Deviation Impact Assessment Template

Equipment Details

Equipment: Distillation Unit / Distillation Column

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 Assessment:

Data Integrity Impact

Data Integrity Assessment:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

CAPA (Corrective and Preventive Actions)

CAPA Summary:

Re-test/Requalification Decision

Re-test/Requalification Decision:

Pass
Fail
Pending

QA Disposition

QA Disposition:

Submit Assessment