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CHAPTER 12

MANAGEMENT SYSTEMS
(QMS & EMS)

(ISO 9001 : 2000)


&
(ISO 14001 : 1996 (E))
QUALITY
MANAGEMENT
SYSTEM (QMS)

ISO 9001 : 2000


What is the purpose of ISO 9000?

The purpose of these standards is to assist


organizations of all types to implement and operate
effective quality management system to achieve customer
satisfaction continuously.
These standards provide a vehicle for consolidating and
communicating concepts in the field of quality management
that have been approved by an international committee of
representatives from national standards bodies. The
primary users of the standards are intended to be
organizations acting as either customers or suppliers.
SCOPE OF THE ISO 9000 (QMS) SYSTEMS

As the quality management system is the means by


which the organisation achieves its objectives, it follows that
the scope of the system (What it covers) is every function and
activity of the organization that contributes to these objective.
This should leave no function or activity outside the system.
The system must also include suppliers because the
organisation depends upon its suppliers to achieve it objectives.
The chain of processes from the customer interface and back
again includes the suppliers. The scope of the system does not
need to be the same as the scope of certification as was
explained.
What is ISO 9000?
ISO 9000 : 2000 is a series of three
international standards for Quality
Management Systems. The specify
requirements and recommendations for
the design of management systems. ISO
9000 is not a product standard. None of
the standards in the family contain
requirements with which a product or
service can comply. They are no product
acceptance criteria in ISO 9000 so you
can't inspect a product against the
standard.
ISO 9000: 2000 QUALITY
MANAGEMENT SYSTEMS
FUNDAMENTALS AND
VOCABULARY

ISO 9001: 2000


QUALITY MANAGEMENT
SYSTEMS REQUIREMENTS

ISO 9004: 2000 QUALITY


MANAGEMENT SYSTEMS GUIDE
LINES FOR PERFORMANCE
IMPROVEMENTS
IMPORTANCE OF ISO 9000

Productivity and business efficiency:

The ISO 9000 compliance standards are designed to help an


organization review its production processes and establish a
system to improve and maintain the quality of its products and /or
services. By documenting its processes and production systems
and implementing a quality management system, ISO 9000
provides a manufacturer with a methodical means of reviewing its
operation, identifying inefficiencies and gaps in its systems and
implementing actions to eliminate those inefficiencies and gaps.
COMPETITION:
In certain industries, registration to ISO
9000 is widespread and is all but required
to remain competitive against companies
already registered. In fields where ISO
9000 is recognized as an effective
management tool and serves as a guarantee
of product quality registration offers as
significant business advantages to a
company over its competitors
Customer requirements:
More and more companies and
certain industries, are requiring their
suppliers to become registered to the ISO
9000 conformance standards in order to
meet contract specifications for quality
management in certain countries 9000
registration is a requirements for conducting
grade with government entities and
companies covered by industry and
government regulations.
Productivity and profitability:
By increasing the organizations efficiency.
Retaining or enhancing the organizations
competitive edge, and meeting customer and
market requirements for doing business, the
organization will increase its productivity,
maintain or enhance its product quality, and
maintain or increase sales, which will result
in improvement to the company’s
profitability.
Continued up gradation of knowledge and
skills of employees:
The system under Resource
Management ensures that the
management identifies training
requirements of all individuals in the
organization, organize training to
upgrade their knowledge and skills on a
continuous basis. The system also
ensures monitoring effectiveness of the
training imparted.
Efficient and Effective Work Methods:
This documented quality system
has Quality Systems Procedures (QSPs)
and Work Instructions (WIs) for
performing various activities to ensure
conformance, minimize variations and
improve overall efficiency of the
organization by reducing non-
conformities and wastages.
Eight Quality Management Principles

