Risk Assessment & Prioritization Flashcards

In a Risk Priority Number (RPN) calculation, which three factors are multiplied together?

Answer: Severity, Occurrence, Detection

RPN = Severity × Occurrence × Detection, a core FMEA-based risk scoring method used in CAPA prioritization.

A CAPA team discovers two nonconformances: one with RPN 120 and one with RPN 250. Which should be addressed first?

Answer: The one with RPN 250

Higher RPN indicates greater combined risk, so the nonconformance with RPN 250 takes priority for corrective action.

Which risk assessment method uses a grid to plot likelihood against consequence to visualize overall risk level?

Answer: Risk matrix

A risk matrix (probability-consequence matrix) plots likelihood on one axis and consequence on the other to assign risk levels visually.

When assessing severity in FMEA for a medical device CAPA, which scenario would receive the highest severity rating?

Answer: A defect that could cause patient death

Severity ratings peak when a failure mode can result in patient harm or death, especially in regulated medical device environments.

What does a low 'Detection' score in FMEA indicate?

Answer: The failure is very likely to be detected before reaching the customer

In FMEA, a low detection number (e.g., 1-2) means existing controls are very effective at catching the failure before it escapes.

A quality manager wants to focus CAPA resources on the most common defect causes. Which tool best supports this prioritization?

Answer: Pareto chart

A Pareto chart applies the 80/20 rule, showing which defect causes account for the majority of problems so teams can prioritize effectively.

Which factor is NOT typically part of a standard risk assessment in a CAPA context?

Answer: Employee tenure length

Employee tenure is not a standard risk factor; CAPA risk assessments focus on severity, probability, and detectability of nonconformances.