Deviation Impact Assessment
Equipment Details
Equipment: Bin/IBC Washer
Area: Production/Cleaning
Criticality: Major
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification: [Enter classification of the deviation]
Product/Patient Impact
Potential Impact on Product: [Describe potential impact on product quality]
Potential Impact on Patient: [Describe potential impact on patient safety]
Data Integrity Impact
Data Integrity Impact: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of the investigation process]
Investigation Findings: [Summarize findings]
CAPA (Corrective and Preventive Action)
CAPA Description: [Describe the corrective and preventive actions taken]
CAPA Implementation Date: [Enter date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Re-test/Requalification Details: [Provide details if applicable]
QA Disposition
QA Disposition: [Enter QA decision regarding the deviation]