This is a great discussion topic! I believe many of the failures in risk assessment can come from a lack of resources within the company. By resources I mean information and or the personnel required to adequately provide an honest assessment to the medical device. An example would be a poorly managed complaints department at a medical device company. If you are doing a risk assessment and the complaints department is a year behind (I’ve personally seen this), how can you make an adequate risk assessment of your product? How would you know how your current manufacturing process and external factors are affecting the risk level? Maybe your product has already crossed a risk threshold requiring a CAPA but you would only know about in the next review process.