1. Customer focus
2. Leader ship
3. Involvement of people
4. Process approach
5. Systems approach to Management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships
Eight Quality Management Principles
1. Customer focus
- Understand current and future needs of customers &
other interested parties
- Meeting them
- Strive to exceed customer expectations.
2.Leader Ship
- Establish purpose & direction of the organisation
- Create internal environment conductive for employee
active participation.
3. Involvement of People
- Full involvement enabling to use their abilities for
achieving organizational goals.
Eight Quality Management Principles

4. Process approach
-Managing resources and activities for achieving organizational
goals efficiently.

5. Systems approach to management


-Identifying, understanding and managing
interrelated processes as a system which
contributes organization's effectiveness and
efficiently in achieving its objectives.
6. Continual Improvement
-Improvement in organization's over all
performance on continual basis.
Eight Quality Management Principles

7. Factual approach to decision making


-Effective decisions are based on the
analysis of data and information.
8. Mutually beneficial supplier relationships
-Organisation and its suppliers are
interdependent and mutually beneficial
relationship enhances the ability of both to
create value.
ENVIRONMENTAL
MANAGEMENT SYSTEMS
(EMS)

ISO 14001 : 1996 (E)


ENVIRONMENTAL
MANAGEMENT HARD FACTS
1. World population went up by 7 times in 200
years In 1800 (Year) it was 90 Croces now 600
Crores.

2. 200 crores people live within 100 kms from sea.


Its level is going up.

3. Pollution cloud of 3 kms thickness over India &


other Asian countries.
4. Environmental pollution going up rapidly
due to increase in population, reduction in
Forests and Agriculture land.

5. In world 50% of patients die water


pollution.

6. On earth 75% area is with water, out of


which 97.5% sea water, only 2.5% is
useable water.
7. CPCB (Central Pollution Control Board) study in
200: Findings Highly polluted cities: Kanpur, Delhi,
Bangalore, Mumbai, Kolkatta, Ahmdabad, Pune,
Baroda.

ENVIRONMENTAL MANAGEMENT HARD FACTS

8. Wars also contributed to pollution 1991 Gulf war &


2003 Irag war.

9. Some of the key industries which contribute


environmental pollution
* Sugar * Chemical *Insecticides * Fertilizers * Leather
* Cement * Iron & Steel *Thermal power * Pharmaceuticals * Plastics
10. Environmental pollution impact 7.5 lakh
crores of rupees loss in world during next
10 years.

11. Air pollution, water pollution, food


adulteration - 5500 children die every
day.

12. Two biggest problems we are going to face


in world Shortage of water &
environmental pollution.
ISO 14001 : 1996(E) – EMS
DEFINITIONS/TERMS

Environmental: Surroundings in which an


organization operates, including air, water, lad,
natural resources, flora, fauna,. humans and their
interrelation.

Environmental Aspect: Element of an


organization's activities, products or services, that
can interact with the environment.
Note: A significant environmental aspect is an
environmental aspect that has or can have a
significant environment impact.
• Environmental Impact: Any change to the
Environmental, whether adverse r
beneficial, wholly or partially resulting from
an organization's activities, products or
services.

• Environmental Objective: Over all


Environmental goal, arising from the
Environmental policy & significant aspects
that an organization sets itself to achieve,
and which is quantified where practicable.
Environmental Management System: The
part of the overall Management system that
includes organizational structure, planning,
activities, responsibilities, practices,
procedures., process and resources for
developing, implementing, achieving,
viewing and maintaining the environmental
policy.
• Environmental Management system
audit: a systematic and documented
verification process of objectively
obtaining and evaluation evidence to
determine whether an organization's
environmental Management system
conforms to the environmental
Management system audit criteria set by
the organisation, and for communication
of the results of this process to
management.
• Environmental Performance:
Measurable results of the environmental
Management system, related to an
organization's control of its
environmental aspects, based on its on its
environmental policy, objectives and
targets.
ENVIRONMENTAL MANAGEMENT SYSTEMS
NEED

Organizations of all kinds are increasingly


concerned to achieve and demonstrate sound
environmental performance by controlling the
impact of their activities, products and services
on the environment taking into consideration
their environmental policy and objectives. The
environmental management systems of an
organisation is expected to meet the following
needs
 Meet the regulatory, and legislative requirements.

