Deviation Impact Assessment
Equipment: HVAC System
Area: System
Criticality: Indirect
Product Impact: Control temperature, humidity, and pressure
CSV Required: Yes
Deviation Details
Provide a detailed description of the deviation encountered during the qualification activities.
Classification
Classify the deviation based on its severity and potential impact on product quality.
Product/Patient Impact
Assess the potential impact on product quality and patient safety due to the deviation.
Data Integrity Impact
Evaluate any implications on data integrity resulting from the deviation.
Affected Batches/Studies
List all affected batches or studies related to the HVAC system qualification.
Investigation
Outline the steps taken to investigate the deviation, including root cause analysis.
CAPA (Corrective and Preventive Actions)
Detail the corrective and preventive actions proposed or implemented to address the deviation.
Re-test/Requalification Decision
Document the decision regarding re-testing or re-qualification of the HVAC system.
QA Disposition
Provide the Quality Assurance disposition regarding the deviation and its resolution.