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The Beginning of the End for Fake ISO 13485 Certificates
Grant Ramaley
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
NIST
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
Arun Hariharan
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
Dirk Dusharme @ Quality Digest
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
Arun Hariharan
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
Lawrence Berkeley National Laboratory
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
MIT News
‘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
Harry Hertz
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
Mark Schmit
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?
Jack Dunigan
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
LRQA Business Assurance
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?
Paul Naysmith
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?
Quality Digest
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
(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
Alan Nicol
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
Knowledge at Wharton
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
Louis Columbus
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
Matthew E. May
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…
NIST Measures Laser Power with Portable Scale
NIST
Researchers at the National Institute of Standards and Technology (NIST) have demonstrated a novel method for measuring laser power by reflecting the light off a mirrored scale, which behaves as a force detector. Although it may sound odd, the technique is promising as a simpler, faster, less…
Less Activity Makes Organizations More Effective
Gallup
I met with a client yesterday who had an all-too-common complaint. She asked for Gallup’s ideas on creating a stronger leadership development program, and we obliged by sharing some practices we’ve seen work well in other organizations. Our client gave us a wry smile and said that her company has…
Profound Knowledge in Complex Systems: A Business Case
Quality Digest
There is no substitute for knowledge... —W. Edwards Deming The W. Edwards Deming Institute (deming.org) and Purdue University held their 2013 Annual Fall Conference in West Lafayette, Indiana, last week, focusing on Deming’s ideas and their connection to the critical concept of sustainability.…
Nuts-and-Bolts Factory Truths
Toni Gilpin
During Manufacturing Day on Oct. 4, 2013, our Evanston, Illinois, legislators endorsed the theory that there are many good factory jobs left unfilled for want of qualified applicants. But, as I indicated in a previous column, there’s not much evidence that this “skills gap” exists. Accepting the…
Of Meetings, Metrics, and Dishwashing
Kevin Meyer
Last week I started a discussion post in the lean Six Sigma LinkedIn group about Gemba Academy’s latest featured video showing a morning stand-up meeting at my old company, Specialty Silicone Fabricators. I had started the morning meetings years ago. My successor has added some really interesting…
Cracked Metal, Heal Thyself
MIT News
It was a result so unexpected that MIT researchers initially thought it must be a mistake: Under certain conditions, putting a cracked piece of metal under tension—that is, exerting a force that would be expected to pull it apart—has the reverse effect, causing the crack to close and its edges to…
Quality: Art or Science?
Arun Hariharan
I was once in a room full of people to whom a presentation was being made. The findings of a root cause analysis that had been done on a recent defect in the company’s product were being presented. A couple of young people were enthusiastically presenting how they had identified the root cause of…

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