Automated Visual Inspection Machine – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Automated Visual Inspection Machine

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification: [Insert classification]

Product/Patient Impact

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

Data Integrity Impact

Impact Assessment: [Insert assessment of data integrity impact]

Affected Batches/Studies

Batches/Studies Affected: [Insert affected batches/studies]

Investigation

Investigation Summary: [Insert summary of the investigation]

CAPA

Corrective and Preventive Actions: [Insert CAPA details]

Re-test/Requalification Decision

Decision: [Insert decision regarding re-test/requalification]

QA Disposition

Disposition: [Insert QA disposition]

See also  Dropper/Tip Insertion Machine – Equipment Validation SOP

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