
rating systems, preparing quality plans, project management, configuration
management, auditing, quality assurance for measuring equipments,
managing the economics of the quality, guidelines for performance
improvements, training, application of statistical techniques, etc. We need
to work out as to which standard is applicable to us, and adopt it so as to
get the benefits of the systems. It is advisable to have continuous touch
with the national body for standards, and get the information on the
amendments in standards from time to time. In India, Bureau of Indian
Standards provides the information on the changes in standards through
their periodicals.
Following are the standards referred in ISO 9001:2008:
1. ISO 9004 Managing for the sustained success of an organization
A quality management approach.
2. ISO 10001 Quality Management Customer Satisfaction
Guidelines for codes of conduct for organizations.
Guidelines for complaint handling in organizations.
Guidelines for dispute resolution external to organizations.
5. ISO 10005 Quality Management Systems Guidelines for quality
plans.
6. ISO 10006 Quality Management Systems Guidelines for quality
management in projects.
7. ISO 10007 Quality Management Systems Guidelines for
configuration management.
8. ISO 10012 Measurement Management Systems Requirements
for measurement processes and measuring equipments.
9. ISO 10013 Guidelines for quality management system
documentation.
10. ISO 10014 Quality Management Guidelines for realizing financial
and economic benefits.
11. ISO 10015 Guidelines for training.
12. ISO 10017 Guidelines for statistical techniques.
13. ISO 10019 Guidelines for selection of quality management system
consultants and use of their services.
16
14. ISO 14001 Environmental management Systems Requirements

with guidance for use.
15. ISO 19011 Guidelines for quality and/or environmental
management systems auditing.
16. IEC 60300-1, Dependability management Part I, Dependability
management systems.
17. IEC 61160 Design review.
18. ISO/IEC 90003 Software engineering Guidelines for the
application of ISO 9001 to computer software.
The purpose of the Clause 3, i.e. the Terms and Definitions, is to give
clarity about the terms used in the documents as well as in our daily
communications. We can see that in normal life we use some abbreviations
but with different meanings at different places leading to confusion. For
e.g., TV is refereed as television, transfer voucher, tere-viscose, etc. The
abbreviation MIS is used for management information systems, material
issue slip, monthly income statement, materials in stock, etc. The term
AGM is referred for additional general manager, assistant general
manager and also for annual general body meeting. Some times we see
same activity or material is referred by different names or abbreviations.
For example GRN (Goods Receipt Note) and GIN (Goods Inward Note)
for the materials received at stores. CEO (Chief Executive Officer), COO
(Chief of Operations), Executive Director, VP (Vice President) Operations,
Sr. Vice President Operations, GM (General Manager) Operations, etc.,
are the different nomenclature for the simple term Head of the Unit.
These different nomenclatures are developed for satisfying the ego of
certain people, but can lead to confusion for the people in understanding
their roles and responsibilities. One word should have only one meaning,
so that there can be no confusion. To avoid confusions, ISO 9000:2005
was prepared as a guideline for vocabulary, by which every one in the
organization, and also the auditors use the same terms and avoid confusion
in understanding. It is suggested for the organizations to make a list of all
abbreviations used in their organization and attach as an appendix to quality
manual and the procedure documents. More than documenting, it is
important to ensure that everyone uses the same nomenclatures and
abbreviations all the time. As far as possible, avoid the abbreviations.
The practical implementation in an organization starts from Clause 4,
which says that the organization shall establish, document, implement and
maintain a quality management system and continuously improve its
effectiveness. This starts with the identification of various processes,
determination of the sequence and interaction of the processes, determining
the criteria and methods needed to ensure the operation and control of the
processes, ensuring the availability of resources and necessary information,
17
monitoring, measuring and analysis of the processes and implementing

necessary actions to achieve the planned results and to improve. However
to this activity, we need first to decide on the purpose for which we are
running our organization, and align all our activities to achieve our
company objectives. Again, each of the procedure developed should be
clear about the purpose for which that procedure was developed. We need
to have a mechanism to verify its effective implementation as without such
verification implementation cannot be effective.
The Clause No. 4 to 8 should be seen as one and not as separate, as
these are interconnected. We need to interpret the guidelines given and
decide the step-by-step implementation. The following 50 points are just
an effort to explain the concepts in simple language so that people working
in an industry or an organization can understand.
2.2
Fifty Steps for implementation
1. The first step in doing any activity is deciding on the purpose. We

need to be clear on the purpose of the organization. This is called as
Mission and need to be stated precisely as a Statement. This statement
is supposed to be prepared by the top management; however, in a
number of companies it is seen that these are left to some juniors or
to some consultants. None other than the top management can be
clear about the purpose for which the organization is being run. The
consultants or the junior staff cannot really know the real purpose,
which the top management wants to achieve. For e.g., a co-operative
spinning mills might be having a mission of uplifting the cotton
growers of their area and supply yarns at a reasonable price to the
weavers in their area, where as some other mill might be having a
purpose of exporting maximum so as to enhance the foreign exchange
earnings of the nation. Some mills have only short-term goals of
making quick profits, where as some are interested in the development
of community around them. Some management are interested in
diversification where as some others are interested in remaining in
one field and emerging out as leaders. Unless the purpose is clear,
planning the activities and identifying the processes shall not be
proper. Therefore, defining the purpose shall be the first job of the
top management.
2. Once the purpose is clear, the top management needs to spell out
their Vision. It means what they would like to be over a period of
time; this is worked out by understanding the trends and the possible
developments in the future. Some companies are having a vision of
expanding the activities and be the largest manufacturer in their field,
where as some are interested in maintaining the same strength of
18
employees and achieve higher sales turnover and value additions.

Some are interested in maintaining the same capacity of production,
but change the product mix to get higher revenues. It is very essential
to have a practical vision by considering the facts relating to strengths,
weaknesses, opportunities and threat, or else, the vision shall remain
only on paper.
3. The policy is the path in which we need to move to make the vision
a reality while adhering to the purpose. In ISO 9000, it is termed as
Quality Policy as here the concentration is on implementing the
quality management system. The quality policy should be appropriate
to the purpose of the organization, and should be committed to comply
with the requirements of the quality management systems and to have
continuous improvement in the systems. The quality policy should
provide a framework to review the company objectives, and should
be communicated down the line so that every one in the organization
understands the policy and works in line with the policy. The top
management should use the quality policy as a means for leading the
organization towards improvement of its performance. It should be
a consistent part of companys overall policies and strategies. One
should ensure that quality objectives are understood and pursued
through out the organization. The quality policy should demonstrate
the commitment and leadership of top management for achieving
quality and for providing necessary resources for achieving the
objectives. It should demonstrate the commitment for continuous
improvement as related to satisfaction of customers and other
interested parties like share holders, suppliers, employees,
community, government, etc. Therefore, the quality policy is not a
slogan for advertisement, but is a guide for implementing the systems.
It should be written in as simple language as possible and ensure
that every one understands it.
4. The quality objectives are derivatives of quality policy and the
strategic planning of the organization. The top management should
establish these objectives for leading the organization for
improvement. These are to be capable of being measured in order to
facilitate an effective and efficient review by management. These
should consider the current and future needs of the organization and
market served, relevant findings from the management review, current
product and process performance, levels of satisfaction of interested
parties, self-assessment results, benchmarking, competitor analysis,
opportunities for improvement and the resources needed to meet the
objectives. The communication of the objectives through out the
organization shall be called as effective, when people in the
organization can contribute effectively for the achievement. These
19
objectives should be periodically reviewed and amended as per the

change in the scenario. Therefore, we should not write vague phrases
as quality objectives.
The quality objectives of the organization should help in deriving
quality objectives of each department and section of the organization.
There should be a clear link between the company objectives and
departmental objectives. It is suggested to prepare a matrix as shown
in Fig. 2.1 and verify the linkages.
2.1 Linking company objectives to departmental objectives.
5. Once we are clear about our mission, vision, policy and objectives,
we can work out the action plan. The plan should consider various
aspects like the processes required, the present situation and the
changes needed, the sequence and interaction of processes, the
authorities and responsibilities, the control points and check points,
the review frequency, skills and knowledge needed by the
organization, resources needed, need for improvements at different
levels, method of improving them, training needed to adopt the
improved process or to experiment the proposed process to achieve
the result, documentation and recording. Inputs for effective and
efficient planning include the strategies of the organization, the
20
objectives, defined needs and expectation of customers and other

interested parties, evaluation of the applicable statutory and regulatory
requirements, performance data of the product and processes, the
process capability and the maturity of systems, lessons learned from
previous experiences, the strength, weakness, opportunity and threat
analysis, etc.
The plans should be written as precisely as possible, so that the
implementers should not have any doubts or confusion. A chart may
be prepared as shown in Table 2.1 to guide people as to which are
the procedures that are to be referred for a particular action plan and
the person responsible for that process.
There should be periodical review to ensure that the persons shown
as responsible have understood the action plan and are monitoring
the activities.
6. Once the action plans are ready, we need to decide on the procedures
for implementing the plans. They should clearly specify the
objectives, the responsibility and the actions, how to do the work,
when to do, where to do, what to control, what to check, when to
check, how to check, what is to be recorded, where to record, in case
of deviations what is to be done, etc., depending on the process. The
procedures, therefore, should aim at the achievement of goals, which
are to be revised from time to time depending on the situation.
Therefore, procedures cannot remain same all the time, and the
procedures written by some one cannot be copied and adopted at a
different place, unless we have the same goals as the other person,
and do not wish to improve. If it is the case, there is no meaning of
implementing ISO 9001, as it aims at continuous improvement. It is,
therefore, necessary to review all the procedures, instructions, job
descriptions, process parameters, etc., periodically and amend them
as per the changed situation. Some times, we may find some procedure
/ instruction / job description / process parameter as suitable in todays
context, it can be re-approved; but reviewing is a must.
7. The procedures depend on the processes involved, the type of
equipments and infrastructures available, the competency of the men
involved, the customer feed back relating to our quality and services,
the resources available, and the goals to be achieved. When we talk
of processes in a factory, normally people refer to manufacturing
activities. But there are a number of other processes, which are as
essential as manufacturing to make the company efficient and
effective. Some of the examples are customer order fulfilment
process, complaint management process, human resource
management process, procurement process, supply chain management
21
Table 2.1 Typical action plan chart

Department /
section
objective
Action plan
1. Reduction 1.1 Reducing the travel

expenses by planning
in working
expenses
the vehicle movement,
pooling the persons and
materials and optimizing
the truck capacities
Applicable
procedure
Responsibility
Vehicle in1.1.1 Procedure

for planning charge
and monitorring vehicle
movement
1.1.2 Procedure
for sending
people on
out station
activities
Factory
manager
Logistic in1.1.3 Procedure

for out sour- charge
cing transport vehicles
and taxis
1.1.4 Procedure
for optimizing the
truck loads
1.2.1 Procedure
1.2 Reducing the material
for procuring
cost by monitoring the
materials
wastes at all levels,
accepting only good
1.2.2 Procedure
quality materials to avoid
for vendor
in process wastes due to
selection
poor material and
and vendor
purchasing materials
evaluation
from reliable sources.
1.2.3 Procedure
for determining maximum allowable process
wastes and
monitoring
them
Purchase incharge
Purchase incharge
Purchase incharge
Production incharge
1.2.4 Procedure
for working
out material
realization
percent and
reporting
Quality incharge
1.2.5 Procedure
for inspectting the
incoming
materials
Quality incharge
22
process, quality assurance process, company policy deployment

process, product design process, investment process, information
management process, strategic planning process, management review
process, etc. When we talk of identifying the process and their
sequence and interactions, we need to address all these.
8. Each process should have some objectives, those should be specified
clearly. We need to identify the measurable parts of the objectives.
These are called as key result areas (KRA). It is essential to develop
methods and means to measure the same and periodically review the
progress. The targets need to be fixed for each of the result area, and
communicated down the line so that the men on spot are aware of
the requirements and expectations. It is a good practice to display
Table 2.2 KRA and unit of measurement
Department / Action plan
section
objective
Key result area
1. Reduction 1.1 Reducing the

1.1.1 Reduction in
travel expenses
in working
vehicle
by planning the
expenses
movement
vehicle move1.1.2 Reduction in
ment, pooling
people sent
the persons and
out on out
materials and
station actioptimizing the
vities
truck capacities
1.1.3 Reduction in
out-sourcing
expenses of
transport vehicles and taxis
Measurement unit
Total KM of vehicle
movement
Number of men sent
out and the distance
travelled
Transport bills and

taxi bills
1.1.4 Optimizing the Ratio of partial trucks

truck loads
to full trucks
1.2 Reducing the
material cost by
monitoring the
wastes at all
levels, accepting
only good
quality materials
to avoid in
process wastes
due to poor
material and
purchasing
materials from
reliable sources
1.2.1 Reduction of
incoming
materials
Percent of materials
rejected
1.2.2 Procuring
materials at
lowest possible price
Ratio of purchase
price to the average
market price for
similar quality
material on the day
of procurement
1.2.3 Developing
reliable vendors
Number of vendors
developed and their
rating
1.2.4 Increase in
Material realization
material reali- percent
zation percent
23
the departmental KRAs so that every one in the department shall be

clear about the same. The sectional KRA has to be displayed in the
section and individuals need to be given their KRA in writing with a
copy to the concerned HOD.
9. A documented quality manual has to be prepared to guide the people
in implementing the systems. This manual should give an over view
of the company, the mission statement, the product range, the target
customers and market, the company policies and the steps taken to
implement them, the authorities and responsibilities of key personnel
implementing the systems, the process and procedures involved, the
system of monitoring, measurement and taking suitable corrective
and preventive actions, maintenance of records, reference to the
procedures adopted against each clause of the standard, etc., so that
any one can easily understand the systems. It is advisable to refer
ISO 10013, that give guidelines for developing quality manuals and
quality management system documentation, so that all necessary
points are covered.
10. Effective internal communication is a very important means of
implementing the systems to achieve the objectives, as there are a
number of inter relations between the processes. A free, clear and
interacting communication is very essential for the success of not
only the systems but also for the organization. Therefore, the
transparency of the system has to be maintained at all levels; however,
it should be ensured that the information flow is restricted to the
people involved in the operations, and should not go to unconnected
persons, as it can create more problem than any help.
11. The customer focus is often talked, and one of the responsibilities of
the top management is to communicate down the line the customer
requirements. Here we need to understand a lot. It does not mean
that all the terms and conditions of sales are to be told to each and
every person in the organization. It also does not mean that the top
management should conduct open programme and announce that
meeting the customer requirements are important. The top
management should demonstrate by their deeds that they are
respecting the customer needs in all their activities, which shall
automatically percolate down the line. There is a saying that People
follow the deeds of a leader and not the talks. Same thing holds
good here also. It is needed to explain to the concerned people
regarding the specific requirements of the customers. For e.g., the
delivery schedule should be known to the production in-charge, the
production planning person and the despatch person, where as the
product quality related requirement is to be known to even the
24
operators in production, but need not be to the despatch person. There

are a number of commercial and trade regulatory requirements, which
are to be known to the concerned persons, so that they monitor and
fulfil the requirements.
Primary requirements
1.
2.
3.
4.
Products of the specified quality

Delivery in time
Affordable price
Prompt after sale service
1.
Quick response to the enquiries The customer contact person

should always be available to the customer.
Quick and prompt resolution of complaints and other issues The
resolution should always be in favour of the customer.
Packing should be attractive, but easily removable and disposable It
should help customer to build his reputation in case the products are
directly going to showroom in the name of the customers.
Supplier to communicate proactively regarding the despatch
positions, changes if any in product configurations, the developments
in the technology.
Supplier to educate the people at customers end on the care to be
taken while using the products and the correct methods of using
them.
Supplier should help in maintaining the equipments supplied by them
either freely or with concessional rates.
Supplier should maintain the stock of finished materials in his
account, preferably in a warehouse near to customers place, to help
customer to get materials just in time.
Supplier should take back the materials and replace with fresh
materials whenever customer expresses dissatisfaction.
Supplier should treat well whenever customer visits the suppliers
place and attend to all his needs The senior members from the
suppliers management should attend the customer.
Supplier should give evidence of adhering to legal, regulatory and
statutory requirements so that the customers should not be put in
trouble for non-compliance.
Supplier should bear with customer in case of any late payment due
to any reason.
Supplier should accept the change in product configuration
suggested by customer at any time irrespective of whether
production is started or not.
Supplier should hold the deliveries if desired by the customer due to
any reason.
Supplier should give some discount either formally or informally
Informal discounts are preferred.
The supplier should agree to change the product configurations or
nomenclature in the delivery documents and packages to help
customer getting some tax benefits.
and so on.
Secondary requirements
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
25
In some of the companies, there is a system of nominating one of

their middle management personnel as a custodian of a particular
customer, who in addition to his/her regular activities, verify the
processes and quality of the materials that are being produced and
shall have direct interaction with the buyer. In garment factories, it
is a normal practice to have quality assurance persons and the
merchandisers nominated for different customers. There are
companies who boldly display the name of the customer for whom
the materials are being manufactured and the previous complaints of
that customer regarding the products and services. This system helps
the operators and middle management to be alert in the specific areas
where the customer has a concern. Some companies have a system
of sending their senior workers and middle management staff to their
customers on a periodic basis to understand the performance level of
their products and to get their changed requirements if any, which
are not normally identified and discussed while placing orders or
taking orders by the commercial people. Some companies publish
periodicals, either monthly or quarterly, exclusively for the use of
their staff and workmen, in which they discuss about the market feed
back and the changing requirements of the customers.
The customers needs could be grouped as primary needs and
secondary needs. It is essential to meet the primary needs, but in a
number of cases, the business is lost not because of meeting the
secondary needs effectively.
12. Another important responsibility of the top management is to
communicate down the line the regulatory requirements. Here again,
we need to understand what is to be communicated. The section heads
should have a list of legal and regulatory requirements applicable
for their section, and it is their responsibility to update themselves
regarding the changes and implications. We cannot expect the top
management to interpret all the changes and explain to the section
chiefs. If it is the case, why it is put in the top management
responsibility? It is because, the top management is responsible in
case of any violation, they need to periodically review and ensure
that the required statuary and legal requirements are being met.
It is a normal practice in number of companies to have one senior
HR manager exclusively for compliance. They boast of meeting all
the regulatory requirements and they take various certificates of
compliance. However, when we see in detail, that person shall be
more interested in preparing the documents to convince the auditors,
and also shall spend more time in entertaining the auditors and
government officials. The standards want people to respect and follow
26
the legal and regulatory requirements all the times. Each one should
be aware of the legal and regulatory requirements concerning to the
activities being done and the product being produced. The standards
insist more on implementation of the system rather than on convincing
the auditor and getting certificate. There is a need to educate people
concerned regularly on the legal requirements and the changes if
any, and ensure that they work as per the requirements, rather than
having a separate person to patch up the records to show to the
auditors.
13. The standards requires certain documents to be maintained as
mandatory, which include the quality policy, quality objectives, quality
manual, documented procedures required by the standards, documents
needed by the organisation to ensure effective planning, operation and
control and records required by the standards. If one reads calmly, he
can understand that the scope of documentation covers all the essential
activities of the organization. There is a need to identify and define
the documents and relevant records needed to establish, implement
and maintain the quality management systems, and to support an
effective and efficient operation of the organizations processes. The
nature and extent of the documentation should satisfy the contractual,
statutory and regulatory requirements, and the needs and expectations
of customers and other interested parties. This also should be
appropriate to the organization. The documents can be in any form or
medium suitable for the needs of the organization. For e.g., written
procedures for implementing regulatory requirements, where as we
can think of a video cassettes for showing the work practices like
material handling systems, assembling and checking the parts,
operating fire extinguishers, etc. We can have sign boards at appropriate
places to give instructions to workmen relating to Dos and Donts,
or can have online work instructions on each machine for attending to
routine problems. The option is left to the organization, but one should
ensure that the documents are properly controlled. Figure 2.2 illustrates
the documents needed for effective implementation of quality
management systems in any organization.
14. What do we understand by the word document control? It means the
documents are (a) approved by certain authorised and responsible
persons after ensuring its adequacy and relevance to the operations,
(b) are suitably identified to ensure that only the current version are
in use, (c) given only to the concerned users and avoided from going
to unauthorized persons, (d) the obsolete documents are promptly
removed from the place of use, and (e) they are legible and easily
identifiable.
27
Quality policy
Quality objectives Company
Quality objectives Department
Quality objectives Products
Quality manual
Work procedures
Work instruction
Organization structure with functional designations
Job descriptions
List of forms
List of records
List of external documents
List of legal and regulatory requirements applicable
List of equipments for inspection and testing and monitoring
The specific terms used in documents definitions to be given
Specifications need not be separate, as it is given with individual batches
2.2 List of documents needed for effective implementation of QMS.
It is normal practice to have a control copy seal and a control copy

number on the documents to show it as a Controlled Document.
The organizations also maintain number of Uncontrolled documents
and Records, but are not clear as to why it should be uncontrolled.
When asked, people normally reply that controlled documents were
for ISO purpose and the uncontrolled were for their day-to-day
activities. The controlled documents are kept in clean folders, where
as there are number of over writings and some important tips about
the activities. People should understand, if any document is required
for the effective functioning of the organization, those documents
need to be controlled. There is no need to have separate documents
for ISO 9001 purpose. If anyone is maintaining certain documents
that are not related to the organizations functioning, for e.g. technical
28
articles collected from some magazines for reference, the activities

of annual social gatherings, felicitations to some achievers etc.,
they can be kept as uncontrolled. However, if the employee
development is one of the objectives, even these records need to be
controlled.
15. In the documents relating to meeting the satisfaction of customer
and other interested parties, the management should consider the
contractual requirements from the customers as well as the
requirements of the interested parties; acceptance of international,
national, regional and industry sector standards, relevant statutory
and regulatory requirements, decisions by the organization, source
of external information relevant for the development of the
organizations competencies and information about the needs and
expectations of the interested parties. Therefore, it is essential to
identify and control the distribution of documents of external origin.
Access to documentation needs to be ensured for people in the
organization and to other interested parties depending on the
organizations communication policy and requirements. The other
interested parties include customers, suppliers, employees, share
holders, government and the community around us.
16. The method of doing a work or performing a process is often called
as procedure, where as what was done and its effects are recorded
as a document is normally referred as record. The records are the
data bank giving information about various aspects while
implementing a procedure. They serve as an input for review and
planning. Therefore, they should be preserved properly. However,
the life of the records changes depending on the nature of data
and its utility. Hence the management should decide on the life of
each record. The records should be easily retrievable when needed
and hence proper identification and storage is necessary. As the
records are meant for using by others for review and decisionmaking, they need to be legible and protected from damages due
to handling or any other reasons. People should develop the habit
of keeping back the records in their original designated place
immediately after the work. It is a good practice to specify the
cupboard number and rack number also on the records along with
the department and the sections. A full-proof method of putting a
diagonal band as suggested by Shyam Talawadekar 11 is a very good
system. Figure 2.3 gives an illustration of that simple, but very
effective system.
In order to have easy retrieval of information, it is essential to have
standard formats for data gathering and presentation. This shall avoid
29
2.3 Simple Poka-Yoke for storing files.
Name of the Company..

Department/Section
Subject.
From. To..
Not to be discarded before (date).
Location.
Responsibility
2.4 Legent of a record.
duplication of work and also help in computing the data for analysis.
It is essential to list all the formats, index them and display so that
people do not create a new format or use a wrong format. It is normal
practice to allocate form numbers to all formats, and give reference
of that format in the procedures, work instructions and job
descriptions.
17. One of the prime functions of any management is to review the
activities to ensure that they are effective and helping to meet the
company objectives. This is called as management review. This
30
includes the review of all activities relating to the implementation of

quality management systems, product and process performance,
feedback from customers and other interested parties, adhering to
legal and regulatory requirements, actions proposed and taken to
correct the deviations found in internal and external audits, and the
changes in policies. The management review should be a planned
activity and cover all the areas; however, the periodicity might depend
on the criticality of the activity. Normally people refer management
review to a meeting held after internal/external audits for ISO 9001
compliance, but it is not correct. It is only a management review for
quality management system implementation; however, for the process
conformance, product conformance, company performance, customer
requirements analysis, financial commitments, supplier performance,
human resource management, etc., the reviews need to be held at
different levels, and the overall performance reviewed by the top
management. Some people think that reviews should be done in a
meeting only, where as, it is sufficient that the top management review
the situation and take appropriate action in-time to correct the
deviations and to improve the situation. A meeting shall help in
solving the differences if any and brings people closer. The
commitment of the top management to review the situation
considering all the requirements of the system and the organization
is very important. Following Table 2.3 gives an illustration as to how
the reviews can be delegated and made effective
Table 2.3 Delegation of reviews
Production
Quality issues
Suggestions received
Complaints
Corrective actions
Preventive actions
Profit and loss
Actions on audit finding
Supervisor
HOD
Unit head
MD
Each shift
Each shift
NA
NA
NA
NA
NA
NA
Daily
Daily
Weekly
As and when received
Weekly
Monthly
Monthly
Monthly
Weekly
Weekly
Monthly
Weekly
Monthly
Monthly
Monthly
Quarterly
Monthly
Monthly
Quarterly
Monthly
Quarterly
Quarterly
Quarterly
Quarterly
18. The provision of resources is very important part from the top
management commitment point of view. However, there should be a
justification for the resources to be provided. It should help the
management in enhancing customer satisfaction and satisfaction of
other interested parties, i.e. stakeholders, to achieve the company
objectives and fulfil the applicable statutory and regulatory
requirements. Hence, the top management should identify the
resources essential to the deployment of strategy and the achievement
31
of the organizations goals. The resources may be people,

infrastructure, work environment, knowledge, information, suppliers
and partners, natural resources, financial resources and time.
19. The human resource is a very important resource. Even the best
equipments and systems if handed over to non-competent people can
result in a disaster. Therefore it is essential to identify the minimum
competency level required for each job, and ensure that people with
competence are engaged. The competency for doing a job depends
on the job requirements and is expressed in terms of knowledge,
skills, physical fitness and the maturity for taking decisions. One
need to note down the work to be done and split the work into events,
and then decide what competency is required. For e.g., a tester needs
to collect material from each machine and check for the properties.
For this work he should be able to identify the machine and material,
the production element, time, etc. Hence an education to read and
write the language in which the communications has to be made is
required. Also he needs to test for the required property, and enter
the figures in registers or in computer as per the system, and show to
the concerned. This requires knowledge of basic mathematics,
computer data entering, etc. Depending on the level of education in
that area, one may prescribe it as 10th standard, metric, pre-university
and degree, etc. He should be able to carry the material [samples] to
the testing spot, and hence he should have a good physique to do
that job. He should have good eyesight to identify the labels, signs
written on machines, etc. He needs to communicate with the
production people to find out the changes that have taken place and
the changes required. Hence, he should be trained in basic
communication skills, and should have the basic knowledge of the
machineries and the technical words used in the production area. To
that extent he should have been trained. Like this we have to analyse
each and every activity with in a given job, and arrive with the
minimum competency required (Table 2.4).
20. We need to verify the competency level of the people doing the job
to ensure that they are qualified for doing the job allotted. This can
be verified by the consistency in their performance rather than
referring to their educational qualifications and the experience
certificates. In case of low performance, it is needed to identify the
cause, and if the competency is found as the reason, a suitable action
like training, reallocation of job, simplifying the systems and
providing an opportunity for the man to improve his skills and
knowledge. What is more important is reviewing the actions taken
and ensuring that they are giving the required results. Hence periodic
evaluation is required.
32

Table 2.4 Competency requirements of a tester
S.
No.
Jobs done
Skills needed
Education needed
1.
Collect samples
from each
machine for
testing
1. Identify the machines

2. Identify the materials
3. Understand the
properties to be
tested
4. Decide on the sample
size
5. Identify and record the
exact source of
sample in multiple
delivery machines
1. Able to read the

numbers
2. Able to understand
the codifications
3. General awareness
of the properties to
be tested
4. General awareness
of deciding sample
size
5. Able to identify the
delivery positions
2.
Marking the
samples, recording
the sample details.
1. Identify the labels on

samples and signs
written on machines
(Needs to have a good
eye sight)
1. Able to read and

write English
3.
Test for the

required
parameters
1. Operating the testing

equipment
2. Checking the
calibration before
starting the test
3. Handling the samples
with out disturbing or
hurting self
1. Able to read the

standard
procedures and
conduct the test
2. Able to check the
calibration of
materials
3. Understand the
property of
materials, study
sample handling
systems and
safety precautions
4.
Entering the data

in register or in
computer systems
1. Data entering in
registers or systems
without mistake
2. Working out the mean,
deviations and
highlight the major
deviations
1. Basics of data
entry in computers
and registers
2. Basic
mathematics,
fundamentals of
statistics
5.
Carrying the
samples from
machine to testing
lab and returning
the samples back
after testing
1. Material handling skills

(Should be physically
fit to carry the
samples)
1. Education is not a
must for this
operation
6.
Submitting the
results to
concerned
supervisor or fitter
for taking action
1. Communication skills
to explain the real
deviation and the
actions needed
2. Communicate the
actions to be taken
1. Able to read, write

and speak in the
language of the
people taking
action
(Contd.)

