Deviation Impact Assessment Template
Equipment Information
Equipment: VHP Generator
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert 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
Data Integrity Impact Assessment: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Summarize investigation findings]
Investigation Completed By: [Insert name]
Date of Investigation: [Insert date]
CAPA (Corrective and Preventive Actions)
CAPA Summary: [Describe corrective and preventive actions taken]
CAPA Implementation Date: [Insert date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Provide details if applicable]
QA Disposition
QA Disposition: [Describe QA disposition]