Changes

| Verify if design Design input documents are sufficient.

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

| Verify that design 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 Product performance specifications correspond to appropriate design output 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.

| verify that appropriate 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; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA.