All Features
Mike Micklewright
The 5S System is one of the most powerful activities of lean manufacturing. Focusing on simplifying the work environment, reducing waste, and improving quality and safety, this strategy is a topic of much discussion. Unfortunately, many of those discussing 5S don't really "get" 5S. Including many…
Davis Balestracci
My last column, “Dealing With Count Data and Variation,” showed how a matrix presentation of stratified count data could be quite effective as a common-cause strategy. I’ll use this column to review some key concepts of count data as well as to demonstrate the first of two common statistical…
Akhilesh Gulati
An important concept within TRIZ is that someone, somewhere, has already solved your current problem. In other words, they have “been there, done that.” Or course, the problem has to be clearly stated, in a generic sense, to enable the recognition of existing valid solutions.
TRIZ is not alone in…
Denise Robitaille
Unless you’ve been hiding under a rock for the last two years, you can’t help to have noticed that the ISO 9001 standard is in the middle of its revision process. Seems like people have been talking about this revision for ages. And, it’s not even a whole new standard. They’re not starting from…
Tim Lozier
This is the fifth installment of our six-part series on common business challenges and the quality management system (QMS) tools that can help alleviate them. Here we’ll focus on the supplier management tool and why it is beneficial for both stakeholder and supplier.
The challenge: No visibility…
Bob Emiliani
The lean community continues to face a problem that hurts efforts to advance progressive lean management: It is the great difficulty in clearly separating and effectively communicating the difference between real lean and fake lean, i.e., lean management done right vs. lean management done wrong…
Tripp Babbitt
Are you losing customers? Is your employee morale low? Is your management focused on the wrong things?
Customers come into contact with your culture daily. Culture is shaped by your organization’s perspective on work and how best to do work. Your organizational performance is the result of the…
Whitney Andrews
Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.
ISO 13485 is an internationally recognized quality…
NIST
Recent experiments have confirmed that a technique developed several years ago at the National Institute of Standards and Technology (NIST) can enable optical microscopes to measure the 3D shape of objects at nanometer-scale resolution—far below the normal resolution limit for optical microscopy (…
Harry Hertz
I have always been fascinated by new words. A few years ago Larry Potterfield, the Founder and CEO of Baldrige Award recipient MidwayUSA, shared one of his “words”: voluntold. “Voluntold” is helping people understand the wisdom of doing something that Larry thinks is good for the company (and them…
NIST
Crash-test dummies, yarn-spinning machines, and steel girders in bridges. What do they have in common? Look inside them all and you find transducers, devices that measure the forces that push, pull, weigh upon, and slam into them. But transducers also have something in common: Until recently, it…
Thomas Prewitt Jr.
I am concerned about the rush to consolidation we are seeing in the hospital industry. It seems all too tidy and easy, and if there is anything I have learned from my 30+ years in clinical medicine, it is that nothing in healthcare is easy.
Larger hospitals began acquiring smaller hospitals in…
Lucien G. Canton
Just surviving a disaster or rapidly resuming operations is not always sufficient to guarantee the future of a company. Physical damage is often the easiest problem to deal with following a disaster, but quick repairs alone do not equate to business survival if you cannot produce goods and…
Paul Naysmith
If your preferred media outlet has yet to cover the current topic of conversation about Scottish independence, the following may be, well, news to you. On Sept. 18, 2014, the people living in Scotland will be given the opportunity to vote to become, once again, an independent and sovereign country…
Annette Franz
When a colleague asks you why you do things a certain way, do you find yourself responding, “I don't know. Because we’ve always done it that way?” Many years ago, I worked for a couple companies where that was the stock answer, and it was so frustrating. It’s hard to believe that no one ever…
Arun Hariharan
On a recent visit to Japan, I had an opportunity to visit Toyota’s headquarters. During a meeting with some of its top executives, I asked one of them what role the senior leadership played in Toyota’s much-admired quality philosophy. The reply I received was, like many things about Toyota and…
Tab Wilkins
What’s still based on centuries-old technology but is experiencing a renaissance of growth and entrepreneurship today? Brewing beer—that frothy, cold beverage that millions enjoy responsibly each day. You’ve probably seen a new local brewery open, literally in a garage, based on someone’s home-…
Joel Smith
Learning to ride a bike is a rite of passage for any kid, so much so that we even use the expression “taking the training wheels off” for all kinds of situations. We say it to mean that we are going to let someone perform an activity on his own after removing some safeguard, even though we know he…
Jeff Freeman
You’re about to head off to IMTS next week in search of a solution for your latest manufacturing challenge. With myriad technologies available, it is likely you will find one or more possible solutions. Maybe you have a budget in mind to help you reach the next level of productivity, or maybe you’…
Mike Micklewright
According to a new study from the W. P. Carey School of Business at Arizona State University, “The best bosses are humble bosses, those who empower and appreciate their employees, are open to feedback, and care about the greater good.” And yet, bosses who yell, threaten, and micromanage their way…
Donald J. Wheeler
Outlier tests such as the W-ratio test and Dixon’s outlier test suffer from a problem that can mislead the user. This article will outline the problem and provide guidelines for the appropriate use of these tests.
Dixon’s outlier test
In 1953, W. J. Dixon proposed a test for detecting outliers…
Taha A. Kass-Hout, Jeffrey Shuren
In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but…
Jeff Hajek
In any field, there are a handful of common mistakes. Continuous improvement is no different. Some of these errors come as a result of ignorance about the proper way of doing things. Some are the result of habit. And a handful come as a function of taking the path of least resistance.
Regardless…
Michael Causey
Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.
As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use…
Ryan E. Day
'Pssst! Hey kid, ya wanna be a metrologist?"..."Uh, what's a metrologist?"... "Ya get paid to measure stuff."..."Sounds kinda boring." So it goes at colleges and universities all across the United States.
The fields of science, technology, engineering, and mathematics—collectively known as STEM—…
