CAPA Regulatory Requirements & Standards 3 — Questions and Answers
Question 1: Under ISO 9001:2015, how is 'preventive action' formally addressed compared to earlier versions of the standard?
- It is expanded with a dedicated clause 8.7
- It is absorbed into risk-based thinking throughout the standard rather than a separate clause (Correct answer)
- It is renamed 'continual improvement' and moved to clause 10
- It requires a documented procedure unlike earlier versions
Correct answer: It is absorbed into risk-based thinking throughout the standard rather than a separate clause
ISO 9001:2015 replaced the standalone preventive action clause with risk-based thinking (Clause 6.1), embedding preventive intent throughout the entire management system.
Question 2: Which IATF 16949 requirement distinguishes automotive CAPA from standard ISO 9001:2015 corrective action?
- IATF 16949 requires CAPA only for warranty claims
- IATF 16949 mandates specific problem-solving methods and containment actions within defined timeframes (Correct answer)
- IATF 16949 allows verbal approval for CAPA closure
- IATF 16949 requires CAPA only when the customer requests it
Correct answer: IATF 16949 mandates specific problem-solving methods and containment actions within defined timeframes
IATF 16949 Clause 10.2.3 specifies requirements for problem-solving methods and containment actions with customer-defined response timelines.
Question 3: Under 21 CFR Part 211 (pharmaceutical cGMP), what term is used for the process most analogous to CAPA in the medical device world?
- Out-of-Specification (OOS) investigation
- Change Control
- CAPA as defined in 21 CFR 211.192 investigations (Correct answer)
- Deviation Report
Correct answer: CAPA as defined in 21 CFR 211.192 investigations
21 CFR 211.192 requires investigation of failures and discrepancies, which functions as the pharmaceutical equivalent of a CAPA system, though 21 CFR Part 211 uses the term 'investigation.'
Question 4: An ISO 13485-certified company receives a customer complaint about a sterile device failure. Which sequence best reflects regulatory requirements?
- Close complaint → open CAPA → notify regulators
- Complaint intake → evaluate for reportability → investigate → implement corrective action → verify effectiveness (Correct answer)
- Notify regulators → close complaint → conduct audit
- Open CAPA immediately → close complaint → submit PMS report
Correct answer: Complaint intake → evaluate for reportability → investigate → implement corrective action → verify effectiveness
ISO 13485 Clause 8.2.2 and 8.5.2 together require complaint evaluation, potential regulatory reporting assessment, root cause investigation, corrective action, and effectiveness verification in sequence.
Question 5: What does 21 CFR 820.100(b) require manufacturers to document regarding CAPA activities?
- Only the corrective action taken
- All activities required under 820.100(a) including investigation, root cause, actions taken, and results (Correct answer)
- Customer notifications only
- A summary report to FDA within 30 days
Correct answer: All activities required under 820.100(a) including investigation, root cause, actions taken, and results
21 CFR 820.100(b) requires documenting all CAPA activities specified in 820.100(a), creating a complete audit trail of the investigation, findings, actions, and outcomes.
Question 6: Under ICH Q10 (pharmaceutical quality system), which element most closely aligns with CAPA requirements?
- Knowledge management
- CAPA system as a key enabler of the pharmaceutical quality system (Correct answer)
- Change management only
- Senior management review
Correct answer: CAPA system as a key enabler of the pharmaceutical quality system
ICH Q10 Section 3.2 explicitly identifies the CAPA system as one of four key enablers of an effective pharmaceutical quality system.
Question 7: When a CAPA results in a change to a manufacturing process covered by a 510(k), what additional regulatory step is typically required?
- No additional steps are needed once CAPA is closed
- A new or supplemental 510(k) submission may be required if the change could affect safety or effectiveness (Correct answer)
- An IDE submission must be filed
- A PMA must be submitted regardless of the change scope
Correct answer: A new or supplemental 510(k) submission may be required if the change could affect safety or effectiveness
21 CFR 807.81 and FDA's 510(k) change guidance indicate that changes affecting safety or effectiveness may require a new or supplemental 510(k) submission.
CAPA Regulatory Requirements & Standards 3
Under ISO 9001:2015, how is 'preventive action' formally addressed compared to earlier versions of the standard?