With ISO 9001:2026 just around the corner, the topic of internal auditing is likely on the minds of many quality professionals. This is the perfect time to reexamine your resources and strategies for internal auditing. The single biggest success factor of your audit program is who you select to…

Two years ago, the dominant conversation around AI in enterprise software was about pilots. Every company of a certain size had at least one: a proof of concept running in a sandbox, a chatbot layered over a knowledge base, or a model fine-tuned on proprietary data that never quite made it to…

The U.S. Food and Drug Administration scrutiny of AI and machine learning in medical devices is intensifying. Yet most companies still apply failure mode and effects analysis (FMEA) methods designed for deterministic hardware failures. AI failures are probabilistic, context-dependent, and often…

Manufacturers have spent millions investing in safer equipment, smarter automation, and increasingly sophisticated operational technology. Yet employee disengagement, one of the most significant risks to workplace safety and productivity, remains stubbornly difficult to address. Gallup’s recent…

Businesses running equipment that depends on actuators, especially in high-cycle or nonstop operations, already know this: It’s common for actuators to fail without showing any warning signs. All of a sudden, the production line stops midshift. It’s not until hours later that you find out that the…

We often think of AI as a technological revolution that will transform industries, disrupt jobs, and change the nature of competitive advantage. But inside organizations, it’s unfolding in a much more complex, less predictable way. In many firms, AI is still more narrative than operational reality…

Artificial intelligence (AI) workloads are reshaping the scale, speed, and risk profile of data center construction. As AI adoption accelerates, operators need more physical infrastructure, faster deployment cycles, and greater confidence that critical systems will perform as intended after handoff…

During a recent visit to a brewery in Dublin, I was stopped by one statement displayed on the tour: “The quality of our advertising must be equal to the quality of our beer.” It was intended as branding. But it pointed to something most organizations quietly overlook: They assume quality begins…

All too often, leaders seek to build support for an idea by talking—a lot. They may go on and on about why the decision is a good one, detailing its benefits, the reasons others should support it, and the path forward. There’s passion and excitement behind the talk, and the leader lets it show…

Midtier life sciences companies are spending more than ever on quality and regulatory technology, yet many are paying enterprise prices for capability they never use. The right question isn’t whether to invest in a quality management system (QMS) or regulatory information management (RIM) platform…

Teams building software as a medical device (SaMD) tend to think of ISO 14971 as the hardware team’s problem. Risk management files, FMEA tables, severity scores: all quality and regulatory territory, while the engineers close Jira tickets. That split is where things go wrong. ISO 14971 applies to…

High-mix manufacturing has become the norm. Production lines are expected to produce more part variants in smaller batches and at a faster pace than ever before—all while maintaining very high quality. To keep up, many manufacturers turn to automated quality control (AQC). Robots and 3D scanning…

As we celebrate the United States’ 250th anniversary this year, NIST experts have been working to preserve our nation’s history for the next 250-plus years. Among other historic preservation efforts, NIST engineers and scientists created a bespoke time capsule with artifacts from around the country…

As a significant portion of the experienced manufacturing workforce approaches retirement, companies face the critical threat of losing undocumented tribal knowledge. Veteran operators possess decades of hard-won, job-specific insights that rarely exist in paper manuals or corporate file systems.…

Inbound receiving operations (aka goods-in) in the electronics industry are under increasing pressure. Countless components from a wide range of manufacturers arrive with constantly changing label layouts, multilingual markings, and ever shorter throughput times. What once could be managed…

When people hear the word innovation, they often think of groundbreaking products, disruptive technologies, or revolutionary ideas. But not every improvement needs to reinvent the wheel. Small changes might seem insignificant at first, but their cumulative effect can be transformative. Improved…

The office lights are on, but plenty of seats stay empty. Employees have heard the policy, nodded at talking points, and then organized their week around what helps them live well. That quiet opt-out shows up in badge data and calendar behavior, and it’s reshaping how leaders must think about…

In this article I’m looking at Shunryū Suzuki’s beginner’s mind in Zen and Heinz von Foerster’s ethical imperative. Readers of my blog know that I love connecting the dots often in seemingly varying fields. Suzuki said something useful: “In the beginner’s mind, there are many possibilities. In the…

Ask anyone in manufacturing or in a project-driven company who has the most difficult job, and without hesitation they will say: the scheduler/planner. It’s no wonder. Foolproof scheduling is critical to the smooth operation of most companies. Yet, planning and scheduling the workflow is akin to…

For years, many medical device manufacturers approached U.S. Food and Drug Administration (FDA) inspections through a familiar lens: Prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework. That approach was shaped by the…

ISO has set its focus on revising three key management system standards this year. It started with ISO 14001, which covers environmental management and was published on April 15, 2026. ISO 9001 for quality management will follow in the fall. For ISO 45001, the occupational health and safety…

With Hexagon Manufacturing Intelligence’s recent announcement of its inclusion in the NASCAR Competition Partner Program, details on the strategic partnership have emerged. By cementing this tie, the two companies can expand a professional relationship that will enable them to focus on precision,…

The Weibull distribution is a continuous probability distribution often used in reliability analysis to model time-to-failure and product lifespans. It has applications in engineering, medicine, energy, and insurance. It’s also good at describing survival statistics, such as survival times after…

A food company spends months and significant budget on consumer research before launching a new product. The survey scores are strong, so the store managers stock it. Six months later, the product is quietly pulled from the shelves. The consumers who said they would buy it didn’t. This pattern—…

A line operator in a chemical packaging plant notices a torque inconsistency on a capping head. The deviation is within tolerance on the individual reading, but the operator has seen this pattern before; it usually precedes a run of out-of-spec caps over the next two shifts. He would normally flag…