CAPA Investigation Techniques 2

Question 1

Which technique involves asking 'why' repeatedly until the fundamental cause of a problem is identified?

Accepted Answer

5 Whys

Answer

The 5 Whys technique iteratively asks 'why' (typically five times) to drill down from symptoms to root causes.

Question 2

In a CAPA investigation, what is the primary purpose of a Fault Tree Analysis (FTA)?

Accepted Answer

To map all possible causes leading to an undesired top event using logic gates

Answer

FTA uses Boolean logic gates to systematically map combinations of failures or events that can lead to a defined top-level undesired outcome.

Question 3

When conducting a failure investigation, 'preservation of evidence' is critical primarily because:

Accepted Answer

Physical evidence may degrade or be lost, making root cause identification impossible later

Answer

Evidence preservation ensures that physical samples, conditions, and data are secured before they can degrade, be altered, or discarded, which is essential for accurate root cause analysis.

Question 4

A 'contributing cause' in a CAPA investigation is best described as:

Accepted Answer

A factor that increased the likelihood or severity of the problem but did not cause it alone

Answer

Contributing causes are factors that worsen or facilitate a problem but are not the direct root cause; addressing them strengthens corrective actions.

Question 5

Which investigation approach is MOST appropriate when a problem involves complex interactions among multiple subsystems?

Accepted Answer

Fault Tree Analysis

Answer

FTA excels at revealing how combinations of subsystem failures interact through logic gates to produce a top-level failure in complex systems.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Investigation Techniques 2