Deviation Impact Assessment
Equipment Details
Equipment: Drum Lifter
Area: Production/Material Handling
Criticality: Major
Product Impact: Indirect
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Potential Impact on Product: [Describe potential impacts]
Potential Impact on Patient: [Describe potential impacts]
Data Integrity Impact
Impact on Data Integrity: [Describe impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Corrective and Preventive Actions (CAPA)
CAPA Actions: [List proposed CAPA actions]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Provide details if applicable]
Quality Assurance Disposition
QA Disposition: [Insert QA disposition]
Signatures
Prepared By: [Insert name]
Date: [Insert date]
Reviewed By: [Insert name]
Date: [Insert date]