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Standardization &

Quality Assurance

PolicyManagement

Cross- Functional Management

DailyManagement

Suggestion

System

Quality Control

Circle

5 S

STANDARDIZATION & QUALITY ASSURANCE

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STANDARDSTANDARDDefinition

Is the • best way• easiest way• safest way in particular time

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STANDARDIZATIONSTANDARDIZATIONOBJECTIVE(1)OBJECTIVE(1)

• Gather and “preserve “ know-how• As standard to measure

performance• Prevent the occurrence of the

same mistake • As a basis for improvement

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STANDARDIZATION STANDARDIZATION OBJECTIVES (2)OBJECTIVES (2)

• Assure stability• As basis for Training• Ease the job delegation and its

monitoring• As basis for audit• Increase efficiency• Lower cost

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STANDARD TYPESSTANDARD TYPES

•Company (In-House) Standard

•Association Standard•National Standard•International Standard

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TYPES OF WRITTEN TYPES OF WRITTEN STANDARDSSTANDARDS

• Regulations• Norms• Specifications• Engineering / Technical Standards• Work/ Process Standards• Manuals• Circular Notices• Memos

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QUALITY ASSURANCEQUALITY 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

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FORMAL QUALITY SYSTEM

Method defined to manage whole necessities that affect quality

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WHAT IS ISO 9000 ?WHAT IS ISO 9000 ?

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

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THE HISTORY OF ISO 9000 SERI

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

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ISO 9000ISO 9000QUALITY STANDARD SYSTEMQUALITY STANDARD SYSTEM

Structure of ISO 9000 Seri

ISO 9000Selection of Model

Non Contractual Contractual

ISO 9001ISO 9002ISO 9003

ISO 9004

ModelQuality system

Reference

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ISO 9000 QUALITY SYSTEM STANDARD

• 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

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CROSS REFERENCE OFCROSS REFERENCE OFQUALITY SYSTEM ELEMENTQUALITY SYSTEM ELEMENT

Clausul Element ISO 9001 ISO 9002 ISO 9003

4.1 Management responsibility V V V4.2 Quality system V V V4.3 Contract review V V V4.4 Design control V N/A N/A4.5 Document and data control V V V4.6 Purchasing V V N/A4.7 Control of supplied good owned by purchaser V V V4.8 Identification and traceability of product V V V4.9 Process control V V N/A4.10 Inspection and Measurement V V V4.11 Control of inspection, measurement and test equipment V V V4.12 Inspection and measurement status V V V4.13 Control of non-conformance product V V V4.14 Corrective action and prevention V V V4.15 Handling, Storage, and maintenance of delivery V V V4.16 Quality record V V V4.17 Internal quality audit V V V4.18 Training V V V4.19 Service V V N/A4.20 Statistic technique V V V

N/A = Not Applicable

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EVOLUTION OF QUALITY SYSTEM EVOLUTION OF QUALITY SYSTEM ELEMENTSELEMENTS

improvementimprovement

TOTAL QUALITYTOTAL QUALITYMANAGEMENTMANAGEMENT

DesignDesign

QUALITY ASSURANCEQUALITY ASSURANCE

ProcessingProcessing

QUALITY CONTROLQUALITY CONTROL

INSPECTIONINSPECTION

SortingSorting

ISO

90

01

ISO

90

01IS

O 9

00

2IS

O 9

00

2

ISO

90

03

ISO

90

03

20 clausesexternal contractual

19 clausesexternal contractual

16 clausesexternal contractual

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ISO 9001ISO 9001

QUALITY SYSTEM CONTROLQUALITY SYSTEM CONTROL THE OPERATING PROCESSTHE OPERATING PROCESS SUPPORT ACTIVITIESSUPPORT ACTIVITIES

4.1. Management Responsibility

4.2. Quality System

4.5. Document Control

4.14. Corrective Action

4.17. Internal Quality Audits

4.3. Contract Review

4.4. Design Control

4.9. Process Control4.10. Inspection & Testing4.7. Purchaser Supplied Product4.12. Inspection & Test Status4.13. Control of Non-Conforming Products

4.15. Handling, Storage, Packaging & Delivery

4.19. Servicing

4.6. Purchasing4.11. Inspection, Measuring & Test Equipment4.18. Training

4.8. Product Identification & Traceability4.16. Quality Records4.20. Statistical Techniques

SALES & MARKETINGSALES & MARKETING

DESIGNDESIGN

SHOPFLOORSHOPFLOOR

DISTRIBUTIONDISTRIBUTION

AFTER SALESAFTER SALES

QUALITY RESOURCESQUALITY RESOURCES

QUALITY DATAQUALITY DATA

Source: BS 5750-THE STANDARD FOR QUALITY SYSTEM

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STRUCTURE OF QUALITY SYSTEM STRUCTURE OF QUALITY SYSTEM DOCUMENTATIONDOCUMENTATION

WhatWhat

How, what,How, what,who, wherewho, wherewhen, whywhen, why

How,How,what withwhat with

QUALITY MANUALQUALITY MANUAL

QUALITY SYSTEM PROCEDUREQUALITY SYSTEM PROCEDURE

WORK INSTRUCTIONWORK INSTRUCTION

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QUALITY MANUALQUALITY MANUAL 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

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QUALITY SYSTEM QUALITY SYSTEM PROCEDUREPROCEDURE

Procedure objective

Scope of procedure

Term of definition

Cross reference with other relevant document

Procedure description

Form attachment, checklist, or label used

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QUALITY PLANQUALITY PLAN 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

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WORK INSTRUCTIONWORK INSTRUCTION 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.)

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IMPLEMENTATION PROCESSIMPLEMENTATION PROCESS

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

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CERTIFICATION PROCESSCERTIFICATION PROCESS APPLICATION QUESTIONER QUESTIONER EVALUATION + QUALITY

MANUAL AUDIT AT PLACE IMPROVEMENT STEPS (If any) RECOMMENDATION FOR CERTIFICATION CERTIFICATION SURVEILLANCE AUDIT CERTIFICATION RENEWAL (Every three year)

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WHY ISO 9000 IS ESSENTIAL ?WHY ISO 9000 IS ESSENTIAL ?Company benefit(1)Company benefit(1)

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

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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?WHY ISO 9000 IS ESSENTIAL?Company Benefit (2)Company Benefit (2)

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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 ?MENGAPA ISO 9000 PENTING ?Marketing benefitMarketing benefit