Deviation Impact Assessment
Equipment Details
Equipment: Micro-molding Press / Hot Embossing Unit
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification, e.g., Minor, Major, Critical]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Describe the potential impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
Investigation Findings: [Summarize findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Describe actions taken to correct and prevent recurrence]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Provide details if applicable]
Quality Assurance (QA) Disposition
QA Disposition: [Provide QA decision based on assessment]