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
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