quality management system

Quality Management System

A Presentation byK.JayachandranDeanNICMAR, Hyderabad.

Session Brief Introduction Quality Management Systems -

Fundamentals & Vocabulary ISO 9000 : 2000 Quality Management System

- Requirements Quality Management Systems – Guidelines

for performance improvements Case Study of Gammon India Interaction Conclusion

Quality Management Systems – Fundamentals

and Vocabulary

Introduction

0.1 General The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.

– ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.

– ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction.

– ISO 9004 provides guidelines that consider both the effectiveness and efficiency and efficiency of the quality management system. The aim of this standard is improvement of the organization and satisfaction of customers and other interested parties.

– ISO 19011 provides guidance on auditing quality and environmental management systems.

Introduction Cont…

0.2 Quality management principlesa) Customer focusb) Leadershipc) Involvement of Peopled) Process approache) System approach to managementf) Continual improvementg) Factual approach to decision makingh) Mutually beneficial supplier relationships

1. Scopea) Organizations seeking advantage through the

implementation of a quality management system;b) Organizations seeking confidence from their suppliers

that their product requirements will be satisfiedc) Users of the productsd) Those concerned with a mutual understanding of the

terminology used in quality management (e.g. suppliers, customers, regulators)

e) Hose internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/ registration bodies)

f) Those internal or external to the organization who give advice or training on the quality management system appropriate to that organization

g) Developer of related standards.

2 Fundamentals of quality management Systems

2.1 Rationale for quality management systems

2.2 requirements for quality management systems and requirements for products

2.3 Quality management systems approach2.4 the process approach2.5 Quality policy and quality objectives

Model of a process-based quality management Systems

Value-adding activities Information flowKey

Continual improvement of The quality management system

Product realization

Managementresponsibility

Measurement, Analysis andimprovement

Resourcemanagement

Require-ments

Satisfaction

Customers(and other interested

parties)Customers(and other interested

parties)

input Product output

2 Fundamentals of quality management Systems Cont…

2.6 Role of top management within the quality management system

a) to establish and maintain the quality policy and quality objectives of the organization;

b) To promote the quality policy and quality objectives throughout the organization to increase awareness, motivation and involvement;

c) To ensure focus on customer requirements throughout the organization;

d) To ensure that appropriate processes are implemented to enable requirements of customers and other interested parties to be fulfilled and quality objectives to be achieved;

e) To ensure that an effective and efficient quality management system is established, implemented and maintained to achieve these quality objectives;

f) To ensure the availability of necessary resourcesg) To review the quality management system periodically


2.7 Documentation2.7.1 Value of documentation2.7.2. Types of document used in quality

management systems

2.8 Evaluating quality management systems2.8.1 Evaluating processes within the quality management system2.8.2 Auditing the quality management system2.8.3 Reviewing the quality management system2.8.4 Self-assessment


2.9 Continual improvementa) Analysing and evaluating the existing situation

to identify areas for improvementb) Establishing the objectives for improvementc) Searching for possible solutions to achieve the

objectivesd) Evaluating these solutions and making a

selectione) Implementing the selected solutionf) Measuring, verifying, analysing and evaluating

results of the implementation to determine that the objectives have been met.

g) Formalizing change


2.10 Role of Statistical techniques2.11 Quality management systems and

other management systems focuses2.12 Relationship between quality

management systems and excellence modelsa. Enable an organization to identify its

strengths and weaknesses,b. Contain provisions for evaluation

against generic modelsc. Provide a basis for continual

improvement, andd. Contain provision for external

recognition.

