HVAC System – Deviation Impact Assessment

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.

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