Deviation Impact Assessment Template

Equipment Details

Equipment: Continuous Blender

Area: Production/Continuous Manufacturing

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification Level: [Insert classification level]

Justification for Classification: [Insert justification]

Product/Patient Impact

Potential Impact on Product: [Insert potential impact]

Potential Impact on Patient: [Insert potential impact]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment]

Affected Batches/Studies

Affected Batches/Studies: [List affected batches or studies]

Investigation

Investigation Summary: [Insert summary of investigation]

Investigation Findings: [Insert findings]

Corrective and Preventive Actions (CAPA)

CAPA Summary: [Insert summary of CAPA]

Actions Taken: [Insert actions taken]

Re-test/Requalification Decision

Re-test/Requalification Required: [Yes/No]

Decision Rationale: [Insert rationale]

Quality Assurance Disposition

QA Disposition: [Insert QA disposition]

Disposition Date: [Insert date]