Automotive Quality Systems Handbook

ISO/TS 16949:2002 (TS2) will have a huge impact on the whole of the automobile industry as it formalises, under a single world-wide standard, the quality system that must be met by vehicle manufacturers and their suppliers. This handbook is the only comprehensive guide to understanding and satisfying the requirements of ISO/TS 16949:2002. Written by best-selling quality author David Hoyle (ISO 9000 Quality Systems Handbook) this new book is ideal for those new to the standard or establishing a single management system for the first time, as well as those migrating from existing quality management systems. It will suit quality system managers and quality professionals across the automotive industry, managers and executive level readers, consultants, auditors, trainers and students of management and quality.

• The only complete ISO/TS 16949:2002 (TS2) reference: essential for understanding both TS2 and ISO 9001:2000
• TS2 becomes mandatory for all auto manufacturers and their many thousands of suppliers in 2006
• Includes details of the certification scheme, the differences with previous standards, check lists, questionnaires, tips for implementers, flow charts and a glossary of terms
• David Hoyle is one of the world's leading quality management authors

1;Cover;1 2;Automotive Quality Systems Handbook;4 3;Contents;6 4;Preface;10 4.1;Approach to the requirements;10 4.2;How to use this handbook;11 4.3;Structure and style of the handbook;12 5;Acknowledgements;14 6;Chapter 1 Basic concepts;16 6.1;Introduction;16 6.2;Principles or prescription;18 6.3;Quality;19 6.4;The interested parties;23 6.4.1;The customer;23 6.4.2;The internal customer;24 6.4.3;The supply chain;24 6.4.4;Society;24 6.4.5;Employees;25 6.4.6;Suppliers;25 6.4.7;Investors;25 6.5;The characteristics of quality;26 6.5.1;Classification of products and services;26 6.5.2;Quality and price;27 6.5.3;Quality and cost;28 6.5.4;High quality and low quality; poor quality and good quality;29 6.5.5;Quality characteristics;30 6.5.6;Quality, reliability and safety;31 6.5.7;Quality parameters;31 6.5.8;Dimensions of quality;32 6.6;Achieving sustaining and improving quality;33 6.6.1;Quality management;33 6.6.2;Quality management principles;34 6.6.2.1;Customer focus;35 6.6.2.2;Leadership;36 6.6.2.3;Involvement of people;37 6.6.2.4;Process approach;38 6.6.2.5;System approach to management;39 6.6.2.6;Continual improvement;40 6.6.2.7;Factual approach to decision-making;41 6.6.2.8;Mutually beneficial supplier relationships;42 6.6.2.9;Using the principles;43 6.6.2.10;Alignment of principles with the Business Excellence Model;43 6.6.3;Quality control;45 6.6.3.1;Control before the event;46 6.6.3.2;Control during the event;46 6.6.3.3;Control after the event;48 6.6.3.4;Quality control as a label;48 6.6.3.5;Universal sequence of steps;49 6.6.3.6;Variation;49 6.6.4;Special cause;50 6.6.5;Common cause;50 6.6.6;Quality improvement;51 6.6.7;Six sigma;55 6.6.8;Level of attention to quality;61 6.6.9;Quality assurance;59 6.6.10;Quality management systems;62 6.6.10.1;Philosophy;62 6.6.10.2;Scope of the system;66 6.6.10.3;Design of the system;66 6.6.11;Functional approach versus process approach;68 6.7;Managing processes;69 6.7.1;Finding a definition;71 6.7.2;Business process re-engineering;7
2 6.7.3;Process characteristics;72 6.7.3.1;Process purpose;73 6.7.3.2;Process objectives;73 6.7.3.3;Process inputs;73 6.7.3.4;Process outputs;74 6.7.3.5;Process resources;74 6.7.3.6;Process constraints;74 6.7.3.7;Process results;75 6.7.3.8;Process classes;76 6.7.3.9;Making the connections;78 6.7.3.10;Process effectiveness;78 6.7.3.11;Process management principles;79 6.7.3.11.1;Consistency of purpose;79 6.7.3.11.2;Clarity of purpose;79 6.7.3.11.3;Connectivity with objectives;79 6.7.3.11.4;Competence and capability;80 6.7.3.11.5;Certainty of results;80 6.7.3.11.6;Conformity to best practice;80 6.7.3.11.7;Clear line of sight;80 6.8;Developing an effective system;80 6.8.1;Establishing the goals;81 6.8.1.1;Purpose, mission and vision;81 6.8.1.2;Values;81 6.8.1.3;Stakeholder needs;82 6.8.1.4;Stakeholder satisfaction indicators;82 6.8.2;Develop the processes;82 6.8.2.1;Identifying business processes;82 6.8.2.2;Deriving process control parameters;82 6.8.2.3;Identifying work processes;83 6.8.2.4;Determining work process activities;83 6.8.2.5;Determining the competence and capability;87 6.8.2.6;Resourcing processes;87 6.8.2.7;Installing processes;87 6.8.2.8;Commissioning processes;87 6.8.2.9;Process integration;88 6.8.2.10;System integration;88 6.8.2.11;Review performance;88 6.8.2.12;Reviews during development;88 6.8.2.13;Reviews after development;88 6.9;Summary;89 6.10;Basic concepts Food for thought;90 7;Chapter 2 Perceptions of ISO 9000 and its derivatives;91 7.1;Introduction;91 7.2;How we think about ISO 9000;92 7.3;How we think about quality management system;93 7.4;How we think about certification;97 7.4.1;Pressure for certification;97 7.4.2;The approach to certification;99 7.4.3;The approach to auditing;99 7.4.4;Auditor training;100 7.4.5;The effect of competition;100 7.4.6;Misplaced objectives;101 7.5;How ISO 9000 made us think about quality;102 7.6;How we think about reviews, inspections and audits;105 7.7;Is ISO/TS 16949:2002 any different?;106 7.8;Summary;107 7.9;P
erceptions of ISO 9000 and its derivatives Food for thought;109 8;Chapter 3 Role, origins and application of ISO/TS 16949;110 8.1;The role of ISO/TS 16949;110 8.1.1;What is ISO/TS 16949?;110 8.1.2;What is the purpose of ISO/TS 16949?;110 8.1.3;Do we need to comply with other standards in the ISO 9000 family?;111 8.1.4;What does ISO/TS 16949 apply to?;111 8.2;The origins;112 8.2.1;Why is a sector standard needed?;112 8.2.2;The origins of ISO/TS 16949;113 8.2.3;Emergence of sector requirements;113 8.2.3.1;The British contribution;114 8.2.3.2;The American contribution;115 8.2.3.3;The German contribution;116 8.2.3.4;The Italian contribution;116 8.2.3.5;The French contribution;117 8.2.3.6;The motivation;117 8.2.3.7;Harmonization;119 8.3;Emergence of a common certification scheme;120 8.3.1;The ISO 9000 certification scheme;120 8.3.2;The ISO/TS 16949 certification scheme;122 8.3.3;ISO/TS 16949 certification criteria;123 8.3.4;ISO/TS 16949 and the EU;124 8.4;Applications of ISO/TS 16949 requirements;125 8.4.1;Using ISO/TS 16949;125 8.4.2;Responding to ISO/TS 16949 requirements;125 8.4.3;Anomalies in ISO/TS 16949;126 8.4.3.1;Contract-specific requirements;126 8.4.3.2;Duplicated requirements;126 8.4.3.3;Order of requirements;127 8.4.3.4;Exclusions;127 8.5;Summary;128 8.6;Role, origins and application Food for thought;129 9;Chapter 4 Quality management system;130 9.1;Summary of requirements;130 9.2;Establishing a quality management system;131 9.2.1;What does this mean?;131 9.2.2;Why is this necessary?;131 9.2.3;How is this implemented?;132 9.2.4;Establish the goals;132 9.2.5;Develop the processes;132 9.2.6;Review performance;133 9.2.7;Improve capability;133 9.3;Identifying processes;133 9.3.1;What does this mean?;133 9.3.2;Why is this necessary?;134 9.3.3;How is this implemented?;134 9.3.3.1;Top-down approach;135 9.3.3.2;Bottom-up approach;137 9.3.3.3;Naming processes;139 9.4;Sequence and interaction of processes;140 9.4.1;What does this mean?;140 9.4.2;Why is this necessary?;
140 9.4.3;How is this implemented?;140 9.5;Criteria and methods for effective operation and control;141 9.5.1;What does this mean?;141 9.5.2;Why is this necessary?;141 9.5.3;How is this implemented?;142 9.6;Documenting a quality management system;143 9.6.1;What does this mean?;143 9.6.2;Why is this necessary?;143 9.6.3;How is this implemented?;144 9.7;Documented procedures;147 9.7.1;What does this mean?;147 9.7.2;Why is this necessary?;148 9.7.3;How is this implemented?;149 9.8;Documents that ensure effective planning, operation and control of processes;150 9.8.1;What does this mean?;150 9.8.2;Why is this necessary?;151 9.8.3;How is this implemented?;152 9.8.3.1;Policies and practices;152 9.8.3.2;Policies;152 9.8.3.3;Process descriptions;154 9.8.3.4;Procedures;156 9.8.3.5;Standards;156 9.8.3.6;Guides;157 9.8.3.7;Derived documents;157 9.8.3.8;Specifications;157 9.8.3.9;Plans;157 9.8.3.10;Reports;157 9.8.3.11;Records;157 9.8.3.12;Instructions;158 9.8.3.13;Internal references;158 9.8.3.14;External reference documents;158 9.9;What should be documented?;158 9.9.1;Size of organization;159 9.9.2;Type of organization;159 9.9.3;Complexity of processes;159 9.9.4;Competence;160 9.9.5;Factors affecting the amount of information you document;160 9.9.6;Reasons for not documenting information;161 9.10;Implementing a quality management system;162 9.10.1;What does this mean?;162 9.10.2;Why is this necessary?;162 9.10.3;How is this implemented?;162 9.11;Managing processes;163 9.11.1;What does this mean?;163 9.11.2;Why is this necessary?;163 9.11.3;How is this implemented?;164 9.12;Ensuring information availability;164 9.12.1;What does this mean?;165 9.12.2;Why is this necessary?;165 9.12.3;How is this implemented?;165 9.13;Ensuring the availability of resources;165 9.13.1;What does this mean?;166 9.13.2;Why is this necessary?;166 9.14;Measuring, monitoring and analyzing processes;166 9.14.1;What does this mean?;166 9.14.2;Why is this necessary?;167 9.14.3;How is this implemented?;167
