Deviation Impact Assessment
Equipment Details
Equipment: Pin Mill
Area: Production/Milling
Criticality: Major
Product Impact: Direct
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name/position]
Classification
Classification of Deviation: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Potential Impact on Product: [Insert details on how the deviation impacts the product]
Potential Impact on Patient: [Insert details on how the deviation impacts patient safety]
Data Integrity Impact
Impact on Data Integrity: [Insert details on how the deviation affects data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation conducted]
Root Cause Analysis: [Insert root cause analysis]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert details of the CAPA plan]
Responsible Person: [Insert name/position]
Due Date: [Insert due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Insert details if applicable]
QA Disposition
Disposition by QA: [Insert QA decision]
Date of Disposition: [Insert date]