Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Risk scoring has been, historically, a significant part of many risk management activities. It is a method for evaluating which risks are the most critical to control. Successive scoring of risk controls allows teams to see how the level of risk on the evaluated design, process, function, operation, etc. may improve over time. Within risk exercises such as failure modes effects analysis (FMEA), risk scoring is a multiplicative process involving three factors: severity of harm (S), probability of occurrence (O), and detectability (D). These will yield a risk priority number (RPN) that, depending on the guidelines a business has in place, will determine whether a risk is acceptable or requires risk control measures. Because these scores are often expressed on scales between 1 and 10 (least to greatest), the RPN for FMEAs has a potential scoring range between 1 and 1,000.