 Improve the control of the environmental impact.

 Provide confidence to the customers that the products


and services are manufactured with the aim of
reducing the negative impact on the environment.

 Suitability accommodate changing market trends ad


gain competitive edge.

 Gain public and media support.


PURPOSE OF AN EMS – ISO 14001 :
1996 (E)

Organisation ensure that their objects and targets are


pursued effectively through a systems of coordination.
An EMS therefore, is intended to link different
processes through a network of management actions.
Procedures, documentation and records, with the aim
to:
Identify and control significant environmental aspects
and impacts.
Identify significant environmental opportunities.
Identify relevant environmental regulatory
requirements.
Establish a sound environmental policy as basis for
environmental management.
Establish priorities, determine environmental
objectives and work towards their achievement.
 monitor performance and evaluate the effectiveness
of the environment management systems.
 Clear up the organisation to meet new challenges and
explore new opportunities.
ISO 14001 : 1996

ENVIRONMENTAL MANAGEMENT SYSTEM –


SPECIFICATIONS WITH GUIDANCE FOR USE.

ISO 14004 : 1996

ENVIRONMENTAL MANAGEMENT SYSTEM-


GENERAL GUIDELINES ON PRINCIPLES, SYSTEMS
AND SUPPORTING TECHNIQUES.
ISO 14011 : 1996

ENVIRONMENTAL MANAGEMENT SYSTEM-


GUIDELINES FOR ENVIRONMENTAL AUDITING &
AUDIT PROCEDURES
ISO 9002 Certification
A Case Study
l Steps taken by A Company to
obtain ISO 9002 certification
SELECTION PHASE:

* Selection of ISO 9002 as quality


assurance model for GOC shops.

* Appointment of Sr. EDPM as the


management Representative.
Steps taken by GOC to obtain ISO
9002 certification selection phase:

* Selection of Cylinder Liner Plating


Shop (CLP), Coil Manufacturing
Shop (CMS), Engine Block
Reclamation Shop (EBR) and related
areas viz., stores, maintenance and
drawing office for implementing ISO
9002 quality system.
Steps taken by GOC to obtain ISO
9002 certification selection phase:

* Formulation of Quality policy and


objectives.
* Engaging M/S. ABC Consultants Pvt.
Ltd., as consultant, for training and
for guidance in documentation and
implementation.
Steps taken by GOC to obtain ISO
9002 certification selection phase:
* Formation of ISO 9002 core team
consisting of supervisors with work
manages/QA as the coordinator.
* Selection of M/s. Peat Marwick LLP of
USA as the certifying agency for
registration.
TRAINING PHASE:
• Training on “ISO 9000 awareness”
to all officers, supervisors and staff.
• Documentation training and training
of trainers for twenty five supervisors.
• Training four officers and twenty
to supervisors on “Internal Quality
Auditing”.
DOCUMENTATION PHASE:

Once the organisation was ready


to go for ISO 9000 the quality system
was documented.
DOCUMENTATION:
The quality system documents were prepared
at four levels as depicted below:

Level I Quality system Manual


Level II Procedures
Level III Work instructions
Level IV Forms/Records
G
S MA
E
E T IN
N C C
B O TE
E L M
R R NA
R P S
E NC
A
S E
l
QUALITY SYSTEMS MANUAL:
This is the strategic document that
comprises of the profile quality policy and
objectives of GOC.
It details the scope of certification.

The policies of GOC with respect to


the pertinent clauses of ISO 9000 series
have been laid down in this document.
QUALITY POLICY

“TO ACHIEVE AND MAINTAIN


EXCELLENCE IN QUALITY OF
PRODUCTS AND SERVICES
AND
TO STRIVE FOR CONTINUEOUS
IMPROVEMENT”
QUALITY OBJECTIVES

*Customer satisfaction.

