Deviation Impact Assessment
Equipment Details
Equipment: Die Cutting / Punching Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Potential Impact on Product: [Enter details]
Potential Impact on Patient: [Enter details]
Data Integrity Impact
Impact on Data Integrity: [Enter details]
Affected Batches/Studies
Affected Batches/Studies: [Enter batch/study numbers]
Investigation
Investigation Summary: [Enter summary of the investigation]
CAPA
Corrective Actions: [Enter corrective actions taken]
Preventive Actions: [Enter preventive actions taken]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Enter details if applicable]
QA Disposition
Disposition Decision: [Enter decision]
Comments: [Enter any additional comments]