All Features
Patrick Stone
The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.
This is troubling. My first question: How are IRBs going to assure that clinical investigators will abide by requisite 21 code of federal…
Patrick Runkel
It’s usually not a good idea to rely solely on a single statistic to draw conclusions about your process. Do that, and you could fall into the clutches of the “duck-rabbit” illusion shown below.
If you fix your eyes solely on the duck, you’ll miss the rabbit—and vice-versa.
If you’re using…
ThomasNet
(ThomasNet: New York) -- ThomasNet today announced that it is bringing “Buy it Now on Amazon” functionality to ThomasNet.com. This e-commerce capability supports ThomasNet.com’s position as the leading platform for product sourcing and supplier discovery. Purchasing professionals and engineers can…
Carrie Van Daele
After the economic downturn of 2009, when many workers were phased out, subject matter experts (SMEs)—people who held the most knowledge about companies’ products and processes—found themselves assuming more job duties. Feeling overworked and underappreciated, SMEs have been biding their time…
Brian Maskell
It is vitally important for lean people to know nothing when working on improvement. This sounds like a crazy idea, but it is another 100-percent turnaround from traditional management thinking.
To do this, it’s necessary to do three things: • Understand how lean thinkers go about radically…
Mika Javanainen
Standard operating procedures (SOPs) are woven into almost every facet of the manufacturing world to help employees and subcontractors complete their tasks safely and in compliance with regulations and standards. It sounds simple enough: Describe the processes in SOPs and verify that they are…
Debora McLaughlin
(Van Daele & Associates Inc.) -- Businesses do a poor job picking managers to lead their employees, collectively costing companies billions of dollars each year, according to the recent Gallup report “State of the American Manager.”
The report is based on more than “four decades of extensive…
Jim Bevier
A simple calculation—available time divided by demand—known as takt time, is a fuzzy concept for many people in healthcare. That’s understandable when you consider a hospital is open 24 hours a day, and you never know how many people are going to show up at the door. Let’s look at two concepts…
The Un-Comfort Zone With Robert Wilson
In my last column, I wrote about leaders having AIM, which is my acronym for the key characteristics of leadership: authenticity, innovation, and motivation. Here, I’ll expand on the characteristic of authenticity.
Over the years I’ve enjoyed many leadership roles, most of them as a volunteer in…
Michelle LaBrosse
What comes to mind when you think of “return on investment?” For most of us, our mind jumps to calculations of costs and revenues. The end goal, no matter the project, is for the last cell in the spreadsheet to be black or green—not red.
In this column, I want to encourage you to expand your…
Rip Stauffer
Recently, in one of the many online discussion groups about quality, Six Sigma, and lean, this question was posed: “Can X-bar R and X-bar S be used interchangeably based on samples size (n) if the subgroup size is greater than one and less than eight?” Answers varied, of course.
In some of these…
HEIDENHAIN Corp.
(HEIDENHAIN: Schaumburg, IL) -- The HEIDENHAIN 4×12 Inspection Master is now available for use in calibrating optical comparator system axes. It is especially useful in verifying its X and Y axis position when using the calibration standard in conjunction with evaluation electronics from…
Thomson Reuters
(Thomson Reuters: New York) -- Thomson Reuters, a leading source of intelligent information for businesses and professionals, has published the findings of its sixth annual Cost of Compliance survey, which reveals that regulatory fatigue, resource challenges, and personal liability are expected to…
Mary Ann Pacelli
Recently, Mary Doyle Keefe passed away at the age of 92. You may not recognize her name, but you’ll definitely recognize her face. Keefe was the model for Norman Rockwell’s famous 1943 painting, Rosie the Riveter.
During the 1940s, various versions of the painting symbolized the contributions of…
Jack Dunigan
If it didn’t work then, will it work now? Elephant syndrome is what I call it, the tendency to never forget. But I’m not referring to a good memory; I’m talking about a faulty forgetter.
Like the elephant in the photo, we remain tied with string to obstacles we could readily overcome. That…
Donald J. Wheeler
While the computations for a process behavior chart are completely general and very robust, the secret to using a process behavior chart effectively lies in the art of rational sampling and rational subgrouping. Rational subgrouping has to do with organizing your data so that the chart will answer…
Robert Napoletano
Overall, lean is the toolbox we should all be using to help eliminate waste—the stuff you don’t want to do, and the stuff your customer’s don’t want to pay for. The best way to eliminate waste is to communicate what it is and what it isn’t.
One of the key elements in the ISO 9001 standard has…
FDA
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has taken important steps to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product.…
Thomas Prewitt Jr.
One of our major problems with healthcare reform is that we are doing it from the top down.
At the top, a bloated bureaucracy works in an environmental context of regulations and finance that seems to be focused on what is best for government and payers. The perils of out-of-control costs have…
Chad Kymal
The final draft international standard (FDIS) of ISO 9001:2015 will be released in July, and the revised standard is slated for publication in September. Per Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration of…
Dawn Keller
Generally speaking, I have a problem with authority. I don’t like being told what to do or how to do it. I’m not proud of that.
I recall debating with my high school trigonometry teacher regarding the value of the homework “process”—specifically in those situations where the student in question…
Jesse Lyn Stoner
If you are in a leadership role, chances are you believe it’s better to give than to receive. This means you also probably believe you should always be competent, never make mistakes, and always be strong. You may also feel that you should only receive when you have something to give in return.…
Vision Engineering Ltd.
(Vision Engineering: New Milford, CT) -- Mantis Elite-Cam HD brings image and video-capture capabilities to the outstanding optical performance of the Mantis family of “eyepiece-less” stereo microscopes. Vision Engineering, a global manufacturer of unique ergonomic stereo microscopes and…
Taran March @ Quality Digest
In an era when every square foot and extra minute along a supply chain mean dollars saved or squandered, it’s not surprising that auto dealerships have been facing uncomfortable scrutiny. Protected by franchise laws, these icons of American commerce struggle to justify their value to customers as…
NIST
(NIST: Gaithersburg, MD) -- The National Institute of Standards and Technology’s (NIST) Hollings Manufacturing Extension Partnership (MEP) has announced that it will hold two separate competitions in 2016 for MEP centers in 21 states and Puerto Rico. The upcoming competitions are part of a…
