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=== Review: Design Input ===
# Verify if design input documents are sufficient.
# Verify if these input documents have been adequately linked to the product performance specifications.
=== Review: Product Performance Specifications (PPS) ===
# Verify that design inputs correlate adequately to the specifications and that appropriate design verification and validations (DV&V) are performed.
# Also verify if DV&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans.
# Verify that product performance specifications correspond to appropriate design output documents.
=== 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 ===
# Drawings would be reviewed for completeness.
# Help perform a First Article Inspection in order to verify the dimensions on the drawings.
=== Review: Manufacturing documents ===
# Review manufacturing procedures, component specifications, raw material specifications, in-coming and in-process inspection procedures for completeness.
# Review linkage between component and raw material specifications and appropriate in-coming inspection procedures.
# Ensure inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials.
# Review of calibration records and preventive maintenance records would be also performed. This would also include a review of the in-process / incoming inspection test methods and related test method validations.
=== Validation Report Review ===
# DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports would be reviewed.
# This would also include a review of the design test methods and related test method validations.
=== Potential DHF Review Outcomes ===