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IAF Creates New International Certification Database
On Dec. 23, 2015, a vote was taken among 78 nations with accreditation bodies that are part of the International Accreditation Forum (IAF). From the vote it was determined that a new international database for quality management system (QMS) certifications should be created. The intent of the…
FDA 2015: A Look Back (and Ahead), Part 1
Since March 2015 it’s been my pleasure to serve as the Food and Drug Administration’s (FDA) Acting Commissioner. The FDA has broad responsibilities, and I’d like to share some important accomplishments during 2015. Tasked with overseeing products that account for about 20 cents of the consumer…
What It Takes to Improve City Government
As a city leader, Tommy Gonzalez started using the Baldrige Excellence Framework in 2008 to achieve operational excellence within a municipal government. In his role as manager of Irving, Texas, at that time, Gonzalez introduced the framework to improve the city’s performance in all areas. The…
Lean, Quality, and Risk-Based Thinking in ISO 9001:2015
I’ve made the point many times that the quality function and the lean/continuous improvement/kaizen function within an enterprise are really one and the same. Treating them as separate value streams with their own documentation, procedures, and goals is wasteful, short-sighted, and disrespectful…
The Power of Parting
A young man came to his wise leader and asked how he could be a better leader. The wise leader said, “Let me pour you a cup of tea.” And so he started pouring a cup of tea; he kept pouring and pouring and pouring until the young man screamed, “Stop! The cup is full.” The wise leader looked at the…
The Wait Is Over
A collaboration between NIST researchers and a private-sector firm has led to the development of a commercial device to fill a critical need in industry: calibration of laser tracking systems. Laser trackers are state-of-the-art instruments capable of measuring the dimensions of objects as large…
Qualities of a Successful Quality Professional
I don’t claim to be qualified to advise other quality professionals. However, having had an opportunity to work for many years in this field with reasonable results and also having made my share of mistakes, I’ve observed that certain qualities help make a successful quality professional. I didn’t…
Validating Methods, Procedures, and Instructions for ISO/IEC 17025
A study conducted by the Laboratory Accreditation Bureau of noncompliances during accreditation assessments to ISO/IEC 17025—“General requirements for the competence of testing and calibration laboratories” found that the most cited clauses were found in section 5.4—“Methods and method validation…
Minor Changes, Major Consequences
My article, “Change and Risk-Based Thinking” describes management of change (MOC) as a safety-related phrase from the chemical process industry. MOC says that anything new, different, or nonroutine (such as repairs, equipment replacement, and process startups) creates a safety risk, but the same…
Five Ways Smart Importers Cut Inspection Costs
You import promotional goods from China. You're sitting at your desk, staring down at the balance sheet, burning the midnight oil again. You have an order of 20,000 pens currently in production and scheduled to leave the factory in less than a week. You have a choice to make. Do you save some…
Fowler High Precision Creates Mobile Tech Centers
(Fowler: Newton, MA) -- Fowler High Precision has announced the launch of its mobile tech centers (MTCs) and 3D mobile tech vans, which will travel across the United States, equipped with the newest, most popular, and technologically advanced products in measurement and inspection. These mobile…
What We Mean When We Talk About ‘Data’
Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an immense new set of sources for data about health and…
What We Mean When We Talk About ‘Data’
Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an immense new set of sources for data about health and…
What Is Total Productive Maintenance?
You’re only as strong as your weakest link. Although trite, the phrase embodies what manufacturing plants and processing facilities have worked to overcome for years: How do you plan for and prevent broken equipment in your lean production culture? Another trite phrase hints at the answer: The…
Manufacturing Relies on the Strengths of American Communities
Today, five years after the U.S. economy stumbled and nearly collapsed, American manufacturing continues to usher new products and innovations into the marketplace. From February of 2010 to now, 865,000 new manufacturing jobs have been added—the first sustained job growth in the sector since the…
Leadership Trumps Strategy
Creating a great culture is a key responsibility of leadership. When you invest in building a strong culture, the business and financial results follow. Fail to do so and your business will end up in unpleasant situations. Great leaders drive excellence in their organizations. They lay the…
<em>Kanbanversation</em> Video Series Looks at Lean, Visibility, and the Supply Chain
(Upland: Austin, TX): -- Kanbanversation is a new episodic video program sponsored by Ultriva by Upland Software. The program examines all aspects of the demand-driven supply chain. During each episode industry experts and thought leaders are interviewed by manufacturing journalist Thomas R.…
Six Layers of Resistance, Part 3
In part one of this three-part series, we looked at the first two layers of resistance to change. Part two looked at the second two layers. Here we look at the final two layers, obstacles to implementing the proposed solution, and unverbalized fear. We are close to achieving true buy-in, but…
Approaching Statistics As a Language
Not long ago, I couldn’t abide statistics. I respected the field, in much the same way a gazelle respects a lion. Most of my early experiences with statistics indicated that close encounters resulted in pain, so I avoided further contact whenever possible. So how is it that today I write about…
Ford’s Smartphone App Interface to Become OEM Standard
(Quality Digest: Chico, CA) -- The IoT just took a giant leap forward. Ford Motor Co. has announced that the first wave of automakers and industry suppliers will adopt SmartDeviceLink (SDL), Ford’s open-source smartphone app interface software that allows smartphone apps like Spotify, Glympse,…
How ‘Focused Factories’ Deal With Disruption
Establishing a clear and consistent focus, and knowing when to change it, is the essence of manufacturing agility. Factories don’t just make things. Viewed properly, they are where the rubber of corporate strategy meets the road of the marketplace. Ideally, then, a factory should operate in…
Six Layers of Resistance, Part 2
In part one of this three-part series, we moved through the initial and often overlooked layers of resistance: first, why change; and second, how to overcome disagreement on the nature of the problem. Here we move on to the next two layers, namely, disagreeing on the solution and undesirable side…
SAE Releases ISO Geometrical Product Specifications Pocket Guide
(SAE: Warrendale, PA) -- Effective Training Inc. (ETI), an SAE International company and global leader in standards training, has released its newest reference publication, the ISO Geometrical Product Specifications (GPS) Ultimate Pocket Guide. The ISO GPS guide is the newest installment in ETI’s…
Ten Ways to Simplify Your Leadership
Leadership may be complex, but it doesn’t have to be complicated. We can always simplify. Often our greatest hardships are those we impose upon ourselves. There are some who think that in order to be a great leader, we must allow life to teach us the hard way. But in truth, if we are open to…
Statistical Tolerance Intervals
One computation that modern software offers to unsuspecting users is the statistical tolerance interval. Since this sounds very much like limits for individual values, some have been tempted to use them on process behavior charts in place of the traditional three-sigma limits for individual values…

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