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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…
(Wiley: Hoboken, NJ) -- Scaling a business is not for the faint of heart. It’s a mind-bending journey that causes millions of business owners around the globe to either throw in the towel or avoid risk entirely and suffer from smallness and mediocrity.
Most of these businesses fail because they…
(InspectionXpert: Apex, NC) -- InspectionXpert Corp., a software development company, broke the Guinness World Record for the World’s Largest Paper Ball. Made from cardboard, paper, and paper cord, the final ball came in at 576 lb, 9-ft 8.6-in. tall, and 33-ft around.
InspectionXpert broke the…
(Phillips Precision’s Products Division: Boylston, MA) -- Phillips Precision announces its Sturdy Lever Clamp as part of the Inspection Arsenal, the first universal fixturing system providing a complete set of tools for all inspections.
The heavy-duty Sturdy Lever cantilevered clamp is ideal for…
I’ve written previously about 11 myths and mistakes about journey mapping, but I should add one more myth, which is really the umbrella myth that likely encompasses all the others: Journey mapping is just a tool.
Nope, it’s not just a tool; it’s not just a workshop: It’s a process. Journey mapping…
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…
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…
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…
There is rising enthusiasm all over the country and the world when it comes to apprenticeships. According to the Bureau of Labor Statistics, from 2013 to 2017, the number of those participating in apprenticeship programs grew from 375,000 to almost 534,000, an increase of about 42 percent. In 2017…
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…
(Greenlight Guru: Indianapolis) -- Greenlight Guru, the only quality management software platform designed specifically for medical device companies, announces a new integration with Jira, creating an adaptive system for managing product development and post-market quality for devices with software…
In this era of artificial intelligence, where bots can mimic human minds and outperform humans, a new-age process automation tool called “robotic process automation” (RPA) has been creating a lot of buzz. It is highly versatile and can be used by every industry to streamline and optimize their…
(ISO: Geneva) -- The number of management systems has risen dramatically in recent years, reflecting the needs and demands of more organizations looking to improve their performance across a wide range of areas and sectors. And most companies have more than one. The International Organization for…
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…
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…
I recently had eye surgery that required me to sleep on my back for two weeks following the operation. I have always slept on my side, ever since I was a kid. My back-sleeping attempts are so challenging, I am never able to nap on those United States to Europe flights. I usually end up burning a…
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…
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…
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…
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…
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…
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,…
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…
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…
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…
