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FDA Sponsors e-Learning for Evaluating Drug Promotion
You probably have seen many consumer advertisements for prescriptions drugs—on TV, in magazines, or online. Although those ads are expensive, did you know that in 2010, pharmaceutical companies actually spent more money advertising to healthcare professionals than they spent advertising to…
Lean or Innovation? Wrong Question!
I get the question all the time, especially from organizations that have significant investment in some process improvement program—like a lean Six Sigma or lean kaizen initiative. (I hear the ghosts of Toyota engineers booing.) These companies have picked all the low-hanging fruit, squeezed as…
‘The Human Brand’: Our Relationships With Companies
Customers describe how they feel about companies and brands in profoundly personal ways. We hate our banks; we love our yoga pants. We can’t stand the cable company, but we consider our smartphone one of our very best friends. How are we making these judgments? According to a new book titled, The…
The Martini Debrief: Management Standard Mayhem
It was the end of a long day. While sitting over dirty martinis with extra olives, my long-time colleague, Tisha Tomlinson, and I were discussing a situation and trying to plan a strategy that met the needs of all involved. We had spent the day with various quality and environmental, health, and…
EQMS on Cloud Nine
They say the world is getting smaller all the time. Tell that to your supply chain manager. It’s something of a conundrum that as technologies allow companies to deal with suppliers farther and farther away (for cheaper labor and reduced costs) the opportunity for a logistics nightmare increases…
Introducing the EHC-03
(Danatronics: Danvers, MA) -- Danatronics has announced the latest addition to its thickness gauge family: the EHC-03. Packaged in the same, field-proven, IP54-rated case as its  EHC-09 series, the EHC-03 is now Danatronics’ entry-level thickness gauge. Key features of the EHC-03: • Made in the…
Doggy DOE, Part 1
Design of experiments (DOE) is an extremely practical and cost-effective way to study the effects of different factors and their interactions on a response. But finding your way through DOE-land can be daunting when you’re just getting started. So I’ve enlisted the support of a friendly golden…
The Beginning of the End for Fake ISO 13485 Certificates
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately,…
New Spectrometry Standard for Handheld Chemical Detectors Aids First Responders
When it comes to detectors for dangerous chemicals, toxins, or nefarious germs, smaller and faster is better. But size and speed must still allow for accuracy, especially when measurements by different instruments must give the same result. The recent publication of a new standard—a culmination…
Standardize to Improve, Part 2
In “Standardize to Improve, Part 1,” I talked about how to map or document business processes, which I illustrated through the story of Grandma Cakes, a cake-baking business that boomed from secret recipes in one kitchen to eight factories in several cities. In this second part of the article, let…
Once More Into the Gap
Frequently, Quality Digest Daily has reported that many of our manufacturing readers say there is a lack of skilled talent to fill technical positions. For our audience, this has typically been in the area of metrology, which involves not only specialized knowledge but also a lot of experience,…
Standardize to Improve, Part 1
Taiichi Ohno, the father of the Toyota Production System, once said, “Where there is no standard [process], there can be no kaizen [improvement].” In an earlier column, I wrote about how we used the customer-output-process-input-supplier (COPIS) method, which is a customer-first or an outside-in…
Weatherizing Homes to Uniform Standard Can Save Billions
With winter around the corner, some homeowners may be thinking about plugging all the leaks in their homes to make them less drafty. Imagine if every homeowner in the country did that: How much energy could be saved? Using physics-based modeling of the U.S. housing stock, researchers from Lawrence…
A Course for Making Things
‘It’s all about the process,” says MIT professor Warren Seering. He’s referring to his product design and development class (identified as Course 2.739), but he could easily be talking about product development itself.  “We want 2.739 students to leave with a set of methods readily available to…
I Admit It; I Am an Introvert
I am an introvert; INTJ for those who admire Myers-Briggs indicators. I remember being particularly pleased a few years ago when I read a Harvard Business Review article  that extolled the virtues of introverts as effective leaders. The article stated conventional wisdom and a decade of academic…
Manufacturing Is Who We Are
Toward the end of summer, I was part of an assembled mass of governors and manufacturers at a Walmart-led summit in Florida. My boss, the Secretary of Commerce (or most accurately, my boss’s boss’s boss’s boss) was there, too. There we all were, attending a summit designed to revitalize,…
What’s in It for Me?
I was working with a group of mixed-age volunteers to decide on the type of advertising they should use for their charity. Because broadcast media was one option, we needed to know the radio stations that typical users of their services would likely listen to. The target audience would most likely…
Future-Proofing Asset Management
As ISO/FDIS 55001—“Asset management—Management systems—Requirements” (now in the final draft international standard stage) moves toward its formal publication around the end of this year, organizations that use and depend on a wide range of assets would benefit from spending some time reviewing…
What Is the Hawthorne Effect?
A long time ago in a galaxy far, far away… well, 10 years ago in The Midlands of England, I was introduced to the “Hawthorne Effect.” I remember sitting in the Black Belt class being taught about improvement projects. The course tutor, a wise old man with absolutely no physical resemblance to Obi-…
What’s Risk Got to Do With It?
Some of the [ISO 9001: 2015] requirements are relatively clear; others are more “euphemisms,” and you don’t know how to react… —James Lamprecht, author of ISO 9000: Preparing for Certification (CRC Press, 1992) and former member of ISO/TC 176 During an Aug, 16, 2013, interview on Quality Digest’s…
Software Reveals Local Deformation of Specimen and Component Surfaces
(Instron: Norwood, MA) -- Instron, a leading provider of testing equipment designed to evaluate mechanical properties of materials and components, has launched its Digital Image Correlation (DIC) Software. This new combination of hardware and software is designed to optically detect strain and…
Innovation Is an Attitude
Recently I took a day to volunteer at my children’s elementary school. It was their annual field day where students get to spend half of the school day outdoors, on the game field, participating in a rotation of team-building and fitness events. It’s a great deal of fun. I was one of a great many…
As Developing Economies Grow, Global Value Chains Reach a Turning Point
In the “flying geese paradigm,” Japanese economist Kaname Akamatsu explains that companies restructure to find the cheapest labor costs by moving low-value activities to nearby less-developed countries. Today that story rings truer than ever as global value chains (GVCs) reach a critical turning…
Making Analytics Pay in Manufacturing
From metal-fitting factories that keep machinery calibrated manually to high-tech companies whose production systems use self-diagnosing analytics, every manufacturer is continually working to improve shop-floor performance using analytics. The best manufacturers I’ve worked with continually…
The Presence of Purpose
Scene: corporate retreat for senior leaders of a Fortune 100 company. Theme: creativity. Agenda item: purpose. I have placed a solitary Zen stone in the center of each table. The group members eye the rocks suspiciously. “Speak your mind, one and all,” I urge. “Why is there a rock here?” pipes up…

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