Deviation Impact Assessment
Equipment Information
Equipment: CIP Skid
Area: Production/Cleaning
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter deviation description]
Date of Deviation: [Enter date]
Reported By: [Enter name/position]
Classification
Classification of Deviation: [Enter classification]
Product/Patient Impact
Potential Impact on Product: [Enter impact details]
Potential Impact on Patient: [Enter impact details]
Data Integrity Impact
Impact on Data Integrity: [Enter assessment]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Enter summary of investigation]
Root Cause Analysis: [Enter root cause]
CAPA
Corrective Actions: [List corrective actions]
Preventive Actions: [List preventive actions]
Re-Test/Requalification Decision
Re-Test/Requalification Required: [Yes/No]
Comments: [Enter comments]
QA Disposition
QA Disposition: [Enter disposition]
Reviewed By: [Enter name/position]
Date of Review: [Enter date]