Deviation Impact Assessment
Equipment Details
Equipment: Extrusion Machine
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
Impact Assessment: [Describe the potential impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Assess any potential data integrity issues]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Summarize the investigation findings]
Investigation Team: [Insert team members]
Corrective and Preventive Actions (CAPA)
Proposed CAPA: [Detail proposed corrective actions]
Preventive Actions: [Detail preventive actions to avoid recurrence]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Provide details on re-test or requalification requirements]
Quality Assurance Disposition
QA Disposition: [Insert QA decision on the deviation]