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Transcript of 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 Fundamentals of quality management Systems Cont…
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 Fundamentals of quality management Systems Cont…
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 Fundamentals of quality management Systems Cont…
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
Quality management systems – Guidelines for performance improvements Cont…
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
6.1.1 Introduction6.1.2 Issues to be considered
Quality management systems – Guidelines for performance improvements Cont…
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
Quality management systems – Guidelines for performance improvements Cont…
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
Quality management systems – Guidelines for performance improvements Cont…
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
8.1.1 Introduction8.1.2 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 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
Quality management systems – Guidelines for performance
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.