Deviation Impact Assessment Template

Equipment Details

Equipment: Sanitary Transfer Pump (Mag Drive/Centrifugal)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: No

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Deviation Classification: [Insert classification, e.g., Major/Minor]

Product/Patient Impact

Potential Impact on Product: [Insert potential impact]

Potential Impact on Patient: [Insert potential impact]

Data Integrity Impact

Impact on Data Integrity: [Insert description of data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [List affected batches or studies]

Investigation

Investigation Summary: [Insert summary of investigation]

Root Cause: [Insert root cause]

Corrective and Preventive Actions (CAPA)

Actions Taken: [Insert actions taken]

Responsible Person: [Insert name]

Due Date: [Insert due date]

Re-test/Requalification Decision

Decision on Re-test/Requalification: [Insert decision]

QA Disposition

QA Review: [Insert QA review details]

Disposition: [Insert final disposition]

Signatures

Prepared By: [Insert name and date]

Reviewed By: [Insert name and date]