All Features
Stephen Ostroff
In this third and final article reflecting on the FDA’s work to protect and promote public health during 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation. In part one I shared the FDA’s 2015 accomplishments in medical product innovation…
Quality Transformation With David Schwinn
Wherever you stand, be the Soul of that place. —Rumi
I was blessed last week to spend two glorious days with my wife, Carole, our daughter, Lisa, and Lisa’s consulting partner, Rox. Those two days were a model for how we could be in every one of our workplaces... and the world would be a better…
MARK-10 Corp.
(Mark-10: Copiague, NY) -- In an effort to reduce the incidence of accidental gun discharge, the New York City Police Department (NYPD) has been modifying its standard, off-the-shelf firearms to require a greater amount of force to activate the trigger.
Following any shooting incident, the weapon…
Douglas C. Fair
When a consumer goes to purchase a new car, the first thing they’ll notice is the vehicle’s make. Yes, the car may say “Toyota” or “Ford” on the outside, but what’s on the inside? In reality, the car’s components—from the tires to the transmission—are typically manufactured by third-party vendors…
Stephen Ostroff
In my first look back on the FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make available safe, effective, and innovative products. Because the FDA’s responsibility covers the entire life cycle of products, in the second part of…
Grant Ramaley
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…
Stephen Ostroff
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…
Christine Schaefer
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…
Mike Micklewright
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…
Lolly Daskal
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…
NIST
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…
Arun Hariharan
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…
Randy Long
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…
William A. Levinson
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…
George Huang
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
(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…
Robert M. Califf, Rachel E. Sherman
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…
Jordy Byrd
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…
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…
Diane Adams
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…
Upland Software
(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.…
Jason Furness
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…
Eston Martz
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…
Quality Digest
(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,…
Luk Van Wassenhove
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…
