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The QA Pharm
If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.
When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure.
The…
Elliot Begoun
Kevin Murphy is the CEO of Driscoll’s. My guess is that if you were to look at the strawberries, blueberries, blackberries, and more in your refrigerator, you’d find the Driscoll’s logo adorning the package.
Murphy’s route to Driscoll’s was hardly direct. He was born in South Africa. After…
Jeffrey Phillips
I
was thinking over the weekend that for years we've positioned innovation incorrectly. Too often we position innovation as creating a new and valuable offering or solution, ready when customers demand new products and services. In other words, we've positioned innovation as something to do to…
Eston Martz
Control charts take data about your process and plot it so you can distinguish between common-cause and special-cause variation. Knowing the difference is important because it permits you to address potential problems without over-controlling your process.
Control charts are fantastic for…
Mike Richman
During the Nov. 3, 2017, episode of QDL, we (figuratively) traveled the globe to bring you quality information. Let’s take a closer look:
“‘Made in Japan’ Falls from Grace Amid Scandals, Systematic Flaws in Manufacturing Industry” Kobe Steel is the latest Japanese manufacturer to admit to…
Scott A. Hindle, Donald J. Wheeler
In theory, a production process is always predictable. In practice, however, predictable operation is an achievement that has to be sustained, which is easier said than done. Predictable operation means that the process is doing the best that it can currently do—that it is operating with maximum…
Steven Brand
Manufacturing’s role is changing and evolving in ways that make the traditional methods of creating products and services outdated. As manufacturing enters a dynamic era, policymakers need new approaches and improved capabilities to save on costs while fulfilling the changing needs of consumers.…
Olympus
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High-volume manufacturers need fast, nondestructive testing methods to help avoid material mix-ups and to meet customer quality requirements. Quality assurance (QA) inspectors are responsible for evaluating incoming raw materials by determining their elemental makeup and…
Dirk Dusharme @ Quality Digest
I have a friend. Let’s call him Ryan. I respect Ryan, and we talk about a lot of things: work, religion, technology, politics, bikes, the truck he’s always working on—you name it, and we both have an opinion, sometimes strong opinions. Our problem is, we don’t always speak the same language (well…
Jennifer V. Miller
According to a Deloitte Consulting study, 88 percent of executives state that to build an “organization of the future,” they must transform their business practices. Transformation requires extensive change, which is difficult. Or is it?
In the Harvard Business Review article, “Stop Using the…
Bill Kalmar
Several high schools throughout the country are now experimenting with eliminating recognition of students who have high GPAs. In fact, some schools have curtailed the labeling of a valedictorian or salutatorian. The rationale is that some students feel intimidated by other students who are…
Henrik Bresman
The auto industry may be in for a double upending in the near future. First, the tipping point for self-driving cars is expected to occur between 2020 and 2026, according to experts’ estimates. Second, the rise of ride-sharing (otherwise known as “Uberization”) poses a potentially fatal threat to…
Tonianne DeMaria
Lean says: Map the value stream. Your brain says: I’ve been doing this so long, it’s become second nature to me. The steps are right here—in my head.
What’s at play here: • Illusion of transparency • Curse of knowledge/information imbalance • Status quo thinking • Groupthink/false consensus…
Timothy Lozier
Document control is probably one of the most sought-after applications within the quality management system (QMS). It allows an organization to manage the creation, approval, distribution, and archiving of all controlled documents and processes. It is an integral part of quality, environmental…
Kemper Lewis
President Trump has long talked about reinvigorating U.S. manufacturing, which has suffered heavy job losses as a result of automation, trade deals, and other factors. In July, the Trump administration even celebrated “made in America” week by showcasing things built in the United States and…
Mike Figliuolo
The better you understand your people, the better you will relate to them. First, you must treat them like individuals. No one wants to be a nameless cog in a big machine. All too often we inadvertently make people feel that way. You disagree, you say? Have you ever heard or said things like the…
Eric Stoop
General Motors (GM) recently published updated customer-specific requirements for IATF 16949 compliance. The new requirements take effect Nov. 1, 2017, and cover layered process audit (LPA) requirements in greater depth than previous versions.
LPAs use a series of frequent audits to check high-…
Dirk Dusharme @ Quality Digest
Our Oct. 27, 2017, episode of QDL looked at Ford, autonomous cars, and changes to FDA compassionate use rules.
“Ford Plans $14B in Cost Cuts as Part of New CEO’s Strategy”
Ford Motor Co’'s new CEO plans to cut $14 billion in costs, drop some car models, and focus the company’s resources on…
Harish Jose
Today I will look at epistemology at the gemba. Epistemology is the part of philosophy that deals with the theory of knowledge. It tries to answer the questions, “How do we know things, and what are the limits of our knowledge?” I have been learning about epistemology for a while now, and I find…
Scott Berkun
While researching my new book, The Dance of the Possible (Berkun Media, 2017), I studied the history of some of the most misleading ideas that have been popularized about creative thinking. Like the myth of epiphany and the other creative myths of innovation, these sayings are misleading despite…
Bruce Hamilton
The first two books I ever read about lean were Zero Inventories (McGraw-Hill, 1983) by Robert Hall, and Japanese Manufacturing Techniques (Free Press, 1982) by Richard Schonberger. In 1985, these definitive academic works were among just a few sources of information about what was then referred…
Christopher Martin
Nearly two decades ago, rising from the ashes of the once-giant video game hardware manufacturer Sega, Microsoft debuted the Xbox and entered into the video game market with the intent of competing directly with Sony’s PlayStation brand. By 2006, Microsoft’s launch of the second-generation of Xbox…
Lily Elefteriadou
What self-driving cars want, and what people want from them, varies widely. Often these desires are at odds with each other. For instance, carmakers—and the designers of the software that will run autonomous vehicles—know that it’s safest if cars stay far away from each other. But traffic…
Jun Nakamuro
The world first became aware of the Toyota Production System (TPS) when Taiichi Ohno published a book about his groundbreaking efforts at Toyota. It was published in Japan in 1978. The Japanese version of his book wasn’t translated into English until 1988. Because 10 years had passed, this…
Sheronda Jeffries, Carmine Reda
Companies purchase lots of things. They purchase tangible goods, like raw materials and equipment, or intangible services, like calibration and transportation. And most companies have basic criteria that they use to qualify and select suppliers.
Many companies require their suppliers to obtain…