ISO AUDITOR CAPA Implementation & Tracking 3

Question 1

An auditor reviews a CAPA where the root cause was identified as 'human error.' What should the auditor look for next?

Accepted Answer

A deeper analysis identifying why the human error occurred

Answer

'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?

Accepted Answer

The nature of the nonconformity and actions taken

Answer

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?

Accepted Answer

Open a CAPA targeting the supplier qualification and monitoring process

Answer

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?

Accepted Answer

When the root cause involves strategic or resource decisions beyond the quality team

Answer

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?

Accepted Answer

Ishikawa (fishbone) diagram

Answer

An Ishikawa diagram systematically explores multiple cause categories (machine, method, material, man, environment) to identify all potential root causes.

(ISO AUDITOR) ISO 9001 Certified Auditor Practice Test

(ISO AUDITOR) ISO 9001 Certified Auditor Practice Test

ISO AUDITOR CAPA Implementation & Tracking 3