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In a world where change is the only constant, organizations can no longer afford to be complacent. Keeping up with the pace of technological change is tough, and all business leaders must learn to adapt. It’s no longer enough to react to disruption. To get ahead of the competition, organizations…
Megan Wallin-Kerth
When you think of good customer service—particularly the barriers to it—two factors generally come to mind: timing and wording. Imagine walking into a store that sells soap and bodywash products and immediately being bombarded with, “May I help you?” “Looking for anything today?” or the dreaded, “…
James Chan
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the businesses…
William A. Levinson
Most quality practitioners are familiar with the Taguchi loss function, which contends that the cost of any deviation from the nominal follows a quadratic model. This is in contrast to the traditional goalpost model, where anything inside the specification limits is good, and anything outside them…
Mike Figliuolo
Susan Strayer, a friend of mine, posed a question on social media the other day: “Can you sum up your expertise in 140 characters or less?” Great question. A few people took her up on the challenge. Being an overachiever, I did it in three words. Before I dive in, let me provide some context.
For…
Etienne Nichols
Design controls are a set of quality practices and procedures used to ensure that a finished device meets its user needs, intended use, and specified requirements.
The requirement for medical device companies to use design controls is established in 21 CFR Part 820, as well as ISO 13485:2016.
The…
George Schuetz
We ended the previous gaging article talking about the 10:1 rule as it applies to the performance of a gage.
The rule says that the gage should perform to a level better than 10% of the tolerance. Although this rule has mostly been replaced by the more scientific and standardized GR&R…
Nadav Klein
When conflicts in a team, no matter how minor, are left unresolved, they can eventually breed resentment. If unaddressed, this could lead to cynicism and distrust, as well as harm to individual and team performance. How should leaders deal with this?
The intuitive answer might involve…
Gleb Tsipursky
As businesses navigate the complexities of remote and hybrid work policies, leaders often face questions regarding the perceived fairness of these arrangements. Employees performing similar tasks may have different levels of flexibility, which can lead to concerns about favoritism and inequity.…
Sabine Terrasi
Up-to-date and accurate maps of the waterways are a prerequisite for safe and efficient shipping in Germany. Authorities such as the Federal Maritime and Hydrographic Agency, but also private harbor operators, are obliged to provide these maps in an up-to-date form at all times. Primarily, the…
Jennifer King
Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.
MYCIN, a computer-based model with machine learning capabilities, was developed by a team of researchers at Stanford…
Alexander Shipps
The phrase “practice makes perfect” is usually reserved for humans, but it’s also a great maxim for robots newly deployed in unfamiliar environments.
Picture a robot arriving in a warehouse. It comes packaged with the skills it was trained on, like placing an object, and now it needs to pick items…
Donald J. Wheeler
The objective of all improvement projects should be to improve the overall process. Everything else should be secondary to this objective. If you improve the efficiency of a support process, or even a portion of the core process, but at the same time lower the efficiency of the overall process,…
Jones Loflin
As a leadership keynote speaker, I’ve encountered countless professionals struggling with procrastination. We’ve all been there–staring at a mountain of “should-do” tasks while our minds wander to more enticing activities. But what if I told you there’s a way to turn those dreaded tasks into…
Oliver Hagenlocher
MR Components, of Grigno, Italy, has significantly increased its production capacity and simultaneously improved quality by introducing intelligent automation with EMAG CNC machines.
The company, which specializes in the production of parts for differential and planetary gears, now produces around…
Dawn Bailey
Nearly everyone by now has experienced artificial intelligence (AI) in some capacity. It has become part of our lives, from interactive voice assistants (e.g., Alexa, Siri) to Face ID on smart phones , virtual filters on apps, and algorithms on search engines and screening sites that use our…
Michael Platt, Vera Ludwig
Four years after the Covid-19 pandemic accelerated remote work, its advantages and drawbacks have been well documented. For leaders, the biggest hurdles have remained constant: building employee engagement, trust, and communication.
Nano Tool
Scientists from the Wharton Neuroscience Initiative …
Mike Figliuolo
In case you missed it, the apocalypse happened a few weeks ago. The end of days. The reckoning. It was a time to take a step back and reflect on all you’ve accomplished or failed to accomplish in your life. Even though the world was not torn asunder by explosions, the reflection on what life means…
Automated Precision Inc.
In the highly competitive automotive industry, quality control is paramount to ensuring the reliability, safety, and performance of vehicles. Metrology, the science of measurement, plays a crucial role in achieving these high standards at every stage of automotive production and testing. Let’s…
Gleb Tsipursky
In the brave new world of hybrid work, where the lines between office and home are blurred, employers are navigating uncharted waters. Some have resorted to a draconian approach, implementing surveillance measures to monitor their employees’ productivity. Yet, evidence is mounting that such Big…
Robyn Coward, Brian Brooks
This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle.”…
Akhilesh Gulati
Maria took a moment to reflect on how much had changed in just over a year since she first explored ChatGPT with her informal innovation group. Back then it was more of a novelty, a fun challenge to see whether artificial intelligence could answer their mundane questions correctly. Sometimes it…
Mark Graban
In the world of continuous improvement and lean management, clear and respectful communication is crucial.
Let’s take a moment to examine two different approaches to communicating a simple instruction regarding the operation of a centrifuge, as seen in the images below—pictures I took in a…
Megan Wallin-Kerth
As societal norms change with each passing generation, so do work trends and expectations. Today, employers are seeing a notable shift in the attitudes, values, and goals of the next generation of workers.
At TalentLMS, surveys capture these changes with targeted questions. A recent report found…
Harish Jose
Recently, I wrote about the process capability index and tolerance interval. Here, I’m writing about the relationship between the process capability index and sigma. The sigma number here relates to how many standard deviations the process window can hold.
A +/– 3 sigma contains 99.73% of the…
