All Features
Jon Speer
During the past several years, the FDA has been more aggressive and active in performing medical device company inspections. This has led to a far greater number of companies receiving Form 483 warning letters and citations. FDA Form 483s are a good way for your medical device company to flush $…
Chad Kymal
ISO 9001:2015, ISO 14001:2015, and ISO 45001:2015 establish clear expectations for top management. Not only are executives accountable for the effectiveness of these respective systems, they also have specific tasks ranging from establishing objectives to supporting relevant managers in their…
Lawrence Livermore National Laboratory
Although the most common method of metal 3D printing is growing exponentially, moving forward from producing prototypes to manufacturing critical parts will be possible only by reaching a fundamental understanding of the complex physics behind the process, according to a new paper written by…
Gilles Hilary
In March 2014, Malaysian Airlines flight 370 disappeared on its way to Beijing. To this day, the fate of the plane has not been established. The tragedy of the aircraft’s disappearance was exacerbated by the images of distressed relatives herded into hotels in Kuala Lumpur and Beijing and being…
Thomas R. Cutler
Quality professionals in most manufacturing plants still have safety under their area of responsibility. Safety has been a growing concern in the workplace for decades, and in warehouse operations, forklift safety is one of the biggest.
OSHA statistics report that more than 100 workers are killed…
Kevin Cundiff
Ask how you can help, always keep a smile, respond to requests promptly... the list goes on. You’ve probably been exposed to an abundance of tips and tricks about how to become more customer-friendly.
That kind of advice can definitely be valuable, but what you likely don’t hear—unless you’re a…
Arun Hariharan
Technology is a useful tool in quality. That said, there are limits to what technology can do. Here’s my summary of its advantages and disadvantages for quality professionals.
1. Data and measurements. Technology can help you automate measurements and analysis of data (Minitab statistical software…
Grant Ramaley
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member countries: the…
Annette Franz
What happens when we really understand our customers’ desired outcomes or the jobs they are trying to do? Something pretty incredible.
A few weeks ago I wrote about “Faster Horses... and Customer Outcomes” and the importance of asking the right questions to understand desired outcomes in order to…
Brandon Henning
Although the FDA’s Food Safety Modernization Act (FSMA) was passed in 2011, the reality is that the rules that went along with the law—and that truly define how it will be executed and regulated—are just now being finalized. Enforcement of these rules should really ramp up in 2016 and 2017.
Will…
NIST
Flu season typically peaks between December and February, but by the time the winter holidays roll around, many of us will have already waited in line at area clinics, grocery stores, and pharmacies to get our annual flu shot. The Centers for Disease Control reports that U.S. vaccination efforts…
These days, even a cursory scan of the headlines brings fresh reminders of risk, from the ramifications of climate change to shocking terror events such as the recent attacks on Paris by the Islamic State. Now more than ever, companies need risk managers.
Paradoxically, however, the new ubiquity…
Donald J. Wheeler
The Levey-Jennings chart was created in the 1950s to answer questions about the quality and consistency of measurement systems in the chemical and process industries. This column will illustrate the fatal flaw in this technique and show a better way to track the consistency of your measurement…
Nathan Furr
Hackers and hipsters may be behind the innovative success of today’s startups, but established companies require different skill sets.
It’s becoming obvious to the startup world that entrepreneurial teams based on the corporation’s typical structure work poorly. The idea that a team should be…
Greg Fox
Unless you live under a rock, you’ve no doubt heard that the world recently lost David Bowie, one of the greatest artists of our time. My memories of the Thin White Duke go all the way back to my formative years. I recall his music echoing through the halls of our house as I crooned along while…
Jesse Lyn Stoner
When applied to people’s intelligence, the theory behind the bell curve says that most people will be average, with a small percent being top performers and a small percent being losers. But when it comes to performance, the truth is the bell curve only exists if you believe it does.
Robert…
NIST
Manufacturers, robot suppliers, and researchers, here’s your chance to get in on the ground floor of an upcoming national competition intended to help make robots more handy and nimble on the factory floor.
The National Institute of Standards and Technology (NIST) is launching the Agile Robotics…
Michael Webb
This month Quality Digest Daily welcomes Michael Webb, a noted author and consultant who writes about how the quality and productivity sciences improve sales and marketing departments.
How well does your company benefit from quality improvement and productivity? For instance, how well do you…
Joe Humm
While contemplating the teachings of Edwards Deming, who is widely known for being vocal on the topics of quality and statistical analysis, I thought I’d delve into a few areas where he was a little less known, but just as passionate and to a certain extent influential: leadership and innovation…
Davis Balestracci
As I was preparing this column, one of my resources referred to chapter 48 of the 2,500-year-old Tao te Ching (quoted below), which, as some of you know, is one of my favorite sources of wisdom. It really tied today’s message together, and I hope you can apply its wisdom to your improvement…
Howard Yoon
As a physicist who explores ways to measure light more accurately, it should come as no surprise that I’m fascinated by even common optical phenomena that we see all around us (e.g., rainbows or oil slicks on butterfly wings).
Rainbows occur because light travels through water and air at…
Miriam Boudreaux
Before 2015, many of us rode one of the largest waves of success in the history of the oil and gas industry. Everything was booming—companies, salaries, bonuses, cities, services, etc. Then 2015 came and crashed the party, leaving us all a bit uncertain.
Now, entering 2016, you may have some your…
Lolly Daskal
T
he negotiation phase of my client’s merger with a larger organization was drawing to a close. This consolidation was going to be big news, and everyone was looking forward to getting it done. I sat with my client through a long week of agreeing to terms, and then it happened: The other CEO’s…
Katherine Watts
It amazes me how seemingly disparate ideas, when considered together, can create new ways of seeing the world. Bear with me for a minute, and I’ll share an insight I’ve received lately based on two seemingly unrelated ideas.
Here’s the first idea: New York Times bestselling author Bruce Feiler…
Niranjan Deodhar
As process improvement practitioners, we get hired to drive waste and variation out of our clients’ businesses. But what if we hired ourselves, provided frank advice, and then listened to it to drive waste out of our own business or process?
Could we then drive down the cost of organizational …
