ISO AUDITOR CAPA Implementation & Tracking 3 — Questions and Answers
Question 1: An auditor reviews a CAPA where the root cause was identified as 'human error.' What should the auditor look for next?
- Evidence that the employee was retrained
- A deeper analysis identifying why the human error occurred (Correct answer)
- Disciplinary records for the responsible employee
- A statement that the error will not happen again
Correct answer: A deeper analysis identifying why the human error occurred
'Human error' is rarely a true root cause; auditors should verify that analysis continued to identify systemic or process-level factors that enabled the error.
Question 2: ISO 9001:2015 requires that corrective action records include which of the following?
- A list of all employees involved in the nonconformity
- The nature of the nonconformity and actions taken (Correct answer)
- Customer approval of the corrective action plan
- Financial impact of the nonconformity
Correct answer: The nature of the nonconformity and actions taken
Clause 10.2.2 requires documented information on the nature of nonconformities and results of corrective actions taken.
Question 3: A supplier delivers nonconforming product three times in six months. Under a robust CAPA system, what action is MOST appropriate?
- Issue a customer complaint for each delivery
- Open a CAPA targeting the supplier qualification and monitoring process (Correct answer)
- Replace the supplier immediately without investigation
- Accept the product with a concession each time
Correct answer: Open a CAPA targeting the supplier qualification and monitoring process
A pattern of supplier nonconformances signals a systemic issue in the supplier qualification or monitoring process that warrants a formal CAPA.
Question 4: When should an organization consider escalating a CAPA to top management?
- When the CAPA involves a process improvement suggestion
- When the root cause involves strategic or resource decisions beyond the quality team (Correct answer)
- When the corrective action has been open for more than 30 days
- When the nonconformity was detected by an external auditor
Correct answer: When the root cause involves strategic or resource decisions beyond the quality team
Escalation to top management is warranted when the CAPA requires authority, resources, or strategic decisions that exceed the quality department's scope.
Question 5: Which tool is MOST appropriate for identifying all potential root causes of a complex nonconformity in a CAPA investigation?
- Pareto chart
- Ishikawa (fishbone) diagram (Correct answer)
- Control chart
- Scatter diagram
Correct answer: Ishikawa (fishbone) diagram
An Ishikawa diagram systematically explores multiple cause categories (machine, method, material, man, environment) to identify all potential root causes.
Question 6: An effectiveness check for a CAPA should be performed:
- Immediately after the corrective action is implemented
- After sufficient time has passed to demonstrate the problem has not recurred (Correct answer)
- Only if the original nonconformity resulted in a customer complaint
- At the same time as the corrective action is implemented
Correct answer: After sufficient time has passed to demonstrate the problem has not recurred
Effectiveness checks require adequate time post-implementation to confirm that the root cause has been eliminated and the problem has not recurred.
Question 7: During an audit, you find that an organization's CAPA procedure requires 8 levels of approval before implementation. This MOST likely creates:
- Higher quality corrective actions due to thorough review
- Excessive bureaucracy that delays timely problem resolution (Correct answer)
- Better cross-functional ownership of CAPA outcomes
- Stronger compliance with ISO 9001 requirements
Correct answer: Excessive bureaucracy that delays timely problem resolution
Excessive approval layers delay implementation, prolonging exposure to the nonconformance risk and reducing the system's responsiveness.
ISO AUDITOR CAPA Implementation & Tracking 3
An auditor reviews a CAPA where the root cause was identified as 'human error.' What should the auditor look for next?