CAPA Regulatory Compliance & Quality Standards 2

Question 1

Under 21 CFR Part 820, what is the primary purpose of the CAPA subsystem within a Quality Management System?

Accepted Answer

To identify and eliminate root causes of nonconformities and prevent their recurrence

Answer

21 CFR Part 820.100 requires CAPA to analyze data, identify nonconformities, investigate root causes, implement corrections, and verify effectiveness.

Question 2

Which ISO 9001:2015 clause specifically addresses corrective action requirements?

Accepted Answer

Clause 10.2 — Nonconformity and Corrective Action

Answer

ISO 9001:2015 Clause 10.2 mandates that organizations take action to control nonconformities, determine root causes, and implement corrections to prevent recurrence.

Question 3

A medical device manufacturer receives an FDA Warning Letter citing inadequate CAPA procedures. Which regulation most directly applies?

Accepted Answer

21 CFR Part 820.100

Answer

21 CFR Part 820.100 is the FDA Quality System Regulation (QSR) section that specifically governs CAPA requirements for medical device manufacturers.

Question 4

In the context of EU MDR 2017/745, what term is used for the ongoing process that feeds data into CAPA?

Accepted Answer

Post-Market Surveillance (PMS)

Answer

EU MDR 2017/745 requires Post-Market Surveillance (PMS) as a proactive process that gathers real-world data to feed back into CAPA and design improvements.

Question 5

An organization implementing ISO 13485:2016 must ensure CAPA is proportionate to what factor?

Accepted Answer

The magnitude of the problem and the risk it presents

Answer

ISO 13485:2016 Clause 8.5.2 specifies that corrective action shall be appropriate to the effects of the nonconformities encountered, including the associated risk.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Regulatory Compliance & Quality Standards 2