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Quality’s Role in Biomedical Morals and Ethics
The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political…
Life Science Pioneer Takes Cues From 21 CFR and ISO 13485
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products,…
Top Five Things Life Science Companies Need to Know about ISO and FDA Requirements
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies…
Speed, Accuracy, Ease of Use
Technological breakthroughs tend to change the way users perceive of a problem, offering a solution that, in retrospect, comes to seem obvious and apparent. So it is with the new FARO 8-Axis Quantum ScanArm and FaroArm. “This is such an obvious solution to a challenge that every single portable-arm…
Metrics: The Good, the Bad, and the Ugly
This is the second article in a three-part series to help readers distinguish good metrics from bad. In part one we discussed good metrics. Here, we will look at a bad metric and consider how to change it into a useful, good metric. A bad metric is one that fails in one or more of the attributes of…
The Difference Between Mission, Vision, Purpose, Strategy, and Goals
Confused about the difference between mission and vision? Or between purpose and mission? You’re not alone. I am frequently asked about the difference between mission, vision, purpose, strategy, and goals, and where do values fit? Many people don’t care about definitions, and that’s unfortunate.…
Quality 4.0 in Life Sciences: Selecting Technology for Competitive Advantage
What a difference a year and a half make. In mid-2017, LNS Research coined the term “Quality 4.0” and published definitive research on the topic. At that time, an early but large group of manufacturers started to make Quality 4.0 one of their top digital transformation initiatives. This continues…
Data Snooping Part 4
In Part One and Part Two of this series we discovered some caveats of data snooping. In Part Three we discovered how listening to the voice of the process differs from the model-based approach and how it also provides a way to understand when our models do and do not work. Here we conclude the…
Use ISO 45001 to Support OSHA VPP Star Status
Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent framework, modeled on Annex SL, which defines the structure of all the new ISO standards, for an…
GE’s Lessons Won’t Determine Whether You Succeed or Fail
The news that General Electric ousted CEO John Flannery was surprising to many of us, and it certainly matters to investors, analysts, employees, and competitors (and probably, historians). But does the success or failure of GE’s CEO really matter that much when it comes to how most of us lead,…
Bruker and Greening Testing Labs Partner to Provide Benchtop Brake Screening Services
(Bruker Nano Surfaces: San Jose, CA and Detroit) -- Bruker Nano Surfaces has announced a partnership with Greening Testing Laboratories of Detroit to provide convenient and cost-effective benchtop friction test and particle-screening capabilities to developers of friction materials. Under this…
d2: More Than Just a Control Chart Constant
Perhaps the reader recognizes d2 as slang for “designated driver,” but quality professionals will recognize it as a control chart constant used to estimate short-term variation of a process. The basic formula shown below is widely used in control charting for estimating the short-term variation…
A Survival Guide for the Era of ‘Alternate Facts’
Last year I was invited to give a lecture on critical thinking to the U.S. Navy. I opened my presentation with a story I’d read in Reader’s Digest magazine as a child. It’s an old story you may have heard before, but it’s a perfect introduction to the importance of critical thinking. Here’s how it…
Work That Matters Starts With Matters That Work
To most of us, the phrase “work that matters” infers job satisfaction. The outcome is lower stress, lower turnover, and higher productivity—in business, a win-win for employees, customers, and shareholders. The logic is infallible. So, I ask you, why is there such a gap between the theory and the…
Inside Quality Digest Live for Nov. 2, 2018
Our industry embodies many aspects, but “Big Q” quality generally involves issues affecting management, measurement, and methodologies. This week on QDL, we covered all of them, and more. Let’s look closer: “Ripped from the Headlines: Tariff Fallout” U.S. manufacturers are currently dealing with…
New (E-)Takeoff for Aviation Industry
(ISO: Geneva) -- New technologies, from robotics to machine learning, are ushering in a period of rapid change and development. While the aviation industry is working to reap the benefits of this industrial automation, standards, especially those of the International Organization for…
How and Why to Ask Better Questions
To ask a good question requires two things: insight and gumption. The root of all worthy questions is a desire to fill in a gap in your understanding of something. The insight in good questions comes from seeing that gap, exploring its edges, and forming a question that can serve as an invitation…
Assessing the Health of a Measurement System
Measurement devices in manufacturing facilities are as ubiquitous as Skittles in trick-or-treat bags. Some companies have thousands of devices in their inventories and depend on them to provide accurate information. This is why timely calibration of all measurement devices is critical to…
Preparing for Quality
For manufacturers in diverse sectors such as automotive, aerospace, electronics, and medical device, there’s little question that ensuring great quality would be impossible without the proper testing of materials. And proper material testing applications begin with reliable and repeatable…
How to Choose the Best Regression Model
Choosing the correct linear regression model can be difficult. Trying to model it with only a sample doesn’t make it any easier. Let’s review some common statistical methods for selecting models, complications you may face, and look at some practical advice for choosing the best regression model.…
Will Robots Take My Job?
This story was originally published by Knowable Magazine. Back in the 1990s, when U.S. banks started installing automated teller machines in a big way, the human tellers who worked in those banks seemed to be facing rapid obsolescence. If machines could hand out cash and accept deposits on their…
Will Robots Take My Job?
This story was originally published by Knowable Magazine. Back in the 1990s, when U.S. banks started installing automated teller machines in a big way, the human tellers who worked in those banks seemed to be facing rapid obsolescence. If machines could hand out cash and accept deposits on their…
CCPA Recent Updates: What You Need to Know
(CompliancePoint: Duluth, GA) -- It should come as no surprise to anyone that the California State Legislature has passed, and the California governor has signed, amendments to the California Consumer Privacy Act (CCPA). Having previously been a ballot initiative, one of the main drivers to get the…
Inside Quality Digest Live for Oct. 26, 2018
In this episode we look at a history of quality, how you serve your customer in the housing industry, and what makes a good review. “Young couples ‘trapped in car dependency’” Building entry-level housing along highways may give couples the chance to buy a home, but at what cost to them and the…
Midnight at the <em>Gemba</em>
During the late 1990s, I was working in the Silicon Valley for a medical device company, responsible for a drug-infusion pump manufacturing operation. I had just completed a crazy period where I had also “temporarily” (months and months...) led the advanced engineering department after that manager…

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