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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 probability of detection assumptions, which leads to inspectional observations and audit findings.
Risk Ranking
FMEA helps quantify and prioritize risk using criticality/severity, occurrence, and detection ratings that are used to determine the level of risk. Criticality/severity (S) is a measure of the seriousness of the possible consequences of a hazard. Probability of occurrence ....

Mark Durivage , Automotive Industry Group , Quality Systems Compliance , Detection Ratings , Occurrence Action Requirements , Priority Number , Occurrence Action , Example Action Priority , தானியங்கி தொழில் குழு , தரம் அமைப்புகள் இணக்கம் , கண்டறிதல் ரேடிஂக்ஸ் , ப்ரையாரிடீ எண் , உதாரணமாக நடவடிக்கை ப்ரையாரிடீ ,