Dr. Donald J. Wheeler has been one of Quality Digest’s most highly read authors for decades. His teaching on the use of control charts in industrial settings has long been considered the gold standard. He has conducted more than 1,100 seminars in 17 countries on six continents, and his books have…

As global trade uncertainty intensifies, health systems should take steps to minimize the effect of this volatility on their medical equipment inventory. The evolving policies of the United States and its trading partners could strain global supply chains and make acquiring or maintaining medical…

What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind. People reach out to me all the time asking how to break into the medical device industry—and I love those conversations…

How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being? People are the foundation of every…

Risk-based thinking—it sounds easy. How hard can it be to think about risk? But did you know that the phrase “risk-based thinking” was only invented in 2015?  Did you know that the ISO says “risk-based thinking” is one of the foundations of quality management, but never defines it? Or that it…

Global risks are rising, and many companies are struggling to adapt. The World Economic Forum’s 2025 Global Risks Report makes it clear that challenges like escalating global tensions and conflicts, climate change, economic instability, and supply chain disruptions are interconnected and build on…

Geopolitical risk is emerging as one of the greatest challenges facing domestic and international business today. It has risen from a boardroom issue to one drawing the awareness and attention of both personnel and the general public. These days everyone knows the word “supply chain” and has some…

This current job market is plagued by fake job postings that have been misleading American job seekers, wasting their time and distorting employment data. These deceptive listings—often created to collect résumés, inflate company growth metrics, or manipulate job market statistics—erode trust in…

Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out. Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to share his…

Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…

After spending years working alongside frontline manufacturing teams, I’ve come to see one thing clearly: Preventing incidents isn’t just a legal requirement. It’s the heartbeat of a healthy operation. With workplace safety making headlines daily—often with tragic details—it’s time to highlight how…

Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21 CFR 211.67—“Equipment cleaning and maintenance,”1,2…

Quality control (QC) teams need reliable results they can trust to make informed decisions and address manufacturing challenges. This is why they rely on the coordinate measuring machines (CMMs). However, a CMM’s speed is often a limitation, making the idea that routine quality control can be…

A safe work environment will foster productivity, reduce hazards, and enhance overall work morale. Keeping your team and assets safe requires implementing the right policies, medical necessities, vigilant oversight, ongoing assessments, and proper training. As the COO of DUSAW, making smart locks…

The collapse of Baltimore’s Francis Scott Key Bridge in March 2024 was the consequence of a long-standing problem: the fragility of aging infrastructure. As reconstruction gets underway on an estimated four-year timeline, the disaster reflects the urgent need for better bridge inspection nationwide…

When first responders need to rescue people from an earthquake-ravaged home, they need real-time information. If law enforcement officers are looking for a shooter in a crowded building, they must learn everything they can about the scene.  Emergency responders need to know where people are and…

Quality management has evolved far beyond traditional checklists and periodic inspections. For complex supply chains, quality is no longer a static endpoint. It’s a dynamic real-time process deeply interwoven with collaboration, transparency, and data-driven decision-making. As supply chains grow…

In a growing business milieu, ISO quality management system compliance ensures that organizations meet global standards for quality, safety, and efficiency. However, maintaining compliance with ISO frameworks such as ISO 9001 (quality management), ISO 45001 (occupational health and safety), and ISO…

Every time you squeeze toothpaste onto your toothbrush, spray perfume on your skin, or swallow a pill, you’re using the result of a carefully crafted recipe made in a lab. These are called formulations. Formulations aren’t just simple mixtures—they’re complex arrangements of ingredients designed…

What are the elements of a successful team? In a nutshell—whether it’s an athletic team, a dance team, or a business team—the critical elements are people who are knowledgeable, dedicated, productive, work well with others, and constantly seek to improve their skills. But hiring and firing are…

Today I’m looking at the free energy principle (FEP) by the British neuroscientist Karl Friston. The FEP basically states that to resist the natural tendency to disorder, adaptive agents must minimize surprise. This has implications for the gemba, as you’ll see. A good example to explain this is…

In the ever-changing landscape of business management, the concept of quality has undergone significant transformations. What began as a focus on maintaining standards such as ISO 9001 and AS9100 is evolving into a more holistic approach encompassing organizational excellence. Tom Taormina’s book…

A September 2024 Gallup poll revealed that nearly 30% of U.S. adults have little to no confidence in the safety of U.S. foods at the grocery store. Considering recent recalls, is it any wonder? What good is a quality control program if it doesn’t include food safety? Boar’s Head’s Jarratt,…

Wharton management professor Peter Cappelli is routinely asked to predict the future of work. His expert answer is always the same: “The future looks like the past.” He’s not trying to be cryptic. It’s just that the big changes ushered in by the pandemic five years ago are still unfolding—remote…

In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss. Since then, the industry has seen explosive growth of AI in medical device manufacturing, which is…