Deviation Impact Assessment Template

Equipment Details

Equipment: Leak Test Machine (Implant Packaging)

Area: Production/QC

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation: [Insert detailed description of the deviation]

Date of Occurrence: [Insert date]

Reported By: [Insert name]

Classification

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

Product/Patient Impact

Impact on Product: [Insert details on how the product is affected]

Impact on Patient: [Insert details on potential patient impact]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment of data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [Insert details of affected batches or studies]

Investigation

Investigation Summary: [Insert summary of investigation conducted]

Root Cause Analysis: [Insert root cause analysis]

CAPA (Corrective and Preventive Actions)

CAPA Summary: [Insert summary of CAPA actions]

Responsible Person: [Insert name]

Due Date: [Insert due date]

Re-test/Requalification Decision

Re-test/Requalification Required: [Insert yes/no]

Details: [Insert details of re-test/requalification plan]

QA Disposition

QA Disposition: [Insert QA decision]

Reviewed By: [Insert name]

Date of Review: [Insert date]