Deviation Impact Assessment Template
Equipment Details
Equipment: Multi Mill
Area: Production/Milling
Criticality: Major
Product Impact: Direct
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Classification
Classification: [Enter classification of deviation]
Product/Patient Impact
Impact Assessment: [Enter assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Findings: [Enter findings from the investigation]
Corrective and Preventive Actions (CAPA)
CAPA Description: [Enter description of CAPA]
Re-test/Requalification Decision
Decision: [Enter decision regarding re-test/requalification]
Quality Assurance Disposition
Disposition: [Enter QA disposition]