Hi, so here we are talking about two different kinds of Risk Managment Plans. In project management the Risk management plan is how we identify risk throughout the project. At the start of the project the project team will identify potential risks and how that would impact the cost, timeline, or quality of the overall project. They can then create a plan to mitigate risks. For example, if the project included and FDA submission a risk might be that the FDA does not accept the first submission and asks for additional information. What is the likelyhood of that happening? How would this impact cost? timeline? How can we mitigate that risk? Project Risk management plan should be updated throughout the project as new risks are identified.

The second type of Risk Management we are discussing here is product risk management and 14971 is specific to risk management of medical devices. This is a process that will identify risks in the design, process and use of the devices and how these risks would potentially impact a patient. These risks need to be brought down to an acceptable level to reduce the impact to the patient. These risks can be reduced by improving a design or process, implementing quality control procedures, or creating instruction for use to the physician/patient. These risk managment documents which usually include a Risk Managment Plan, PFMEA, DFMEA, AFMEA, and Hazards lists, should also be updated throughout the life of the product and whenever a new risk or failure mode is identified.