Deviation Impact Assessment Template

Equipment Details

Equipment: PLC System (Programmable Logic Controller)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation: [Enter details of the deviation]

Date of Deviation: [Enter date]

Reported By: [Enter name]

Classification

Classification of Deviation: [Enter classification]

Product/Patient Impact

Impact on Product: [Describe impact on product]

Impact on Patient: [Describe impact on patient]

Data Integrity Impact

Impact on Data Integrity: [Describe impact on data integrity]

Affected Batches/Studies

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

Investigation

Investigation Summary: [Summarize investigation findings]

Investigation Lead: [Enter name]

Investigation Date: [Enter date]

CAPA (Corrective and Preventive Action)

CAPA Summary: [Describe CAPA actions]

Responsible Person: [Enter name]

Due Date: [Enter date]

Re-test/Requalification Decision

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

Details: [Provide details if applicable]

QA Disposition

QA Disposition: [Enter QA disposition]

Reviewed By: [Enter name]

Review Date: [Enter date]