9.14.3.1;Process measurement;167 9.14.3.2;Process monitoring;168 9.14.3.3;Process analysis;168 9.15;Maintaining a quality management system;170 9.15.1;What does this mean?;170 9.15.2;Why is this necessary?;170 9.15.3;How is this implemented?;170 9.16;Continual improvement in the quality management system and its processes;171 9.16.1;What does this mean?;171 9.16.2;Why is this necessary?;171 9.16.3;How is this implemented?;172 9.17;Outsourcing;173 9.17.1;What does this mean?;173 9.17.2;Why is this necessary?;173 9.17.3;How is this implemented?;173 9.18;Preparing the quality manual;174 9.18.1;What does this mean?;174 9.18.2;Why is this necessary?;174 9.18.3;How is this implemented?;175 9.19;Scope of the quality management system;177 9.19.1;What does this mean?;177 9.19.2;Why is this necessary?;177 9.19.3;How is this implemented?;177 9.20;Referencing procedures in the quality manual;177 9.20.1;What does this mean?;177 9.20.2;Why is this necessary?;178 9.21;Describing the processes and their interaction;178 9.21.1;What does this mean?;179 9.21.2;Why is this necessary?;179 9.21.3;How is this implemented?;179 9.22;Control of documents;179 9.22.1;Documents required for the management system;179 9.22.1.1;What does this mean?;180 9.22.1.2;Why is this necessary?;180 9.22.1.3;How is this implemented?;181 9.22.2;Document control procedures;181 9.22.2.1;Why is this necessary?;182 9.22.2.2;How is this implemented?;182 9.22.2.2.1;Document development and maintenance;182 9.22.2.2.2;Document security;183 9.22.3;Document approval;184 9.22.3.1;What does this mean?;184 9.22.3.2;Why is this necessary?;184 9.22.3.3;How is this implemented?;184 9.22.3.3.1;Adequacy of documents;184 9.22.3.3.2;Approval authorities;185 9.22.3.3.3;Denoting approval;185 9.22.3.3.4;Issuing documents;186 9.22.3.3.5;Approving external documents;187 9.22.3.3.6;Approving data;187 9.22.4;Document review;187 9.22.4.1;What does this mean?;187 9.22.4.2;Why is this necessary?;188 9.22.4.3;How is this implemented?;188 9
.22.5;Revision of documents;188 9.22.5.1;What does this mean?;188 9.22.5.2;Why is this necessary?;189 9.22.5.3;How is this implemented?;189 9.22.5.3.1;The change process;189 9.22.5.3.2;What is a change?;189 9.22.5.3.3;Request for change;189 9.22.5.3.4;Permission to change;190 9.22.5.3.5;Making the change;191 9.22.6;Identifying the change;192 9.22.6.1;Why is this necessary?;193 9.22.6.2;How is this implemented?;193 9.22.7;Identifying the current revision of documents;194 9.22.7.1;What does this mean?;194 9.22.7.2;Why is this necessary?;194 9.22.7.3;How is this implemented?;194 9.22.7.3.1;Revision conventions;194 9.22.7.3.2;Document referencing;195 9.22.8;Re-approving documents after change;195 9.22.8.1;What does this mean?;196 9.22.8.2;Why is this necessary?;196 9.22.8.3;How is this implemented?;196 9.22.9;Ensuring the availability of controlled documents;196 9.22.9.1;What does this mean?;196 9.22.9.2;Why is this necessary?;197 9.22.9.3;How is this implemented?;197 9.22.9.3.1;Availability;197 9.22.9.3.2;Relevant versions of internal documents;198 9.22.9.3.3;Relevant versions of external documents;198 9.22.9.3.4;Issuing change instructions;199 9.22.10;Ensuring documents are legible and identifiable;200 9.22.10.1;What does this mean?;200 9.22.10.2;Why is this necessary?;200 9.22.10.3;How is this implemented?;200 9.22.10.3.1;Legibility;200 9.22.10.3.2;Identification;200 9.22.11;Control of external documents;201 9.22.11.1;What does this mean?;201 9.22.11.2;Why is this necessary?;201 9.22.11.3;How is this implemented?;201 9.22.12;Preventing unintended use of obsolete documents;202 9.22.12.1;What does this mean?;202 9.22.12.2;Why is this necessary?;202 9.22.12.3;How is this implemented?;203 9.22.13;Reviewing engineering specifications;204 9.22.13.1;What does this mean?;204 9.22.13.2;Why is this necessary?;204 9.22.13.3;How is this implemented?;204 9.22.14;Maintaining modification records;205 9.22.14.1;What does this mean?;205 9.22.14.2;Why is this necessary?;205 9.22.14.3;
How is this implemented?;205 9.23;Control of records;206 9.23.1;Establishing and maintaining records;206 9.23.1.1;What does this mean?;206 9.23.1.2;Why is this necessary?;207 9.23.1.3;How is this implemented?;207 9.23.1.3.1;Establishing records;207 9.23.1.3.2;Maintaining records;209 9.23.2;Establishing a records procedure;210 9.23.2.1;What does this mean?;210 9.23.2.2;Why is this necessary?;211 9.23.2.3;How is this implemented?;211 9.23.2.3.1;Records procedures;211 9.23.2.3.2;Legibility of records;211 9.23.2.3.3;Identification of records;211 9.23.2.3.4;Retrieving records;212 9.23.2.3.5;Storage of records;212 9.23.2.3.6;Protection of records;213 9.23.2.3.7;Retention of records;214 9.23.2.3.8;Disposition of records;215 9.23.2.3.9;Validation of records;215 9.24;Summary;216 9.25;Quality management system requirements checklist;217 9.25.1;General requirements;217 9.25.2;Documentation requirements;217 9.25.2.1;General;217 9.25.2.2;Quality manual;217 9.25.2.3;Control of documents;217 9.25.2.4;Engineering specifications;218 9.25.2.5;Control of records;218 9.25.2.6;Records retention;218 9.26;Quality management system Food for thought;219 10;Chapter 5 Management responsibility;220 10.1;Summary of requirements;220 10.2;Management commitment;221 10.2.1;Commitment to the QMS;221 10.2.1.1;What does this mean?;221 10.2.1.1.1;Top management;221 10.2.1.1.2;Commitment;221 10.2.1.1.3;Commitment to a management system;222 10.2.1.2;Why is this necessary?;223 10.2.1.3;How is this implemented?;223 10.2.1.3.1;Defining top management;223 10.2.1.3.2;Commitment;224 10.2.1.3.3;Commitment to a management system;225 10.2.2;Communicating the importance of requirements;225 10.2.2.1;What does this mean?;225 10.2.2.1.1;Communication;225 10.2.2.1.2;Statutory and regulatory requirements;226 10.2.2.2;Why is this necessary?;226 10.2.2.3;How is this implemented?;226 10.2.3;Establishing quality policy;227 10.2.3.1;What does this mean?;227 10.2.3.2;Why is this necessary?;229 10.2.3.3;How is this implemente
d?;229 10.2.4;Establishing quality objectives;230 10.2.4.1;What does this mean?;230 10.2.4.2;Why is this necessary?;230 10.2.4.3;How is this implemented?;231 10.2.5;Conducting management reviews;231 10.2.5.1;What does this mean?;231 10.2.5.2;Why is this necessary?;231 10.2.5.3;How is this implemented?;232 10.2.6;Ensuring availability of resources;232 10.2.6.1;What does this mean?;233 10.2.6.2;Why is this necessary?;233 10.2.6.3;How is this implemented?;233 10.2.7;Process efficiency;234 10.2.7.1;What does this mean?;234 10.2.7.2;Why is this necessary?;234 10.2.7.3;How is this implemented?;234 10.3;Customer focus;235 10.3.1;Determining customer requirements;235 10.3.1.1;What does this mean?;235 10.3.1.2;Why is this necessary?;235 10.3.1.3;How is this implemented?;236 10.3.1.3.1;Understanding customer needs;236 10.3.1.3.2;Gathering the data;238 10.3.2;Meeting requirements;239 10.3.2.1;What does this mean?;239 10.3.2.2;Why is this important?;239 10.3.2.3;How is this implemented?;240 10.4;Quality policy;240 10.4.1;Ensuring policy is appropriate;240 10.4.1.1;What does this mean?;240 10.4.1.2;Why is this necessary?;240 10.4.1.3;How is this implemented?;240 10.4.2;Expressing a commitment;242 10.4.2.1;What does this mean?;242 10.4.2.2;Why is this necessary?;242 10.4.2.3;How is this implemented?;243 10.4.3;Providing a framework for quality objectives;243 10.4.3.1;What does this mean?;244 10.4.3.2;Why is this necessary?;244 10.4.3.3;How is this implemented?;244 10.4.4;Ensuring policy is communicated and understood;245 10.4.4.1;What does this mean?;246 10.4.4.2;Why is this necessary?;246 10.4.4.3;How is this implemented?;246 10.4.5;Ensuring that the policy is reviewed;248 10.4.5.1;What does this mean?;248 10.4.5.2;Why is this necessary?;248 10.4.5.3;How is this implemented?;248 10.5;Quality objectives;249 10.5.1;Establishing objectives;249 10.5.1.1;What does this mean?;249 10.5.1.2;Why is this necessary?;249 10.5.1.3;How is this implemented?;250 10.5.1.3.1;Objectives for contro
