-
Viraj D replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices 8 years, 8 months ago
In the current company I work at, we identify risks through a PHMM or Product Hazard and Mitigation Matrix. In these meetings you have directors from R&D, Quality, Manufacturing, and the Medical director discuss the potential applicable product risk management plan. To maintain and organize the risks each description of the harm or hazard/hazardous situation is associated with a Hazard ID, along with the severity of the harm and if it is covered by a Standard. Then the matrix also contains the potential cause of the event that initiates the risk and the foreseeable sequence of events that may occur due to the risk. Next, includes the plan for mitigation on how to prevent the risk from occurring or creating a risk mitigation plan if the event is not preventable before but how to plan post-risk. Then also document if some risks are acceptable or unacceptable.