Question 6 of 6 Advanced Scenario
How would you prioritize CAPA actions by risk?
Short answer
Prioritize controls according to credible patient and product harm, likelihood of exposure, available detection mechanisms and uncertainty, while meeting all mandatory regulatory duties.
Why
A sterile-fill barrier problem threatens contamination control and may need rapid containment before a lower-severity documentation correction. Evaluate affected lots, potential harm, route of exposure, ability to detect failure and recurrence history. Assign immediate containment separately from permanent remediation, and give high-risk actions clear accountable owners and due dates.
Risk ranking tools can support transparent decisions but should not reduce complexity to a single arbitrary score. Where evidence is weak, conservative controls or additional study may be warranted. Communicate residual risk, resource tradeoffs and triggers for escalation.
After implementation, assess whether prioritized actions worked without shifting the burden to another failure mode. Low risk does not justify noncompliance with a binding requirement.
Common mistakes
- Using a numerical risk matrix to argue that a statutory requirement can be postponed indefinitely
The interviewer might ask next
How would you decide between two high-severity actions with different levels of uncertainty?