All Features
Seb Murray
Last year, the corporate world adopted a new term: flattening. This refers to how tech companies, which rapidly hired droves of middle managers during the pandemic boom, are now eliminating this layer through widespread job cuts.
Recent research by Mustafa Dogan, Alexandre Jacquillat, and Wharton’…
ISO
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…
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…
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…
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…
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…
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,…
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 …
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.”…
John Tschohl
Are your employees empowered to make decisions on the spot in favor of the customer? Your single goal should be to have overly happy customers. Too many things go wrong each day. You want your employees to understand they are in customer service, and their No. 1 responsibility is to take care of…
Touradj Ebrahimi
For the last 30 years, the JPEG image format has been a staple for the internet’s billions of users. While the technologies used to display images have evolved tremendously during the past few decades, the JPEG format is still used everywhere. This is a great example of what can happen when a new…
John Hilgendorf
Whether you’re an executive with limited energy or an hourly employee trying to minimize work, the bottleneck in your productivity isn’t time or money but mental effort. And in a digital age where all data can be stored electronically, the most valuable functions of software—especially those in…
Mike Figliuolo
Reading the news (or even your email) can be distressing to the point of despondency. It can also be fun. It’s especially fun when people say or write silly stuff, and the reporter or editor has to write [sic] after a misspelling or a stupid comment in the original transcript. Sic, usually placed…
Etienne Nichols
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).
The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation (QSR) with the…
Megan King
In 2018, the world agreed to redefine the kilogram. Instead of being pegged to the mass of a physical object in a vault in France, the kilogram is now defined by a few fundamental constants in nature.
This means researchers no longer have to worry about a physical object that can decay or change…
Stephanie Ojeda
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact…
George Schuetz
In this job, I get a lot of questions. In fact, I did some figuring the other day and estimated, conservatively, that we have probably answered at least 50,000 gauging questions over the past 35 years or so.
Some of these questions have been challenging. They’ve pushed me to learn more about my…
Chris Rush
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices when…
ISO
Global awareness of climate change and sustainability has grown exponentially during the past decade, making terms like corporate responsibility, carbon footprint, and transparency the new buzzwords of our time.
The drive toward a more sustainable future has propelled environmental, social, and…
ISO
When a patient comes into a clinic or hospital, healthcare practitioners have all the tools at their disposal to conduct thorough examinations. However, when they see a patient online, they may lack the necessary equipment to conduct the visit properly. One reason for this is that virtual care…
Chip Bell
The cost of acquiring a new customer can be five to 10 times the cost of keeping an existing customer, depending on the industry. You already knew that. But while most organizations know why their customers opened the exit door, they devote little effort to understanding what prompted customers to…
Patty Davidson
For the U.S. Department of Labor’s Wage and Hour Division, protecting children in the workplace is the top priority. The division is responsible for enforcing foundational labor standards, including the child labor provisions of the Fair Labor Standards Act (FLSA). The FLSA establishes minimum wage…
James Chan
Maintenance teams operate in challenging environments that can often produce workplace mishaps, near misses, and other potential hazards. That’s where maintenance incident reports come in. Not only do these reports help team members isolate and problem-solve safety concerns, leading to a safer…
Andrey Solin
Disclaimer: This isn’t meant to be a car review. This is an article on brand authenticity.
Back in 2021, when Ford was promoting the Mustang Mach-E GT, its high-performance electric vehicle, the company found a way to appeal to potential buyers who somehow missed the sensory appeal of gasoline-…