Investigation Techniques Flashcards

What does the 'Is / Is Not' analysis tool help investigators accomplish?

Answer: Sharpen problem definition by contrasting where and when the problem occurs versus where it does not

Is/Is Not analysis narrows the investigation scope by systematically comparing conditions where the problem is present against those where it is absent.

In the context of CAPA investigations, 'systemic root cause' refers to:

Answer: A flaw in a process, system, or management practice that allows failures to occur repeatedly

Systemic root causes reflect weaknesses in underlying systems or processes and must be corrected to prevent recurrence across multiple product lines or processes.

When using a Cause-and-Effect (Fishbone) diagram for a manufacturing defect, which category would 'inadequate training records' fall under?

Answer: Man (People)

Training records relate to the people (Man) category in the 6M fishbone framework, as they reflect personnel competence and qualification.

Which statistical tool is BEST suited for determining whether a process change actually caused an improvement during CAPA verification?

Answer: Control chart

Control charts track process performance over time and can statistically confirm whether a shift in process behavior occurred after a corrective action was implemented.

A thorough CAPA investigation should trace the problem back to its origin primarily to:

Answer: Determine when and where the problem was introduced so containment and correction are accurate

Tracing to the origin pinpoints the exact process step or input where the nonconformance began, enabling targeted and effective corrective actions.

During a CAPA investigation, 'stratification' of data is useful because it:

Answer: Separates data into subgroups to reveal patterns hidden in aggregate data

Stratification breaks data into meaningful subgroups (by shift, operator, machine, etc.) to identify whether the problem is concentrated in a specific subset.

Which of the following BEST describes 'comparative analysis' in failure investigations?

Answer: Analyzing differences between defective and nondefective items to identify distinguishing characteristics

Comparative analysis contrasts failing and passing items to isolate unique factors present only in the defective population, pointing toward root causes.