*Quality system.

*Human resource development.

*Vendor development.
PROCEDURES: (level II documents):

These are the tactical documents


Which form the basic documentation used
for overall planning and administration of
activities with impact on quality. These
detail and specify what has to be done, by
whom, where and when it will be done.
The following are the different procedures
prepared at GOC that conform to the
different clauses of the standard.
PROCEDURES (level II documents):

• General System Procedures.

• Shop Specific Procedures.

• Procedure for Maintenance.

• Procedure for Purchasing & Stores


Depot Management.
WORK INSTRUCTIONS: (Level III
Documents)

Work instructions form part of the


operational documents.
These are required where their absence
would affect quality.
These should detail the activities beyond
what is being detailed in the procedures.
WORK INSTRUCTIONS: (Level III
Documents)

Instructions are to be developed for


activities performed during production,
inspection, maintenance and laboratory
tests.
WORK INSTRUCTIONS: (Level III
Documents)
Following details should be there in these
instructions.
• Activity to be carried out specifically
and sequentially.

• Materials/equipments/tools to be used.
WORK INSTRUCTIONS: (Level III
Documents)

• Process parameters that are to


be maintained.

• References, guidelines, standards


or drawing to be followed.
The following are the various work
instruction manuals prepared at GOC

i) Work instructions for important stages


in CLP, CMS and EBR.

ii) Laboratory Instruction for CMT lab


The following are the various work
instruction manuals prepared at GOC

iii) Mechanical maintenance instructions.

iv) Electrical maintenance instruction.


FORMS/RECORDS: ( Level IV
Documents)

The fourth level of documents


comprise of forms, records, registers, files,
reports, minutes, etc. These are the
objective evidences in meeting the specific
requirements.
AUDIT PHASE:

• Conducting three rounds of internal


quality audits.
• Pre-assessment audit by M/s. KPMG
• Conducting the fourth round of internal
quality audit.
• Adequacy and compliance audits by
M/S. KPMG.
CERTIFICATION PHASE:

• Recommendation by M/s. KPMG


for certification.

• Confirmation by M/s. KPMG Head


Quarters.

• Issue of ISO 9002: 1994 certificate.


QUALITY IMPROVEMENTS MADE
DURING IMPLEMENTATION OF ISO
9000 AND THEIR BENEFITS:
The modifications made in each
activity during this process falls under two
categories.
General changes that were made in all the 3
shops and
specific changes in the techniques applied in
each shop. The condition prior to and after the
changes and their quantified benefits are listed
as follows:
General improvements (No quantified benefits)
No. Previous Improved Benefits
Process Process
1 No Various codes Avoids
identification are used for mixing and
and traceability identification. easy
of products. traceability
2 No calibration Calibration Improved
of measuring from April reliability
inspection & ’96. and quality
Test of work.
equipments.
General improvements (No quantified benefits)
No. Previous Improved Benefits
Process Process
3 No Training Reduce
Systematic programme rework and
training of adopted. awareness.
personnel.
4 No work Clear cut
instructions work
available at the instructions -
work spot. made
available.
General improvements (No quantified benefits)
No. Previous Improved Benefits
Process Process
5 Problem Systematic Reduced
solving analysis of the quantum
techniques reasons for of rejection
were not used in house in
for analyzing process
non conforming rejection and
products and other factors.
in process
rejection.
Specific Improvements (With quantified
benefits)
1. COIL MANUACTURING SHOP

No. Previous Improved Benefits


Process Process
1 Conductor cut Conductor Savings in
to length cut to length length of
before after conductor
straightening straightening Rs. 1,67,340
using using p.a
markings on stopper.
template.
Specific Improvements (With quantified
benefits) 1. COIL MANUACTURING SHOP

