New analysis confirms three of the five worst harvests on record have occurred in the past five years on the back of extreme heat, drought, and rainfall

NBC News reported last month that Tesla vehicles using Full Self-Driving software sometimes fail to stop for train tracks.

A Halloween confession from someone who spends their days investigating quality failures Halloween seems like the perfect time for a personal confession: I'm a horror film devotee. Not the kind who seeks out the latest gore-fest or jump-scare factory, but someone drawn to the films that understand fear as something more complex than shock value. These ten films have shaped not just my appreciation for cinema, but my understanding of how we process uncertainty, confront the unknown, and maintain psychological safety in the face of genuine threat.

Reading Tomas Chamorro-Premuzic's latest research on authenticity has me wrestling with some uncomfortable truths about my own advice. In my post about bringing your authentic self to work, I championed the power of psychological safety through genuine connection. But Chamorro-Premuzic's work reveals a blind spot in that thinking—one that challenges us to be more sophisticated about what authenticity actually means in practice.

Safety science has evolved from a narrow focus on preventing individual errors to a sophisticated understanding of how complex socio-technical systems create both failure and resilience. The intellectual influences explored in this guide represent a paradigm shift from traditional "blame and fix" approaches to nuanced frameworks that recognize safety and quality as emergent properties of system design, organizational culture, and human adaptation.

When I encounter professionals who believe they can master a process in six months, I think of something the great systems thinker W. Edwards Deming once observed: "It is not necessary to change. Survival is not mandatory." The professionals who survive—and more importantly, who drive genuine improvement—understand something that transcends the checkbox mentality: true ownership takes time, patience, and what some might call "stick-to-itness."

Beyond the Shadow of Failure Problem-solving is too often shaped by the assumption that the system is perfectly understood and fully specified. If something goes wrong—a deviation, a batch out-of-spec, or a contamination event—our approach is to dissect what "failed" and fix that flaw, believing this will restore order. This way of thinking, which I call the malfunction mindset, is as ingrained as it is incomplete.

In my recent exploration of the Jobs-to-Be-Done tool I examined how customer-centric thinking could revolutionize our understanding of complex quality processes. Today, I want to extend that analysis to one of the most persistent challenges in pharmaceutical data integrity: determining when electronic signatures are truly required to meet regulatory standards and data integrity expectations. Most organizations approach electronic signature decisions through what I call "compliance theater"—mechanically applying rules without understanding the fundamental jobs these signatures need to accomplish.

Parenthood, criminality or death: these are now the all-too-expensive options for many women in the wake of the Dobbs decision

I'm excited to share that I recently had the opportunity to appear on the Risk Revolution podcast, joining host Valerie Mulholland for what turned out to be a provocative and deeply engaging conversation about the future of pharmaceutical quality management. The episode, titled "Quality Theatre to Quality Science - Jeremiah Genest's Playbook," aired on September 28, 2025, and dives into one of my core arguments: that quality systems should be designed to fail predictably so we can learn purposefully.

Pfizer Inc. Chief Executive Officer Albert Bourla said the company secured a three-year grace period from President Donald Trump’s promised tariffs on pharmaceuticals in a deal that would lower some o...

How the Quality Industry Repackaged Existing Practices and Called Them Revolutionary As someone who has spent decades implementing computer system validation practices across multiple regulated environments, I consistently find myself skeptical of the breathless excitement surrounding Computer System Assurance (CSA). The pharmaceutical quality community's enthusiastic embrace of CSA as a revolutionary departure from traditional Computer System Validation (CSV) represents a troubling case study in how our industry allows consultants to rebrand established practices as breakthrough innovations, selling back to us concepts we've been applying for over two decades.

I have written in the past that I do not treat all regulatory compliance actions with equal importance. Not every Form 483 or Warning Letter carries the same weight; their significance is determined by the nature of the company involved. Take the April 2025 Warning Letter to Cosco International, for example. One might quickly react with, “Holy cow! No process validation or cleaning validation—how is this even possible?” This could spark an exhaustive discussion about why these regulations have been in place for 30 years and the urgent need for companies to comply.

Podcast Episode · Risk Revolution · 09/30/2025 · 1h 2m

In my recent exploration of the Jobs-to-Be-Done (JTBD) tool for process improvement, I examined how this customer-centric approach could revolutionize our understanding of deviation management. I want to extend that analysis to another fundamental challenge in pharmaceutical quality: risk management. As we grapple with increasing regulatory complexity, accelerating technological change, and the persistent threat of risk blindness, most organizations remain trapped in what I call "compliance theater"—performing risk management activities that satisfy auditors but fail to build genuine organizational resilience.

In the relentless march of quality and operational improvement, frameworks, methodologies and tools abound but true breakthrough is rare. There is a persistent challenge: organizations often become locked into their own best practices, relying on habitual process reforms that seldom address the deeper why of operational behavior. This “process myopia”—where the visible sequence of tasks occludes the real purpose—runs in parallel to risk blindness, leaving many organizations vulnerable to the slow…

With over 1,400 police departments in the U.S. already using drones, “Drones as First Responder” programs are beginning to proliferate with little oversight or accountability. In this paper, ACLU's J...

Risk blindness is an insidious loss of organizational perception—the gradual erosion of a company’s ability to recognize, interpret, and respond to threats that undermine product safety, regulatory compliance, and ultimately, patient trust. It is not merely ignorance or oversight; rather, risk blindness manifests as the cumulative inability to see threats, often resulting from process shortcuts, technology overreliance, and the undervaluing of hands-on learning.