Deviation Impact Assessment
Equipment Information
Equipment: Bag Dump Station / Sack Tip Station
Area: Production/Dispensing
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Potential Product Impact: [Describe the potential impact on product quality]
Potential Patient Impact: [Describe the potential impact on patient safety]
Data Integrity Impact
Impact on Data Integrity: [Describe the impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
Root Cause Analysis: [Describe the root cause identified]
Corrective and Preventive Actions (CAPA)
Actions Taken: [List actions taken to address the deviation]
Preventive Measures: [Describe measures to prevent recurrence]
Re-Test/Requalification Decision
Re-Test/Requalification Required: [Yes/No]
Details: [Provide details if re-test/requalification is required]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA disposition]
Comments: [Any additional comments]