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hc255 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 7 years, 6 months ago
My company utilizes FMEA while the planning phase to assess risk. As mentioned in the lecture, FMEA is Failure Mode Effects Analysis. This systematic approach allows primarily those within the healthcare industry to evaluate a process to identify how failure may occur and how can this be handled so the company, hospital, the patient is not affected. Failures are prioritized according to how serious the risk consequences can be along with the occurrence associated with the risk. As a Quality Engineer, we have checks in place to handle the risk such as CAPAs which aim to investigate an issue, some given priority to business standard issues.