l and improvement;250 10.5.1.3.2;Process for establishing objectives;250 10.5.1.3.3;Corporate goals;252 10.5.1.3.4;Process objectives;253 10.5.1.3.5;Product objectives;253 10.5.1.3.6;Departmental objectives;253 10.5.1.3.7;Personal objectives;254 10.5.2;Expressing quality objectives;254 10.5.2.1;What does this mean?;254 10.5.2.2;Why is this necessary?;254 10.5.2.3;How is this implemented?;255 10.5.2.3.1;Setting objectives;255 10.5.2.3.2;Consistency with policy;256 10.5.2.3.3;Measures;256 10.5.2.3.4;Business plan;259 10.6;Quality management system planning;259 10.6.1;Planning to meet quality objectives;259 10.6.1.1;What does this mean?;259 10.6.1.2;Why is this necessary?;260 10.6.1.3;How is this implemented?;260 10.6.1.3.1;Processes for planning;261 10.6.1.3.2;Corporate planning;261 10.6.1.3.3;Department planning;262 10.6.1.3.4;Product and process development planning;262 10.6.1.3.5;Personal planning;262 10.6.2;Planning for change;263 10.6.2.1;What does this mean?;263 10.6.2.2;Why is this necessary?;263 10.6.2.3;How is this implemented?;264 10.7;Responsibility and authority;264 10.7.1;Defining responsibilities and authority;264 10.7.1.1;What does this mean?;264 10.7.1.2;Why is this necessary?;265 10.7.1.3;How is this implemented?;265 10.7.2;Communicating responsibilities and authority;266 10.7.2.1;What does this mean?;266 10.7.2.2;Why is this necessary?;266 10.7.2.3;How is this implemented?;267 10.7.3;Responsibility for quality;270 10.7.3.1;Alerting authorities to nonconformities;270 10.7.3.1.1;What does this mean?;270 10.7.3.1.2;Why is this necessary?;270 10.7.3.1.3;How is this implemented?;270 10.7.3.1.4;What does this mean?;271 10.7.3.1.5;Why is this necessary?;271 10.7.3.1.6;How is this implemented?;271 10.7.3.2;Staffing production shifts;272 10.7.3.2.1;What does this mean?;272 10.7.3.2.2;Why is this necessary?;272 10.7.3.2.3;How is this implemented?;272 10.8;Management representative;273 10.8.1;Appointing management representatives;273 10.8.1.1;What does this mea
n?;273 10.8.1.2;Why is this necessary?;274 10.8.1.3;How is this implemented?;275 10.8.2;Responsibility for establishing and maintaining processes;276 10.8.2.1;What does this mean?;276 10.8.2.2;Why is this necessary?;276 10.8.2.3;How is this implemented?;276 10.8.3;Responsibility for reporting on QMS performance;277 10.8.3.1;What does this mean?;277 10.8.3.2;Why is this necessary?;277 10.8.3.3;How is this implemented?;277 10.8.4;Responsibility for promoting awareness of customer requirements;278 10.8.4.1;What does this mean?;278 10.8.4.2;Why is this necessary?;278 10.8.4.3;How is this implemented?;278 10.8.4.3.1;Responsibility for external liaison;279 10.8.5;Customer representative;279 10.8.5.1;What does this mean?;279 10.8.5.2;Why is this necessary?;279 10.8.5.3;How is this implemented?;280 10.9;Internal communication;280 10.9.1;Establishing communication processes;280 10.9.1.1;What does this mean?;281 10.9.1.2;Why is this necessary?;281 10.9.1.3;How is this implemented?;281 10.9.2;Communicating the effectiveness of the QMS;283 10.9.2.1;What does this mean?;283 10.9.2.2;Why is this necessary?;283 10.9.2.3;How is this implemented?;283 10.10;Management review;284 10.10.1;Purpose of review;284 10.10.1.1;What does this mean?;284 10.10.1.2;Why is this necessary?;285 10.10.1.3;How is this implemented?;285 10.10.2;Planning the review;288 10.10.2.1;What does this mean?;288 10.10.2.2;Why is this necessary?;288 10.10.2.3;How is this implemented?;288 10.10.3;Scope of review;288 10.10.3.1;What does this mean?;289 10.10.3.2;Why is this necessary?;289 10.10.3.3;How is this implemented?;289 10.10.4;Records of management reviews;290 10.10.4.1;What does this mean?;290 10.10.4.2;Why is this necessary?;290 10.10.4.3;How is this implemented?;290 10.10.5;Review inputs;291 10.10.5.1;What does this mean?;291 10.10.5.2;Why is this necessary?;291 10.10.5.3;How is this implemented?;291 10.10.6;Monitoring quality objectives;292 10.10.6.1;Cost of poor quality;292 10.10.6.2;Audit results;293 10
.10.6.3;Customer feedback;293 10.10.6.4;Process performance;294 10.10.7;Product performance;294 10.10.7.1;Corrective actions;294 10.10.7.2;Preventive actions;295 10.10.7.3;Actions from management reviews;295 10.10.7.4;Changes affecting the management system;295 10.10.8;Review outputs;296 10.10.8.1;What does this mean?;296 10.10.8.2;Why is this necessary?;296 10.10.8.3;How is this implemented?;296 10.11;Summary;297 10.12;Management responsibility requirement checklist;298 10.12.1;Management commitment;298 10.12.2;Process efficiency;298 10.12.3;Customer focus;298 10.12.4;Quality policy;298 10.12.5;Planning;298 10.12.5.1;Quality objectives;298 10.12.5.2;Quality management system planning;298 10.12.6;Responsibility, authority and communication;298 10.12.6.1;Responsibility and authority;298 10.12.6.2;Responsibility for quality;299 10.12.6.3;Management representative;299 10.12.6.4;Customer representative;299 10.12.6.5;Internal communication;299 10.12.7;Management review;299 10.12.7.1;General;299 10.12.7.2;Quality management system performance;299 10.12.7.3;Review input;299 10.12.7.4;Review output;299 10.13;Management responsibility Food for thought;300 11;Chapter 6 Resource management;301 11.1;Summary of requirements;301 11.2;Determining resources;303 11.2.1;What does this mean?;303 11.2.2;Why is this necessary?;304 11.2.3;How is this implemented?;304 11.3;Providing resources;306 11.3.1;What does this mean?;306 11.3.2;Why is this necessary?;306 11.3.3;How is this implemented?;307 11.3.3.1;Inventory;308 11.4;Competence of personnel;309 11.4.1;What does this mean?;309 11.4.2;Why is this necessary?;311 11.4.3;How is this implemented?;311 11.5;Training awareness and competence;313 11.5.1;Determining competence necessary;313 11.5.1.1;Why is this necessary?;314 11.5.1.2;How is this implemented?;315 11.5.2;Providing for training;318 11.5.2.1;What does this mean?;318 11.5.2.2;Why is this necessary?;318 11.5.2.3;How is this implemented?;318 11.5.2.3.1;Competence assessment;318 11.
5.2.3.2;Bridging the competence gap;319 11.5.2.3.3;On-the-job training;319 11.5.2.3.4;External training;320 11.5.2.3.5;Training aids;320 11.5.3;Evaluating the effectiveness of personnel development activities;321 11.5.3.1;What does this mean?;321 11.5.3.2;Why is this necessary?;321 11.5.3.3;How is this implemented?;321 11.5.3.3.1;Development activity evaluation (the initial stage);322 11.5.3.3.2;Development activity effectiveness short term (the intermediate stage);323 11.5.3.3.3;Development activity effectiveness long term (the final stage);323 11.5.4;Increasing sensitivity to the impact of activities;323 11.5.4.1;What does this mean?;324 11.5.4.2;Why is this necessary?;324 11.5.4.3;How is this implemented?;325 11.5.4.3.1;Designing the awareness process;325 11.5.4.3.2;Measuring effectiveness;326 11.5.5;Maintaining training records;327 11.5.5.1;What does this mean?;327 11.5.5.2;Why is this necessary?;328 11.5.5.3;How is this implemented?;328 11.5.6;Awareness of the consequences of nonconformity;329 11.5.6.1;What does this mean?;329 11.5.6.2;Why is this necessary?;330 11.5.6.3;How is this implemented?;330 11.5.7;Employee motivation and empowerment;330 11.5.7.1;What does this mean?;330 11.5.7.2;Why is this necessary?;331 11.5.7.3;How is this implemented?;331 11.5.7.3.1;Motivation;331 11.5.7.3.2;Empowerment;333 11.6;Infrastructure;333 11.6.1;What does this mean?;333 11.6.2;Why is this necessary?;334 11.6.3;How is this implemented?;334 11.6.3.1;Identifying infrastructure;334 11.6.3.2;Providing infrastructure;335 11.6.3.3;Maintaining infrastructure;335 11.6.3.4;Maintenance of equipment;337 11.6.3.5;Jigs, tools and fixtures;339 11.6.4;Plant, facility and equipment planning;340 11.6.4.1;Plant layouts;340 11.6.4.1.1;What does this mean?;340 11.6.4.1.2;Why is this necessary?;340 11.6.4.1.3;How is this implemented?;340 11.6.4.2;Effectiveness monitoring methods;341 11.6.4.2.1;What does this mean?;341 11.6.4.2.2;Why is this necessary?;341 11.6.4.2.3;How is this implemented?;341