3 Terms and definitions3.1 Terms relating to quality

3.1.1 quality3.1.2 requirement3.1.3 grade3.1.4 customer satisfaction3.1.5 capability

3.2 Terms relating to management3.2.1 system3.2.2 management system3.2.3 quality management system3.2.4 quality policy3.2.5 quality objective

3 Terms and definitions cont …3.2.6 management3.2.7 top management3.2.8 quality management3.2.9 quality planning3.2.10 quality control3.2.11 quality assurance3.2.12 quality improvement3.2.13 continual improvement3.2.14 effectiveness3.2.15 efficiency

3 Terms and definitions cont …3.3 Terms relating to organization

3.3.1 organization 3.3.2 organizational structure3.3.3 infrastructure3.3.4 work environment3.3.5 customer3.3.6 supplier3.3.7 interested party

3.4 Terms relating to process and product3.4.1 process3.4.2 product3.4.3 project3.4.4 design and development3.4.5 procedure

3 Terms and definitions cont …3.5.Terms relating to characteristics

3.5.1 characteristic3.5.2 quality characteristic3.5.3 dependability3.5.4 traceability

3.6 Terms relating to conformity3.6.1 conformity3.6.2 nonconformity3.6.3 defect3.6.4 preventive action3.6.5 corrective action 3.6.6 correction3.6.7 rework3.6.8 regrade3.6.9 repair

3 Terms and definitions cont …3.6.10 scrap3.6.11 concession3.6.12 deviation permit3.6.13 release

3.7 Terms relating to documentation3.7.1 information 3.7.2 document3.7.3 specification3.7.4 quality manual3.7.5 quality plan3.7.6 record

3 Terms and definitions cont …3.8 Terms relating to examination

3.8.1 objective evidence3.8.2 inspection3.8.3 test3.8.4 verification3.8.5 validation3.8.6 qualification process3.8.7 review

3.9 Terms relating to audit3.9.1 audit3.9.2 audit programme3.9.3 audit criteria

3 Terms and definitions cont …– 3.9.4 audit evidence– 3.9.5 audit findings– 3.9.6 audit conclusion– 3.9.7 audit client– 3.9.8 auditee– 3.9.9 auditor– 3.9.10 audit team– 3.9.11 technical expert– 3.9.12 competence

3 Terms and definitions cont …

3.10 Terms related to quality assurance for measurement process3.10.1 measurement control system3.10.2 measurement process3.10.3 metrological confirmation3.10.4 measuring equipment3.10.5 metrological characteristic3.10.6 metrological function

