All Features
Erwin Miller
The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to…
Right now, scientists all over the world are trying to understand how we get injured when our bodies are subjected to strong, dynamic loads—a hard body-check on the hockey rink, a tackle on the football field, a car crash, or even a bomb blast. Fortunately, I haven’t had any experience with bomb…
Davis Balestracci
Today I want to concentrate on the foundation of what is most commonly taught as design of experiments (DOE)—factorial designs.
Elsewhere I’ve mentioned three of C.M. Hendrix’s “ways to mess up an experiment.” After 35 years of teaching DOE, I’ve concluded that he pretty much captures the…
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…
NIST
A high-tech version of an old-fashioned balance scale at the National Institute of Standards and Technology (NIST) has just brought scientists a critical step closer toward a new and improved definition of the kilogram. The scale, called the NIST-4 watt balance, has conducted its first measurement…
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…
Sam Manzello
I’m a dragon wrangler. Although that might sound like something straight out of Harry Potter or Game of Thrones, this isn’t fantasy—it’s serious science.
As a fire researcher, or more colloquially, a dragon wrangler, my job is to help protect people and property from fire’s devastating effects.…
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…
James Olthoff
I’m a physicist, and as anyone who watches the popular TV series The Big Bang Theory knows, it’s a commonly held conception that there is a strong connection between being a scientist and being enthralled with all things science fiction, fantasy, and superheroes. Anyone who walks into my office at…
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…
NIST
Anyone who has ever covered a wall with sticky notes to clearly map all of the steps in a process knows how valuable that exercise can be. It can streamline workflow, increase efficiency, and improve the overall quality of the end result. Now, a public-private team led by the National Institute of…
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…
Brian Stanton
Doors that are obviously meant to be pushed not pulled, footprints painted on the floor telling you where to stand at the airport—these are examples of good design and usability. You don’t have to think too hard about what to do because someone else put a lot of thought into how to get across the…
Chad Kymal
The aerospace standard AS9100 Revision D was originally planned to be released in April 2014. Many of us close to the standard expected it to be released in May 2016 after the April International Aerospace Quality Group (IAQG) meeting in Singapore. However, this was not the case; the IAQG decided…