ISO AUDITOR CAPA Implementation & Tracking 2 — Questions and Answers
Question 1: During a CAPA audit, you find that corrective actions were implemented but the problem recurred six months later. What does this most likely indicate?
- The root cause was not correctly identified (Correct answer)
- The corrective action was implemented too quickly
- The problem was too complex for a single CAPA
- The verification activity was completed on time
Correct answer: The root cause was not correctly identified
Recurrence of a problem after corrective action typically indicates that the true root cause was not identified and the action addressed only symptoms.
Question 2: Which metric is MOST useful for tracking the effectiveness of a CAPA system over time?
- Number of CAPAs opened per quarter
- Percentage of CAPAs closed on time
- Recurrence rate of corrective actions (Correct answer)
- Average cost per CAPA
Correct answer: Recurrence rate of corrective actions
Recurrence rate directly measures whether corrective actions eliminated root causes, making it the best effectiveness indicator.
Question 3: An organization closes a CAPA without completing the effectiveness check. Under ISO 9001, this is BEST described as:
- An acceptable shortcut if resources are limited
- A nonconformity against clause 10.2 requirements (Correct answer)
- A minor deviation requiring only a note in the record
- Permissible if the initial corrective action was thorough
Correct answer: A nonconformity against clause 10.2 requirements
ISO 9001 clause 10.2.1(f) explicitly requires reviewing the effectiveness of corrective actions taken, making omission a nonconformity.
Question 4: When tracking preventive actions under ISO 9001:2015, an auditor should note that:
- Preventive action is a standalone clause identical to the 2008 version
- Risk-based thinking in clause 6.1 has absorbed the preventive action concept (Correct answer)
- Preventive actions are only required for manufacturing organizations
- The standard now requires a separate preventive action log
Correct answer: Risk-based thinking in clause 6.1 has absorbed the preventive action concept
ISO 9001:2015 replaced the explicit preventive action clause with risk-based thinking embedded throughout the standard, particularly in clause 6.1.
Question 5: A CAPA tracking system shows 45 open corrective actions, with 30 past their due date. What should an auditor recommend first?
- Increase the number of personnel assigned to close CAPAs
- Review prioritization criteria and assess risk of overdue items (Correct answer)
- Extend all due dates by 90 days to reduce overdue count
- Close all low-priority CAPAs without verification
Correct answer: Review prioritization criteria and assess risk of overdue items
Reviewing prioritization and risk assessment ensures that the most critical overdue CAPAs are addressed first rather than just reducing the number.
Question 6: Which of the following BEST demonstrates that a CAPA process is truly preventive rather than reactive?
- CAPAs are opened only after customer complaints are received
- Trend analysis of near-misses triggers CAPAs before failures occur (Correct answer)
- The CAPA log is reviewed annually by top management
- All CAPAs are assigned to the quality department
Correct answer: Trend analysis of near-misses triggers CAPAs before failures occur
Using trend analysis of near-misses to initiate CAPAs represents proactive prevention, which is the intent of risk-based thinking in ISO 9001:2015.
Question 7: During CAPA implementation, an auditor observes that corrective actions are consistently assigned to individuals without authority to change the process. This is MOST likely to cause:
- Faster closure of CAPAs due to reduced bureaucracy
- Ineffective corrective actions and recurring nonconformities (Correct answer)
- Improved cross-functional collaboration
- Reduced CAPA cycle time
Correct answer: Ineffective corrective actions and recurring nonconformities
Assigning CAPAs to people without process authority means they cannot implement systemic changes, leading to superficial fixes and recurrence.
ISO AUDITOR CAPA Implementation & Tracking 2
During a CAPA audit, you find that corrective actions were implemented but the problem recurred six months later.
What does this most likely indicate?