Implant Inspection System – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Implant Inspection System

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

Impact Description:

Data Integrity Impact

Impact Description:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

CAPA (Corrective and Preventive Action)

CAPA Details:

Re-test/Requalification Decision

Decision:

QA Disposition

Disposition:

See also  Automated Visual Inspection (AVI) Machine – IQ Protocol

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