CAPA Regulatory Compliance & Quality Standards 2 — Questions and Answers
Question 1: Under 21 CFR Part 820, what is the primary purpose of the CAPA subsystem within a Quality Management System?
- To document all product defects for annual reporting
- To identify and eliminate root causes of nonconformities and prevent their recurrence (Correct answer)
- To train employees on quality procedures
- To manage supplier qualification records
Correct answer: To identify and eliminate root causes of nonconformities and prevent their recurrence
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?
- Clause 8.3 — Design and Development
- Clause 9.1 — Monitoring and Measurement
- Clause 10.2 — Nonconformity and Corrective Action (Correct answer)
- Clause 6.1 — Actions to Address Risks
Correct answer: Clause 10.2 — Nonconformity and Corrective Action
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?
- 21 CFR Part 11
- 21 CFR Part 820.100 (Correct answer)
- 21 CFR Part 211.192
- 21 CFR Part 600
Correct answer: 21 CFR Part 820.100
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?
- Vigilance Reporting
- Post-Market Surveillance (PMS) (Correct answer)
- Technical Documentation Review
- Notified Body Audit
Correct answer: Post-Market Surveillance (PMS)
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?
- The cost of remediation
- The magnitude of the problem and the risk it presents (Correct answer)
- The number of complaints received
- The time elapsed since the nonconformity was detected
Correct answer: The magnitude of the problem and the risk it presents
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.
Question 6: Which FDA enforcement action most commonly results from systemic CAPA failures in pharmaceutical manufacturing?
- Establishment Inspection Report (EIR)
- 483 Observation or Warning Letter citing 21 CFR Part 211 (Correct answer)
- Voluntary Action Indicated (VAI) classification
- Pre-Approval Inspection hold
Correct answer: 483 Observation or Warning Letter citing 21 CFR Part 211
Systematic CAPA failures in pharma facilities under 21 CFR Part 211 (cGMP) are a leading cause of FDA 483 observations and Warning Letters.
Question 7: Under IATF 16949:2016 for automotive quality systems, what additional requirement distinguishes its CAPA process from ISO 9001:2015?
- IATF 16949 requires CAPA only for customer complaints, not internal audits
- IATF 16949 mandates error-proofing (poka-yoke) as a preferred corrective action method (Correct answer)
- IATF 16949 eliminates the need for root cause analysis on minor nonconformities
- IATF 16949 requires corrective actions to be completed within 24 hours
Correct answer: IATF 16949 mandates error-proofing (poka-yoke) as a preferred corrective action method
IATF 16949 places strong emphasis on error-proofing (poka-yoke) techniques as preferred solutions in corrective action to prevent recurrence mechanically rather than relying on human vigilance.
CAPA Regulatory Compliance & Quality Standards 2
Under 21 CFR Part 820, what is the primary purpose of the CAPA subsystem within a Quality Management System?