Risk Assessment & Prioritization Flashcards

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

Answer: Stop the process or quarantine affected product and initiate urgent CAPA

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

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

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

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

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

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

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

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

Answer: Initiate a preventive action CAPA based on the identified trend risk

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

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

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

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

When using Fault Tree Analysis (FTA) in CAPA risk assessment, what is the starting point of the analysis?

Answer: The undesired top-level event (the failure or nonconformance)

FTA begins with the undesired top-level event and works downward to identify all potential contributing causes through logical AND/OR gates.

A CAPA effectiveness check shows that the RPN dropped from 280 to 40 after implementing corrective actions. What does this indicate?

Answer: The corrective actions were highly effective and residual risk is now at an acceptable level

A dramatic RPN reduction from 280 to 40 demonstrates that severity, occurrence, or detection improved significantly, confirming effective corrective action.