Deviation Impact Assessment
Equipment: Air Shower
Area: Facility
Criticality: Major
Product Impact: Indirect
Deviation Details
Provide a detailed description of the deviation observed with the Air Shower.
Classification
Classify the deviation according to internal guidelines (e.g., Major, Minor, Critical).
Product/Patient Impact
Describe the potential impact on product quality and patient safety.
Data Integrity Impact
Assess the impact on data integrity related to the deviation.
Affected Batches/Studies
List any affected batches or studies that may be impacted by the deviation.
Investigation
Outline the steps taken during the investigation of the deviation.
CAPA (Corrective and Preventive Action)
Detail the CAPA plan developed to address the deviation.
Re-test/Requalification Decision
Document the decision regarding re-testing or re-qualification of the Air Shower.
QA Disposition
Provide the Quality Assurance disposition regarding the deviation assessment.