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FDA, International Regulators Look at Common Challenges to Innovation
Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified…
BEA Lasers Expands MIL Series With New Laser Alignment Modules
(BEA Lasers: Elk Grove Village, IL) -- BEA Lasers, a manufacturer of rugged laser modules and assemblies, introduces two new additions to their MIL Series of Laser Diode Modules for alignment applications. Both new MIL RA Alignment Modules feature a low profile 3/8 in. rugged laser housing, fitted…
Acu-Gage Wins Patent for ACU-THIK Proprietary Thickness Measuring Technology
(Acu-Gage: Hudson, NH) -- Acu-Gage Systems has been awarded Patent No. 10,088,304 by the U.S. Patent and Trademark Office for its ACU-THIK precision thickness measuring system. All 21 patent claims were approved readily because there is no other machine available that can match ACU-THIK for thin…
Starrett Introduces High-Performance Automatic Vision System
(The L.S. Starrett Company: Athol, MA) -- The L.S. Starrett Company, a leading global manufacturer of precision measuring tools and gages, metrology systems, and more, has introduced its AV450 Automatic Vision System. Versatile, accurate, fast, and American made, the new three-axis vision system…
Ghost of Old Cars Past
I loved my Honda. Is it OK to cling to that emotion, even after a car takes its final drive and lands in a dissection yard to be pulled to pieces so other old Hondas can stay on the road? Are there counselors out there specializing in car grief who might advise? ’Tis the Christmas season, so I can…
How to Practice Mindful Working
Among the most significant qualities demonstrated by effective leaders is the ability to make meaning of their experiences by interpreting the deeper insights that can be gained from daily interactions in the workplace, especially when times are challenging. This reflective quality is like a…
Learning From the Best of the Best
For the last 30 years, NIST and the Department of Commerce, together with the President of the United States, have been recognizing the nation’s most outstanding organizations with the Malcolm Baldrige National Quality Award. It was my privilege on Nov. 15, 2017, to join Secretary of Commerce…
How to Make Corporate Hierarchy More Likable
What would you say about a system that improves performance but is disliked by a significant percentage of those participating in it? Conventional organizational hierarchy may be just such a system. Yet plenty of theorists—including, at times, ourselves—have concentrated on explaining the…
Prioritization Is a Symptom
People are always asking us for help with ways to prioritize. Almost everyone believes prioritization to be an action in and of itself. They ask, “What mechanisms do you use to prioritize?” However, we find most often that prioritization issues, like trust issues, are a symptom of deeper problems…
Four Mindsets Needed for a Better Talent Pipeline
As leaders face the most volatile, uncertain, complex, and ambiguous business conditions ever, one thing is clear: Talent is an organization’s most powerful and sustainable competitive advantage. As a result, improving the talent pipeline by attracting, developing, and retaining the best possible…
How CAPA Connects to Other QMS Processes
Corrective and preventive action (CAPA) is an important process for your medical device company. In fact, the U.S. Food and Drug Administration (FDA) states in its Quality System Inspection Technique (QSIT) guide, “One of the most important quality system elements is the corrective and preventive…
Mentoring Done Right
Start a social media conversation thread about mentoring, and the replies from those in the working world will get your attention. At the summary level, the responses are remarkably similar across geographies, types of business, professions, genders, age, and years of experience. Professionals…
A Shared Innovation Language Accelerates Innovation
I was leading an innovation workshop recently with a company that invited some of its customers to talk about the future. We were interested in getting feedback from key B2B customers about the future of the industry, where things were heading, and what strategies and programs my customer should…
Inside Quality Digest Live for Dec. 15, 2017
Last Friday’s episode of QDL was our final show of the year, and we’re leaving 2017 on a high note! We brought you two great interviews and a terrific Tech Corner, not to mention some advice on increasing your productivity in 2018. Let’s take a look: “AIAG and VDA Release Draft of Harmonized FMEA…
The History (and Menace) of Fake News
ISO 9001:2015, Clause 6.1—“Actions to address risks and opportunities,” relates to Clause 4.1—“Understanding the organization and its context.” The external context includes the social environment, which in turn includes social networking, a potentially devastating vehicle for the delivery of “…
Datum Metrology Prospers With FARO Vantage Laser Trackers and BuildIT Metrology Software
Sponsored Content Datum Metrology LLC (DM) is a metrology service provider specializing in jig building and bond tooling for various industries, including automotive, aerospace, naval, and nuclear energy. With decades of combined experience in multiple skilled-trade backgrounds, the DM team…
Three Steps to Properly Insure Your Small Business Against a Natural Disaster
The recent spate of natural disasters that devastated parts of North America included a violent variety of events. There were three major hurricanes—Harvey, Irma, and Maria—wildfires in California, an earthquake in Mexico, and tornadoes in Oklahoma. One thing these calamities have in common: They…
The Pros and Cons of Destructive Innovation
Each Friday, Mike Richman and Dirk Dusharme co-host Quality Digest Live, a 30-minute web TV show. On QDL they offer up news and commentary about the issues facing quality professionals and their organizations. Often the topics covered on the show and in our editorial content are somewhat divisive…
Which Way You Should Go Depends on Where You Are
I recently read Jordan Ellenberg’s wonderful book, How Not To Be Wrong: The Power of Mathematical Thinking (Penguin Books, 2014). I found the book to be enlightening and a great read. Ellenberg has the rare combination of being knowledgeable and capable of teaching in a humorous and engaging way.…
What Will You Do When Things Go Bad?
There’s a lot to be worried about in business: the political climate, robots and automation, the future of entrepreneurism and innovation, the promise or peril of the gig economy. But imagine if we weren’t in an economy that’s been growing for years. Like it or not, these are the good times, and…
AIAG and VDA Release Draft of Harmonized FMEA Manual
The Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry, or VDA (Verband der Automobilindustrie), have been cooperating in automotive quality management systems since the advent of the second edition of ISO/TS 16949 in 2002. The integration work that…
AIAG and VDA Release Draft of Harmonized FMEA Manual
The Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry, or VDA (Verband der Automobilindustrie), have been cooperating in automotive quality management systems since the advent of the second edition of ISO/TS 16949 in 2002. The integration work that…
Improve Quality and Productivity in Warehouse Operations
How does one define quality in the context of a warehouse? The perfect warehouse is clean, has everything in its place, and is easy to access. Your warehouse looks like the one below, right? You have a perfectly accurate database table that tells you exactly where everything is, correct?  And…
Using Project Management to Improve Process Management
It is common knowledge in the project management field that process management helps with project management; projects go much more smoothly and efficiently if you have a consistent process for doing them. It’s the same in every other area of your company where you do repetitive work—you need…
From Security Parable to Bulletproof Strategy
I have a friend who owns a hardware store. One morning during the 1980s, he strolled into his back-room office to start his day. He was shocked to discover his safe was missing—along with a lot of cash inside. The thing is, when he’d arrived a few moments earlier, all the doors had been locked,…

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