Deviation Impact Assessment
Equipment Details
Equipment: Air Classifier Mill
Area: Production/Milling
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date here]
Reported By: [Enter reporter’s name here]
Classification
Classification: [Enter classification here]
Product/Patient Impact
Impact Assessment: [Enter assessment details here]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment details here]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies here]
Investigation
Investigation Summary: [Enter investigation summary here]
Findings: [Enter findings here]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter CAPA summary here]
Action Plan: [Enter action plan here]
Re-test/Requalification Decision
Decision: [Enter decision here]
Justification: [Enter justification here]
QA Disposition
Disposition: [Enter QA disposition here]
Comments: [Enter additional comments here]