Deviation Impact Assessment Template

Equipment Details

Equipment: Water System (PW/WFI) – Point of Use for LVP

Area: Utilities

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Occurrence: [Insert date]

Reported By: [Insert name]

Classification

Deviation Classification: [Insert classification, e.g., Major, Minor]

Product/Patient Impact

Potential Product Impact: [Describe potential impact on product]

Potential Patient Impact: [Describe potential impact on patients]

Data Integrity Impact

Data Integrity Assessment: [Describe impact on data integrity]

Affected Batches/Studies

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

Investigation

Investigation Summary: [Insert summary of investigation findings]

Root Cause: [Identify root cause of deviation]

Corrective and Preventive Actions (CAPA)

CAPA Plan: [Detail CAPA plan]

Responsible Individual: [Insert name]

Due Date: [Insert date]

Re-test/Requalification Decision

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

Details of Re-test/Requalification: [Describe details if applicable]

Quality Assurance (QA) Disposition

QA Disposition: [Insert QA disposition]

Disposition Date: [Insert date]