Deviation Impact Assessment Template
Equipment Information
Equipment: Co-Mill / Conical Mill
Area: Production/Milling
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Enter details of the deviation]
Date of Occurrence: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: Major
Product/Patient Impact
Potential Impact on Product: [Describe impact]
Potential Impact on Patient: [Describe impact]
Data Integrity Impact
Impact on Data Integrity: [Describe impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Enter investigation details]
Root Cause Analysis: [Describe root cause]
CAPA (Corrective and Preventive Action)
Actions Taken: [List actions taken]
Preventive Measures: [List preventive measures]
Re-test/Requalification Decision
Re-test Required: [Yes/No]
Requalification Required: [Yes/No]
QA Disposition
QA Disposition: [Enter QA decision]