QPPV.COM KNOWLEDGE ASSESSMENT

PSMF Metrics and KPIs

Test your understanding of the concepts covered by PSMF Metrics and KPIs.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A dashboard reports zero overdue updates, but no raw extracts, calculation worksheets or source-system evidence are retained. What is the strongest professional conclusion?

The result is fully inspection-ready because the value is favourable The result may be operationally useful, but its reliability and reproducibility cannot be adequately demonstrated The absence of evidence proves that all updates were completed early Evidence retention is needed only for Red results

Question 2 of 10 Which evidence package would best support an inspector's review of a Red Vendor Inventory Accuracy result?

The final percentage only, without the sampled records The approved KPI definition, raw extract with metadata, reproducible selection and calculation records, verification evidence, governance minutes and CAPA documentation A general organisation chart and a current training matrix An unsigned email stating that the vendor inventory is believed to be accurate

Question 3 of 10 A KPI falls into the Red band and affects a regulatory obligation. Which response best reflects the described governance model?

Wait until the annual KPI review before notifying anyone Delete the KPI from the dashboard to avoid overemphasising an isolated result Notify the QPPV and Head of PV, assess impact, define immediate mitigation and initiate documented remediation Recalculate the KPI using only records that passed

Question 4 of 10 Which situation most clearly requires review of KPI definitions or thresholds under the described lifecycle controls?

A routine monthly result remains within the expected band A major acquisition changes the product and vendor landscape A dashboard is viewed by the PSMF Owner A governance meeting is held according to schedule

Question 5 of 10 Which role is primarily responsible for verifying CAPA effectiveness and controlling KPI SOP compliance?

Quality The procurement function The product marketing team The external vendor being measured

Question 6 of 10 Which metric best measures control effectiveness rather than administrative activity?

Number of pages in the PSMF Number of emails sent by the PSMF Owner Percentage of required annexes reviewed within the defined schedule Number of governance meetings invited to

Question 7 of 10 In the worked vendor example, 11 of 15 sampled vendors were scored accurate. What result and RAG classification follow the defined method?

73.33%, Red 73.33%, Amber 86.67%, Red 95.00%, Green

Question 8 of 10 What is the primary governance purpose of PSMF metrics?

To demonstrate that the PSMF contains a large amount of information To convert PSMF oversight into evidence-based monitoring that supports timely action To replace the QPPV's responsibility for pharmacovigilance system oversight To reduce the number of PSMF annexes requiring document control

Question 9 of 10 An automated KPI report is used for monthly monitoring. Which additional control is most important for inspection readiness?

Allow report logic to change without version control because automation prevents errors Retain the report definition or SQL, validation evidence, change history and data lineage Retain only a screenshot of the dashboard Ask the report user to describe the calculation verbally during an inspection

Question 10 of 10 Which KPI is most directly linked to verifying that remedial actions produced the intended improvement?

CAPA Effectiveness Rate Open CAPAs Annex Completion Rate Average Update Time

PSMF Metrics and KPIs

Cookie Settings