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What Is an Asset Management Policy?
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,…
Does Remote Work Contribute to Inflation?
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,…
Speed Kills: Why Some Multinationals Fail to Pay Attention to Quality
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…
Three Tips For Incorporating Risk Management During Medical Device Product Development
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.…
Two Weeks Resolving a Defect, or...
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…
Cybersecurity: A Critical Component of Industry 4.0 Implementation
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…
Transform Employees to Emergency Responders in Three Easy Steps
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…
Migrating Your QMS From Paper to AI
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…
Avoiding Modern-Day Vaporware and Other Product Launch Mishaps
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…
America Is in the Middle of a Labor Mobilization Moment
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,…
JPMorgan CEO Jamie Dimon Is Exactly Wrong
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…
Farmers Can Save Water With Wireless Technologies, But There Are Challenges
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…
When Your Lean Supply Chains Feel Out of Control, Focus on What You Can Control
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…
Top Five Tips for Managing Workplace Hazards
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…
Why Class 1 Medical Device Companies Need Design Control
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…
Human Nature Can Blind People to New Hazards
Sam Hunter, Gina Ligon
There’s a well-known aphorism that generals are always fighting the last war. It’s a natural human tendency to focus on the kinds of threats you’re used to while playing down the likelihood or importance of some new sort of attack. Of course, novel threats can crop up anytime and anywhere. An…
How to Properly Maintain Your CNC Machines
Bryan Christiansen
CNC (for computer numerical control) machines have made manufacturing easier, faster, and more precise. Supported by the development of IoT technology, the CNC machine market is set to experience significant growth. With that in mind, this seems like a great time to discuss the intricacies of CNC…
Small Manufacturers Can Develop Risk Management Strategies for Their Supply Chains
Katie Rapp
The Covid-19 pandemic brought to light a stark reality about current supply chains. As Nissan Motor’s chief operating officer Ashwani Gupta points out, “The just-in-time model is designed for supply-chain efficiencies and economies of scale. The repercussions of an unprecedented crisis like Covid…
Quality vs. Inflation and the Deficit
William A. Levinson
Inflation has skyrocketed during the first half of 2022, which also saw a sharp downturn in the stock market in response to the Federal Reserve’s increase in interest rates to reduce demand. This resulted in a bear stock market and raised the prospect of an economic recession. The nonpartisan…
It’s Time for the FDA to Fully Embrace ISO 13485
Grant Ramaley
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485. But by 2003, ISO 13485 had changed so significantly that the FDA…
Five Ways to Deal With Burnout at Work
Claudine Mangen
Work has become an around-the-clock activity, courtesy of the pandemic and technology that makes us reachable anytime, anywhere. Throw in expectations to deliver fast and create faster, and it becomes hard to take a step back. Not surprising, many of us are feeling burned out. Burnout—which often…
Food Expiration Dates Don’t Have Much Science Behind Them
Jill Roberts
Florida’s outbreak of listeria has so far led to at least one death, 22 hospitalizations, and an ice cream recall since January 2022. Humans get sick with listeria infections, called listeriosis, from eating soil-contaminated food, undercooked meat, or dairy products that are raw or unpasteurized.…
How a UN Decision on Safety and Health Will Actually Affect Employees
Huw Thomas
In what has been called the “biggest moment for workers’ rights in a quarter of a century,” the International Labour Organization (ILO) adopted a safe and healthy work environment as one of its five fundamental principles and rights at work for all at its June 2022 international conference. This is…
The Danger of Armchair Psychology
Gleb Tsipursky
Imagine you’re driving along the highway and you see an electric sign that reads, “79 traffic deaths this year.” Would this make you less likely to crash your car shortly after seeing the sign? Perhaps you think it would have no effect? Neither are true. According to a recent peer-reviewed study…
How Pharma Quality Leaders Navigate Shifts and Instigate Change
Patricia Santos-Serrao
The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times. They are also being driven by…

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