Deviation Impact Assessment Template
Equipment Details
Equipment: Dose Metering Test System (Spray Pattern / Shot Weight)
Area: QC/Production
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 of the deviation]
Product/Patient Impact
Potential Impact: [Describe potential impact on product/patient]
Data Integrity Impact
Data Integrity Assessment: [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 Description: [Describe proposed CAPA]
Implementation Date: [Enter date]
Re-Test/Requalification Decision
Decision: [State re-test/requalification decision]
QA Disposition
QA Disposition: [Enter QA disposition]