11.7;Work environment;342 11.7.1;What does this mean?;342 11.7.2;Why is this necessary?;344 11.7.3;How is this implemented?;345 11.7.3.1;Dealing with the physical factors;346 11.7.3.2;Dealing with the human factors;346 11.7.3.3;Managing the human factors;351 11.7.4;Personnel safety to achieve product quality;352 11.7.4.1;What does this mean?;353 11.7.4.2;Why is this necessary?;353 11.7.4.3;How is this implemented?;353 11.7.5;Cleanliness of premises;353 11.7.5.1;What does this mean?;354 11.7.5.2;Why is this necessary?;354 11.7.5.3;How is this implemented?;354 11.8;Summary;354 11.9;Resource management requirements checklist;356 11.9.1;Provision of resources;356 11.9.2;Human resources;356 11.9.2.1;General;356 11.9.3;Competence, awareness and training;356 11.9.4;Product design skills;356 11.9.5;Training;356 11.9.6;Training on the job;356 11.9.7;Employee motivation and empowerment;356 11.9.8;Infrastructure;356 11.9.9;Plant, facility and equipment planning;356 11.9.10;Contingency plans;357 11.9.11;Work environment;357 11.9.12;Personnel safety to achieve product quality;357 11.9.13;Cleanliness of premises;357 11.10;Resource management Food for thought;358 12;Chapter 7 Product realization;360 12.1;Summary of requirements;360 12.2;Planning product realization processes;362 12.2.1;Planning and developing product realization processes;362 12.2.1.1;What does this mean?;363 12.2.1.2;Why is this necessary?;364 12.2.1.3;How is this implemented?;364 12.2.1.3.1;Planning product realization processes;364 12.2.1.3.2;Developing product realization processes;367 12.2.2;Creating consistency in process planning;369 12.2.2.1;What does this mean?;369 12.2.2.2;Why is this necessary?;369 12.2.2.3;How is this implemented?;369 12.2.3;Quality objectives and requirement for product;369 12.2.3.1;What does this mean?;369 12.2.3.2;Why is this necessary?;370 12.2.3.3;How is this implemented?;370 12.2.4;Determining the need for specific processes;370 12.2.4.1;What does this mean?;370 12.2.4.2;Why is
this necessary?;371 12.2.4.3;How is this implemented?;371 12.2.5;Determining the need for documentation;371 12.2.5.1;What does this mean?;371 12.2.5.2;Why is this necessary?;372 12.2.5.3;How is this implemented?;372 12.2.6;Determining the need for resources;373 12.2.6.1;What does this mean?;373 12.2.6.2;Why is this necessary?;373 12.2.6.3;How is this implemented?;373 12.2.7;Determining verification, validation and monitoring activities;375 12.2.7.1;What does this mean?;375 12.2.7.2;Why is this necessary?;375 12.2.7.3;How is this implemented?;375 12.2.7.3.1;Product verification;375 12.2.7.3.2;Document verification;377 12.2.8;Determining the criteria for product acceptance;378 12.2.8.1;What does this mean?;378 12.2.8.2;Why is this necessary?;378 12.2.8.3;How is this implemented?;378 12.2.9;Determining the need for records;379 12.2.9.1;What does this mean?;379 12.2.9.2;Why is this necessary?;379 12.2.9.3;How is this implemented?;380 12.2.9.3.1;Product records;380 12.2.9.3.2;Process records;380 12.2.10;Documenting product realization planning;380 12.2.10.1;What does this mean?;380 12.2.10.2;Why is this necessary?;381 12.2.10.3;How is this implemented?;381 12.2.11;Acceptance criteria;381 12.2.11.1;What does this mean?;381 12.2.11.2;Why is this necessary?;382 12.2.11.3;How is this implemented?;382 12.2.12;Confidentiality;382 12.2.12.1;What does this mean?;382 12.2.12.2;Why is this necessary?;382 12.2.12.3;How is this implemented?;382 12.2.13;Change control;383 12.2.13.1;What does this mean?;383 12.2.13.2;Why is this necessary?;383 12.2.13.3;How is this implemented?;383 12.3;Customer-related processes;384 12.3.1;Determination of requirements related to the product;384 12.3.1.1;Products requirements specified by the customer;386 12.3.1.1.1;What does this mean?;386 12.3.1.1.2;Why is this necessary?;387 12.3.1.1.3;How is this implemented?;387 12.3.1.2;Product requirements not specified by the customer;388 12.3.1.2.1;What does this mean?;389 12.3.1.2.1.1;Market need;389 12.3.1
.2.1.2;Specific contract or order;389 12.3.1.2.2;Why is this necessary?;389 12.3.1.2.3;How is this implemented?;389 12.3.1.3;Statutory and regulatory requirements;390 12.3.1.3.1;What does this mean?;390 12.3.1.3.2;Why is this necessary?;390 12.3.1.3.3;How is this implemented?;391 12.3.1.4;Organizations product requirement;392 12.3.1.4.1;What does this mean?;392 12.3.1.4.2;Why is this necessary?;392 12.3.1.4.3;How is this implemented?;392 12.3.1.5;Customer-designated special characteristics;392 12.3.1.5.1;What does this mean?;392 12.3.1.5.2;Why is this necessary?;393 12.3.1.5.3;How is this implemented?;393 12.3.1.6;Review of requirements related to the product;393 12.3.1.6.1;Conducting the review;393 12.3.1.6.1.1;What does this mean?;393 12.3.1.6.1.2;Why is this necessary?;393 12.3.1.6.1.3;How is this implemented?;394 12.3.1.6.1.3.1;New product development;394 12.3.1.6.1.3.2;Proprietary sales;394 12.3.1.6.1.3.3;Custom sales;394 12.3.1.6.2;Timing of review;395 12.3.1.6.2.1;What does this mean?;395 12.3.1.6.2.2;Why is this necessary?;395 12.3.1.6.2.3;How is this implemented?;395 12.3.1.6.3;Ensuring that product requirements are defined;396 12.3.1.6.3.1;What does this mean?;396 12.3.1.6.3.2;Why is this necessary?;396 12.3.1.6.3.3;How is this implemented?;396 12.3.1.6.4;Resolving differences;397 12.3.1.6.4.1;What does this mean?;397 12.3.1.6.4.2;Why is this necessary?;397 12.3.1.6.4.3;How is this implemented?;397 12.3.1.6.5;Ensuring that the organization has the ability to meet defined requirements;398 12.3.1.6.5.1;What does this mean?;398 12.3.1.6.5.2;Why is this necessary?;398 12.3.1.6.5.3;How is this implemented?;398 12.3.1.6.6;Maintaining records of product requirement reviews;399 12.3.1.6.6.1;What does this mean?;399 12.3.1.6.6.2;Why is this necessary?;400 12.3.1.6.6.3;How is this implemented?;400 12.3.1.6.7;Handling undocumented statements of requirements;400 12.3.1.6.7.1;What does this mean?;401 12.3.1.6.7.2;Why is this necessary?;401 12.3.1.6.7.3;How is this impl
emented?;401 12.3.1.6.8;Changes to product requirements;401 12.3.1.6.8.1;What does this mean?;401 12.3.1.6.8.2;Why is this necessary?;401 12.3.1.6.8.3;How is this implemented?;402 12.3.1.7;Customer communication;402 12.3.1.7.1;Providing product information;402 12.3.1.7.1.1;What does this mean?;402 12.3.1.7.1.2;Why is this necessary?;403 12.3.1.7.1.3;How is this implemented?;403 12.3.1.7.2;Handling enquiries;403 12.3.1.7.2.1;What does this mean?;403 12.3.1.7.2.2;Why is this necessary?;403 12.3.1.7.2.3;How is this implemented?;404 12.3.1.7.3;Handling contracts and orders;404 12.3.1.7.3.1;What does this mean?;404 12.3.1.7.3.2;Why is this necessary?;404 12.3.1.7.3.3;How is this implemented?;404 12.3.1.7.3.4;Why is this necessary?;407 12.3.1.7.3.5;How is this implemented?;407 12.3.1.7.4;Customer feedback;407 12.3.1.7.4.1;What does this mean?;408 12.3.1.7.4.2;Why is this necessary?;408 12.3.1.7.4.3;How is this implemented?;408 12.3.1.7.5;Language and format;409 12.3.1.7.5.1;What does this mean?;409 12.3.1.7.5.2;Why is this necessary?;409 12.3.1.7.5.3;How is this implemented?;409 12.4;Design and development;410 12.4.1;Design and development control;410 12.4.1.1;What does this mean?;410 12.4.1.2;Why is this necessary?;411 12.4.1.3;How is this implemented?;412 12.4.2;Design and development planning;412 12.4.2.1;Preparing the plans;412 12.4.2.1.1;What does this mean?;412 12.4.2.1.2;Why is this necessary?;412 12.4.2.1.3;How is this implemented?;414 12.4.3;Stages of design and development process;416 12.4.3.1;What does this mean?;416 12.4.3.2;Why is this necessary?;416 12.4.3.3;How is this implemented?;416 12.4.4;Planning review, verification and validation activities;417 12.4.4.1;What does this mean?;417 12.4.4.2;Why is this necessary?;417 12.4.4.3;How is this implemented?;417 12.4.5;Determining responsibilities and authority for design and development activities;419 12.4.5.1;Why is this necessary?;419 12.4.5.2;How is this implemented?;419 12.4.6;Managing organizational interf
