All Features
Jonathan Jacobi
When I first entered the safety profession, older, more experienced professionals recommended that I consider OSHA as a potential employer. The innuendo I sensed in this advice was that if I worked for the Occupational Safety and Health Administration (OSHA), got to know influential people, and…
Day in, day out, business leaders are reminded that digital disruption is coming for their customers, for their talent, and for their bottom lines. CEOs of traditional companies consistently rate digital upstarts disrupting their business models as their No. 1 concern.
And it’s no wonder. We’re…
ISO
The global food industry has never faced more challenges. From tainted dairy products to contaminated beef, high-profile cases crop up regularly to dent consumer confidence, while leading companies work hard to reclaim lost faith. So how trustworthy is your food?
Food safety is something we tend…
Loic Sadoulet, Thomas Hinterseer
It’s a tragic irony that the day before the 2010 Deepwater Horizon oil well disaster, executives from BP and the rig’s operators, Transocean, visited the platform on a “management tour” that included a number of specific safety-related purposes.
During the tour, there were already signs that all…
Knowledge at Wharton
I t wasn’t that long ago that GM ran commercials advertising that its Oldsmobile division didn’t just produce cars for your grandfather, but also for everyone else. It was an attempt to reinvent the brand’s staid image—and it didn’t work.
Now, the Oldsmobile division and its iconic vehicles are…
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Fred Schenkelberg
A fault tree analysis (FTA) is a logical, graphical diagram that starts with an unwanted, undesirable, or anomalous state of a system. The diagram then lays out the many possible faults, and combinations of faults, within the subsystems, components, assemblies, software, and parts comprising the…
More than 313 million global work-related accidents occur each year, according to the International Labour Organization, with a high percentage of those accidents resulting in significant time away from work. Each accident bears a personal and financial cost for the worker and the employer. Yet,…
Sam Sharter
The tragic shooting in Orlando brought dozens of victims to emergency rooms. Even now, several of those people are still clinging to life. Many across the nation are praying for them and the other victims. Without quick response and high-quality emergency medical care, many more than the 49 already…
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
In fiscal year 2015, there were more than 34 million shipments of FDA-…
Cuong Nguyen
When I go home after work, my wife and I are typically focused on the present moment, and especially on our young son. As new parents, we benefit from many innovative products and services—from improved car seats and creative toys to safer cribs and video baby monitors. One of the first products…
Gilles Hilary
President Obama has been injured in a terrorist attack on the White House. A tweet released by the Associated Press (AP) attests to this. It carries the company’s “verified” stamp of authenticity. The S&P 500 just lost more than $130 billion. Well, not quite.
The AP’s tweet was the byproduct…
The QA Pharm
Aquality management review of data with responsible company leadership is a current good manufacturing practices requirement. Quality management review procedures vary, but there seems to be a struggle with presenting data from across the quality management system in a meaningful and consistent…
Mike Figliuolo
Work is a convenient excuse for not taking care of yourself. Not exercising, poor diet, and stress are a bad combination. You’ve got to make time for you. Work will always be there when you get back.
Just over a year ago, I had a heart attack. My second heart attack. Yep. Two. The first one…
Jeffrey Phillips
The tone of this article is a bit tongue in cheek, but the point is quite serious. Innovators go through a number of phases as they accept the reality of innovation based on what executives and corporate culture allow. Growing as an innovator is something like experiencing the seven stages of…
Rachel Tracy
Two things are true when it comes to making important decisions that affect your company: You need a way to quantify risk to make the best choice, and you need to be able to explain that choice. A risk matrix helps you do both.
Calculating risk across various outcomes can give you clear…
Stephan Manning, Marcus M. Larsen
One of the big themes in the current presidential race is how decades of free trade have dealt a heavy blow to the U.S. worker as millions of jobs were shipped overseas to take advantage of cheap labor.
That’s even turned some pro free-trade Republicans into protectionists. As a result, the…
Rachel E. Sherman, Robert M. Califf
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply these constructs as we go about building such a…
Taran March @ Quality Digest
They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the globe.…
Jeffrey Eves
Sponsored Content
There are many paths for organizations to become good, sustainable, low-footprint citizens of the business world. Production processes can be redesigned to be more efficient, corporate campuses can be located so as to reduce employees’ dependence on fossil fuels, and buildings…
NIST
Recently on the Taking Measure blog, we asked Tara Lovestead, a recipient of the 2016 Presidential Early Career Award for Scientists and Engineers (PECASE), a few questions about her life and work. She was recognized for her extensive application of new methods to rapidly and inexpensively detect…
Rachel E. Sherman, Robert M. Califf
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
Paul Voss
Not long ago, most Americans could safely ignore congressional deliberations about Federal Aviation Administration (FAA) authority, leaving the details to industry experts and lobbyists. But this time, we may need to fasten our seatbelts and actually read the card in the seat pocket.
A bill under…
Tim Lozier
When we look at business dynamics, regardless of industry, we see an increasing rate of change in products, processes, and regulations. One process affects the next, and with a growing focus on regulations and standards, complexity becomes an ever-expanding theme, whether related to quality…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
