Deviation Impact Assessment

Equipment Details

Equipment: Bin/IBC Washer

Area: Production/Cleaning

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Deviation Description: [Enter detailed description of the deviation]

Date of Deviation: [Enter date]

Reported By: [Enter name]

Classification: [Enter classification of the deviation]

Potential Impact on Product: [Describe potential impact on product quality]

Potential Impact on Patient: [Describe potential impact on patient safety]

Data Integrity Impact: [Describe impact on data integrity]

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

Investigation Summary: [Provide summary of the investigation process]

Investigation Findings: [Summarize findings]

CAPA Description: [Describe the corrective and preventive actions taken]

CAPA Implementation Date: [Enter date]

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

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

QA Disposition: [Enter QA decision regarding the deviation]