Investigation Techniques Flashcards

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

Answer: 5 Whys

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

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

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

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

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

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

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.

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

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

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

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

Answer: Fault Tree Analysis

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

During an investigation interview, open-ended questions are preferred over closed-ended questions because they:

Answer: Encourage the interviewee to provide detailed narrative information

Open-ended questions invite elaboration and narrative responses, uncovering details and context that closed yes/no questions would miss.

The 'escape point' in a root cause analysis refers to:

Answer: The earliest point in the process where the problem could have been detected but was not

The escape point identifies the detection opportunity that was missed, guiding improvements to inspection and monitoring controls.