All Features

Dirk Dusharme @ Quality Digest
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…

Megan Wallin-Kerth
Founded in 2012, GoFormz is a uniquely flexible documentation platform for professionals in all industries—and a long-awaited solution for those chasing lean efficiency without sacrificing quality.
What does that mean? Well, unlike using a fillable PDF or Adobe document, GoFormz is an online…

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…

Rob Press
Without the perfect balance of efficient workers, adequate resources, and satisfied customers, manufacturing businesses risk sending their operations into a tailspin.
Workforce optimization (WFO) streamlines manufacturing workflow by cutting costs and increasing productivity—allowing you to…

Rashan Dixon
The ability of flawed and inherently limited humans to lead others like them toward a common goal takes a special skill set. Even if a leader has the talents required to lead a business, that doesn’t mean they’ll immediately see positive results. Good leaders know that they need to find ways to…

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…

Gleb Tsipursky
After firing half its workforce, Twitter is already asking many to come back. Indeed, research from McKinsey finds that even as recession fears grow, 40 percent of workers plan to quit their jobs. And a survey from Greenhouse, a New York-based hiring software provider, finds that 57 percent of 1,…

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…

Donald J. Wheeler
There are four major questions in statistics. These can be listed under the headings of description, probability, inference, and homogeneity. An appreciation of the relationships between these four areas is essential for successful data analysis. This column outlines these relationships and…

Lee Seok Hwai
Think innovation, and what comes to mind? For many, it invariably evokes big names like Apple and Tesla, their epoch-defining products ranging from the smartphone to electric vehicles, and genius leaders like Elon Musk and Steve Jobs. But is innovation only for the select few?
Not at all,…

Harry Hertz
The saying is nothing new: The customer is always right. Customers come first. We’ve heard these adages for a long time. And we’ve questioned them for almost as long. Those of you who know me know that I’ve certainly been doing that for a long time!
Two recent experiences brought this topic back…

Hanen Khemakhem, Mahbub Zaman, Nadia Smaili, Richard Fontaine
Whistleblowing is a cornerstone of corporate governance. It allows employees to anonymously disclose questionable financial matters about their companies to help prevent fraud, which is a pressing issue in Canada. It’s also incredibly effective, with 42 percent of occupational fraud being reported…

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…

David L. Chandler
Terahertz radiation, with wavelengths that lie between those of microwaves and visible light, can penetrate many nonmetallic materials and detect signatures of certain molecules.
These handy qualities could lend themselves to a wide array of applications, including airport security scanning,…

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…

Dirk Dusharme @ Quality Digest
In 2010 a medical device scandal in France set the stage for a new European Union medical device regulation that, according to most experts in the medical device community, may cause more damage than the problem it was intended to address. An unreasonable deadline, lack of notified bodies to…

Tim Mouw
Metallized substrates such as two-piece metal packaging are expensive to produce, and they make print color-control challenging. Although many in the metal decorating sector are hesitant to embrace color measurement, it’s the fastest, most accurate, and cost-effective way to produce consistent…

Nicole Radziwill
The 2022 theme for World Quality Week, an annual campaign presented by the U.K.’s Chartered Quality Institute (CQI) and International Register of Certificated Auditors (IRCA), was “Quality Conscience: Doing the Right Thing.” Working in quality often requires us to make tough calls and stand up for…

Robert Zaruda
Northwest Industrial Resource Center (NWIRC), one of the centers that make up the Pennsylvania Manufacturing Extension Partnership, is helping launch student-run enterprises throughout northwest and north-central Pennsylvania. These enterprises connect industry with high schools and career and…

Maria Guadalupe, Bryan Ng
Soft skills, the behavioral and social traits that enable individuals to work harmoniously with one another, aren’t just nice to have. They’re essential for the growth of a nation.
In France, 60 percent of employers consider soft skills, such as the ability to organize, adapt, and work in teams,…

Gleb Tsipursky
Imagine you put on an old coat you haven’t worn in a while, and to your surprise you find a crumpled $20 bill in your pocket. How good does it feel? Do you go up half of a notch on a 1–10 mood scale—or maybe a full notch?
Let’s imagine a different scenario. Your grandmother calls to say she hopes…

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…