Deviation Impact Assessment
Equipment Details
Equipment: Patch Coating Machine (Knife-over-roll / Slot Die)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date]
Reported By: [Enter reporter’s name]
Classification
Deviation Classification: [Enter classification, e.g., Major, Minor]
Product/Patient Impact
Potential Product Impact: [Describe impact on product]
Potential Patient Impact: [Describe impact on patients]
Data Integrity Impact
Data Integrity Assessment: [Describe any data integrity concerns]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Provide summary of investigation]
Root Cause Analysis: [Enter root cause]
CAPA (Corrective and Preventive Action)
CAPA Summary: [Describe the CAPA plan]
CAPA Implementation Date: [Enter date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Describe details]
QA Disposition
QA Disposition: [Enter QA decision]
Date of Disposition: [Enter date]