Stephanie McArdle
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.
The ASR program originally launched in...
Manfred Kets de Vries
David was extremely gratified when he was named businessman of the year. He felt he deserved the recognition. Many articles had portrayed him as an entrepreneur who had reframed his industry, which...
Knowledge at Wharton
For decades, relatively easy access to space and the big profits to go with it have dangled elusively just over the horizon. With a little more R&D money and a few more advances in the technology...
Stephen Rice
As driverless cars become more capable and common, they will change people’s travel habits not only around their own communities but across much larger distances. Our research has revealed just how...
Romesh Saigal
Soon after the Great Recession, the U.S. stock markets plunged—and rebounded within 36 minutes. The Dow Jones Industrial Average dropped more than 9 percent, losing more than 1,000 points before...
Sameer Hasija
One fine morning in 1909, Henry Ford made a surprise announcement during a company meeting. In the future, Ford Motor would stick to a single car model, the Model T, in black only. No other choices,...
Knowledge at Wharton
CEOs are stepping forward to confront public policy issues that often extend beyond their core business, in part at the urging of their employees, write Caroline Kaeb and David Scheffer in this...
Boris Liedtke
‘Any customer can have a car painted any color that he wants,” said Henry Ford in 1909, “so long as it’s black.” Ford’s strategy of standardization and efficiency made a runaway success of the Model...
Matthew M. Lowe
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace...
James J. Kline
The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for...
Kevin Price
In the world of risk management, maintenance of mission-critical equipment drives priorities and budgets. It is the ultimate test of proactive maintenance and smart decision making. Managing assets...
Venkat Viswanathan
As electric cars and trucks appear increasingly on U.S. highways, it raises the question: When will commercially viable electric vehicles take to the skies? There are a number of ambitious efforts to...
Shobhendu Prabhakar
Someone recently asked me why quality failures and safety incidents continue to occur despite organizations communicating their quality and safety visions to the workforce, developing and...
Ronda Culbertson
The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new...
AssurX
Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the...
Ryan E. Day
More and more, manufacturers are becoming the target of hackers, but what can they do about it, if anything? It seems every month, maybe even every week, we hear about some sort of data breach or...
Beth Humberd
Walmart recently announced it plans to deploy robots to scan shelves, scrub floors, and perform other mundane tasks in its stores as the retail giant seeks to lower labor costs.
Although the retail...
Paul Foster
When you look at standards like IATF 16949 or ISO 9001, the requirements boil down to two essential elements: improving customer satisfaction and reducing risk.
They go hand in hand because effective...
Jeffrey Phillips
One of my favorite quotes comes from George Bernard Shaw, who said that all change in life originates from unreasonable people. Reasonable people, he said, will accept the status quo and change their...
Robyn Metcalf
In an outbreak that has now run for more than 28 months, at least 279 people across 41 states have fallen ill with multidrug-resistant Salmonella infections linked to raw turkey products. Federal...
