Deviation Impact Assessment Template
Equipment Details
Equipment: Implant Coating Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification, e.g., Major, Minor]
Product/Patient Impact
Potential Impact on Product: [Describe potential impact]
Potential Impact on Patient: [Describe potential impact]
Data Integrity Impact
Impact on Data Integrity: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of investigation]
Investigation Findings: [Detail findings]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Describe CAPA plan]
Responsible Person: [Enter name]
Due Date: [Enter due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Rationale for Decision: [Provide rationale]
QA Disposition
QA Disposition: [Enter QA disposition]
Reviewed By: [Enter name]
Review Date: [Enter date]