Deviation Impact Assessment
Equipment Details
Equipment: Pneumatic Conveying (Dense Phase)
Area: Production/Material Transfer
Criticality: Major
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter details of the deviation]
Date of Deviation: [Enter date]
Classification
Classification of Deviation: [Enter classification]
Product/Patient Impact
Potential Impact on Product: [Describe potential impact]
Potential Impact on Patient: [Describe potential impact]
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]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Describe CAPA plan]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Enter details]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA disposition]