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Anthony Murphy
Kendrick Plastics is an IATF/TS 16949-certified, tier one and tier two supplier of interior decorative trim components and assemblies to the automotive industry. Located in Grand Rapids, Michigan, its 300,000 sq ft engineering and manufacturing facility has more than 50 presses serving fully…
The Un-Comfort Zone With Robert Wilson
When I was a kid, I was enamored of cigarette-smoking movie stars. When I was a teenager, some of my friends began to smoke; I wanted to smoke too, but my parents forbade it. I was also intimidated by the ubiquitous anti-smoking commercials I saw on television warning me that smoking causes cancer…
Jamie Flinchbaugh
Editor’s note: This is an excerpt from the new book People Solve Problems: The Power of Every Person, Every Day, Every Problem (Old Dutch Group, 2021) by Jamie Flinchbaugh.
For anyone reading this who is familiar with my teaching, this will come as no surprise: Problem-solving tools are not the key…
Gleb Tsipursky
‘I don’t see how we can replace the serendipitous idea generation of hallway conversations,” said Saul, the director of quality management for a 1,500-employee enterprise software company, during a planning meeting about the company’s post-vaccine return to the office. “If we don’t return to the…
Barnaby Lewis
Harran blinks in the sunlight, adjusting his eyes. He’s an inquisitive child, enthusiastic for all things new, yet still he struggles to understand what he’s looking at. A man is pressing marks—triangles or wedges—into a piece of clay, explaining that in this way he can speak to people, even when…
Grant Ramaley
The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485. IAF MD9:2022—“Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)” provides the mandatory requirements for…
Rodney Rohde
Medical laboratory professionals form the backbone of healthcare and the public health system. They conduct some 13 billion laboratory medicine tests annually in the United States. As of February 2022, these individuals had also performed more than 900 million Covid-19 tests and counting during the…
Ryan E. Day
ISO 9001:2015, Clause 6.1 introduces the term “actions to address risks and opportunities,” as a replacement for the standard’s previous term, “preventive actions.” The juxtaposition of “risks” and “opportunities” seems to imply a relational nature between the two concepts. But is it still…
Georgia Institute of Technology
This country’s semiconductor chip shortage is likely to continue well into 2022. Now, a Georgia Tech expert predicts that the United States will need to make major changes to the manufacturing and supply chain of these all-important chips to stave off further effects. That includes making more of…
Jennifer Helgeson, Maria Dillard
In September 2018, a North Carolina city’s long road to recovery from Hurricane Matthew two years earlier became even longer. Lumberton, a small but diverse city of 21,000 people, 96 km (60 miles) inland from the coast, unfortunately found itself in Hurricane Florence’s sights. The Lumber River,…
Theodoros Evgeniou, Caroline Zimmerman
This isn’t a new story: A novel technology disrupts society, bringing with it many benefits but also major risks and costs. We saw it during the Industrial Revolution, which vastly improved the average living standard but also led to poor labor conditions and environmental degradation, all within a…
Derek Hills
The importance of medical device cybersecurity is growing exponentially. As more devices become connected to the internet, threats to public safety mount. Cybercriminals, formerly interested in stealing financial or medical records, have begun to essentially hold healthcare providers hostage by…
Donald J. Wheeler
Most of the world’s data are obtained as byproducts of operations. These observational data track what happens over time and have a structure that requires a different approach to analysis than that used for experimental data. An understanding of this approach will reveal how Shewhart’s generic,…
Tahira Reid, James Gibert
People interact with machines in countless ways every day. In some cases, they actively control a device, like driving a car or using an app on a smartphone. Sometimes people passively interact with a device, like being imaged by an MRI machine. And sometimes they interact with machines without…
Emily Newton
Welding technology has progressed over the years, thanks to innovations that improve accuracy and overall productivity. Some advances have been in welding automation handled by advanced robots. Other breakthroughs rely on artificial intelligence (AI) and machine vision for better defect detection.…
Rebecca Saenz
There are three key things cobot developers and employers using cobots must remember when considering implementation: 1) human life takes precedence, 2) human life takes precedence, and 3) human life takes precedence.
Dictionary.com defines cobot as “a computer-controlled robotic apparatus that…
Josh Wilson
Paraphrasing Winston Churchill, Rahm Emanuel, a former White House chief of staff and Chicago mayor, famously quipped that you never want a serious crisis to go to waste. Few of us will face the number of crises that a big-city mayor or a presidential aide may deal with in a day, but we still need…
Megan Wallin Kerth
In the wake of manufacturing and chip shortages, some may think that Covid-19 slowed down production on the whole as supply chain issues and remote work presented significant obstacles for manufacturers. However, there were both struggles and some unexpected benefits that arose as professionals…
William A. Levinson
The U.S. Military Academy’s Honor Code says that “A Cadet will not lie, cheat, steal, or tolerate those who do.” Lt. Gen. Darryl A. Williams, the USMA’s superintendent, elaborated, “The tenets of honorable living remain immutable, and the outcomes of our leader development system remain the same,…
Prasad Akella
We are a full two years into post-pandemic manufacturing life, with the omicron variant the latest cause for concern. It might sound hyperbolic, but I’m pretty sure manufacturing will never be the same as it was in 2019. In some ways, that’s a good thing.
One silver lining of the novel coronavirus…
Bill Marler
Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for…
Bruce Hamilton
You may recognize the following quote from Friedrich Nietzsche, or more recently from Kelly Clarkson: “What doesn’t kill you makes you stronger.” I’ve thought about this often during the last 22 months in context of the horrible pandemic and, more parochially, in relation to the efforts of many…
Mike Richman
It’s hard to fathom that Quality Digest, a little Northern California media company respected by all and beloved by many, turned 40 in November 2021. For a human being, 40 may be the new 30, but it’s still just creeping up on middle age. For a small business, on the other hand, 40 years is…
Dr T Burns
I’m a chemical engineer. The fundamentals of the chemical engineering profession were laid down 150 years ago by Osborne Reynolds. Although chemical engineering has seen many advances, such as digital process control and evolutionary process optimization, every engineer understands and uses Reynold…
Steven Severt
Although ISO 19011—“Guidelines for auditing management systems” has included language about remote quality management system (QMS) auditing since the 2018 revision, this became a reality for many of us in March 2020 with the onset of Covid-19 and the mass lockdowns that ensued. Many of us have been…