Deviation Impact Assessment Template
Equipment Details
Equipment: Coding Machine (Inkjet / Laser)
Area: Packaging
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact Assessment: [Describe potential impact on product and patient]
Data Integrity Impact
Data Integrity Assessment: [Describe impact on data integrity]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Batch/Study 1]
- [Batch/Study 2]
- [Batch/Study 3]
Investigation
Investigation Summary: [Provide summary of investigation conducted]
Findings: [List findings from the investigation]
CAPA (Corrective and Preventive Action)
CAPA Plan: [Describe the CAPA plan]
Responsible Person: [Enter name]
Due Date: [Enter due date]
Re-test/Requalification Decision
Decision: [Enter decision regarding re-testing/re-qualification]
QA Disposition
Disposition: [Enter QA disposition]