CAPA Investigation Techniques 4

Question 1

What is the key limitation of the 5 Whys technique in complex investigations?

Accepted Answer

It may follow only one causal path, missing parallel or interacting root causes

Answer

5 Whys follows a single linear chain of causation and can miss multiple simultaneous root causes or complex interactions between factors.

Question 2

In a CAPA investigation, 'timeline reconstruction' helps investigators by:

Accepted Answer

Establishing the sequence of events to identify when conditions changed and the problem emerged

Answer

A reconstructed timeline reveals the chronological sequence of events, process changes, or environmental shifts that preceded the failure, narrowing root cause candidates.

Question 3

Which investigation technique is MOST effective for identifying failure modes and their effects BEFORE a problem occurs?

Accepted Answer

Failure Mode and Effects Analysis (FMEA)

Answer

FMEA is a proactive risk tool that systematically identifies potential failure modes and their effects before failures occur, making it valuable for preventive action.

Question 4

When sampling nonconforming units for investigation, 'representative sampling' means:

Accepted Answer

Choosing samples that reflect the range and distribution of the total nonconforming population

Answer

Representative sampling ensures that conclusions drawn from the sample accurately reflect the broader nonconforming population, avoiding biased root cause findings.

Question 5

In an investigation, 'physical evidence analysis' (e.g., metallurgical testing, SEM imaging) is most critical when:

Accepted Answer

The root cause hypothesis cannot be confirmed through records or interviews alone

Answer

Physical analysis techniques provide objective material evidence that confirms or refutes proposed root causes when document review and interviews are insufficient.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Investigation Techniques 4