Deviation Impact Assessment
Equipment Details
Equipment: Syringe Assembly Machine (Needle Attachment)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description here]
Date of Deviation: [Insert date here]
Reported By: [Insert name here]
Classification
Classification of Deviation: [Insert classification here]
Product/Patient Impact
Impact on Product: [Insert product impact details here]
Impact on Patient: [Insert patient impact details here]
Data Integrity Impact
Impact on Data Integrity: [Insert data integrity impact details here]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches/studies here]
Investigation
Investigation Summary: [Insert investigation summary here]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert CAPA plan here]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision here]
QA Disposition
Disposition: [Insert QA disposition here]