CAPA Risk Assessment & Prioritization 2 — Questions and Answers
Question 1: In a Risk Priority Number (RPN) calculation, which three factors are multiplied together?
- Severity, Occurrence, Detection (Correct answer)
- Likelihood, Impact, Controllability
- Frequency, Consequence, Mitigation
- Probability, Exposure, Vulnerability
Correct answer: Severity, Occurrence, Detection
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?
- The one with RPN 250 (Correct answer)
- The one with RPN 120
- Both simultaneously
- The one discovered first
Correct answer: The one with RPN 250
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?
- Risk matrix (Correct answer)
- Fault tree analysis
- Pareto chart
- Fishbone diagram
Correct answer: Risk matrix
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?
- A defect that could cause patient death (Correct answer)
- A defect causing minor cosmetic blemish
- A defect resulting in a customer complaint
- A defect requiring product relabeling
Correct 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.
Question 5: What does a low 'Detection' score in FMEA indicate?
- The failure is very likely to be detected before reaching the customer (Correct answer)
- The failure is unlikely to be caught in time
- Detection controls are absent
- The defect is minor and easily ignored
Correct 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.
Question 6: A quality manager wants to focus CAPA resources on the most common defect causes. Which tool best supports this prioritization?
- Pareto chart (Correct answer)
- Control chart
- Scatter diagram
- Gantt chart
Correct 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.
Question 7: Which factor is NOT typically part of a standard risk assessment in a CAPA context?
- Employee tenure length (Correct answer)
- Probability of recurrence
- Severity of impact
- Detectability of the issue
Correct answer: Employee tenure length
Employee tenure is not a standard risk factor; CAPA risk assessments focus on severity, probability, and detectability of nonconformances.
CAPA Risk Assessment & Prioritization 2
In a Risk Priority Number (RPN) calculation, which three factors are multiplied together?