English to Russian Medical Medical (general)

Design FMEA

RISK PRIORITY NUMBER (RPN): The combination of probability of occurrence, severity and detectability: RPN for pFMEA = Severity X Occurrence X Detectability
The RPN should be used for guidance only. It is the responsibility of the FMEA team to determine which failure modes to address, using their best judgment. The RPN should be used to identify initial candidates for consideration. Severity level of 5 or RPN numbers above 80 require reduction action or Risks and Benefit analysis attached to the worksheet. RPN numbers do drive Confidence % and Reliability % for use in determining sample sizes.