Changes

!align = "center" bgcolor = "#00CCFF" width="15%"|Reviewand Verification

| Design input documents are sufficient.for sufficiency

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

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

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

| Product performance specifications correspond to appropriate design output documents.

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

| DFMEA links appropriately to the PPS.

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

| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA| ||-!rowspan="2"|Design Output Documents | Completeness of drawings|# Check if the CAD diagrams overlay and "fit" perfectly.| Mechanical engineering, CAD|-| First Article Inspection for the dimensions on the drawings| ||-!rowspan="4"|Manufacturing Documents | Manufacturing procedures, component specifications, raw material specifications, in-coming and in-process inspection procedures for completeness| ||-| Linkage between component and raw material specifications and appropriate incoming inspection procedures| ||-|-| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials| ||-| calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations