Deviation Impact Assessment Template
Equipment Information
Equipment: Implant Cutting Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert deviation description here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification, e.g., Major/Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment details]
Data Integrity Impact
Impact Assessment: [Insert assessment details]
Affected Batches/Studies
Affected Batches/Studies: [Insert batch/study numbers]
Investigation
Investigation Summary: [Insert summary of investigation]
Root Cause Analysis: [Insert root cause]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert details of CAPA]
Responsible Person: [Insert name]
Due Date: [Insert due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Insert re-test/requalification plan]
Quality Assurance Disposition
Disposition: [Insert QA disposition]
Reviewed By: [Insert name]
Date Reviewed: [Insert date]