CAPA Regulatory Requirements & Standards 2 — Questions and Answers
Question 1: Under 21 CFR Part 820, what is the minimum timeframe a manufacturer must retain CAPA records?
- 1 year
- 2 years from the date of approval or release of the device (Correct answer)
- 5 years
- Until the device is obsolete
Correct answer: 2 years from the date of approval or release of the device
21 CFR 820.198 and 820.100 require records be retained for a period equivalent to the design and expected life of the device, but not less than 2 years from the date of release.
Question 2: Which ISO 13485 clause specifically mandates CAPA procedures for medical device manufacturers?
- Clause 7.5
- Clause 8.5 (Correct answer)
- Clause 6.2
- Clause 5.6
Correct answer: Clause 8.5
ISO 13485:2016 Clause 8.5 covers improvement, including corrective action (8.5.2) and preventive action (8.5.3) requirements.
Question 3: In an FDA inspection, an investigator finds a CAPA was closed before verifying effectiveness. This most likely violates which 21 CFR 820 requirement?
- 820.22 Quality audit
- 820.100(a)(7) Verifying or validating corrective and preventive action (Correct answer)
- 820.50 Purchasing controls
- 820.70 Production controls
Correct answer: 820.100(a)(7) Verifying or validating corrective and preventive action
21 CFR 820.100(a)(7) explicitly requires manufacturers to verify or validate corrective and preventive actions to ensure effectiveness before closure.
Question 4: How does EU MDR 2017/745 differ from the previous MDD regarding CAPA in post-market surveillance?
- EU MDR eliminates CAPA requirements entirely
- EU MDR requires more rigorous and proactive PMS with periodic safety update reports linking to CAPA (Correct answer)
- EU MDR limits CAPA to Class III devices only
- EU MDR allows verbal CAPA documentation
Correct answer: EU MDR requires more rigorous and proactive PMS with periodic safety update reports linking to CAPA
EU MDR 2017/745 mandates robust post-market surveillance systems with Periodic Safety Update Reports (PSURs) that must actively link findings to CAPA activities.
Question 5: Which standard provides guidance for complaint handling that directly feeds the CAPA process in medical device companies?
- ISO 9001:2015
- ISO 13485:2016 Clause 8.2.2 (Correct answer)
- ISO 14971:2019
- IEC 62304
Correct answer: ISO 13485:2016 Clause 8.2.2
ISO 13485:2016 Clause 8.2.2 covers feedback and complaint handling, which serves as a primary input source for triggering CAPA investigations.
Question 6: Under AS9100D (aerospace), how does CAPA differ from its ISO 9001:2015 counterpart?
- AS9100D eliminates preventive action as a separate requirement
- AS9100D adds risk management requirements and first article inspection linkage to CAPA (Correct answer)
- AS9100D requires CAPA only for supplier defects
- AS9100D uses a different 8D format exclusively
Correct answer: AS9100D adds risk management requirements and first article inspection linkage to CAPA
AS9100D integrates risk management and aviation-specific requirements such as first article inspection and FOD prevention into its corrective action framework.
Question 7: An FDA Warning Letter cites a company for not having a 'systematic corrective action' for a recurring nonconformance. Which regulatory principle is most violated?
- The company failed to conduct internal audits
- The company addressed symptoms but not root causes, violating 21 CFR 820.100's systemic approach (Correct answer)
- The company did not notify FDA within 30 days
- The company lacked a quality policy
Correct answer: The company addressed symptoms but not root causes, violating 21 CFR 820.100's systemic approach
21 CFR 820.100 requires a systemic approach that identifies and addresses the root cause, not just the immediate symptom, of nonconformances.
CAPA Regulatory Requirements & Standards 2
Under 21 CFR Part 820, what is the minimum timeframe a manufacturer must retain CAPA records?