Deviation Impact Assessment Template
Equipment Information
Equipment: Vision System
Area: Packaging/Inspection
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification]
Product/Patient Impact
Impact on Product: [Insert description of product impact]
Impact on Patient: [Insert description of patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert details of affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Root Cause Analysis: [Insert root cause analysis]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of CAPA]
Re-test/Requalification Decision
Re-test Decision: [Insert re-test decision]
Requalification Decision: [Insert requalification decision]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]