Which of these events typically triggers a CAPA in a quality management system? Response:

Question

Options

• AA scheduled audit with no findings
• BAn observed deviation from standard operating procedures
• CA successful product launch
• DAn annual review meeting

• A
  6% (2)
• B
  78% (28)
• C
  3% (1)
• D
  14% (5)

Explanation

CAPA (Corrective and Preventive Action) is triggered when something goes wrong or deviates from expected standards - exactly what option B describes. An observed deviation from SOPs signals a quality failure or risk that requires investigation, root cause analysis, and corrective action to prevent recurrence.

Why the distractors are wrong:

• A - A scheduled audit with no findings means everything is compliant; there's nothing to correct.
• C - A successful product launch is a positive outcome, not a quality failure requiring remediation.
• D - An annual review meeting is a routine planning/oversight activity, not an event that signals a process breakdown.

Memory tip: Think of CAPA as a problem-response tool. Any time you see a deviation, nonconformance, complaint, or failure - that's a CAPA trigger. If the event is positive or routine (audit pass, successful launch, scheduled meeting), no CAPA is needed. Ask yourself: "Did something go wrong or deviate?" If yes → CAPA.

No community discussion yet for this question.