All Features
Lee Seok Hwai
Hong Kong scientists teaching a panicked populace to make their own surgical masks with paper towels and metallic wire must surely rank as one of the most Kafkaesque moments of the new coronavirus disease outbreak. But the worst is yet to be if global medical supply chains, already stretched in…
Anjalika Singh
The toughest part of being in a relationship is finding a perfect gift for your loved one. Gifting is an essential part of any relationship. You gift your better half for every reason and every season. Gift as a form of bribery in love is a time-tried tool.
Being a system believer, I use the…
Ken Maynard
When educational and public sectors consider applying a proven method like lean Six Sigma, the perception persists that this “manufacturing program” will not work in a nonmanufacturing environment. Along with that limiting assumption, there is an underlying expectation within the service industry…
Sophia Finn
Effective and efficient supplier management is possible, but not when we’re still using old tools and expecting different outcomes.
Emailing suppliers to communicate product specs, corrective action requests, or audit reports may be “the way it’s always been done,” but that doesn’t mean it isn’t…
Gleb Tsipursky
The Covid-19 coronavirus has developed into a widespread pandemic. With growing outbreaks of diagnosed cases in all 50 states, and vastly larger numbers of undiagnosed cases, there’s serious cause for concern. Yet quality professionals who follow the official advice on Covid-19 coronavirus prep…
Jennifer Grant
With Covid-19 continuing to impact many businesses, lead time as well as sourcing new suppliers is increasingly difficult. If you currently outsource manufacturing overseas, it is likely you have encountered some turbulence to your supply chain.
Rapid prototypes and large-quantity production of…
This is supposed to be trade-show season. The time when companies send their employees to industry tech shows and user-group meetings to see and experience the latest offerings in their field. A time when companies expend a good portion of their budget on booth space, shipping costs, and hotel and…
David Pride
‘That escalated quickly!” is a common trope used in popular culture to describe when a situation gets out of hand before you’ve even had a chance to think about it. We don’t often use this trope in medicine, but I can think of nothing better to describe what has been going on in the United States…
Sean Spence
The outbreak of the Covid-19 virus in China and the railway disruptions across Canada represent two different yet similar classic case studies. They remind us that nations and global economies are becoming increasingly interconnected. Incidents thousands of kilometers away are being felt locally.…
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…