CAPA Root Cause Analysis & Investigation Techniques 2

Question 1

Which RCA tool uses a structured tree diagram to display all possible causes of a problem, branching from general to specific?

Accepted Answer

Fault Tree Analysis

Answer

Fault Tree Analysis (FTA) uses a top-down tree diagram to map all potential causes leading to an undesired event.

Question 2

In a 5 Whys analysis, what is the primary risk if the investigation stops too early?

Accepted Answer

Identifying a symptom rather than the true root cause

Answer

Stopping prematurely in 5 Whys leads to treating a symptom or contributing factor instead of the actual root cause.

Question 3

What does the 'M' for 'Methods' represent in a cause-and-effect (Ishikawa) diagram applied to a manufacturing defect?

Accepted Answer

The procedures, work instructions, or processes followed during production

Answer

In the 6M framework, 'Methods' refers to the standard operating procedures, work instructions, and processes involved.

Question 4

When conducting a timeline analysis during an investigation, what is the primary objective?

Accepted Answer

To reconstruct the sequence of events leading up to the nonconformance

Answer

Timeline analysis reconstructs the chronological sequence of events to identify when and how the problem originated.

Question 5

Which of the following best describes the concept of 'escape point' in root cause analysis?

Accepted Answer

The last point in the process where the defect could have been detected but was not

Answer

The escape point identifies the detection failure — the last opportunity where the defect should have been caught.

(CAPA) Corrective and Preventive Action Certified Practice Test