Deviation Impact Assessment Template
Equipment Details
Equipment: Sterile Powder Compounding Vessel (Jacketed SS)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Classification
Classification of Deviation: [Enter classification, e.g., Major/Minor]
Product/Patient Impact
Potential Impact on Product: [Describe impact on product quality]
Potential Impact on Patient: [Describe impact on patient safety]
Data Integrity Impact
Impact on Data Integrity: [Describe any impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of investigation conducted]
CAPA (Corrective and Preventive Actions)
CAPA Plan: [Describe CAPA plan to address the deviation]
Re-Test/Requalification Decision
Re-Test/Requalification Required: [Yes/No]
Details of Re-Test/Requalification: [Provide details if applicable]
QA Disposition
QA Disposition: [Enter QA disposition decision]