Deviation Impact Assessment
Equipment Details
Equipment: Particle Size Classification System (Sieves/Air classifier)
Area: R&D/Production
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Potential Impact on Product: [Insert details]
Potential Impact on Patient: [Insert details]
Data Integrity Impact
Impact on Data Integrity: [Insert details]
Affected Batches/Studies
Affected Batches/Studies: [Insert details]
Investigation
Investigation Summary: [Insert summary of investigation]
Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of CAPA]
Re-Test/Requalification Decision
Decision: [Insert decision]
Rationale: [Insert rationale]
QA Disposition
QA Disposition: [Insert QA disposition]
Reviewed By: [Insert name]
Date of Review: [Insert date]