=== Review: Risk Management documents ===
# Review Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation. # Verify that DFMEA links appropriately to the PPS. # Also verify that appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEA. # 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.
=== Review: Design Output documents ===