Deviation Impact Assessment Template
Equipment Details
Equipment: Jet Mill / Spiral Mill
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Classification
Minor
Major
Critical
Product/Patient Impact
Data Integrity Impact
Affected Batches/Studies
Investigation
Corrective and Preventive Actions (CAPA)
Re-test/Requalification Decision
Quality Assurance Disposition
Approval