Deviation Impact Assessment Template

Equipment Details

Equipment: Raw Material Sampling Booth

Area: Warehouse/Sampling

Criticality: Critical

Product Impact: Direct

CSV Required: No

Deviation Details

Description of Deviation:

Classification

Deviation Classification:

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:

Corrective and Preventive Actions (CAPA)

CAPA Summary:

Re-test/Requalification Decision

Decision:

Quality Assurance Disposition

Disposition: