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How CAPA Connects to Other QMS Processes
Jon Speer
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
Mildred Hastbacka
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
Jeffrey Phillips
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
Mike Richman
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
William A. Levinson
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
Ryan E. Day
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
Peter J. Strauss
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
Quality Digest
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
Harish Jose
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?
James daSilva
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
Chad Kymal, Gregory F. Gruska
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
Trevor Blumenau
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
Michelle LaBrosse
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
Rob Magee
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,…
Five Steps to Being a ‘Smarter’ Manufacturer
Tab Wilkins
There’s no question the digital manufacturing revolution is racing at us. As a small or medium-sized manufacturer, how close are you to already being “smart?” Here are five steps in the journey to becoming a smarter digital enterprise. First and foremost, be cybersecure. Cybersecurity is an…
Why—and How to—Build an Army of Problem Solvers
Robert Stewart
Sponsored Content During the past 40 years, according to a Nov.-Dec. 2015 Military Review article, “The United States Army’s Secret to Success Capitalizing on the Human Dimension to Enhance Its Combat Capabilities,” the U.S. Army has completely transformed its structure and culture by “enabling…
Inside Quality Digest Live for Dec. 8, 2017
Dirk Dusharme @ Quality Digest
Our Dec. 8, 2017, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs. “Smart Manufacturing Trends in 2017” The digital manufacturing environment, or smart manufacturing, is growing by leaps and bounds, and is spurred on by…
Completely Redesigning a Quality Organization
Mark Seay
SSL, a global leader in integrated space technologies, has recently gone through a complete redesign of its quality organization by reinventing its purpose and role in the company. These changes were not only foundational in nature but also required a significant cultural shift by the quality…
Overcoming Strategic Communication Pitfalls
Robin Speculand
Strategy execution is still a relatively new topic in business, and leaders struggle with how to do it. They face many execution challenges, and the top one is communicating the strategy. If you understand the most common pitfalls in communication, you can avoid them. What are your preferences…
The Ten Quality Processes You Can’t Live Without
Alexa Sussman
Sponsored Content There are so many processes that make up quality management. It’s easy to get overwhelmed by the choices or put focus on processes that aren’t essential. However, there are some processes that are crucial to having efficient operations and maintaining compliance. We’ve put…
Would You Love to Change the World?
Laurel Thoennes @ Quality Digest
Who hasn’t been subjected to fear, manipulation, hypocrisy, and greed? The majority of the human race is continuously under the thumb of individuals who have succumbed to these unconscious states of existence. If you want change but don’t know what to do, here are points in a hopeful direction. It…
Smart Manufacturing Trends in 2017
Steven Brand
Smart manufacturing trends in 2017 indicate that a radical transformation in the manufacturing sector is taking place. In a report by global market research firm BCC Research, the global market for smart manufacturing is expected to grow from $159 billion in 2015 to $392 billion by 2020 at a…
How to Manage a Leader Who Makes Everything Urgent
Lolly Daskal
Have you ever worked with a boss who made everything so urgent that you never knew what was truly important? If so, you probably haven’t forgotten how frustrating it is to be unable to prioritize. Or you may have worked for someone who required an immediate response for every little request,…
Leadership vs Management: Questions for Further Study
Kelly Graves
In my career as a business consultant, I’ve helped dozens of companies surface quality issues, develop managers as well as employees, build better trust and communication, transition ownership from one generation to the next, and unleash new levels of financial performance. I’ve worked with…
DNV GL Healthcare and CoxHealth Partnership for Improvement
Patrick Horine
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly after being discharged; readmissions also hurt hospital bottom lines. Readmissions cost hospitals $…

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