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34071 Public Disclosure Authorized ✹Quality Management Public Disclosure Authorized in Photovoltaics Quality Control Manual for Manufacturers Peter F. Varadi PV GAP Public Disclosure Authorized Geneva, Switzerland Ramón Domínguez Domínguez and Associates Rockville, Maryland, USA Loretta Schaeffer PV GAP Board Washington, D.C., USA Public Disclosure Authorized Copyright © 2003 The International Bank for Reconstruction and Development / THE WORLD BANK 1818 H Street, N.W. Washington, D.C. 20433, USA All rights reserved Manufactured in the United States of America First printing January 2001 Second edition March 2003 The findings, interpretations, and conclusions expressed in this book are entirely those of the authors and should not be attributed in any manner to the World Bank, to its affiliated organizations, or to members of its Board of Executive Directors or the countries they represent. The World Bank does not guarantee the accuracy of the data included in this publication and accepts no responsibility for any consequence of their use. The boundaries, colors, denominations, and other information shown on any map in this volume do not imply on the part of the World Bank Group any judgment on the legal status of any territory or the endorsement or acceptance of such boundaries. The material in this publication is copyrighted. The World Bank encourages dissemination of its work and grants permission to reproduce this work. Contents ✹ Chapter 1. Quality in Manufacturing— General Concepts.......................................... 1 1.1 The Photovoltaic Industry ................................................ 1 1.2 Elements of a Quality Manufacturing System ............... 2 1.3 Global Approval Program for Photovoltaics ................. 3 1.3.1 Why Is There a Need for a Global Approval Program for Photovoltaics? ..................................................4 1.3.2 Elements of the PV GAP Approval System......................... 4 1.3.3 ISO Standards for Quality in Manufacturing...................... 5 1.3.4 Standards for the Performance of Products......................... 6 1.3.5 Testing Laboratories................................................................ 6 1.3.6 Auditing by an Outside Organization.................................. 7 1.3.7 Internationally Utilized “PV Quality Mark and Seal” .......8 1.3.8 PV GAP Program Administered by an Internationally Accepted Approval Body .......................... 8 1.3.9 How Expensive Is It to Set Up and to Operate a Quality System? .......................................8 1.4 The Evolution and Merits of Quality Systems............. 11 1.5 Quality Manufacturing Process: Introducing the IEC, IECQ, and ISO .................................................................. 14 1.6 ISO Standards for Quality in Manufacturing ............... 16 1.6.1 What Is ISO 9000? ..................................................................16 1.6.2 Quality System Requirements .............................................17 1.6.3 General Description of ISO 9000:2000 ................................19 1.6.3.1 Process Approach ....................................................................20 1.6.4 Components of the Quality Management System ............22 1.6.5 Definitions (from ISO 9000:2000) .........................................23 1.6.6 ISO Documentation Levels ...................................................24 Level A: Quality Manual ....................................................................25 Level B: Quality Operating Procedures ...........................................25 Level C: Operator Work Instructions ...............................................26 Level D: Other Instructions, Specifications, and Records .............26 1.6.7 ISO Quality Definitions ........................................................26 1.7 The Quality Management System (Clause 4.0) ....................................................................... 27 1.7.1 General Requirements (Clause 4.1) .....................................27 1.7.1.1 What Does Quality Mean for Your Business? .....................27 1.7.1.2 Reviewing the General Requirements ..................................28 Homework Assignment—Day One .................................... 30 Contents. iii Chapter 2. ISO 9001:2000 Standard—Clauses 4–6 ........ 32 ✹ 2.1 Documentation Requirements (Clause 4.2) .................. 32 2.1.1 General Requirements (Clause 4.2.1) ..................................32 2.1.2 Quality Manual (Clause 4.2.2) .............................................33 2.1.3 Control of Documents (Clause 4.2.3) ..................................34 2.1.4 Control of Records (Clause 4.2.4) ........................................39 2.2 Management Responsibility (Clause 5) ........................ 