Something goes sideways at work—missed deadlines, bad customer feedback, you name it—and the first suggestion is: “We need training!” Sound familiar? It’s like reaching for a Band-Aid when what you really need is a lifestyle change. Training can be powerful, but it shouldn’t be your knee-jerk…

A missed birthday. A forgotten anniversary. A milestone that goes unnoticed. These small slights from a manager may seem like no big deal, but new research from Wharton reveals that even the mildest mistreatment at work can affect more than just employee morale. The study found that when managers…

If you’ve flown in the U.S. in recent years, you’re probably familiar with the airport security experience of entering a booth, raising your hands above your head, and having a machine check your body. That machine is called a millimeter wave scanner. I’ve done this many times and never given it…

Traditional styles of lecturing and imparting information can be ineffective in terms of student engagement and triggering deeper learning. This is especially challenging in certain subjects that are difficult to teach in a classroom anyway, and for those who process information differently.…

Medical devices are engineered to solve complex clinical problems. Yet many enter the field without a full accounting for what happens after deployment. Hospitals depend on equipment that performs consistently. But even with strong designs, virtually all devices will eventually require preventive…

Increasingly, inspectors for the U.S. Food and Drug Administration (FDA) will evaluate your CMMS provider’s security controls—not just your internal procedures. In a cloud-hosted GxP environment, data doesn’t stop at your firewall; your vendor’s security posture becomes part of your compliance…

In today’s energy sector, regulatory complexity isn’t a temporary headache—it’s the new normal. Utilities face an accelerating torrent of mandates from multiple levels of government. This includes FERC reliability standards, EPA emissions rules, state-level renewable portfolio standards, …

The digitalization of society during the last decade has created many opportunities for businesses and organizations. But digitalization, combined with a rapidly changing world, has also opened new threats and vulnerabilities that can cause serious damage to businesses. Every day we see headlines…

The manufacturing industry is undergoing a transformation driven by rapid technological advancements, changing consumer preferences, and evolving regulatory frameworks. Manufacturers everywhere face unprecedented challenges as they seek to remain competitive, profitable, and sustainable in the face…

Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible. The pace of innovation in the industry has increased tremendously, thanks to more options for outsourcing and new technology like 3D scanning…

All manufacturing companies must manage an ever-growing mountain of priceless inspection data. Yet measurement results, process iterations, and approval reports are scattered across hard drives and USB sticks. We live in a digital world that advances daily, yet obtaining, accessing, sharing, and…

When I first became involved in lean (continuous improvement), I was the VP of operations at a privately held company in the Midwest. It was 2003, and as a newly promoted senior executive I was eager to find a strategy that could make a real difference in our operations. I quickly realized that…

In this article I want to spend time with Søren Kierkegaard. I’ve been interested in his ideas because he occupies an unusual place in the history of thought. He’s considered a pioneer of existentialism, and yet he was also a man of faith. Most of the existentialist thinkers who followed him,…

As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation. The landscape for quality and regulatory affairs (QARA) professionals continues to shift, driven by emerging AI capabilities, changing…

Your IT team enabled Copilot and Gemini last quarter without checking with the lawyers. Now your employees are putting company secrets into systems that nobody owns, nobody governs, and nobody can reliably retrieve when opposing counsel sends a subpoena. You have a discovery problem, and it’s…

In modern manufacturing, the smartest factories know that safety comes first. Any injury, equipment problem, or unexpected stop can slow everything down. The good news? The right equipment updates can reduce many of these risks. From tool balance systems to better cable management, the right…

The demos look slick, the promises even slicker. In slides and keynotes, agentic assistants plan, click, and ship your work while you sip coffee. Promoters like McKinsey call it the agentic AI advantage. Then you put these systems on real client work and the wheels come off. The newest empirical…

Choosing the correct instrument for surface texture measurement can be confusing, given the wide range of options. Stylus-based instruments are the most prevalent in manufacturing. Yet, measuring a surface with a sharp stylus can seem old-fashioned when so many noncontact optical techniques are now…

For years, manufacturers have been told the future of Industry 4.0 lives in the cloud. Vendors promised plug-and-play AI that could analyze everything, automate anything, and transform the factory floor overnight. In theory, this appears to work, but operationalizing cloud-based AI isn’t always…

When we set out to film Episode 2, we faced a fundamental challenge: How do you make people care about errors they can’t see? (See all the episodes here.) Error propagation is critical to metrology, the science of measurement, but it’s abstract. These are mistakes measured in tiny amounts that…

In today’s digital age, the question isn’t whether you’ll experience a cybersecurity attack, but when this might occur. Cybercriminals strike when you least expect it, with devastating consequences for your day-to-day operations. If your organization is lucky, it can block the attacker and limit…

In manufacturing, failure isn’t an option—it’s a liability. A defective part or a missed delivery triggers a chain reaction that can disrupt schedules, undermine trust, and drain resources. So when someone suggests a strategy with the word fail in it, skepticism is understandable, because…

In 2025, there’s been a marked increase in FDA warning letters. During the second quarter of 2025 alone, the U.S. Food and Drug Administration (FDA) issued 172 warning letters. A notable enforcement surge occurred in September 2025 when the FDA released 80 warning letters in a single week. Although…

Here’s something nobody saw coming: The generation most skeptical of AI isn’t the one that doesn’t understand it. It’s the one that understands it best. Every new technology faces resistance. The internet? A fad. Smartphones? Unnecessary. Social media? A waste of time. But tech skepticism has…

In Episode 1 of The Quality Digest Roadshow, we talked about metrology standards and how those standards and traceability are the glue that holds industry together. While measurement standards are critical, they’re useless without the equipment, processes, and people that use the tools that measure…