Deviation Impact Assessment
Equipment Details
Equipment: Pneumatic Conveying (Dilute Phase)
Area: Production/Material Transfer
Criticality: Major
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name and title]
Classification
Deviation Classification: [Insert classification, e.g., OOS, OOT, etc.]
Product/Patient Impact
Impact Assessment: [Insert assessment of potential product or patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Insert batch/study number]
- [Insert batch/study number]
- [Insert batch/study number]
Investigation
Investigation Summary: [Insert summary of the investigation conducted]
Findings: [Insert findings from the investigation]
CAPA (Corrective and Preventive Actions)
CAPA Plan: [Insert details of the CAPA plan]
Responsible Person: [Insert name and title]
Due Date: [Insert due date]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-testing or re-qualification]
QA Disposition
Disposition: [Insert QA disposition details]