Deviation Impact Assessment Template
Equipment Information
Equipment: Implant Sterilization System (EO/Gamma/Autoclave)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification: [Enter classification]
Product/Patient Impact
Impact Assessment: [Enter impact assessment]
Data Integrity Impact
Data Integrity Assessment: [Enter data integrity assessment]
Affected Batches/Studies
Affected Batches/Studies: [Enter affected batches/studies]
Investigation
Investigation Summary: [Enter investigation summary]
CAPA (Corrective and Preventive Actions)
CAPA Summary: [Enter CAPA summary]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision]
QA Disposition
Disposition: [Enter QA disposition]