CAPA Preventive Action Implementation 3

Question 1

Which statistical tool is BEST suited for identifying whether a process trend signals a potential future nonconformance requiring preventive action?

Accepted Answer

Control chart with run rules

Answer

Control charts with Western Electric or Nelson run rules detect non-random patterns that signal a process trending toward nonconformance before it occurs.

Question 2

When implementing preventive actions, who bears primary responsibility for verifying that the action was effective?

Accepted Answer

The action owner or designated process owner

Answer

The action owner or designated process owner is accountable for confirming that the preventive action achieved its intended risk mitigation.

Question 3

An organization's internal audit finds that preventive actions are being opened but never closed. Which systemic issue does this MOST likely indicate?

Accepted Answer

Lack of defined effectiveness verification criteria and follow-up process

Answer

Open preventive actions without closure typically signal that effectiveness verification criteria are undefined or follow-up accountability is absent.

Question 4

Which of the following BEST represents a leading indicator used to trigger preventive action?

Accepted Answer

Equipment vibration readings trending upward before failure

Answer

A leading indicator like rising equipment vibration predicts a future failure, allowing preventive action before the failure occurs.

Question 5

During preventive action implementation, why is it important to communicate the action plan to all affected personnel?

Accepted Answer

To ensure all stakeholders understand their roles and the changes being implemented

Answer

Communicating the plan ensures all affected personnel understand role changes, new procedures, and the importance of the preventive measure.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Preventive Action Implementation 3