S.
No.
Jobs
done
Skills
needed
33
Education needed
2. Basic knowledge of the working of the
machine and effects of different
operations
Summary Minimum 12th standard passed with Science and Mathematics as

optional, basic training of data entry, handling of samples, basic operations and
functions of different parts, operating the testing equipment, data entry and
presentations, communication skills for reporting the data.
21. People can work efficiently when they are empowered. This can be
done by suitably defining the organization structure, with clearly
defined authorities and responsibilities. Once a competent man/
woman is allotted the job, and is clear about his/her authorities and
responsibilities, and is aware of the relevance of the work in achieving
the objectives of the section and company, he/she shall be enthused
to do the work and shall work with full potential.
22. The work environment needs to be maintained to get the required
quality and productivity. There are two parts in this: one is physical
environment like required lux level of light, maximum allowable dust
level, maximum tolerable noise level, house keeping, level of
pollution and controls, precautions for maintaining good hygiene,
cleanliness, ergonomics, machinery layout, etc.; where as the second
one is relating to human environment, which include the way in which
the people are treated, the promotion policies, grievance handling
systems, discipline at work, social justice, the welfare measures, etc.,
which all help in building a confidence among the employees that
the top management is concerned about the well being of the
employees and are taking care of them.
23. The other resource, viz, infrastructure includes various items like
plant, working space, tools, equipments, support services, information
and communication technology, transport facilities, etc., which are
all essential for getting the product and service realization to achieve
the company goals. Hence it is essential for the users of the above
infrastructure to justify them as required for improving the systems
and/or enhancing customer satisfaction and/or achieving the company
objectives as per strategic plans. It is also essential to utilize the
infrastructures optimally to keep the cost of operation as low as
possible, while not compromising on the quality.
24. Now let us come to the core activity, i.e. product manufacturing, or
as per ISO 9001:2008, product realization. The first activity in this
area is the planning for product realization. We need to understand
the product requirements before going for manufacturing. We need
to know the customers stated needs, implied needs and expectations,
34
and from that we need to work out the quality objectives of the
product. This explains what is expected out of the product when it
reaches the customers end. Let us take some examples:
(a) Textile mill
(i) Ne10s combed hosiery yarn As the name indicates the
yarn is going for knitting application, and hence the yarn
should be soft twisted and waxed. The yarn is combed
and expected to be free from kitties and neps and
imperfections should be lower. The yarn should have
sufficient strength and elongation to give a trouble free
performance. However, we do not know as to what type
of knitting machine the customer has. Now think of
socks knitting, one for baby socks and the other for
sports socks. For baby socks, the comfort of wear is
more important, where as for sports socks, wear
resistance is very important. Hence for baby socks we
need to give a lower T.M. compared to sports socks.
The short-term variations in yarn looks prominent in
socks as the same yarn shall be coming again and again.
(ii) Same Ne10s combed hosiery for doubling to use in
sweaters In this case, as the doubling operation is done
at customers end, we have to give un-waxed yarn. The
short-term variations might not be critical as in the case
of socks. Uniformity in shade of yarn is very important,
as the yarns are likely to be dyed and used as an outerwear.
(iii) Ne10s combed soft twist going for candlewicks In this
case, uniformity in terms of thick and thin places are
very important, and a kitty free yarn is required. The
shade variation is not critical for this end use, and also
the strength of yarn.
(b) Engineering workshop
Customer wants a shaft to be fitted to a drive. The basic
question is: how much load it is supposed to carry. On that
basis the diameter and the material is designed. The second
question is about the speed on which it has to work, on which
the bearing shall be decided. The third question shall be the
atmosphere to which the shaft is exposed, on which the material
to be used for the shaft shall be decided. The functional aspects
are very important in deciding the product objectives.
(c) Cafeteria
Food is to be prepared for 10 people for lunch. We need to be
clear as to whether they need light working lunch or heavy
lunch. The purpose for which the lunch was ordered is very
35
important, i.e. whether it was a happy occasion or just a simple

gathering or lunch for people engaged in a specific official
work. The age and sex of the people coming for lunch and
their culture also have a say on the food to be served.
The quality objectives of products depend on the purpose for
which it is being used. We need to work out the objectives of
the product against each product and for each customer or
contract, so that all precautionary measures are taken while
producing.
25. We need to work out the quality plan for each contract or purchase
order, which should consider the starting date and time, the machines
to work, the men to be engaged, the quality checks to be done,
completing day of the production, despatching day, the procedures
to be followed and the records to be maintained.
It should be documented and circulated to all the concerned in the
supply chain/activity. Follow up is required to ensure that the
activities are carried out as per plan. A typical quality plan can be
as below:
Order no.
PR ######
Product
PQR$$##
Total quantity
25000 Pcs
Production to start on
20 Dec 2008
Production to end on
12 Jan 2009
Machine numbers allotted
Operation 1 Machines 1, 2, 4, 6
Operation 2 Machines 2, 3, 4
Operation 3 Machines 1, 2, 5
Persons suggested
Operation 1 Ticket No 20041, 20042, 20044,

20046
Operation 2 Ticket No 21042, 21043, 21044
Operation 3 Ticket No 23111, 23112, 23115
Testing to be done
As per IS ##, IS#%#, and IS###
Previous complaints on similar

products
(1) Short working life although materials have

required strength.
Actions taken
(a) Testing of water for *%*%*%*%

properties
(b) Conducting ageing test of the product
(c) Monitoring the temperature and curing
time
36
26.
27.
28.
29.
Some companies give date wise break up of machineries to be allotted,

and maintain the records of production in a minusing register that
will be giving the numbers out standing as on date or shift.
In order to understand the real requirements relating to the product,
it is needed to have a close contact with the customers and day-today interactions relating to changing requirements. We need to
understand the critical requirements those affect the performance and
quality at customers end and the regulatory requirements if any. The
critical requirements depend on the type of machines the customer is
having, the working atmosphere, the work culture, the expectation
of their customers, the end use of the materials and the changes in
Once we understand the requirements, we need to verify whether we
can supply the same in terms of required quality, price, delivery
schedule, after sales service requirements if any, and the regulatory
requirements specified. It is common practice to have periodic studies
of process capability and product capability so that one can then enter
into a contract with confidence of fulfilling it. This is called as
contract review. In case we are not in a position to fulfil any of the
requirements, it needs to be suitably conveyed to the customer and
get the contract amended. Similarly, if the customer needs any change,
he needs to inform the supplier and get the contract amended. The
attitude of giving false assurances to get the orders can lead to
dissatisfaction of customers and finally they shall go away from us.
Customers believe in what they got and not on what you assured.
We need to have facilities and systems for an effective communication
with customers relating to the product information, changes in market
positions, performance of our materials at customers end, actions
taken on complaints and feedbacks, the information required by
customers relating to product features offered by us, the contracts
and the production schedules, likely delivery positions, payments,
etc. This shall reduce confusions and complaints, and help in building
a good relationship so that we can have long-term association.
The present day trend is to give free access to the customer to the
ERP systems implemented so that they can see the position of their
orders on line. Some companies have even given the test results online
to the customers.
Once the product requirements are clear, we need to design and
develop the product so that it suits the exact requirements of the
customers. Some manufacturers say that they do not design the
products, as they are making only standard items as per customers
designs. But if we see in detail, we need to do some changes
depending on the raw material properties, seasonal changes, changes
37
in the machinery configuration, etc., even though the basic

specifications remain unchanged. Further, depending on the
production requirement, we need to select the raw materials, change
the speeds, settings, timings and temperatures etc., which are all a
part of product design.
For designing we need to consider the inputs like the customer
requirements, the availability of raw materials, the type and condition
of the machinery we have, the regulatory requirements, the
competency of people working, etc. The designer should have the
complete knowledge of the risks involved and the way in which the
material is likely to be handled at the customers end. He should also
have the knowledge of the process capability of his factory and a
sound knowledge of statistical quality control to draw inferences from
the data obtained while conducting trials.
The design should give information relating to the requirement of
raw materials and spares, the process parameters to be adopted, the
modifications in the machines required, the quality levels achievable,
the controls required, safety precautions required, the cost of
manufacture, the risks involved and the training required to be given
to the employees.
30. The designs need to be verified to ensure that the assumptions and
calculations are correct, reviewed to predict the problems the product
can pose to the organization as well as to customers if manufactured
in bulk, validated by making prototype samples to ensure that the
product meets the customer requirements, documented so that there
are no lapses while implementing in a large scale, and controlled
from being leaked till the process of design is complete and given
for regular manufacturing while ensuring that the design does not
reach the wrong hands which can harm the companys interests. It is
a normal practice in number of companies, especially where large
brand owners are purchasing the materials, the samples from the
development stage as well from the materials being manufactured
are validated by the customer.
31. Once the design is clear, the materials could be procured to start the
production. We need various types of materials, like raw materials,
spares, packing materials, lubricants, capital equipments, etc. If we
need the quality as per our expectations, and the costs as calculated,
we should purchase materials from such suppliers whom we feel as
capable and reliable for supplying materials as per our requirement.
Hence we need to select vendors and periodically review their
performance and ensure that they are suitable to meet our
requirements. For vendor rating, we can make use of IS 12040:2001
by giving suitable weightage for critical factors like quality, price,
38
delivery, service, approachability, etc. The weightage given are to be

decided item wise considering its importance in manufacturing and
in achieving the quality level. The cost factor and the space for storage
is also a point of consideration. For example, for precision spare
parts, the weightage for quality shall be very high compared to price
and delivery, whereas for packing materials, the delivery schedule
becomes more important. Following Table 2.5 gives an idea of giving
weightage to each item being procured in a cotton spinning mill.
Table 2.5 Weightage to be given to items procured in spinning mill
Product
Quality
Delivery
Price
Service
Total
Spindle Top arm

85
80
3
3
2
2
10
15
100
100
Rubber cot
60
20
15
5
100
Bearing Packing material

60
30
10
40
20
20
10
10
100
100
Brooms
30
30
35
5
100
The weightage given can be used for evaluating the vendors as per
the formulae given below.
Quality rating =
Number of items approved

Number of items received
weightage for quality
Number of consignments received in time

Delivery rating =
Number of consignments received
weightage for delivery
Ranking in price among the quotations received

Price rating =
Number of quotations received
weightage for price
Number of satisfactory services

Service rating =
Number of service requests made
weightage for service
32. The information to be given to suppliers in purchase orders should

have the complete description of the product including the catalogue
numbers, (machine serial number for which the spare is being ordered)
reference to standards, drawing or sample depending on the material
being ordered and its criticality in product realization. This also should
include our method of approving the products, the quantity ordered,
delivery requirements, transportation and insurance related data,
applicable taxes, payment terms and any other specific requirements.
39
33. ISO 9004:2000 (18), the guidelines for performance improvements

addresses effective purchasing process as follows:
Timely, effective and accurate identification of needs and

purchase product specifications.
Evaluation of the cost of purchased product, taking account of

product performance, price and delivery.
The organizations need and criteria for verifying purchased

products.
Unique supplier processes.
Consideration of contract administration, for both supplier and

partner arrangements.
Warranty replacement for nonconforming purchased products.
Logistic requirements.
Product identification and traceability.
Preservation of product.
Documentation, including records.
Control of purchased product, which deviates from requirements.
Access to suppliers premises.
Product delivery, installation or application history.
Supplier development.
Identification and mitigation of risks associated with the

purchased product.
Involvement of suppliers in purchasing process in order to

ensure timely supply and reduction of inventory.
It is suggested to read and understand the guidelines given in ISO
9004, and design your systems to align with the guidelines given.
34. It is essential to have a system of verifying the purchased product to
ensure that the products meet the purchase requirements. However,
we need to prioritize the activities considering the criticality of the
products purchased as verifying all the materials procured might not
be feasible.
35. Control of production activities in order to get the required quality
products at the planned productivity rates is the important process in
a manufacturing activity. This involves the availability of information
describing the characteristics of the product to the men on shop floor
engaged in the production activity, availability of procedures and
work instructions, process parameters as necessary, use of suitable
machinery and equipment depending on the product requirement,
availability and use of monitoring and measuring devices,
implementation of release, delivery and post delivery activities.
40
Here it is essential to ensure that the decisions taken in designing,

quality planning, and the environment identified in resource
management are strictly adhered to. The machines needs to be
maintained in such a way that they give the required performance. It
is also essential to ensure safety of men, materials and the machineries
as a part of controlling of production activities.
36. There are processes like turning, drilling, milling, etc., where we
can check the quality of the material while the process is on. We can
check the dimensions and take corrective actions. There are some
processes like painting, welding, polymerization, dyeing and finishing
of textiles, moulding, fusing, operations involving chemical reactions
etc., where the in-between tests are not possible and we need to wait
till the process is completed. This type of process requires a thorough
study and fixing the process parameters, and employing people who
are well trained to get the right quality right at first time. This type
of process is called a special process. Taking a small sample and
processing them to establish the parameters is a normal system
adopted to validate the special processes. It is normal practice to get
the materials validated by the customers or a custodian of customer
for such products produced out of special processes.
37. Whatever may be the process adapted, proper identification of the
materials and processes at all stages are essential to ensure the quality
and accounting. Similarly we should be able to trace the material
backward to the machines and time on which they were processed,
so as to analyse the effects of various actions taken or to identify the
source of a problem when nonconforming products are noticed in
further processes. The system of identification and traceability should
be clearly communicated down the line, as workmen handle the
materials, and the work goes on round the clock. Display of the coding
system is a normal practice in good companies to educate the people
on the materials being worked. The coding may be by colours, labels,
markings, use of specialized containers, barcodes, etc., depending
on the materials and the culture. The allocation of lot numbers, batch
numbers and mentioning of date and time of packing is essential and
the production people should have the history of the complete
processes adopted for that product.
38. In case a factory is processing the materials belonging to customers
on a job work basis, it is essential to ensure proper accounting of the
materials received and inform the customers in case of any
shortcomings. Similarly, the quality of materials received should be
checked and advised to the customer if they are not suitable to produce
the quality as committed. It is always better to nominate a person to
deal with such products by maintaining proper accounts and record
41
the transactions. It is our responsibility to safeguard the customer

property. Normal examples are raw materials received for
manufacturing, semi-finished materials received for finishing, yarns
received for twisting or weaving or dyeing, fabrics received for dyeing
or printing, finished fabrics received for garment stitching, etc. There
are some other products, which are not raw materials but some add
on items, like labels for putting on the final products going for retail
market, hangers for garments, packing materials with neutral labels,
etc. One more very important customer property identified recently
is the technical know-how given by a customer for developing a
product and to exclusively supply the products to them, which are
mainly in the form of a recipe, or software programme.
39. Preservation of products by proper packing and by handling them
properly to avoid damages in storage and transit are also very important.
The first impression the customer gets about our quality is in the
presentation of packages. We need to identify the type and size of packing
depending on the materials being packed, the type of transportation
adopted, the condition of roads and the distance to be travelled, likely
atmosphere conditions at the place of destination and also on the way,
the type of handling systems the customers are having, etc. For example,
if the cartons are loaded in waterproof containers at the factory, the
transit damages shall be less compared to loading material in a truck,
and transporting it on road for a long distance with two or three transshipments in between. At some places, the customers have only lady
workers, and do not have material handling equipments, and hence they
prefer small packages. The customers, who have very high wage rates,
prefer to go for mechanized material handling systems like fork lifts,
and would prefer the material supply on pallets. In some cases, the
customers prefer staple-less cartons, where as some prefer only recyclable
materials depending on the regulatory and ecological requirements.
Hence, it is needed to understand the packing requirements from the
customers rather than offering our standard packing to all.
The packing quality is very important as it gives the first impression
about the product and the company to a customer. Therefore, utmost
care is to be taken in packing area, and only dedicated people are
employed. Any mistake done in packing can spoil all the efforts done
during the manufacturing activities. It is essential to have proper records
of the people engaged in packing and the packages they packed. The
packers are supposed to check the quality of the materials by visual
means before packing, and hence are accountable in case of poor quality
materials reaching the customer. In order to avoid smuggling and
trafficking of banned items, some companies have made the packing
area as restricted and unauthorized persons are not allowed. The names,
42
photos and addresses of the employees permitted to enter packing area

are displayed and a security person monitors.
40. The controlling of measuring and monitoring devices is a very
important aspect of production and quality monitoring. Now we have
a number of online monitoring devices for both quality and
productions, and most of them are electronic based. We need to ensure
that the readings given by these devices are reliable, as the decisions
taken depend on the data provided by them. Similarly, we have
pressure gauges, temperature gauges, length measuring units, etc.,
on various machines. In a number of cases, it is seen that the pressure
gauges become weak after usage for some years, and show higher
pressure even though the actual pressure is low. Similarly, the lengths
measured by length measuring units on machines are normally found
erratic and do not match with that displayed. It is essential to develop
systems to monitor the gadgets, on which we take decisions.
We can take the help of recognized laboratories or can develop our
own system to verify the accuracy and reliability of data, and to apply
corrections depending on the extent of uncertainty noticed. It is
always better to develop full-proof systems to avoid deviations, rather
than depending on the verification of process outputs and taking
corrective actions. Periodic assessment of test results by participating
in round tests help in getting a confidence in testing equipments.
Very important aspect is to ensure that the measuring and monitoring
devises are maintained well and protected from getting tampered. In
case any deviation is noticed, it is essential to trace back the materials
processed, and recheck them and ensure that the quality as okay.
41. The decisions taken should have a base and supported by facts and
figures. Decisions without backing of facts can lead to failures or in
high costs. Measurement data are important for making fact-based
decisions. The measurement is needed for evaluation of quality,
productivity, costs, wastes, product realization, customer satisfaction,
supplier capability, performance of various sections and processes,
effectivity of systems, etc. The measurement data should be converted
into information and the knowledge should benefit the organization.
With the modern machines having online data systems, we get number
of information on the performance, which are either displayed or stored
in memory. In a number of organizations, it is seen that although lots
of measurements are made, people are not using them for taking
decisions. This information should be used to establish appropriate
priorities for the organization. Communication of this information to
the concerned persons in time, and involving the users in decisionmaking is very essential to get the real fruits of the measurement
systems.
43
42. The system compliance is verified by internal quality audits. Periodic

internal audits help the organization to identify the system deviations
and help in correcting the situation, and also for improving the systems
on a continuous basis. The auditors should be suitably trained to see
the systems with an unbiased view, and to project the deviations to the
management without hurting the feelings of the people working. It is
important that managements ensure the improvement actions in
response to internal audit findings. Internal audit is a very good tool
for team building and self-development, as the auditors discuss the
issues with auditee, and indicate the deviations while convincing the
auditee of the deviations and its importance in meeting the objectives.
In the mean time, the auditors also learn the systems adopted at various
sections of the same organization. Over a period of time, they shall
have fairly good knowledge of the overall systems of the organization.
The Chapter 4 deals with various aspects of internal quality auditing.
43. It is very essential that the auditee takes the audit output seriously, and
attends to the non-conformity in time. Getting the audits done and
taking corrective actions in time is the responsibility of the auditee
and not of an auditor or the management representative. The
management representative plans the audits and allots the auditors.
The auditee should follow and get his/her section audited so that the
deviations if any are corrected and system is made effective. Any delay
in attending the non-conformities indicates the lack of commitment of
the top management in communicating the importance of implementing
a quality management system and implementing them.
44. The process measuring and monitoring aims at achieving the targeted
process performance, which involves getting required productivity and
production, reduction of wastes (product/process/system/documents/
cycle time, etc.), reduction of costs, getting best out of people by
suitable training as and when required, getting information,
communicating and recording the information, getting required material
in time by developing suppliers (internal as well as external) capability,
improving infrastructure, preventing problems, developing methods
for processing, monitoring process yield, etc. For each process, there
shall be inputs, and we need to identify the methods for making best
use of the inputs. The process monitoring should result in optimum
utilization of all these. The company should develop checklists and
formats for monitoring the process and decide on the frequency of
monitoring depending on the type of process and the variables involved.
45. Measurement of customer satisfaction has been given importance in
the ISO 9001 since its amendment in 2000. Unless we are in a position
to understand the level of satisfaction of our customers towards our
product and services, we cannot take the required steps. We might
44
be doing a number of unwanted things with out getting fruitful results.

We need to assess the customer satisfaction from the customer
perception. It is always better to discuss frankly with customer and
get his views. There are a number of methods for understanding the
customer satisfaction levels, which include periodic surveys, visiting
the customer place and collecting information, customer conferences,
analysing data on supplies and feedbacks, interaction with
competitors customers, market share analysis, trends in forward
booking, share of our products in the total purchases of a customer,
payment received in time, repeat orders, reference given by our
customers to other customers, etc. Some people try to develop an
index and compare it to understand the trends in customer satisfaction,
where as some other monitor data customer wise, as there is no
meaning in going by average when a particular customer is
dissatisfied. It is needed for the top management to decide on the
method they would like to adopt for monitoring customer satisfaction
so that they can take suitable steps to enhance. The real indication of
a good satisfaction level of customers is the increase in sales and
consistency in demands.
A matrix as shown in Fig. 2.4 helps in understanding the customers
well. In the example given, a supplier is supplying 3 products, viz.,
P1, P2 and P3 and supplied to 3 customers, viz., C1, C2 and C3.
There were 23 complaints assigned to 5 reasons. By this type of
matrix, we can understand clearly the preferences and concerns of
individual customers, and address them accordingly.
46. Product conformity to the customer requirements is to be ensured by
online and offline monitoring of product and process quality. The
product parameters need to be verified with agreed parameters with
customers. Normally, some parameters are regularly checked for
which specifications are available, where as there are a number of
unspecified needs, which we need to meet depending on the quality
objectives of the product. Hence, it is necessary to develop
measurement systems for those parameters and monitor the same.
47. Continual improvement is needed for any business for its survival,
as the competitors are continuously improving. Hence, getting bench
marking information, identifying potential areas for improvements,
plugging the loss making areas, taking timely corrective and
preventive actions and continuous upgradation of knowledge are
essential steps. Prompt and periodic review of targets, objectives,
procedures and policies are indicative of the top managements
commitment for continual improvement. Without modifying the
systems from time to time, continuous improvement cannot be
achieved.
45
R5
R4
R3
R2
R1
Reasons
Period : From__(date)__ to __(date)_
Product
Customer
P1
P2
C1
P3
P1
1
1
P2
P3
4
1
P1
P2
P3
C2
1
C3
1
2.5 Product-wise/reason-wise/customer-wise complaint matrix.
48. The corrective action taken promptly and communicated through out
the organization to prevent it from recurring is a very important step in
achieving improvement. We normally see that the same types of problems
and complaints are repeating, and people happily change the
nomenclature as routine problems. There are a number of books available
on the causes and remedies for routine problems found in an industry.
What is required is to develop Poka-yoke or full proofing the systems
and eliminate those problems once for all. A detailed root cause analysis
for all the deviations and problems is essential and the root of the problem
needs to be attacked to prevent it from surfacing again.
49. We should have a system of identifying the potential problems before
a problem can occur. For example, when a new technology is
implemented, the people on the spot shall not be aware of the
problems they are likely to get. In such cases, a brain-storming session
can help in identifying the potential problems. Similarly changes in
social scenario, political changes, economic changes, competition,
environmental issues, etc., are to be analysed and discussed to identify
the potential problems. It is needed to analyse the problems in detail
to find the root cause, take action, verify the action and if found
suitable standardize.
50. Once we are clear and confident that we are following the system,
we can go for certification. We should understand clearly that a
46
certificate is only a Moral Booster and not guarantee that we are

doing everything right. We have to do the work and get the results.
A certificate shall influence the customer to have some confidence
in us, that we are following some good systems, and we can
understand his needs and work to his expectations. The customer,
during the process of using the materials supplied by us, shall be
observing the performance for the life time. Hence the certificates
cannot influence a customer to come back, but the performance of
our products and services. We need to make our systems strong to
remain strong.
Getting ISO 9000 is not the ultimate goal. It is only a starting point.
We need to go on improving the systems, and win the confidence of
customers, so that they remain loyal to us, and our business can run.
It is just like our baby getting entry to KG 1, and now we can be
confident that she shall get guidance from good teacher. We need to
guide her regularly to see that she comes up. Similarly, we need to
ensure that the systems are reviewed periodically and aligned with
the changing scenario and implemented whole-heartedly to get
continuous improvement.
2.3
Undergo audits
It is seen that normally people hesitate to face audits. They are afraid of
the remarks that are likely to be made by an auditor. The main reason is
the lack of confidence. One needs to understand that audit is a process to
ensure conformity to the systems. It is conducted by trained experts. Auditor
is not interested in finding a mistake, but any deviation found from actual
to practice shall be highlighted as a deviation; might be a non-conformity
or an observation. It does not mean that non-conformity is bad. You might
have done some improvement, but not documented it. The auditor helps
you to document it by raising non-conformity.
We go to doctor periodically to get ourselves checked. If any disease is
found building up, we take preventive medicines, and some times even
undergo surgery to prevent the problem. Here auditor is a doctor, and hence
we should cooperate with him and show frankly whatever is asked. Care
should be taken not to show anything which is not asked, as auditor is not
a perfect doctor to suggest you remedies for everything.
The certifying body conducts and adequacy audit before auditing the
processes. This is done for ensuring that the quality manual documented
addresses all the applicable clauses of ISO 9001 adequately, and there are
procedures are documented appropriately. The auditor shall identify any
lapses and suggests correcting them. Adequacy audit is not meant for
verifying the compliance to the standards, and non-conformities are not
47
raised. The auditor shall discuss with management representative and asks
him to amend the manual wherever it is needed. Once the corrections are
made and the quality manual is found okay, the dates for the audits shall
be fixed.
Wherever an organization is not confident, they can request for a trail
audit from the certifying body. The auditors shall go deep in each process
area and try to identify maximum number of deviations and advise the
organization to correct them. Once all the non conformities are attended,
the organization can offer them for final audit. In case the organization is
confident they can directly opt for final audit without going for a trial
audit.
The auditors verify whether the organization is complying with the
minimum requirements of the quality management system or not, and raise
non-conformities whenever deviations are seen. It is the duty of the auditee
to correct them without delay. Certificate cannot be granted if there are
any pending non-conformities. However, by seeing the nature of the nonconformity, the auditor can recommend for the grant of certificate, while
giving a deadline for correcting the deviations and getting verified by the
auditor.
Even though implementation of QMS is not a one time job and
implemented and monitored on a continuous basis, still we need to prepare
our selves for facing audits. The Chapter 7 explains various fine aspects
of getting ourselves prepared for an audit. Once the audit is started, face
with confidence. Your confidence helps you to win over the auditor.
2.4
Post-certification audits
ISO 9001certification is not a one-time certificate like university degrees.

In case of academic degrees, people study a lot and take the degree, but
forget what they learnt after some time. However, to get continuous good
results, we should continuously work as per system, and cannot afford to
forget. Therefore, we need to get ourselves assessed periodically from a
third party. This type of audit is called surveillance audit. There shall be
minimum four surveillance audits before renewing the certificates. Some
of the auditors and auditees opt for half yearly surveillance audits. During
each surveillance audit, only selected processes shall be audited, so as to
cover all the processes at least twice before going for renewal of certificate.
After a period of 3 years, the complete organization shall be thoroughly
audited, and if found okay, the certificate shall be renewed. This audit is
called as renewal audit.
During the post-certification audits, the auditors are supposed to verify
the improvements compared to previous audits, and ensure that continuous
improvement is visible in the systems and the performance. Therefore, it
48
is suggested to keep records of all amendments and the reasons for

amendments, the corrective and preventive actions taken and the results
after each action, the trends in performance for all the key result areas and
the records of review of documents and policies.
2.5
Points to remember
1. We need to implement ISO 9001 for improving our performance and

to have continuous improvements, and not for the sake of having a
certificate as a mark of superiority.
2. Design system to meet the organizations goal and verify its suitability
from time to time.
3. Systematic and uninterrupted following of systems only can give
results and not ad-hoc implementation.
4. Procedures are to be developed to suit our requirements to meet our
organization goals, and not to be borrowed from others.
5. The process owners should write the procedures and not expect the
management representative to write them.
6. We need to satisfy ourselves that we are on the right path in planning,
implementing, reviewing and controlling.
7. Document what is needed to ensure smooth working and not what is
documented by some one somewhere.
8. Systems designed should empower people to take decisions and move
forward to achieve company goals, and not to wait for instructions
all the time.
9. The ISO 9001 systems are based on eight management principles,
and we need to adhere to them. They are
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision-making
Mutually beneficial supplier relationships.

