CAPA Root Cause Analysis & Investigation Techniques

Question 1

What is the purpose of root cause analysis in the CAPA process?

Accepted Answer

Find the underlying reason for a problem

Answer

Root cause analysis is used to identify the underlying cause of a nonconformity to prevent recurrence.

Question 2

Which of the following tools is commonly used in root cause analysis?

Accepted Answer

Fishbone Diagram

Answer

The Fishbone Diagram helps visualize and categorize possible causes of a problem, supporting systematic analysis.

Question 3

Which technique is used to drill down through layers of symptoms to find the root cause?

Accepted Answer

5 Whys

Answer

The '5 Whys' technique involves asking 'why' multiple times to explore the cause-and-effect relationships.

Question 4

What is the benefit of a multidisciplinary team in CAPA investigations?

Accepted Answer

Ensures broader analysis of issues

Answer

A multidisciplinary team brings diverse perspectives and expertise, improving the accuracy and completeness of the investigation.

Question 5

Which factor is most important when selecting a root cause analysis method?

Accepted Answer

Issue complexity

Answer

The complexity of the issue should guide the choice of RCA method to ensure it effectively uncovers the true root cause.

(CAPA) Corrective and Preventive Action Certified Practice Test