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It’s the Baldrige F-Word Season
Harry Hertz
I am of course talking about feedback; you needn’t admit that you were thinking a different word. Soon the first set of feedback reports will be sent to 2014 Baldrige Award applicants. So I thought this might be a good time to reflect on Baldrige feedback, and feedback in general. I have always…
Statistical Stratification, Part 2
Davis Balestracci
My last article demonstrated a common incorrect technique—based in “traditional” statistics—for comparing performances based on percentage rates. This article will use the same data to show what should be done instead. To quickly review the scenario: In an effort to reduce unnecessary expensive…
This Family Business Does World-Class Lean
Georgia Manufacturing Extension Program
Justin and Michael Seibert knew that Athens, Georgia, was a place they wanted to lay down roots. After talking with a family friend who owned a sign manufacturing business, they determined their skill set and business outlook was a good match for the industry. So seven years ago they opened The…
The FDA Is Reading Your Facebook Page...
Tamar June
In a previous column, Michael Causey looked at the FDA’s relatively ho-hum guidance on social media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary supplement maker for, among other alleged infractions, “liking” off-label claims made about its product on…
The Value of Registration
Paula Oddy
Organizations pursue registration to international standards for a variety of reasons, but in the broadest possible sense most agree that the goal is to improve business operations and reap financial rewards, either by saving money through increased efficiencies or in making money by getting or…
On Alleviating Tortured Data
Steve Moore
Up until a few years ago, I wasn’t a big fan of run charts. Why not just go ahead and construct a process behavior chart and move on? Well, sometimes a run chart is more appropriate for certain data structures. For example, some data are “chunky”—see Donald Wheeler’s treatment of chunky data in…
Interested Parties and Internet Ads
William A. Levinson
Provision 4.2 of ISO 9001:2015 cites “Needs and Expectations of Interested Parties.” Interested parties include not only obvious stakeholders (customers, suppliers, employees, and owners), but also anybody who is affected, or perceives himself as being affected, by the product or service. Not all…
Why Kurtosis Is Like Liposuction
Patrick Runkel
The word “kurtosis” sounds like a painful, festering disease of the gums. But the term actually describes the shape of a data distribution. Frequently, you’ll see kurtosis defined as how sharply “peaked” the data are. The three main types of kurtosis are shown below. Lepto means “thin” or “…
Thanks
Quality Transformation With David Schwinn
Shortly after the death of the brilliant comedian and actor Robin Williams, his daughter Zelda quit Twitter and Instagram following online harassment over his death. How sad. We seem to somehow like to see the dark side of the world. Even my three tennis buddies seem unable to keep from trash…
Beyond Team Player
Mark Murphy
Employees want feedback that is meaningful and relevant to them, but often what they hear sounds like it’s been taken verbatim from one of those phrase books using stock comments like, “Mary is a team player and consistently thinks of others.” That statement could apply to Mary, or it could apply…
It’s Time to Get IEC 62304 Before It Gets You
Russ King
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how the FDA uses IEC 62304, an international standard…
Connecting Customer Decisions to Design Decisions
Alan Nicol
Connecting our information about customer desires with our designs is difficult. If it seems simple, we probably missed something. In the realm of product development, the most challenging and often the riskiest part of the design process is deciding precisely what features or functions our…
Get Greater Visibility Into Audits
Brenda Percy
This is the fifth installment in our six-part series on how automating common business processes with enterprise quality management software (EQMS) can benefit your organization. In this installment, we’ll focus on the automated audit management process. Manual systems often don’t provide the…
Asking Questions Is Important
Mike Figliuolo
Along with an opposable thumb, we share one other trait with our hairy primate cousins: curiosity. We have an innate desire to understand “what happens if…” that begins in childhood. As we grow into adults, that natural curiosity dissipates, and we’re expected to have those answers (school, anyone…
There Are No P Values for the Variables in Nonlinear Regression
Jim Frost
In a previous article, I showed why there is no R-squared for nonlinear regression. Anyone who uses nonlinear regression will also notice that there are no P values for the predictor variables. What’s going on? Just like there are good reasons not to calculate R-squared for nonlinear regression,…
Full-Time Equivalent Math
Lean Math With Mark Hamel
Full-time equivalent(s), commonly referred to as FTE(s), represents the number of equivalent employees working full time. One full-time equivalent is equal to one employee working full time. Typically, FTEs are measured to one or two decimal points. FTEs are not people. Rather, FTEs are a ratio…
Are You a Honeymoon CEO?
Arun Hariharan
Ihave worked with a number of CEOs during my many years of helping companies improve quality. Although all are different in their leadership styles, when it comes to their attitudes toward excellence, most top leaders fall into one of three categories. The honeymoon CEO The first is what I call…
Seven Things Superlative Leaders Understand About Problem Solving
Jack Dunigan
Rachel was a new employee at a retail outlet. She was given the requisite week in the training room and then sent out to the sales floor. Part of her job was to restock merchandise that had been returned. She had been on the job but a few days when an item was returned in a damaged box. She…
Statistical Stratification... of Sorts
Davis Balestracci
I chatted about u-charts for rates last time, and this column was going to be about p-charts for percentage data. These are the two major charts for dealing with count data and are helpful for stratifying a stable section of process performance. But something recently happened that saddens me and…
Do Your Customer Experience Improvements Rob Peter to Pay Paul?
Annette Franz
I recently read an article about a new dress code being imposed on Walmart employees (effective later this month). The purpose of the new dress code is to help customers more easily identify employees. I don't have a problem with that; given my recent experiences in a few different stores, more…
Avoiding Common CAPA Pitfalls
Edna Falkenberg
The regulatory landscape continues to change. One of the quality system approaches defined by regulators and the industry for mitigating risk is corrective and preventive action, better known as CAPA. Companies are often challenged by the CAPA process, which is one of the most important and…
I’m Against It!
Bruce Hamilton
A recent viewing of a Marx Brothers film caused me to reflect on one of the questions I’m frequently asked: “How do you deal with people who are against lean?” My stock response is to quote Shigeo Shingo’s advice that “99 percent of objection is cautionary,” that is, people who appear to…
Ruthless Sorting?
Mike Micklewright
Editor’s note: This article ties in with the new video training series, “Enhancing and Sustaining Lean Improvements While Adding Spark to the Quality Management System” by the author. Click here for more details, or check out the free preview of the series, specifically focused on the topic of…
Old Dogs, Engineers, and Rubik’s Cubes
Quality Digest
The adage that “You can’t teach an old dog new tricks” has been taken to task probably ever since it was first uttered. ThomasNet.com turned that whole idea on its ear with the newest round of upgrades to its website in 2014. In essence, instead of trying to teach old dogs (in this case seasoned…
How to Use a Bias Study
Gary Phillips
Assuming there are still questions about the suitability of a gauge for a particular application after a gauge repeatability and reproducibility (GR&R) study, Measurement Systems Analysis, 4th Edition (MSA-4), published by AIAG in 2010, recommends using an additional study in the calibration…

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