Deviation Impact Assessment

Equipment Information

Equipment: Rotary Sifter

Area: Production/Sieving

Criticality: Major

Product Impact: Direct

Deviation Details

Deviation Description: [Insert deviation description here]

Date of Deviation: [Insert date here]

Reported By: [Insert name here]

Classification

Deviation Classification: Major

Product/Patient Impact

Potential Impact on Product: [Insert details here]

Potential Impact on Patient: [Insert details here]

Data Integrity Impact

Impact on Data Integrity: [Insert details here]

Affected Batches/Studies

Affected Batches: [Insert batch numbers here]

Affected Studies: [Insert study details here]

Investigation

Investigation Summary: [Insert investigation summary here]

CAPA (Corrective and Preventive Actions)

Actions Taken: [Insert actions taken here]

Responsible Person: [Insert name here]

Due Date: [Insert due date here]

Re-test/Requalification Decision

Decision: [Insert decision here]

Rationale: [Insert rationale here]

QA Disposition

Disposition: [Insert disposition here]

Reviewed By: [Insert name here]

Date of Review: [Insert date here]