Deviation Impact Assessment Template

Equipment Details

Equipment: Bin Lifter / IBC Lifter

Area: Production/Material Handling

Criticality: Major

Product Impact: Indirect

CSV Required: No

Deviation Details

Deviation Description: [Insert Deviation Description Here]

Date of Deviation: [Insert Date Here]

Classification

Classification: Major

Product/Patient Impact

Impact Assessment: [Insert Assessment Here]

Data Integrity Impact

Impact Assessment: [Insert Assessment Here]

Affected Batches/Studies

Batches/Studies Affected: [Insert Affected Batches/Studies Here]

Investigation

Investigation Summary: [Insert Summary Here]

Investigation Team: [Insert Team Members Here]

Investigation Findings: [Insert Findings Here]

Corrective and Preventive Actions (CAPA)

Actions Taken: [Insert Actions Here]

Responsible Person: [Insert Name Here]

Due Date: [Insert Due Date Here]

Re-test/Requalification Decision

Decision: [Insert Decision Here]

Rationale: [Insert Rationale Here]

Quality Assurance (QA) Disposition

Disposition: [Insert Disposition Here]

QA Review Date: [Insert Review Date Here]