Deviation Impact Assessment
Equipment Details
Equipment: Cooling Tunnel / Cooling Conveyor
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description here]
Date of Deviation: [Insert date here]
Classification
Deviation Classification: [Insert classification here]
Product/Patient Impact
Potential Impact on Product: [Insert details here]
Potential Impact on Patient: [Insert details here]
Data Integrity Impact
Impact on Data Integrity: [Insert details here]
Affected Batches/Studies
Affected Batches/Studies: [Insert batch/study details 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 here]
Quality Assurance Disposition
QA Disposition: [Insert QA disposition here]