All Features
Del Williams
For owners and operators in the agricultural and food-processing industries, Jan. 1, 2022, was the deadline for completing a dust hazard analysis (DHA) for existing facilities in accordance with Chapter 7 of the National Fire Protection Association’s Standard 61 (2020) for the Prevention of Fires…
Scott Trevino
Nearly a quarter of surveyed healthcare cyberattack victims experienced increased mortality rates following a data breach, and more than half reported poorer patient outcomes due to longer hospital stays and delayed procedures. Healthcare has faced the highest average data breach cost—more than $10…
Gleb Tsipursky
One of the key stakeholders in stakeholder capitalism is the employee. You could argue that the employee is the key stakeholder, because without employees you’d have no stakeholders at all. This is why employers need to stay aware of today’s health environment and its effect on their employees.…
Matthew Barsalou
A root case analysis is performed to identify “what, how, and why something happened, thus preventing reoccurrence” (“Root Cause Analysis for Beginners.” Rooney, J. J. and Vanden Heuvel, L. N. Quality Progress 37, 2004, p. 45). This can be difficult when the problem being investigated is both…
Sue Via
Research shows that during times of economic uncertainty, companies that find a balance between reducing the resources they need to survive and investing in key areas for growth will fare better through a recession and beyond. It’s a nuanced approach that involves playing offense and defense at the…
Harry Hertz
Yes, I have a wicked dream. No, not that definition of wicked—I mean wicked in the sense meant by scientists when they discuss “wicked problems.” Wicked problems are those that typically involve a combination of technical, social, and economic challenges. Wicked problems are daunting. They’re…
Craig Matthews
Producing quality work is imperative in every field, particularly in the construction industry. A well-built structure, whether it’s an educational facility, hospital, or a commercial establishment, provides shelter, safety, and stability, which is why quality should always be a top priority. As…
In a press statement released on Jan. 6, 2023, the European Commission reported the adoption of a proposal to allow more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices…
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,…