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Common Cause: IMDRF and the Medical Device Single Audit Pilot Program
Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent audit of a…
Cost Efficiency Through Short-Series Manufacturing
(Sculpteo: San Francisco) -- Sculpteo, a leader in the online 3D printing industry, has published an ebook study which highlights the cost effectiveness of using 3D printing as a means of manufacturing. The study is available here. Additive manufacturing (or 3D printing) helps product developers…
Plotting the Future of 3D Printing
Additive manufacturing (AM) is hurtling into its wide and wonderful future. Right now heavy attention is being given to the promise AM offers to toy and fanciful trinkets makers or to heavyweights in the aerospace industry. Deservedly, there are great investments and enthusiastic anticipation in…
Now Leaving Dullsville
Drivers, choose boldly! It’s time to break the monopoly of black and white vehicles. The monotonous years of colorless commuting, a sad and safe reflection of the moribund recession, are ending. If you’re planning on buying a car to celebrate the uptrending economy, do not settle for silver. Turn…
Outsmarting Smartphone Users
T he smartphone’s honeymoon has officially ended. Attractive features that once dazzled consumers are now considered a staple of everyday life, as well as an integral part of users’ smartphone experience, which can add up to hours of use every day. Mobile app developers face fierce competition in…
<em>Design of Experiments for Engineers and Scientists, 2nd Edition</em>
(Elsevier: Amsterdam) -- The tools and techniques used in design of experiments (DoE) have been proven successful in meeting the challenge of continuous improvement in many manufacturing organizations over the last two decades. However research has shown that application of this powerful technique…
Countdown to ISO 9001:2015
The ISO 9001 standard is currently under revision. The decision to do so wasn’t driven by one dramatic event happening in the marketplace, but rather by due diligence of the International Organization for Standardization (ISO) committees and working groups that perform systematic reviews of…
Three Types of Confidence Leaders Must Measure
Irecently watched a reality show about a classic car restoration shop in Canada. In the episode, the owners of the shop had hired an apprentice mechanic. After a few months on the job they considered him worthy of increased responsibilities, so they gave him a project to manage. I found the…
Boom in Outsourcing Leads to New ISO Standard
(ISO: Geneva) -- As businesses worldwide look to be more nimble, reduce risks, and tap into wider networks of expertise, it’s no wonder that the trend toward outsourcing has exploded. Just as well that a new ISO standard for outsourcing has been published. Outsourcing—transferring work to…
Are You Putting Marbles in a Bowl?
Probably the most important component of listening to the voice of the customer is acting on what you hear. To do that, we must first optimize how we are listening. What do I mean? When we ask customers for feedback, it’s imperative that we make the most of that conversation. I’m specifically…
A Tale of Two Comparisons
Comparisons are often required as part of doing business. Are these two machines the same? Is this process the same as that process? Are two operators performing in the same way? In this article we will look at two ways of making these comparisons. The data we shall use are the maximum observed…
How Risk Management Improves Compliance
This is the final installment in our six-part series on how automating common business processes with a quality management system (QMS) can benefit your organization. In this installment, we'll focus on risk management. The product life cycle is moving at warp speed, which makes measuring…
Whose Job Is It Anyway?
In every major corporation today, people are going to work. They're focused on processing invoices, holding meetings, and launching new marketing campaigns. They're working hard to ensure that the actual results meet the forecasts, and that the spending is equal to or less than the budgets. These…
Three Steps for Understandable, Meaningful, and Measurable KPIs
In my first article on relevant metrics and key performance indicators (KPIs), I explained why limiting management’s strategic planning to high-level goal setting is doomed to failure. For strategic goals to be realized, they have to be translated into daily KPIs that are meaningful to everyone in…
Taking the Measure of Automotive Noise Standards, Part 2
When auto manufacturers set out to create award-winning vehicles, much consideration is given to interior sound quality. Ironically, the manufacturers have been so successful in mitigating road noise they have inadvertently caused a new problem for themselves: Apparently, the cars are too quiet.…
The Perfect Poison to Success
Mike passed the stack of test papers over his back to me. I lifted one off the top, sniffed the blue mimeograph ink, then passed the rest behind me to Laylah. The teacher instructed us to begin. It started out easy enough; all I had to do was select the proper word, from two or three choices, to…
<em>Measurement Madness</em>
(Wiley: Hoboken, NJ) -- Measurement Madness, by Dina Gray, Pietro Micheli, and Andrey Pavlov (Wiley, 2014), presents a level-headed approach to performance management, helping leaders avoid the often-bizarre and unintended consequences of key performance indicators (KPIs). Using real-life…
Conveying Lean Excellence
It’s rare to find a company where the lean manufacturing culture is companywide, ingrained in every employee. But such is the case of Jonesboro, Arkansas-based Hytrol Conveyors, a designer and manufacturer of advanced conveyor systems. As a longtime contributor to Quality Digest Daily, I wanted to…
Transform Strategic Plans Into Metrics That Matter With KPIs
During annual strategic planning meetings, the temptation is always to spend most of the time working on the business, discussing the big-picture strategic plans and breakthrough developments that are critical to the future of the company. But just looking at long-term plans ignores a critical…
How Much Should I Work?
My son, a member of the optimization generation, where pretty much every aspect of his life will be tracked, measured, and ultimately ruled by the Alg, posed a fascinating question to me the other day. He simply asked, “How much should I work?” Now, the context for the question is that he’s…
Are Your Lean Efforts Only Tool Deep?
Today I read something that reinforced what I have come to understand at some level but now I’m able to make a deeper connection. Shigeo Shingo taught that it is not enough just to teach people “how” to do something; they must also be taught “why” they are doing it. This allows them to think…
One-Shot Measuring Microscope With Image Processing
(Mahr Federal: Providence RI) -- Mahr Federal has introduced MarVision QM 300, a new video measuring microscope with image processing capability, the flagship product for a new line of Mahr optical measuring instruments. Designed for the measurement or dimensioning of geometric elements, the…
Opening the Innovation Aperture
Today I would like to offer a brief tip of the hat to Larry Keeley and his team at Doblin Group, for their concept of the “Ten Types of Innovation.” Keeley and his team created a nice graphic that captures many of the different types of potential outcomes of an innovation activity. That is,…
Gold All Over the Floor
A typical home improvement store here in the United States is more than 100,000 sq ft in size, and costs almost $20 million to build and $5 million to stock. Other big box stores would be similarly equipped and valued. With shelves fully stocked, all well-managed businesses conduct periodic…
From Batch to One-Piece Flow
Two of the more interesting Internet-driven companies these days are Airbnb and Uber. They call themselves part of the “sharing economy.” But let’s take a look at the word “share.” From the MacMillan dictionary, share is “to allow someone to have something you own.” Is that what’s happening here?…

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