Activity

  • I think it would be wise to get everyone familiarized before starting risk management meetings with the ISO 14971 standard. Before even running these risk management meetings it is important that everyone in the group that I am in charge of have a baseline understanding of ISO 14971 and basically what a risk/hazard is. Towards the beginning of the series for these meetings as a PM I would keen in on assessing the risk. This not only would be on the product but the whole process involved around the product encompassing the manufacturing process as well. The main focus of a lot of meetings I would host would be identify unacceptable risk first and then work my way down in severity.
    It would also be important to get buy in subject matter experts not directly involved in the project to provide an outside perspective view on determining potential hazards with the product. Ultimately my main goals for the majority of risk management meetings would be to determine potential hazards and assess those risks. Once there is visibility to those risks, designation can be provided to individuals to work on risk mitigation that can then be discussed with the broader team during risk mitigation meetings.