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William A. Levinson
The U.S. government’s Fourth National Climate Assessment warns that climate change “creates new risks and exacerbates existing vulnerabilities in communities across the United States, presenting growing challenges to human health and safety, quality of life, and the rate of economic growth.” The…
Kelsey Rzepecki
As the global economy grows, it’s more necessary than ever to stay on top of efficiency. Keep up with increasing production demands by implementing a continuous improvement method to streamline the workflow.
Continuous improvement is an ongoing effort to improve products, services, and processes.…
Bruce Hamilton
Last week I joined the New England Idea Generation Consortium (NEIGC) on a tour of the Stone Zoo where we had the opportunity to see how continuous improvement is expressed in an animal-care function.
In the open area for black bears, Senior Keeper Dayle Sullivan-Taylor explained to us the…
Kevin Meyer
Iam not really sure how it started, but one day a couple months ago, I found myself diving down an internet rabbit hole in search of more information on a guy named Alfred Adler. Adler was an Austrian psychotherapist in the early 1900s who, although a good friend of Sigmund Freud, developed a…
Anthony Chirico
Everybody wants to design and conduct a great experiment! To find enlightenment by the discovery of the big red X and perhaps a few smaller pink x’s along the way. Thoughtful selection of the best experiment factors, the right levels, the most efficient design, the best plan for randomization, and…
Jody Muelaner
In this article I will show that the conventional method for calculating uncertainty is not always reliable. In fact, it is generally only exact when the measurement can be represented by a simple linear equation and the input uncertainties are all normally distributed. Whenever the measurement is…
Scott A. Hindle
Walter Shewhart, father of statistical process control and creator of the control chart, put a premium on the time order sequence of data. Since many statistics and graphs are unaffected by this, you might wonder what the fuss is about. Read on to see why.
Figure 1 shows a series of measurements…
NIST
A convocation of delegates representing 60 countries voted last month in Versailles, France, to implement the most significant change to the International System of Units (SI) in more than 130 years. For the first time, all measurement units will be defined by natural phenomena rather than by…
Wudan Yan, Knowable Magazine
Nearly every month, it seems, comes a new report. In March 2018, there was news of contaminated romaine lettuce, which eventually led to five deaths and sickened more than 200 people across the United States and Canada. In May 2018, about 100 people in California got sick after eating raw oysters…
NIST
The U.S. Department of Commerce announced that the 2018 Malcolm Baldrige National Quality Award will be given to two educational institutions, an organ donor group, a hospital, and a project management firm. A presidential-level honor, the award recognizes exemplary U.S. organizations and…
Dirk Dusharme @ Quality Digest
In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.
“GE’s Lessons Won’t Determine Whether You Succeed or Fail”
Does the success or failure of GE’s CEO really matter that much when it comes to how most…
Nicole Radziwill
Even though most businesses have invested in quality management and performance improvement, each organization is unique. People, processes, and machines must be coordinated to achieve desired outcomes. This is not easy.
Whether you’re in discrete manufacturing, a process industry, or a service…
Eric Stoop
The frequently referenced learning pyramid asserts than an average student retains 75 percent of information learned through practice, compared to just 5 percent of what he hears in a lecture. Although experts may dispute the relevance of these figures when applied to modern society, all of us can…
Mike Richman
This Thursday, for the first Thanksgiving in decades, I won’t be watching football, drinking beer, and stuffing myself into oblivion. Instead, I’ll be serving the homeless, giving clothes, and making myself useful.
Thanksgiving is always a time to give thanks—I mean, it’s right there in the holiday…
Paul Foster
Next to defining a problem accurately, root cause analysis is one of the most important elements of problem-solving in quality management. That’s because if you’re not aiming at the right target, you’ll never be able to eliminate the real problem that’s hurting quality.
So which type of root cause…
Minitab LLC
Process validation is vital to the success of companies that manufacture pharmaceutical drugs, vaccines, test kits, and a variety of other biological products for people and animals. According to FDA guidelines, process validation is “the collection and evaluation of data, from the process design…
Amy Mahn
The NIST Cybersecurity Framework consists of standards, guidelines, and best practices to manage cybersecurity-related risk. The framework’s prioritized, flexible, and cost-effective approach helps to promote the protection and resilience of critical infrastructure and other sectors important to…
Ryan E. Day
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life…
Taran March @ Quality Digest
These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest has…
Dirk Dusharme @ Quality Digest
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
Mike Richman
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…
Ryan E. Day
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,…
Matthew M. Lowe
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…
William A. Levinson
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…
Anthony Chirico
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…