Deviation Impact Assessment Template
Equipment Details
Equipment: Ophthalmic Ointment Manufacturing Vessel (Sigma/Planetary/Vacuum)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact on Product: [Enter product impact details]
Impact on Patient: [Enter patient impact details]
Data Integrity Impact
Impact on Data Integrity: [Enter data integrity impact details]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Enter investigation summary]
Investigation Findings: [Enter findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter CAPA summary]
Implementation Date: [Enter implementation date]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision]
Date of Decision: [Enter date]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA disposition]
Date of Disposition: [Enter date]