CAPA Effectiveness Verification 3 — Questions and Answers
Question 1: A pharmaceutical company uses a 'resampling approach' for CAPA effectiveness. What does this typically involve?
- Collecting new product samples and testing them against original specifications after corrective actions (Correct answer)
- Reviewing historical samples from before the CAPA was initiated
- Asking customers to return samples for retesting
- Testing samples only during the next scheduled audit
Correct answer: Collecting new product samples and testing them against original specifications after corrective actions
Resampling involves testing new production lots under the improved process to confirm that nonconforming results no longer occur.
Question 2: Which of the following best describes a 'leading indicator' for CAPA effectiveness?
- Number of customer complaints received after CAPA closure
- Process parameter trending within control limits before failure recurs (Correct answer)
- Total cost of quality reduction measured annually
- Audit findings count for the year
Correct answer: Process parameter trending within control limits before failure recurs
Leading indicators like in-process parameter trends provide early signals of process stability before the failure can recur, unlike lagging indicators such as complaint counts.
Question 3: An FDA investigator asks to see effectiveness verification records for a closed CAPA. The company cannot produce them. What is the likely outcome?
- The investigator will accept verbal confirmation from the quality director
- This is documented as a 483 observation or warning letter finding (Correct answer)
- The CAPA is automatically considered effective since it was closed
- The investigator will reopen the CAPA on the company's behalf
Correct answer: This is documented as a 483 observation or warning letter finding
Inability to provide objective evidence of effectiveness verification is a recordkeeping failure that FDA investigators cite as an observation under 21 CFR Part 820.
Question 4: A company defines CAPA effectiveness as 'no recurrence for 90 days.' After 85 days with no recurrence the issue reappears. What should the quality team do?
- Count the CAPA as effective because it was nearly 90 days
- Mark the effectiveness check as failed and reinvestigate (Correct answer)
- Extend the monitoring period to 180 days and continue
- Close the CAPA and attribute the recurrence to an unrelated cause
Correct answer: Mark the effectiveness check as failed and reinvestigate
The predefined criterion was not met, so the effectiveness check must be documented as failed and the root cause analysis should be reinvestigated.
Question 5: What is the role of statistical process control (SPC) charts in CAPA effectiveness verification?
- To calculate the financial impact of the original nonconformance
- To provide visual, ongoing evidence that a process remains in control after corrective actions (Correct answer)
- To replace the need for a formal effectiveness check
- To identify new nonconformances unrelated to the CAPA
Correct answer: To provide visual, ongoing evidence that a process remains in control after corrective actions
SPC charts show whether the process has shifted to a new, stable, and improved state after corrective actions, providing ongoing objective evidence of sustained effectiveness.
Question 6: Which scenario would be most appropriate for a short (30-day) effectiveness verification period?
- A recurring customer complaint about a complex assembly defect with unknown root cause
- A documentation error corrected by updating a form and retraining one employee (Correct answer)
- A critical sterility failure in a high-risk medical device
- A systemic calibration program gap affecting 200 instruments
Correct answer: A documentation error corrected by updating a form and retraining one employee
Simple, low-risk administrative corrections with clear, confined scope can have shorter verification windows, whereas complex or high-risk issues require longer observation periods.
Question 7: A CAPA was opened after an internal audit found missing batch records. The corrective action was to add a checklist. After 60 days, all batch records are complete. What additional step should be taken before closing?
- Conduct a follow-up audit of the batch record process to verify sustained compliance (Correct answer)
- Simply note that no new audit findings occurred and close the CAPA
- Ask the process owner to self-certify that records are complete
- Wait for the next annual audit before evaluating effectiveness
Correct answer: Conduct a follow-up audit of the batch record process to verify sustained compliance
A targeted follow-up audit or review of the controlled records provides objective evidence that the checklist is being consistently used and the root cause has been addressed.
CAPA Effectiveness Verification 3
A pharmaceutical company uses a 'resampling approach' for CAPA effectiveness.
What does this typically involve?