10. Use of five golden questions12 for self-evaluation helps in making
the systems effective. Ask yourselves the following five questions
every time you are doing an activity and get yourself satisfied.
Are we having a procedure?
How do we ensure it as the best to achieve the goals?
How did we implement?
Did we get the result as anticipated?
How do we compare with our competitors?
3
Roles and responsibilities of management
representative
3.1
Who should be the management

representative?
Management representative is a key person in the implementation of ISO

9000 systems in any company. As per ISO 9001:2008 (14), Clause 5.5.2,
top management shall appoint a member of organizations management
who, irrespective of other responsibilities, shall have responsibilities and
authority that includes
(a) Ensuring that processes needed for the quality management system
are established, implemented and maintained,
(b) Reporting to top management on the performance of the quality
management system and any need for improvement, and
(c) Ensuring the promotion of awareness of customer requirements
throughout the organization.
Note The responsibility of a management representative can include
liaison with external parties on matters relating to the quality management
system.
From the above statements it is clear, that the management representative
represents the top management in implementing the quality management
systems, which are aimed to achieve the company objectives, while
ensuring enhanced customer and other stakeholder satisfaction. He is
therefore authorised by the top management to act on their behalf in
implementing the systems. To make him successful, the management
representative should be a senior person, who commands respect from
other members of management and staff. Appointing a junior person as a
management representative shall be a hindrance for effective
implementation of system organization wide. The management
representative must be a person from the organizations management, and
cannot be an out sourced person.
In some of the companies, it is seen that a fresh candidate from college
is appointed as a junior executive, who does the work of management
49
50
representative. His work is to maintain the records and keeping the manuals
and procedure documents in a safe place. In one such case it was found
that the management representative had not undergone the basic awareness
programme on ISO 9001, but the company was an ISO 9001:2000 certified.
Some consultants were managing to get the certificate. By taking certificate
in this manner, the company cannot get any benefit as the systems are not
improved. They will have a certificate hanging, without realizing that the
companys future itself is hanging.
In some of the companies, it is seen that management representative
is a separate man from the regular activities of the organization and is
not assigned any regular responsibilities. This man will concentrate
only of documentation, conducting audits and liaising for management
reviews and audits. The reason given is The activities are too many
and the documentation is difficult. A separate man as MR can
concentrate on documentation, and shall be able to explain to auditors
so that the certificate is got. Here the basic purpose of implementing
ISO 9000 is lost. The organizations should realize that ISO is not a
separate activity, but a part of the activities that are being carried out
in order to meet the objectives of the company. There is no need for
doing an activity that is not contributing for meeting the objectives of
the company. By keeping MR as a separate entity, without any regular
assignments, the management gives a message to all that ISO 9000
activities are additional activities, and is not a part of regular activities.
By this the MR shall have resistance from the co-employees, who get
a feeling the ISO 9000 activities are a burden. A management
representative should be a role model, who can demonstrate to the
people by implementing the concepts of quality management system in
his routine works. The management representative should be a senior
manager with regular responsibilities, and should be able to implement
the systems while doing his regular activities. Then only he can
command others to implement the systems as a part of their regular
activities. If he is a separate man, he shall never get recognition.
It is a normal practice in majority of the companies that the chief of
quality control becomes the management representative, because they are
implementing quality management systems. It is a wrong understanding.
The quality control activities are normally concentrated on product quality,
and it is a technical job. The ISO 9001 is concentrating on the quality of
the management system and not only on the quality of the products. If the
management system is good, the quality shall be good at all places.
Therefore, a senior manager having command on all the sections and
departments is the best person to become a management representative
and he should be dedicated.
Roles and responsibilities of management representative
3.2
51
Jobs expected from management

representative
The following are the jobs normally expected from the management
representative.
1. Understanding the company mission, vision, policies and objectives
carefully, and communicating the same in simple language down the
line. He should ensure that people have understood the same and
will be able to demonstrate it in their routine activities.
2. Helping HODs in deriving the departmental objectives, policy and
goals considering the company objectives and policies. The concerned
HOD is responsible for writing the policy and goals for his department
and sections. The management representative helps in writing them
precisely by linking them with the company objectives and goals.
3. Liaising with standard bodies and getting the latest applicable national
and international standards required for implementing and
maintaining ISO 9000 series of standards. It is expected that the
management representative is always thorough with the changes in
the standards. It is suggested that he become a member of professional
bodies, create alerts in internets, browse the internet on regular basis
and get updated with the changes. He should be a leader in
understanding the concepts.
4. Explaining the concepts of ISO 9000 throughout the organization.
Help of expert professionals can be obtained in giving training. It is
always better that the management representative trains people within
the organization for explaining the concepts down the line rather
than hiring experts from outside. The help of outside experts are to
be taken only to educate the top management and senior managers.
5. Communicating the importance of meeting customer as well as
regulatory requirements during the training programme or in any other
occasion found suitable for this purpose. The management
representative needs to liaise with marketing, quality and production
people in understanding the real concerns and requirements of
customers and ensure that they are communicated down. It does not
mean that the management representative should personally
communicate these things down the line. He needs to verify and
ensure that the systems are working to communicate the customers
concerns and needs down the line.
6. Proactively discussing with the people and ensuring that all have
understood the real essence of the quality policy, quality objectives
and goals, their role in achieving the goals and in complying with
the statutory, legal and regulatory requirements. He should educate
52
7.
8.
9.
10.
11.
12.
the internal quality auditors to verify the compliance for statutory,

legal and regulatory requirements during the audits. However, it is
found that importance is not given to this point during internal quality
audits in majority of companies.
Preparing quality manual is one of the main responsibilities of the
management representative. This should be done in line with the
guidance given in ISO 10013 and in consultation with the top
management. The manual should be written in simple words so that
all can understand with out any confusion. Getting the manual
approved and releasing them in time is also the responsibility of
management representative.
Identifying the processes required for implementing quality
management systems that can help achieving company goals is a very
important step in the implementation of quality management system.
The management representative should conduct interactive sessions
among departments and map the activities in a flow chart, and identify
the control points.
The management representative should take active part in helping
the HODs in identifying the controls in processes identified and
documented. This should be done by considering the company
objectives, goals, requirements of quality management systems and
legal and regulatory requirements.
Developing procedures for document identification, document control
and amendment of documents, withdrawal of documents, document
distribution and for maintaining documents for reference are the prime
responsibility of the management representative. In some companies
it is seen that the controlling documents relating to ones specific
section is made the responsible of the concerned HOD, and the
management representative does not interfere in it.
Getting the documents viz. work procedures, work instructions, job
descriptions, process parameters and specifications, etc., prepared
by the concerned personnel and bringing them under control is one
of the important jobs of a management representative. In some
companies they expect the MR to prepare those documents, which is
a wrong practice. The concerned HOD, who is doing the work, should
prepare the procedures, instructions, etc. The MR should only control
them from getting duplicated, or going to unauthorized persons.
Over a period of time, we see number of formats is developed in an
organization, and some of them may be a duplication of work.
Scrutinizing all the formats used in the organization and standardizing
them is a very important activity, for which the management
representative is responsible. He need to collect all the forms, list
them and index them, and discus with the concerned people and
13.
14.
15.
16.
17.
18.
19.
20.
21.
53
modify them to reduce the number of forms and make them more
effective and user friendly.
Maintaining the master list of all documents, records and forms, and
the distribution charts is one of the prime responsibilities of the
It is normally seen that numbers of records are maintained in any
organization. There might be duplication of records, and some vital
information might not have documented at any place. It is the
responsibility of management representative to help the HODs in
identifying the records to be maintained considering the company/
department/section and individual activities, goals and targets.
Interpreting the customer requirements and communicating down the
line is an important activity in any organization. The management
representative is expected to help the concerned HODs in preparing
the specifications and guidelines for meeting the requirements.
As the technology advances and the company adopts new technology
and systems, there is a need to amend the procedures and the
documents. Arranging for adequacy audits in case of any changes in
system, process or the people is one of the main tasks of a management
representative.
Preparing the procedures, instructions, manuals and documenting
them is not the end of implementation. Everyone needs to read them,
understand and implement in their routine works. Training the people
to adapt to the systems is very important. The management
representative is expected to arrange for training of users for the use
of documents and records.
We need a team of internal quality auditors to periodically audit the
systems through out the organization. Identifying the potential internal
quality auditors and arranging for their training is one of the
responsibilities of the management representative.
Internal quality audits should be effective and all auditors and auditee
should follow the requirements meticulously. Developing procedures
for internal quality audits and training the users for the
implementation is the responsibility of management representative.
Internal audits needs to be planned in advance and communicated to
the users for the effective implementation of the systems. It cannot
be a surprise audit as a quality control man does. Planning internal
quality audits and arranging for the audits is one of the prime
responsibilities of the management representative.
Closing the non-conformities without undue delay is the responsibility
of the auditee. However, it is seen in a number of cases that unless
the management representative is after the auditee and auditor, the
non-conformities are not attended and closed. Hence, following up
54
22.
23.
24.
25.
26.
27.
28.
29.
with the auditors and auditee for the timely closing of non-conformity
has become the responsibility of the management representative.
Due to various reasons, the auditee might not accept the nonconformity raised by an auditor (especially in the internal quality
audits). Sorting out the difference of opinions between auditors and
auditee relating to the non-conformities and the observations during
audits by referring to the standards is one of the responsibilities of
the management representative.
It is seen in a number of cases that the auditors fail to write the nonconformity notes precisely explaining the nature of the nonconformity and its potential effects and linking the observed nonconformity to the clauses of ISO 9001. Guiding the auditors in writing
the non-conformity notes and linking them to the guidelines given in
the standards has become one of the responsibilities of the
Conducting periodic review of the activities is the responsibility of
the top management. However, due to their varied nature of activities
and the changing priorities, they do not proactively conduct the
reviews. They expect that discussing with the top management and
arranging for periodic review as the responsibility of management
representative. Therefore, this activity becomes one of his regular
tasks.
Similar to internal quality audits, the external audits also are to be
done periodically. Liaising with the certifying body and top
management and getting audits done is the responsibility of
Normally the auditee, although capable, expects the management
representative to guide him in closing the non-conformity raised
during external audits. Following up for closing of non-conformities
in time becomes the responsibility of the management representative.
After the audits, getting the certificate and audit reports is very
essential. Following up with the certifying body in getting certificate
is one of the responsibilities of the management representative.
Educating all concerned in the organization regarding the certificate
and ensuring proper display of the same at prominent points also is
the responsibility of the management representative.
The responsibilities of the management representative include
maintaining the records of internal quality audits, management
review, external audits, auditors attendance and performance,
auditors training, trends in performance, follow up for the actions
decided in the management review and the correspondences relating
to the implementation of quality management systems.
55
30. Reporting the progress in the implementation in the quality

management systems to the top management from time to time is
one of the prime responsibilities of the management representative.
31. The management representative is expected to get information
proactively on the changes coming in the quality management systems
and alarming the people in the organization in time.
3.3
Tips for management representative
1. Help the people in preparing and documenting the procedures, but

do not prepare yourself.
2. Help the auditee to close the non-conformities by showing the path,
but do not prepare the documents yourself for closing the nonconformities.
3. The auditee is responsible for attending and getting the nonconformity closed in time and not you. You can only insist them to
attend.
4. Let the concerned HOD have the responsibility of reviewing and
approving the procedures. Do not take that on your shoulder.
5. You are representing the management, and hence, all your words
shall have a weight, for which top management is accountable. Hence
be careful while talking.
6. You are considered as a Guru for implementing the systems. Involve
yourself and understand the systems fully.
7. Management representative often referred as MR, mentally
retarded as he tries to improve the culture among the people and the
organization that have not felt its need. They feel that they are the
best and there are no ways to improve further, but this mad
management representative goes on insisting them to implement
systems and improve. He is mad, and he should be mad after
implementing the systems.
8. As a management representative, you are a key person for
implementing the quality management systems. You should command
the same respect as the top management.
9. The management representative cannot be an isolated person in the
organization, but a part of daily activities. Therefore, proactively
involve yourself in various activities of the company.
10. Understand your role and responsibilities, and be a role model in
implementing QMS in your routine activities.
56
Internal
quality audits
Effective implementation of quality
management
systems
4
Internal quality audits:
A strong tool for quality management
4.1
Need for audits
We might claim to have developed good procedures and systems and might
be following them religiously; however, we cannot forget that we are human
beings, have a tendency to relax and forget vital things unconsciously.
We, unlike machines, get tired and use our own logics while following
instructions or procedures and tend to bypass parts of system feeling it as
not essential. It also might be a fact, that a particular activity was really
not essential to get our results and meeting objectives without problems.
In a number of cases, we are unable to identify the inadvertent mistakes or
deviations while we are on the job, but can realize when others point it
out. It is essential that there is a system of monitoring.
A process can be monitored by various means, which include supervision
by the concerned supervisors, checking by quality control investigators,
review by heads of the department, online process monitoring by using
electronic devices, internal quality audits and audits by external agencies,
etc.
The quality audit (15) is defined as timely process or system inspection
to ensure that specifications conform to documented quality standards.
An audit also brings out discrepancies between the documented standards
and the standards followed and also might show how well or how badly
the documented standards support the processes currently followed [Ref:
Six Sigma Quality Dictionary].
As per ISO 9000 (16), the audit is a systematic, independent and
documented process for obtaining audit evidence (records, statements
of facts or other information which are relevant to audit criteria), and
evaluating it objectively to determine the extent to which audit criteria
(set of policies, procedures or requirements used as a reference) are
fulfilled. The book by Pradeep Kumar Mathur (4) on implementing ISO
9001:2000 defines quality audit as a systematic, independent and
documented process of examining any activity of an organization based
56
57
on objective evidence, to determine the extent to which quality activities

and related results comply with the planned arrangements, the extent
to which these arrangements have been implemented effectively, and
whether these arrangements are suitable to achieve the quality
objectives.
Periodic audits help us in identifying the deviations in systems,
procedures or quality, so that timely actions can be taken to rectify them.
It helps us in bringing back the systems to track and ensure quality and in
taking corrective actions to prevent recurrence of the problems or
deviations. Audits give a confidence to the management that the systems
and quality produced are as per the requirements.
In a production department the concerned supervisors and the heads of
the departments are responsible for both quality and productivity, where
as the quality control investigators are responsible only for quality. The
auditors of both internal and external shall only identify the deviations
and report, but are not responsible for getting corrective actions. The
auditors are responsible for verifying the corrective actions. The online
monitors are programmed electronic equipments, which monitor certain
parameters and cannot have their own thinking.
The production supervisors and the concerned departmental heads are
normally production oriented as their performance is measured by the
productions they achieve. Therefore, their priority becomes getting
production and pushing them further. They cannot spend time for going in
detail to the adherence to the systems and process parameters, unless
otherwise there is a problem in working. They feel that if the production
is coming as per expectations, the quality and process must be correct.
The quality control investigator otherwise goes in a different direction.
He checks some machine or process and notes down all the deviations. He
informs to the top boss highlighting the deviations. The grievance of the
production people is that the top boss normally fires the production people
for the deviations reported, but never sees how much good work is done
by them; on the contrary, the quality control man does not do any work
other than finding mistakes of production people who are already loaded
with different problems like production, labour handling, maintenance,
balancing of back process, maintaining house keeping, and so on.
Therefore, the quality control people are normally treated as enemies of
production people. In a number of companies, it is not tolerated if quality
control man is friendly with production people.
The latest concepts of quality management always insist on internal
quality audit rather than checking by fixed quality control auditors. Let us
discuss in detail regarding the concepts of internal quality audits.
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4.2
Internal quality audits are done by the people inside the organization, who
are normally engaged in different tasks like production, quality control,
maintenance, accounts, stores, human resource management, information
management, etc. They audit the process of different sections, other than
their own, as per the planned programme. The auditors are specially trained
with a skill of identifying the deviations. They are also trained for
highlighting the non-conformances without targeting the person working,
but as a deviation in the process or system being followed. They explain
the deviations and verify the corrective actions taken and report to the top
management.
Internal quality audits are not surprise checks as done by quality control
investigators, but are planned. They are planned well in advance and
informed to the auditee. In case of surprise checks, only a small area can
be checked, and in that some deviation if found may be highlighted. The
concerned persons correct the deviations highlighted. In this case we do
not know about the deviations in the areas not checked, which shall
continue to produce poor results. In case of internal quality audit, as the
information is given well in advance, the process is checked by the people
on spot thoroughly, and they themselves take corrective actions. What the
company needs is corrective actions in time and produce good results, and
not finding fault and taking action on some one.
The auditors are in-house people, and they know the company systems.
Hence while auditing they shall be keeping that point in view. As the
internal auditors conduct audits of different sections of an organization in
rotation, they get an idea of the complete systems in the organization.
Therefore, it helps the development of staff conducting audits in
understanding the complete systems and problems of the company. It helps
them when they are promoted to higher posts and they shall be able to
tackle the problems effectively. This system also wakens up the inner
morale of the auditors. When I see a deviation in some other department,
my mind works to find out whether I have a similar deviation in my section.
I shall try to attend it immediately, as I do not want someone raising nonconformity in my operations. So in one stroke we are correcting at two
places, with out making a hue and cry.
4.3
Quality control versus quality audits
The quality control and quality audit, although look similar, have number
of differences. A process can be monitored by various means, which include
supervision by the concerned supervisors, check by quality control
investigators, review by heads of the department, online process monitor
59
by using electronic devices, internal quality audits, and audits by external

agencies, etc. The concerned supervisors and the heads of the departments
are responsible for both quality and productivity, where as the quality
control investigators are responsible for checking the quality and reporting
suitably in time. The auditors of both internal and external shall identify
the deviations and report, but are not responsible for getting corrective
actions; however, they are responsible for verifying them. The online
monitors are programmed electronic equipments, which shall monitor
certain parameters only and cannot have their own thinking. Let us study
the definitions.
Control [As explained by Six Sigma Quality Dictionary] (15)
Statistical control process is one that is free of assignable/special causes
of variation. Such a condition is most often evidence on a control chart
which displays an absence of non-random variation. It is a technical
function in nature and a continuous process by which the expected results
are measured against predetermined criteria or standards. In case of
variances, a disciplinary action will be undertaken or improvement actions
will be pursued.
Quality control [As explained by Six Sigma Quality Dictionary] (15)
Quality control is the managerial process during which actual process
performance is evaluated and actions are taken on unusual performance.
It is a process to ensure whether a product meets predefined standards and
requisite action taken if the standards are not met. Quality control measures
both products and processes for conformance to quality requirements
(including both the specific requirements prescribed by the product
specification, and the more general requirements prescribed by quality
assurance). It identifies acceptable limits for significant quality attributes
and identifies whether products and processes fall within those limits or
falls outside them and reports accordingly. Correction of product failures
generally lies outside the ambit of quality control. Correction of process
failures may or may not be included.
Audit [As explained by Six Sigma Quality Dictionary] (15) A timely
process or system, inspection to ensure that specifications conform to
documented quality standards. An audit also brings out discrepancies
between the documented standards and the standards followed and also
might show how well or badly the documented standards support the
processes followed. Corrective, preventive and improvement actions should
be undertaken to mitigate the gap(s) between what is said (documented),
what is done and what is required to comply with the appropriate quality
standard. Audit is not only be used in accounting or something that relates
to mathematics but also used in information technology.
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4.4
Product audit versus system audit
The product audit consists of verifying the parameters of the product against
customer requirements; for e.g., in garments the fabrics feel, garment
dimensions, fittings, the trims used, the labels, etc. In case of deviations found
the materials are returned for rework. If rework is not possible or not feasible,
they shall be down graded. Depending on the lot size offered for inspection,
sample size is decided. The acceptance or rejection is decided referring to
AQL tables or as agreed between customer and the supplier. The product
audits do not verify whether the people are following the systems as required
to get the required quality. The system audits emphasize on following of the
systems in line with standards or documented procedures. If system is followed
religiously, the result is bound to come and assure quality.
In labour-oriented consumer product industry, both product audit and
system audits are followed regularly. The system audit is more important,
when it is a labour intensive industry, and the employee turnover is very
high. Recruitment, training and system audits are continuous processes.
The system audits verify not only the manufacturing activities but also the
management systems, adhering to legal and regulatory requirements, social
accountability, and welfare activities.
4.5
Top management review versus quality audits
The top management reviews the performance on a regular basis to

understand whether the activities are carried out as per the plan. They
base their reviews on certain control points and check points, which they
feel important. This is also called management by exception. The effectivity
depends on the capability of the top man. As the same person reviews the
activities, there are chances of bias getting developed, and might not be
able to see the deviations. In case of internal quality audits, different
auditors from different sections conduct audits, and hence their views are
different. They can identify certain vital deviations, which top man cannot
identify. The people working observe the top man on a regular basis and
identify his likings, disliking and expectations. Moreover, the review
frequency and the timings are almost fixed and people try to project only
those points which are liked by the top man. By this, some vital deviations
or drawbacks get camouflaged and go unnoticed. As auditors are unbiased
and outsiders, one cannot selectively hide the facts and hence the real
deviations are exposed. Actions can be initiated to correct the deviations.
The top man, by his involvement and experience, shall be clear about
the process and able to identify vital deviations faster. Auditor shall not be
able to identify inefficient procedures that are followed, where as an
experienced top man with deep knowledge of the process requirements
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questions the basis of the procedure adopted, and modifies them. An auditor
being an outsider cannot suggest any improvement, but can only say that
a deviation is found. He doesnt know whether the deviation found was
advantageous or disadvantageous. Table 4.1 gives few differences among
quality control, review by top man and internal quality auditing.
Table 4.1 Few differences among quality control, review by top man and internal
quality auditing.
Type of
monitoring
Quality control
checks
Review by top
man
Planned/Surprise
Surprise checks
Planned review
Planned audit
Action taken on
Deviations found
Deviations found
On all aspects in
advance, and
especially on
deviations found.
Relations
The production
person always
sees QC man as
a faultfinder, and
hence no team
work.
Top man is the

boss, and hence
people down the
line hesitate to
highlight the
mistakes in
instructions.
Free atmosphere as
auditor is a third
person, and does not
find only faults, but
shows the area for
improvement. Hence it
is teamwork.
Action starts
Action starts after

the deviation is
noticed.
Action starts after

the deviation is
noticed.
Actions start before

deviation is noticed.
What is reported
Mainly deviations
Both compliance
and deviations
Both compliance and

deviations
Career
development
No chances
Slight to the extent

the boss educates.
Self-learning while
auditing the systems
of other sections.
Improvement
chances at the
other end
Nil
Nil
Auditee improves his

own systems after
seeing good systems
at auditee place.
Anxiety
Anxiety prevails
as we do not
know what shall
be reported by
QC man to top
person.
No anxiety as the
boss tells clearly
his findings.
No anxiety as the
auditor discusses with
auditee while drafting
his report, and while
rising nonconformities.
Participation
Only by the incharges and the

QC investigator.
Only by boss and

the in-charges
By all working in the

section along with the
auditors and the boss.
4.6
Types of internal quality audits
The internal audits are of two types: adequacy audit and compliance audit.
The adequacy audit is to ensure that the procedures laid out cover all the
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aspects of the quality management, where as the compliance audit ensures

that the procedures laid out are followed religiously.
The adequacy audits for process and systems shall be done by the senior
officers of the concerned section, where as they can take the help of the
management representative of ISO 9000 to ensure proper linking to the
requirements of ISO 9000. In some industry, teams are made to audit the
system for adequacy, which can see the systems from different angles
because of their varied experiences. The teams such formed might include
senior officers, junior officers, officers from quality control as well as
production, senior workmen, etc.
The compliance audits are normally done by a third person from another
section or department. He shall first go through the procedures laid out
and verify the compliance to the laid out procedure. He shall have no
authority to judge and report a deviation as a better system, although it
gives better results. He shall only say that the system followed is different
from the system laid out. It is up to the auditee to change either the
documented procedures or to adhere to the documented procedures. One
can take the help of outsiders to do compliance audits if needed.
The internal audits for process may be decided for a particular part of
process and need not be for complete operations of a section, like checking
the systems of channelisation and colour codification, the system of new
product introduction, the system of changes to be made during product
changes, the system of training the workmen, the system of material
handling, the system of safety operations, maintenance systems, record
keeping and their utility, actions on complaints and feed back, etc. The
machine audit, the tools audit, the safety gadgets audit, the power
distribution system audit, the material handling equipments audits etc.,
are specialized audits done only by qualified and experienced technical
personnel, and not by others.
4.7
Pre-requirements of an auditor
Internal auditors are people from within the organization those have been
trained to conduct audits. The training can be done by the organization
itself if the expertise exists or by an expert body hired for the purpose.
There may be any number of internal auditors in a section. More the
auditors, it is always better.
The auditors shall not audit their own section except for internal
adequacy audits.
The auditing is not a fault-finding process but a fact-finding process. It
is not a crime if deviations are found. If we are not getting the results as
required, then we need to re-discuss as to whether follow the process as
documented or not. When we get the results, it is suggested to document
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the process as being followed. Our final aim is to achieve the results as a
result of following a judicious system and not getting a result by chance,
or in other words, by grace of someone like God. So the auditor shall
instigate the auditee to think and take the real corrective action for the
deviation found, and not just changing the documents to close the nonconformity rose.
The auditor is a friend and not an enemy. He comes to show the
deviations made by us so that we correct ourselves. Auditor is not supposed
to suggest corrective actions. However, in case of process management
relating to production operations done by a senior technical person of the
same organization, the advantage can be taken to improve the system.
The auditor finds the deviation as a deviation from the system and not
as a mistake done. A deviation in system can be due to improper
communication, improper understanding of the process or by some new
developments done recently for improvement that was not documented.
The auditor shall not target any person for highlighting the deviations.
He shall highlight the events where deviations were found, and can give
the name of the person as an example.
The auditor should verify the compliance by asking for evidences, like
production records, test results, demonstration of calibration, demonstration
of an activity, personally checking the speeds, setting, etc., visiting the
spot of actions being taken and the process going on, questioning the people
on the spot to understand the extent of understanding of the objectives,
targets, procedures and systems by the people working on the spot, the
display boards put in the department for giving various instructions, etc.
The auditor is not supposed to assume any thing, and he should record
only what he has verified.
The auditor should go with a proper checklist prepared after carefully
going through the procedures, work instructions, job descriptions, process
parameters, etc. He should identify the links between the processes and
procedures and verify the effects of non-compliance. This is called a linking
exercise. A change done at one place might affect the performance of other
section, and auditor is the person who can highlight that.
The auditor should be friendly with people and has no authority to fire
any of the auditee members, even though he is a junior person. His job is
to convince the other man regarding the deviation observed comparing to
what was planned.
The auditor is not a trouble shooting man, going with a mission of
identifying a root cause for a problem and implementing corrective actions.
His job ends only in identifying the deviations. If required, the company
can ask the auditor, after the audits are over, to become a member of trouble
shooting team to solve the problems found during audit, as a normal process
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of forming a cross-functional team for problem solving. This activity should

not be linked to auditing activity.
The auditor is supposed to give a written report of the findings, with
clarity on what was actually found and what was in the documents, how it
affects the systems and objectives. Therefore, the auditor should have good
knowledge of writing the reports in the language that can be understand
by the auditor. The auditee should write the cause for that deviation and
proposes corrective actions. Once the corrective actions are taken, the
non-conformity shall be closed.
The wordings used in the report given by an auditor should be simple,
easy to understand and give clear meaning of what the auditor found as a
deviation. Hence, writing the report is a highly skilled job, and the auditors
are to be suitably trained. The auditor should hence be a good
communicator.
4.8
What is to be verified?
The auditors need to plan and carry out internal audits based on the status
and importance of the area to be audited as well as the results of the previous
audit. The most important is ensuring objectivity and impartiality in the
audits carried out. The auditor should ensure that the actions taken after
audit are verified again.
In order to make the job easy, the auditor should prepare a questionnaire
before starting an audit and prioritize the questions in order to save his as
well as the auditees time. This depends on the purpose of audit.
In case of adequacy audits, the questions are prepared to verify whether
a particular aspect is addressed effectively or not. These are done mainly
for the formats designed for various purposes in process monitoring, the
flow chart and the procedures, the work instructions and process
parameters. For example, a questionnaire designed to verify a form for
sort change on loom in a textile mill could be as follows.
Table 4.2 Questionnaire for sort change
Question
Status
Whether the sort number is allotted?

