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Interpreting the FDA View of Medical Device Design Controls
Dennis Payton
Some of the shortest descriptions in the Food and Drug Administration's (FDA) CFR 21 Part 820—“Quality System Regulation” are found in Section 820.30 and Section 820.40, totaling about a page of information about design and document controls. However short, these two sections outline some of the…
Questions That Will Help You Avoid Quality Problems
Arun Hariharan
Experience teaches us that most quality problems can be preempted, or at least prevented from recurring, if you make it a habit to ask seven simple questions: what, where, who, how much, when, why, and how. What: Ask what are you trying to achieve, or what is the desired outcome (of your business…
The Good and Bad Sides of Single-Mindedness
Jack Dunigan
Ours was a great idea. As residents and business owners in the Caribbean, we had identified a niche market and determined to fill it. We formed a business partnership for a small manufacturing company. For a short time it went OK. Then we processed our first large order and delivered the product…
Figuring Out Our Financial Flops
Elizabeth Gasiorowski Denis
Among the hardships faced today by many workers are families and communities linked to a declining number of good jobs, dwindling incomes, and the soaring cost of living. Many families are existing in a state of almost constant financial stress. Way too many parents are spending way too many…
QMS Essentials, Part 1
Tim Lozier
When it comes to quality management, there is a set of tools often used for managing common business processes, regardless of industry. Chances are you’re already familiar with how processes such as document control, audits, and corrective action work. The issue facing many companies isn’t how to…
Gauge Calibration: It Starts (and Ends) With the Label
Dave K. Banerjea
When we think about gauge calibration management, we usually think of the actual calibration process: sending the gauge to the calibration lab, comparing it to a traceable measurement standard, making changes to the gauge to bring it into the calibration range, entering the calibration results…
3D Engineering Solutions, Nikon Metrology Create North American Partnership
3D Engineering Solutions
(3D Engineering Solutions: Cincinnati) -- 3D Engineering Solutions has partnered with Nikon Metrology to create a first in North America—the first combination of advanced metrology-grade industrial CT scanning capabilities, joined with all the engineering services needed to maximize those…
Adapting Baldrige to the Housing Industry
Dawn Bailey
Senior leaders often ask, “How will my investment in a criteria/award program impact my company’s bottom line?” This is a polite way of phrasing what they’re really thinking, which is, “What’s in it for my organization?” For senior leaders in the home-building industry who have invested in the…
Using EPEI to Visualize Capacity
Phil Coy
Every part every interval (EPEI) is my favorite lean metric for high mix/low volume (HMLV) value streams, and it’s probably the least known. It’s especially helpful when changeovers are a significant portion of capacity, as frequently is the case with machine-oriented operations. I want to share…
What You See Is What You Get
Jack Dunigan
I should have kept a running tally, but I didn’t. During 40 years of training and consulting, I’ve worked with a great number of leaders and managers at all levels, from team leaders up to corporate heads. I usually began by asking what should be a simple question: What is your vision for this…
Harnessing Big Data With a Systems Thinking Approach
Tom Kadala
With 90 percent of the world’s data created during the last two years, what can we expect our data vaults to hold two or even 20 years from now? Today we measure our lives in peta-bytes, but by 2020 estimates show a 2,300-percent increase in the bits and bytes that will define our lives. How then…
Tired, Scared, or Shopping?
Quality Transformation With David Schwinn
After Nelson Mandela’s death, I asked my students how Mandela’s life might inform our views of management and leadership. They were not very forthcoming with responses, and I asked them why this would be. As you can imagine, many of them are much younger than I. They responded that they had heard…
A Headless Chicken Leading the Blind
Alan Nicol
My wife coined the phrase “headless chicken leading the blind” last week to describe the phenomenon of her organization experiencing a bit of a crisis. It’s a common enough situation that we all feel familiar with it. Something goes wrong that affects most or all of the business, and suddenly…
Weighing Particles at the Attogram Scale
MIT News
MIT engineers have devised a way to measure the mass of particles with a resolution better than an attogram—one millionth of a trillionth of a gram. Weighing these tiny particles, including both synthetic nanoparticles and biological components of cells, could help researchers better understand…
Some Thoughts on FMEAs and Unknown Risks
James Lamprecht
Anyone who has done an online search using the terms “risk analysis,” “managing risk,” “risk management,” or any other variation will have discovered that the subject has been around for a long time and been covered by numerous authors. Still, the daunting challenge remains: How can one conduct…
If the Shoe Pinches
Michelle LaBrosse
Have you ever worn a shoe that doesn’t fit just right? Sometimes, when you first try it on, it appears to fit just fine. As more time goes on though, you notice that it is pinching here and there, creating calluses as you walk, and just doesn’t feel right. In this particular situation, would you…
Three Lean Blogs to Follow This Year
Kevin Meyer
Once again I have the privilege to be part of Curious Cat’s annual management improvement blog review and will be taking a look back at three of my favorite blogs. TimeBack by Dan Markovitz Dan has become one of my favorite bloggers, and a good friend, by showing how lean can be applied to personal…
Tomorrow’s Talent
Julie Mitchell
With a growing population placing ever-greater pressure on resources and clamoring for new technology, engineers are in demand like never before. But expanding the talent pool is a global challenge. “The well-being of the world largely depends on the work of the engineer,” said Sir William…
What Is the Third Rail of Customer Experience?
Annette Franz
For those of you who have never heard the phrase “The third rail,” here are a couple of definitions to get you started. The Urban Dictionary defines it as: “A dangerous area of discussion, a point at which the mere mention of a subject results in disaster. Commonly used in politics.” Wikipedia…
Hexagon Metrology Unveils WLS qFLASH White Light Measurement Solution
Hexagon Manufacturing Intelligence
[Hexagon Metrology: North Kingstown, RI] -- Hexagon Metrology has announced the release of WLS qFLASH, a compact white light solution (WLS) that utilizes state-of-the-art blue light technology, for industrial measurement applications. The new Hexagon Metrology WLS qFLASH is a non-contact, stereo…
New Algorithm Streamlines Solutions to the ‘Max Flow’ Problem
MIT News
Finding the most efficient way to transport items across a network like the U.S. highway system or the Internet is a problem that has taxed mathematicians and computer scientists for decades. To tackle the problem, researchers have traditionally used a maximum-flow algorithm, also known as “max…
Machine Vision Helps Citrus Packer Achieve PTI Compliance
Cognex Corp.
The produce industry is moving to implement a systematic, industrywide approach to closely track where fresh produce comes from and where it goes. One of the great challenges in this effort is the automatic recognition of a wide range of different package designs and hand stamps currently used to…
Stagnation Nation
Bruce Hamilton
Twenty years ago, I was introduced to a graphical method for, as it was put to me, “sharing what you see” with others. It was referred to as a material and information flow diagram, or M&I for short. Brian S., a consultant from TSSC who was assisting my factory, pointed to a diagram he had…
Top 10 Project Management Trends for 2014
ESI International
ESI International’s top 10 trends in project management highlight the need for leadership within projects, whether Agile or Waterfall. They also discuss the challenges associated with finding qualified project managers, and finding the right balance of project management approaches in this…
Applying 3D Metrology at Andretti Autosport
FARO
Today’s new 3D metrology technology is making an impact on the design of championship Indy race cars. Andretti Autosport uses 3D metrology and laser scanning technology for applications in design, reverse engineering, and quality assurance. Advancement in, and simplification of, technologies such…

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