Quality Management System

A Presentation by K.Jayachandran Dean NICMAR, 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 principles
a) Customer focus b) Leadership c) Involvement of People d) Process approach e) System approach to management f) Continual improvement g) Factual approach to decision making h) Mutually beneficial supplier relationships

1. Scope
a) b) c) d)

e)

f)

g)

Organizations seeking advantage through the implementation of a quality management system; Organizations seeking confidence from their suppliers that their product requirements will be satisfied Users of the products Those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators) 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) Those internal or external to the organization who give advice or training on the quality management system appropriate to that organization 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 approach 2.4 the process approach 2.5 Quality policy and quality objectives

Model of a process-based quality management Systems
Continual improvement of The quality management system

Customers (and other interested parties)

Management responsibility

Customers (and other interested parties)

Resource management

Measurement, Analysis and improvement

Satisfaction

Requirements

input

Product realization

Product

output

Key Value-adding activities Information flow

2.6

Role of top management management system

2 Fundamentals of quality management Systems Cont…
within the

quality

a) b)

c) d)

e)

f) g)

to establish and maintain the quality policy and quality objectives of the organization; To promote the quality policy and quality objectives throughout the organization to increase awareness, motivation and involvement; To ensure focus on customer requirements throughout the organization; 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; To ensure that an effective and efficient quality management system is established, implemented and maintained to achieve these quality objectives; To ensure the availability of necessary resources To review the quality management system periodically

2.7 Documentation 2.7.1 Value of documentation 2.7.2. Types of document used in quality management systems 2.8 Evaluating quality management systems
2.8.1 Evaluating processes within the quality management system 2.8.2 Auditing the quality management system 2.8.3 Reviewing the quality management system 2.8.4 Self-assessment

2 Fundamentals of quality management Systems Cont…

2 Fundamentals of quality management Systems Cont…
2.9 Continual improvement
a) Analysing and evaluating the existing situation b) c) d) e) f)

g)

to identify areas for improvement Establishing the objectives for improvement Searching for possible solutions to achieve the objectives Evaluating these solutions and making a selection Implementing the selected solution Measuring, verifying, analysing and evaluating results of the implementation to determine that the objectives have been met. Formalizing change

2 Fundamentals of quality management Systems Cont…
2.10 Role of Statistical techniques 2.11 Quality management systems and other management systems focuses 2.12 Relationship between quality management systems and excellence models
Enable an organization to identify its strengths and weaknesses, b. Contain provisions for evaluation against generic models c. Provide a basis for continual improvement, and d. Contain provision for external recognition.
a.

3 Terms and definitions
3.1 Terms relating to quality 3.1.1 quality 3.1.2 requirement 3.1.3 grade 3.1.4 customer satisfaction 3.1.5 capability 3.2 Terms relating to management 3.2.1 system 3.2.2 management system 3.2.3 quality management system 3.2.4 quality policy 3.2.5 quality objective

3 Terms and definitions cont …
3.2.6 management 3.2.7 top management 3.2.8 quality management 3.2.9 quality planning 3.2.10 quality control 3.2.11 quality assurance 3.2.12 quality improvement 3.2.13 continual improvement 3.2.14 effectiveness 3.2.15 efficiency

3 Terms and definitions cont …
3.3 Terms relating to organization
3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 organization organizational structure infrastructure work environment customer supplier interested party process product project design and development procedure

3.4 Terms relating to process and product

3 Terms and definitions cont …
3.5.Terms relating to characteristics
3.5.1 3.5.2 3.5.3 3.5.4 3.6.1 3.6.2 3.6.3 3.6.4 3.6.5 3.6.6 3.6.7 3.6.8 3.6.9 characteristic quality characteristic dependability traceability conformity nonconformity defect preventive action corrective action correction rework regrade repair

3.6 Terms relating to conformity

3 Terms and definitions cont …
3.6.10 scrap 3.6.11 concession 3.6.12 deviation permit 3.6.13 release 3.7 Terms relating to documentation 3.7.1 information 3.7.2 document 3.7.3 specification 3.7.4 quality manual 3.7.5 quality plan 3.7.6 record

3 Terms and definitions cont …
3.8 Terms relating to examination 3.8.1 objective evidence 3.8.2 inspection 3.8.3 test 3.8.4 verification 3.8.5 validation 3.8.6 qualification process 3.8.7 review 3.9 Terms relating to audit 3.9.1 audit 3.9.2 audit programme 3.9.3 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 process 3.10.1 measurement control system 3.10.2 measurement process 3.10.3 metrological confirmation 3.10.4 measuring equipment 3.10.5 metrological characteristic 3.10.6 metrological function

Quality Management Systems – Requirements

No control to control at all stages
NO CONTROL
Consumer needs Few good products

Process

Results •High wastage •Less customer satisfaction

CONTROL AT ALL STAGES

Consumer needs

Requirements

Plan

Process

Good products

Results •Low wastage •High customer satisfaction

The Design Control Process
DESIGN REVIEW

Design specification

Design input

Design process

Design output

Product

Verification

Validation

The hidden structure of ISO 9001
Purchasing4.6 Customer-supplied Product 4.7

YOUR WORK
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 4.1 Training 4.18 YOUR SYSTEM Quality system 4.2 Document control 4.5 Corrective action 4.14 Internal quality audit 4.17 YOUR INFORMATION Product identification 4.8 Records 4.16 Statistical techniques 4.20

