Deviation Impact Assessment Template
Equipment Details
Equipment: Bottle Blow Molding Machine
Area: Production
Criticality: Major
Product Impact: Indirect
CSV Required: Yes
Deviation Details
Deviation Description: [Enter a detailed description of the deviation]
Date of Deviation: [Enter date]
Classification
Classification: Major
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Evaluate the impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide details of the investigation process]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Outline the proposed CAPA measures]
Re-test/Requalification Decision
Decision: [State the decision regarding re-testing or re-qualification]
QA Disposition
QA Disposition: [Provide the QA’s final decision regarding the deviation]