CAPA Root Cause Analysis Methods 3

Question 1

What distinguishes a 'contributing cause' from a 'root cause' in RCA?

Accepted Answer

A contributing cause increases the likelihood of the problem but alone would not produce it

Answer

A contributing cause is a factor that influences the problem's occurrence but is not sufficient on its own to produce it, unlike the root cause.

Question 2

In Failure Mode and Effects Analysis (FMEA), the Risk Priority Number (RPN) is calculated as:

Accepted Answer

Severity × Occurrence × Detection

Answer

RPN is the product of Severity, Occurrence, and Detection ratings, each scored on a 1–10 scale, to prioritize failure modes for corrective action.

Question 3

An affinity diagram is most useful in the RCA process when:

Accepted Answer

Organizing large volumes of qualitative ideas or data into logical groupings

Answer

Affinity diagrams help teams organize brainstormed ideas or data points into natural groupings to reveal underlying themes or root cause categories.

Question 4

Which statement best describes the 'Is / Is Not' method used in RCA?

Accepted Answer

It defines what the problem is and is not to narrow the search for root causes

Answer

The Is/Is Not method systematically defines the boundaries of a problem by specifying where, when, and to what extent the problem does and does not occur.

Question 5

In process failure analysis, a 'latent cause' refers to:

Accepted Answer

An underlying systemic weakness that enables failures to occur and remain undetected

Answer

A latent cause is a dormant systemic flaw — such as inadequate procedures or oversight gaps — that sets the stage for active failures.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Root Cause Analysis Methods 3