Activity

  • sjm39 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    For high severity of risk I would use mitigation and avoidance. A device with a high severity risk has the potential to kill or severely harm someone which is not only morally wrong but leads to huge lawsuits. It is important to avoids or mitigate these types of risks as they would cause the most financial loss to a company. I would use acceptance for low severity risks. Acceptance does not reduce the risk and it used when the risk is small and would not effect the project or company much if it does arise. Transference can be used for both high or low severity risks as it deflects the risk to someone else. Another strategy of dealing with risk that has not been mentioned is exploiting the risk. This is used when the risk would have a positive impact. For example, the risk could be that if the item is too popular there would not be enough sales staff to keep up. A company would not want to transfer or stop this from happening, instead they would want to maximize the chances of this risk happening. Exploitation looks for ways to make the positive risk happen or for ways to increase the impact if it does.