Factors used in the risk assessment using failure mode and effects analysis (FEMA) to access the criticality of process parameters and their impact on process performance and product quality attributes. Match the categories to their correct definitions and then click Submit. Severity The impact of quality attribute on product efficacy and patient safety PRN Score > The probability of quality attributes falling outside acceptable ranges due to a deviation in the unit operation The probability a QA excursion going undetected Detection > Occurrence Risk priority number, multiplication of Severity, Occurrence, and Detection