Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based...
Nico Thomas
Each new year brings about a period of reflection, where one can think back on the path that the previous year took us on. 2020 represents an even larger opportunity for reflection as the world...
Jack Dunigan
When the definition of power includes the “ability to exert influence,” then you’re also describing an element of leadership: knowledge. Take, for example, Ann Landers.
Ann Landers is a pen name...
Jon Speer
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens...
Rupa Mahanti
We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the...
Manfred Kets de Vries
Recently, I spoke to a CEO who had commissioned a survey on his organization’s health. To his great surprise—and that of his executive team—more than 80 percent of the respondents said that they were...
Gleb Tsipursky
Perhaps the worst quality failure of modern times is Boeing’s 737 Max disaster.
Due to the grounding of its 737 Max airplane following two deadly crashes that killed 346 people, Boeing lost $5...
Ian Hesketh
Most people are familiar with presenteeism, where employees spend many more hours at the workplace than necessary—out of a sense of duty or to impress the boss or whatever. Presenteeism damages...
Ken Voytek
I find that every so often it is good to step back and think about the current state of manufacturing in the broadest sense. We all see bits and pieces as part of our daily work with manufacturers...
Randall Goodden
The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the...
Matthew Hora
When her college started requiring students to complete an internship in order to graduate, it created a serious dilemma for Janelle.
“I wouldn’t be able to do classes, do the internship, and work...
NIST
Artificial intelligence (AI) promises to grow the economy and improve our lives, but along with these benefits, it also brings new risks that society is grappling with. How can we be sure this new...
Jon Speer
Believe it or not, paper is very expensive. Although the going rate for a ream of standard copy paper is only about 10 bucks, the expense of relying on paper for your medical device quality...
Anne Trafton
After a patient has a heart attack or stroke, doctors often use risk models to help guide their treatment. These models can calculate a patient’s risk of dying based on factors such as the patient’s...
Tom Taormina
In part one of this series, I said that I want to help my colleagues use their ISO 9001 implementation as a profit center and to turn risk-based thinking into risk avoidance. To do this I will share...
Kelvin Lee
Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders. Manufacturing medicine using biology presents different...
Gleb Tsipursky
In the context of our increasingly disrupted, globalizing, and multicultural world, quality leaders greatly appreciate the security and comfort of clear-cut strategic plans for the future. After all...
William A. Levinson
The Automotive Industry Action Group’s (AIAG’s) and German Association of the Automotive Industry’s (VDA’s) new Failure Mode and Effects Analysis Handbook (AIAG, 2019) offers significant advances...
Michael Lueck
After the first crash, of Lion Air in Indonesia in October 2018, people blamed poor maintenance and insufficient pilot training. When a second airliner, an Ethiopian Air aircraft, crashed in March...
Anton Ovchinnikov
Left to their own devices, humans tend to fall prey to biases that make them poor decision makers. For instance, among other foibles, most purchasing managers routinely under-order. In fact, past...
