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Quality Management
Documents & Templates

                                           Design Verification
      •    Verification Protocols
      •    Verification Reports
      •    Design Review documents
      Each of these deliverables shall be approved by the PL/HE and Quality Assurance. Design
      Review documents shall also be approved by the DRC.

7.3       Design Output
      The Design Outputs and Verification Matrix demonstrate traceability between each Product
      Requirement and the Verification Results. It is a summary of the Verification Phase.
      Design Outputs Verification Matrix
      The first three columns of the Design Outputs and Verification Matrix were populated during the
      Design Output Phase:
      •    “Requirements Paragraph Number”
      •    “Design Output Document Number”
      •    “Verification Method”
      As Verification Tests are completed, Verification Test Report Numbers are entered into column
      four. If Design changes are necessary, the numbers of the documents that describe the change
      are entered into column five.

7.4       Design Verification Matrix (detail)
      The Design Verification Detail Matrix provides details of each test associated with each Product
      Requirement.
           •   Product Requirements (column 1) - list the Product Requirement number
           •   Verification Protocol# (column 2) - list the title and number of the Verification Protocol
           •   Responsible Party (column 3) - the person or group responsible for the Verification is
               listed
           •   Verification Method (column 4) - the Verification method (inspection/test approach) is
               described. In this section a summary of the activity to be performed to verify the
               requirement is described. Activity details are entered into the Protocol.
           •   Non-conformances (column 5) - enter YES if non-conformances were found during the
               test; otherwise enter NO
           •   Non-conformance Responsibility (column 6) - enter person or group responsible for non-
               conformance resolution
           •   Resolution Due Date (column 7) - enter due date for non-conformance resolution
           •   Non-conformance Resolved (column 8) - enter YES if non-conformance was resolved
               satisfactorily.




      Document Type                                  Document ID                                 Version        Status        Page
           SOP                                 XX_WWW_ZZZ_YYYY                                     1.0       Approved          9/18

                                                    Copyright © by QMdocs 2010
 Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited by law. Neither the document
              nor the information contained therein may be reproduced or disclosed without written consent of QMdocs.

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Md 009-design-verification-sop-1.0

  • 1. Quality Management Documents & Templates Design Verification • Verification Protocols • Verification Reports • Design Review documents Each of these deliverables shall be approved by the PL/HE and Quality Assurance. Design Review documents shall also be approved by the DRC. 7.3 Design Output The Design Outputs and Verification Matrix demonstrate traceability between each Product Requirement and the Verification Results. It is a summary of the Verification Phase. Design Outputs Verification Matrix The first three columns of the Design Outputs and Verification Matrix were populated during the Design Output Phase: • “Requirements Paragraph Number” • “Design Output Document Number” • “Verification Method” As Verification Tests are completed, Verification Test Report Numbers are entered into column four. If Design changes are necessary, the numbers of the documents that describe the change are entered into column five. 7.4 Design Verification Matrix (detail) The Design Verification Detail Matrix provides details of each test associated with each Product Requirement. • Product Requirements (column 1) - list the Product Requirement number • Verification Protocol# (column 2) - list the title and number of the Verification Protocol • Responsible Party (column 3) - the person or group responsible for the Verification is listed • Verification Method (column 4) - the Verification method (inspection/test approach) is described. In this section a summary of the activity to be performed to verify the requirement is described. Activity details are entered into the Protocol. • Non-conformances (column 5) - enter YES if non-conformances were found during the test; otherwise enter NO • Non-conformance Responsibility (column 6) - enter person or group responsible for non- conformance resolution • Resolution Due Date (column 7) - enter due date for non-conformance resolution • Non-conformance Resolved (column 8) - enter YES if non-conformance was resolved satisfactorily. Document Type Document ID Version Status Page SOP XX_WWW_ZZZ_YYYY 1.0 Approved 9/18 Copyright © by QMdocs 2010 Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited by law. Neither the document nor the information contained therein may be reproduced or disclosed without written consent of QMdocs.