Quality Management Systems –

Requirements

No control to control at all stages

Consumer needs

Results •High wastage•Less customersatisfaction

Few good products

Process

Require-ments

Consumer needs

Plan ProcessGood

products

NO CONTROL

CONTROL AT ALL STAGES

Results •Low wastage•High customersatisfaction

DESIGN REVIEW

The Design Control Process

Design

specification

Design

input

Design

process

Design

outputProduct

Verification

Validation

The hidden structure of ISO 9001

YOUR WORKPurchasing4.6Customer-suppliedProduct 4.7

Design control 4.4

Contract review 4.3

Process control 4.9

Testing 4.10 – 4.12

Control of nonconforming product 4.13

Handling, storage, packing and delivery 4.15

Servicing 4.19

YOUR PEOPLE

Management responsibility 4.1Training 4.18

YOUR SYSTEM

Quality system 4.2Document control 4.5Corrective action 4.14

Internal quality audit 4.17

YOUR INFORMATION

Product identification 4.8Records 4.16

Statistical techniques 4.20

Typical Action PlanMonth 1

Month 3

Month 5

Month 7

Month 9

Month 11

Month 13

ISO awareness campaign

Nominate ISO representative

Task force + Planning

Quality manual – Level A

Write Level B documents

Write Level C documents

Monitor implementation process

First internal audit

Clear nonconformities

Pre-registration audit

Quality training

Compliance audit

Clear discrepancies

Registration

The ISO 9000 implementation process

Decide to go for

ISO 9000

ACTION

Appoint

coordinator

Select

ISO 9001 or 9002

Defineresponsibilities

Describe processAnd carry out gap

analysis

Set up steering

committee

Get staff

commitment

OUTPUTS

Write policy Quality policy

Jobdescription

Organizationalchart

Describe processAnd carry out gap

analysis

Involve and train staff

Get staff to adopt new procedures Manual

ISO 9000certificate

The ISO 9000 implementation process Cont…

Maintain the system

Implement Quality system

Get

registered

Publicize

Your success

Audit the system

Procedures

Audit reportTrain auditors

Write procedures

Structure of quality system documentation

LEVEL ALEVEL A

LEVEL BLEVEL B

LEVEL CLEVEL C

Quality manual

Quality system

procedures

Work instruction

, forms reports etc

Describes the quality system as

per stated quality policy &

objectives

For each functional unit,

describes activities needed to implement the

quality system element

Detailed work instructions,

methods, drawings, forms,

reports

Audit process flow sheet

Plan audit

Do audit

No problems found

Issue reportDetermine

cause

Issue Nonconformance

report

Take corrective action

Problem found

The process of certification & surveillanceContact several

certification bodiesComplete questionnaire;

get quotations

Select certificationbodies

Apply for certification

Agree date for assessment

Certification body checks your system

Certification body checks your manual

Make changes

Get ISO 9000certification

Regular surveillance Visits for 3 yrs

Make changes

Make changesFAIL

FAIL

FAIL

PASS

PASS

PASS

ISO 9000: the base for the journey to TQM

QUALITYIMPROVED

UNCOMMITTED

WORLD CLASS

JOURNEY TO TQM

ISO 9000SYSTEM

Quality Management Systems – Guidelines for

performance improvements

Introduction

0.1 General 0.2 Process approach0.3 Relationship with ISO 90010.4 Compatibility with other management systems

Model of a process-based quality management Systems

Value-adding activities Information flowKey

Continual improvement of The quality management system

Product realization

Managementresponsibility

Measurement, Analysis andimprovement

Resourcemanagement

Require-ments

Satisfaction

InterestedParties

InterestedParties

input Product output

Quality management systems – Guidelines for performance

improvements1. Scope2. Normative reference3. Terms and definitions4. Quality management system

4.1 Managing systems and processes 4.2 Documentation 4.3 Use of quality management principles

a. Customer focusb. Leadershipc. Involvement of peopled. Process approache. System approach to managementf. Continual Improvementg. Factual approach to decision makingh. Mutually beneficial supplier relationships

Quality management systems – Guidelines for performance improvements Cont…

5. Management responsibility5.1 General guidance

5.1.1 Introduction5.1.2 Issues to be considered

5.2 Needs and expectations of interested parties5.2.1 General5.2.2 Needs and expectations5.2.3 Statutory and regulatory requirement

5.3 Quality policy5.4 Planning

5.4.1 Quality objectives5.4.2 Quality planning


5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority5.5.2 Management representative5.5.3 Internal communication

5.6 Management review5.6.1 General5.6.2 Review input5.6.3 Review output

6 Resource management6.1 General guidance



6.2 People6.2.1 Investment of people6.2.2 Competence

6.2.2.1 Competence6.2.2.2 Awareness and training

6.3 Infrastructure6.4 work environment6.5 information6.6 Suppliers and partnerships6.7 Natural resources6.8 Financial resources


5. Product realization7.1 General guidance

7.1.1 Introduction7.1.2 Issues to be considered 7.1.3 Managing processes

7.1.3.1 General7.1.3.2 Process inputs, outputs and review7.1.3.3 Product and process validation and changes

7.2 Processes related to interested parties7.3 Design and development

7.3.1 General guidance7.3.2 Design and development input and output7.3.3 Design and Development review


7.4 Purchasing7.4.1 Purchasing process7.4.2 Supplier control process

7.5 Production and services operations7.5.1 Operation and realization7.5.2 Identification and traceability7.5.3 Customer property7.5.4 Preservation of product

7.6 Control of measuring and monitoring devices

8. Measurement, analysis and improvement8.1 General guidance



improvements Cont…8.2 measuring and monitoring

8.2.1 Measurement and monitoring of system performance

8.2.1.1 General8.2.1.2 Measurement and monitoring of

customer satisfaction8.2.1.3 Internal Audit8.2.1.4 Financial measures8.2.1.5 Self-assessment

