CAPA Risk Assessment & Prioritization 3

Question 1

In ISO 9001:2015, what is the primary purpose of risk-based thinking in the context of CAPA?

Accepted Answer

To proactively identify and address potential failures before they occur

Answer

ISO 9001:2015 emphasizes risk-based thinking so organizations proactively prevent nonconformances rather than only reacting after they occur.

Question 2

A CAPA is raised for a recurring contamination event. During risk prioritization, the team determines detection is nearly impossible at current stages. How does this affect priority?

Accepted Answer

It increases priority because low detectability raises the RPN

Answer

Low detectability increases the Detection score in FMEA, which raises the RPN and therefore elevates the CAPA's priority.

Question 3

Which of the following best describes a 'residual risk' in a CAPA context?

Accepted Answer

The remaining risk after corrective controls have been implemented

Answer

Residual risk is what remains after corrective and preventive actions have been applied; it must be evaluated to confirm it is acceptable.

Question 4

A team is using a 5x5 risk matrix. A risk rated 4 for likelihood and 5 for consequence falls into which zone?

Accepted Answer

High (critical) risk zone

Answer

A score of 4×5=20 on a 5×5 matrix (max 25) places the risk in the high/critical zone, requiring immediate CAPA action.

Question 5

What is the correct sequence when prioritizing multiple open CAPAs using risk-based criteria?

Accepted Answer

Assess severity and occurrence, calculate risk scores, rank by score, assign resources accordingly

Answer

Effective CAPA prioritization requires scoring each issue for severity and occurrence, ranking them, and directing resources to highest-risk items first.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Risk Assessment & Prioritization 3