Client wishes to acquire a ureteral stent company. Dolcera provides the following Design History File (DHF) review.
{|border="2" cellspacing="0" cellpadding="4" width="95%"
!align = "center" bgcolor = "#00CCFF" width="15%"|Reviewand Verification
!bgcolor = "#00CCFF" width="30%"|Activity
!bgcolor = "#00CCFF" width="40%"|Tasks
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!rowspan="2"|Design Input
| Design input documents are sufficient.for sufficiency
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# Access electronic data room.
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| Design input documents have been adequately linked to the product performance specifications.
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!rowspan="3"|Product Performance Specifications (PPS)
| Design inputs correlate adequately to the specifications; appropriate design verification and validations (DV&V) are performed.
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| DV&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans.
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| Product performance specifications correspond to appropriate design output documents.
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!rowspan="4"|Risk Management Documents
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation.
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| DFMEA links appropriately to the PPS.
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| Appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEA.
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| 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
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