All News
If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.
Although not much has changed in this final rule in regards…
A recent survey by ASQ and Forbes Insights found that leaders and quality management professionals from all sorts of enterprises agree on some quality culture fundamentals. One is that customer expectations and experiences are the ultimate criteria for determining what quality is and the degree to…
I recently wrapped up a jam-packed, five-day visit to China, a fascinating country with a dramatically growing economy and an increasingly significant effect on the products that U.S. citizens consume. Indeed, a key reason for my trip is the important and growing collaboration between the FDA and…
I recently participated in the AME conference in Jacksonville, Florida, a terrific rally for manufacturing excellence with the tongue-twisting theme, “Strategic Success Through People-Powered Excellence.”
I had a small role on a keynote panel that attempted to answer questions from attendees…
Have you ever received a customer complaint with blurry photos and a demand for immediate action, but insufficient detail to actually take that action? Or the customer, in his or her haste to get the complaint out, neglected to mention which part failed or to provide a clear description of what …
A number of recent articles in quality literature (and in the quality blogosphere) have posited the death or failure of Six Sigma. More articles, from many of the same sources, discuss the outstanding success of current Six Sigma efforts in manufacturing, healthcare, government, and financial…
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…
(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…
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…
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…
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…
(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…
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…
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…
(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…
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…
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…
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…
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…
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…
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.…
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…
(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…
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…
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…
