Deviation Impact Assessment
Equipment Details
Equipment: Sigma Mixer / Kneader
Area: Production/Granulation
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Deviation Number: [Enter deviation number]
Classification
Classification of Deviation: [Enter classification]
Product/Patient Impact
Impact on Product: [Describe impact on product]
Impact on Patient: [Describe impact on patient]
Data Integrity Impact
Impact on Data Integrity: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of investigation]
Investigation Findings: [Outline findings]
CAPA (Corrective and Preventive Action)
CAPA Plan: [Describe CAPA plan]
Responsible Person: [Enter responsible person]
Due Date: [Enter due date]
Re-test/Requalification Decision
Re-test Decision: [Enter decision]
Requalification Required: [Yes/No]
QA Disposition
QA Disposition: [Enter QA disposition]