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FDA Form 483 Observations and Warning Letters: What’s the Difference?
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…
Layered Process Audits: Going Beyond Compliance to Get More Value
Joe Plata
Do layered process audits drive real improvement in your organization? Or are they just another hoop to jump through for customers like General Motors and Fiat Chrysler? A layered process audit (LPA) is composed of quick checks of high-risk processes. LPAs can prevent defects by identifying when…
The Seven Basic Tools of Quality
Jody Muelaner
The seven basic tools of quality are a standard set of graphical methods for improving quality. They can help with understanding variation and determining the root cause of errors in processes. The seven basic tools are most commonly used within lean manufacturing. All of the tools are graphical…
Is Paranoia Widespread in Your Firm? You’re Not Alone.
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…
Turn the Office Into a Lab
Maria Guadalupe
When the 2019 Nobel Prize in Economics was announced, it was an exceptional moment because in addition to celebrating contributions to economic science, a methodology was also recognized. The laureates Abhijit Banerjee, Esther Duflo, and Michael Kremer are known for their work in randomized…
How to Make the Dreaded Task of Data Entry Less Despised
Lisa Cohen
A recent study showing that data entry is one the most redundant and hated workplace tasks raises questions about why, in the age of artificial intelligence, data mining, and smart technologies, this task is still being done manually. Is there any way it could be less despised? My ongoing…
Normalcy Can Kill You
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…
Maximal Productivity, Part 3
Naphtali Hoff
OK. So we’ve planned our work, and put systems in place to keep our people informed and rowing in the right direction. The next step—step three—toward increased productivity is to roll up our sleeves and get to work. The five components of this step are: • Remove distractors • Schedule tasks and…
Maximal Productivity, Part 2
Naphtali Hoff
Now that we have planned in part one what we want to see accomplished, step two, toward increased productivity, is to share information effectively. We must involve others to ensure that everyone is as productive as possible, and that tasks and projects move forward on schedule. The five…
Leaveism: Welcome to the Dark Side of 21st-Century Flexible Working
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…
High Wages for Everybody
William A. Levinson
Almost half of Americans work in low-wage jobs despite the nation’s low unemployment rate. Aimee Picchi, writing for CBS News, cites a Brookings study that says “44 percent of U.S. workers are employed in low-wage jobs that pay median annual wages of $18,000.”1 A Bloomberg story adds, “An estimated…
Karakuri Kaizen
Harish Jose
As readers of my columns know, I am an ardent student of the Toyota Production System (TPS). One of the core philosophies of TPS is kaizen, often translated from Japanese as “continuous improvement.” It is the idea that one should continuously find ways to eliminate nonvalue-adding activities, and…
The Manufacturing Landscape: Looking Forward, Looking Back
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…
Handling Product Recalls and Product Liability Lawsuits
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…
When It Comes to Leadership, This Is What Really Matters
Lolly Daskal
When I first started out as an executive leadership coach, not many CEOs saw the importance of leadership coaching or development. During the past few years attitudes have changed, and recent research finds that 90 percent of CEOs are planning to increase their investment in leadership development…
Five Obstacles That Stop Many Students From Taking an Internship
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,”…
Trustworthy AI
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…
Fourteen Leadership Principles That Drive Amazon to Be Customer-centric
Ian Golding
During the last five years, a small number of organizations have been featured multiple times in my writing. In the vast majority of cases, I have used these businesses as a way of bringing to life global best practices in the field of customer experience management. It is inspiring to be able to…
Maximal Productivity, Part 1
Naphtali Hoff
Workplace productivity is a huge challenge for nearly every company, business, and organization. Leaders struggle to get their own work done (and do the right work,) while also guiding, empowering, and motivating their people to achieve maximal productivity. Although the projections vary, estimates…
Offshoring, Reshoring, or Rightshoring?
Paavo Käkelä
After two decades of offshore productions in low-cost countries, manufacturers are now struggling with the rapidly growing salaries and countereffects of cheap production. The question that industries are asking today is: Do we continue offshoring, or should we consider reshoring? The right answer…
Paper Is Expensive
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…
Is a Four-Day Workweek Possible?
Anthony Veal
When Microsoft gave its 2,300 employees in Japan five Fridays off in a row, it found productivity jumped 40 percent. When financial services company Perpetual Guardian in New Zealand trialed eight Fridays off in a row, its 240 staff reported feeling more committed, stimulated, and empowered.…
The Future of Quality Management Is Business Success, Part 2
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…
Where AI Can Help Your Business (and Where It Can’t)
Phanish Puranam
Machine learning, the latest incarnation of artificial intelligence (AI), works by detecting complex patterns in past data and using them to predict future data. Since almost all business decisions ultimately rely on predictions (about profits, employee performance, costs, regulation, etc.), it…
Helping Public-Sector Agencies to Be More Efficient and Effective
Ryan E. Day
Lean: an employee-championed method of waste reduction. Six Sigma: a robust method of defect reduction. Embracing both methods provides organizations with multiple tools for continuous improvement. Developed for manufacturing, lean Six Sigma has now been recognized by government agencies as a…

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