CMDA ASQ Practice Questions

Question #6 (Topic: Demo Questions)

When applying the elements of CAPA, which of the following is critical in ensuring the effectiveness of corrective actions? Response:

A.

Prioritizing actions based on financial impact

B.

Focusing on actions with the easiest implementation

C.

Prioritizing actions based on risk

D.

Assigning responsibility based on department seniority

Correct Answer: C

Explanation not available for this question.

Question #7 (Topic: Demo Questions)

In preparing for an audit, which aspects are crucial? (Choose two) Response:

A.

Deciding on the lunch menu

B.

Choosing the color of the audit report cover

C.

Establishing the audit type

D.

Verifying audit authority

Correct Answer: C, D

Explanation not available for this question.

Question #8 (Topic: Demo Questions)

FDA CPG 7382.845 is critical for understanding the FDA's criteria for _______ based on quality system audit results. Response:

A.

regulatory action

B.

market approval

C.

financial penalties

D.

product recalls

Correct Answer: A

Explanation not available for this question.

ASQ CMDA - Certified Medical Device Auditor Certification Exam

When applying the elements of CAPA, which of the following is critical in ensuring the effectiveness of corrective actions? Response:

Prioritizing actions based on financial impact

Focusing on actions with the easiest implementation

Prioritizing actions based on risk

Assigning responsibility based on department seniority

Correct Answer: C

In preparing for an audit, which aspects are crucial? (Choose two) Response:

Deciding on the lunch menu

Choosing the color of the audit report cover

Establishing the audit type

Verifying audit authority

Correct Answer: C, D

FDA CPG 7382.845 is critical for understanding the FDA's criteria for _______ based on quality system audit results. Response:

regulatory action

market approval

financial penalties

product recalls

Correct Answer: A