aces;420 12.4.6.1;What does this mean?;420 12.4.6.2;Why is this necessary?;420 12.4.6.3;How is this implemented?;420 12.4.7;Ensuring that plans are updated as the design progresses;422 12.4.7.1;What does this mean?;422 12.4.7.2;Why is this necessary?;422 12.4.7.3;How is this implemented?;422 12.4.8;Multidisciplinary approach;422 12.4.8.1;What does this mean?;423 12.4.8.2;Why is this necessary?;423 12.4.8.3;How is this implemented?;423 12.4.9;Design and development input;423 12.4.9.1;Determining and recording design inputs;423 12.4.9.1.1;What does this mean?;424 12.4.9.1.2;Why is this necessary?;424 12.4.9.1.3;How is this implemented?;424 12.4.9.2;Defining functional and performance requirements;425 12.4.9.2.1;What does this mean?;425 12.4.9.2.2;Why is this necessary?;426 12.4.9.2.3;How is this implemented?;426 12.4.9.3;Defining statutory and regulatory requirements;426 12.4.9.3.1;What does this mean?;426 12.4.9.3.2;Why is this necessary?;426 12.4.9.3.3;How is this implemented?;427 12.4.9.4;Defining information from previous designs;427 12.4.9.4.1;What does this mean?;427 12.4.9.4.2;Why is this necessary?;427 12.4.9.4.3;How is this implemented?;427 12.4.9.5;Identifying other essential requirements;428 12.4.9.5.1;What does this mean?;428 12.4.9.5.2;Why is this necessary?;428 12.4.9.5.3;How is this implemented?;428 12.4.9.6;Reviewing design input requirements;429 12.4.9.6.1;What does this mean?;429 12.4.9.6.2;Why is this necessary?;429 12.4.9.6.3;How is this implemented?;429 12.4.9.7;Manufacturing process design input;430 12.4.9.7.1;What does this mean?;430 12.4.9.7.2;Why is this necessary?;430 12.4.9.7.3;How is this implemented?;430 12.4.9.8;Special characteristics;430 12.4.9.8.1;What does this mean?;430 12.4.9.8.2;Why is this necessary?;431 12.4.9.8.3;How is this implemented?;431 12.4.10;Design and development output;431 12.4.10.1;Documenting the design and development output;431 12.4.10.1.1;What does this mean?;432 12.4.10.1.2;Why is this necessary?;432 12.4.10.1.3;
How is this implemented?;432 12.4.10.1.3.1;Product specifications;433 12.4.10.1.3.2;Design calculations;433 12.4.10.1.3.3;Design analyses;434 12.4.10.2;Ensuring that design output meets design input requirements;434 12.4.10.2.1;What does this mean?;434 12.4.10.2.2;Why is this necessary?;434 12.4.10.2.3;How is this implemented?;434 12.4.10.3;Providing information for purchasing, production and service provision;435 12.4.10.3.1;What does this mean?;435 12.4.10.3.2;Why is this necessary?;435 12.4.10.3.3;How is this implemented?;435 12.4.10.4;Defining acceptance criteria;435 12.4.10.4.1;What does this mean?;436 12.4.10.4.2;Why is this necessary?;436 12.4.10.4.3;How is this implemented?;436 12.4.10.5;Specifying essential characteristics;436 12.4.10.5.1;What does this mean?;436 12.4.10.5.2;Why is this necessary?;436 12.4.10.5.3;How is this implemented?;437 12.4.10.6;Approval of design outputs;437 12.4.10.6.1;What does this mean?;437 12.4.10.6.2;Why is this necessary?;437 12.4.10.6.3;How is this implemented?;438 12.4.10.7;Manufacturing process design output;439 12.4.10.7.1;What does this mean?;439 12.4.10.7.2;Why is this necessary?;439 12.4.10.7.3;How is this implemented?;439 12.4.10.7.3.1;Specifications and drawings;439 12.4.10.7.3.2;Process flow charts;440 12.4.10.7.3.3;Process layouts;440 12.4.10.7.3.4;Process FMEA;440 12.4.10.7.3.5;Control plan;440 12.4.10.7.3.6;Work instructions;441 12.4.10.7.3.7;Process approval acceptance criteria;441 12.4.10.7.3.8;Quality, reliability, maintainability and measurability data;441 12.4.10.7.3.9;Error-proofing data;441 12.4.10.7.3.10;Nonconformity detection and feedback;441 12.4.11;Design reviews;441 12.4.11.1;Planning design reviews;441 12.4.11.1.1;What does this mean?;442 12.4.11.1.2;Why is this necessary?;442 12.4.11.1.3;How is this implemented?;443 12.4.11.1.3.1;Review schedules;443 12.4.11.1.3.2;Design review input data;443 12.4.11.2;Conducting design reviews;443 12.4.11.2.1;What does this mean?;443 12.4.11.2.2;Why is this necessa
ry?;444 12.4.11.2.3;How is this implemented?;444 12.4.11.3;Participants at design reviews;444 12.4.11.3.1;What does this mean?;444 12.4.11.3.2;Why is this necessary?;444 12.4.11.3.3;How is this implemented?;445 12.4.11.4;Design review records;445 12.4.11.4.1;What does this mean?;446 12.4.11.4.2;Why is this necessary?;446 12.4.11.4.3;How is this implemented?;446 12.4.11.5;Monitoring;446 12.4.11.5.1;What does this mean?;446 12.4.11.5.2;Why is this necessary?;446 12.4.11.5.3;How is this implemented?;447 12.4.12;Design verification;447 12.4.12.1;Performing design verification;447 12.4.12.1.1;What does this mean?;448 12.4.12.1.2;Why is this necessary?;448 12.4.12.1.3;How is this implemented?;449 12.4.12.1.3.1;Timing;449 12.4.12.1.3.2;Verification process;449 12.4.12.1.3.3;Development tests;450 12.4.12.1.3.4;Verifying compliance with regulations;450 12.4.12.1.3.5;Alternative design calculations;450 12.4.12.1.3.6;Comparing similar designs;451 12.4.12.2;Recording design verification results;451 12.4.12.2.1;What does this mean?;451 12.4.12.2.2;Why is this necessary?;451 12.4.12.2.3;How is this implemented?;451 12.4.13;Design validation;452 12.4.13.1;Performing validation;452 12.4.13.1.1;What does this mean?;452 12.4.13.1.2;Why is this necessary?;453 12.4.13.1.3;How is this implemented?;453 12.4.13.1.4;Prototype programmes;453 12.4.13.1.5;Tracking performance testing;454 12.4.13.1.6;Outsourcing prototyping services;455 12.4.13.1.6.1;Demonstrations;455 12.4.13.2;Timing of validation;455 12.4.13.2.1;What does this mean?;456 12.4.13.2.2;Why is this necessary?;456 12.4.13.2.3;How is this implemented?;456 12.4.13.3;Recording results;456 12.4.13.3.1;What does this mean?;457 12.4.13.3.2;Why is this necessary?;457 12.4.13.3.3;How is this implemented?;457 12.4.13.4;Product approval process;457 12.4.13.4.1;What does this mean?;457 12.4.13.4.2;Why is this necessary?;457 12.4.13.4.3;How is this implemented?;458 12.4.13.4.3.1;Approval of supplied parts;458 12.4.14;Control of design and de
velopment changes;459 12.4.14.1;Identification and recording of design changes;459 12.4.14.1.1;What does this mean?;459 12.4.14.1.2;Why is this necessary?;459 12.4.14.1.3;How is this implemented?;460 12.4.14.1.3.1;Product design changes;460 12.4.14.1.3.2;Identifying and recording product design changes;460 12.4.14.1.3.3;Identifying and recording product modifications;461 12.4.14.1.3.4;Process design changes;462 12.4.14.2;Review and evaluation of changes;463 12.4.14.2.1;What does this mean?;463 12.4.14.2.2;Why is this necessary?;463 12.4.14.2.3;How is this implemented?;463 12.4.14.3;Verification and validation of design changes;464 12.4.14.3.1;What does this mean?;465 12.4.14.3.2;Why is this important?;465 12.4.14.3.3;How is this implemented?;465 12.5;Purchasing;465 12.5.1;Purchasing process;465 12.5.1.1;What does this mean?;466 12.5.1.2;Why is this necessary?;466 12.5.1.3;How is this implemented?;466 12.5.2;Control of suppliers;467 12.5.2.1;What does this mean?;467 12.5.2.2;Why is this necessary?;467 12.5.2.3;How is this implemented?;467 12.5.2.3.1;Selecting the degree of control;467 12.5.2.3.2;Defining supplier controls;470 12.5.3;Evaluation and selection of suppliers;470 12.5.3.1;What does this mean?;471 12.5.3.2;Why is this necessary?;471 12.5.3.3;How is this implemented?;471 12.5.3.3.1;Selection process;471 12.5.3.3.2;Preliminary supplier assessment;472 12.5.3.3.3;Pre-qualification of suppliers;475 12.5.3.3.4;Qualification of suppliers;476 12.5.3.3.5;Invitation to tender;477 12.5.3.3.6;Tender or quote evaluation;477 12.5.3.3.7;Contract negotiation;478 12.5.3.3.8;Satisfying regulatory requirements;478 12.5.3.3.9;Criteria for periodic evaluation;479 12.5.4;Results of supplier evaluation;479 12.5.4.1;What does this mean?;479 12.5.4.2;Why is this necessary?;479 12.5.4.3;How is this implemented?;480 12.5.4.3.1;Evaluation records;480 12.5.4.3.2;Listing suppliers;480 12.5.5;Regulatory compliance;481 12.5.5.1;What does this mean?;481 12.5.5.2;Why is this necessary?;481