8.2.2 Measurement and monitoring of processes

8.2.3 Measurement and Monitoring of product

8.2.4 Measurement and monitoring the satisfaction of interested parties


improvements Cont…

8.3 Control of nonconformity8.3.1 General8.3.2 Nonconformity review and

disposition

8.4 Analysis of data8.5 Improvement

8.5.1 General8.5.2 Corrective action8.5.3 Loss prevention8.5.4 Continual improvement of the

organization

ISO 9001 IMPLEMENTATION-A CASE STUDY OF

GAMMON INDIA LTD

Session brief

Introduction Background of the Company-Gammon India Ltd. Earlier attempts of ISO 9001 Certification Revival of thought process Strategy for revival of the certification process Brainstorming session on 3rd Sep 97 Final decision

Action taken Appointment of Consultants Sensitising Programme for Top Management Appointment of : Management Review Committee Management Representative Task Force

Action taken Drafting of Quality Policy Preparation of Quality Manual Preparation of Quality System Procedures Preparation of Work Instructions Preparation of Quality Plans

Training and Development Training of 75 Trainers(4 days) Training of 25 Auditors(4days) Training of 500 Engineers(2days) Training of 700 Non-Engineers(2days) Training of 4000 LMR staff(1day) Training of Sub contractors and DMR staff

(Half day) Continuous training programme

Strategy of Total Involvement Identification of dissenters Task group members to work on them

individually Open discussion during Management Review

Meetings and thrashing out differences

Preparation of Quality documents

Quality Policy Quality Manual Existing System and Quality System

Procedures Exhaustive documentation? Quality Plan Vs Method statement Client like it/ do not like it

Implementation Cumbersome procedure and will affect

progress of work? Incomplete documents Latest Version of System and procedures not

available at site Complete responsibility is of MR others are

not responsible Site is getting closed; ISO is not applicable

Internal Audit It is an Audit ie finding fault? Can a non-engineer be an Auditor? Hundreds of Non- conformities MR to remove all non – conformities? Appointment of SMR to assist PM Internal Auditors as facilitators Presentation of Auditors to MRC

Some specific challenges Age group of the company 18-75 First construction company to go for ISO Consultants with no experience in construction

industry History of 80 years Failures of 2 earlier occasions Older group not convinced about the requirement of

ISO 40 sites spread over India, Nepal& Bhutan

Some specific challenges Union staff in HO and their pending salary

settlement Projects of varied types He work force of 15-20000 Interpersonal relation issues Sweet and sour approach at different levels

Mock Audit Mock Audit was Shock Audit MOCK audit at 10 different sites Removal of NCs on war footing Final gear up for Assessment Audit

Final Assessment Audit Audit in Sep 2000 Bad effects of missing the date-2000 Version

was to be repeated afresh Collective decision not to miss the

opportunity Final Audit for 10 days by 3 different teams

of Auditors D day and final briefing on results

recommending for certification

Award of certificate Validity for next 3 years Breathing time for 2000 version Six monthly audit

Present status Certified for ISO 9001: 2000 Entire gamut of construction activities

including pipe line project First Infrastructure Development company to be certified for the entire operation of the

company

Mistakes and learnings Seeking 100% co-operation can delay the

targets Voluminous procedures can kill motivation of

staff in implementing the procedures Getting into HiFi mode can create problem

for the lower level staff All directors have to be equally concerned

about the progress

Learnings Having a clear goal and knowing why it is

essential helps in achieving the goal Seek co-operation from all - from top to

bottom, but do not wait for their cooperation if a few have some reservation

It is not easy to attempt for the entire company with more than 40 sites working

Learnings Union may oppose it for their own reasons but are not against itDo not mix up other Quality Management

Initiatives like ERP with ISOLet the stake holders of the process

understand the benefits first and then the system and the processes connected with it; they will be able to appreciate better

Learnings At last don’t give up; you may miss your mile

stones but not the final destination Celebrate your achievements.

quality management system

Documents

management management

effective quality management

quality policy

auditing quality

quality objectives model

requirements of iso

requirements of customers

customer requirements