mini project - iso9000 and efqm_titus

8/3/2019 Mini Project - IsO9000 and EFQM_Titus

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What is ISO ?

Stands for International Organisation for Standardization

ISO is not an acronym, it is derived from the Greek word

ISOS, meaning equal It is an NGO, founded in Feb 23, 1947

Prime focus on worldwide proprietary, industrial and

commercial standards Has its headquarters in Geneva, Switzerland

A network of the national standards institutes of 163

countries with one member per country


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ISO Its members

Presently 163 members out of 204

countries in the world


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ISO Its History

Began in 1926, as the International Federation of the

National Standardizing Associations

Disbanded in 1942 during the second World War

Re-organized under the name ISO, in 1947


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ISO Its products

Main products are the International Standards (ISO 9000)

Technical Reports (e.g., ISO/IEC TR 19791:2006)

Technical Specifications (e.g., ISO/TS 16949:2009)

Technical Corrigenda (e.g., ISO/IEC 13818-1:2007/Cor 1:2008)

Guidelines (a guidance to technical committees for the preparation of

standards)


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ISO Its family of standards & Portfolio

Developed over 18500 international standards on wide

variety of subjects

About 1100 new standards are published every year The ISO Portfolio

Agriculture

Building construction

Environmental protection

Food technology

Health technologies

Oil & Gas

Plastics

Ship building


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ISO 9000 Quality management system

ISO 9000 family of standards deals with the fundamentals of quality

management system

It is based on the eight quality management principles

Principle 1: Customer focus Principle 2: Leadership Principle 3: Involvement of people Principle 4: Process approach Principle 5: System approach to management Principle 6: Continual improvement Principle 7: Factual approach to decision making

Principle 8: Mutually beneficial supplier relationships

Describes the use of process approach for continual improvement

Deals with the requirements that organizations wishing to meet the standard

have to fulfill


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The ISO 9000 family addresses "Quality management". This means what the organization does to fulfill:

The customer's quality requirements,

Applicable regulatory requirements, while aiming to Enhance customer satisfaction, and Achieve continual improvement of its performance in pursuit ofthese objectives



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ISO 9000 is composed of 5 different, but related parts ISO 9000, 9001,9002, 9003 and 9004

ISO 9000 and 9004 are guidelines, while ISO 9001, 9002, and 9003 are thecategories in which a company may apply for certification.

ISO 9000: Quality Management and Quality Assurance Standards Guidelines for Selection and Use . Written in order to determine whichcategory your organization should apply for.

ISO 9001: Quality Systems Model for Quality Assurance in

Design/Development, Production, Installation, and Servicing. This is the

category for companies which are involved in manufacturing or the creationand delivery of a service.

ISO 9002: Quality Systems Model for Quality Assurance in Productionand Installation. Companies who perform many functions, with the

exception of design and development, may apply to this category.


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ISO 9003: Quality Systems Model for Quality Assurance in Final Inspection andTest .This category is useful for outside of the manufacturing sector, such as indistributors ISO 9003 is being used less and may be dropped in the future.

ISO 9004:

Quality Management and Quality System Elements Guidelines

. Usedin order to help interpret the categories included in ISO 9000 certification.

The most widely used standards are the latest version of 9000 series, i.e. ISO9001:2008 and ISO 14001



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ISO 9000 The Process Approach

Plan

Do

check

Act


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ISO 9000 The Documentation Pyramid


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ISO 9000 Audit & Certification Process

Auditing Process

Internal audit by trained staffs or hired consultants

External audit by certification bodies (bureau veritus)

Auditing findings

Major Non-Compliances (to be rectified before recommendation)

Minor Non-Compliances (does not affect the recommendation)

Certification (valid only for 3 years)

Surveillance (audits will be conducted every year)

Re-certification (at the end of 3rd year)


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1. Get the Big Picture

2. Evaluate Your Quality System and Start The Implementation Project

3. Develop The Implementation Plan And Quality Goals

4. Create The Documentation Control Procedures

5. Create The Corrective and Preventive Actions System

6. Generate A Quality Manual

7. Start Training Employees and Maintaining Training Records

8. Inventory and Customer Fulfillment Documentation

9. Purchasing Control Documentation

10. Maintaining Nonconforming Materials

11. Design Control12. Calibration And Maintenance Of Equipment

13. Detailed Work Instructions

14. Management Review

15. Internal Audit And Closure

16. The Certification Audit

17. Continuous Improvement

ISO 9000 Steps for implementation


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Creates a more efficient, effective operation

Increases customer satisfaction and retention

Reduces audits

Enhances marketing

Improves employee motivation, awareness, and morale

Promotes international trade

Increases profit

Reduces waste and increases productivity.

