Deviation Impact Assessment
Equipment Details
Equipment: Strip Packing Machine
Area: Packaging/Primary
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Classification
Deviation Classification: [Enter classification, e.g., Major/Minor]
Product/Patient Impact
Potential Impact on Product: [Describe potential impact on product]
Potential Impact on Patient: [Describe potential patient impact]
Data Integrity Impact
Impact on Data Integrity: [Describe how data integrity is affected]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Batch/Study 1]
- [Batch/Study 2]
- [Batch/Study 3]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
CAPA (Corrective and Preventive Actions)
CAPA Description: [Enter details of corrective and preventive actions]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Enter details if applicable]
QA Disposition
QA Disposition: [Enter QA decision]