Deviation Impact Assessment Template
Equipment Information
Equipment: Nasal/Otic Compounding Vessel (Jacketed SS)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation:
Classification
Classification of Deviation:
Minor
Major
Critical
Product/Patient Impact
Potential Impact on Product/Patient:
Data Integrity Impact
Impact on Data Integrity:
Affected Batches/Studies
List of Affected Batches/Studies:
Investigation
Investigation Details:
Corrective and Preventive Action (CAPA)
CAPA Plan:
Re-test/Requalification Decision
Decision on Re-test/Requalification:
Quality Assurance (QA) Disposition
QA Disposition: