On March 3, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Tentamus India Private Limited. The inspection it describes started the way most do, with one difference. At the initiation of the inspection, the agency’s investigator observed the firm attempting to remove…

At first glance, the next version of RC14001, the management standard for the chemical industry, looks like a simplification. In practice, it gives organizations more flexibility, but also more responsibility. The revised standard no longer hands organizations a predefined list of stakeholder…

Board meetings are a total pain. They can also be some of the most powerful get-togethers for your company. The difference lies in how you approach the meeting itself. Before you say, “I never present to the board,” and stop reading, allow me to expand the definition of a board meeting. A board…

Self-driving cars are often controlled by deep learning models that sometimes fail in unexpected situations. For instance, the car might inexplicably brake and block the path of an oncoming emergency vehicle. A human driver or passenger may need to react rapidly to prevent a collision. To help…

They may seem simple, but standard operating procedures (SOPs) are surprisingly tricky. On the surface, they describe how a specific process is carried out at your organization. Pretty straightforward, right? In reality, there are a lot of requirements for writing a good SOP, and auditors have a…

In order to do business, we have to use predictions of various sorts. These range from seat-of-the-pants guesses to the results of sophisticated modeling. In every case, the key to effective forecasting is to understand the uncertainty in the forecast. Ways to do this are the subject of this…

A quality team’s supplier toolbox is deep. Supplier questionnaires, PPAP, supplier scorecards, incoming inspection, audits, corrective action—the list goes on. In my years of experience as a quality leader, the challenge I see is matching each one to the right stage in the supplier process and the…

A measurement isn’t only a number. It’s a number obtained by an instrument in a physical state. That distinction becomes critical when the instrument moves, bends, conforms to a surface, or relies on software to correct its own geometry. A rigid gauge can often treat its working geometry as a…

Finding something underground is one thing. Giving a project team information they can actually use is another. A technician might pick up a signal with an electromagnetic locator. A ground-penetrating radar scan might show an anomaly running through a proposed work area. An old drawing might…

A new Financial Times analysis reports that U.S. technology companies have cut nearly 140,000 jobs in 2026 while pouring record sums into artificial intelligence infrastructure. The obvious story is that AI is replacing workers. The more important story is that executives are using AI to justify…

In today’s politically correct business world, too many leaders are more concerned about not offending their employees than they are about helping them grow. One of the biggest issues keeping teams from achieving greater success is a leader’s fear of mandating the activities and behaviors…

On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to Purolea Cosmetics Lab, reference 722591-04022026. By now, most of you have heard the story. The company had used AI agents to write drug product specifications, procedures, and master production records. No qualified…

For decades, reverse engineering was a tool reserved for large manufacturers. Aerospace manufacturers leaned on it to keep aging fleets in service when computer-aided design (CAD) data were missing. Defense contractors relied on it to re-create components that had long outlived their original…

Consider an AI tool that delivers consistently accurate results and demonstrates impressive capabilities. If the people who are expected to rely on it can’t understand how decisions are reached or challenge outcomes that appear wrong, why would they trust it with an important decision? Would an…

Michele Gelfand has studied and taught negotiation for years. A professor of organizational behavior at Stanford Graduate School of Business, she sees negotiation as a skill that’s imperative for everyone to learn. “It’s not something we’re born with,” she says. “It’s something we learn over time…

I’ve now watched every quality management concept I learned during my professional career unfold in my granddaughter’s first five months of life.  As I observed her feeding habits, sleeping routines, health monitoring, and interactions with her environment, I found remarkable similarities to…

Walk any well-run plant and you’ll find statistical process control doing quiet, faithful work: control charts on the critical dimensions; capability studies before a line change; gage R&R before anyone trusts a measurement; out-of-control signals investigated; root causes found; corrective…

When doctors need to deliver precise doses of medicine on a strict schedule, they often administer it intravenously. Intravenous drug delivery methods need to carefully control the flow of medicine into a patient. Knowing the medicine’s flow rate—or the volume of fluid flowing into the patient each…

Trust is the foundation of business and commerce. Every transaction, partnership, and working relationship depends, to some degree, on confidence that others will deliver on their commitments. In business, we often focus on customer trust that products and services will meet their needs and…

Manufacturing has a people problem, but not in the way we usually talk about it. We talk about the skilled-labor shortage. We talk about retirements. We talk about doing more with fewer people. Usually those are treated as separate problems. They aren’t. Rather, they are compounding. Deloitte and…

Extreme heat, drought, wildfires, floods, record-low rivers, and rising energy demand have defined much of the summer of 2026. But for businesses, the important story isn’t simply that weather records are being broken. It’s where those physical changes enter the operating system of a company. A…

Six weeks after a global manufacturer’s leadership team approved a group of promising new ideas, someone asked for an update. There wasn’t one. Not because the ideas had been rejected. Not because priorities had changed. Not because anyone had decided innovation no longer mattered. The projects…

The real test of a quality system isn’t what happens when everything works. It’s what happens when something doesn’t. Recently, two of my cameras failed. They were newer versions of models whose older predecessors still worked, so I contacted the manufacturer to report the problem. I expected a…

Researchers at MIT have overcome a major challenge holding back the real-world deployment of microwave quantum technologies for advanced signal processing and secure communications. The team developed a scalable platform that generates pairs of highly correlated radio frequency waves without bulky…

Poor quality rarely announces itself as a single, contained problem. In manufacturing environments, it may first appear as a rejected batch, a scrapped component, an unexpected line stoppage, or a customer complaint that requires investigation. These visible failures matter, and most manufacturers…