You are on page 1of 30

Unit-5

Quality Systems Organizing and


Implementation

Prepared By

M.KAVIARASU
AP/Mech-NIET

contents
Introduction to IS/ISO 9004:2000
Quality management system
Guidelines for performance improvement
Quality audits
TQM culture
Leadership
Quality council, employee involvement, motivation, empowerment,
recognition and reward
TQM framework

International organization for


standardization(ISO)
Worlds largest developer and publisher of international standards, headed
at Geneva Switzerland from 1947.
Non-governmental organization that forms a bridge between public and
private sectors.

What is ISO 9000?


Set of 5 world wide standards that establish the requirement for mgmt* of quality.
Unlike product standards , ISO 9000 are for quality mgmt system which provide a universal
framework for quality assurance through internal and external audits.

one size fits all standards

Contd.,
Standard

Content

Application

ISO 9000

Provide definitions and concepts.


Explains how to select over standards
for a given business

All industries including software


development

ISO 9001

Qualiity assurance in design,


development, production, installation
and servicing.

Engineering and construction


firms, manufacturers that design,
develop, install and service
products.

ISO 9002

Quality assurance in production and


installation.

Companies in the chemical


process industries that are not
involved in product design in after
sales services.

ISO 9003

Quality assurance in test and


inspection.

Companies in the chemical


process industries that are not
involved in product design or
after- sales service.

ISO 9004

Quality management and quality


system elements.

All industries.

ISO 9000
The Evolution of ISO 9000:
Quality system standards were first developed and widely used as a means of supplier
assessment by American Defence organisations such as the NATO, etc.
During the post-war period, the need for such standards were felt in general industry too.
Therefore Britain refined its defence standards and formulated the BS : 5750. In 1987, the ISO
formulated the ISO 9000 series of standards, after considering similar standards of various
countries, but designing it predominantly based on the BS 5750.

Uses of The ISO 9000:


Internal Audit. An organisation can audit its existing systems with reference to the
standard to provide feedback to management regarding the deficiencies of the system.

Vendor Assessment. To assess and ensure a vendors capability to consistently meet the
quality standards for products standards desired by the organisation.
Supplier Capability. To provide confidence to its customers regarding its capability to
consistently meet the quality standards desired by the customer.

ISO 9004
Essence of the Standard:
To put it in the simplest of terms the standard (9001-3)
recommends that an organisation should Decide its Quality Policy.

Determine how the policy is to be implemented and design a system accordingly.


Implement the system.
Review the system regularly to gauge its effectiveness.
Review the system regularly to gauge its effectiveness.

(The 9004 provide guidelines to the organisation on all the above activities)

ISO 9004 -whats in it?


Quality system have to be tailor-made to suit the organisations requirements, so as to
be effective. Therefore, the standard only provides the basic framework for the system
and offers unlimited freedom within the basic framework.
Lets take an example of quality policy
The standard does not specify the contents of the policy(anywhere between the two
extremes-to produce zero-defects or to produce a certain level of defects).
what the standard does specify is that whatever be the policy, the management should
ensure that it is understood and implemented at all levels in the organisation.
The standard only specifies the presence of quality control elements such as planning, review,
correction action etc. and gives the freedom to org. for satisfying the elements.

Contd..
Important aspects to be noted:
1. The standard specifies that the quality system be Documented (through Quality manuals,
work instructions, organisation charts, process charts, and the like).
2. In any customer-supplier relationship (internal/external the onus is on the supplier to fully
clarify and comprehend all customer requirements, stated as well as implied.
For example, the Purchasing Department, should clarify and review all requirements stated in the
purchase requisition before placing the order.

3. The standard does not specify requirements for Cost of Quality, continuous improvement
and does no dwell upon employee participation, morale, attitudinal change etc., though all
these are mentioned in the form of guidelines in the 9004 which are the ingredients from
TQM Philosophy.

How ISO 9004 certified?


Certification is not mandatory for all organisations that conform to the standard(iso
9004)
If an organisation decides that vendors for a particular product should conform to the ISO
9000.
It can send its own team of qualified auditors to assess the vendors organisation. However,
an ISO 9000 certificate is a proof of conformance, which therefore obviates such individual
assessments.
Accreditations to the standard (ISO 9004) is achieved only after the QMS* of an organisation
is assessed and approved by a recognized third party certifying body periodically.

contents
Introduction to IS/ISO 9004:2000
Quality management system
Guidelines for performance improvement
Quality audits
TQM culture
Leadership
Quality council, employee involvement, motivation, empowerment,
recognition and reward
TQM framework

About quality management systems


QMS can be seen as a complex system consisting of all the parts and
components of an organization dealing with the quality of processes and
products.
ISO 9000 series, QS 14001, AS 9100., - They are QMS*; standard used for
registration by demonstrating conformity of QMS to customers.
The fundamental principles of QMS:
Customer focus

Leadership

Involvement of people

Process approach

System approach

Continual improvement

Factual approach to decision


making

Mutually beneficial supplier


relationship

QMS Contd.,
They are developed by 3 big auto manufacturers Chrysler, ford & general
motors(GM).European manufacturers are included later.
A good QMS does not itself make an organization more profitable,
efficient or customer focused, but it will give to an org* the ability to do
anything better, from production to sales

Documentation in QMS or QS
The mgmt. should define the documentation needed to support the QMS, provided for
implementation, maintenance and improvement of the system which includes the
provision for
Policy documents including the quality manual
Doc. For control of processes
Work instructions to define tasks and
Standard formats for collection and reporting of data.

Why documentation?
1. Brings the clarity of objective-transparency
2. Generates customers confidence
3. Serves as a reference

4. Provides basis for continuous improvement.


5. Consistency of operations.

Documentation pyramid
Level 1: QUALITY POLICY MANUAL
Signed by CEO(or)MD. Its quality policy
statement-what will be done and why it is
done.
Communicates the quality policy and
objectives of an organization.

