Automated Visual Inspection (AVI) Machine – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Details

Equipment: Automated Visual Inspection (AVI) Machine

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Describe Product/Patient Impact:

Data Integrity Impact

Describe Data Integrity Impact:

Affected Batches/Studies

List Affected Batches/Studies:

Investigation

Investigation Findings:

Corrective and Preventive Actions (CAPA)

Describe CAPA:

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

Submit Assessment