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) Organizations seeking advantage through the
implementation of a quality management system;
b) Organizations seeking confidence from their suppliers
that their product requirements will be satisfied
c) Users of the products
d) 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 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

Management Customers
responsibility (and other
Customers interested
(and other parties)
interested
parties) Measurement,
Resource Analysis and Satisfaction
management improvement

output
Require- input Product
Product
ments realization

Key
Value-adding activities Information flow
 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 resources
g) To review the quality management system periodically
 2 Fundamentals of quality
management Systems Cont…
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…
2.9 Continual improvement
a) Analysing and evaluating the existing situation
to identify areas for improvement
b) Establishing the objectives for improvement
c) Searching for possible solutions to achieve the
objectives
d) Evaluating these solutions and making a
selection
e) Implementing the selected solution
f) Measuring, verifying, analysing and evaluating
results of the implementation to determine that
the objectives have been met.
g) 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
a. 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.
 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 organization
3.3.2 organizational structure
3.3.3 infrastructure
3.3.4 work environment
3.3.5 customer
3.3.6 supplier
3.3.7 interested party
3.4 Terms relating to process and product
3.4.1 process
3.4.2 product
3.4.3 project
3.4.4 design and development
3.4.5 procedure
 3 Terms and definitions cont …
3.5.Terms relating to characteristics
3.5.1 characteristic
3.5.2 quality characteristic
3.5.3 dependability
3.5.4 traceability
3.6 Terms relating to conformity
3.6.1 conformity
3.6.2 nonconformity
3.6.3 defect
3.6.4 preventive action
3.6.5 corrective action
3.6.6 correction
3.6.7 rework
3.6.8 regrade
3.6.9 repair
 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 Few good

Results
Process •High wastage
needs products
•Less customer
satisfaction

CONTROL AT ALL STAGES

Consumer Require- Good

Plan Process
needs ments products

Results
•Low wastage
•High customer
satisfaction
 The Design Control Process

DESIGN REVIEW

Design Design Design Design

Product
specification input process output

Verification

Validation
 The hidden structure of ISO 9001
YOUR WORK
Purchasing4.6
Design control 4.4
Customer-supplied
Product 4.7 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 YOUR SYSTEM YOUR INFORMATION

Management responsibility 4.1 Quality system 4.2 Product identification 4.8

Training 4.18 Document control 4.5 Records 4.16
Corrective action 4.14 Statistical techniques 4.20
Internal quality audit 4.17
 Typical Action Plan
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
 The ISO 9000 implementation process
ACTION
OUTPUTS

Select Decide to go for

ISO 9001 or 9002 ISO 9000

Set up steering Appoint

committee coordinator

Get staff
Write policy Quality policy
commitment

Define Job
responsibilities description

Describe process
And carry out gap Organizational
analysis chart
 Describe process
And carry out gap
analysis

Involve and train

Write procedures Procedures
staff

Get staff to adopt Implement Quality

new procedures system Manual

Train auditors Audit the system Audit report

Maintain the Get ISO 9000

system registered certificate

Publicize
Your success
The ISO 9000 implementation process Cont…
 Structure of quality system documentation

Describes the
quality system as
Quality
per stated quality
manual LEVEL
LEVELAA policy & objectives

For each
functional unit,
Quality describes
system LEVEL
LEVELBB activities needed
procedures to implement the
quality system
Work element
instruction, Detailed work
forms instructions,
reports etc LEVEL
LEVELCC methods,
drawings, forms,
reports
 Audit process flow sheet
Plan audit

Do audit

No problems
Problem found
found

Determine
Issue report cause

Issue
Nonconformance
report

Take corrective
action
The process of certification & surveillance
Contact several Complete questionnaire;
certification bodies get quotations
Select certification
bodies

Apply for certification

Certification body
Make changes
checks your manual FAIL
PASS
Agree date for assessment

Certification body
checks your system Make changes
FAIL
PASS
Get ISO 9000
certification

Regular surveillance
Make changes
PASS Visits for 3 yrs FAIL
 ISO 9000: the base for the journey to TQM

WORLD CLASS

QUALITY
IMPROVED
JOURNEY TO TQM

ISO 9000
SYSTEM

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

Management Interested
responsibility Parties
Interested
Parties

Measurement,
Resource Analysis and Satisfaction
management improvement

output
Require- input Product
Product
ments realization

Key
Value-adding activities Information flow
 Quality management systems –
Guidelines for performance
improvements
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
4.1 Managing systems and processes
4.2 Documentation
4.3 Use of 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
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 Infrastructure
6.4 work environment
6.5 information
6.6 Suppliers and partnerships
6.7 Natural resources
6.8 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
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
 Draftingof 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
 Itis 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
 Validityfor 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.