CAPA Implementation & Tracking Flashcards

A CAPA for a critical product safety issue has been open for 120 days with no progress. What is the auditor's MOST appropriate response?

Answer: Raise a major nonconformity due to lack of action on a safety-related issue

Inaction on a safety-critical CAPA represents a significant failure of the quality management system warranting a major nonconformity.

Which of the following BEST describes 'containment action' in the context of a CAPA?

Answer: Immediate action to isolate and control the impact of the nonconformity

Containment action is the immediate response to limit the scope and impact of a nonconformity before the root cause investigation is complete.

An organization claims to have implemented a CAPA but cannot produce any documented evidence. Under ISO 9001:2015, this means:

Answer: The CAPA cannot be considered complete as documented information is required

ISO 9001 clause 10.2.2 explicitly requires documented information as evidence of the nature of nonconformities and results of corrective actions.

During a CAPA review, you discover that the same root cause ('inadequate training') appears across 15 different CAPAs from multiple departments. What does this pattern indicate?

Answer: A systemic issue with the training needs analysis or competency management process

Repeated 'inadequate training' root causes across departments suggest a systemic failure in the competency management or training needs analysis process itself.

When an auditor evaluates whether corrective actions taken are 'appropriate to the effects of the nonconformities,' they are assessing:

Answer: Proportionality between the severity of the issue and the depth of corrective action

ISO 9001 clause 10.2.1 requires corrective actions to be appropriate to the effects of the nonconformity, meaning the response must be proportionate to the risk and impact.

An organization integrates its CAPA data with management review inputs. Under ISO 9001:2015, this practice:

Answer: Fulfills the requirement of clause 9.3 to review quality performance and improvement

Clause 9.3.2(e) requires management review inputs to include information on nonconformities and corrective actions, making CAPA integration a mandatory input.

A 5 Why analysis for a labeling error concludes at the third 'why' with 'operator was distracted.' The auditor should:

Answer: Challenge the team to continue analysis to find the systemic cause of distraction

'Operator was distracted' is still a symptom; continuing the analysis would reveal systemic causes such as workload, environment, or procedural gaps that can be corrected.