CAPA Regulatory Compliance & Quality Standards 3

Question 1

What distinguishes a preventive action from a corrective action in a CAPA system?

Accepted Answer

Preventive action addresses potential nonconformities before they occur while corrective action addresses existing ones

Answer

Preventive action is proactive — taken to eliminate causes of potential nonconformities before they occur — while corrective action is reactive, addressing existing problems.

Question 2

An aerospace company operating under AS9100 Rev D identifies a recurring fastener torque issue. Which CAPA step most directly prevents recurrence?

Accepted Answer

Implementing and verifying effectiveness of the root cause corrective action

Answer

AS9100 Rev D requires that after root cause identification, corrective actions must be implemented and their effectiveness verified to ensure the problem does not recur.

Question 3

Under 21 CFR Part 820, which of the following data sources is explicitly required to be analyzed as input to the CAPA process?

Accepted Answer

Processes, work operations, concessions, quality audit reports, quality records, service records, and complaints

Answer

21 CFR Part 820.100(a)(1) specifically lists processes, work operations, concessions, quality audit reports, quality records, service records, and complaints as required CAPA input sources.

Question 4

In ISO 9001:2015, the concept of 'risk-based thinking' most directly influences CAPA by requiring organizations to:

Accepted Answer

Prioritize corrective actions based on the risk and impact of nonconformities

Answer

ISO 9001:2015's risk-based thinking approach requires that CAPA resources and urgency be proportional to the risk and potential impact of identified nonconformities.

Question 5

A pharmaceutical company conducting an internal audit finds that CAPA closure times average 18 months. Under 21 CFR Part 211, this most likely indicates:

Accepted Answer

An inadequate CAPA system that may result in FDA citations for systemic quality failures

Answer

While no specific timeframe is mandated, FDA expects timely CAPA completion; prolonged open CAPAs signal systemic quality system failures and are frequently cited in Warning Letters.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Regulatory Compliance & Quality Standards 3