Deviation Impact Assessment Template
Equipment Details
Equipment: Plunger Insertion Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation 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 (QA) Disposition