CAPA Preventive Action Implementation 2

Question 1

Which tool is MOST commonly used in the proactive identification of potential failure modes during preventive action planning?

Accepted Answer

Failure Mode and Effects Analysis (FMEA)

Answer

FMEA proactively identifies potential failure modes and their effects before a nonconformance occurs, making it a cornerstone of preventive action.

Question 2

When performing a risk assessment as part of preventive action, which factor determines the priority risk number (PRN) in an FMEA?

Accepted Answer

Severity × Occurrence × Detection

Answer

The Risk Priority Number (RPN) in FMEA is calculated by multiplying Severity, Occurrence, and Detection scores.

Question 3

A preventive action plan should include which of the following elements as a minimum?

Accepted Answer

Action item, owner, due date, and verification method

Answer

A complete preventive action plan requires defined actions, assigned ownership, target dates, and a method to verify effectiveness.

Question 4

Which quality management system standard explicitly requires organizations to determine actions to address risks and opportunities as a form of preventive action?

Accepted Answer

ISO 9001:2015

Answer

ISO 9001:2015 replaced the traditional 'preventive action' clause with risk-based thinking, requiring actions to address risks and opportunities.

Question 5

During preventive action implementation, what is the purpose of a pilot or trial run before full deployment?

Accepted Answer

To validate that the proposed action effectively mitigates the identified risk

Answer

A pilot run validates the preventive action's effectiveness on a small scale before committing to full organizational deployment.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Preventive Action Implementation 2