To add to previous posts on this forum, an approach I have seen is to breakdown risk analysis in three parts; design, manufacturing, and use of finished product. These analyses may involve experts from each area of focus, for example; the risk analysis related to design would include engineers involved in the design of the device to identify ways or modes in which the design might fail, the manufacturing risk analysis would include assembly and automation engineers involved in the device manufacturing process to identify ways or modes in which a failure in the process could lead to a device malfunction, and risk analysis would involve human factors experts assessing use errors i.e. critical and important tasks users need to perform in order to safely use the finished product and consequences in case these tasks are not performed as per the product intended use. Once the failure modes/ use errors are identified they are prioritized based on the company risk criteria and acceptability which is usually defined upfront as part of the risk management plan.