Whether the material and count details are covered?
Whether the construction details are given?
Whether the loom speed is specified?
Whether the set lengths are specified?
Whether the reed type is defined?
Whether the fabric specifications are defined?
Whether the selvedge construction specified?
Whether starting and end time of loom gaiting mentioned?
Whether customer feed back indicated?
Yes
Yes
Yes
No. left to the weaver
Yes
No. Left to the weaver
Only construction.
No. Left to the weaver
Yes
Yes
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The technicians can prepare their own questionnaire or a checklist

depending on the importance of the activity. Following are some of the
guidelines.
4.8.1
General
1. Understand the activities carried out in the auditee section, and link
it to the main process of the company.
2. Find out the importance of the activity in achieving the company
goals.
3. Verify whether any targets are set for the goals.
4. Find out how the auditee is monitoring the activity.
5. Check for the evidence for monitoring.
6. Find out whether the procedure for doing and monitoring the activities
are documented.
7. Verify how the objectives stated in the procedures have been linked
to the targets set.
8. Verify whether the objectives specified for each procedure are
measurable or not.
9. Enquire how the procedure written is helping in achieving the targets
set.
10. Verify whether the people performing the job have understood the
procedures documented.
11. Check whether the resources required are adequately documented.
12. Verify the process of getting the resources for performing the job.
13. Verify whether the applicable legal, regulatory and statutory
requirements are identified and documented.
14. Verify the legal and regulatory requirements section wise that are to
be fulfilled.
15. Check whether the people performing are clear about the legal and
regulatory aspects that they need to fulfil.
16. Verify the records identified by the section.
17. Verify whether the records cover all the activities of the section or not.
18. Verify how the records are used in taking decisions.
19. Whether the records identified cover all the objectives spelled out?
20. Whether the records are maintained properly to have easy retrieval?
21. Verify whether the records are controlled and protected from getting
damaged.
22. Verify whether the life and disposal of records are determined and
followed.
23. Verify whether the people are aware of their authorities and
responsibilities.
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24. Verify how the authorities and responsibilities determined help in

achieving company goals?
25. Whether the people are aware of the complaints and feed backs from
internal and external customers?
26. Verify the actions initiated considering the feedback and complaints.
27. Find out whether the actions taken are documented and relevant
procedures amended to prevent the problem from recurring.
28. Verify how the customer (internal/external) gets reaction for the
feedback/complaint.
29. Verify the activities reviewed periodically and their frequency.
30. Verify the actions taken on the review out puts.
31. Verify whether the actions taken gave the required results.
32. Where the required results are not achieved, verify the process
adopted to rectify the same.
4.8.2
Top management
1. Verify whether the purpose (mission), vision, quality policy and

quality objectives are defined.
2. Verify the linkages between the various statements made by top
management, viz, mission, vision, quality policy, quality objectives,
departmental objectives, company concerns and the policy decisions
taken from time to time.
3. Verify the organization structure defined and compare with the actual.
4. Verify the involvement of top management in communicating down
the line the importance of meeting legal and regulatory requirements.
5. Verify the involvement of top management in monitoring the
compliance to legal and regulatory requirements.
6. Verify the regularity of conducting reviews and follow up actions on
the review out puts.
7. Verify whether the inputs for management review meet the minimum
requirements for quality management systems.
8. Verify whether the reviews are effective and helping in achieving
continuous improvement in process, system, product and customer
related results.
9. Verify the process of deploying the policies down the line by the top
management.
10. Verify whether the people down the line have understood the policies.
11. Verify the system of reviewing for adherence to legal and regulatory
requirements.
12. Verify whether the potential problems in meeting the regulatory
requirements are identified and suitable remedial actions taken.
67
13. Verify the system of communications for conveying the importance

of meeting customer and regulatory requirements down the line.
14. Verify the involvement of top management in planning the quality
management systems.
15. Verify the resources identified as required for enhancing quality
systems.
16. Verify the system of reviewing the resource requirements in order to
enhance customer satisfaction, achieving company objectives and
for improving quality management systems.
17. Verify the involvement of top management in providing/maintaining
human related work environment.
18. Verify whether the management representative is adequately trained
to implement the systems.
19. Verify whether the management representative is updating self
regarding the changes in the quality management systems and
applicable standards
20. Verify whether the internal quality auditors are adequately trained.
21. Verify whether the trainers were competent.
22. Verify whether the internal quality audits were done as scheduled.
23. Verify the actions taken on the findings of internal quality audits and
their effectivity.
24. Verify whether the actions are taken without undue delay for closing
the nonconformities raised during audits or quality control checking.
25. Whether the results of internal quality audits show a trend of
continuous improvement?
26. Verify the system of identifying potential problems and taking
remedial actions.
27. Verify the system of getting involvement of people in improvement
activities.
4.8.3
Production
1. Verify the system of planning the processes needed for product

realization.
2. Verify the linkage of the system of planning for product realization
to the adopted quality management system.
3. Verify whether quality plans are available for all the products being
manufactured.
4. Verify whether quality objectives are defined for each product being
worked.
5. Verify whether the customer requirements are clear to the people in
production line.
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6. Verify whether any minimum information requirements are worked

out to assess the customer needs and to help translating them to
production parameters.
7. Whether the process capability is worked out for the production
process to ensure meeting the customer requirements?
8. Verify the production activities as on date and their relevance to the
quality plan.
9. Whether the products to be manufactured are adequately designed to
meet the customer requirements?
10. Whether the product quality objectives are translated into product
specifications?
11. Whether the resources specific to the product are prepared?
12. Whether the required verification, validation, monitoring, inspection
and test activities specific to the product are worked out and
documented?
13. Verify whether the required verification, validation, monitoring,
inspection and test activities for each product are conveyed to the
people on the spot responsible for production.
14. Whether the authorities and responsibilities are determined for the
design and development activities during planning for the product
realization?
15. Whether a system exists for interface between the different groups
involved in design and development of the product?
16. How the planning of designs ensure effective communication during
design and development of the product?
17. Verify the system in force for ensuring the inputs for design are
adequately defined and documented.
18. Verify whether the functional and performance requirements of the
product are considered as a part of the input requirement or not.
19. Verify whether the applicable statutory and regulatory requirements
are considered as a part of the design input requirements or not.
20. Whether all the determined design inputs are reviewed for its
adequacy?
21. Is it ensured that the design requirements are complete, unambiguous
and not in conflict with each other?
22. Are the outputs of design and development provided in a form
enabling verification against the design and development inputs?
23. Whether the designs are reviewed to ensure trouble free working?
24. Whether the designs are verified by competent authorities to ensure
that the product meets the required quality objectives?
25. Whether the designs are validated to ensure that the product meets
the requirements?
69
26. Verify whether the design out put meet the design input requirements
or not.
27. Whether the design changes are properly recorded?
28. Verify whether the designs of the products are controlled effectively
or not.
29. Verify the process parameters adopted and compare with those derived
by the design process.
30. Whether any special processes exist in the production line, where
the results can be known only after the work is complete?
31. Whether the special processes are identified or not?
32. In case of special processes, whether the process is validated to ensure
the requirements are met?
33. Does the validation demonstrate the ability of these processes to
achieve planned results?
34. Whether any control points and check points are prepared for the
process being followed?
35. Verify whether the working conditions like temperature, humidity,
noise level, light, dust level, etc., are maintained as appropriate to
the process.
36. Verify whether the men employed are having adequate knowledge
and skills required for the job.
37. Verify the safety precautions that are followed in relation to the safety
requirements.
38. Verify the system adopted for identification and traceability of
materials in relation to the systems documented.
39. Verify whether the status of the product is displayed based on
monitoring and measurement requirements.
40. Look for the monitoring systems available on the production
equipments, and their utilization in process monitoring.
41. Is the monitoring and measuring device that has been devised and
implemented are capable of providing evidence of conformity of
product to determined requirements?
42. Does the monitoring and measuring are in a manner that is consistent
with the monitoring and measuring equipment?
43. Check whether the validity of results measured previously are
revalidated when equipment is found non-conforming to the
requirements.
44. Check the material handling systems adopted and their suitability
for the materials being handled.
45. Inspect the material storage place and verify in relation to norms
considering the safety and quality.
46. Verify the maintenance systems adopted and compare with
documented system.
70
47. Verify whether the maintenance activities gave the results as

anticipated or not.
48. Whether any auditing is done for maintenance system to ensure its
effectiveness?
49. Whether any records are available to study the trend of continuous
improvement in maintenance activities and results as a result of good
maintenance in quality, production etc.?
50. Whether the materials being produced are checked at different levels
as decided in quality planning?
51. Whether the equipments used for testing and monitoring are calibrated
and ensured for reliability and accuracy, and are traceable to national
or international standards?
52. Whether the maintenance of testing instruments done to ensure the
accuracy of the readings?
53. Whether there are any material supplied by customers to be
incorporated in the product being produced?
54. Whether proper accounts are maintained to monitor the customer
supplied products?
55. Whether any person is designated to monitor and communicate
relating to customer supplied products?
56. Whether adequate care is taken to prevent materials from damages
during handling, storage and transporting?
57. Whether material handling equipments are maintained periodically
to ensure their quality?
58. Whether places are demarked for keeping non-conforming products?
59. What measures are taken to monitor the process?
60. Whether process monitoring is done as per the planned programme?
61. Whether any norms are given to the process monitoring personnel
for monitoring?
62. Whether the persons monitoring the processes have the knowledge
as to why they are maintaining those process-monitoring norms?
63. How the non-conforming materials are being dispatched?
64. Whether any structured system is available to take corrective actions
for non-conforming process and products?
65. What data are collected for daily monitoring of the process?
66. How the data collected are utilized?
67. Whether the auditee can demonstrate continuous improvement in the
process and product quality?
68. Whether any systems exist to proactively look into the problems and
take preventive actions?
4.8.4
71
Human resource management
1. Verify whether the human resource requirements are planned.

2. Verify the method adopted for planning the human resources.
3. Verify how the human resource planned is linked to company
objectives and goals.
4. Whether the objectives of HRD for the process being audited are
specified?
5. Whether the HRD objectives are achieved as committed?
6. Verify the actions initiated where the objectives are not fulfilled.
7. Whether the actions taken are evaluated to ensure that they gave the
results?
8. Whether minimum competency requirements are spelled out for the
jobs being handled?
9. Whether the competency levels of the person engaged meet the
minimum requirements specified?
10. Whether records are available for monitoring the competency levels
of persons and the job requirements with the concerned process
owner?
11. In case the competency levels are not up to the requirements, what
actions are taken to correct it?
12. How the actions taken are evaluated?
13. Verify whether the people working are aware of the relevance and
importance of their work in achieving the quality objectives of the
product and also the company objectives.
14. Whether the work environment required for the process are defined
and documented?
15. What processes are adopted to maintain the work environment to
uplift the morale of the employees?
16. Whether the critical processes like taking disciplinary action,
recruitment and promotion etc., have defined procedures?
17. Whether the training needs are identified for critical persons?
18. Verify the method of imparting the training and evaluation of its
effectivity.
19. Whether the persons giving training are adequately qualified to give
training?
20. Verify whether the training needs identified is logical to bridge the
gap in the competency level.
21. Whether the persons working are clear about the legal and regulatory
requirements?
22. How the auditee section of the process ensures that the legal and
regulatory requirements are met?
23. Verify the evidence of meeting regulatory requirements.
72
24. Verify the system of analysing data related to accidents, fires,

absenteeism, indiscipline reported, grievances, unrest, strike etc., and
the results of actions taken.
25. Verify the system of planning welfare activities, and prioritizing the
activities.
26. Verify the system of evaluating the effects of welfare activities
undertaken.
4.8.5
Maintenance activities
1. Verify the system of planning the maintenance activities.

2. Verify how the maintenance activities planned help fulfilling the
company objectives.
3. Verify whether the tools being used for various activities are suitable
for the purpose.
4. Whether the workmen are clear about the tools to be used for various
works?
5. Whether the maintenance gadgets are adequately calibrated to ensure
accuracy and reliability?
6. Whether the workmen are adequately trained to handle the
equipments?
7. Whether safety precautions to be taken are known to workmen?
8. Verify the safety precautions taken while working.
9. Verify the objectives of the maintenance section and their relevance
to company objectives.
10. Verify the action plans developed for meeting the maintenance
objectives and targets.
11. Verify the method of monitoring the maintenance activities.
12. Verify the results of maintenance activities in terms of reduced
breakdowns, reduced machine downtime due to breakdown, improved
quality of the products, reduced power consumption and costs.
13. Verify the system of maintaining safety equipments including fire
fighting, ambulance and safety gadgets provided on machines, safety
alleys, etc.
14. Verify the systems for maintenance of civil works, water supply,
power supply, water purification, boiler, effluent treatment and
sanitation systems.
15. Verify the methods followed for waste disposals.
4.8.6
Marketing
1. Verify the process of getting the customer requirements and

communicating to production and service operations.
73
2. Verify the system of segmenting the markets and products, and for
targeting the customers before approaching them for offering the
products.
3. Verify whether any requirement is given by the production/service
department as minimum information to be collected from customer
while deciding on the customer requirements.
4. What is the system adopted to determine the customer requirements
when the customer has not given documented requirements?
5. Whether the product requirements worked out by the mills are
communicated to customers and their approval taken prior to
acceptance of order?
6. Verify the communication systems for dealing with customer.
7. Verify whether the communication systems followed with customers
cover the product information, enquires, contracts or order handling,
amendments to contracts, customer feed backs and customer
complaints.
8. Verify the training needs identified for the customer contact
personnel.
9. Verify whether the training is imparted effectively.
10. Verify whether the contracts or orders differing from those previously
expressed and accepted are resolved.
11. Whether records are maintained for the reviews done for each contract
and their results?
12. Verify whether the contracts entered have been reviewed to ensure
taking care of company capability for supplying the product.
13. Verify how the customer perception as to whether the product and
services met their requirements is gathered.
14. How the customers perception data and feedback are analysed to
take suitable action to enhance customer satisfaction?
15. Verify whether all the requirements of customers are documented in
the contracts or not.
16. Verify the method of ensuring that all the requirements of the
customers are covered in the contract.
17. Verify whether the legal requirements relating to products and trade
applicable are identified and communicated to the personnel
responsible to fulfill.
18. Verify the system of communicating the customer requirements,
including the amendments in time to concerned personnel at
production area, viz, production planning, manufacturing and quality
assurance, packing of final products, despatch, costing and training
sections.
19. Verify the system of following up to ensure that the customers get
the materials and services as specified by them.
74
20. Whether any defined procedure is there to collect the dues from
customer in time for the materials supplied to them?
21. Verify the system of getting customer feedback/complaints, and
communicating the information to concerned production personnel
and back to customers.
22. Verify the system of deciding on the prices and other terms and
conditions of marketing while entering a contract.
23. Verify the system of reviewing marketing performance.
24. Verify whether the system adopted to review marketing performance
has helped in achieving continuous improvements.
4.8.7
Purchases and stores including outsourcing
1. Verify the system of getting requirement from the users for various
materials to be procured.
2. Verify the system of ensuring that the users have given the complete
description of the materials required to ensure procurement of correct
material.
3. Verify the system of identifying the appropriate supplier for various
materials being procured.
4. Verify the system of grouping the materials and suppliers in order to
have effective purchase management.
5. Verify the system of evaluating the suppliers to ensure their suitability
for supply.
6. Verify whether there exists a formal periodic vendor rating system.
7. Verify the factors and weightage for various materials considered
for supplier evaluation and the logic behind it.
8. Verify whether the description given by users is promptly forwarded
to suppliers.
9. Verify the system of informing suppliers on their supply performance
to enhance supply services.
10. Verify the system of ensuring the statutory requirements are met in
purchase activities.
11. Verify the system of following up with suppliers for timely supplies.
12. Verify whether the acceptance criteria and the method of inspection
are made clear to the supplier.
13. Verify the system adopted for identifying the received items and their
inspection and storing.
14. Verify whether the persons involved in inspection of received
materials are adequately trained and equipped.
15. Verify whether the system of storing is suitable for the type of material
being stored to prevent any damage or deterioration during storage.
75
16. Verify the system of issuing materials to users while ensuring only
approved materials are issued.
17. Verify the methods adopted for effective traceability of supplies and
suppliers.
18. Verify whether any system exists for visiting suppliers for inspection
evaluation. In such cases whether the suppliers are informed suitably
the purpose of visit.
19. Whether any material is given to suppliers for conversion or
incorporation in the product being procured. In such cases, what
system is followed to ensure that the same materials are being used
and accounted properly?
20. Verify the system of covering the risk while materials are in transit
or in stores.
21. Verify the system of ensuring that the materials in stock maintain the
properties similar to that of while receiving.
22. In case of materials likely to lose their salient features over a period
of time, verify how the shelf-life is determined and the deliveries
monitored.
23. Verify the system of informing accounts section relating to the
materials received and approved.
24. Verify the system of informing the users relating to the delivery
positions of the materials ordered.
25. Verify the system of monitoring the stock levels of regular moving
items in order to have smooth working.
26. Verify the system of actions taken for non-moving items and rejected
items.
27. Verify the system of stocktaking and their valuation.
4.8.8
Despatches
1. Verify the system of receiving and storing the materials at warehouse

ready for despatch.
2. Verify whether applicable regulatory requirements are identified and
listed and system exists for proactive monitoring.
3. Verify the system of identifying the materials in warehouse.
4. Verify the storage system adopted to ensure that the materials are
prevented from damages.
5. Verify the system of storage of flammable and/or hazardous items
like chemicals, petrol, diesel, etc., before despatch.
6. Whether any system exists to ensure that the material in stock has
not deteriorated during storing for a long time?
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7. Verify the system of handling the materials while loading and

unloading to ensure that the materials are not damaged.
8. Verify the system of identifying the rejected materials in warehouse.
9. Verify the procedure for engaging the transporters for shipment of
materials to customers.
10. Verify the system of preparing the dispatch documents and compare
with the legal and contractual requirements.
11. Verify the system of preparation of invoice and compare with the
contractual requirements.
12. Verify the system of stock updating and valuation.
13. Verify the actions taken on the deviations found during stock
verification.
14. Verify the safety measures taken in warehouse and during transit.
4.8.9
Information management
1. Verify the system of identifying the information required for decisionmaking in the process adopted.
2. Verify how the data source is identified to get the required
information.
3. Verify the system of data integration and information generation.
4. Verify how the reliability of data is ensured.
5. Verify the system of data control to ensure that data are made available
to concerned only.
6. Verify the system of data accessibility for the users.
7. Verify the system of reviewing the information generation and utility.
8. Verify the systems of maintenance of IT equipments and software.
9. Verify the system of validation of software for reliability.
10. Verify the system of educating users for use of data integration and
information generation activities.
4.8.10 Quality assurance

1. Whether the criteria for acceptance for the products under
manufacture are determined and conveyed to all concerned in
production, quality assurance and marketing?
2. Verify the system of identifying the parameters to assess the product
and process conformity.
3. Verify the linkage of parameters identified for assessing product and
process conformity to the product quality objectives.
4. Whether records needed to provide evidence that the product
realization process meet requirements are available?
77
5. Whether records are available to provide evidence that the resulting

products from the process adopted for product realization meet the
product requirements?
6. Whether the customer requirements are reviewed prior to committing
to customers?
7. Verify the system of determination of sample size for ensuring
reliability of the test results.
8. Verify the system of ensuring reliability of test data.
9. Verify the quickness in getting and conveying test results and other
data to the users for taking suitable action.
10. Verify the system of maintenance and calibration of measuring and
monitoring equipments.
11. Verify the system of compiling test data and informing the concerned
to take timely action.
12. Verify the system of arriving at acceptance criteria for various product
and process quality.
13. Verify the system of approving materials for despatch to further
process.
14. Verify the system of follow up for disposal/correction of nonconforming products.
15. Verify the system of analysis of process deviations.
16. Verify the system of analysing customer complaints and feedback.
17. Verify the actions taken basing on customer feedback to prevent
market complaints.
18. Verify whether the complaint and feedback redressing are documented
suitably in procedures, instructions, and records are maintained
appropriately.
19. Verify the actions taken on market complaints and feed backs and
the changes in procedures, instructions, product specifications or
process parameter as required.
20. Verify the system of educating the concerned for on-line quality
monitoring and assurance.
4.8.11 Capital investments (Projects)

1. Verify the system of identifying and justifying the capital investments
required for improving the process efficiency and to enhance customer
satisfaction.
2. Verify the system of identifying the infrastructure requirement to
achieve the product conformity to requirements.
3. Verify the system of prioritising and allotting funds for capital
expenses.
78
4. Verify the system of identifying and grouping the investments as short

term, medium term and long term.
5. Verify the system of deciding on the technology, equipments and the
manufacturers.
6. Verify whether the equipment manufacturers are evaluated for their
performance in providing equipments and services.
7. Verify the system of educating and training the users for using the
new technology and equipments.
8. Verify the system of planning the installation of equipments.
9. Verify whether the applicable legal and regulatory requirements are
identified and provisions made to fulfil them.
10. Verify the system of addressing safety and pollution control aspects
in the projects.
11. Verify whether the system for evaluation and selection of contractors
for implementation of project works.
12. Verify the system of implementation of projects, viz. Installation and
commissioning of projects.
13. Verify the system of evaluation of project for its effectiveness.
14. Verify the system of presenting the project reports for top management
for review.
4.8.12 Finance and accounts

1. Verify the system of planning finance requirements for the processes
identified.
2. Verify the system of prioritizing the finance allocations.
3. Verify the system of users giving their requirements of resources for
allotting finance.
4. Verify the system on deciding the source of finance.
5. Verify the system of evaluation of finance providers so as to select
the one suitable for the circumstance.
6. Verify the system of following and collecting the dues so as to provide
finance for the required expenses.
7. Verify the system of following up for the payments made and to be
made.
8. Verify the system of accounting incomes and expenditures.
9. Verify the system of getting data from various functions for working
out the costs and budgets.
10. Verify the system of verifying the data obtained from various sources
for costing and accounting for their accuracy and reliability.
11. Verify the system of presenting data for top management for review.
12. Verify the system of identifying the applicable legal and regulatory
requirements and proactively acting to fulfill them.
79
13. Verify the system of handling cash and assuring security for the
persons handling cash.
4.8.13 Security
1. Verify the system of checking the incoming vehicles and the materials.
2. Verify the method of checking the incoming men and their belongings.
3. Verify the system of checking the out going vehicles, men and
materials.
4. Verify the system of checking the documents and signatures on
documents and gate passes.
5. Verify the system followed for security in final packing area.
6. Verify the system of security patrols.
7. Verify the training provided for the security personnel.
8. Verify the method of selecting security service providers and the
security personnel.
9. Verify the system of monitoring the fire extinguishers, fire hoses
and the condition of fire fighting equipments.
10. Verify the system of maintenance of weapons and security tools.
4.9
Can we discontinue quality control

investigation?
From the discussions we had till date, we can conclude that the internal
quality audit is a strong tool for monitoring the process. It does not mean
that we should discontinue with routine quality control checks or reviews.
Internal quality auditing should be an additional activity, as it shall bring
involvement of people for taking proactive corrective and preventive
actions. Also the expertise of internal auditors is different compared to
the expertise of quality control investigators. Where analysis of a specific
technical problem and trouble shooting is to be done, the quality control
investigators shall be more helpful. They shall concentrate on one area
and spend more time, and view the problem with different angles. They
shall be able to do root cause analysis, where as an internal quality auditor
can only identify that there is a deviation, but cannot identify the root
cause.
The quality control investigator is a specialist trained in a particular
area, and has always has the market complaints and feed back in the back
of his/her mind, and hence shall concentrate from the point of view of
customer. The internal quality auditor concentrates only on adhering to
systems as documented, and cannot visualize the necessity for change in
a system from his angle. The quality control investigator goes beyond the
set procedures, and insists a change in system to avoid market complaints
80
by looking into to potential problems. However, by systematically following

the internal quality audit systems, some of the checks done by quality
control investigators might be dispensed, which depends on the technology
adopted, the product features, the market for which the products are
supplied and the customers critical requirements.
A proper balancing of the activities of quality investigators, internal
auditors and the reviews by concerned senior officers together gives the
results as expected.
4.10
Process audits
Normally, internal quality audits are done department wise, as an auditor

cannot audit his own section. By this it is difficult to understand whether
the interaction between sections is congenial for the success of a process.
Process audit is a strong tool for understanding the process flow, whether
all the activities are done as per requirement, and more over, whether the
inter departmental communications, interactions are going with the process
requirement. Let us see how a process audit can be done.
Steps to do the process audit of a particular purchase order:
1. Go to marketing department and select a consignment which was
dispatched recently.
2. Note down the following details:
(a) Purchase order received from customer and date
(b) Customer
(c) The product description
(d) The committed date of despatch as per contract
(e) Actual date of despatch
(f) Quantity expected to be dispatched
(g) Actual quantity dispatched
(h) Whether customers consent is taken for variation in quantity
and the difference in despatch date?
(i) Whether any analysis is done for this discrepancy?
(j) What was the finding and whether any action is initiated?
3. Verify the method of informing the concerned in the purchase,
production and PPC (Production Planning and Control) sections
regarding the order requirement.
(a) Whether all the requirements are communicated?
(b) Whether the requirements communicated is documented by the
actual implementer or service provider?
4. Verify the minutes of order clarity meeting (Meeting before execution
of an order to understand the requirements of the order) for this
consignment.
5.
6.
7.
8.
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(a) Decision on the quality and quantity of raw material.

