CAPA Risk Assessment & Prioritization 2

Question 1

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

Accepted Answer

Severity, Occurrence, Detection

Answer

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

Question 2

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

Accepted Answer

The one with RPN 250

Answer

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

Question 3

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

Accepted Answer

Risk matrix

Answer

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

Question 4

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

Accepted Answer

A defect that could cause patient death

Answer

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

Question 5

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

Accepted Answer

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

Answer

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

(CAPA) Corrective and Preventive Action Certified Practice Test