Deviation Impact Assessment
Equipment Details
Equipment: Sanitary Transfer Pump
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification, e.g., Major/Minor]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product and/or patient]
Data Integrity Impact
Assessment: [Describe any potential impact on data integrity]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Batch/Study 1]
- [Batch/Study 2]
- [Batch/Study 3]
Investigation
Investigation Summary: [Summarize the investigation conducted]
Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
Actions Taken: [Describe actions taken to address the deviation]
Preventive Measures: [Describe measures to prevent recurrence]
Re-Test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition, e.g., Accept/Reject]
Comments: [Insert any additional comments]