CAPA Regulatory Compliance & Quality Standards 3 — Questions and Answers
Question 1: What distinguishes a preventive action from a corrective action in a CAPA system?
- Preventive action addresses actual nonconformities while corrective action addresses potential ones
- Preventive action addresses potential nonconformities before they occur while corrective action addresses existing ones (Correct answer)
- Preventive action is only required by ISO standards, not FDA regulations
- Preventive action requires management approval while corrective action does not
Correct answer: Preventive action addresses potential nonconformities before they occur while corrective action addresses existing ones
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?
- Reopening the nonconformance report
- Implementing and verifying effectiveness of the root cause corrective action (Correct answer)
- Notifying the customer of the defect
- Placing the affected components on quarantine hold
Correct answer: Implementing and verifying effectiveness of the root cause corrective action
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?
- Employee satisfaction surveys
- Processes, work operations, concessions, quality audit reports, quality records, service records, and complaints (Correct answer)
- Financial audit reports and budget variance data
- Marketing analytics and sales trend data
Correct answer: Processes, work operations, concessions, quality audit reports, quality records, service records, and complaints
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:
- Assign a financial cost to every nonconformity before initiating CAPA
- Prioritize corrective actions based on the risk and impact of nonconformities (Correct answer)
- Eliminate all risks before a product can be released to market
- Replace CAPA with a risk register as the primary quality tool
Correct answer: Prioritize corrective actions based on the risk and impact of nonconformities
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:
- Acceptable performance if all CAPAs are documented
- An inadequate CAPA system that may result in FDA citations for systemic quality failures (Correct answer)
- Compliance with regulations since no time limits are specified
- A sign of thorough investigation methodology
Correct answer: An inadequate CAPA system that may result in FDA citations for systemic quality failures
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.
Question 6: Which element is NOT typically part of a compliant CAPA record under major quality standards (ISO 9001, ISO 13485, 21 CFR Part 820)?
- Description of the nonconformity or potential nonconformity
- Root cause analysis documentation
- Estimated financial impact of the defect on company revenue (Correct answer)
- Verification of effectiveness of actions taken
Correct answer: Estimated financial impact of the defect on company revenue
Regulatory standards require description of the problem, root cause analysis, actions taken, and effectiveness verification — financial impact analysis is not a required CAPA record element.
Question 7: Under EU MDR 2017/745 Article 83, manufacturers must establish a PMCF plan. How does this relate to CAPA?
- PMCF replaces CAPA for Class I devices
- PMCF data serves as proactive input to identify potential nonconformities and trigger preventive actions (Correct answer)
- PMCF is only required for Class III devices and has no CAPA linkage
- PMCF documents are submitted to Notified Bodies instead of CAPA records
Correct answer: PMCF data serves as proactive input to identify potential nonconformities and trigger preventive actions
Post-Market Clinical Follow-up (PMCF) systematically collects clinical data post-market, which feeds into the PMS system and can trigger preventive CAPA when trends are identified.
CAPA Regulatory Compliance & Quality Standards 3
What distinguishes a preventive action from a corrective action in a CAPA system?