Objective Evidence Record (OER) - SAE

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11 8 9 10 Objective Evidence/Comments Item # Quality Management System Requirements C NCR (e.g., observations, OFIs) 7.22 Review of requirements related to the product 161 Reviews product requirements prior to commitment to supply a product Reviews conducted to the customer documentation to ensure: 162 a. product requirements are defined 163 b. differing contract requirements are resolved 164 c. organization has the ability to meet the requirements 165 d. contractual requirements are being reviewed for special product requirements (9110 only) 166 d. special product requirements are determined 167 e. risks have been identified 168 Records of reviews and actions are maintained Review record(s) ref.: 169 Where the customer provides no documented requirements, they are confirmed before acceptance 170 Documents are amended and personnel made aware when product requirements are changed 171 Contract processes include provisions for disposition of out-of-scope defects discovered during maintenance (9110 only) 7.2.3 Customer communication Implements effective customer communications for: 172 a. product information 173 b. enquiries, contracts, or order handling 174 c. customer feedback 7.3 Design and development (D&D) 7.3.1 Design and development planning (not applicable to 9120) 175 Plans and controls the product D&D process D&D planning includes: 176 a. defined stages 177 b. reviews, verifications, and validations for each stage 178 c. responsibilities and authorities 179 Where appropriate, the organization divides the D&D effort into distinct activities and defines the tasks, resources, responsibilities, design content, input/output data, and design constraints 180 D&D tasks are based on the safety and functional objectives of the product to customer, statutory, and regulatory requirements 181 D&D planning considers the ability to produce, inspect, test, and maintain the product 182 Interfaces between groups involved are managed to ensure effective communication and clear assignment of responsibility 183 Planning output is updated as the D&D progresses
Item # 11 8 9 10 Objective Evidence/Comments Quality Management System Requirements C NCR (e.g., observations, OFIs) 7.3.2 Design and development inputs (not applicable to 9120) 184 Product input requirements are determined and records maintained Product input requirement record ref.: D&D inputs include: 185 a. functional and performance requirements 186 b. applicable statutory and regulatory requirements 187 c. information derived from previous designs 188 d. other essential D&D requirements 189 Inputs are reviewed for adequacy 7.3.3 Design and development outputs (not applicable to 9120) 190 Outputs are in a suitable form for verification against the inputs and are approved prior to release D&D outputs: 191 a. meet the input requirements 192 b. provide appropriate information for purchasing, production, and service 193 c. contain or reference product acceptance criteria 194 d. specify product characteristics 195 e. specify critical items, including any key characteristics and specific actions to be taken 196 Outputs define the data required for identification, manufacturing and inspecting including: 197 drawings, part lists, and specifications 198 material, process, manufacturing, and assembly data 7.3.4 Design and development review (not applicable to 9120) D&D reviews are performed to: 199 a. evaluate the ability of the results to meet requirements 200 b. identify any problems and propose actions 201 c. authorize progression to the next stage 202 Participants in reviews include representatives from all functions concerned with the D&D stage(s) being reviewed 203 Records of reviews and actions are maintained Review record(s) ref.:
Page 1 and 2: This material is derived from SAE A
Page 3 and 4: 11 8 9 10 Objective Evidence/Commen
Page 5 and 6: Item # 11 8 9 10 Objective Evidence
Page 11: 11 8 9 10 Objective Evidence/Commen
Page 17 and 18: Item # 8 Quality Management System
Page 25 and 26: FORM INSTRUCTIONS APPENDIX A - OBJE
Page 27 and 28: FORM INSTRUCTIONS APPENDIX B - NONC
Page 29 and 30: APPENDIX C - PROCESS EFFECTIVENESS
Page 31 and 32: APPENDIX D - QMS PROCESS MATRIX REP
Page 33 and 34: 7.2.3 Customer communication 7.3.1*
Page 35 and 36: APPENDIX E - AUDIT REPORT (Stage 2,
Page 37 and 38: 34 Opportunities for Improvement/Ob
Page 39 and 40: FORM INSTRUCTIONS APPENDIX E - AUDI
Page 41 and 42: Ref # FORM INSTRUCTIONS (cont.) APP
Page 43 and 44: 22 High Level Requirements Confirma
Page 45 and 46: 29 Key Information (specific inform
Page 47 and 48: Ref # Description FORM INSTRUCTIONS
Page 49 and 50: APPENDIX G: SUPPLEMENTAL AUDIT REPO
Page 51: FORM INSTRUCTIONS APPENDIX G - SUPP

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