CAPA Effectiveness Verification 3

Question 1

A pharmaceutical company uses a 'resampling approach' for CAPA effectiveness. What does this typically involve?

Accepted Answer

Collecting new product samples and testing them against original specifications after corrective actions

Answer

Resampling involves testing new production lots under the improved process to confirm that nonconforming results no longer occur.

Question 2

Which of the following best describes a 'leading indicator' for CAPA effectiveness?

Accepted Answer

Process parameter trending within control limits before failure recurs

Answer

Leading indicators like in-process parameter trends provide early signals of process stability before the failure can recur, unlike lagging indicators such as complaint counts.

Question 3

An FDA investigator asks to see effectiveness verification records for a closed CAPA. The company cannot produce them. What is the likely outcome?

Accepted Answer

This is documented as a 483 observation or warning letter finding

Answer

Inability to provide objective evidence of effectiveness verification is a recordkeeping failure that FDA investigators cite as an observation under 21 CFR Part 820.

Question 4

A company defines CAPA effectiveness as 'no recurrence for 90 days.' After 85 days with no recurrence the issue reappears. What should the quality team do?

Accepted Answer

Mark the effectiveness check as failed and reinvestigate

Answer

The predefined criterion was not met, so the effectiveness check must be documented as failed and the root cause analysis should be reinvestigated.

Question 5

What is the role of statistical process control (SPC) charts in CAPA effectiveness verification?

Accepted Answer

To provide visual, ongoing evidence that a process remains in control after corrective actions

Answer

SPC charts show whether the process has shifted to a new, stable, and improved state after corrective actions, providing ongoing objective evidence of sustained effectiveness.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Effectiveness Verification 3