Deviation Impact Assessment Template

Equipment Details

Equipment: Parts Washer

Area: Production

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

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

Product/Patient Impact

Impact Assessment: [Insert assessment of how the deviation impacts the product or patient]

Data Integrity Impact

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

Affected Batches/Studies

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

Investigation

Investigation Summary: [Insert summary of the investigation conducted]

Investigation Team: [Insert names of team members]

Investigation Findings: [Insert findings from the investigation]

CAPA (Corrective and Preventive Actions)

CAPA Summary: [Insert summary of corrective and preventive actions taken]

Responsible Person: [Insert name]

Due Date: [Insert due date]

Re-test/Requalification Decision

Re-test/Requalification Required: [Yes/No]

Details: [Insert details regarding re-test or requalification]

QA Disposition

QA Disposition: [Insert QA’s final disposition regarding the deviation]

Disposition Date: [Insert date]