Deviation Impact Assessment

Equipment Details

Equipment: Bin Dumper / IBC Dumper

Area: Production/Material Handling

Criticality: Major

Product Impact: Direct

CSV Required: No

Description of Deviation:

[Insert detailed description of the deviation here]

Classification of Deviation: Major

Impact on Product/Patient:

[Describe the potential impact on product quality and patient safety]

Impact on Data Integrity:

[Describe any potential data integrity issues]

Affected Batches/Studies:

[List the affected batches or studies]

Investigation Summary:

[Provide a summary of the investigation conducted]

CAPA Summary:

[Detail the corrective and preventive actions taken]

Re-test/Requalification Decision:

[State the decision regarding re-testing or re-qualification]

QA Disposition:

[Provide QA’s final disposition on the deviation]