Deviation Impact Assessment Template
Equipment Details
Equipment: Capsule Filling Machine (Automatic)
Area: Production/Capsules
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Potential Impact on Product: [Describe potential impact on product quality]
Potential Impact on Patient Safety: [Describe potential impact on patient safety]
Data Integrity Impact
Impact on Data Integrity: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Summarize investigation findings]
Root Cause Analysis: [Insert root cause]
Corrective and Preventive Actions (CAPA)
Corrective Actions: [Describe corrective actions taken]
Preventive Actions: [Describe preventive actions implemented]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Insert details if applicable]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]
Disposition Date: [Insert date]