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EU Pharmacovigilance Inspection Findings: CAPA Effectiveness and Recurrence of Deficiencies

Test your understanding of the concepts covered by EU Pharmacovigilance Inspection Findings: CAPA Effectiveness and Recurrence of Deficiencies.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A central case-processing workflow is found to contain a control failure. Which scope assessment is most appropriate?

Review only the case sampled by the inspector. Review only cases processed by the individual involved. Consider all products and activities using the workflow, as well as relevant periods, affiliates, systems and personnel. Assume the issue is systemic across the entire company without further analysis.

Question 2 of 10 What is the best basis for selecting the observation period for CAPA effectiveness verification?

A fixed period applied to every CAPA for consistency. The shortest period that permits the CAPA record to be closed. The process frequency, risk, recurrence mechanism and availability of relevant evidence. The period preferred by the CAPA owner, regardless of process characteristics.

Question 3 of 10 A CAPA addresses missed escalation triggers. Which effectiveness measure is most directly aligned with the intended control?

The percentage of staff who completed escalation training. The date on which the revised escalation SOP was approved. A review of subsequent cases to determine whether escalation occurred when defined triggers were met. The number of CAPAs closed by their due date.

Question 4 of 10 Which situation most strongly suggests that a recurrence may reflect an inadequate original effectiveness assessment?

The later event involves a completely different process and cause. The original assessment measured training completion but did not test whether the affected intake control operated correctly. The later event was detected through routine monitoring. The original CAPA was implemented before the recurrence occurred.

Question 5 of 10 Why are traceability and representativeness important in CAPA effectiveness evidence?

They make the CAPA record longer and more formal. They help show that the evidence is reliable, connected to the relevant process and suitable for the question being answered. They eliminate the need for root-cause analysis. They guarantee that no future error will occur.

Question 6 of 10 Why can a high on-time CAPA closure rate be misleading as an indicator of quality-system performance?

On-time closure is never useful for management. It may demonstrate administrative timeliness while providing little evidence that CAPAs solved underlying problems. It proves that CAPAs were closed without appropriate approval. It measures only external inspection findings.

Question 7 of 10 How should risk influence CAPA effectiveness verification?

Risk should determine whether a recurring problem is investigated at all. Higher-risk failures generally justify more intensive or robust verification of the revised control. Risk is relevant only after effectiveness verification has been completed. All findings require identical sampling and observation periods to ensure regulatory consistency.

Question 8 of 10 A workflow change prevents a case from progressing until a required quality review is documented. Which additional evidence would best support effectiveness?

A list of users who were notified about the change. The date the system change request was approved. Subsequent monitoring and independent verification that the control operates as intended. A reduction in the number of quality documents.

Question 9 of 10 A company undergoes a major reorganisation after CAPA implementation, including transfer of responsibilities to a new service provider. What should be considered?

The CAPA remains effective automatically because it was previously closed. The organisation should assess whether the change altered the assumptions or interfaces underlying the control and whether further verification is needed. The CAPA should be deleted and replaced with a training record. The change is relevant only to financial and procurement controls.

Question 10 of 10 What does a sample with no observed errors during effectiveness verification demonstrate?

That the process can no longer fail. That the sample provides evidence about performance under the sampled conditions, but not absolute proof of future performance. That the root cause was correctly identified. That the sample size was necessarily adequate.

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EU Pharmacovigilance Inspection Findings: CAPA Effectiveness and Recurrence of Deficiencies

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