41 2.2.1 Management Commitment (Clause 5.1) ............................41 2.2.2 Customer Focus (Clause 5.2) ................................................42 2.2.3 Quality Policy (Clause 5.3) ...................................................42 2.2.4 Planning (Clause 5.4) ............................................................45 2.2.4.1 Quality Objectives (Clause 5.4.1) ..........................................45 2.2.4.2 Quality Planning (Clause 5.4.2) .............................................45 2.2.5 Responsibility, Authority, and Communication (Clause 5.5) ......................................47 2.2.5.1 Responsibility and Authority (Clause 5.5.1) .......................47 2.2.5.2 The Management Representative (Clause 5.5.2) .................50 2.2.5.3 Internal Communication (Clause 5.5.3) ...............................55 2.2.6 Management Review (Clause 5.6) .......................................55 2.2.6.1 General (Clause 5.6.1) .............................................................55 2.2.6.2 Review Input (Clause 5.6.2) ...................................................56 2.2.6.3 Review Output (Clause 5.6.3) ................................................56 2.3 Resource Management (Clause 6) .................................. 57 2.3.1 Provision of Resources (Clause 6.1) ....................................57 2.3.2 Human Resources (Clause 6.2) ............................................57 2.3.2.1 General (Clause 6.2.1) .............................................................57 2.3.2.2 Competence, Awareness and Training (Clause 6.2.2) ............................................................................58 2.3.3 Infrastructure (Clause 6.3) ....................................................61 2.3.4 Work Environment (Clause 6.4) ..........................................62 Homework Assignment—Day Two .................................... 63 Chapter 3. ISO 9001:2000 Standard— Clause 7 ..................................................... 66 3.1 Product Realization (Clause 7) ....................................... 66 3.1.1 Planning of Product Realization (Clause 7.1) ....................66 3.2 Customer-Related Processes (Clause 7.2) ..................... 69 3.2.1 Determination of Requirements Related to the Product (Clause 7.2.1) .........................................................................69 3.2.2 Review of Requirements Related to the Product (Clause 7.2.2) .........................................................................70 3.2.3 Customer Communication (Clause 7.2.3) ..........................72 3.3 Design and Development (Clause 7.3) .......................... 72 Contents. iv 3.3.1 Design and Development Planning (Clause 7.3.1) ...........72 3.3.2 Design and Development Inputs (Clause 7.3.2) ................76 ✹ 3.3.3 Design and Development Outputs (Clause 7.3.3) ............77 3.3.4 Design and Development Review (Clause 7.3.4) ..............77 3.3.5 Design and Development Verification (Clause 7.3.5) ......78 3.3.6 Design and Development Validation (Clause 7.3.6) .........79 3.3.7 Design and Development Changes (Clause 7.3.7) ............79 3.3.8 Procedures to Control and Verify the Design of Products ........................................................80 Case Study No. 1 .................................................................... 80 3.4 Purchasing (Clause 7.4) ................................................... 81 3.4.1 Purchasing Process (Clause 7.4.1) .......................................81 3.4.1.1 Evaluation of Suppliers ..........................................................82 3.4.1.2 Inventory Control ....................................................................84 3.4.1.3 Vendor Evaluation ..................................................................85 3.4.2 Purchasing Information (Clause 7.4.2) ...............................85 3.4.3 Verification of Purchased Product (Clause 7.4.3) .............85 Case Study No. 2 .................................................................... 87 3.5 Production and Service Provision (Clause 7.5) ............ 89 3.5.1 Control of Production and Service Provision (Clause 7.5.1) .........................................................................89 3.5.1.1 Inspection and Testing ...........................................................93 3.5.1.2 Incoming Inspection ...............................................................93 3.5.1.3 In-Process Inspection and Testing ........................................93 3.5.1.4 Final Inspection and Testing ..................................................96 3.5.1.5 Servicing ...................................................................................98 3.5.1.6 Planning and Scheduling Servicing Activities ....................98