All Features
Brian Brooks
Manufacturers spend too much on quality issues. Some issues they are blind to, some are due to poor detection, and some are the costs incurred when issues escape to a customer.
It seems like in recent years the challenges have been great in both magnitude and quantity—supply chain turmoil, global…
William A. Levinson
Corrective action and preventive action (CAPA) is probably the most important process in any quality management system because so much else depends on it. This includes not only its traditional role as a response to defects, nonconformances, customer complaints, and audit findings, but also outputs…
Ann Brady
Few of us today are unaware of the significance of cybersecurity and the threat of cyberattacks on our computers, smartphones, and other devices. We’re constantly reminded never to disclose passwords and to be on the lookout for spam and phishing emails that attempt to manipulate us into divulging…
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…
Dirk Dusharme
Updated 12/12/22
At a meeting of EU health ministers in Brussels on Dec. 9, 2022, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council announced it will be proposing an extension to the transition date for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). On…
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…
Bryan Christiansen
An important part of production is to carefully monitor and control temperature, speed, volume, weight, or mass. To ensure these measurements are always accurate, manufacturers need to calibrate their equipment and instruments regularly.
Devising a proper equipment calibration schedule can be a…
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…
NIST
An improvement to a Nobel Prize-winning technology called a frequency comb enables it to measure light pulse arrival times with greater sensitivity than previously possible—potentially improving measurements of distance along with applications such as precision timing and atmospheric sensing.
The…
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,…
Leeza Garber, Allison Jegla
In late spring 2022, the U.S. Securities and Exchange Commission (SEC) charged an elite investment adviser for “misstatements and omissions” about environmental, social, and governance (ESG) considerations related to its managed mutual funds. This same financial firm has also faced myriad…
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,…
Jeff Dewar
This is the fourth installment of a five-part series.
As detailed in our third installment, ASQE is a new legal entity connected to the ASQ we all know and love. It’s a trade organization to which organizations, rather than individuals, can belong. Current membership is about 180 organizations,…
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…