About this episode

The episode discusses the shift in FDA inspections from procedural compliance to evaluating risk-based decision making in quality systems.

Summary “FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.” In this episode of the Let’s Talk Risk Podcast , host Naveen Agarwal speaks with Michelle Lott about what early FDA 483 observations under QMSR are already revealing: a clear shift from procedural compliance to evaluating how well companies actually make risk-based decisions across their quality systems. This conversation goes beyond clauses and documentation. It explores how FDA is now looking at system effectiveness, how risk must be integrated across the full product lifecycle, and why leadership teams need to rethink how decisions are made, justified, and communicated under increasing ambiguity. Michelle brings a practical, field-level perspective on what is changing, where companies are most vulnerable, and how QA/RA teams can prepare their organizations for a more dynamic, judgment-driven inspection model. Key Points * FDA is increasingly citing deficiencies in risk management and system-level effectiveness , not just individual subsystems. * QMSR shifts inspections toward how decisions are made , not just whether procedures exist. * ISO 14971 alone is not…

Explore listener stats, chart rankings, contacts and more on the Let's Talk Risk! with Dr. Naveen Agarwal podcast page.