12.5.5.3;How is this implemented?;481 12.5.6;Supplier quality management system development;482 12.5.6.1;What does this mean?;482 12.5.6.2;Why is this necessary?;482 12.5.6.3;How is this implemented?;482 12.5.7;Customer-approved sources;483 12.5.7.1;What does this mean?;483 12.5.7.2;Why is this necessary?;484 12.5.7.3;How is this implemented?;484 12.5.8;Purchasing information;484 12.5.8.1;Describing products to be purchased;484 12.5.8.1.1;What does this mean?;484 12.5.8.1.2;Why is this necessary?;485 12.5.8.1.3;How is this implemented?;485 12.5.8.1.3.1;Product identification;485 12.5.8.1.3.2;Purchasing specifications;485 12.5.8.1.3.3;Quality management system requirements;485 12.5.8.2;Adequacy of purchasing requirements;486 12.5.8.2.1;What does this mean?;486 12.5.8.2.2;Why is this necessary?;486 12.5.8.2.3;How is this implemented?;486 12.5.9;Verification of purchased product;487 12.5.9.1;Ensuring purchased product meets requirements;487 12.5.9.1.1;What does this mean?;487 12.5.9.1.2;Why is this necessary?;488 12.5.9.1.3;How is this implemented?;488 12.5.9.1.3.1;Timing of verification activities;488 12.5.9.1.3.2;Receiving inspection;489 12.5.9.1.3.3;Evaluation of suppliers statistical data;489 12.5.9.1.3.4;Purchased labour;489 12.5.9.1.3.5;Dealing with product audits on suppliers premises;490 12.5.9.1.3.6;Third-party assessments or part evaluation;490 12.5.9.2;Legitimizing verification on suppliers premises;490 12.5.9.2.1;What does this mean?;490 12.5.9.2.2;Why is this necessary?;491 12.5.9.2.3;How is this implemented?;491 12.5.9.2.3.1;Verification by the organization;491 12.5.9.2.3.2;Verification by the customer;491 12.5.9.3;Supplier monitoring;492 12.5.9.3.1;What does this mean?;492 12.5.9.3.2;Why is this necessary?;492 12.5.9.3.3;How is this implemented?;492 12.6;Production and service provision;493 12.6.1;Control of production and service provision;493 12.6.1.1;Planning production and service provision;493 12.6.1.1.1;What does this mean?;493 12.6.1.1.2;Why is th
is necessary?;495 12.6.1.1.3;How is this implemented?;495 12.6.1.2;Availability of information that describes the product;496 12.6.1.2.1;What does this mean?;496 12.6.1.2.2;Why is this necessary?;496 12.6.1.2.3;How is this implemented?;496 12.6.1.3;Availability of work instructions;498 12.6.1.3.1;What does this mean?;498 12.6.1.3.2;Why is this necessary?;498 12.6.1.3.3;How is this implemented?;499 12.6.1.4;Use of suitable equipment;499 12.6.1.4.1;What does this mean?;499 12.6.1.4.2;Why is this necessary?;500 12.6.1.4.3;How is this implemented?;500 12.6.1.5;Use of monitoring and measuring devices;500 12.6.1.5.1;What does this mean?;500 12.6.1.5.2;Why is this necessary?;501 12.6.1.5.3;How is this implemented?;501 12.6.1.6;Implementation of monitoring and measurement activities;501 12.6.1.6.1;What does this mean?;501 12.6.1.6.2;Why is this necessary?;501 12.6.1.6.3;How is this implemented?;501 12.6.1.7;Release processes;502 12.6.1.7.1;What does this mean?;502 12.6.1.7.2;Why is this necessary?;503 12.6.1.7.3;How is this implemented?;503 12.6.1.7.3.1;Release from storage areas;503 12.6.1.7.3.2;Held product;504 12.6.1.7.3.3;Release from job set-ups;504 12.6.1.7.3.4;Release from inspection;504 12.6.1.8;Delivery processes;504 12.6.1.8.1;What does this mean?;504 12.6.1.8.2;Why is this necessary?;504 12.6.1.8.3;How is this implemented?;505 12.6.1.8.3.1;On-time delivery;507 12.6.1.8.3.2;Customer notification;508 12.6.1.9;Post-delivery processes;508 12.6.1.9.1;Why is this necessary?;508 12.6.1.9.2;How is this implemented?;508 12.6.1.10;Control plan;509 12.6.1.10.1;What does this mean?;509 12.6.1.10.2;Why is this necessary?;509 12.6.1.10.3;How is this implemented?;509 12.6.1.11;Verification of job set-ups;511 12.6.1.11.1;What does this mean?;511 12.6.1.11.2;Why is this necessary?;511 12.6.1.11.3;How is this implemented?;512 12.6.1.12;Preventive and predictive maintenance;512 12.6.1.12.1;What does this mean?;512 12.6.1.12.2;Why is this necessary?;512 12.6.1.12.3;How is this imple
mented?;512 12.6.1.13;Management of production tooling;512 12.6.1.13.1;What does this mean?;513 12.6.1.13.2;Why is this necessary?;513 12.6.1.13.3;How is this implemented?;513 12.6.1.14;Production scheduling;514 12.6.1.14.1;What does this mean?;514 12.6.1.14.2;Why is this necessary?;514 12.6.1.14.3;How is this implemented?;515 12.6.1.15;Feedback of information from service;515 12.6.1.15.1;What does this mean?;515 12.6.1.15.2;Why is this necessary?;515 12.6.1.15.3;How is this implemented?;516 12.6.1.16;Servicing agreement with customer;516 12.6.1.16.1;What does this mean?;516 12.6.1.16.2;Why is this necessary?;516 12.6.1.16.3;How is this implemented?;516 12.6.1.17;Validation of processes;516 12.6.1.17.1;What does this mean?;517 12.6.1.17.2;Why is this necessary?;517 12.6.1.17.3;How is this implemented?;517 12.6.2;Identification and traceability;518 12.6.2.1;Identifying product;518 12.6.2.1.1;What does this mean?;518 12.6.2.1.2;Why is this necessary?;518 12.6.2.1.3;How is this implemented?;519 12.6.2.2;Verification status;520 12.6.2.2.1;What does this mean?;520 12.6.2.2.2;Why is this necessary?;520 12.6.2.2.3;How is this implemented?;520 12.6.2.3;Traceability;522 12.6.2.3.1;What does this mean?;522 12.6.2.3.2;Why is this necessary?;522 12.6.2.3.3;How is this implemented?;522 12.6.3;Customer property;523 12.6.3.1;Care of customer property;523 12.6.3.1.1;What does this mean?;523 12.6.3.1.2;Why is this necessary?;524 12.6.3.1.3;How is this implemented?;524 12.6.3.2;Identification of customer-supplied property;525 12.6.3.2.1;What does this mean?;525 12.6.3.2.2;Why is this necessary?;525 12.6.3.2.3;How is this implemented?;525 12.6.3.3;Verification of customer-supplied property;525 12.6.3.3.1;What does this mean?;525 12.6.3.3.2;Why is this necessary?;525 12.6.3.3.3;How is this implemented?;526 12.6.3.4;Protection of customer-supplied property;526 12.6.3.4.1;What does this mean?;526 12.6.3.4.2;Why is this necessary?;526 12.6.3.4.3;How is this implemented?;526 12.6.3.5;Maint
enance of customer-supplied property;527 12.6.3.5.1;What does this mean?;527 12.6.3.5.2;Why is this necessary?;527 12.6.3.5.3;How is this implemented?;527 12.6.3.6;Reporting problems to the customer;527 12.6.3.6.1;What does this mean?;528 12.6.3.6.2;Why is this necessary?;528 12.6.3.6.3;How is this implemented?;528 12.6.3.7;Preservation of product;528 12.6.3.7.1;What does this mean?;528 12.6.3.7.2;Why is this necessary?;529 12.6.3.7.3;How is this implemented?;529 12.6.3.7.3.1;Identification;529 12.6.3.7.3.2;Handling;530 12.6.3.7.3.3;Packaging;530 12.6.3.7.3.4;Storage;531 12.6.3.7.3.5;Segregation;533 12.6.3.7.3.6;Cleaning;533 12.6.3.8;Inventory;533 12.7;Control of monitoring and measuring devices;533 12.7.1;Determining monitoring and measurements to be undertaken;533 12.7.1.1;What does this mean?;533 12.7.1.2;Why is this necessary?;534 12.7.1.3;How is this implemented?;535 12.7.2;Determining monitoring and measuring devices needed;536 12.7.2.1;What does this mean?;536 12.7.2.2;Why is this necessary?;537 12.7.2.3;How is this implemented?;537 12.7.2.3.1;Physical measurement;537 12.7.2.3.2;Service measurements;538 12.7.3;Defining the monitoring and measuring processes;538 12.7.3.1;What does this mean?;539 12.7.3.2;Why is this necessary?;539 12.7.3.3;How is this implemented?;539 12.7.3.3.1;Measurement process;539 12.7.3.3.2;Controlling measurements;539 12.7.3.3.3;Measurement uncertainty;540 12.7.3.3.4;Measurement laboratories;542 12.7.4;Calibrating and verifying measurements;543 12.7.4.1;What does this mean?;543 12.7.4.2;Why is this necessary?;544 12.7.4.3;How is this implemented?;544 12.7.4.3.1;Calibration of monitoring and measuring devices;544 12.7.4.3.2;Traceability;545 12.7.4.3.3;Determining calibration frequency;545 12.7.4.3.4;Reference materials;546 12.7.5;Recording the basis for calibration;547 12.7.5.1;What does this mean?;547 12.7.5.2;Why is this necessary?;547 12.7.5.3;How is this implemented?;547 12.7.6;Adjustment of devices;547 12.7.6.1;What does this mean?;
548 12.7.6.2;Why is this necessary?;548 12.7.6.3;How is this implemented?;548 12.7.7;Indicating calibration status;548 12.7.7.1;What does this mean?;548 12.7.7.2;Why is this necessary?;549 12.7.7.3;How is this implemented?;549 12.7.8;Safeguarding monitoring and measuring devices;549 12.7.8.1;What does this mean?;549 12.7.8.2;Why is this necessary?;550 12.7.8.3;How is this implemented?;550 12.7.9;Protection of monitoring and measuring devices;550 12.7.9.1;What does this mean?;550 12.7.9.2;Why is this necessary?;550 12.7.9.3;How is this implemented?;550 12.7.10;Action on equipment found out of calibration;551 12.7.10.1;What does this mean?;551 12.7.10.2;Why is this necessary?;551 12.7.10.3;How is this implemented?;551 12.7.11;Calibration and verification records;552 12.7.11.1;What does this mean?;552 12.7.11.2;Why is this necessary?;553 12.7.11.3;How is this implemented?;553 12.7.12;Software validation;554 12.7.12.1;What does this mean?;554 12.7.12.2;Why is this necessary?;554 12.7.12.3;How is this implemented?;554 12.7.13;Measurement system analysis;555 12.7.13.1;What does this mean?;555 12.7.13.2;Why is this necessary?;555 12.7.13.3;How is this implemented?;556 12.7.14;Laboratory requirements;557 12.7.14.1;Internal laboratory;557 12.7.14.1.1;What does this mean?;557 12.7.14.1.2;Why is this necessary?;557 12.7.14.1.3;How is this implemented?;557 12.7.14.2;External laboratory;557 12.7.14.2.1;What does this mean?;558 12.7.14.2.2;Why is this necessary?;558 12.7.14.2.3;How is this implemented?;558 12.8;Summary;559 12.9;Product realization requirements checklist;560 12.9.1;Product realization;560 12.9.1.1;Planning of product realization;560 12.9.1.2;Planning of product realization Supplemental;560 12.9.1.3;Acceptance criteria;560 12.9.1.4;Confidentiality;560 12.9.1.5;Change control;560 12.9.2;Customer-related processes;560 12.9.2.1;Determination of requirements related to the product;560 12.9.2.2;Customer-designated special characteristics;560 12.9.2.3;Review of requireme
