CAPA Process Fundamentals

Question 1

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

Accepted Answer

Eliminate existing nonconformities

Answer

Prevent future audits

Answer

Improve documentation

Answer

Train new employees

Question 2

Which of the following best defines a preventive action?

Accepted Answer

Eliminate causes of potential problems

Answer

Fix problems after they happen

Answer

Improve product packaging

Answer

Increase process steps

Question 3

What is typically the first step in the CAPA process?

Accepted Answer

Identify and document the problem

Answer

Root cause analysis

Answer

Verification of effectiveness

Answer

Implement training

Question 4

Why is root cause analysis important in the CAPA process?

Accepted Answer

To prevent problem recurrence

Answer

To blame the responsible department

Answer

To meet audit requirements

Answer

To identify training needs

Question 5

Which document typically initiates the CAPA process?

Accepted Answer

Nonconformance report

Answer

Training manual

Answer

Audit schedule

Answer

Supplier contract

Question 6

What should be done after implementing a corrective action?

Accepted Answer

Conduct a verification of effectiveness

Answer

Close the CAPA immediately

Answer

Wait for customer feedback

Answer

Submit it for management review