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The GD&T Encoding Process—Final Steps
William Tandler
Encoding the mating flange: In Workshop No. 7, we used Smart GD&T processes to encode the operation, assembly, and other functions of a flange. In this workshop, we take a deeper look at the mating aspect of the game by encoding the mating flange. The additional steps, 7 through 9, are…
Six Sigma Busy Work
Thomas R. Cutler
Manufacturing firms intent on capturing and distilling rich streams of data will find them. Companies will often look at a capability maturity model (CMM) in rows and columns—a format common across many industries and many applications—in Excel. Most data dumped from a database end up in a grid,…
Six Sigma Busy Work
Thomas R. Cutler
Manufacturing firms intent on capturing and distilling rich streams of data will find them. Companies will often look at a capability maturity model (CMM) in rows and columns—a format common across many industries and many applications—in Excel. Most data dumped from a database end up in a grid,…
How’s Your Credibility?
Bill Kalmar
It seems that not a day goes by that some politician, government official, or CEO of a major company has to retract a misspoken remark or admit that a previous message was either exaggerated or wasn’t factual. Despite the seriousness of the transgression, we as a forgiving society, are prepared to…
Busting Myths About Health Care Quality
Carolyn M. Clancy M.D.
If you’ve ever watched the popular “MythBusters” program on the Discovery Channel, you know that many supposed truths are based on old, incomplete, or simply incorrect information.The same can be said about beliefs about the quality of health care in America. How many times have you heard that more…
3 Nevers of Control Limits, Part 3
Douglas C. Fair
Never say “never”? I guess I overlooked that memo. In case you missed it, the last two columns were written about what you should never do with control limits. These three nevers, if avoided, will ensure that your control charts are useful, reliable tools. The first two nevers of control limits are…
Essential Elements of Effective CAPA Systems
Ken Peterson
From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls,…
An Effective Safety Program
David A. Marshall
Not long ago many manufacturing companies considered accidents and the resulting costs part of the expense of doing business. Today’s companies are creating better safety programs that benefit the financial health of the organization and significantly improve the protection provided to individuals…
Show Me the Money
Steven Ouellette
If you have been following my articles for the last few months, you know that we’re almost done with an experimental analysis and that today we will be doing the final step—making our company money. If you haven’t been following my articles, then you should probably be flogged with a soggy…
Changing to Lean, Part 3
Mike Thelen
Mark Graban, consultant and host of www.leanblog.org , and a good lean friend, once posted a web log topic on “lean or lame” (a phrase he coined). That topic drew a variety of comments from his readership. He described L.A.M.E. as “lean as misguidedly executed,” and it’s his description that so…
Changing to Lean, Part 3
Mike Thelen
Mark Graban, consultant and host of www.leanblog.org , and a good lean friend, once posted a web log topic on “lean or lame” (a phrase he coined). That topic drew a variety of comments from his readership. He described L.A.M.E. as “lean as misguidedly executed,” and it’s his description that so…
The GD&T Encoding Process
William Tandler
T he actual purpose of GD&T: It’s common to think that the primary purpose of GD&T is to unambiguously communicate design intent to manufacturing and inspection. In fact, the most important objective is to ensure that what we communicate is worth communicating, and that it…
The Farmer and the Stork
Denise Robitaille
A farmer was experiencing a serious problem with cranes eating his seed, so he decided to cast a net upon his fields in an attempt to capture the cranes. Along with the cranes, he snared a stork. The stork pleaded for his life saying, "Honorable farmer, I am not like these others who came to steal…
Cyber Security
Greg Hutchins
This is the first of a new QualityInsider column that will discuss new practices, processes, tools, and lessons learned in what I think is the future of quality—risk management. I’ll feature quality and other professionals who use quality and risk in supply management, auditing, health care,…
Cyber Security
Greg Hutchins
This is the first of a new QualityInsider column that will discuss new practices, processes, tools, and lessons learned in what I think is the future of quality—risk management. I’ll feature quality and other professionals who use quality and risk in supply management, auditing, health care,…
Lean Culture at Cardinal Division
Patricia C. La Londe
Cardinal Health Alaris Products, which makes pumps and disposables used during infusions, was in critical shape in the late 1990s and needed to address improvement on all fronts. The prescription included improvements in customer satisfaction and in the company’s finances, which required the…
Demystifying Design of Experiments
Peter J. Sherman
Few process improvement topics generate more questions or may be least understood than design of experiments (DOE). This is regrettable as DOE is probably one of the most important activities—after the charter definition—that a manager/Black Belt will be performing during the Six Sigma process.This…
The Lost Art of Shutting Up
Mike Staver
It’s an election year in the United States, and if there ever was a need for clarity in communication, it’s now. Yet no matter how specific the question or how many times it’s asked, the candidates from both parties just seem to drone on and on. If you think you don’t suffer from the same problems…
An Open Letter to the Leaders of Chrysler, Ford, and General Motors
America needs you to get your act together. This isn’t just about jobs, although many people are getting hurt because of your mismanagement of three of the most important name brands in America. You’re a symbol of what used to be the strength of America, and you have lost your way. Two of you have…
We Need a Quality Time-Out
Bill Kalmar
Starbucks’ announcement that it would close for three hours on February 26 to retrain about 135,000 in-store employees sent shudders through the thousands of coffee fanatics in the nation. Would java aficionados have to forego their venti-decaf-no foam-double vanilla-light whip-extra caramel-…
Pharma’s Transition from Paper to Pixels
MasterControl Inc.
The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous. Automation speeds up and connects all interrelated processes (corrective and preventive actions, customer complaints, audits, deviation…
The Greatest Waste
Mike Micklewright
Question:What do you call it when a quality manager is caught cheating on a quality exam? Answer:Benchmarking Several months ago, I taught a three-day internal-audit class to about 15 people. On the morning of the first day, Joe, the quality manager, gave me an Excel spreadsheet of the lunch orders…
Homoscedasticity
Steven Ouellette
For the last couple of columns, we have been analyzing a simple experiment where we look for the best choice for a new gear material. We have used analysis of variance (ANOVA) to detect a difference in the mean wear for the four different materials. In the last column, we performed a post-hoc…
Six Sigma and Innovation
Alan P. Brache
Six Sigma promoters and innovation advocates have emerged as opposing camps in the battle for tool supremacy in the organization improvement wars. As Business Week said in “Six Sigma: So Yesterday?” and “At 3M, A Struggle Between Efficiency and Creativity,” which described how GE, Home…
Changing to Lean, Part 2
Mike Thelen
As is the case with any lean implementation in a traditional environment, culture change is the most difficult obstacle to success. A company can hire consultants, develop work teams, and begin lean initiatives, but if it only talks the talk, the initiative soon becomes just talk. The…

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