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  • lurongyang replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices 6 years, 4 months ago

    To run a risk management meeting, always follow the cycle of assess-evaluate-manage-measure. First thing you should do is to have quality member gather all members in the project team, because it is important to make everyone get the information of potential risks. Second thing is brainstorming the risks that could happen in the product, product design and manufacturing process, this is called assessment. Thirdly, quality member need to evaluate the potential risks in its generation mechanism, severity and probability so that we could put our attentions accordingly and make most of it to expedite the project progression without ignoring risks. The fourth point comes to how to manage those risks after knowing their existence, four general strategies commonly used are avoidance, mitigation, acceptance, and transference. Then the last thing in the cycle is measurement, which is to confirm whether the management is effective in lowering the risks and how much does it reduce. This cycle will keep rolling throughout the project in order to deal with any new risks that could emerge in the progress.