Level 2 : QUALITY SYSTEM PROCEDURE


Documents written by dept heads, used to
implement& perform the stated policies.
Define what should perform at specific task
Clearly defines organization's operations from
receiving an enquiry to delivering the
complete order.

Documentation pyramid contd.,


Level 3 : WORK INSTRUCTIONS
how individual work process is done
who will do the work and what records are
to be maintained
Detail drawing, routing sheet, specific job
function

Level 4 : RECORDS/FORMS
They provide evidence of activity
They are filled out, a stamp of approval on a
product

They are used for tracing the problems

Purpose and benefits of ISO documents


QMS documentation establishes the organization is dependent on the system,
and not on the person.
It describes the QMS of the organization.

It provides evidence of mgmt. commitment to the system.


It provides an invaluable training aid to its employees.
Assist employees to carry out their jobs more effectively by removing ambiguities,
defining the system designing responsibilities and identifying those responsible for
the activities.it helps employees to understand the roles within the organization.

Principles of ISO 9004:


There are about 8 quality management principles defined in ISO 9004:2000.
These are the guidelines for performance improvements.
1. Customer focus

2. Leadership
3. Involvement of people/employee involvement
4. Process approach- a desired result is achieved more effectively when activities and
related resources are managed as a process.
5. System approach to management-identifying ,understanding and managing
interrelated processes as a system contributes to the organization's effectiveness and
efficiency.
6. Continual improvement
7. Factual approach to decision making- effective decisions are based on the logical
and intuitive analysis of data and information.
8. Mutually beneficial supplier relationships

contents
Introduction to IS/ISO 9004:2000
Quality management system
Guidelines for performance improvement
Quality audits
TQM culture
Leadership
Quality council, employee involvement, motivation, empowerment,
recognition and reward
TQM framework

Guidelines for performance improvement in QMS


The guidance in international standards are generic and applicable to all org.
regardless of type, size and the product provided.
1. Managing systems and processes
The org. should define their system and processes ,that are to be understood, managed
and improved.
Detailed guidance on content and implementation of QMS is to be in international
standard .

2. General documentation requirements


The extent and nature of documentation and records should be appropriate , it can be in
any form or media suited to the needs of the org.

3. Quality principles
The eight quality principles to be followed.

contents
Introduction to IS/ISO 9004:2000
Quality management system
Guidelines for performance improvement
Quality audits
TQM culture
Leadership
Quality council, employee involvement, motivation, empowerment,
recognition and reward
TQM framework

Quality audits
Overview :
Auditing is done to verify whether a quality system is effective and suitable.
Systematic and independent examinations to determine whether quality activities and related
results comply with planned arrangements, whether these arrangements are implemented
effectively and whether they are suitable to achieve objectives.
They are conducted by staff who are not directly responsible in the areas being audited.
It is the information gathering activity and not the policing activity.
They need not cover the whole system.

Types:
First party (INTERNAL )audit

Done by inter-department.

Second party audit

Done by one org. on another org. (e.g)supplier by a customer.

Third party audit

done by an independent org. on a supplier for accredation assessment purposes

Objectives and stages of audit


Objectives of quality audits:
To determine the conformity(or)non-conformity of the quality system with regard
to specified requirements.
To determine the effectiveness of quality system implemented.
To evaluate on organizations own quality systems against the quality standard.

Stages:

AUDIT
PLANNING

AUDIT
PERFORMANCE

AUDIT
REPORTING

AUDIT FOLLOW-UP

1. Audit planning:
Time schedule

Audit personnel

Notification to auditee

Preparation of specific questions

2. Audit performance:
Opening meeting

Run of auditing

Audit deficiencies
3. Audit reporting:
Observation of non-conformities

Corrective action request

Identification of reference
document.
4. Audit follow-up:

Auditees is responsible for determining and initiating corrective action needed to


correct a non conformity.

contents
Introduction to IS/ISO 9004:2000
Quality management system
Guidelines for performance improvement
Quality audits
TQM culture
Leadership
Quality council, employee involvement, motivation, empowerment,
recognition and reward
TQM framework

TQM culture
culture is a body of learned behavior, a collection of beliefs, habits and
traditions ,shared by a group of people and successfully learned by a people who
enter society
ELEMENTS FOR TQM CULTURE: -by Sashkin and Kisher.
1. Use of information on performance of quality
2. Authority
3. Reward and recognition
4. Teamwork

5. Job security
6. Fairness
7. Equitable compensation
8. Employee ownership

Cultural changes for implantation of TQM


1. Culture of communication
2. customer first" attitude
3. Transparency in the organization

4. Empowerment of people
5. Continuous improvement and learning
6. Customer- focused horizontal processes

contents
Introduction to IS/ISO 9004:2000
Quality management system
Guidelines for performance improvement
Quality audits
TQM culture
Leadership
Quality council, employee involvement, motivation, empowerment,
recognition and reward
TQM framework

leadership
leadership is ultimately about creating a way for people to contribute to making
something extraordinary happen- Alan Keith.
Doing right things while management is doing things right.

12 important Characteristics of leader


Ability to inspire others

Problem solving skills

Emotional maturity

Ability to understand human behavior

Willingness to take risks

Dedication to organizational goals

Intelligence

Sound physique

Foresight and vision

Leader should be trustworthy

Must do things in systematic manner

Must be focused

Importance of leaders in TQM


They establish plans and goals for the organization.
They help to shape the culture of the org. through key decisions and symbolic
actions.
They contribute resources.
If the above mentioned points are not considered with quality.. Then think about
the outcome!!