Deviation Impact Assessment Template
Equipment Details
Equipment: V Blender
Area: Production/Blending
Criticality: Major
Product Impact: Direct
Deviation Details
Deviation Description: [Insert deviation description here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: Major
Product/Patient Impact
Impact Assessment: [Insert assessment details here]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment details here]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches/studies here]
Investigation
Investigation Summary: [Insert investigation summary here]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA details here]
Re-test/Requalification Decision
Decision: [Insert decision details here]
QA Disposition
QA Disposition: [Insert QA disposition here]