All Features
William A. Levinson
The Chinese character for “crisis” means danger and opportunity. The coronavirus, aka Covid-19, outbreak has already wreaked havoc in the global economy, curtailed international and even domestic travel, and caused roughly 7,146 fatalities to date around the world.1 The reaction to this outbreak,…
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 quality management system (QMS). They will help implementers evolve quality management to overall…
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 enters a new decade. Reflection provides an opportunity to learn and improve, and extends beyond just an…
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 invented by Chicago Times columnist Ruth Crowley in 1943 and taken over by Eppie Lederer in 1955. For…
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 after that inspection that we’re concerned with in this article.
The unfortunate truth of the matter is…
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 same, and they continue to amass more and more data with each passing day. With the large amount of…
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 reluctant to speak their mind. They felt unsafe to express their opinions, doubts, or frustrations…
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 billion in direct revenue by summer 2019. The overall losses—ranging from damage to the brand to losing…
Ian Hesketh, Cary Cooper
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 productivity, ultimately weakening the economy, and many companies now prioritize stamping it out.
A few…
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 across the country and from reading the news, but sometimes it can be difficult to fit those puzzle…
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 United States. With all of this growth, it is also apparent that many manufacturing corporations are…
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 to make money—which is kind of important because I’m basically just paying for school as I can,”…
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 technology is not just innovative and helpful, but also trustworthy, unbiased, and resilient in the…
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 management system is downright outrageous.
Some medical device manufacturers have recognized how expensive…
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 age, symptoms, and other characteristics.
While these models are useful in most cases, they do not…
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 a set of tools that help evolve quality management into business management.
These tools include…
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 challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills…
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, following our in-the-moment intuitions frequently leads to business disasters, and strategic plans…
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 over FMEA as practiced 15 or 20 years ago.1 The publication is definitely worth buying because the new…
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 2019, similarities quickly transpired. There was no apparent external influence such as poor weather.…
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 research has shown that managers are typically 10 to 20 percent off the mark when it comes to ordering…
Miriam Boudreaux
If you are wondering whether your organization could benefit from formal root cause analysis (RCA) and corrective action training, read on to see if any of these issues are present in your day-to-day operations. RCA and corrective actions are some of the most useful tools for continual improvement…
Penelope B. Prime
The United States and China have reportedly reached a so-called phase one deal in their ongoing trade war.
While few details have been disclosed, the agreement principally seems to involve the United States calling off a new round of tariffs that were slated to take effect on Dec. 15, 2019, and…
Nathan Furr
Few companies and CEOs have attracted as much praise, derision, skepticism, and enthusiasm as Telsa Motors and its founder Elon Musk. Having interviewed Musk and the Tesla leadership as part of my research, one of the questions I’m asked most frequently is: How can you make sense of Tesla’s wild…
Dirk Dusharme @ Quality Digest
What a year.
No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX, Hong Kong riots, North Korea, Brexit, impeachment. What a mixed bag of ups and downs that has…