ISO 9000 Its benefits


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Common criticism of ISO 9001 is the amount of money, time, and paperwork required for

registration

Only for documentation

ISO 9001 promotes specification, control, and procedures rather than understanding andimprovement

ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead

companies into thinking that certification means better quality

Prone to failure when a company is interested in certification before quality

Certifications are in fact often based on customer contractual requirements rather than a

desire to actually improve quality

Certificate on the wall, chances are you will create a paper system that doesn't have much

to do with the way you actually run your business

ISO 9000 Pitfalls


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ISO 9000 A case study of TVS Motor Company

1. Management decides to go for QMS for the reasons of achieving the business results in a

more systematic manner.

2. Top management decides on the QMS model, i.e. ISO or EFQM or etc..

3. It decides on the certification bodies, i.e. BVCI, BSI etc..

4. Appointing an ISO consultant for grooming the industry. It is done by evaluation of

background, history etc..5. Conduct top management awareness program on QMS, TS 16949

6. Formation of task force, MR appointment and kick-off is done. Representative from each

department.

7. Fix the target date for certification

8. Chalk out a milestone on a broader perspective.

9. Derive mission, Q policy, business objectives and cascading matrix for all functions of thecompany.

10. Prepare Quality manual for the company.

11. Prepare process maps for all process functions in all departments(process approach)

12. Derive Quality System Procedure(QSP) for all departments.

13. Prepare Quality system work instructions, guidelines.

14. Measure the current status of output and make records of it with respect to the standards


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15. Align to company's objectives and confirm with the respective departments.

16. Once system is created, TS training is conducted across the company at all levels

17. Conduct self-audit and compare with respect to the standards created.

18. If there is a gap, try to bridge it by improving the standard or the process.

19. Conduct audit by 2nd party, i.e. Internal auditors

20. Conduct friendly audit by auditors from the certification body21. Understand the audit findings and fill the gap if any

22. Apply for the certification body for final certification

23. Fix the dates for audit

24. Followed by Preliminary audit

25. Fill the gap by the timelines given by the certifying authority

26. Followed by the final audit27. Findings of final audit will be in the form of Major & Minor NCR and

observations/guidelines

28. Disposition of NCRs and call for verification.

29. Certification (valid only for 3 years) ISO/TS 16949, ISO 14001

30. Surveillance audit (once in a year)

31. Recertification at the end of 3rd year and so the cycle continues..


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Time lines for implementation

Started the TS process in 2002

ISO/TS 16949 Certification done in 2006

Re-certification in 2009

Due for re-certification in 2012

Cost of the certification process

Initial cost was 10 lakhs INR/year

Subsequently 3-4 lakhs INR/year

Towards certifications fees, auditors expenses etc..


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The independent certification body of Bureau Veritas

NONCONFORMITY REPORT (SF 02E)

DATE ORGANIZATION FILE REF REPORT NO

21-Aug-07TVS MOTOR COMPANY LIMITED 177.46

RKS 05/08Corporate scheme - Manufacturing site 2

NONCONFORMITY OBSERVED DURING SURVEILLANCE AUDIT 1

NONCONFORMITY OBSERVED IN PROCESS PED

FINDING (NONCONFORMITY)

It is observed that 53 dimensions out of 86 identified dimensions are not capable in relation to project U 86 requirements of process capability of 1.67. There is no evidence of a strategic action

plan to achieve the capability requirements

ISO/TS 16949:2002 - SECTION AND REQUIREMENT

8.2.3.1 - Monitoring and measurement of manufacturing processes:

The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow

diagram are implemented, including adherence to the specified measurement techniques, sampling plans, acceptance criteria, and reaction plans when acceptance cri teria are not met.

Significant process events, such as tool change or machine repair, shall be recorded.

DESCRIPTION OF OBJECTIVE EVIDENCE

GRADE LEAD ASSESSOR ASSESSOR ORGANIZATION REP.

minor nonconformityRajendra Kumar Sharma Rajendra Kumar Sharma Mr. Raghavendra

TO BE COMPLETED BEFORE (max. 80 days)

09-Nov-07

ISO 9000 Sample minor NCR


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INCIDENT SPECIFICCORRECTIVE ACTION (What is done to solve this problem)

ROOTCAUSE ANALYSIS. Determine what caused the failure in the system t o allow this nonconformity to occur.

Ask yourself 5 tim es: "Why". (Multiple causes may exist - do not reword the auditor's nonconformity description)

CORRECTIVE ACTION (What is done to prevent recurrence)

VERIFICATION OF CORRECTIVE ACTION

DATE OF COMPLETION

ORGANIZATION

REPRESENTATI

VE

Mr. Raghavendra

VERIFICATION OF CORRECTIVE ACTION

RESULT VERIFICATION OF THE CORRECTIVE ACTIONS

ASSESSOR DATE

VERIFICATION EFFECTIVENESS OF THE

CORRECTIVE ACTIONS

RESULT EFFECTIVENESS OF THE CORRECTIVE ACTIONS

ASSESSOR DATE

ISO/TS 16949:2002SF B02/15.01.06

ISO 9000 Sample minor NCR

TOB

ECOMPLETED

BY

BVQI

TOB

ECOMPLETED

BY

THEORGANIZATION

mini project - iso9000 and efqm_titus

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