Changes

# Compare document list with standard client document list.

# Check whether each specified document has appropriate content.

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| Verify if these input documents have been adequately linked to the product performance specifications.

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!rowspan="3"|Product Performance Specifications (PPS)

| Verify that design inputs correlate adequately to the specifications and that appropriate design verification and validations (DV&V) are performed.

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| Also verify if DV&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans.

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| Verify that product performance specifications correspond to appropriate design output documents.

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!rowspan="4"|Risk Management Documents

| Review Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation.

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| Verify that DFMEA links appropriately to the PPS.

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| verify that appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEA.

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| Similarly verify that PFMEA links appropriately to the process validation protocol acceptance criteria and that in-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA.

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