I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of the risk(s) for each hazard. In a three-tiered version, the severity, probability of occurrence, and detectability of each hazard are evaluated, scored, and placed in a hierarchy of “danger of risk” using a cutoff value to identify and assign risk mitigation candidates. Once this evaluation is complete, the team should then focus on risk control and risk reduction and implementation of risk control measure(s), sometimes taking into account risk/benefit analysis and risks arising from risk control measures. The team completes its effort by publishing a risk management report to be used as production and post-production information throughout the product lifecycle. This goes hand-in-hand with the widely accepted PDCA (plan-do-check-act) practices.

-Nicole

http://www.meddeviceonline.com/doc/the-what-why-when-and-how-of-risk-management-for-medical-device-manufacturers-0001