(b) Decision on the accessories to be procured.
(c) Decision on the quality checking issues.
(d) Decision on the production lines to be utilized.
(e) Decision on the date of starting of first operation.
(f) Decision on outhouse activities and their control.
Note down the responsibility and commitment of different sections
for this consignment.
(a) For deciding and placing orders for raw material.
(b) For deciding the accessories and giving indent for purchases.
(c) For preparing the samples and submitting for approval stages,
numbers and dates.
(d) For preparing pattern/dies and markers.
(e) For sending the materials for value adding processes and their
receipt after the work is done.
Check for the working out of requirements for raw materials and
other accessory required for this consignment:
(a) The raw material specifications
(b) The product realization (Percent of raw material getting turned
out as the final product) assumed and the basis for assumption
(c) Specific accessories required for this consignment quantity,
quality specifications.
(d) The outhouse activities, the selection of vendors and getting
the work done.
Verify whether costing is approved from costing section for the
activities.
(a) Costing for raw material procurement
(b) Costing for accessories procurement.
(c) Costing for out house activities.
(d) Costing for production activities.
Verify the following in the purchase order for raw material:
(a) The purchase order and date.
(b) The supplier; verify whether the supplier is in approved list.
(c) Quantity ordered.
(d) Delivery schedule demanded.
(e) Actual date of receipt of materials.
(f) Inspection report of incoming fabric quality.
(g) Remarks written by the incoming material inspector.
(h) Verify the action taken on the inspection report.
(i) Verify the quantity ordered and quantity received.
(j) Verify the records of materials sent to warehouse for issue to
production.
(k) Verify the requisitions from production for this consignment.
82
9. Verify the following in the purchase orders for accessories:

(a) The specification of accessories.
(b) The quantity ordered for each of the accessory.
(c) Date of ordering accessory wise.
(d) The specified delivery date accessory wise.
(e) Actual date of receipt accessory wise.
(f) Follow up action for late receipts.
(g) The normal lead time, minimum and maximum for each of the
accessory for last one year.
(h) The lead time assumed/negotiated while placing order.
(i) Quality inspections specified.
(j) Quality inspections done and their remarks.
(k) Actions taken on the remarks of quality checking.
10. Verify the production planning activities as follows:
(a) Data of production rate for the type of product in the order.
(b) The efficiency assumed and the logics for efficiency
assumption.
(c) The basis for deciding the number of lines and dates allocated
for this consignment.
(d) Manufacturing charges and its relation to tech pack
(Specifications given by the customer) for this consignment.
(e) Number of lines loaded, and the plant utilization considered
for the period.
(f) Actual efficiency achieved against the planned in this
consignment.
(g) Logics for assuming efficiency and utilization.
(h) Analysis made for deviation in efficiency.
(i) Action taken for the deviation in efficiency.
11. Verify the following in the production process:
(a) Date on which the production plan was given for production
for this order.
(b) The tables/machines/lines allotted for this order.
(c) Production records.
(d) Efficiency achieved against planned.
(e) Wastes generated vs. the projected wastes.
(f) Quality reports of the activities.
(g) Actions taken on deviations in production and utilization losses.
(h) The quantity produced against the quantity to be produced as
per purchase order.
(i) Verify the identifications put to identify the process.
12. Verify the following in finishing process
(a) Packing planned and actually packed.
(b) Quality check reports of finishing.
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(c)
13.
14.
15.
16.
Verify the identification made for tracing the production

process.
Quality assurance and audits
(a) Check the inspections made in line for this consignment and
compare with the purchase order requirements.
(b) Verify the final product inspection (Final Statistical Audit)
report, and the remarks.
(c) Verify when the final audit was done and when the material
was dispatched.
(d) Check the analysis made for defects and the actions.
(e) Check the details of laboratory tests if any relating to this
consignment.
(f) Verify the status of calibration of equipments used during the
manufacture of this consignment.
(g) Verifications done for the outhouse activities.
(h) Actions taken for the deviation found in out house activities.
Check the following in maintenance:
(a) The machines which failed during the manufacturing of this
consignment.
(b) The reasons for machine failures. Has it any link with the
products?
(c) What actions are taken to prevent failures?
(d) Verify the online performance reports for this consignment.
Verify the following at costing:
(a) Whether the deviation in production efficiency is considered
in costing, and actions taken?
(b) Whether the variance in packing cost and cost of accessories
are updated for this consignment.
(c) Whether any alarm was given to top management for the
deviation in costs?
Verify the following from HRD:
(a) Who were the people working on different lines/machines/
tables for this consignment?
(b) Whether all the operators were trained as per the need of the
material?
(c) Whether the critical requirements of this consignment were
explained to the operators before starting productions?
4.11
Imperatives of effective audit
To have an effective audit, the involvement of auditee is very important. The

head of the department of auditee section should take lead and invite the
auditor to conduct the audits and ensure that all his subordinates participate
84
actively in the audits. He should encourage people to give prompt answers

and show the records and documents as required. One should always remember
that the audits are for the benefit the auditee, and the auditee is responsible
for getting the audits conducted at his place and taking timely actions.
Audits should be planned in advance, and the dates and times are to be
mutually agreed between auditor and auditee. However, the audits are not
supposed to go on getting postponed with the excuse of either Auditee is
busy or Auditor is busy. Audit should be conducted with in the time
frame allotted.
The auditing has a number of stages as information gathering, preparation
including adequacy auditing, opening meeting, auditing and report
preparation, closing meeting, attending the non-conformities and closing of
the non-conformities. The information gathering includes understanding of
size, complexity and scope of the area being audited, the standards against
which the audits are conducted, and the activities. The auditor should
carefully read the manuals and procedures, and understand the system being
followed. A checklist needs to be prepared so that all relevant points are
verified, and in the process, time is not wasted. Audit should start with a
formal meeting with the head of the department in his office, where the
members of the auditors are introduced to auditee, and the scope of auditing
is explained. The leader of the auditee team should provide necessary support
to the auditors for conducting audits, like providing disturbance-free place
to sit and verify the documents, conducting audits, writing reports, etc.
During the audits, the auditee should ensure that disturbances are not there
because of phone calls, subordinates coming and asking for clarifications,
the bosses calling and asking some reports or information, etc. The role of
top management is very important, and they should have the basic discipline
of not disturbing the people who are doing audits or getting audited. The
top management must insist that the audits are conducted as per the agreed
plan, and ask for explanations for not conducting audits in time. During
audits, the auditor should ensure that entire scope of audit is covered, clear
and precise discrepancy reports are raised based on sound objective evidence,
and the auditee is explained of the deviations. The auditee should understand
the root cause of the deviation and make sincere attempt to eliminate the
cause and avoid recurrence of the deviation. Just doing something and getting
the non-conformity closed will not help the organization in improving the
quality, but deteriorates the systems and controls. Top management must
insist on root cause analysis and taking effective corrective actions, and not
just be happy for closing the non-conformities. Rather than closing the nonconformities, the process adopted in identifying the root cause, explaining
all concerned about the cause of the deviation, taking corrective actions and
educating the concerned to work with improved system to avoid the
recurrence of the non-conformity is more important.
85
Auditing is a very useful tool for continual improvement provided we

take it seriously, document them properly and refer again and again.
Records are not just meant for showing to auditors but for us to refer and
improve. Auditor is a catalyst for improvement provided we are sincere in
our efforts and value the auditing system.
4.12
Linking exercises a strong tool for quality

auditing
Audit programme are planned considering the status and importance of

the process and areas to be audited. The management responsible for the
area being audited ensures that actions are taken without delay to eliminate
detected non-conformities and their causes, which leads the company for
continual improvement. The role of an auditor is very important in this
process. The auditor is required to identify the non-conformities that are
hindrance to the performance of the organization, communicate it in a
convincing way to the auditee in order to help taking corrective actions.
The auditor needs to understand the systems by referring various manuals
and documents, and confirm the conformance. Only by referring what is
documented and verifying for its conformity might not identify the pits
and potential problems. Linking exercises explained here can help the
auditor to effectively identify the loopholes in the systems.
Organizations have a number of activities. The activities are normally
interlinked. The decisions taken or the modifications done at one place, will
affect at some other place. Normally, when systems are started afresh,
considerable care would have been taken to integrate the systems. Because of
changes in the situations and developments taking place at different spheres,
amendments are made in the procedures. The amendments normally are done
to overcome some problems or shortcomings at some place; where as, its
after effects or the effects at other places are not worked out in detail. Also in
a number of cases, the activities and developments are not considered at other
places. We base our decisions and actions on our own experience. We will not
know where we are and get lost. We need to understand the relations and
links to ensure that systems do not affect elsewhere and are implemented
fully. The activities to understand the links are termed as linking exercises.
4.12.1 Use management tools

Seven management tools were identified by Shigeru Mizuno in 1989 to help
taking decisions. A careful understanding of these tools can help us identify
the links between systems and processes. The seven tools are as follows.
Affinity diagram
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Relation diagram
Tree diagram
Matrix data analysis
Matrix diagram
Process decision programme chart (PDPC)
Arrow diagram
Affinity diagram This collects large amount of disorganized and

confused verbal data and groups based on natural relationship. It is a
creative process and not a logical process. Affinity diagram is used where
participants have no past experience, situation is complex, need to find a
pattern among thoughts and when there is a need to arrive at a consensus
and no unity exists.
We can use affinity diagram to link working by identifying the group to
which the activity belongs. Next we need to identify similar activities
supporting this and then verify the linkage between activities. The
differences in the style of performing the activity are then verified and
also the reasons for having different styles. By this we can verify the likely
effect of the action taken at one place.
Relations diagram This is a tool for finding solution to problems that
have complex casual relationships. It helps to untangle and find the logical
relations among the intertwined causes and effects and allows for multidirectional thinking rather than linear thinking. This can be used to identify
the relation between documents and systems (Fig. 4.1).
4.12.2 Relation among QMS elements

It can be used for verifying whether the relations identified are addressed in
procedures, instructions, job descriptions and flow charts, and how strong
the relation is. Then the system of communication and co-ordination and
the decision making authorities inline are verified with Relationship diagram.
Tree diagram It is a technique for mapping out full range of paths and
tasks for identifying the primary goals and related sub-goals. It is similar
to an organization chart and helps to understand the sequence of tasks that
need to be completed. The links between primary goals and secondary
goals are represented as a tree. We can make use of this tool to link the
effect of various activities. In the illustration in Fig. 4.2, the root cause for
work not being done is the lack of clarity with the top management as to
who should be given responsibility for doing a certain job.
During auditing, the auditor needs to map the process and find out the
links between process steps. This helps in auditing the links. Figure 4.3
shows a typical process mapping.
Customer
Expectations
Company
Policies and
Objectives
87
Departmental
Policies and
Objectives
Departmental
Procedures
Statutory,
Legal and regulatory
Requirements
Company Manual
and
General Procedures
Organization
Structure
Training
Work Instructions
Job Descriptions
Records
4.1 Indicates relations between different documents used in implementation

of ISO 9000.
Arrow diagram or PERT chart (Fig. 4.4), which helps in project planning,
scheduling and monitoring is a network technique using nodes for events
and arrows for activities. It is a very useful tool when we want to plan the
activities of a known but complex task. Process mapping can be in the
form of an arrow diagram also.
After mapping the process, it becomes easy to find the links.
Documents may have reference of other documents. This can be

verified by writing down a matrix.
Organization can follow a system which has a link to another system
or document.
Different documents may use different words or terms may be used
for the same activity or material.
Some records are identified and referred in the procedures, but some
other are in practice.
Certain objectives are defined by the company and something else is
defined for the departments.
Organization has developed data collection check sheets.
A matrix can be used to analyse the links between processes, procedures,

standards, instructions and other documents (Fig. 4.5).
88

Result
work is
not done
HOD is leaving the
responsibility to
senior executive
Job description of
senior executive
mentions this
Job description of
HOD does not
mention
Quality manual says HOD is
responsible for the activity
Senior executive
is waiting for the
instructions from
HOD
Work procedure says

HOD is responsible
No clarity with the

top management as
to who should do the
work
4.2 Tree diagram for not doing work.
The matrix can also be used to identify the links between the company
objectives, the departmental objectives, the targets and action plans.
Table 4.3 is an illustration for the same.
Process design programme chart This is a useful and powerful method
to overcome problems when a goal is to be achieved by mapping out all
the conceivable events or contingencies that can occur in the
implementation stage. A PDPC chart is constructed by the following steps.
Identify existing situation.

Draw a normal flow chart assuming that no problem will be
encountered.
Discuss the constraints.
Write the activities that are to be done in case of constraints.
Prepare a list showing the possible problems and the contingency plan.
Review for any missing information.
Prepare final drawing and implement.
Watch the progress and darken the line where activities are completed.
Study deviations and re-plan.
89
Map the Process

Start
Support 1
Activity 1
Check 1
Activity 2
Support 2
Support 1
Activity 3
Check 2
Support 3
Support 5
Check 3
Activity 4
Activity 7
Check 4
Activity 7
Activity 2
Activity 8
4.3 Mapping the process.
The auditor need to verify whether the procedures address alternative

actions in case of any deviation is expected.
4.12.3 Tips for auditors

The following tips are useful to auditors to do an effective auditing
considering the links between processes and documents.
Read carefully each line in the documents like procedure, instructions,

job description and quality manual, etc.
Ask for evidence for each statement/instruction in the document.
Ask for linked instructions, job descriptions, forms etc., for each step.
Verify the linking document, and identify further links.
Verify the checklists. Verify whether there is any instruction to gather
those data and information
Verify the link between the objectives written in the top of the
procedure to the steps written.
Ask for the data for the objectives written in the procedure.
Ask for the system of monitoring the implementation of a procedure.
Verify the responsibility written in the procedure and compare with the
responsibility written in the job description and in the quality manual.
Verify the hierarchy as per organization structure.
Verify whether job descriptions are written for all the jobs in the
organization.
90
Arrow Diagram
6
5 days
1
Start
4 days
3
4
4.4 PERT chart.
4.5 Matrix showing linking between different clauses of ISO 9001:2008.
End
91

Table 4.3 Linking of policy to objectives and action plans
Objective 5
=
=
Objective 4
=
=
Objective 3
=
=
Objective 2
=
=
Objective 1
=
=
=
Objective 4
Objective 3
Objective 2
Objective 1
Action plans
Plan 1
Plan 2
Plan 3
Plan 4
Quality Policy
Departmental objectives
Sectional objectives
Company objectives
Objective - 1
=
Objective - 2
=
=
=
= =
Objective - 3
=
=
= =
Objective - 4
Objective - 5
=
=
Verify the responsibilities documented and compare with hierarchy.

Verify the specified minimum competency requirement and compare
with the hierarchy.
Verify the actions recommended in case of failures or emergency.
Verify the link between alternate actions recommended to the
instructions or procedures.
Verify the link between parallel activities.
Verify the process of monitoring parallel activities.
Let us discuss some examples of how an auditor can expand the meaning
of a small statement made in a document and search for the links.
Example 1
Procedure says Supervisor shall give an indent for..
Verify the job description and find out whether supervisor is

authorized to give that indent.
92
Verify the list of format, and see whether that indent format is
controlled.
Ask for the record where the copies of indent are filed.
Check the list of records, whether that record is controlled.
Check to whom this indent is given. Verify the procedure at the
receiving end, whether the acceptance of this indent is documented.
Verify whether any work instruction is written for writing this indent.
Verify the procedure for deciding on writing the indent.
Verify whether all the criteria were fulfilled for a completed indent.
Example 2
Verification of the linkage between procedure and departmental objectives.
Note down the points in the procedure that has a link with the objectives.
Department ABC
Linking procedure to departmental objectives
Department objectives
WP No
OBJ- 1
OBJ- 2
XXX-WP-01
Point 1 Point 5
XXX-WP-02
OBJ- 3
Point 2
OBJ- 4
OBJ- 5
OBJ- 6
OBJ- 7
Point 5
XXX-WP-03
Point 2
XXX-WP-04
XXX-WP-05
OBJ- 8
Point 3
Point 5
Point 7
Point 8
Point 2
Point 3
Point 8
XXX-WP-06
XXX-WP-07
XXX-WP-08
Point 5
Point 3
In the example above, no procedure is found addressing the objective

no. 4 of the department. It normally happens as the objectives are specified
by the top management, and the procedures are not verified.
Example 3
Verification of links between job description and the departmental objectives.
Following is an example of linking job descriptions to objectives.
93

Linking job description to departmental objectives
Department objectives
JD No
OBJ- 1
OBJ- 2
XXX-JD-01
Point 1 Point 5
XXX-JD-02
OBJ- 3
OBJ- 4
Point 2
OBJ- 5
OBJ- 6
OBJ- 7
Point 5
XXX-JD-03
Point 2
XXX-JD-04
XXX-JD-05
Point 7
Point 3
XXX-JD-06
Point 6
XXX-JD-07
XXX-JD-08
OBJ- 8
Point 3
Point 5
Point 8
Point 3
Example 4
Verification of the minimum competency levels specified and comparing
with the hierarchy for the mismatches. The competency expectations must
be of higher level for seniors in the hierarchy compared to those at junior
level. Following is an example of mismatch.
Minimum competency Training staff in a garment factory
Education
Experience
Training
Skills
Training
manager
Any degree with

Knowledge of local
language and
English
10 years
experience in
shop floor
G.S.D
Good communicator
Training
in-charge
Degree or Diploma
in garment
manufacturing
8 years of experience as a training in-charge in

a garment
factory
G.S.D and
train the
trainer
course
Good communicator,
keen observer, good
counsellor
Training
executive
PG degree or
diploma in garment
manufacturing
5 years as a
trainer
G.S.D
Good communicator,
keen observer, good
counsellor
Trainer
Diploma in tailoring
Not specified
Not
specified
Training skills
94
Example 5
Verify the records of stoppages and the reasons documented. Link it to the
efficiency or productivity achieved. Say, the production department has
recorded 4 hours stoppage of a machine for breakdown, where as the
maintenance department has recorded 3 hours stoppage. When the
production is verified, they have achieved 60% of their normal production
in that shift indicating a loss of 3 hours and 12 minutes. It means the
machine was started 12 minutes late after it was handed over by the
maintenance, but additional stoppage was shown to project a better
efficiency.
Example 6
Verify the objectives and targets specified for a section and between
sections of an organization. See whether they are complementary or
contradictory.
Example 7
For each target check the proposed action plan. Each target should be
supported by an action plan in order to achieve it. The method of
implementation of the action plans must be specified in the work
procedures, or else it is not possible to implement. There should be the
responsibilities defined and the records identified. Auditor needs to check
whether the documents explain the method of taking action, where the
records are kept and who is responsible.
Linking exercises can be a very powerful tool for an auditor. It helps in
identifying the real pits and helps the management to take necessary
corrective actions. The seven management tools can be suitably made use
for linking exercises.
Linking exercise helps to integrate different activities of an organization.
It helps effective implementation of systems organization wide.
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5
5.1
Need for measurement
It is a known fact that unless we measure, we cannot improve. It is suggested

to convert all subjective statements to objective statements by developing
some means for measurement. In the quality management systems,
measuring the results is given maximum importance. All objectives must
be measurable. The standards also insist on continuous improvement at
all places. Continuous improvement can be demonstrated only when we
have objective evidences, and the means for measuring. The QMS
implementation is not an exemption for this. We need to improve the
effectivity of implementation of quality management systems on a
continuous basis. Therefore, we need to learn the method of measuring
the maturity of QMS implementation.
ISO 9000 quality management systems have emerged out as one of the
most popular quality management systems. The standards which were
adopted from BS 5750 in 1987 underwent amendments in 1994 and 2000,
and now again in 2008. Why these amendments? There is a mechanism
for reviewing the suitability of the systems to the changing business
environment. Similarly, it is essential to see the suitability of the systems
adopted in a company to the changing requirements. Only adhering to
basic requirements to get a certificate is not sufficient.
By considering the advantages of getting consistency in the supplies
and smooth working, the organizations who were familiar with BS 5750
/ ISO 9000 started insisting their suppliers for getting accredited to ISO
9000. The government agencies also started insisting on ISO 9000
certificate from their suppliers before submitting tenders for various
supplies of products and services. This insistence compelled number of
organizations to align their activities inline with the requirements of QMS,
and the number of companies with ISO 9001 certification is increasing
alarmingly. People started using different means to (some how) get the
certificate. As the numbers of certifying bodies are increased there is a
competition between them. Their survival depends on the number of clients
they have. Therefore, they are forced to grant more and more certificates.
The certifying agencies started becoming lenient in giving certificates. In
95
96
a number of cases, it is found that auditors are closing their eyes even
when a major non-conformance is noticed.
ISO 9001 guidelines give basic requirements for a good quality
management system, which are practical and simple. In the initial stages,
people were considering the certification of ISO 9000 as a great
achievement, but now due to innumerable number of certificate holders, it
is no more considered as an achievement. It has become the basic or
fundamental requirement for any organization to survive. If one is not
following a QMS, he is likely to collapse shortly.
With over one million ISO 9000 certified companies world over, the
significance of the certificate is getting lost. Almost everyone is ISO
certified. The customers, who were recognising their suppliers because of
their accreditation to QMS, are now in confusion. They are finding
difficulty in identifying good suppliers those are matured in understanding
the requirements, could proactively respond and have quality management
systems implemented effectively company wide and following religiously.
There is no method of assessing the effectiveness of implementation,
although some companies have developed their own systems to measure
their performance. There is a need for scientific/logical measurement of
the maturity of implementation of quality management in an organization.
5.2
Measuring maturity by linking to

the principles
The British Standard Institute (BSI) (17) has recently started benchmarking
system in QMS. The companies are assessed considering the eight quality
management principles adopted in ISO 9001:2000. For each principle five
criteria are verified, and the companies are fitted in one of the five levels,
viz No level, Bronze, Silver, Gold and Platinum.
In BSI method, there are 5 8 = 40 questions, and each question has
maximum of 50 marks. Total marks are 2000. The companies scoring 20%
and below shall not get any rank. The Bronze status is given for companies
getting 2140% marks, Silver for 4160% marks, Gold for 6180% marks
and Platinum for 81100%. The members can have an access to find out
the highest ranking in each category. BSI gives reports for each principle
separately and also indicates threat, risk, business impact and area for
improvement. Any company, whether ISO 9000 certified or not, can
participate in this benchmarking assessment. Once a company is assessed
and graded, a certificate is issued, which is valid for 2 years. There shall
be one assessment every year.
This certificate helps the companies in impressing their customers. The
customers are likely to prefer the companies with platinum ranking
compared to bronze or silver ranking, although they are ISO 9001 certified.
5.3
97
Measuring maturity by considering the clauses
Any one if wants to improve, should first know the level in which he is. It
is true for the companies also. It might not be feasible for all to go for a
benchmarking survey, as one need to wait for one year after getting
assessment to understand the changes in status if any. Also the external
auditors might not get complete exposure to the depth the systems have
gone. As the purpose is to assess self and plan for improvement, we need
to device a method, which is simple and can be handled by internal quality
auditors. The assessment should be done after each internal quality audit
so that the effects of efforts made can be understood.
One needs to carefully understand the requirements of the quality
management system and the extent to which it can be implemented. The
various levels between a starting level company and the best company
may be identified and marks may be allotted. By this it shall be possible
to understand the level at which we are working and the area needed to be
improved and track the performance of quality management systems in
numerical terms.
The internal auditors, who are matured enough and trained in assessment
for maturity, can allot the marks independently followed by a consensus
method. By this the company can assess the level of implementation of
QMS and work out the plans to make it more effective.
The guidelines are explained in section 5.4. The companies, who are
still not matured enough to have self-assessment, can understand the
expectations of a good QMS system by reading the guidelines for
assessment. The concepts which have been given higher marks are the
ones to be benchmarked.
In the guidelines prepared, the maturity is assessed by 100 different
angles, referred as elements of implementation of QMS. In each element,
5 possible levels are identified and marks are allotted for them. One need
to verify in which level the company is there against each element of QMS.
The maximum marks are 5 for each element and minimum is 1. Zero mark
is not considered as we have taken a company for assessment which already
has implemented QMS and is certified.
A company can therefore have maximum of 500 marks and minimum
of 100. If the company scores 100 marks, it is considered as base level or
Level 1. Company scoring between 101 and 200 is Level 2, 201 and 300
is Level 3, 301 and 400 is Level 4 and 401 and 500 shall be Level 5. The
chances of a company falling in Level 1 is very remote, as they cannot
score just 1 in all the 100 elements, but could score more than 1 in number
of elements.
As the concepts in QMS change depending on the developments of
new concepts, the guidelines prepared also will change. However, by the
98
logics adopted here, we can measure the effectiveness of implementation

of any quality management system.
5.4
Guidelines for assessing maturity in

QMS implementation
The following are the general guidelines. They are developed considering
the clauses of ISO 9001:2008. The auditee should give frank answers.
There is nothing called as wrong. Frankness helps in understanding the
level, and suitable action plan might be prepared to move further. As
systems undergo changes, we can rework the guidance.
Level
and
marks
1
2
Description
1. Scope of application
Covers production, maintenance and quality control sections.
Covers production, purchases, production planning, quality
control, research and development, maintenance and delivery
operations.
control, research and development, marketing, maintenance and
delivery operations.
control, research and development, designing, marketing,
outhouse trading, maintenance and delivery operations.
Covers all sections of the organization including accounts,
finance and corporate functions.
2. Purpose of implementing QMS
1
2
3
4
The customers are demanding. To get entry in export market,

and also in some public bidding with out ISO certificate.
Implementation of QMS improves the image of company and
helps entering into new markets with ease.
Implementing QMS gives confidence to customers that product
and services shall meet their requirement.
We can analyse self, identify the loop holes and work towards
continual improvement. This can build confidence in our
customers and we can have long-lasting relations.
Apart from self-analysis and correcting the loops, we can
identify potential problems and take suitable strategic decisions
to prevent the problems.
99
3. Awareness and use of quality policy

1
4
5
Quality policy is released and displayed at prominent places.

However, people working are not in a position to explain what
it is.
Quality policy is explained to all employees by conducting
programme apart from display at prominent places. However,
no evaluation is done to understand whether the people have
understood it.
Understanding of quality policy is verified during internal
quality audits, and the people are able to recite the quality policy
any time. However, they are unable to explain how it is
connected to the day-to-day activities.
People are clear about the linking of their activities to the quality
policy and are able device procedures accordingly.
All procedures are reviewed periodically and verified for its
suitability to meet the changed quality policy considering the
changing situation. The procedures are modified to work inline
with the changed policy.
4. Deriving of quality policy
1
2
3
4
Quality policy is decided by referring to a number of good

companies, and the combination is made to get the best Policy.
Quality policy was decided by the chairman after discussing
with eminent consultants in QMS.
Quality policy was decided based on the purpose of the company
by the chairman.
Quality Policy was decided basing on the purpose of the
company by the chairman after a number of rounds with chief
executive and the functional heads.
Quality policy is reviewed periodically by the team consisting
of chairman, chief executive and the functional heads
considering the changing economic and social scenario.
5. Deployment of quality objectives
Quality objective is defined for the company and displayed at

prominent places. However, there is no clarity as to how the
objectives were arrived.
Departmental objectives and goals are prepared and displayed
at prominent places in the work spot. However, there is no clarity
as to how the departmental objectives are arrived.
100
3
Integration of quality policy, company quality objectives and

department objectives are made by involvement of top
management and the functional heads. The procedures and
action plans are prepared to achieve them and concerned officers
are educated.
The employees on work spot are clear about the departmental
objectives and company objectives, but are not in a position to
link their day-to-day works for achieving the objectives.
Individuals are clear about their roles, responsibilities and goals,
which are aligned with department objectives and goals, and in
turn are aligned with company objectives and goals. People
review the achievements periodically and modify the action
plans wherever required.
6. Determination of quality objectives
1
2
3
4
5
Quality objectives are specified considering the benchmark

companies.
The objectives are defined for the area where the company has
strength, so that the auditors could be impressed.
Objectives are determined by considering the quality policy
requirements.
Objectives are decided considering the requirements of the
customers and the effectiveness of processes.
Objectives are reviewed periodically to suit the changing
requirements of the customers, the company and the society.
7. Preparation of quality manual
1
2
3
4
Quality manual is prepared by referring the manual of a

benchmarking company that has been certified long back.
Quality manual is prepared referring to the clauses of quality
management system, and care is taken to ensure that all clauses
are addressed.
Quality manual is prepared to guide the people to work as per
the requirement of quality management system.
Quality manual is prepared to explain how we are implementing
the QMS at our company by taking the guidance of international
standards.
Special training classes are conducted for the staff to read and
understand quality manual, and to link their procedures and
other documents to the quality manual.
101
8. Distribution of quality manual

1
2
3
4
The quality manual is kept with management representative.

It is issued to senior managers and a copy is kept in the library.
The copies are given to each departmental head and the section
head for reference.
All employees are made aware of the quality manual and its
use, and interested employees were given permission to read
the manual and return to the head of the department.
The HOD ensures that every one has read the manual and
understood the contents and refers them regularly as a routine
work. They either correct or advise the management if any
deviations are observed in the system.
9. Process evolution
1
2
3
4
5
Processes being followed in the company are listed down.

