CAPA Process Fundamentals

Question 1

What is the primary goal of a corrective action in the CAPA process?

Accepted Answer

Eliminate existing nonconformities

Answer

Corrective actions are taken to eliminate the causes of existing nonconformities or other undesirable situations.

Question 2

Which of the following best defines a preventive action?

Accepted Answer

Eliminate causes of potential problems

Answer

Preventive actions aim to eliminate the causes of potential nonconformities to prevent their occurrence.

Question 3

What is typically the first step in the CAPA process?

Accepted Answer

Identify and document the problem

Answer

The process begins by identifying and documenting the problem, which is critical to understanding and solving it.

Question 4

Why is root cause analysis important in the CAPA process?

Accepted Answer

To prevent problem recurrence

Answer

Without identifying the root cause, corrective actions may not prevent recurrence of the issue.

Question 5

Which document typically initiates the CAPA process?

Accepted Answer

Nonconformance report

Answer

A nonconformance report (NCR) is a common trigger that begins the CAPA process.

(CAPA) Corrective and Preventive Action Certified Practice Test