MEDICAL DEVICE INSPECTION WORKFLOW: STREAMLINED AUDIT & COMPLIANCE MANAGEMENT

Created by ChecklistGuro (https://checklistguro.com)

[ ] Initialize Inspection Record: Creates a new inspection record, capturing essential details like inspection date, device ID, and assigned inspector.
[ ] Retrieve Device Master Data: Fetches necessary background information (e.g., Model Number, Calibration Schedule) for the specific medical device being inspected.
[ ] Generate Task List & Assign Inspectors: Automatically generates the required inspection checklist tasks and assigns them to relevant team members.
[ ] Perform On-Site Inspection Steps: Guides the inspector through standardized, sequential physical inspection steps using interactive checklists.
[ ] Document Inspection Findings & Observations: Allows inspectors to record detailed observations, including pass/fail status, non-conformances, and corrective actions directly on the device record.
[ ] Update Non-Conformance Details: Updates the severity, root cause, and proposed corrective actions for identified defects or non-conformances.
[ ] Calculate Overall Risk Score: Executes a formula based on collected data (e.g., weighted average of failure points) to determine the overall risk level of the device.
[ ] Review and Approve Inspection Report: Creates a final review task assigned to the Quality Manager for official sign-off.
[ ] Generate Final Inspection Report: Compiles all collected data, tasks completed, and identified non-conformances into a comprehensive, traceable final report.
[ ] Notify Stakeholders of Completion: Automatically emails the final report and next steps to relevant parties (e.g., Engineering, Quality, Management).
[ ] Schedule Follow-up Actions: Generates follow-up tasks and due dates for necessary Corrective and Preventive Actions (CAPA).

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