Deviation Impact Assessment

Equipment Details

Equipment: Vibro Sifter

Area: Production/Sieving

Criticality: Major

Product Impact: Direct

Deviation Details

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

Date of Deviation: [Insert date]

Reported By: [Insert name of the person reporting the deviation]

Classification

Classification: Major

Product/Patient Impact

Impact Assessment: [Insert assessment of product/patient impact]

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]

Findings: [Insert key findings from the investigation]

Corrective and Preventive Actions (CAPA)

CAPA Plan: [Insert CAPA plan details]

Responsible Person: [Insert name of responsible person]

Target Completion Date: [Insert target completion date]

Re-test/Requalification Decision

Re-test/Requalification Decision: [Insert decision regarding re-testing or re-qualification]

QA Disposition

QA Disposition: [Insert QA disposition outcome]