A product risk can be a faulty release mechanism on a drug delivering device. Under FMEA this would be a Concept Design / Hardware risk where we could monitor its probability of failure throughout its development process. Specifically, risk can be monitored with modeling software; designs would be imputed into the software then the software can assess the probability of failure for that design (like Hiren’s post). If failure does occur, we can mitigate it by coming-up with different design concepts then analyze them again by functionality, risk and trade-offs with choosing one over the other. But as Roberto has said nothing is without some risk. Even the methods for evaluating risk like FMEA are not without limitations (especially since its about 60 years old now). The best we can do is lower it as much as possible.