CAPA Regulatory Requirements & Standards 3

Question 1

Under ISO 9001:2015, how is 'preventive action' formally addressed compared to earlier versions of the standard?

Accepted Answer

It is absorbed into risk-based thinking throughout the standard rather than a separate clause

Answer

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?

Accepted Answer

IATF 16949 mandates specific problem-solving methods and containment actions within defined timeframes

Answer

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?

Accepted Answer

CAPA as defined in 21 CFR 211.192 investigations

Answer

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?

Accepted Answer

Complaint intake → evaluate for reportability → investigate → implement corrective action → verify effectiveness

Answer

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?

Accepted Answer

All activities required under 820.100(a) including investigation, root cause, actions taken, and results

Answer

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.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Regulatory Requirements & Standards 3