nts related to the product;561 12.9.2.4;Review of requirements related to the product Supplemental;561 12.9.2.5;Organization manufacturing feasibility;561 12.9.2.6;Customer communication;561 12.9.2.7;Customer communication Supplemental;561 12.9.3;Design and development;561 12.9.3.1;Design and development planning;561 12.9.3.2;Multidisciplinary approach;561 12.9.3.3;Design and development inputs;561 12.9.3.4;Product design input;562 12.9.3.5;Manufacturing process design input;562 12.9.3.6;Special characteristics;562 12.9.3.7;Design and development outputs;562 12.9.3.8;Product design outputs Supplemental;562 12.9.3.9;Manufacturing process design output;562 12.9.3.10;Design and development review;563 12.9.3.11;Monitoring;563 12.9.3.12;Design and development verification;563 12.9.3.13;Design and development validation;563 12.9.3.14;Design and development validation Supplemental;563 12.9.3.15;Prototype programme;563 12.9.3.16;Product approval process;563 12.9.3.17;Control of design and development changes;563 12.9.4;Purchasing;563 12.9.4.1;Purchasing process;563 12.9.4.2;Regulatory compliance;564 12.9.4.3;Supplier quality management system development;564 12.9.4.4;Purchasing information;564 12.9.4.5;Verification of purchased product;564 12.9.4.6;Incoming product quality;564 12.9.4.7;Supplier monitoring;564 12.9.5;Production and service provision;564 12.9.5.1;Control of production and service provision;564 12.9.5.2;Control plan;564 12.9.5.3;Work instructions;564 12.9.5.4;Verification of job set-ups;565 12.9.5.5;Preventive and predictive maintenance;565 12.9.5.6;Management of production tooling;565 12.9.5.7;Production scheduling;565 12.9.5.8;Feedback of information from service;565 12.9.5.9;Service agreement with customer;565 12.9.5.10;Validation of processes for production and service provision;565 12.9.5.11;Identification and traceability;565 12.9.5.12;Customer property;565 12.9.5.13;Customer-owned production tooling;565 12.9.5.14;Preservation of product;566 12.9.5.15;St
orage and inventory;566 12.9.5.16;Control of monitoring and measuring devices;566 12.9.5.17;Measurement systems analysis;566 12.9.5.18;Calibration or verification records;566 12.9.5.19;Laboratory requirements;566 12.10;Product realization Food for thought;567 13;Chapter 8 Measurement, analysis and improvement;568 13.1;Summary of requirements;568 13.2;Monitoring, measurement, analysis and improvement processes;571 13.2.1;Processes to demonstrate conformity;571 13.2.1.1;What does this mean?;571 13.2.1.2;Why is this necessary?;572 13.2.1.3;How is this implemented?;573 13.2.1.3.1;Planning the monitoring, measurement and analysis processes;573 13.2.1.3.2;Determining measurement methods;574 13.2.2;Processes to ensure conformity of management system;575 13.2.2.1;What does this mean?;575 13.2.2.2;Why is this necessary?;577 13.2.2.3;How is this implemented?;577 13.2.3;Processes to continually improve the effectiveness of the management system;577 13.2.3.1;What does this mean?;577 13.2.3.2;Why is this necessary?;578 13.2.3.3;How is this implemented?;579 13.2.4;Identification of statistical tools;579 13.2.4.1;What does this mean?;579 13.2.4.2;Why is this necessary?;579 13.2.4.3;How is this implemented?;579 13.2.5;Knowledge of basic statistical concepts;580 13.2.5.1;What does this mean?;580 13.2.5.2;Why is this necessary?;580 13.2.5.3;How is this implemented?;581 13.3;Customer satisfaction;581 13.3.1;What does this mean?;581 13.3.2;Why is this necessary?;582 13.3.3;How is this implemented?;582 13.3.3.1;Repeat orders;582 13.3.3.2;Competition;582 13.3.3.3;Referrals;583 13.3.3.4;Demand;583 13.3.3.5;Effects of product transition;583 13.3.3.6;Surveys;583 13.3.3.7;Focus meetings;584 13.3.3.8;Complaints;584 13.3.3.9;Compliments;584 13.3.3.10;Performance indicators;584 13.4;Internal audit;585 13.4.1;Auditing for conformance with planned arrangements;585 13.4.1.1;What does this mean?;585 13.4.1.2;Why is this necessary?;586 13.4.1.3;How is this implemented?;586 13.4.1.3.1;Policy audit;58
6 13.4.1.3.2;Strategic audit;587 13.4.1.3.3;Project audit;587 13.4.2;Auditing for conformity;587 13.4.2.1;What does this mean?;587 13.4.2.2;Why is this necessary?;588 13.4.2.3;How is this implemented?;588 13.4.3;Auditing for effective implementation and maintenance;590 13.4.3.1;What does this mean?;590 13.4.3.2;Why is this necessary?;590 13.4.3.3;How is this implemented?;590 13.4.4;Defining audit criteria, scope, frequency and methods;597 13.4.4.1;What does this mean?;597 13.4.4.2;Why is this necessary?;597 13.4.4.3;How is this implemented?;598 13.4.5;Selection of auditors;598 13.4.5.1;What does this mean?;598 13.4.5.2;Why is this necessary?;598 13.4.5.3;How is this implemented?;599 13.4.6;Audit procedures;600 13.4.6.1;What does this mean?;600 13.4.6.2;Why is this necessary?;600 13.4.6.3;How is this implemented?;600 13.4.7;Taking action;603 13.4.7.1;What does this mean?;603 13.4.7.2;Why is this necessary?;603 13.4.7.3;How is this implemented?;604 13.4.8;Follow-up audits;604 13.4.8.1;What does this mean?;604 13.4.8.2;Why is this necessary?;605 13.4.8.3;How is this implemented?;605 13.5;Monitoring and measurement of processes;605 13.5.1;Monitoring and measuring methods;605 13.5.1.1;What does this mean?;605 13.5.1.2;Why is this necessary?;606 13.5.1.3;How is this implemented?;606 13.5.2;Process capability;606 13.5.2.1;Process capability studies;606 13.5.2.1.1;What does this mean?;607 13.5.2.1.2;Why is this necessary?;608 13.5.2.1.3;How is this implemented?;608 13.5.2.1.3.1;Achieving objectives;608 13.5.2.1.3.2;Achieving best practice;609 13.5.2.1.3.3;Fulfilling purpose;609 13.5.2.2;Maintaining process capability;610 13.5.2.2.1;What does this mean?;610 13.5.2.2.2;Why is this necessary?;610 13.5.2.2.3;How is this implemented?;610 13.5.2.3;Reaction plans;610 13.5.2.3.1;What does this mean?;610 13.5.2.3.2;Why is this necessary?;610 13.5.2.3.3;How is this implemented?;611 13.6;Monitoring and measurement of product;611 13.6.1;Verifying conformity with product requirements;61
1 13.6.1.1;What does this mean?;612 13.6.1.2;Why is this necessary?;612 13.6.1.3;How is this implemented?;613 13.6.1.3.1;In-process verification;613 13.6.1.3.2;Finished product verification;614 13.6.2;Evidence of conformity;614 13.6.2.1;What does this mean?;615 13.6.2.2;Why is this necessary?;615 13.6.2.3;How is this implemented?;615 13.6.3;Identifying the person(s) authorizing release;616 13.6.3.1;What does this mean?;616 13.6.3.2;Why is this necessary?;617 13.6.3.3;How is this implemented?;617 13.6.4;Product release approval;617 13.6.4.1;What does this mean?;617 13.6.4.2;Why is this necessary?;618 13.6.4.3;How is this implemented?;618 13.6.5;Layout inspection and functional testing;619 13.6.5.1;What does this mean?;619 13.6.5.2;Why is this necessary?;619 13.6.5.3;How is this implemented?;619 13.6.6;Appearance items;619 13.6.6.1;What does this mean?;619 13.6.6.2;Why is this necessary?;619 13.6.6.3;How is this implemented?;620 13.7;Control of nonconforming product;620 13.7.1;Preventing unintended use;620 13.7.1.1;What does this mean?;620 13.7.1.2;Why is this necessary?;621 13.7.1.3;How is this implemented?;621 13.7.1.3.1;Identifying nonconforming product;622 13.7.1.3.2;Controlling nonconforming product;622 13.7.1.3.3;Documented procedures;622 13.7.1.3.4;Defining responsibility;623 13.7.2;Correction of nonconforming product;624 13.7.2.1;What does this mean?;624 13.7.2.2;Why is this necessary?;624 13.7.2.3;How is this implemented?;624 13.7.3;Authorizing use of nonconforming product;625 13.7.3.1;What does this mean?;625 13.7.3.2;Why is this necessary?;625 13.7.3.3;How is this implemented?;626 13.7.4;Action to preclude use or application;627 13.7.4.1;What does this mean?;627 13.7.4.2;Why is this necessary?;627 13.7.4.3;How is this implemented?;627 13.7.5;Records of nonconformity;627 13.7.5.1;What does this mean?;627 13.7.5.2;Why is this necessary?;628 13.7.5.3;How is this implemented?;628 13.7.6;Re-verification of corrected product;628 13.7.6.1;What does this mean?;628
