CAPA Investigation Techniques 3

Question 1

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

Accepted Answer

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

Answer

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

Question 2

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

Accepted Answer

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

Answer

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

Question 3

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

Accepted Answer

Man (People)

Answer

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

Question 4

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

Accepted Answer

Control chart

Answer

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

Question 5

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

Accepted Answer

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

Answer

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

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Investigation Techniques 3