Month 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

Typical Action Plan

The ISO 9000 implementation process
ACTION OUTPUTS
Select ISO 9001 or 9002 Set up steering committee Get staff commitment Decide to go for ISO 9000 Appoint coordinator

Write policy

Quality policy

Define responsibilities Describe process And carry out gap analysis

Job description

Organizational chart

Describe process And carry out gap analysis Involve and train staff Get staff to adopt new procedures

Write procedures Implement Quality system

Procedures

Manual

Train auditors

Audit the system Get registered Publicize Your success

Audit report

Maintain the system

ISO 9000 certificate

The ISO 9000 implementation process Cont…

Structure of quality system documentation
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

Quality manual

LEVEL A LEVEL A

Quality system procedures Work instruction, forms reports etc

LEVEL B LEVEL B

LEVEL C LEVEL C

Audit process flow sheet
Plan audit

Do audit

No problems found Issue report

Problem found Determine cause Issue Nonconformance report Take corrective action

The process of certification & surveillance
Contact several certification bodies Select certification bodies Apply for certification Certification body checks your manual Make changes Complete questionnaire; get quotations

FAIL

PASS
Agree date for assessment Certification body checks your system

FAIL

Make changes

PASS
Get ISO 9000 certification Regular surveillance Visits for 3 yrs

PASS

FAIL

Make changes

ISO 9000: the base for the journey to TQM

WORLD CLASS QUALITY IMPROVED ISO 9000 SYSTEM

JOURNEY TO TQM

UNCOMMITTED

Quality Management Systems – Guidelines for performance improvements

Introduction
0.1 General 0.2 Process approach 0.3 Relationship with ISO 9001 0.4 Compatibility with other management systems

Model of a process-based quality management Systems
Continual improvement of The quality management system

Interested Parties

Management responsibility

Interested Parties

Resource management

Measurement, Analysis and improvement

Satisfaction

Requirements

input

Product realization

Product

output

Key Value-adding activities Information flow

1. 2. 3. 4.

Quality management systems – Guidelines for performance improvements
Scope Normative reference Terms and definitions Quality management system

4.1 Managing systems and processes 4.2 Documentation 4.3 Use of quality management principles
a. b. c. d. e. f. g. h. Customer focus Leadership Involvement of people Process approach System approach to management Continual Improvement Factual approach to decision making Mutually beneficial supplier relationships

Quality management systems – Guidelines for performance improvements Cont…
5.

Management responsibility 5.1 General guidance 5.1.1 Introduction 5.1.2 Issues to be considered 5.2 Needs and expectations of interested parties 5.2.1 General 5.2.2 Needs and expectations 5.2.3 Statutory and regulatory requirement 5.3 Quality policy 5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality planning

Quality management systems – Guidelines for performance improvements Cont…
5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output

6 Resource management 6.1 General guidance 6.1.1 Introduction 6.1.2 Issues to be considered

Quality management systems – Guidelines for performance improvements Cont…
6.2 People
6.2.1 Investment of people 6.2.2 Competence
6.2.2.1 Competence 6.2.2.2 Awareness and training

6.3 6.4 6.5 6.6 6.7 6.8

Infrastructure work environment information Suppliers and partnerships Natural resources Financial resources

Quality management systems – Guidelines for performance improvements Cont…
5.

Product realization 7.1 General guidance 7.1.1 Introduction 7.1.2 Issues to be considered 7.1.3 Managing processes 7.1.3.1 General 7.1.3.2 Process inputs, outputs and review 7.1.3.3 Product and process validation and changes 7.2 Processes related to interested parties 7.3 Design and development 7.3.1 General guidance 7.3.2 Design and development input and output 7.3.3 Design and Development review

Quality management systems – Guidelines for performance improvements Cont…
7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Supplier control process 7.5 Production and services operations 7.5.1 Operation and realization 7.5.2 Identification and traceability 7.5.3 Customer property 7.5.4 Preservation of product 7.6 Control of measuring and monitoring devices 8. Measurement, analysis and improvement 8.1 General guidance 8.1.1 Introduction 8.1.2 Issues to be considered

Quality management systems – Guidelines for performance improvements Cont…
8.2 measuring and monitoring
8.2.1 Measurement and monitoring of system performance
8.2.1.1 General 8.2.1.2 Measurement and monitoring of customer satisfaction 8.2.1.3 Internal Audit 8.2.1.4 Financial measures 8.2.1.5 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

Quality management systems – Guidelines for performance improvements Cont…
8.3 Control of nonconformity
8.3.1 General 8.3.2 Nonconformity review and disposition

8.4 Analysis of data 8.5 Improvement
8.5.1 General 8.5.2 Corrective action 8.5.3 Loss prevention 8.5.4 Continual improvement of the organization

ISO 9001 IMPLEMENTATIONA 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 it Do not mix up other Quality Management Initiatives like ERP with ISO Let 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.

Sign up to vote on this title
UsefulNot useful