Deviation Impact Assessment Template
Equipment: Sterile Filtration Skid
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
[Enter detailed description of the deviation here]
Classification
[Enter classification of the deviation (e.g., Major, Minor, etc.)]
Product/Patient Impact
[Describe the potential impact on product quality and patient safety]
Data Integrity Impact
[Assess the impact on data integrity, if applicable]
Affected Batches/Studies
[List affected batches or studies]
Investigation
[Summarize the investigation process and findings]
CAPA (Corrective and Preventive Actions)
[Outline the CAPA plan to address the deviation]
Re-test/Requalification Decision
[Document the decision regarding re-testing or re-qualification]
QA Disposition
[State the Quality Assurance disposition of the affected product]