CAPA Risk Assessment & Prioritization 5

Question 1

A quality team applies a risk matrix and finds a nonconformance in the 'intolerable' zone. What is the required immediate response?

Accepted Answer

Stop the process or quarantine affected product and initiate urgent CAPA

Answer

Intolerable risk requires immediate containment action to stop potential harm and triggers an urgent, high-priority CAPA response.

Question 2

In a CAPA system, 'risk appetite' refers to:

Accepted Answer

The level of risk an organization is willing to accept in pursuit of its objectives

Answer

Risk appetite defines the threshold of acceptable risk for an organization, guiding which issues require CAPAs and how aggressively they must be addressed.

Question 3

Which action should be taken when multiple CAPAs compete for limited resources and all have similar RPNs?

Accepted Answer

Use secondary criteria such as regulatory impact, customer exposure, or trend data to break ties

Answer

When RPNs are similar, secondary criteria like regulatory risk, customer impact, or trending severity data provide the tie-breaking logic for prioritization.

Question 4

A trend analysis shows a 15% increase in defect rate over three months, but no single event triggered a CAPA. What should happen?

Accepted Answer

Initiate a preventive action CAPA based on the identified trend risk

Answer

Trending data revealing systematic increases in defect rates constitutes a risk signal that warrants a preventive CAPA, even without a single triggering event.

Question 5

Which of the following is a key output of a risk assessment performed during CAPA initiation?

Accepted Answer

A prioritization decision that determines urgency, scope, and depth of investigation required

Answer

At CAPA initiation, risk assessment outputs a prioritization decision—how urgent, how broad, and how deep the investigation needs to be.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Risk Assessment & Prioritization 5