Investigation Techniques Flashcards

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

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

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

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

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

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

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

Answer: Failure Mode and Effects Analysis (FMEA)

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

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

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

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

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

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

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

A 'proximate cause' differs from a 'root cause' in that the proximate cause is:

Answer: The immediate, direct cause that produced the nonconformance

The proximate cause is the direct trigger of the failure, while the root cause is the deeper systemic reason that allowed or created the condition for the proximate cause to act.

Which of the following BEST supports the principle of 'going to the gemba' during a CAPA investigation?

Answer: Physically observing the actual process at the location where the problem occurred

Going to the gemba (the actual place of work) allows investigators to observe real conditions, identify anomalies, and gather firsthand evidence not captured in records.