Deviation Impact Assessment Template

Equipment Details

Equipment: Extruder (Twin Screw)

Area: Production/Pellets

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Potential Impact on Product/Patient:

Data Integrity Impact

Impact on Data Integrity:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

CAPA

Corrective and Preventive Actions (CAPA):

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition: