All Features
Gleb Tsipursky
What’s your decision-making philosophy? Do you toss a coin, or do you consider all the risks of your decisions? As a quality professional, you've probably developed a well-thought-out approach to decision making and risk management. But have you considered how other people’s decision-making…
Joshua Sadlock
Yup, that’s me in the photo. You’re probably wondering how I ended up hanging under a bridge over the Mississippi River. I’m a certified bridge safety inspector.
If you have questions after seeing people hanging under a bridge, in a basket suspended from the long arm of a truck, or have seen…
Stephanie Ojeda
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS), and a critical piece in the plan-do-check-act process approach. Like any quality process, tracking CAPA key performance indicators (KPIs) is crucial to continuous improvement.
It’s also a focus of…
Bryan Christiansen
Every day, manufacturers rely on a large number of tools, machinery, and infrastructure to produce their goods. And while all of those assets help you generate profit, they are a significant expenditure—both in terms of the purchase cost and ongoing maintenance costs.
When deciding which…
Doug Folsom
Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable for medical devices. So, dealing with the potential threat isn’t usually straightforward. The stakes…
Gleb Tsipursky
Why do companies bury their heads in the sand instead of facing dangerous facts, whether about quality problems or other issues? It happens more often than you might think—most recently with Adidas. It usually boils down to companies falling for three cognitive biases.
“Adidas does not tolerate…
Del Williams
With the threat of contamination from harmful pathogens such as salmonella, listeria, and e. coli a continual concern, food processors are seeking to protect not only the public but also their companies’ bottom lines from the massive costs, reputational damage, and greater regulatory scrutiny…
Anton Ovchinnikov
In the age of mass production, the demand for customization is increasing. Customers prefer products catered to their individual needs and preferences over standard items—albeit at a cost.
Fortunately, recent advances in information technology, logistics, and advanced manufacturing processes such…
Christopher Dancy
Despite the important and ever-increasing role of artificial intelligence in many parts of modern society, there is very little policy or regulation governing the development and use of AI systems in the United States. Tech companies have largely been left to regulate themselves in this arena,…
Jake Mazulewicz
A technician spills a toxic chemical. She isn’t injured but easily could have been. The hazmat cleanup costs more than $10,000 and shuts down a critical building for a week.
An electrical engineer flips the wrong switch in a substation control room. He isn’t injured. But within seconds, a $50,000…
Bryan Christiansen
Assets are resources owned and used by a company to generate a positive economic benefit. Assets can be physical items, like equipment or furniture, or they can be intangibles like software, patents, or documents.
As a business owner, it’s important to know which assets you own, their location,…
Gleb Tsipursky
BlackRock CEO Larry Fink claimed in a recent interview with Fox that “we have to get our employees back in the office.” According to him, doing so would result in “rising productivity that will offset some of the inflationary pressures.”
Fink didn’t provide any data in the form of statistics,…
Quy Huy
In September 2022, Boeing agreed to pay $200 million for charges that it misled investors about two crashes of its 737 Max aircraft that killed 346 people. The penalty imposed by the U.S. Securities and Exchange Commission is small change compared to the $2.5 billion shelled out by the plane maker…
Jon Speer
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these two processes are related. But it is important to realize that product development and risk management share more than that.…
Tom Taormina
It’s a conundrum that faces everyone who operates a manufacturing or service business: Most are unaware of the dire consequences of a defect reaching a customer until a process server hands them a lawsuit. By then it’s too late. Regardless of the outcome, the people and businesses will be…
Pat Toth
In an earlier article in this series, “Cybersecurity and Industry 4.0: What You Need to Know,” we discussed the four aspects of Industry 4.0: cyber-physical systems (CPS)/cobots, internet of things (IoT), cloud manufacturing, and automation, as well as how they are interconnected. Strong…
Patrick Hardy
Responding to disasters is one of the most important activities that employees can be asked to grapple with. From natural disasters like hurricanes and earthquakes to technological situations such as power outages, chemical spills, and transportation accidents, as well as security emergencies like…
Dirk Dusharme @ Quality Digest
Every company wants to succeed, but not all can say they meet the current requirements to do that. More than a focus on capital, business plans, or staff, a successful business in 2022 must operate digitally. Yet for the 45 percent of small and medium-sized businesses (SMBs) that still rely on…
David Isaacson
In 1982, when asked about the state of the company’s Xenix operating system, a Microsoft engineer reportedly called it “vaporware“ to indicate that the operating system had really not yet materialized. Unfortunately, the term stuck for this and many other premature software launches.
It’s not only…
John Logan
Labor Day 2022 came smack-bang in the middle of what is increasingly looking like a pivotal year in the history of American unions.
The summer saw a steady stream of workforce mobilizations. Employees at Trader Joe’s locations in Massachusetts and Minneapolis both voted to unionize. Meanwhile,…
Gleb Tsipursky
Recently, JPMorgan CEO Jamie Dimon claimed that returning to the office will help improve diversity. If he’s right, that’s an important argument for office-centric work. After all, extensive research shows that improving diversity boosts both decision-making and financial performance.
Yet does…
Abdul Salam
Water is the most essential resource for life, for both humans and the crops we consume. Around the world, agriculture accounts for 70 percent of all freshwater use.
I study computers and information technology in the Purdue Polytechnic Institute, and direct Purdue’s Environmental Networking…
Gene Kaschak
Many manufacturers that adopted lean principles by applying a “just-in-time” (JIT) mindset to inventory of materials and parts have been burned, sometimes badly, by cascading supply chain disruptions. Broken links in the supply chain have created havoc, especially for smaller manufacturers.
Some…
Dwayne Duncum
The workplace has changed forever, having gone through a revolution similar to the Industrial Revolution. Our workplaces are diverse, complex, and frequently changing. If we take any lesson from the Covid pandemic, it’s that the way we work, where we work, and how we work have fundamentally shifted…
Etienne Nichols
I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls. “So why would I waste time on design controls?”
The fact is…
