Deviation Impact Assessment Template
Equipment Details
Equipment: TEM / SEM
Area: QC/R&D
Criticality: Major
Product Impact: Indirect
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Impact on Product: [Insert details on product impact]
Impact on Patient: [Insert details on patient impact]
Data Integrity Impact
Impact on Data Integrity: [Insert details on data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches or studies]
Investigation
Investigation Details: [Insert details of the investigation]
Investigation Findings: [Insert findings]
CAPA (Corrective and Preventive Action)
CAPA Plan: [Insert CAPA plan]
Implementation Date: [Insert date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Insert details if applicable]
QA Disposition
QA Disposition: [Insert QA decision]
Date of QA Disposition: [Insert date]