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Corrective action is an essential tool for any business. It helps to identify adverse events and pinpoint any systemic issues that must be resolved. However, a corrective action system can’t work effectively by itself.
Leading quality and compliance management systems include a corrective action…
Once upon a time, in a land called “Industrial Age,” the leaders of organizations resided at the top of a hierarchy, managers were in the middle, and workers were supervised.
It was the job of leaders to do the important thinking and come up with bright ideas to move the company forward, and the…
Among the fallout from the final draft of the ISO 9001:2015 revision is a contextual change in the concept of “continual improvement.” The standard’s intent that organizations preemptively address likely issues before they become problems hasn’t changed; if anything, there’s an explicit toughening…
(NIH: Bethesda, MD) -- Poor quality medicines are a real and urgent threat that could undermine decades of successful efforts to combat HIV/AIDS, malaria, and tuberculosis, according to the editors of a collection of journal articles published April 20, 2015.
Scientists report up to 41 percent…
If there’s anything we can count on in putting together Quality Digest Daily each and every day, it’s that good, in-depth case studies will be well read. When those case studies also offer real context in terms of the historical underpinnings of movements or methodologies, all the better.
The…
With the recent release of the movie The Avengers: Age of Ultron, now is the perfect time to contemplate whether Tony Stark, aka Iron Man, needs a quality management system (QMS) to help him identify and prevent the disasters that seem to plague him.
Tony Stark is a billionaire genius who…
“It is good to have an end to journey toward, but it is the journey that matters, in the end.” —Ursula K. LeGuin
This is the story of how and why the Manufacturing Extension Partnership (MEP) was created. It’s the first in a series of tributes celebrating the upcoming 25th anniversary of a program…
We learned in science class that we should use the scientific method to evaluate hypotheses. We should study the problem, formulate a hypothesis, run a controlled experiment, analyze the resulting data, and then make an objective decision. We have also heard innumerable times that we should make “…
(LNS: Cambridge, MA) -- As a manufacturing leader, you’re familiar with ever-present challenges like ensuring quality, demolishing informational silos, and responding more effectively to customer demands.
What you might be less familiar with are the revolutionary strategies emerging to solve them…
(Werth: Old Saybrook, CT) -- The newly developed ScopeCheck MB from Werth Messtechnik GmbH is a multisensor CMM for the precise measurement of large-volume components in the shop-floor environment.
The measuring range of this series is up to 800 mm in the X axis and 2,000 mm in the Y axis. 3D…
The fifth edition of ISO 9001, which is slated for publication in late 2015, has some good ideas regarding improvement and harmonization with other management system standards such as ISO 14001. However, ISO/Draft International Standard (DIS) 9001:2015 has taken away prescriptive language for a…
You’ve no doubt heard (or can recall) Hans Christian Andersen’s story, “The Ugly Duckling.” If not, here’s a quick refresher: It’s about a baby swan who suffers abuse from his barnyard companions because of how he looks—he’s assumed to be a baby duckling, and an “ugly” one at that—until one day,…
Once a project is completed, a common question is, “How do we deploy this improvement to other areas in the company?” A fair number of formal improvement structures include the final step of “standardize,” implying that the improvement is laterally copied or deployed into other, similar situations…
(AssurX: Morgan Hill, CA) -- A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms uncertain if post-approval studies can replace premarket studies at the time of…
Companies purchase scales because the value of goods entering or exiting a facility is based on their weight. Without assured scale accuracy, a company can lose thousands, if not hundreds of thousands, of dollars annually.
Depending on the requirements and type of weighing device, annual…
In my last article, I presented the psychological steps of change and how to overcome the natural human resistance to it. In this installment, I’ll present an example of how to transfer those concepts into plans, the plans into actions, and the actions into continuous behaviors.
This process…
(ACSI: Ann Arbor, MI) -- Passenger satisfaction increased 2.9 percent for airlines, historically one of the lowest-scoring tracked categories, in the recent American Customer Satisfaction Index (ACSI) Travel Report 2015. Airlines reach an ACSI benchmark of 71 on a scale of 0 to 100 for 2015—…
Strong leadership and kindness are not mutually exclusive. In fact, they fit together effectively. The most successful leaders treat their team members with kindness. They realize that kindness is motivating. As Bob Kerrey has said, “Unexpected kindness is the most powerful, least costly, and most…
(ASQ: Milwaukee, WI) -- The ASQ Inspection Division received a record number of applications for its scholarship in 2015 and it is pleased to announce that it has awarded $1,125 to both Timothy Spichiger of Granville, OH, and Haukio (Kevin) Yin of Thousand Oaks, CA, and it has also awarded $750 to…
The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles not necessarily contained in the document.
This “Plain Jane” action plan, taken straight from the document, reads as…
I am nothing if not a consumerist. Meaning, I am constantly impressing upon the companies with which I work the importance of a deep and empathic understanding of customers past, present, and future. This is especially true if a company is contemplating a strategic shift that entails repositioning…
With quality the driving force behind innovation and operational improvements in the vast majority of organizations, it’s no surprise that every industry sector has embraced it, from manufacturing to the service. For some sectors, however, quality improvements can be the difference between life…
(ANSI: Washington, DC) -- The American National Standards Institute (ANSI) is pleased to announce the redesign of its Standards Portal, an online resource and educational tool for global trade which provides answers to critical standards, conformance, market access, and trade-related questions…
What is the real value of those who work for your company? For that matter, what is your real value?
As employers and/or potential employers, it’s our responsibility to evaluate those who work for us. It isn’t by chance that the term “evaluate” is used here, because evaluate means to form an idea…
Suppliers play a major role in bringing products to market. This means that the product received from suppliers must be safe and of the highest possible quality, which is a must because stakeholders not only rely on their suppliers to help bring products to market—they also rely on them to help…
