1. Quality Management System
A Presentation by
ASHOK S JAIN
ABHAY

2. 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

3. Quality Management Systems – Fundamentals and Vocabulary

4. 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 provides guidance on auditing quality and environmental management systems.

5. Introduction Cont… 0.2 Quality management principles Customer focus
Leadership
Involvement of People
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships

6. 1. Scope
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.

7. 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

8. Model of a process-based quality management Systems
Value-adding activities
Information flow
Key
Continual improvement of
The quality management system
Product
realization
Management
responsibility
Measurement,
Analysis and
improvement
Resource
management
Require-
ments
Satisfaction
Customers
(and other
interested
parties)
input
output

9. 2 Fundamentals of quality management Systems Cont…
2.6 Role of top management within the quality management system
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

10. 2 Fundamentals of quality management Systems Cont…
2.7 Documentation
2.7.1 Value of documentation
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

11. 2 Fundamentals of quality management Systems Cont…
2.9 Continual improvement
Analysing and evaluating the existing situation 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

12. 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,
Contain provisions for evaluation against generic models
Provide a basis for continual improvement, and
Contain provision for external recognition.

13. 3 Terms and definitions 3.1 Terms relating to 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

14. 3 Terms and definitions cont …
3.2.6 management top management quality management quality planning quality control quality assurance quality improvement continual improvement effectiveness efficiency

15. 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

16. 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

17. 3 Terms and definitions cont …
scrap
concession
deviation permit
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

18. 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

19. 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
audit team
technical expert
competence

20. 3 Terms and definitions cont …
3.10 Terms related to quality assurance for measurement process
measurement control system
measurement process
metrological confirmation
measuring equipment
metrological characteristic
metrological function

21. Quality Management Systems – Requirements

22. No control to control at all stages
Results
High wastage
Less customer
satisfaction
Consumer
needs
Process
Few good
products
CONTROL AT ALL STAGES
Consumer
needs
Require-
ments
Plan
Process
Good
products
Results
Low wastage
High customer
satisfaction

23. The Design Control Process
DESIGN REVIEW
Design
specification
Design
input
Design
process
Design
output
Product
Verification
Validation

24. The hidden structure of ISO 9001
YOUR WORK
Purchasing4.6
Customer-supplied
Product 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 4.1
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

25. Typical Action Plan Month 1 Month 3 Month 5 Month 7 Month 9 Month 11
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

26. The ISO 9000 implementation process
ACTION
OUTPUTS
Select
ISO 9001 or 9002
Decide to go for
ISO 9000
Set up steering
committee
Appoint
coordinator
Get staff
commitment
Write policy
Quality policy
Define
responsibilities
Job
description
Describe process
And carry out gap
analysis
Organizational
chart

27. The ISO 9000 implementation process Cont…
Describe process
And carry out gap
analysis
Procedures
Involve and train staff
Write procedures
Get staff to adopt new procedures
Implement Quality system
Manual
Train auditors
Audit the system
Audit report
Maintain the system
Get
registered
ISO 9000
certificate
Publicize
Your success
The ISO 9000 implementation process Cont…

28. 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
Quality system procedures
Work instruction, forms reports etc

29. Audit process flow sheet
Plan audit
Do audit
No problems
found
Problem found
Determine
cause
Issue report
Issue
Nonconformance
report
Take corrective
action

30. The process of certification & surveillance
Contact several
certification bodies
Complete questionnaire;
get quotations
Select certification
bodies
Apply for certification
Certification body
checks your manual
Make changes
FAIL
PASS
Agree date for assessment
Certification body
checks your system
Make changes
FAIL
PASS
Get ISO 9000
certification
Regular surveillance
Visits for 3 yrs
Make changes
FAIL
PASS

31. ISO 9000: the base for the journey to TQM
WORLD CLASS
QUALITY
IMPROVED
JOURNEY TO TQM
ISO 9000
SYSTEM
UNCOMMITTED

32. Quality Management Systems – Guidelines for performance improvements

33. Introduction
0.1 General 0.2 Process approach 0.3 Relationship with ISO Compatibility with other management systems

34. Model of a process-based quality management Systems
Key
Continual improvement of
The quality management system
Product
realization
Management
responsibility
Measurement,
Analysis and
improvement
Resource
management
Require-
ments
Satisfaction
Interested
Parties
input
output
Value-adding activities
Information flow

35. 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
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual Improvement
Factual approach to decision making
Mutually beneficial supplier relationships

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

37. 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
Issues to be considered

38. 6.6 Suppliers and partnerships 6.7 Natural resources
Quality management systems – Guidelines for performance improvements Cont…
6.2 People
6.2.1 Investment of people
6.2.2 Competence
Competence
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

39. Quality management systems – Guidelines for performance improvements Cont…
Product realization
7.1 General guidance
7.1.1 Introduction
7.1.2 Issues to be considered
7.1.3 Managing processes
General
Process inputs, outputs and review
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

40. 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

41. Quality management systems – Guidelines for performance improvements Cont…
8.2 measuring and monitoring
8.2.1 Measurement and monitoring of system performance
General
Measurement and monitoring of customer satisfaction
Internal Audit
Financial measures
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

42. 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

43. ISO 9001 IMPLEMENTATION- A CASE STUDY OF GAMMON INDIA LTD

44. 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

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

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

47. 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

48. 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

49. 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

50. 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

51. 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

52. 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

53. Some specific challenges
Union staff in HO and their pending salary settlement
Projects of varied types
He work force of
Interpersonal relation issues
Sweet and sour approach at different levels

54. 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

55. 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

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

57. 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

58. 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

59. 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

60. 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

61. Learnings
At last don’t give up; you may miss your mile stones but not the final destination
Celebrate your achievements.

62. Thankyou