All Features
Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR…
Kate Zabriskie
‘Who designed this convoluted process? A monkey could have done a better job.”
“Why do I have to come in and talk to someone? This whole transaction could be handled online. Frustrating!”
“I dread going there. The parking lot is impossible to navigate, you fill out what seems like 8,000 forms…
Bryan Christiansen
Creating a well-run facility isn’t as simple as it appears. It requires meticulous planning, dedicated resources, and a keen eye for detail to ensure that all elements, from the largest machines to the smallest fixtures, function as intended.
All these aspects fall under the umbrella term of…
Max Farrell
While recent economic reports on inflation have signaled positive signs for the future, frontline industry turnover rates remain high. With further supply chain disruptions looming, retaining top talent has never been more important for employers. These pressing challenges and continual raw-…
Michael Jarrett
History is filled with tales of courageous and decisive heroes. Individuals like Julius Caesar and Winston Churchill, for example, have led from the front to guide people through adversity and achieve ultimate success. This myth building is especially prominent in business, with stories of…
Donald J. Wheeler
A simple approach for quantifying measurement error that has been around for over 200 years has recently been packaged as a “Type 1 repeatability study.” This column considers various questions surrounding this technique.
A Type 1 repeatability study starts with a “standard” item. This standard…
Ian Wright
It’s been a long and arduous road, but you’re almost ready for that first production run. You made it through supplier selection, your designs and production processes have been finalized, preproduction is finished, and now there’s just one more hurdle to clear: first article inspection (FAI).…
Gleb Tsipursky
Hybrid employees don’t hate the office; they hate commuting to it, surveys show, since for many workers commuting takes more than an hour per day and costs thousands of dollars per year. Peer-reviewed studies find clear associations between longer commute times and lower job satisfaction, increased…
Del Williams
Along the coasts and in many countries, seawater is widely used for cooling systems at power plants, as well as for some mining and industrial processes. The challenge, however, is that strainers must sufficiently filter out both small particles (e.g., sand, silt, suspended solids) and larger…
Stephanie Ojeda
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.
Consider, for example, an electronics manufacturer that introduces a new product model with updated features and components. This new model requires…
Russell Riddiford
Manufacturing has moved on from simple cutting tools; your customers expect you to create high-quality tools from top-end materials with little room for error. The industry is focused now on the end-to-end process, from sourcing the best materials to providing the best customer experience, and that…
Jones Loflin
One of the things I hear from many people is they want to improve their ability to focus. If they just had a distraction-free environment, they could get the right things done. Well, I’m writing this from a distraction-free environment—one of those booths they have at airports where you can make…
Etienne Nichols
Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under finance’s umbrella.
1. Start by learning about your…
Fred Sievert
Ask any executive what he or she considers the most important skills for team members who aspire to leadership roles, and you will get answers ranging from clear communication to collaboration to adaptability.
During my career, especially as the president of New York Life Insurance, I found that…
Mike Figliuolo
Sometimes you fire someone who doesn’t deserve it. Your job as a leader is to admit the mistake and do your best to rectify it properly as soon as possible.
Many of you (likely about 80%) have fired someone at some point. The odds are that some of you made a mistake in doing so along the way. A…
Megan King
If you’ve ever tried on clothing at a store only to have it look completely different at home, you know how much our eyes depend on lighting to help us see colors.
We also all interpret colors a little differently, even with the same lighting.
Remember the social media controversy over the color…
Kari Miller
Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S. Food and Drug Administration (FDA) inspections, particularly for the medical device industry. Issues can occur while…
Chandrakant Isi
Additive manufacturing (AM) and AI are two of the most exciting fields in technology today. 3D printing has revolutionized manufacturing and design, allowing for the creation of complex objects with ease. Meanwhile, AI tools such as ChatGPT, MidJourney, Stable Diffusion, and Resemble have shown…
Automated Precision Inc.
As industries around the world work to make their process and products not only automated but also autonomous, there has been an explosion in the use of detection and ranging systems during the last 20 years. Detection and ranging systems date back to radar systems that were developed during World…
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).
A QMS contains everything that…
National Physical Laboratory
Graphene and related 2D materials have the potential to disrupt technologies such as energy storage devices, composites, and electronics through their exceptional material properties. Depending on the material, these can include properties such as high electrical conductivity, high mechanical…
FABTECH
Manufacturers understand that their businesses won’t grow if their workforces don’t grow along with them. That’s why the talent shortage in the metal fabrication industry continues to be a pressing concern—and three-quarters of respondents in the National Association of Manufacturers’ 2023 First…
Hank C. Andersen
Not many years ago, there was a CEO so exceedingly fond of finding the right strategy that he spent all of his money on consultants to tell him what the strategy should be. One day there came two consultants, and they said they could craft the most magnificent strategy imaginable. Not only would it…
Megan Wallin-Kerth
Business owners and employees alike have long debated over how best to achieve quality standards and what those standards ought to be. However, as much as linear thinking may help when measuring degrees of improvement, increases in profit, or low turnover rates, it can’t tell you that your company…
Angie Basiouny
Wharton experts used machine learning to help uncover the secret formula for successful healthy habit formation, and it turned out there’s no one formula.
“There’s this widely spread rumor that it takes 21 days to form a habit,” says Katy Milkman, a Wharton professor of operations, information,…
