Differences between RBQM and RBM
Those of you who know me know that RBQM is one of my biggest professional passions. I believe so strongly that this is the future of clinical trial quality that I decided to develop an RBQM software to help organizations implement it in a practical, structured, and traceable way.
But I am tired of hearing so many “experts” talk about RBQM without truly understanding the process. And I am especially tired of seeing RBQM (Risk-Based Quality Management) directly equated with RBM (Risk-Based Monitoring)!
Because, ladies and gentlemen, RBQM and RBM are not the same thing. I have said this many times, and I will keep saying it.
Here are the differences between RBQM and RBM:
➖ RBM (Risk-Based Monitoring) is mainly focused on risk detection and monitoring controls. It is often site-centric and looks at signals, trends, data anomalies, monitoring outputs, and potential issues during trial conduct.
And yes, RBM is important. But it is only one piece of the puzzle.
➖ RBQM (Risk-Based Quality Management) is much broader, deeper, and more strategic. It starts much earlier. It starts with understanding what truly matters in the study (i.e, critical-to-quality factors).
RBQM is not just about detecting problems once the study is already running. It is about designing quality into the trial from the beginning, making better decisions, focusing resources where they matter most, and documenting the rationale behind those decisions.
It is about OVERSIGHT, ACCOUNTABILITY, PROPORTIONALITY, and CONTINUOUS REVIEW. And no, this CANNOT be reduced to a monitoring dashboard or a few KRIs.
And this is where I got really frustrated and decided to publish this post. This week, while listening to a webinar, I honestly froze when the speaker was asked how risks should be linked to mitigation actions and answered, with complete confidence, that in order to implement mitigation actions, the risk first needs to materialize.
No!!!!!
That is precisely the opposite of what a QbD – RBQM approach is trying to achieve.
Mitigation (or risk control) is not reactive. It is what you put in place upfront to prevent the risk from occurring, reduce its likelihood, improve early detection, or minimize its impact if it still materializes. A contingency action is one type of mitigation: a predefined response to be triggered if the risk occurs, so its impact can be contained. What makes no sense is to claim that mitigation only starts once the risk has already materialized.
Let’s stop selling smoke and let’s start implementing it properly.
And if you want to truly understand this methodology, I invite you to subscribe to the Qlarix newsletter, where we will continue sharing practical insights, examples, and reflections on how to implement RBQM in a way that actually makes sense.
—–
WiseCLIN is our purpose-built RBQM software designed to help sponsors implement risk based quality management in a structured, traceable, and inspection-ready way. Aligned with the principles of ICH E6(R3), WiseCLIN supports proactive RBQM by connecting risk identification, evaluation, mitigation, review, and oversight in one practical workflow.
Contact us here to learn more or request a demo.
Thank You,
Dr. Leire Zuñiga – PharmD PhD
Co-Founder and CQO, Qlarix | Founder and Managing Director, Pharmity | Risk-Based Quality Management (RBQM) Expert.
20+ years experience in Pharma, Biotech, CROs. Skilled in Quality Management, Good Clinical Practice and Computerised System Validation.