Processes mandatory for the implementation of QMS are
identified and listed.
Processes required for achieving the company objectives while
moving in the path defined by quality policy are identified.
Processes required to enhance QMS to achieve continual
improvements are identified.
Processes required to achieve the results at par with benchmarks
are identified and implemented.
10. Process implementation
1
2
3
4
5
Processes required for the implementation of QMS are identified

and listed.
The sequence and interaction of the processes are identified
and charts prepared.
Control points and check points for each process are determined,
and the users are educated to use them on regular basis.
The processes are evaluated periodically to ensure their
effectiveness, and modifications made to make it more effective.
The users do the analysis of process performance and compare
with the best achieved results. Root cause analysis is made for
the deviations and actions taken to correct them.
11. Terms and definitions
People are supposed to understand the terms used as they are

working here from a long time.
102
2
3
4
List of abbreviations used are given in the end of each document

and the meaning is defined.
The abbreviations used in different documents are listed and a
chart is made giving the meaning.
A separate document is prepared indicating all the technical
terms and abbreviations used company wide and in the industry,
and are defined.
Periodic audits are done to ensure that the terms used give the
same meaning as defined, and the users are repeatedly trained
to use the words with same meaning all the time.
12. Work procedures documentation and control
1
2
Mandatory procedures as per the guidelines for the

implementation of QMS are documented and controlled.
All the processes required for fulfilling the company objectives
are identified and procedures documented. The procedures are
controlled and referred in the quality manual.
All the managers and staff are trained for using the documented
procedures and its usage is ascertained by periodic audits. A
separate committee of experts reviews the procedures for their
suitability.
The procedures are reviewed at a periodic interval by the
concerned heads of the department and the senior staff to ensure
their suitability considering the changing need. The trials are
conducted with changed systems before deciding on the
amendments.
Employees are encouraged to read the procedures and give their
feedback from time to time for the suitability and effective
implementation. The procedures are amended as and when
required. All employees refer the procedures on regular basis
even for the routine works.
13. Procedure deployment
1
2
3
4
The copies of the procedures are given to concerned heads of

the department.
The copies of the procedures are made available to all users by
displaying them prominently at strategic points.
The HOD conduct monthly meeting for the staff and ensure
that everyone has read the procedure and understood.
The internal quality auditors verify the understanding level of
procedures by asking number of questions during audits.
103
The head of the department conducts monthly review of the

performance, and verifies the achievement of objectives against
specified in the procedure. Corrective actions are taken for the
deviation.
14. Review of procedures
1
2
3
4
5
While writing a new procedure, or while amending a procedure,

review is done by the management representative.
While writing a new procedure, or while amending a procedure,
review is done by the person preparing the procedure.
Procedures are reviewed for suitability by the concerned HOD
before approving.
Procedures are reviewed at least once in 2 years by the HOD to
ensure that they are suitable for working condition.
Procedures are reviewed periodically to ensure them as the best
possible for the activity in question. Amendments are made as
and when better method is established or defined.
15. Work instructions
1
2
3
4
5
The work instructions are written for important activities in

production area.
Work instructions are documented for all the activities done by
workers, and displayed at prominent places.
The work instructions are written in local language and the
workers are encouraged to read them while working.
Senior workers are involved in writing work instructions so as
to ensure that all practical aspects are covered.
Senior workers train the junior workers on a regular basis for
the use of work instructions in their routine works and they
contribute for amending the instructions when needed.
16. Organization structure
1
2
3
The company has a documented organization structure giving

broad outline of the authorities and responsibilities.
The organization structure is defined up to shop floor supervisor
level. Their authorities and responsibilities are documented.
The staff is involved in preparing the organization structure as
and when a change is made. The HOD specifies the authorities
and responsibilities of each designation.
The top management reviews periodically the changes taking
104
place, and changes needed in the organization structure. They

define the authorities and responsibilities of all key positions,
and empower them to perform.
The top management ensures that the organization structure
defined is effective in achieving the company objectives, the
communications are smooth and there is no confusion or friction
at any place. People are suitably empowered so that there is no
need for them to wait for instructions in routine matters.
17. Roles and responsibilities
1
2
3
4
Roles and responsibilities of heads of the departments are

documented in quality manual.
Roles and responsibilities of all the staff are documented as
separate job descriptions and controlled.
Roles and responsibilities of all the designations in the company
are established and documented and made known to all concerned.
Roles and responsibilities are reviewed as and when there is a
change in organization structure, and documented. All
concerned are educated on the changes.
Roles and responsibilities of all employees are reviewed
periodically and aligned with the company and departmental
objectives. People are completely aware of their roles and
responsibilities in achieving the goals.
18. Document control
1
2
3
4
The documents required as per the QMS requirements are

identified, listed and controlled.
All documents generated are identified with specific codes,
listed in the master list and their distribution controlled.
Document distribution is reviewed periodically by an expert
committee and their distribution controlled.
In addition to the in-house documents, the external documents
are also listed and maintained at a centralized library for the
benefit of users.
All documents including those of external origin are reviewed
periodically by users for their continued suitability, and revised
suitably.
19. Document changes
Documents prepared for the implementation of QMS are not
2
3
4
5
105
changed unless there is a non-conformity identified by an

auditor.
Documents are verified before each audit and amendments are
made as needed to avoid non-conformities during audit.
Documents are reviewed periodically by an expert committee
along with management representative and changes are made
as required.
Documents are reviewed periodically by internal auditors with
in the sections and amendments are made as per the suitability.
The management representative reviews the changes suggested
by users in the documents, verify the alignment with the QMS
requirements and releases the changed document.
20. Control of obsolete documents
The management representative sends note to all users to return

the old documents while issuing new documents. He keeps one
set for his reference, and destroys others.
The internal auditors verify the documents during the audits
and raise nonconformity if obsolete documents are found. Such
documents are removed and NC is closed.
The team representatives periodically verify the documents they
have and compare with the master list of documents with the
All users have an access to the master list of documents with
the amendment status, and are empowered to do self-auditing
to identify redundant documents.
The HOD verifies periodically the master list of documents and
the documents he has. He ensures the return of old documents
to management representative.
21. Record control
1
2
3
4
5
Records as specified in QMS are identified, maintained in files

or registers.
All the files and registers maintained in the company are listed,
coded and brought under control.
All the records including those maintained in soft copies are
listed and controlled.
Records are scrutinized by the concerned HOD on periodic basis
for its effective maintenance.
All records are reviewed periodically and aligned with the
changing needs and controlled.
106
22. Maintenance of records

1
4
5
All records are having title, starting date, responsibility, life

and storage place mentioned on it as per the list of files and
records.
The records are kept in their identified places, and office boys
are trained to maintain the records in their places. The record
keeping place is clean and tidy.
Periodically, the record maintenance is audited by internal
quality auditors, and corrective actions are taken as per their
findings.
Each user ensures that the records used by him/her are kept
back in the specified place after the work is completed.
The HOD personally conducts a file recall exercise and ensures
that all records are available as required.
23. Information availability
1
2
The users are responsible for ensuring that they get the required
information from the right source.
The concerned HOD by his experience and knowledge identifies
the key information requirement, and arranges for data
collection and information generation on a regular basis.
The information required for the effective implementation of
QMS is identified by an expert committee, and programme is
developed to collect those data and information on a regular
basis.
The users review periodically the effectiveness of the
information available for the implementation and control of the
required activities, and design means to acquire the data from
the reliable sources.
The HODs review the information availability for taking
decisions and for carrying out the activities, and discuss with
the concerned persons and make arrangements for their
procurement.
24. Understanding customer requirements
1
2
3
4
Whatever customer sends in writing is regarded as requirements.

Customer is asked to send a sample and complete specifications
to avoid confusions.
Agent visits the customer and collects all information.
Senior marketing personnel visit the customer and understand
the requirements.
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Senior production personnel visit the customer along with

marketing personnel and understand the customer needs by
discussing with the actual users.
25. Communicating the customer requirements
1
2
3
4
5
Marketing sends the customer needs to PPC and production

managers.
Marketing persons discuss with production, PPC and quality
heads regarding the orders booked and enquiries received.
Marketing persons discuss with all HODs regarding the market
trends, feedbacks, requirements and specific customer
requirements in a meeting.
Customers are invited to the company to discuss with the
concerned production, quality, PPC, maintenance and sourcing
personnel regarding the specific requirements of customers.
Production, quality and maintenance personnel are sent to
customers place to discuss with the actual users to understand
their specific requirements.
26. Communicating customer concerns
1
2
3
4
5
All market complaints are recorded and discussed in the

management review meeting.
All market complaints received are displayed prominently in
the work area so that concerned persons can take suitable
remedial actions.
Marketing person visits the customer and brings the feedback
and complaint samples and discusses with concerned production
and quality personnel.
Senior managers visit the customers place to understand the
concerns, and explain the same in an open house to all the staff.
Production and quality executives visit the customer place, study
the working, discuss the concerns with the actual users, and
explain the same to the people involved in manufacturing and
quality control.
27. Communicating legal and
regulatory requirements
1
2
The circulars relating to legal and regulatory requirements are

kept in a file at the library, and HODs has an access to them.
The CEO conducts a meeting of all HODs and explains the
legal and regulatory requirements. HRD collects the latest
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gazette notices and sends circular to concerned officers as and

when required.
The persons responsible for monitoring the compliance to legal
and regulatory requirements are given periodic refresher
training, and sent to seminars and conferences as needed.
Periodical audits are conducted by internal auditors for
compliance to legal and regulatory requirements, and corrective
actions are taken.
The procedures, work instructions, job descriptions etc., are
reviewed periodically to ensure their alignment with legal and
regulatory requirements. The quality auditors verify the
compliance, and the HODs take action.
28. Verification of compliance to legal and
regulatory requirement
1
2
3
4
5
The government authorities verify the compliance by their

surprise rounds. If any deviation is found, suitable action is taken.
The buyer nominated auditors verifies the compliance during
audits.
The HRD officers are responsible for adhering to compliance,
and hence they verify adherence on a regular basis.
A special committee headed by HRD verifies the adherence to
The CEO takes personal interest in ensuring that the legal and
regulatory requirements are met, and nominates internal auditors
to audit the systems on a regular basis.
29. Compliance to safety requirements
1
2
3
4
5
A separate safety officer is appointed to take care of all safety

requirements.
Safety audit is conducted once in every 3 months and deviations
found are reported to management.
A safety committee is formulated, which meet every month and
discuss on the requirements, and give report to management.
The safety officer along with the maintenance in charge takes
rounds especially for safety and ensures the compliance.
The users are educated on safety requirements, and they check
the safety gadgets before starting the work, and the shop floor
supervisor monitors the activities.
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30. Management representative

1
2
3
4
A fresh, highly qualified person is recruited specially for

implementing QMS as a management representative.
A young officer from quality control section is freed from all
responsibilities and made independent to work as management
representative.
The head of the quality control section is given the responsibility
of management representative.
A senior manager is relieved from his regular responsibilities
and made management representative, and is assisted by a
trained internal auditor in documentation works.
A senior manager has taken the additional responsibility of
becoming management representative, who is a certified lead
auditor and has undergone training in management
representative skills.
31. Management representative reports to
1
2
3
4
5
Quality control in-charge

Head of production operations
Factory manager / Head of HRD
General manager / Unit head
CEO / MD of the company
32. Management review is conducted by
1
2
3
4
5
Quality control in-charge

Head of production operations
Management representative
General manager / Unit head
CEO / MD of the company
33. Consistency of management review
1
2
3
4
5
Conducted
Conducted
Conducted
Conducted
Conducted
when the CEO and HODs are free.

before external audits.
before the next internal audit.
with in one month from the scheduled date.
periodically on the specified date and time.
34. Records of management review

1
The management representative maintains the record.
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2
3
4
5
Management representative prepares the minutes and sends hard

copies to the members who attended the meeting.
Minutes are sent to all the HODs irrespective of their attending
the meeting.
The minutes of meeting are sent by e-mail to all, and the users
keep the record at their place for reference and taking actions.
The internal quality auditors verify the records for the actions
taken on the decisions made at management review.
35. Points discussed in management review
1
2
3
4
5
The non-conformities rose in the audits and whether they are

closed.
The performance against the targets fixed for production,
quality, cost and the non-conformities.
The corrective actions taken for the non-conformities and
market complaints, along with the performance review.
The performance, resource utilization, the cost cutting, future
plans, non-conformities and market feedback.
The performance, proactive preventive actions, customer
feedback, future plans, resource utilization, recommendations
for improvements and changes that could affect QMS
implementation.
36. Members attending management review
1
2
3
4
5
The internal auditors and the auditee who faced the audits
All staff members
One representative from each department
The heads of the departments or their next person in hierarchy
All HODs and senior executives
37. Minimum competency fixed
1
2
3
4
People best suitable for the job are selected from the available
candidates. No minimum criteria are fixed.
Minimum competency is documented for all posts by actually
referring to the competency the people have.
The minimum competency is fixed in consultation with a
qualified HR consultant.
Jobs of similar nature are identified and grouped. The company
requirement is judged by a team of experts along with an expert
in HRD.
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Each element of the job needed to be performed is analysed

and the competency required is identified. The highest level
got is decided as minimum requirement.
38. Competency evaluation
1
2
3
Competency is checked while recruiting, and promotions are

given as per seniority.
Efficiency and performance levels are judged by the concerned
heads of the department.
Records are maintained of individuals for their efficiency and
quality and the one with higher productivity and quality is
considered as competent.
Periodic assessments are made for performance, behaviour,
attendance and records are maintained, which is used for
evaluating the competency.
Periodically, the employees are interviewed and enquired about
the additional skill or competency acquired by them. They are
encouraged to participate in trial order production or take extra
assignments. Performance is measured by experts.
39. Training need identification
1
2
3
4
5
Good performers are encouraged to attend trainings conducted

by eminents. About 4 to 6 people are sent for training in a year.
We ensure that everyone undergoes training. Hence, people are
sent on rotation to seminars and conferences.
The HOD identifies the training needs at the time of annual
appraisal. He recommends the trainings from the selected
subjects given by the HRD.
The performance of individuals is tracked, and the low
performers are sent for training to training department.
The competency requirements for the jobs to be done and the
changes likely to take place are considered, and the competency
of the persons likely to do those are analysed. The training is
provided in case a gap is found.
40. Maintaining the record of competency
The HRD maintains personal files of all employees with details

of their qualification and experience which was collected during
recruitment.
Training manager maintains the records of persons attending
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different training programme. HOD can get the data as to who

all have completed the training.
Training manager maintains the person wise record of trainings
attended in our company. The industrial engineer maintains the
records of skill and speed.
The industrial engineering department maintains the records
of skill and speed of each operator. The training department
maintains the person wise records of training attended. The
medical officer maintains the record of physical fitness.
The HOD maintains the records of people working under him
with the details of trainings undergone, not only in this company
but also prior to joining this company, the types of works done,
the responsibilities shouldered along with the present physical
condition.
41. Training evaluation
1
2
3
4
Immediately after a training programme, a feedback form is

given to all participants and their opinions taken.
Members participating in training are encouraged to make a
presentation to colleagues and explain what they learnt.
Feedback is taken from the HOD regarding the performance of
the candidate after 3 months of the training.
The performance of individuals are tracked for quality,
productivity, discipline, safety precautions etc., depending on
the programme undergone and analysed for trends.
The extent to which the departmental objectives were met as a
result of trainings given are analysed, which not only evaluates
the participants for their learning, but also the competency of
the HOD in identifying the training needs and utilising the
trained persons effectively.
42. Infrastructure decided by
1
2
3
4
5
Project engineer or an expert consultant

Heads of the department
General manager discusses with CEO
Board of Directors and MD
Users discuss their requirements with CEO and give justification
that the infrastructure is for improving customer satisfaction,
achieving the company goals and for meeting legal and
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43. Physical work environment

1
2
3
4
5
Minimum requirements given as per Act.

We are better than the neighbouring company.
We have provided better than the best benchmark.
Work environment provided considering the suggestions given
by employees.
Studies are conducted as to which level of light, noise, dust
level, passage etc., give the best results considering the quality
and productivity.
44. Human related work environment
1
2
3
4
5
We honour the agreements made.

We give incentives to the best performers.
We sit and negotiate before taking any decision.
We take suggestions from employees and act in time to solve
their grievance.
Transparency is there in all the activities and decisions relating
to Human relations.
45. Quality objectives of the product
1
2
3
4
5
We go by our standard specifications.

We honour the specifications agreed with in the limits of legal
requirements.
We study our competitors quality and try to give slightly better
than that, but with in the legal limits.
We analyse the market feedback and complaints and arrive at
unspecified needs of the customer.
We understand the real requirements and concerns by personally
discussing with the customers.
46. Quality planning
1
2
3
The shift supervisors plan the activity for their shift considering
the production completed and to be completed.
Production plans for next day is written on a white board, so
that the activities can be done smoothly.
Weekly planner board with the details of machines to be used,
the critical points to be observed is displayed prominently.
Monthly operation plans are maintained with the HOD.
Order-wise plans are made and the shop-floor operators are
made clear about the production plan by their superiors so that
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they can keep all the required materials ready to achieve

maximum production.
Market complaints and feedback received for a similar product
and from the same customer are displayed on the machines to
facilitate inspection and testing by quality control personnel
and the machine operators.
47. Contract review
1
2
3
4
5
The orders booked and are served on first-come first-served basis.

Marketing personal refers the monthly plan and target proposed
by PPC, and books order accordingly.
PPC indicates the orders blocked and capacity available on daily
basis to the marketing personnel, who in turn books the order.
Detailed review is done by production, quality, maintenance
and planning personnel of the proposal given by marketing.
The limitations if any in providing quality of products and
services are discussed with customer representative, and
consensus is made if they can have an in-between solution when
we do not have confidence.
48. Complaint handling
1
2
Customer contact person is responsible for convincing the

customer.
The complaints are received at marketing. The marketing chief
and the manufacturing chief shall study together and make a
reply to customer.
Customer complaint is recorded, and sent for analysis to
laboratory. After getting the reply, the customer is suitably
informed by marketing.
Customers complaint is acknowledged and a senior person from
marketing visits the customer to assess the losses. If needed, a
technical person from factory shall visit to suggest the actions
to be taken at customers end to overcome the problem.
Customer is provided with an alternate supply to prevent
production loss while the complaint is being analysed. The
customer is apprised of the situation, and the help offered to
consume the materials in stock made for them.
49. Design inputs considered
Customer specification or the sample dimensions.
2
3
4
5
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Functional and performance requirements of the products and

applicable statutory and regulatory requirements.
Details of previous similar product development and the
problems faced during the development of previous sample.
Apart from the product requirements, the present process
capability, human capability, availability of raw materials, etc.
Apart from the product requirement and company capabilities,
the critical concerns of the customer, the seasonal effects on
quantity and quality.
50. Design output
1
2
3
4
5
Blue print and standard operating procedures developed.

Apart from blue print and SOP the raw material requirement,
availability, cost etc., are worked out.
Product characters are described for its safe use in the blue
print and SOP.
Estimation of wastes, seconds and reworks are made along with
the blue print, SOP, production parameters and specification.
Problems likely to be faced while manufacturing, the skill level
of workmen required, the modifications to be done on the
machines, etc., are provided along with SOP, blue print and
other details.
51. Design review
1
2
3
4
5
The design head knows the problems and shall specify if there
is any thing likely to affect.
The design head discusses with the design team members and
quality control team.
The design team discuss with production team for the likely
problems.
A team consisting of members from design, quality and
production work together to identify the likely problems.
A team consisting of members from design, manufacturing,
quality, maintenance, purchase study the design in detail and
identify the likely problems.
52. Design verification
1
2
3
Verification is done by the designer himself.

The design head verifies the designs made by all subordinates.
The design is verified by quality control personnel.
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4
5
Design is verified by senior production personnel.

Design is verified in a team meeting, consisting members from
production, design, quality, maintenance and purchase.
53. Design validation
1
2
3
4
5
Design validation is done by the design team.

Validation is done by quality control team.
Validation is done jointly by quality and production team.
Validation is done by market team.
Validation is done by the customer.
54. Control of design and development changes
1
2
Final parameters of the approved samples are entered in a

register, and the samples are kept in cup board.
Records with the parameters of the product, process and raw
materials are maintained along with a sample for all the
successful designs, after getting approval from marketing/
quality head.
Records with all the parameters of the product, process, raw
materials etc., are maintained along with a sample for all the
successful designs, after getting approval from customer.
While records are maintained for all the trails conducted along
with the samples, the approved samples and their records are
maintained in a separate file.
All trials are coded, and the parameters used are documented.
The reason for not approving the sample is discussed and
documented. A cause and effect analysis is made for the
approved samples and the rejected samples.
55. Vendor selection
1
2
3
4
5
Vendors are selected by closed tender system, and lowest price

bidder gets the order.
Vendors are selected after verifying the samples, and negotiating
the price.
Vendors are selected by referring to other companies who are
buying materials from them.
Vendors are selected after getting their profile and getting
approval from the CEO.
Vendors are selected after visiting the actual manufacturing area
and assessing their quality and performance level, capacity,
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logistic problems, technical capability for giving after sales

service.
56. Vendor evaluation
1
2
3
We purchase from the lowest bidder.

Vendors are evaluated for quality along with price on yearly
basis.
Vendor evaluation is done for major suppliers on the basis of
quality and price on yearly basis. Vendors are updated by a
separate letter.
Vendors are evaluated on the basis of quality, price, delivery
and service on yearly basis. Vendors are updated by a separate
letter.
Vendors are evaluated on the basis of quality, price, deliver,
after sales service, with different weightage depending on the
product on a quarterly basis. Vendors are updated on-line and
invited to discuss their problems and plans.
57. Vendor development
1
2
3
Purchasing shall be done from standard vendors and original

manufacturers.
Chance shall be given to new vendors to develop by giving
free trial orders.
Our technical team shall explain the critical requirements, and
the suppliers are encouraged to see our machines and type of
working so that they can decide on developing.
Our technical team shall be involved in the designing,
developing and validation of products at suppliers end before
bulk supply.
Our technical and commercial teams keep regular vigil on the
happenings and provide necessary assistance where the supplier
finds it difficult to manage.
58. Purchasing information
1
2
Purchase order consists of product name, purchase conditions,

transport requirements, quantity and value.
Apart from the product name, the catalogue number, the
standard reference (for e.g., ISI Number) is given in purchase
order.
Apart from the normal purchase order details, the criteria for
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approval of the product and the procedure reference of testing

are incorporated.
Purchase orders are verified for adequacy by an expert team
before the orders are sent to suppliers. Samples are provided
where ever it is required.
Supplier is invited for discussions to understand the critical
requirements of the product and also to collect dimensions and
other details in case required to avoid duplication or rejection.
59. Verification of purchased product
1
2
3
4
Stores verify the quantity and issue the materials to users.

Users verify the quality and approve the products received. Only
approved product shall be issued.
The representative of supplier is invited while inspecting critical
materials.
The quality checkers visit the supplier place and check the
materials ready for despatch to ensure that they meet our
requirement.
The quality checkers visit the supplier place and check the
critical components being used for the product being
manufactured for us.
60. Validation of processes
1
2
3
4
5
Special processes are not identified.

Special processes are identified and the work procedures are
documented.
Procedure for establishing process parameters is established.
Periodic validation is done for the process parameter fixed to
ensure its continued suitability.
The workers are retrained whenever there is a change in process
parameter and audited periodically to ensure adherence to the
systems.
61. Identification and traceability
1
2
3
All materials in process are identified by their physical

appearance.
Materials in process and material in stock are identified by
suitable colour coding / bar-coding systems.
The codes used for identification and traceability are displayed
prominently in the production area.
4
5
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A record is maintained of the identifications used on different

days for the products being manufactured.
Employees are repeatedly educated on the colour codes being
used, and periodically audited to ensure that every one is
following the same coding system.
62. Customer property
Customer supplied materials are used along with other materials.

At the end of the production, account is given considering the
materials supplied back to customer.
Account is maintained at stores for the customer supplied
products, entries are made while issuing it to production and
information is sent to customer regarding rejections.
Senior managers are nominated for different customers to follow
up with the materials being supplied by customer for
incorporation in the product. Quality issues or any discrepancy
in quantity are handled by that nominated manager.
Periodic audits are done by the nominated manager for the
materials in stock, the wastes generated and materials consumed.
Periodic reconciliation is made and submitted to customer.
Nominated managers keep in touch with customer on day to day
basis and update them on quality and productivity aspects, and
take instructions for correcting the situation in case of problem.
63. Preservation of product
1
2
3
4
5
Final product is packed as required by customer by taking all

care, and are preserved in a dry and clean area.
Apart from the final product, the raw materials are ensured of
proper packing and kept in clean warehouses to avoid losses.
The in-process materials are kept in suitable containers to
prevent them from getting damaged due to handling.
Suitable material handling equipments are used to ensure no
damage due to handling.
Materials in stock are periodically checked for their continued
acceptability.
64. Control of monitoring and measuring devices
1
2
A list of all monitoring and measuring equipments is made.

Master samples of each equipment or device is identified and
got calibrated by an authorised laboratory.
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3
Calibration is done for all monitoring and measuring devices.

Operators are trained for handling the monitoring and measuring
devices.
Periodically, the equipments are validated by conducting round
tests apart from the calibration. The deviations if found are
analysed statistically.
Periodic checks are done for the validity of calibration and the
accuracy of results.
65. Decision of out sourcing
1
2
3
4
5
Out sourcing is done to reduce the cost of manufacturing.

Out sourcing is done not only to reduce costs but also to avoid
labour problems.
Out sourcing is done as we are not capable of meeting the
despatch schedules.
Out sourcing is done from a good party when we are not getting
quality.
Out sourcing is done for the process which we do not have.
66. Control of out-sourced goods
1
2
3
4
Payment shall be made only for good quality materials supplied

in time.
Out sourcing contractor is educated on our requirements by the
sourcing manager.
Our quality control person visits the out sourcing unit regularly
and inspects the materials before packing.
The staff and other employees of the out sourcing unit are
educated on the quality requirements, and trained on job by
experts at our cost to produce required quality.
The internal quality auditors audit the out sourcing units also
on a regular basis to ensure compliance to the system
requirements.
67. Measurement of customer satisfaction
1
2
3
Reputed consultants are appointed for conducting customer

satisfaction survey.
The customer satisfaction is measured by the number of
complaints received and the orders booked.
Customer satisfaction is measured by continuity of a customer
for a long time with repeated orders.
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Customer satisfaction is measured by discussing with the

customer regarding the critical concerns and our ability to meet
his requirement in a scale of 1 to 5.
The customers customers are contacted with the knowledge of
our customers to find out the performance of our products at
the customers end.
68. Customer satisfaction assessment
1
2
3
4
5
The customer is assumed as satisfied when we do not get any

complaint.
Customer is assumed as satisfied when he is coming back with
repeated orders.
Customer is assumed as satisfied when he comes and discusses
the performance and gives suggestions for improvement.
Customer is assumed to be satisfied when he increases our share
in his purchases.
Periodic reviews are made to validate the customer satisfaction
data by linking it to company performance. New devices are
developed to get fairly reliable information for taking action in
time.
69. Internal quality audits schedule
1
2
3
4
5
Audits are not done as per plan and in some cases audits are
not done.
Audits are not done as per plan in 50% of the cases and are replanned where it is not done.
Audits are not done as per plan in some area, where as 75%
area, it is as per plan.
Audits are not done as per plan on the same day but at different
timing.
All audits are done as per plan.
70. IQA Quality of audit
The audit reports are written but auditors have not written date,
time, etc. at number of places. The auditee has signed and
accepted the non-conformity, but has not written the root cause,
the proposed date of taking action. The clause numbers are not
correct.
The clause numbers written by auditor are not correct and no
one has taken objection for that. The auditee has written the
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3
4
5
proposed date of action, but has not identified the root cause.
The clause number is correct, but the non-conformity is in a
suggestion mode or dictation mode. The root cause analysis is
not made by the auditee. The MR has written the root cause.
The root cause analysis is made by the auditee for all the nonconformities and actions taken.
Trend analysis is made for identifying the repeated type of nonconformities and taking preventive actions. The MR is tracking
the progress.
71. IQA Closing of the NC
2
3
4
5
Number of NC is not closed and kept pending for months. They

are closed after the follow up of MR just before the external
audits.
Non-conformities are closed but later than the committed date.
The MR follows up on weekly basis for closing the NCs.
Non-conformities are closed on the committed day in majority
of the cases, where as in few cases it was late. The auditee
takes initiative.
Majority non-conformities are closed before the committed date.
Average days for closing NC is monitored and trends are drawn
which show a continuous improvement.
72. IQA Auditor competency
1
2
3
Quality control checkers are taken as quality auditors as they

have experience of auditing on a regular basis.
Smart intelligent officers from different sections are taken and
given the responsibility of auditing.
Auditors are selected from all sections, with an aptitude for
learning and are smart in identifying the deviations. They were
trained internally by a consultant as auditor.
Auditors are sent for training by a competent authority, which
train and conduct a test and give certificate to those who have
completed successfully.
Auditors are trained under eminent lead auditors, and refresher
trainings are given to improve their auditing skills.
73. IQA Auditor punctuality
A number of auditors have not reported for the audit and MR

could not make any alternative arrangement.
2
3
4
5
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Some of the auditors could not attend in time, but have informed
the MR in advance. No alternative arrangement is made.
Auditors are conducting the audits on specified date or on
mutually agreed date in consultation with the management
representative. Some reports are delayed.
Analysis of auditors punctuality shows a positive trend and
continuous improvement. Some audit reports are submitted late.
All auditors are attending the audit as per schedule, and
submitting the report in time.
74. IQA Auditee response
1
2
3
4
5
Auditee is afraid of the audits and wishes to avoid. Some of the

HODs have not faced the internal audits.
Some of the auditee team members are confident of facing an
audit, and are covering other colleagues. The HOD always
presents such persons to face the audit.
All members are ready to face an audit, but prefer not to get
audited.
All members are willing to get audited and invite the auditor to
conduct audit in his/her area.
Members are disappointed if the auditor does not visit their
area.
75. IQA AuditorAuditee interaction
1
2
3
4
5
Auditee simply accepts the report given by the auditor.

