CAPA CAPA Process & Documentation 3 — Questions and Answers
Question 1: In a CAPA system, 'trend analysis' is best described as:
- A comparison of two competing corrective actions
- Monitoring data over time to detect patterns that may indicate systemic issues (Correct answer)
- A one-time review triggered by a customer complaint
- A financial forecast of quality costs
Correct answer: Monitoring data over time to detect patterns that may indicate systemic issues
Trend analysis involves monitoring quality data over time to identify recurring patterns or worsening conditions that may signal systemic problems requiring preventive action.
Question 2: Which CAPA documentation practice best supports traceability during an FDA inspection?
- Storing all CAPAs in a single shared folder
- Cross-referencing CAPAs to related complaints, audits, and change controls (Correct answer)
- Archiving closed CAPAs in paper files only
- Limiting CAPA access to quality managers
Correct answer: Cross-referencing CAPAs to related complaints, audits, and change controls
Cross-referencing CAPAs to related records such as complaints, audit findings, and change controls creates a traceable chain of evidence that inspectors can follow.
Question 3: A CAPA is classified as 'closed' when:
- The root cause has been identified
- The action plan has been approved by management
- All actions are implemented and effectiveness has been verified (Correct answer)
- The initial containment action is complete
Correct answer: All actions are implemented and effectiveness has been verified
A CAPA can only be closed after all planned actions are implemented and the effectiveness check confirms the root cause has been eliminated and recurrence prevented.
Question 4: What is the purpose of a CAPA log or tracking register?
- To replace individual CAPA records
- To provide a summary view of all open and closed CAPAs for management oversight (Correct answer)
- To document customer complaints only
- To record equipment calibration intervals
Correct answer: To provide a summary view of all open and closed CAPAs for management oversight
A CAPA log provides management with an at-a-glance summary of all CAPAs, their status, risk levels, and owners, enabling oversight and resource allocation.
Question 5: When a CAPA investigation reveals multiple contributing causes, the best documentation approach is to:
- Select the most significant cause and document only that one
- Document all identified contributing causes and address each in the action plan (Correct answer)
- Close the CAPA and open separate ones for each cause
- Escalate to senior management without documenting causes
Correct answer: Document all identified contributing causes and address each in the action plan
All contributing causes identified during investigation should be documented and addressed in the action plan to ensure the CAPA is comprehensive and effective.
Question 6: Which statement about CAPA documentation retention is correct under FDA's QSR?
- CAPA records must be retained for the life of the device plus two years
- CAPA records must be retained for a period equivalent to the design and expected life of the device (Correct answer)
- CAPA records may be discarded after closure
- Retention is optional for preventive actions
Correct answer: CAPA records must be retained for a period equivalent to the design and expected life of the device
Under 21 CFR Part 820, quality records including CAPAs must be retained for a period equivalent to the design and expected life of the device, but not less than 2 years from the date of release.
Question 7: Which tool is most appropriate for visually displaying the hierarchy of causes in a CAPA root cause analysis?
- Pareto chart
- Scatter diagram
- Fishbone (Ishikawa) diagram (Correct answer)
- Control chart
Correct answer: Fishbone (Ishikawa) diagram
A fishbone (Ishikawa) diagram visually maps potential causes across categories such as people, process, equipment, and environment, making it ideal for structured root cause analysis.
CAPA CAPA Process & Documentation 3
In a CAPA system, 'trend analysis' is best described as: