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Introduction: The Quality System 1 Applying the System 2 Program Management 4 Subsystem 1 Quality System Management 7 1.1 Quality Policy 8 1.2 Quality Standards 10 1.3 Quality Objectives 12 1.4 Quality Manual 14 1.5 Documentation Control 15 1.6 Growth Planning and Control 16 1.7 Quality Cost Program 18 1.8 Product Liability Prevention 34 1.9 Material Tracking 39 1.10 Quality Inputs to Advertising 41 1.11 Product Certification 42 1.12 Corrective Action Program 44 1.13 Product and Process Modification 46 1.14 Audit of Procedures, Processes, and Product 48 1.15 Quality Program Effectiveness Review 52 1.16 Quality Organization Evaluation 54 1.17 Reference Library 56 Subsystem 2 Product Development Control 57 2.1 New Product Introduction Activity 58 2.2 Product Description 60 2.3 Competitive Product Evaluation 62 2.4 Design Responsibility for Manufacturability 63 2.5 Tolerance Partitioning 65 2.6 Tolerance Interpretation 67 2.7 Product Design Review 69 2.8 Customer-Centered Quality Audit 72 2.9 Preproduction Quality Planning 74 2.10 Preproduction Material Handling and Control 75 2.11 Preproduction Testing 77 2.12 Test Method Control 79 2.13 Product Approvals 80 2.14 Quality Inputs to Make-or-Buy Decision 81 Subsystem 3 Purchased Material Control 82 3.1 Quality Information Package for Vendors 84 3.2 Vendor Surveys and Capability Determination 86 3.3 Vendor Measurement Compatibility 88 3.4 Qualification of Parts and Vendors 89 3.5 Vendor Control at Source 91 3.6 Vendor Certification and Objective Evidence of Quality 93 3.7 Quality Engineering and Training for Vendors 94 3.8 Appraisal Status Marking 97 3.9 Nonconforming Material Disposition 98 3.10 Vendor Rating Plans 100 Subsystem 4 Process Development and Operation Control 109 4.1 Process Design Review 110 4.2 Process Documentation 112 4.3 Special Process Control 114 4.4 Quality Check Stations 115 4.5 Packaging and Packing Control 117 4.6 Production Material Handling and Control 118 4.7 Manufacturing Quality Plan 121 4.8 Quality Work-Force Determination 123 4.9 Contingency Planning 125 4.10 Inspection and Test Performance 127 4.11 Inspection and Test Support 128 4.12 Housekeeping 130 4.13 Yield Control Program 131 Subsystem 5 Quality Data Programs 133 5.1 Quality Data Planning 135 5.2 Forms Control 137 5.3 Received and Produced Quality Data Reporting 138 5.4 Appraisal Activity Evaluation Data 141 5.5 Field Quality Data Reporting Control 142 Subsystem 6 Special Studies 144 6.1 Classification of Characteristics 145 6.2 Classification of Nonconformities 149 6.3 Design and Analysis of Reliability and Safety Studies 151 6.4 Environmental Impacts 153 6.5 Machine and Process Capability 155 6.6 Quality Level Improvement 157 6.7 Statistical Technique Application 160 6.8 Unique Delivery Requirement Management 162 Subsystem 7 Quality Measurement and Control Equipment 163 7.1 Quality Measurement and Control Equipment Plan 164 7.2 Quality Measurement and Control Equipment Safety 166 7.3 Quality Measurement and Control Equipment Facilities 167 7.4 Quality Measurement and Control Equipment Documentation 168 7.5 Quality Measurement and Control Equipment Applications 169 7.6 Equipment Calibration and Maintenance 171 7.7 Audit of Quality Measurement and Control Equipment 173 Subsystem 8 Human Resource Involvement 174 8.1 Overall Training in Quality System Subjects 175 8.2 Management and Technical Personnel Training 177 8.3 New Operator Quality Familiarization 179 8.4 Inspector and Tester Training 181 8.5 Field Personnel Training 182 8.6 Rotational Training 183 8.7 Participation in Company-Sponsored Training Programs 184 8.8 Training Effectiveness Measurement 185 8.9 Personnel Development 186 8.10 Personnel Quality Participation 188 8.11 Qualification Standards 192 8.12 Quality System Personnel Performance 194 8.13 Quality Information Transfer 196 8.14 Field Quality Orientation Program 197 Subsystem 9 Customer Contact 199 9.1 User's Safety Warnings 201 9.2 Installation and Field Test 202 9.3 Product Service 204 9.4 Field and Factory Standards Coordination 206 9.5 Field Document Relevance 207 9.6 Customer-Furnished Material 209 9.7 Drop-Shipped Item Control 211 9.8 Renewal Parts Control 212 9.9 Customer Data and Support Program 214 9.10 Field Problem Predictions 216 9.11 Installation and Service Difficulties 218 9.12 Field Problem Controls 220 9.13 Field Problem Handling 222 9.14 Customer Satisfaction Measurement 224 9.15 Audit of Field Quality Activities 226 Section 10 Quality System Engineering 228 Section 11 Managing the Quality System 234