13.7.6.2;Why is this necessary?;630 13.7.6.3;How is this implemented?;630 13.7.7;Consequences of nonconformity;630 13.7.7.1;What does this mean?;630 13.7.7.2;Why is this necessary?;630 13.7.7.3;How is this implemented?;630 13.8;Analysis of data;631 13.8.1;Collecting and analysing appropriate data;631 13.8.1.1;What does this mean?;631 13.8.1.2;Why is this necessary?;632 13.8.1.3;How is this implemented?;632 13.8.1.3.1;Determining what data to collect;632 13.8.1.3.2;Data collection;633 13.8.2;Evaluating where improvements in effectiveness can be made;634 13.8.2.1;What does this mean?;634 13.8.2.2;Why is this necessary?;635 13.8.2.3;How is this implemented?;635 13.8.2.3.1;Reviewing established objectives;635 13.8.2.3.2;Reviewing uncontrolled performance attributes;635 13.8.3;Analysis of customer satisfaction data;636 13.8.3.1;What does this mean?;636 13.8.3.2;Why is this necessary?;636 13.8.3.3;How is this implemented?;636 13.8.3.3.1;The process;637 13.8.3.3.2;Frequency of measurement;637 13.8.3.3.3;Trends;638 13.8.3.3.4;Customer satisfaction index;638 13.8.4;Analysis of conformance to customer requirements;638 13.8.4.1;What does this mean?;639 13.8.4.2;Why is this necessary?;639 13.8.4.3;How is this implemented?;639 13.8.5;Analysis of product and process characteristics;639 13.8.5.1;What does this mean?;639 13.8.5.2;Why is this necessary?;640 13.8.5.3;How is this implemented?;640 13.8.6;Analysis of supplier data;641 13.8.6.1;What does this mean?;641 13.8.6.2;Why is this necessary?;642 13.8.6.3;How is this implemented?;642 13.8.6.3.1;Order value;642 13.8.6.3.2;Order quantity;642 13.8.6.3.3;Quality risk;642 13.8.6.3.4;Delivery risk;643 13.8.6.3.5;Suppliers per item;643 13.8.6.3.6;Costs;643 13.8.7;Analysis and use of data;644 13.8.7.1;What does this mean?;644 13.8.7.2;Why is this necessary?;644 13.8.7.3;How is this implemented?;644 13.9;Improvement;644 13.9.1;Continual improvement;644 13.9.1.1;What does this mean?;645 13.9.1.2;Why is this necessary?;645 13.9.1.3;How is t
his implemented?;646 13.9.2;Continual improvement of the organization;647 13.9.2.1;What does this mean?;647 13.9.2.2;Why is this necessary?;648 13.9.2.3;How is this implemented?;648 13.9.3;Manufacturing process improvement;648 13.9.3.1;What does this mean?;648 13.9.3.2;Why is this necessary?;648 13.9.3.3;How is this implemented?;649 13.9.4;Corrective action;650 13.9.4.1;Eliminating the cause of actual nonconformities;650 13.9.4.1.1;What does this mean?;650 13.9.4.1.2;Why is this necessary?;651 13.9.4.1.3;How is this implemented?;652 13.9.4.2;Reviewing nonconformities;653 13.9.4.2.1;What does this mean?;653 13.9.4.2.2;Why is this necessary?;653 13.9.4.2.3;How is this implemented?;653 13.9.4.3;Customer complaints, rejected and returned product;655 13.9.4.4;Nonconformity reduction;656 13.9.4.5;Determining the cause of nonconformities;656 13.9.4.5.1;What does this mean?;656 13.9.4.5.2;Why is this necessary?;657 13.9.4.5.3;How is this implemented?;657 13.9.4.5.3.1;Discovering the cause (5 Whys);657 13.9.4.6;Common problem-solving tools;659 13.9.4.7;Evaluating the need for action;662 13.9.4.7.1;What does this mean?;662 13.9.4.7.2;Why is this necessary?;662 13.9.4.7.3;How is this implemented?;663 13.9.4.8;Determining and implementing actions;663 13.9.4.8.1;What does this mean?;663 13.9.4.8.2;Why is this necessary?;663 13.9.4.8.3;How is this implemented?;664 13.9.4.9;Recording results of actions taken;665 13.9.4.9.1;What does this mean?;665 13.9.4.9.2;Why is this necessary?;665 13.9.4.9.3;How is this implemented?;665 13.9.4.10;Reviewing corrective action taken;666 13.9.4.10.1;What does this mean?;666 13.9.4.10.2;Why is this necessary?;666 13.9.4.10.3;How is this implemented?;666 13.9.4.11;Preventive action;667 13.9.4.11.1;Eliminating the cause of potential nonconformities;667 13.9.4.11.1.1;What does this mean?;667 13.9.4.11.1.2;Why is this necessary?;668 13.9.4.11.1.3;How is this implemented?;669 13.9.4.11.2;Determining potential nonconformities;671 13.9.4.11.2.1;What does
this mean?;671 13.9.4.11.2.2;Why is this necessary?;671 13.9.4.11.2.3;How is this implemented?;671 13.9.4.11.2.3.1;Determining objectives, requirements and constraints;671 13.9.4.11.2.3.2;Organizing diagnostic teams;672 13.9.4.11.2.3.3;Analysis of critical success factors;672 13.9.4.11.2.3.4;Failure modes;672 13.9.4.11.2.3.5;Failure effects;673 13.9.4.11.2.3.6;Severity;674 13.9.4.11.2.3.7;Probability of occurrence;674 13.9.4.11.2.3.8;Determining cause;675 13.9.4.11.3;Evaluating the need for action;675 13.9.4.11.3.1;What does this mean?;675 13.9.4.11.3.2;Why is this necessary?;675 13.9.4.11.3.3;How is this implemented?;675 13.9.4.11.3.3.1;Adequacy of current provisions;675 13.9.4.11.3.3.2;Probability of detection;676 13.9.4.11.3.3.3;Risk priority number;678 13.9.4.11.3.3.4;Financial impact;678 13.9.4.11.4;Determining and implementing preventive action;678 13.9.4.11.4.1;What does this mean?;678 13.9.4.11.4.2;Why is this necessary?;678 13.9.4.11.4.3;How is this implemented?;679 13.9.4.11.4.3.1;Recalculating the RPN;679 13.9.4.11.4.3.2;Error-proofing;680 13.9.4.11.5;Recording the results of preventive action;680 13.9.4.11.5.1;What does this mean?;680 13.9.4.11.5.2;Why is this necessary?;680 13.9.4.11.5.3;How is this implemented?;681 13.9.4.11.6;Reviewing preventive action;681 13.9.4.11.6.1;What does this mean?;681 13.9.4.11.6.2;Why is this necessary?;681 13.9.4.11.6.3;How is this implemented?;683 13.10;Summary;683 13.11;Measurement, analysis and improvement requirements checklist;685 13.11.1;Monitoring measurement, analysis and improvement process;685 13.11.1.1;General;685 13.11.1.2;Identification of statistical tools;685 13.11.1.3;Knowledge of basic statistical concepts;685 13.11.1.4;Monitoring and measurement;685 13.11.1.5;Customer satisfaction Supplemental;685 13.11.1.6;Internal audit;685 13.11.1.7;Quality management system audit;685 13.11.1.8;Manufacturing process audit;685 13.11.1.9;Product audit;686 13.11.1.10;Internal audit plans;686 13.11.1.11;Internal auditor q
ualifications;686 13.11.1.12;Monitoring and measurement of processes;686 13.11.1.13;Monitoring and measurement of manufacturing processes;686 13.11.1.14;Process capability;686 13.11.1.15;Monitoring and measurement of product;686 13.11.1.16;Layout inspection and functional testing;686 13.11.1.17;Appearance items;686 13.11.1.18;Control of nonconforming product;686 13.11.1.19;Control of nonconforming product Supplemental;687 13.11.1.20;Control of reworked product;687 13.11.1.21;Customer information;687 13.11.1.22;Customer waiver;687 13.11.1.23;Analysis of data;687 13.11.1.24;Analysis and use of data;687 13.11.1.25;Improvement;687 13.11.1.26;Continual improvement of the organization;687 13.11.1.27;Manufacturing process improvement;687 13.11.1.28;Corrective action;687 13.11.1.29;Problem-solving;688 13.11.1.30;Error-proofing;688 13.11.1.31;Corrective action impact;688 13.11.1.32;Rejected product test/analysis;688 13.11.1.33;Preventive action;688 13.12;Measurement, analysis and improvement Food for thought;689 14;Appendix A Glossary;690 14.1;A;691 14.2;B;691 14.3;C;691 14.4;D;693 14.5;E;694 14.6;F;694 14.7;G;695 14.8;H;695 14.9;I;695 14.10;J;696 14.11;K;696 14.12;L;696 14.13;M;697 14.14;N;697 14.15;O;697 14.16;P;698 14.17;Q;699 14.18;R;700 14.19;S;701 14.20;T;702 14.21;U;702 14.22;V;702 14.23;W;703 14.24;Z;703 15;Appendix B Related web sites;704 15.1;Articles and publications;704 15.2;Auditing;704 15.3;Benchmarking;704 15.4;Competence;704 15.5;Customer satisfaction;704 15.6;International organizations;705 15.7;Process management;705 15.8;Related initiatives;705 15.9;Six sigma;705 15.10;Standards;705 15.11;Product recall;705 16;Bibliography;706 16.1;Chapter 1;706 16.2;Chapter 2;707 16.3;Chapter 3;707 16.4;Chapter 4;707 16.5;Chapter 5;708 16.6;Chapter 6;708 16.7;Chapter 7;708 16.8;Chapter 8;709 17;Index;710 17.1;A;710 17.2;B;711 17.3;C;711 17.4;D;713 17.5;E;714 17.6;F;715 17.7;G;715 17.8;H;715 17.9;I;715 17.10;J;716 17.11;K;716 17.12;L;716 17.13;M;717 17.14;N;718 17.15;O;718
17.16;P;718 17.17;Q;720 17.18;R;721 17.19;S;722 17.20;T;723 17.21;U;724 17.22;V;724 17.23;W;724 17.24;Z;724