Auditee seeks the help of management representative for
understanding the comments made by auditor.
Auditee demands clarification where the wordings are not clear.
Refuses to accept a non-conformity if clarity is not there.
Auditee accepts the non conformities willingly and works to
close at the earliest.
Auditee closes the NC at the earliest and goes to auditor to
close the NC.
76. Top management commitment in audits
1
2
3
Heads of the department are not following for getting their area
audited.
Heads of the department are not getting their area audited, but
are directing the auditors towards subordinates.
Head of the department sits for audit for some time, and then
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4
5
goes out because of emergency works/meeting/follow up for

production.
Head of the department attends the audit fully, but leaves the
responsibility of closing the NC on the subordinates.
Head of the department takes active part in audits and follows
up with his subordinates and gets the non-conformities attended
at the earliest.
77. Measurement of processes
1
2
3
4
Processes are assessed on a subjective basis, as no measurables

are identified.
Majority of the processes have measurable parameters.
All processes have measurable parameters that can be controlled
and used as a tool to measure.
Critical processes are periodically reviewed by top management
for performance, where as others are left to supervisors and
shop floor workers.
Critical processes are reviewed by top management on a regular
basis, and the HODs review all the processes in their work area
on a periodic basis.
78. Monitoring of process
1
2
3
4
Processes are set as per the suggested parameters before the

start of the works.
Quality control investigators study the process efficiency and
give their report to the management.
Control points identified for the process are monitored by shop
floor supervisors and reported to HOD on daily basis.
The HOD is reviewing the monitoring activities at random along
with the supervisors and ensures the compliance and
performance.
The system of process monitoring is reviewed periodically by
the top management for its effectiveness.
79. In-process product inspection
1
2
3
Concerned departmental head sends samples to laboratory and

get the quality tested before starting any new lot.
Laboratory assistant collects samples as per the sampling plan
given to him, and get the materials tested in lab.
The shift supervisors test themselves some of the lots in addition
125
to laboratory testing in case of critical quality requirements.

The operators ensure the quality by checking the materials
produced with reference to a standard material at the start of
each day/shift.
The operators ensure the quality by checking the materials
produced with reference to a standard material at regular
intervals.
80. Final product inspection
1
2
3
4
SQC inspectors draw the samples from packed materials at

random and check for the conformance.
SQC inspectors draw samples ready for packing and check for
the parameters and then allow the packing to be done.
SQC inspectors draw samples from ready stock as well as from
warehouses and check for their conformance.
SQC draws sample on daily basis before packing and test them.
The results are compiled for the lot, and the variations with in
lot are studied before despatching.
Apart for checking the materials before packing, after packing
before despatch, SQC draws samples from the passed lots and
preserve at the laboratory, and check them for change in
properties after lapse of certain months and season.
81. Acceptance criteria
The specifications and tolerance developed by statistical

approach by our R&D shall be the base. Any material out of
tolerance shall be rejected.
The specifications and tolerance given by the customer shall
be the base. If any material is found out of tolerance shall be
rejected.
Basing on the customer specifications control charts are
developed and run theory is applied for accepting and correcting
the product. A process capability index of 1.33 is targeted (3
level).
Control limits are made stringent to accept only if the process
capability is 1.7 and above with the specifications and tolerance
given by the customer as the base.
Control limits are set to accept materials if the process capability
index is around 2 with the specifications and tolerance given
by the customer as the base (6 level).
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82. Identification of non-conforming product

1
2
3
The packers identify the non-conforming products and remove

them before packing.
Non-conforming products are identified by specially trained QC
checkers on line apart from the final inspection by packers.
Apart from the QC checker, whenever the HOD and general
manager come on round, they identify some non-conforming
products and remove them.
Supervisor checks the quality of material in process and in stock
and removes the non-conforming material. This is in addition
to checking by QC and the final packers.
The operators ensure the quality by carefully observing the
materials produced and identifying the non-conforming products
on-line, in addition to inspection by QC, supervisors and the
packers.
83. Segregation of non-conforming products
1
2
Rejected materials are kept at a specified place as decided by

the supervisor and the details are written in log book.
Rejected materials are tagged with Red tag and kept at the place
decided by the supervisor, and the details are written in log
book.
Specific bins are identified and earmarked for keeping the
rejected material. The supervisor enters the details in the log
book.
Specific bins are identified and earmarked for keeping the
rejected material. The supervisor ensures that all rejected
materials are kept in that bin, and entered in the log book.
Non-conforming materials are put a tag or given a different
colour code and kept at the bin reserved for rejected materials.
A separate register is maintained for tracking the generation
and use of rejected material.
84. Authority to dispose non-conforming products
1
2
3
Worker on the spot is empowered to take a decision for

scrapping or using the nonconforming materials.
The supervisor on floor is authorised to decide on spot the
disposing of the nonconforming material.
The chief of production operation is authorised to decide on
the mode of disposal of rejected goods including its reuse as
per the situation.
4
5
127
The chief of quality shall discuss with the chief of production,

and jointly decide the disposal action.
The chief of marketing, chief of production and chief of quality
jointly take a decision for the disposal of non-conforming
materials.
85. Recording of non-conformities and actions
1
2
The supervisor daily enters the quantity of wastes produced in

the log book.
The supervisor daily enters the quantity of wastes produced
and the wastes reused, the rejections made and sent as saleable
wastes in the log book.
The supervisor records the reason-wise non-conformities found
and the quantity rejected and reused/altered in log book, which
is reviewed by the HOD on daily basis.
A separate register is maintained for tracking the generation
and use of rejected material. The supervisor ensures the entry
of required information reason-wise.
The physical verification of non-conforming materials in stock
is made once in month to reconcile the data entered in the
register.
86. Verification after correction
1
2
3
4
5
The one who is correcting is responsible for ensuring the quality,

and delivers to packing.
The packing in-charge gets the verification done of the repaired/
corrected items.
A separate quality control team verifies the corrections made
and approves the corrected material.
Verification after correction is done by the same person who
had rejected it.
Verification after correction is done by a team consisting of
quality control and marketing personal along with the person
who had rejected it earlier.
87. Analysis of data
1
2
The concerned supervisor or in-charge analyses the data on dayto-day basis to ensure it as correct, and takes decision accordingly.
The HOD analyses the data submitted to him for its correctness
and takes actions for the deviations.
128
3
4
The HOD gets the trend charts prepared of the data and analyses
on a monthly basis.
The cause-wise trends are prepared and analysis is made on
monthly basis, season wise, product wise and submitted to top
management.
The trends of improvement or deterioration are compared with
similar industry, and also with the best in the class. The reasons
for deviations are identified.
88. Measuring the objectives
1
2
3
4
The company objectives are the targets to be achieved on a

long-term ideal situation and cannot be measured.
Measurable for each objective is identified, and the unit of
measure is defined.
The extent to which the objectives are achieved are verified on
an annual basis while preparing for surveillance audits.
The measurable are identified for each of the key result area
identified for the objectives, and performance is measured and
reviewed on a monthly basis.
The measurable identified are reviewed on a yearly basis to
find their suitability to represent the achievement of the
objective in a true sense.
89. Continual improvement
1
2
3
4
Areas where improvements are seen are highlighted on monthly

basis to encourage others to improve.
Targets are revised considering the performance of previous
month on a practical approach.
Targets are given in selected area, and teams are formed to achieve
it. The results are monitored and presented in management review.
Key result areas are identified for meeting the company
objectives and targets are fixed for them. Action plans are made
to achieve them.
Targets are stretched where the results are achieved to move
towards the benchmarks or to remain as benchmarks.
90. QMS effectiveness
The quality policy and objectives are known to senior officials.

The procedures are written as per mandatory requirements.
Quality manual is written.
129
Procedures and instructions are written for all activities.

Processes are audited as per schedule. Records are maintained
as per the requirement
The policy, objectives, procedures, organization structure are
reviewed periodically and communicated to all. The people are
adequately trained to perform their jobs.
All the processes are realigned considering the market needs,
the resources are provided to achieve the results, and process
is corrected when deviations are found.
Proactive actions are taken to prevent deviations in the process
performance and in delivering the goods and services. Continual
improvement is achieved in customer satisfaction, company
performance, and in the employee morale.
91. Corrective action
1
2
3
Reply made in time for the complaint and non-conformities

received.
Complaints and non-conformities are discussed with senior
members and suitable reply is drafted in a convincing way.
The persons responsible for the non-conformity are apprised
of the situation and the corrective actions to be taken are decided
depending on the situation.
Analysis of the complaint and non-conformity are done by a
team of experts and the root cause is found. Actions are taken
to correct the root cause.
People working are involved in analyzing the problem, and
identifying the root cause. The corrective actions are jointly
arrived at by considering the pros and cons. Actions are taken
and the procedures are modified to ensure that the problem does
not repeat.
92. Preventive action
1
2
The Board of Directors by taking views of eminent consultants

works out the strategy to face the potential problems.
The CEO discusses the potential problems with the HODs in a
meeting during his visit to the company. Serious issues are
discussed by taking the union into confidence.
The HR, purchase and marketing personnel, who have daily
contacts with outside world, collect information through various
sources regarding the changes that are taking place and advise
the management regarding the potential problem.
130
4
All employees are encouraged to identify potential problems

according to their level of thinking and submit to the HRD.
These are reviewed by a committee where preventive actions
are proposed for the potential problem.
The person identifying a potential problem is encouraged by
making him a committee member for identifying a suitable
preventive action and for training the fellow employees in
preventing the problem. The top management gives full support
to prevent that problem.
93. Involvement of top management
1
2
3
4
Preparation of quality policy and objectives.

Involved in defining of organization structure, authorities and
responsibilities, and preparing the quality manual.
Involved in the regular internal audits, reviews of all activities
and training programme.
Actively involved in getting the nonconformities closed in time
of all sections, physically verifying the resource utilization and
company wide implementation of QMS.
Reviewing periodically the effectiveness of implementation of
QMS and providing necessary guidance and resources for
making it effective company wide.
94. Employee well-being
Minimum wages are assured for employees as per the statutory

requirements. Workers are paid bonus, gratuity, provident fund,
ESI facilities etc., as per the regulations.
Workers are encouraged to do overtime so that they can earn
something extra. Salary advances are given for festivals.
Employees are allowed to accumulate their leaves and encash
when needed.
Incentives are given based on regularity in attendance and
achievement of production. Workers intending to study are
encouraged by adjusting their shifts and providing leaves for
examinations.
Scholarships are paid to meritorious children of employees in
tenth standard. Soft loans are given to needy employees
considering their performance. Employees children are given
preference for jobs.
Interactions are made with families of employees to understand
their needs, and help rendered where ever practical.
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95. Employee satisfaction measurement

1
2
3
4
Employee satisfaction is measured by conducting survey from

external agencies.
Employee satisfaction is measured by the absence of strikes
Employee satisfaction is measured by the reduction in
absenteeism, employee turn over.
Employee satisfaction is measured by improved performance
per employee, i.e. production along with quality at lower
expenses.
Employee satisfaction is assessed by close interaction with
employees and understanding their views and problems.
96. Strategy for continual improvement
1
2
3
4
5
Latest technology shall be adopted by keeping continuous vigil

on the technological developments.
Training and retraining the employees shall be given preference
to improve productivity and reduce wastes.
Benchmarking the best in category shall be adopted to improve
the systems continually and reduce costs.
Unexplored area by our competitors shall be explored to develop
niche products and markets.
Market surveys are done along with customers for their market
to understand the change in requirements and processes are
aligned as per the future needs.
97. Involvement of people
1
2
3
4
5
People never refuse instructions.

People willingly come forward and take instructions.
People discuss the points before accepting.
People do the work as required and there is no need for follow
up.
People report the activities from time to time and get ensured
that they are as per target.
98. Supplier relationship
1
2
Suppliers have to agree to our terms as we are giving them

business.
We ensure proper payment in time as agreed provided the quality
of materials are good and supplied in time.
132
3
4
5
Supplier takes back the materials and settles claims whenever

we complain.
Supplier discusses his problems and costs and the same are
studied carefully to enhance price if needed.
Supplier is involved in product development and the costs are
worked out jointly and processes are adjusted to suit the
required.
99. Leadership
2
3
4
5
People respect the CEO. Whenever he visits, complete premises

shall be kept clean and senior officers shall be present during
his rounds.
Whatever the CEO says is the ultimate and everyone follows it
with out any grumbling.
CEO discusses the plans and problems with senior managers,
and reviews during his next visit.
CEO demonstrates his commitment to the system by personally
following it all the time.
CEO discusses his plans even with senior workmen and union
leaders while planning for future, and implements the plan as
discussed.
100. Fact-based decision
1
2
3
4
5
Records are maintained at all important places, and decisions

are based on the data available.
The decisions are taken basing on the facts provided by the
concerned heads of the department who scrutinize the data
before submitting further.
ERP system is implemented and hence all data are captured by
the system and decisions taken accordingly.
Computer software is periodically calibrated to ensure its
suitability and reliability for the purpose.
Linking exercises are done to cross check the validity of data
before taking any decision.
By assessing our present level of maturity, targets can be given to achieve

the next level in certain time frame. Once the targets are given, it is not
only the employees, but also the top management must work to achieve
the target. Once we achieve the score at highest level, the questions may
be changed considering the latest developments in the concepts and the
systems.
Welcome
Welcome
the complaints
133
6
Sulabha purusha loke satatam priyavaadina

Apriyasya cha pathyascha vakta shrota cha durlabha
Vasista
$.1
Who is interested in complaining?
The shloka (stanza) quoted above is from Ramayana, the first known written
epic on this earth; that was written about 51 centuries back by saint
Valmeeki. He quotes the advices of Guru Vasista explaining to Lord Rama
when he was crowned as an emperor. He says that it is very easy to get
people always uttering sweet words and praising, but it is very difficult to
get people who can tell the truth (comments and facts) that is not liked or
tolerated by others and also the people who can listen to those comments
and facts. This does not apply only to an emperor like Lord Rama, but also
for all and at all the time. It is true with our customers also.
The customers are interested in doing their business and are not really
interested in wasting their time and efforts in making comments, either
good or bad, about the products and services they received. If the quality
is good, they shall be happy to come back to us. If the quality is not
satisfactory, the customer might grumble. Customer makes a complaint
when he/she feels that the complaint is likely to help his/her business/
activities.
It is observed that a customer will not complain every time even though
the quality of products and services are very poor. Out of 100 customers,
only 1015 customers make complaints or comments. Even if we send the
questionnaire, or personally request the customers also, we never get 100%
response. A response of 2530% is found normal in the customer
satisfaction surveys. Let us have some examples.
While you are driving in an unfamiliar road, you go to a road side

caf and take a cup of coffee or tea. The quality is not good. Are you
going to complain? The answer is No. But if the quality of tea is
bad in your favourite hotel, where you go regularly, you will complain.
If you happen to go in the same road again, you might prefer to try
133
134
6.2
at some other caf, and not go to same place where your experience
was not good.
You feel something as unethical and you are not doing it. Some one,
whom you do not know is doing that unethical work, are you going
to advise him? The answer is No. It is not my business. If the same
is done by your brother or a close friend, you are advising.
In your office, your boss is not good in language. He makes mistakes
in using appropriate words, and hence it might mean different. Are
you going to tell your boss to correct his language? The answer is
No. If the same mistake is done by your younger brother or sister,
you would like to correct them and explain as to why that was wrong.
Some times you might make a skit by imitating the language and
style of your boss on a happy occasion with your friends.
When customer complains?
A customer makes a complaint when he/she has a feeling that the company
listen him/her and is likely to improve. When customer is interested in
your products and services, and feels to continue business, he shall explain
the lapses and request you to improve in those areas. The customer is
interested in getting good products and services in time so that his business
is not affected.
Normally, customers are not interested in changing their suppliers. You
can take your own example. Even though there are hundreds of grocery
shops dealing with the same commodities in a market, you normally go to
a specific shop. The products are same, the quality is same, the price is
same and even then you do not go to another shop. Somehow you are
comfortable with that shop. If some one asks you, you cannot justify with
proper reasons as to why you like that shop. Similar is the case with our
customers also.
For any business identifying new customers and convincing them to buy
their products and services is not an easy task. It requires lot of efforts and
there will be expenses. Similar is the case with developing a supplier.
Developing a supplier to meet our exact requirements may be sometimes
costlier and also risky. This is truer when we are making specialty products
with our own innovations. The customers do not like to change their suppliers
if they have a confidence that the supplier shall improve and provide quality
and services as needed. The customers give their feed back to their suppliers
when they are satisfied with the performance. If the supplier is not improving,
the customers have no other alternative than to search for a new one.
Another interesting phenomenon observed is that as the quality
improves, the complaints also increase. People might laugh at this
statement, but it is true. Take some examples.
135
People travel daily in crowded city busses or local train. The buses or
trains might come late or the commuters might not get a seat to sit
comfortably. But they never complain either for the train or bus coming
late or for not getting a seat for sitting comfortably, although they have
paid money for ticket. They can sue the railways or bus service for not
providing a seat and making them standing or virtually hanging in a bus or
train, or not for maintaining the time as per the published time table. It is
the duty of railways or road transport corporations to provide seat to all
their passengers, or charge less for the passengers standing. The bus or
train services should compensate for loses incurred by the commuters for
delays. But it never happens. By seeing the plight of their employees, if a
company introduces free bus service, then people complain of not coming
in time. Normally, seat is provided for all on all the days; however, on a
particular day, due to some emergency, if one or two passengers are taken
extra, the people make complaint.
The customers want consistency in quality and supplies and not very
good quality at some times. If you are consistently providing a poor quality
and service, your customers get adjusted to it. They will be coming to you
till they find another alternative that is better than you. They will not make
any complaint. However, if you start improving your quality of products
and services, the customers shall be happy and they will stick to you. The
expectations of customer will increase as your quality of product and
services improve. They will now have a different tolerance for the same
products and services, based on the best services you provided. They will
show their displeasure if you slip down from your achieved levels.
Therefore, you should always have a system of reinforcing the systems
and sustaining the performance at improved levels.
6.3
When customer does not complain?
Normally, people will be happy when they do not receive any complaint.
They assume that their products and services are good. They feel bad when
they receive a complaint. However, we need to go deep and analyse.
A customer, who was earlier making complaints, has stopped making
complaints. Is it a good sign or a bad sign? Please make analysis. Have
you really improved the products and services to his satisfaction? Have
you responded to customer all the time positively? Whether customer had
agreed with your views and changes made? Are you having a mechanism
to verify from whom that customer is procuring similar products? What is
your share in the products and services to that customer? Whether that
share is increasing or decreasing? Whether the customer is having the
same confident as he was having earlier? A customer who was regularly
complaining cannot stop complaining unless he has decided to move out
136
from you. People in business do not want to complain while departing as

they want to maintain relationship. They may come back to you after some
time.
If the customer loses confidence in you, he will not complain. The
customer might be continuing with you because he has no alternate source.
The moment he identifies another source, he shall stop buying from you.
Till that time, he shall be somehow managing with you. It does not mean
that he is very happy.
The customers come to you by seeing your advertisements, outward
look of you factory, the certificates you have, the machineries and the
infrastructure. However, he gets the real feel of your company after getting
your products and services. He makes an analysis and finds the gap between
his expectations about your company and the extent to which they are
accomplished. If the gap is more, the customer makes an opinion that you
are not suitable for his business. He does not want to waste his time and
money in complaining, sending the complaint samples, making
correspondence, etc. He rather utilizes that time and money to find an
alternative source.
It is observed that the customers those are complaining are the ones
taking more materials from us. It is observed that only 1015% of the
customers make complaints but they normally lift 6575% of the materials
produced. Non-complaining customers are normally one time visitors, or
using us as a standby supplier.
The one-time customers are very dangerous. A dissatisfied customer,
who is moving out, is found to advocate at least 20 other potential customers
not to try with that supplier. These 20 potential people quote this customer
to their friends for not choosing a particular supplier.
It is very difficult to build an image, but is very easy to destroy.
6.4
Customer a free consultant
If we are responding to customer needs, the customers shall proactively

give us feedback on the changes in market requirements, the changes we
need to incorporate in our products and services, the likely changes in the
legal and regulatory requirements, etc. Good companies make use of this
and improve. If we do not listen to the customers, and feel that he is making
complaint only to squeeze us, then he will not make any complaint or give
any feedback.
Customer is a free consultant. He shall not charge for the suggestions
given by him, but would like us to incorporate those suggestions in regular
working. If we improve, he will get good quality products and services.
Therefore, he can improve. If he improves because of us honouring his
suggestions, he will stay with us. It is therefore essential for us to respond
137
to the customer and take advantage of his knowledge and experience in

making our products and services competent, so that we can survive in the
market.
If we want the suggestions from a consultant, he shall charge for it. The
consultant can give a suggestion, but not the business. But a customer
gives business when his suggestions are honoured. Customer shall be happy
and give business even if his idea or suggestion could not give an
anticipated result. He shall be happy that we have honoured him and are
with him.
138
Face the audits

Effective implementation of quality management
systems
7
Face the audits
7.1
Why to face audits?
The audits are conducted to ensure that the company is adhering to the
requirements of the standards, and are following their procedures that are
written in order to achieve their organization goals. A periodic audit helps
the auditee to take corrective actions on the deviations and align the
processes inline with the requirements. This helps in reducing the mistakes.
Audits may be internal or external, but have the same objective of ensuring
compliance to the systems and to highlight the deviations for taking actions.
Audits are the eye openers and help in detecting the deviations in the
beginning itself, before it grows as a major problem or become fatal. The
studies and experiences have shown that eliminating a problem at seed
stage is easier than removing a grown tree.
The analysis made by American Association for Safety and Health revealed
that behind every fatal accident there were 30 near misses and 300 unsafe
conditions. To prevent fatal accidents one has to concentrate for proactively
eliminating unsafe conditions. The unsafe condition is easy to attend like a
problem in the seed stage; but people ignore the signal given by the spread of
unwanted seeds. The near misses are like a problem in the seedling stage. It
is possible to remove the seedling with slight effort, but people do not spare
their time to do that. Finally, when it becomes a tree, it is not possible to
remove or not viable to remove. People learn living with the problem or become
a victim of it. The same is true in case of the non-conformities raised by the
internal and external auditors. It is easy to stabilize the systems by making
root cause analysis for all the non-conformities observed and taking prompt
corrective and preventive actions. However, it is seen in a number of cases
that the people try to avoid facing audits because of the fear of a non-conformity
being identified in their section. They feel bad when non-conformity is written.
By feeling bad or avoiding the auditor, we will be allowing the unwanted
seeds of problem to grow ultimately resulting in major problems.
One might have devised a very good system, but whether the same is
implemented as per expectations is always a question, as the one who
designed is normally different from the one implementing. There might
be number of unintentional deviations because of communication lapses,
understanding with a different perspective and the circumstances.
138
Face the audits
139
Some times it is seen that the system documented is outdated and the
people have adopted an improved method for their works. In such cases,
the audits indicate that the procedures need to be documented properly as
per the changed working systems. If the documentation is not changed,
there are chances of some people following the old system and some with
new, finally resulting in the variations and poor quality. It is a known fact
that one cannot identify some of his/her mistakes or deviations, where as
an outsider with an open mind can identify them. Therefore, getting the
self-audited by an outsider at periodic intervals is suggested.
Audit is a process to ensure conformity to the systems.
Audit is conducted by trained experts.
Auditor is not interested in finding a mistake, but any deviation found
from actual to practice shall be highlighted as a deviation; might be
a non-conformity or an observation.
We go to doctor periodically to get ourselves checked. If any disease
is found building up, we take preventive medicines, and some times
even undergo surgery (for e.g. by pass surgery) to prevent the problem.
Here auditor is a doctor, and hence we should cooperate with him
and show frankly whatever is asked.
Do not show anything which is not asked, as auditor is not a perfect
doctor to suggest you remedies for everything.
Behind every fatal accidents there are 30 near misses and 300 unsafe conditions.
Problem in tree stage

[Disasters at work place/
Company is in trouble]
Problem in seedling stage
[Prompt actions not taken on
market complaints
Problem in seed stage

[Signal ignored/ Actions not
taken on the NC found in
Audits]
1 Fatal Accident
30 Near Misses
300 Unsafe
Conditions
Problems at work place //Deviations in systems
7.1 Theory of 130300.
140
7.2
Basic human nature
It is normal that human beings want to rest and enjoy their life. They try
to avoid the works whenever an opportunity is there. This basic nature led
to the development of science and technology. Lots of automations are
done and the machines are doing the works that were earlier done by
humans. The basic aim is to reduce the works as much as possible and still
get the result.
Another nature of a human being is to forget. It is a gift given by got,
although we find in a number of cases the ill effects of forgetting. We
cannot remember everything. But we cannot always remember what we
are supposed to remember. The reason for forgetting is mainly due to
diversions in our attention because of changed requirements. We normally
do not forget the steps in an activity that is done on a regular basis. As the
time passes, we forget those events. It is therefore suggested to refer the
documented manual and procedures periodically and ensure that we are
following all the steps as documented, and modify the documents in the
event of any improvement done.
7.3
What shall be audited?
The auditing is done mainly to verify the conformity to systems and not to
pinpoint that a person has done a mistake. It should identify the deviations
in systems and not one persons failure in performing an act. The audit
should concentrate on;
Whether we are clear on our roles and responsibilities.

