Activity

  • kak33 replied to the topic Risk Management – Identification in the forum Risk Analysis for Medical Devices 7 years, 5 months ago

    I work for a medical device company as a manufacturing engineer. It is part of every design change procedure to conduct a Cause and Mitigation Impact Assessment where we evaluate the risks associated with the proposed changes. There is a set matrix of potential hazards, their causes, and mitigations. The intent of the meeting is to evaluate any impact to the existing hazards, causes, and mitigations as well as to assess if the design change introduces any new hazards, causes, and mitigations. Risk assessment is typically a cross functional effort. But the meetings are conducted by approved risk management facilitators. I would say, I think my company should provide more training for engineers to better assess risks and priorities independent of the facilitators.