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Quality Management System

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Presentation on theme: "Quality Management System"— Presentation transcript:

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


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