Whether we have established systems to carry out the activities.
Whether all are working as per the established systems that are
documented.
Whether we can provide evidence of adhering to documented systems
all the time.
Whether we are clear with the job description for each job with clear
authorities and responsibilities.
Whether we have defined clearly the minimum competency levels
for each job.
Whether we are clear about the competency levels of the people doing
the jobs and whether the records are maintained with the concerned
HOD or section head to facilitate them allotting job to people.
Whether we are analysing the deviations for the root cause and taking
appropriate corrective and preventive actions.
The questions detailed in Chapter 4 under the heading of internal quality

audits holds good for external audits also.
Face the audits
7.4
141
Preparing for the audit
Although we say that we work always as per the systems, the mind needs
certain preparation before facing an audit. We need to keep some time
reserved for interacting with an auditor. Therefore it is common that the
audit date and time are fixed with the consent of the auditor and the auditee.
The dates are announced in advance so that both auditor and auditee can
prepare themselves.
The auditor prepares himself by reading the manuals, procedures and
the previous audit reports before coming for an audit. The auditee needs
to ensure that all are working as per the systems, people are confident and
can explain their activities to the auditor and clarify the doubts or questions
asked. The following are some of the tips to prepare for facing an audit.
Ensure that all the staff members have read quality manual and
understood.
Ensure that all are well versed with the procedures and instructions.
Ensure that all are clear about quality policy and can explain their
role in implementing it.
Prepare trend chart for the objectives achieved in your section for at
least one year.
Ensure that all records are up to date.
See that records are kept in their respective places all the time.
Check for the label, title etc., for the records as per procedure.
Ensure that for all non-conformities, complaints etc., actions are taken
and are recorded. [Note: There should not be any pending nonconformity]
Check the calibration status for all the equipments.
Ensure calibration stickers on instruments.
Demark place for keeping non-conforming products at appropriate
places in production, stores and ware houses.
Do not keep any unwanted material, machine, men etc., in work place.
If any idle machine is there, put a board stating it as idle, and not to
start. Remove the fuse for safety.
Ensure that all associates are clear about work instructions. They
should read and explain.
Ensure that all forms used are numbered, and referred in work
procedures and work instructions.
Ensure that all non-conformities raised in previous audits are closed
in time.
There should be a root cause analysis for each of the market
complaints, non-conformities raised not only in ISO 9000 audits,
but also for the points given in quality control audits, buyer audits,
safety audits, tool audits etc. Keep evidences for the actions taken.
142
7.5
Ensure that actions are taken in time for the points raised in
Management Review Meeting. [Note: Any delay or non-taking action
shall be taken seriously by external auditors as they reflect badly on
top management commitment].
Make market complaint analysis party wise, reason wise, and product
wise and show the trends for at least one year.
Keep the records of vendor analysis ready.
Keep the proof of letter written to suppliers for rejections, and low
rating in vendor evaluation.
Keep the records of training need identified and training given as
per the training need identified.
Face the audits
Face the audits with confidence. There is no need for panicking. An auditor
is a friend who has come to show us the possible areas for improvement.
Following are some tips for facing an audit.
The Audit shall start with an Opening Meeting. All H.O.D and the
guides must be present in time. No one should come late.
Introduce yourself briefly to the auditor during opening meeting and
express your willingness to improve self by the audits.
Ensure that meeting is concluded as per the time table given. Do not
waste the time by talking unrelated matters.
Keep good house keeping as it shall give the first impression of your
systems.
Head of the Department must be present in the audit.
Introduce yourself and your assistants to the auditor before the audit
starts.
Offer Tea, Coffee or soft drinks while the audit is going on, but after
asking the auditor about his/her choice.
Do not attend to any phone calls during audits. Tell very clearly that you
are in audit, and no one should disturb you. The top management must
ensure that they do not disturb any one when an audit is in progress.
Do not allow any one to enter the auditing area, unless the auditor/
auditee wanted him/her for audit purpose.
Listen to the question carefully before answering.
Answer only to the point, and do not show or tell any thing which is
not asked.
Do not argue with auditor while auditing is going on. Just note down
his remarks and discuss with MR and unit head before closing
meeting.
Do not bluff. Remember that auditor is a well matured person who
Face the audits
7.6
143
can make out what is real. He shall be linking your statement to some
other area for verification.
Do not become nervous. Remember that auditor is our friend who
shall show the area where we need improvement.
Auditor has seen different industries and has a fair idea of what is
practicable and what is not. Although auditor is not supposed to
suggest, shall give a hint while asking questions. Observe him
carefully and note down his reactions or observations.
Show the actions taken on the observations and nonconformities to
the auditor before the closing meeting. It shall impress the auditor
and shall demonstrate our enthusiasm for improvement.
Everyone who attended the opening meeting must be present in the
closing meeting, along with representatives of the area audited.
Maintain timings of the audit and the meetings.
Role of a guide
As auditors are out siders and do not have the clarity of different departments
and sections you have, please provide some one as guide. The guide should
be a neutral person for the section being audited. He shall just introduce the
auditor to auditee and make arrangements for getting the required people.
The guide will not answer any question on behalf of the auditee. He shall
just note down the questions and the reactions, and inform the management
representative in brief. Following are some tips for the guides.
7.7
A guide is a person who shall take the auditor round the sections as
required and introduce him to auditee.
Guide shall not answer to any question asked during audit, unless
the auditor asks the guide to give clarification.
Guide shall note down all the points like the questions asked, answers
given, points highlighted and remarks of auditor etc.
Normally a guide shall be a trained auditor from other section. We
need to announce the guides in the opening meeting itself and
introduce them to auditors.
Guide shall be interacting with management representative regarding
the progress of the audits, deviations found etc., so that MR shall
initiate corrective actions to close the NC before the closing meeting.
Understand the non-conformities and

observations
During the audits, the auditors observe some deviations. They either put
it as nonconformity or as an observation. The non-conformities are
144
supposed to be closed without undue delay by the auditee. It is found that

some of the leading certifying bodies have a practice of giving 90 days
time to close the non-conformity irrespective of the nature of the
non-conformity. The auditee feels it as not urgent. One should understand
that the non-conformity is a deviation and needs to be corrected without
wasting time. If a non-conformity can wait for 90 days to correct, there is
no harm if it is not corrected at all.
The auditee is found normally happy when non-conformity is converted
as an observation, as there is no need for closing it. However, these
observations, if not attended can lead to serious problems. The external
auditors are normally not interested in writing non-conformities for a
certified company, as they are afraid of their accreditation bodies who
question them as to how the certificate was granted. They are writing the
serious problems, where top management involvement is needed and time
taken to close it shall be more as Observations instead of
Non-conformity. If any deviation is simple and the auditee can take
immediate action, it is written as non-conformity. It is actually a bad
practice of the certifying bodies. If a company wants to improve, give
equal weightage for observations also and see that they are attended without
undue delay.
It is normally seen that the people regard the auditors as experts and go
by the wordings. It should be noted that an auditor is an out sider, and in
a number of cases, a man from different discipline. You are the one working
all the time and you know your business. Therefore try to understand the
essence and device the systems suitable to you. If you are not convinced
with a non-conformity or observation, you can discuss with the auditor
and ask him to clarify your doubts.
On should remember that auditors also are human being like us, and in
number of cases, they do not have the practical experience. Therefore,
there are instances that they are over emphasizing and making the life of
auditee miserable. Numbers of unwanted documents are prepared just to
satisfy the auditors, and hence in a number of companies, people hate the
audits and the auditors. The auditor should be able to explain the ill effects
of a non conformity and its severity in making a company ineffective. The
concept of So What? is to be applied. The auditor should ask himself as
to what will happen as a result of the deviation found. There are cases
where the auditee has maintained his records and documents in soft copy,
and are maintaining hard copies because the auditor insisted. In one of the
textile mill, the auditor had raised a non-conformity on quality control
department for not maintaining the action taken record for the
environmental impacts because of shrinkage testing. In shrinkage testing,
a 50 50 cm grey fabric is soaked in water and dried. What environmental
impact can be made by this test? In another instant, the auditor had raised
Face the audits
145
non-conformity for computer services department of a large textile mill,

that the power consumption was not monitored, where as that room had
one server, 4 personal computers and 8 tube lights. What is the impact of
power of this section compared to the machineries run in the textile mill?
The same auditor writes it as an observation if the testing laboratory has
no adequate control on the humidity being maintained, as it needs an
investment and the auditee cannot close the nonconformity immediately.
The testing results are affected by the temperature and humidity, and the
international norms insist that 652% RH at 20C are maintained and
materials are conditioned in that atmosphere for 24 hours before testing.
As the mills cannot wait for 24 hours for taking a decision, the same is not
maintained. A number of equipments have come out to give rapid
conditioning for textile materials and all leading laboratories are following
it. But still the international standards organizations are not geared up to
understand the user requirements and are still insisting the 24 conditioning.
Whatever may be the case, for an external auditor as the auditee refers
that testing procedures as written by the internal standard organizations
like ASTM, BSI, BIS, etc., it should be viewed as non-conformity, but
they are just writing it as an observation.
The auditee should challenge if the auditor is insisting on something that
is not practicable or not helping the industry to improve. The impact of that
deviation on the quality and environment are to be seen. If it is a legal
requirement, then also a careful analysis is to be made of the situation. If the
deviation is affecting the safety then it should be regarded as non-conformity,
and not just an observation. In a number of companies, it is seen that the
safety precautions are not adequate, and the auditors just write it as an
observation. It is seen that numbers of companies do not follow the rules
relating to overtime payment, hours of working, payment of wages, etc., but
none of them are reflected as nonconformity during the audits by external
auditors. They argue that as out side the purview of their audits, but forget
that ISO 9001 insists following all the legal and regulatory requirements,
and clause 6.4 talks on work environment, not only the physical environment
but also the social environment that can motivate the people to concentrate
and work towards achieving quality and productivity. Therefore the people
are not recognizing an ISO 9001 certified company as an ethical company.
Even the companies having ISO 14001 are not respected by public.
Whatever may be the stand an auditor takes, the auditee should be sincere
in addressing all the issues and take corrective actions as the ultimate
judge is the customer, who shall be inspecting each and every product
through out its life, and can make an opinion of the company depending
on the products and services given on a consistent basis. Getting certificate
is to boost the morale of the people, and cannot be to satisfy the customer
or community around.
146
Appendix
Effective implementation of quality management
systems
Appendix 1
Departmental objectives and expectations
In this appendix, some examples are given for different sections of an

organization about their objectives, methods of measuring performance,
the results that can be shown, the procedures required and the records that
are to be maintained. Each organization should work out for themselves
depending on their activities and the objectives and develop systems.
1. Training
Objectives
1. To provide required training to the employees to meet the product
requirements and to achieve company objectives while adhering to
2. To enhance the skill of employees to help them improve productivity
and quality while reducing the wastes.
3. To build confidence in the employees regarding their ability to
perform and to achieve.
4. To build the feeling of oneness among the employees.
Performance indicators
1.
2.
3.
4.
Reduction in market complaints relating to worker controllable errors.

Improvement in worker efficiency.
Reduction in wastes relating to worker errors.
Clarity about the job content, the responsibility and authorities among
the employees.
5. Clarity about the product requirement among the employees.
6. No loss of production due to shortage of required skills.
Key result areas
1. Number of people trained; department wise, subject wise, skill wise,
in-house and out-house, on-the-job and in class room.
2. Number of training classes conducted; department wise, subject wise,
skill wise, in-house and out-house, on-the-job and in class room.
146
Appendix
147
3. Improvement in average skill level among employees.

4. The changes in syllabus/curriculum made to enhance the level of
learning and knowledge .
5. Number of group discussions, experience exchange programme,
brainstorming, seminars and conferences conducted and the
participants attended.
6. The results of training evaluation for all the trainings conducted: inhouse as well as out-house.
7. No repetition for the training need identified for the same person.
Procedures
1.
2.
3.
4.
5.
6.
Planning the training activities and training resources.

Preparing training calendar.
Evaluation of trainers; both in-house and external faculty.
Evaluation of trainees.
Evaluation of training activities.
Preparation and evaluation of training syllabus.
Records
1.
2.
3.
4.
5.
The persons trained subject wise, section wise.

The training hours per employee.
Training evaluation report.
Evaluation report of training faculty.
Evaluation report of the training aids; machines, equipments, slides
and other presentation materials, books and manuals, slogans and
displays etc.
Reference documents
1.
2.
3.
4.
5.
6.
Operating instructions
Standard work practices
Work norms
Product safety requirements
Company standing orders
Job descriptions
2. Human resource development departments

Objectives
1. To provide required human resources to the organization to meet the
requirements.
148
2. To enhance the cohesion among employees and management to help

them improve productivity and quality.
3. To build confidence in the employees and the community regarding
companys activities as ethical and legal.
4. To monitor all the activities of recruitments, promotion, termination,
disciplinary actions, welfare, industrial relations etc., while ensuring
them in line with the legal and regulatory norms, the business ethics
and human values.
5. To build the feeling of oneness among the employees.
1. No loss of production or delay in activities due to short of human
resource.
2. Reduction or no complaints relating to non-compliance of regulatory
norms.
3. Reduction in legal expenses.
4. Reduction in absenteeism.
5. Reduction in strikes and disputes.
6. Reduction in employee turnover.
7. Reduction in employee expenses as a percent of sales turnover.
8. Availability of complete information in the personal records regarding
the employees.
Key result areas
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Number of people indented and recruited department wise.

The time taken for recruitment.
Expenses for recruitment as percent of sales turnover.
Employee turnover.
Absenteeism.
Number of grievances reported and settled.
Number of strikes and loss due to strikes.
Number of legal cases in court.
Legal expenses as percent on sales turnover.
Welfare activities and amount spent (Budgeted and actual).
Welfare expenses as percent of sales turnover.
Number of activities conducted for uplifting the morale of employees
and management.
13. The results of exit interviews.
14. The results of employee satisfaction surveys.
15. Employee expenses as percent of turnover.
Appendix
149
Procedures
1. Planning the human resource requirement.
2. Calling the applications, conducting interviews, selecting the
candidates by referring to minimum competency requirements.
3. Providing induction to new recruits and explaining Standing orders
of the company and the legal requirements.
4. Maintaining attendance and providing data to accounts section for
salary and bonus payments.
5. Preparation and maintenance of personal records.
6. Preparation of statutory returns and submitting.
7. Monitoring the compliance to statutory, legal and regulatory
requirements.
8. Taking disciplinary actions for wilful violations of laid out laws and
systems.
9. Taking actions on absenteeism.
10. Taking action on negligence.
11. Monitoring overtime.
12. Counselling and handling grievances.
13. Encouraging employee involvement in activities of the company.
14. Receiving suggestions, processing them and taking necessary actions.
15. Transferring of employees.
16. Promoting employees.
17. Fixing salary for each job category.
18. Evaluating the job contents and fixing work loads.
19. Negotiating with trade unions and community leaders.
20. Planning welfare activities and implementing them.
Records
1. Personal files of each employee including those of retired, left and
dead.
2. Applications received for jobs.
3. Selection formalities like written tests, interviews and offers.
4. Attendance records.
5. Leave records.
6. Provident fund records.
7. ESI records.
8. Records of welfare activities.
9. Suggestions received and actions taken.
10. Records of grievances received and handled.
11. Minutes of meetings and negotiations.
12. Correspondence with factory inspector and other government offices.
13. Records of legal proceedings.
150
Reference documents
1. Applicable Factory Acts
(a) Minimum wages
(b) ESI
(c) PF
(d) Safety
(e) Working hours
(f) Settlement of disputes etc.
2. Applicable legislations Copy of gazettes
3. Reference of dispute settlements (Court judgments)
4. Standing orders
3. Stores
Objectives
1. To receive the materials and store them in identified location.
2. To get the approval of materials received by the concerned user
department.
3. To issue the approved materials to the users as per requirements.
4. To send the bills of approved materials for passing to accounts section.
5. To ensure safe storage of material .
6. To educate management regarding non-moving items from time-totime .
7. To maintain accounts of materials received, issued and materials in
stock and provide information for taking decisions on purchases.
8. To dispose rejected, damaged and non-moving items.
9. To send materials out on returnable or non-returnable basis depending
on the situation.
1. Reduction in complaints relating to non-traceability of materials intime.
2. Time taken for preparing the goods receipt notes (GRN) and getting
the materials approved.
3. Zero difference in stock shown and the actual stocks in stores.
4. Reduction in wastes and damages due to handling/storing at stores.
5. Clarity about the shelf-life of materials, storing them accordingly
and issuing by referring to expiry date.
6. Clarity about the materials requirement for different sections of the
organization.
7. No loss of production due to shortage of required materials in stores.
Appendix
151
8. Following up activities relating to materials sent out on returnable

basis.
Key result areas
1. The complaints and feedbacks received from other departments.
2. Number of days for preparing goods received notes and sending for
approval.
3. Number of days taken for sending the bills for passing to accounts.
4. Difference in actual stock and book figures.
5. Stock of non-moving materials in stores.
6. The damages during storage.
7. Inventory in stores as a percent of annual sales turnover.
8. Following up and receiving the materials sent out on returnable basis.
Procedures
1.
2.
3.
4.
5.
6.
7.
8.
Receiving, storing and issuing of materials.

Preparation of goods receipt notes and sending to user department.
Sending the bills of approved materials for passing.
Perpetual and periodic stock taking.
Identification and traceability of materials in stores.
Storing of hazardous materials.
Disposal of rejected, damaged and non-moving items.
Sending materials out on returnable and non-returnable basis.
Records
1.
2.
3.
4.
5.
6.
7.
The materials received

The materials issued
The materials waiting for inspection
Materials rejected
Rejected materials in stock
Evaluation report of stocks
Material sent out on returnable basis
Reference documents
1.
2.
3.
4.
Material safety data of the materials received

Shelf-life information of the materials in stores
Insurance guidelines for materials stored
Directory of transporters and material handling crew
152
4. Accounts department
Objectives
1.
2.
3.
4.
To maintain accounts of all monetary transactions.

To verify and approve the spending with respect to budget.
To pass the bill of approved materials and making payments.
Verifying the legal aspects and ensuring adherence to legal
requirements in money transactions.
5. To prepare the returns of monetary transactions as per statutory
requirements and filing them in time.
6. To prepare the statement of accounts like income and expenditure,
profit and loss, current assets and liabilities, balance sheets, etc., as
needed by the top management and submitting in time.
7. Advise the management in case of unwanted or excess expenses,
transactions violating the statutory and legal norms.
1. Speed of giving the accurate information relating to monetary
position.
2. Time taken for preparing the accounts statements like Income and
Expenditure statements, Profit and Loss accounts, Balance sheet, etc.
3. Zero difference in accounts shown and the actual money in hand.
4. Reduction in wastes and losses due to improper accounting and nonfulfilment of statutory and legal requirements.
5. Clarity about the accounts, and appropriate allocations.
6. Clarity about the money requirement for different activities of the
organization.
7. No loss to the company due to mistakes or delays in accounts sections.
8. Following up activities relating to money to be recovered.
Key result areas
1. The complaints and feedbacks received from other departments,
suppliers and customers relating to accounts.
2. Number of days for preparing accounts statements and balance sheet.
3. Number of days taken for passing the bills and making payment.
4. Difference in actual money in hand and book figures.
Procedures
1. Classification of income and expenditure and entering in records.
2. Preparation of accounts statements and submitting to management.
Appendix
153
3. Preparing returns as per statutory requirements.

4. Monthly stock taking and preparing the statements of inventory and
realization.
5. Identification and traceability of records.
6. Maintaining the records securely.
7. Disposal of obsolete records.
8. Following for payments for materials send out, money given on loan,
payments to be received as per regulations, etc.
Records
1.
2.
3.
4.
5.
The money received and spent party wise, section wise, reason wise.
The statutory returns filed.
The tax deducted and paid to government and taxes to be deducted.
Cash flow analysis and cash in-hand.
Audited statement of accounts and balance sheet.
Reference documents
1. Tax regulations latest.
2. Bank and other financial institution regulations.
3. Statutory regulations.
5. Production department
Objectives
1. To produce the required quality materials in time of the required
quantity.
2. To maintain the efficiency and utilization at optimum level to have
the lowest cost and get the required quality.
3. To maintain health and safety conditions for the employees as well
as for the products and equipments.
1.
2.
3.
4.
5.
6.
Production achieved product wise

Quality levels of the products
Reduction in rejections
Utilization of men and machinery
Production efficiency
Reduction in wastes
154
7.
8.
9.
10.
Increase in product realization

Cost of manufacturing per unit production
Accident free performance
Provision of required work environment
Key result areas

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
The production achieved against targeted.

Machinery utilization percent.
Reason-wise loss of production.
Production per operator.
Rejection percent.
Delivery committed and the actual delivery of final product to ware
house.
Cost of manufacturing per unit production product wise.
Number of accidents.
Product realization as a percent of material consumed.
Power consumption per unit production.
Water consumption per unit production.
Dust level in production area.
Noise level in production area.
Level of light (Lux) in working area.
Procedures
1.
2.
3.
4.
5.
6.
7.
8.
9.
Production procedures for different products.

Production planning.
Work instructions for each activity of workmen.
Allocation of men as per product requirement.
Arriving at process parameters for each product.
Identification and traceability of materials.
Maintaining the production records.
Disposal of obsolete records.
Following for maintenance and attending of breakdowns.
Records
1.
2.
3.
4.
5.
6.
Production records
Rejection records
Analysis of rejections and action taken
Analysis of breakdowns and actions taken
Analysis of accidents and actions taken
Action taken records for other non-conformities
Appendix
155
7. Maintenance and machine history

8. Materials received and consumed, wastes generated and product
realization
Reference documents
1. Customer requirements (specifications and purchase order details)
2. Industry norms of production, quality and work allocations
6. Maintenance department
Objectives
1. To maintain the machines to produce the required quality materials
in time of the required quantity.
2. To maintain breakdown free performance of the machines.
3. To maintain health and safety conditions of the machines and
equipments.
4. To maintain machines at lowest possible cost.
1.
2.
3.
4.
5.
6.
Breakdown free performance

Quality levels of the products and rejections
Utilization of machinery
Production efficiency
Cost of maintenance per unit
Accident free performance
Key result areas

1.
2.
3.
4.
5.
6.
7.
8.
9.
The availability of machines for production as percent of available time.

Machinery utilization percent.
Reason-wise breakdown.
Production loss due to breakdowns.
Rejection percent due to improper maintenance.
Cost of maintenance per equipment/machine.
Power consumption per unit production or per machine shift.
Noise level in production area.
Consumption of critical parts.
Procedures
1. Procedures for periodic preventive maintenance.
156
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Planning maintenance activities.

Planning for spares and indenting for procurement.
Procedure for attending breakdowns.
Work instructions for each activity of workmen.
Allocation of men as per skill requirement.
Setting the machines as per required process parameters.
Identification and traceability of materials.
Maintaining the maintenance records.
Conducting tool audits.
Verification of calibration of equipments and setting them.
Disposal of obsolete records.
Records
1.
2.
3.
4.
5.
6.
Machine-wise maintenance records

Machine history
Analysis of breakdowns and actions
Action taken records for rejections and other non-conformities
Spares and other materials received and consumed
Calibration records
Reference documents
1. Machinery catalogues and manuals.
2. Catalogues and manuals of lubricants, bearings, belts, etc., required
in the company.
References
157
References
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
DR . ALI AL -ZUBAIDI Business Sustainability: Key to Long-term Success

training organized by HKQAA on 27 March 2009. http://
qualityalchemist.blogspot.com.
B . PURUSHOTHAMA Winning Strategies Pubadchi Publications 2009.
D . L . SHAH TRUST ISO 9000 Quality Management Systems Guidelines for
enterprises in developing countries 1996.
PRADEEP KUMAR MATHUR Implementing ISO 9001:2000 Vikas Publishing House
Pvt Ltd 2003.
NAVIN SHAMJI DEDHIA Quality from Many perspectives D . L . SHAH TRUST .
B. PURUSHOTHAMA Guidelines for Process Management in Textiles CVG Books
2007.
Wikipedia The Free Encyclopedia http://en.wikipedia.org/wiki/Quality_
management_system.
ISO 9001:2000 guidelines.
Quality Standards ISO 9001:2000, Quality Management System http://
www.engineers-international.com/qualitysystem.html.
Definitions of Quality http://web2.concordia.ca/Quality/definitions.html.
SHYAM TALAWADEKAR Visual Management through Five-S: A Japanese Tool of
Kaizen Publisher Quality Management Systems Thane.
B . PURUSHOTHAMA Five Golden Questions A self assessment tool Quality
Update Nov 2007 Indian Society for Quality.
B . PURUSHOTHAMA Role and Responsibilities of Management Representative
Quality Update April 2007 Indian Society for Quality.
ISO 9001:2008 Guidelines Quality Management System Requirements.
Six Sigma Quality Dictionary.
ISO 9000:2005 Quality Management Systems Fundamentals and Vocabulary.
British Standard Institute Bench marking QMS implementation.
ISO 9004:2000 QMS Guidelines for Performance Improvements.
Index
Accounts department, 152

Action plan, 19
Adequacy audit, 46, 62
Affinity diagram, 86
American Society for Quality, 6
Arrow diagram, 87
Audit evidence, 56
Auditee interaction, 123
Auditee response, 123
Auditee, 83, 84
Auditor competency, 122
Auditor punctuality, 122
Auditor, 43, 63, 84
Audits, 46, 59, 138
Benchmarking assessment, 97
Boom period, 3
British Standard Institute, 4, 96
Bureau of Indian Standards, 15
Business ethics, 10
Capital investments, 77
Certificate, 47
Certification, 47
Coding system, 40
Communication systems, 73
Community, 9
Company objectives, 19, 51, 128, 146
Competency evaluation, 111
Complaint handling, 114
Compliance audit, 62
Continual improvement, 44
Contract review, 36, 114
Controlled document, 27
Corrective action, 45, 58
Cost factor, 38
Customer complaints, 133
Customer feedback, 74
Customer focus, 23
158
Customer perception, 73
Customer property, 41, 119
Customer requirements, 12, 72, 73, 77, 106
Customer satisfaction, 43, 120
Data analysis, 127
Departmental objectives, 19
Design control, 37
Design documentation, 37
Design review, 37, 115
Design validation, 116
Design verification, 37, 115
Despatch, 75
Document changes, 105
Document control, 26, 104
Documentation, 26
Documented quality standards, 56
Documents, 26
list of, 27
Effective audit, 83
Effective communication, 36
Employees, 9
Engineers International, 5
Ethical requirements, 9
Final audit, 47
Finance requirements, 78
Free consultant, 136
Full-proof systems, 42
General regulatory requirements, 10
Human resource, 31, 147
Information availability, 106
Information management, 76
Information, 42
Infrastructure, 33
Index
Internal auditors, 62
Internal communication, 23
Internal quality audits, 43, 56, 58
International Organization for Standardization, 5
International Quality Standards, 8
ISO 9000 activities, 50
ISO 9000 quality management systems, 95
ISO 9000 series, 4, 14
ISO 9000, 12, 46
ISO 9000:2005, 16
ISO 9001 guidelines, 96
ISO 9001, 13
Key result areas, 22, 146, 148
Legal and regulatory requirements, 9, 26,
107, 108
Linking exercises, 85, 94
Maintenance activities, 72
Maintenance department, 155
Management representative, 49, 50, 109
Management review, 29, 30, 109
Management system, 4
Management tools, 94
Market complaints, 107
Marketing performance, 74
Material handling, 41
Maximum retail price, 10
Measurement data, 42
Measuring devices, 42
Minimum competency, 31
Mission, 17
Monitoring devices, 42
Non-conformities, 122, 138
Normative references, 15
Obsolete documents, 105
Organization structure, 33, 103
Out sourcing contractor, 120
Out sourcing, 120
Packing quality, 41
Packing, 41
Performance indicators, 146
Periodic audits, 57, 119
Periodic evaluation, 31
Periodic reviews, 121
159
Planned arrangements, 57
Poka-Yoke, 29
Potential problems, 45
Procedure, 20, 28
Process audit, 80
Process design programme chart, 88
Process evolution, 101
Process implementation, 101
Process mapping, 87
Processes, 21
Product audit, 60
Product conformity, 44
Product design, 37
Product preservation, 41
Product realization, 33, 38
Product safety requirements, 10
Production control, 39
Production department, 153
Provision of resources, 30
Purchase order, 117
Purchased product verification, 39
QMS effectiveness, 128
QMS elements, 86
QMS implementation, 95, 98
Quality assurance, 76
Quality audit, 56, 79
Quality control investigator, 79
Quality control, 58, 59
Quality management system, 4, 5, 13, 14,
49, 52
Quality manual, 15, 23, 52, 100
Quality objective, 18, 19, 34, 35, 99
Quality plan, 35
Quality policy, 18, 99
Quality standards, 11
Quality systems, 11
Quality, 6, 7, 11
Questionnaire, 64, 65
Rationalization of employment, 2
Recession, 2, 3, 4
Record control, 105
Record maintenance, 106
Record, 28
Regulatory requirements, 9, 10, 25
Rejected materials, 126
Relations diagram, 86
Renewal audit, 47
Reviews, delegation of, 30
160
Effective implementation of Quality Management Systems
Routine problems, 45
Safety requirements, 108
Security, 79
Societal safety factors, 11
Special process, 40
Specific bins, 126
Standard formats, 28
Statement, 17
Statistical control process, 59
Stoppages, 94
Storage space, 38
Store, 150
Surveillance audit, 47
Sustained success, 4
System audit, 60
Technical know-how, 41
Top management review, 60

Top management, 25, 130
Trade regulations, 10
Trail audit, 47
Training evaluation, 112
Training need, 111
Tree diagram, 86
Uncontrolled documents, 27
Vendor development, 117
Vendor evaluation, 117
Vendor selection, 116
Vision, 17
Voluntary retirement scheme, 2
Work environment, 33
Work instructions, 103

Effective Implementation of Quality Management Systems (0857090011)

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Effective Implementation of Quality Management Systems (0857090011)

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Effective implementation of

quality management systems

WOODHEAD PUBLISHING INDIA PVT LTD

Published by Woodhead Publishing India Pvt. Ltd.

Understanding and implementation of

Roles and responsibilities of management

Who should be the management representative?

Internal quality audits: A strong tool for

Need for audits

Types of internal quality audits

Measuring maturity in QMS implementation

Need for measurement

Welcome the complaints

Who is interested in complaining?

Face the audits

Why to face audits?

Appendix 1: Departmental objectives and expectations

To survive on this earth, it is necessary to keep ourselves fit. It might be

Effective implementation of quality management systems

The recent developments of free trade and globalization opened the

As the technology progressed, the speeds of production increased. The

1.1 Cycle of recession.

The recession affects the organizations and the economy as a whole.

Effective implementation of quality management systems

The Quality Management Systems (QMS) was developed in response to

International Organization for Standardization at Geneva. These standards

Effective implementation of quality management systems

cost reductions, competitive advantages, participation and motivation of

Quality is defined by number of people in different ways (10). Joseph Juran

Effective implementation of quality management systems

Feigenbaum that Quality as a customer determination based upon a

The company is polluting the environment.

Can we call this as a quality company? The definition of quality has

The quality should consider the following requirements:

Customer Product features and tolerances, the delivery in time,

marking should meet the statutory and regulatory requirements. They

No violation of the law of the land like minimum wages,

When the activities are outsourced, it is the responsibility of

The employees need to be insured for their safety and health.

All safety aspects are to be maintained as per the law of the

Effective implementation of quality management systems

The training of the employees is the responsibility of the

Regulatory requirements relating to product safety and the

Use of metal free buttons and other accessories in garments.

Avoiding carcinogenic azonic dyes.

Preventing metal pieces like broken needle parts and staple

The washing instructions are to be given with the

The quantity despatched should match exactly the invoice and

The product features mentioned should match the actual

The packages should have the details of manufacturer, the

Specifying expiry date is very essential for perishable products.

Specifying maximum retail price (MRP) is essential for

The product shown in the catalogue to match with the final

Performance according to the promises given to the buyer,

The product quality to match the samples shown while taking

Proper documentation as agreed during negotiations.

High quality label and instructions clearly describing the

Timely delivery of material is as important as its quality and

Making in-time payment to suppliers, contractors, service

Apart from the International Standards, it is necessary to refer

to the trade practices and the regulations prevailing in the

It might include the ban on certain chemicals, packing materials,

Products do not create problem to the user because of its

No loss is made to society or environment because of the processes.