Using Production And Postmarket Data To Validate FMEA Assumptions
Using Production And Postmarket Data To Validate FMEA Assumptions By Mark Durivage, Quality Systems Compliance LLC Failure mode and effects analysis (FMEA) risk priority number (RPN) scores have traditionally been used to quantify risks for users, designs, and processes. Recently, action priority (AP) tables were introduced as an alternative method to compute relative risk. One common issue with regulatory agencies and certification bodies regarding FMEA is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probabil...
Source: meddeviceonline.com