No. Previous Improved Benefits


Process Process
2 End End a) Improved
insulation insulation labour
of removed by productivity.
conductor buffing b) Avoided
removed machine accidental
by knife from Feb. damage to
’96. insulation by
knife Rs. 1.56
lakhs p.a.
Specific Improvements (With quantified
benefits)
1. COIL MANUACTURING SHOP

No. Previous Improved Benefits


Process Process
3 Lead Lead Improved
dressing by dressing by labour
file. grinding productivity
machine Rs. 1.04
from Lakhs p.a
June ’96.
Specific Improvements (With quantified
benefits)
1. ENGINE BLOCK RECLAMATION SHOP
No. Previous Improved Benefits
Process Process
1 The The Reduction in
temperature temperature furnace oil
indicators indicators consumption
in the are from 500 to 450
furnace calibrated. liters Heat
were not treating time
calibrated. reduced by1 hour
Rs. 18,240/- p.a
Specific Improvements (With quantified
benefits)
1. ENGINE BLOCK RECLAMATION SHOP

No. Previous Improved Benefits


Process Process
2 The block was The stress
being heated relieving cycle
up to 640 is modified -
degree and is now
centigrade being heated
only up to
540 C.
Specific Improvements (With quantified
benefits)
1. CYLINDER LINER PLATING SHOP
No. Previous Improved Benefits
Process Process
1 Herdnless test The Annually 84
were carried frequency of liners will be
out by tests have saved along
destroying one been with plating
liner out of modified to cost Rs.
every 100 one liner for 2,52,000/- p.a.
liners from each bath
each bath. per month.
TOTAL QUANTIFIED SAVINGS

CMS - 4.27 lakhs


CLP - 17.24 lakhs
EBR - 5.88 lakhs
COST - 3.00 lakhs
INTANGIBLE BENEFITS

Productivity - up by 20%
Rework - Reduced
Life of linss - Increased
Idle Time - Reduced
Cleanliness - Increased
ISO 14000 SERIES

Organizational Product
evaluation Evaluation
Standards Standards
Environmental
Management
Standard
Organizational 14001: Specification
14004:Gen.Guide
Lines
Evaluation Environmental
Standards Auditing
14010:
14011:
14012:
Environmental
Performance
Evaluation
1403:Guidelines
Environmental Aspects
in Product Standards
Product Guide 64 EAPS Guide
Evaluation
Environmental
Standards Labeling
14020:Basic Principle
14021:self declaration
14022: Symbols

Life cycle
Assessment
ENVIRONMENTAL LABELING

14020:BASIC PRINCIPLES
14021:SELF DECLARATION
14022:SYMBOLS
14023:TESTING AND VERIFICATION
14024:THIRD PARTS
LIFE CYCLE ASSESSMENTS

14040: Principle & fomenters


14041: Goals & Define
14042: Impact Assessment
14043: Imp. Assessment
REQUIREMENTS OF ISO14000

4.1: Gen. Requirements


4.2: Env. Policy
4.3: Planning
4.3.1: Env. Aspects
4.3.2: Legal & other Requirements
4.3.3: objectives & Targets
4.3.4: Env. Management
REQUIREMENTS OF ISO14000
4.4: Implementation& opn.
4.4.1: Structure & Responsibility
4.4.2: Training, awareness & Competency
4.4.3: Communication
4.4.4: Ems Documentation
4.4.5: Document Control
4.4.6: Operational Control
4.4.7: Emergency preparedness &
Response
4.5 CHECKING & CORRECTIVE
ACTION

4.5.1 Monitoring & Measuring


4.5.2 Non Conformances & Correction
& preventions action
4.5.3 Records
4.5.4 EMS audit
4.6 MANAGEMENT REVIEW
BENEFITS
GENERAL:
• Facilities Trade
• Improve env. Performance of Earth
• Build consensus as need for env.
management
BENEFITS
ORGANISATIONAL

• Assure customers the commitment to


environment
• Reduce liability cost
• Reduce litigation
• Conserve Energy

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