Deviation Impact Assessment
Equipment Details
Equipment: Induction Sealing Machine
Area: Packaging/Primary
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
Classification of Deviation: [Enter classification]
Product/Patient Impact
Potential Impact on Product: [Enter potential impact]
Potential Impact on Patient: [Enter potential impact]
Data Integrity Impact
Impact on Data Integrity: [Enter impact assessment]
Affected Batches/Studies
Affected Batches/Studies: [Enter batch/study numbers]
Investigation
Investigation Summary: [Enter summary of investigation]
Root Cause Analysis: [Enter root cause]
CAPA (Corrective and Preventive Actions)
Actions Taken: [Enter actions taken]
Responsible Person: [Enter name]
Due Date: [Enter due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Enter details]
QA Disposition
QA Disposition: [Enter disposition]
Reviewer: [Enter name]
Date of Review: [Enter date]