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S tandardization & Quality Assurance

Policy Management. Quality Control Circle. Suggestion System. S tandardization & Quality Assurance. Cross- Functional Management. Daily Management. 5 S. STANDARDIZATION & QUALITY ASSURANCE. Is the best way easiest way safest way in particular time.

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S tandardization & Quality Assurance

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  1. Policy Management Quality Control Circle Suggestion System Standardization & Quality Assurance Cross- Functional Management Daily Management 5 S STANDARDIZATION & QUALITY ASSURANCE

  2. Is the best way easiest way safest way in particular time STANDARDDefinition

  3. Gather and “preserve “ know-how As standard to measure performance Prevent the occurrence of the same mistake As a basis for improvement STANDARDIZATIONOBJECTIVE(1)

  4. Assure stability As basis for Training Ease the job delegation and its monitoring As basis for audit Increase efficiency Lower cost STANDARDIZATION OBJECTIVES (2)

  5. Company (In-House) Standard Association Standard National Standard International Standard STANDARD TYPES

  6. Regulations Norms Specifications Engineering / Technical Standards Work/ Process Standards Manuals Circular Notices Memos TYPES OF WRITTEN STANDARDS

  7. QUALITY ASSURANCE • Provide product/service the customer want at the time required and at reasonable price • Formal quality system • Prevention not Detection • getting it right at the first time, every time

  8. FORMAL QUALITY SYSTEM Method defined to manage whole necessities that affect quality

  9. ISO, is a non-government organisation ISO means “same” used as name for standards made by International Organization for Standardization International Organization for Standardization based in Geneva, Swiss ISO 9000 is Quality system standard not product standard WHAT IS ISO 9000 ?

  10. EXPERIENCE FROM WORLD WAR II Europe : NATO - AQAP (1945) UK: MINDEF, DEF STANS 05-21 SERIES (1960) UK: BS 4891, A GUIDE TO QUALITY ASSURANCE (1972) UK: BS 5179, PART 1,2 AND 3 (1975) UK: BS 5750, PART 1,2 AND 3 (1979) INTERNATIONAL: ISO 9000 SERIES EUROPE: EN 29000 SERIES THE HISTORY OF ISO 9000 SERI

  11. ISO 9000QUALITY STANDARD SYSTEM Structure of ISO 9000 Seri ISO 9000 Selection of Model Contractual Non Contractual ISO 9001 ISO 9002 ISO 9003 ISO 9004 Model Quality system Reference

  12. ISO 9000 Quality Management and Quality Assurance Standard - Guidelines for Selection and Use ISO 9001 Quality Systems- Model for Quality Assurance in Design/Development, Production, Installation, and Servicing ISO 9002 Quality Systems- Model for Quality Assurance in Production and Installation ISO 9003 Quality systems- Model for Quality Assurance ISO 9004 Quality Management and Quality System Element- Guidellines ISO 8402 Quality - Vocabulary ISO 9000 QUALITY SYSTEM STANDARD

  13. CROSS REFERENCE OFQUALITY SYSTEM ELEMENT N/A = Not Applicable

  14. EVOLUTION OF QUALITY SYSTEM ELEMENTS improvement TOTAL QUALITY MANAGEMENT Design QUALITY ASSURANCE Processing ISO 9001 QUALITY CONTROL 20 clauses external contractual Sorting ISO 9002 19 clauses external contractual ISO 9003 INSPECTION 16 clauses external contractual

  15. ISO 9001 QUALITY SYSTEM CONTROL THE OPERATING PROCESS SUPPORT ACTIVITIES SALES & MARKETING QUALITY RESOURCES 4.3. Contract Review 4.6. Purchasing 4.11. Inspection, Measuring & Test Equipment 4.18. Training DESIGN 4.1. Management Responsibility 4.2. Quality System 4.5. Document Control 4.14. Corrective Action 4.17. Internal Quality Audits 4.4. Design Control QUALITY DATA SHOPFLOOR 4.9. Process Control 4.10. Inspection & Testing 4.7. Purchaser Supplied Product 4.12. Inspection & Test Status 4.13. Control of Non-Conforming Products 4.8. Product Identification & Traceability 4.16. Quality Records 4.20. Statistical Techniques DISTRIBUTION 4.15. Handling, Storage, Packaging & Delivery AFTER SALES 4.19. Servicing Source: BS 5750-THE STANDARD FOR QUALITY SYSTEM

  16. STRUCTURE OF QUALITY SYSTEM DOCUMENTATION QUALITY MANUAL What How, what, who, where when, why QUALITY SYSTEM PROCEDURE How, what with WORK INSTRUCTION

  17. Company profile (brief history, scope of business, domicile, quality system had and currently applied) Quality policy Quality objectives Management representative Company organization description Job description Job qualification Outline of quality system currently applied QUALITY MANUAL

  18. Procedure objective Scope of procedure Term of definition Cross reference with other relevant document Procedure description Form attachment, checklist, or label used QUALITY SYSTEM PROCEDURE

  19. Process of production affecting quality Handling tools Machine / production tool Number and Qualification of employee needed Inspection and Test point for each job Inspection and test method Acceptance criteria at each inspection and test point Measuring tool, inspection and test used production, inspection and test record QUALITY PLAN

  20. Can be in form of simple flowchart diagram Step by step guidelines for conducting job Filling forms Production process Operating machine/ tool Conducting inspection and test Handling / storage of product Calibration tools Work Instruction consist : Tools/ Material/Operator qualification Work step (includes description of acceptance criteria “workmanship” or with product sample/ prototype/ mock-up/ show unit.) WORK INSTRUCTION

  21. SURVEY AND SYSTEM EVALUATION DEVELOPING IMPLEMENTATION ORGANIZATION PROJECT PLANNING BRIEFING FOR TOP MANAGEMENT COACHING DOCUMENTATION TECHNIQUE DESIGN, REVIEW, IMPLEMENTATION, DOKUMENTATION AND SYSTEM IMPROVEMENT AWARENESS TRAINING INTERNAL QUALITY AUDIT CERTIFICATION IMPLEMENTATION PROCESS

  22. APPLICATION QUESTIONER QUESTIONER EVALUATION + QUALITY MANUAL AUDIT AT PLACE IMPROVEMENT STEPS (If any) RECOMMENDATION FOR CERTIFICATION CERTIFICATION SURVEILLANCE AUDIT CERTIFICATION RENEWAL (Every three year) CERTIFICATION PROCESS

  23. Assure quality consistence of the product/service minimize rework - and save cost build good foundation to enable fast evolvement ( to facilitate training and Human resources development) Customize company to act based on data Equip management with tool to make a tight observation of quality achievement possible Increase the clarity of responsibility and authority in every function WHY ISO 9000 IS ESSENTIAL ?Company benefit(1)

  24. Standardize and distribute good practices Eliminate quality dependency on one / few personnel A program where commitment and employee motivation are realized (example: targeted time for certification drives every action to achieve same goal) Quality system documented will improve communication inter department Quality system documented will contribute the training Quality system documented will become a ground for continuous improvement WHY ISO 9000 IS ESSENTIAL?Company Benefit (2)

  25. Improve company “Quality Image” Open up the access to large market requiring ISO 9000 certificate Increase Customer confidence of company quality A prerequisite for applying other certificate, such as CE mark MENGAPA ISO 9000 PENTING ?Marketing benefit

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