CAPA Implementation & Tracking Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 CAPA Implementation & Tracking flashcards as text
An auditor reviews a CAPA where the root cause was identified as 'human error.' What should the auditor look for next?
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.
ISO 9001:2015 requires that corrective action records include which of the following?
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.
A supplier delivers nonconforming product three times in six months. Under a robust CAPA system, what action is MOST appropriate?
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.
When should an organization consider escalating a CAPA to top management?
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.
Which tool is MOST appropriate for identifying all potential root causes of a complex nonconformity in a CAPA investigation?
Answer: Ishikawa (fishbone) diagram
An Ishikawa diagram systematically explores multiple cause categories (machine, method, material, man, environment) to identify all potential root causes.
An effectiveness check for a CAPA should be performed:
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.
During an audit, you find that an organization's CAPA procedure requires 8 levels of approval before implementation. This MOST likely creates:
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.