Deviation Impact Assessment Template

Equipment Details

Equipment: Bag Washing / Blow-off Station (if used)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Impact Assessment:

Data Integrity Impact

Impact Assessment:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

CAPA (Corrective and Preventive Action)

CAPA Plan:

Re-test/Requalification Decision

Decision:

QA Disposition

Disposition Summary:

Signatures

Prepared By: ________________________

Reviewed By: ________________________

Approved By: ________________________