Risk Assessment & Prioritization Flashcards
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Read the first 7 Risk Assessment & Prioritization flashcards as text
When a risk assessment reveals that a nonconformance has high severity but very low probability of recurrence, what is the most appropriate CAPA response?
Answer: Still investigate thoroughly because the potential impact justifies it
High severity demands investigation regardless of low probability; potential harm to patients or customers justifies thorough corrective action.
Which risk prioritization approach aligns best with FDA 21 CFR Part 820 expectations for medical device CAPAs?
Answer: Risk-based prioritization using severity, probability, and detectability
FDA 21 CFR Part 820 requires that CAPA processes reflect the degree of risk associated with the nonconformance, consistent with severity/probability/detectability frameworks.
A risk assessment matrix labels a risk as 'tolerable.' What does this typically mean for CAPA planning?
Answer: Controls should be maintained and monitored, but immediate escalation is not required
Tolerable risks fall in a middle zone where existing controls are adequate for now but should be monitored and reviewed periodically.
How does Failure Mode and Effects Analysis (FMEA) support CAPA prioritization?
Answer: It quantifies risk for each failure mode so teams can rank and address the highest-risk issues first
FMEA assigns RPNs to each failure mode, enabling objective, data-driven ranking of CAPA priorities.
A CAPA team is deciding how much investigation effort to invest. Which principle should guide their decision?
Answer: Effort should be proportional to the risk level of the nonconformance
Risk-based CAPA management requires that investigation depth and resource allocation scale with the severity and probability of harm.
What is the purpose of re-evaluating risk after a corrective action has been implemented?
Answer: To confirm the residual risk is acceptable and the action was effective
Post-implementation risk re-evaluation verifies that the corrective action actually reduced risk to an acceptable level (residual risk assessment).
Which scenario represents a situation where a preventive action (PA) rather than a corrective action (CA) is most appropriate?
Answer: A risk assessment identifies a potential failure mode in a new process before any defects have occurred
Preventive actions are triggered by risk assessments of potential issues—not actual events—making a pre-failure risk finding the ideal PA trigger.
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