CAPA Implementation & Effectiveness Monitoring 3

Question 1

When selecting key performance indicators (KPIs) for CAPA effectiveness monitoring, which characteristic is MOST important?

Accepted Answer

KPIs should be directly linked to the problem statement

Answer

Effectiveness KPIs must be tied to the specific problem described in the CAPA so they can objectively confirm whether the root cause has been eliminated.

Question 2

Which scenario demonstrates an ineffective CAPA implementation despite actions being completed on time?

Accepted Answer

The same defect type recurs within the monitoring period

Answer

Recurrence of the same defect within the monitoring window is a direct indicator that the corrective action failed to eliminate the root cause.

Question 3

A CAPA action plan includes both immediate containment and long-term systemic fixes. During monitoring, which should be tracked separately?

Accepted Answer

Containment effectiveness and systemic fix effectiveness should each have distinct metrics

Answer

Tracking containment and systemic actions with separate metrics ensures each type of action is evaluated appropriately against its own objectives.

Question 4

Under FDA 21 CFR Part 820, what must be documented when verifying that a corrective action was effective?

Accepted Answer

Results of the investigation and any corrective action taken

Answer

21 CFR 820.100 requires documenting the investigation results and the corrective actions taken, including evidence of effectiveness.

Question 5

Which approach BEST supports sustainable CAPA effectiveness after the monitoring period ends?

Accepted Answer

Embedding the corrective measures into the quality management system and standard processes

Answer

Integrating corrective measures into the QMS and standard processes institutionalizes the improvement, reducing dependence on individual vigilance.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Implementation & Effectiveness Monitoring 3