Deviation Impact Assessment
Equipment Details
Equipment: Leak Test Machine (Bag – Pressure/Vacuum)
Area: Production/QC
Criticality: Critical
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 based on severity]
Product/Patient Impact
Impact Description: [Describe the potential impact on product and patient]
Data Integrity Impact
Data Integrity Status: [Assess 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: [Identify root cause of the deviation]
Corrective and Preventive Actions (CAPA)
CAPA Description: [Describe the corrective and preventive actions taken]
Re-test/Requalification Decision
Decision: [State the decision regarding re-testing or requalification]
Quality Assurance (QA) Disposition
Disposition: [Provide the QA disposition regarding the deviation]