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Joel Bradbury
One of the most important goals of lean manufacturing is the elimination of waste. Taiichi Ohno, father of the Toyota Production System (TPS), defined three categories of waste: mura, muri, and muda. While muda is the most widely known, muri and mura are equally important to understand.
Muda
Muda…
Tom Middleton
Just inside the entrance to Thomas Edison’s winter home in Naples, Florida, is a bronze bust of Edison himself. The base of the sculpture reads: “There is a way to do it better—find it.” As an accredited auditor of management systems and good manufacturing practices (GMPs), I have always seen…
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all…
Gwendolyn Galsworth
One of my favorite sayings is, “Nothing changes if nothing changes.” The reverse is also true: If nothing changes, nothing changes. Perfect! So I was more than a little surprised recently when I visited a company that had made a sizeable investment in bringing continuous improvement into the…
Michael Causey
Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will accomplish under a new chairman. Efforts at quality management could be affected by what appears to be an…
Bruce Hamilton
Most often when we think of a wheel, it’s in the context of transportation, one of the more obvious and ever-present of the 7 wastes in lean. In fact, the first likely use of a wheel and axle was not for transport but for processing—actual work.
According to the Smithsonian, the potter’s wheel…
Christine Schaefer
Last month, 2001 Baldrige Award-winning University of Wisconsin-Stout hosted a lively campus engagement session. (See for yourself via this video of the live-streamed event, which kicked off with dancing.) The university holds the “You Said... We Did” sessions each January to demonstrate its…
Jeffrey Phillips
The attempt to eliminate noise from an operating system or a business process is an interesting and perhaps worthwhile challenge, until one considers the question: What is the real signal? What is creating the noise?
In many businesses today, there are several signals, what we might call noise…
DNV GL
More than a million organizations around the world embrace the ISO 9001 quality management system (QMS) standard to guide their businesses and operate in the most efficient manner possible. The International Organization for Standardization (ISO) has recently updated ISO 9001 from its 2008 version…
Roger Jensen
For several decades, manufacturers have been pursuing lean on their shop floors to reduce costs and improve lead times through waste elimination and process improvement. They have been less successful, however, in reaping lean’s potential benefits in their purchasing, planning, and supply chain…
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by…
Christopher Martin
Recently, during one of my many adventures across the internet, I stumbled across a photo that struck me. It depicts an aisle of a U.S. drugstore, where nearly every single product facing has a tag on it announcing a price and a limited-time promotion. The entire row is covered with bright yellow…
Mark Whitworth
Layered process auditing (LPA) is a quality management approach increasingly used by manufacturing and service companies alike to address a gap in traditional product-oriented approaches. When properly implemented, layered auditing is the most effective way to ensure that processes consistently…
Stefan Geib
While the fallout of the United Kingdom’s decision to exit the European Union has sent shockwaves throughout the political and economic world, Brexit is merely a footnote in the global supply chain risk story. According to the latest risk index from the Chartered Institute of Procurement &…
Bruce Hamilton
Here is an article I wrote 10 years ago, recently resurrected from the lost letter file. I can’t remember why I wrote it or for whom. Originally titled, “What is Kaizen?” the article still resonates with me as I hope it will with you.
My study of TPS has been guided by book learning, tacit…
Pam Bethune
One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?
What the standard says
When making sense of Clause 4.1—“Understanding the organization and its context…
Daniel Blake, Caterina Moschieri
Pulling out of a country is an expensive proposition for a multinational firm, but it is sometimes required for the corporate bottom line. If the host country changes laws or even expropriates a subsidiary, it is often time to leave or divest.
Divestiture—pulling out assets or closing down part…
Mary McAtee
Sponsored Content
Technical and commercial media sources are constantly discussing how design safety and security has not kept pace with quickly evolving technologies. Pundits are pointing to issues with everything from self-driving cars to new holiday toys that latch on to your home Wi-Fi and…
Tim Lozier
Sponsored Content
For quality management to be effective, a solid corrective action process is critical. ISO standards and general best-practice guides suggest—and even mandate—a set procedure and proper documentation for addressing and correcting issues.
In fact, 72 percent of quality…
Tim Lozier
When it comes to quality management, it’s not just about the requirements. As companies register to ISO 9001:2015, we see an additional shift. Not only are management system requirements changing to build an improved framework for the standard, but we also see an emphasis on an overall mindset…
Harish Jose
As our new year unfolds, I wanted to write an article to remind myself of three pieces of advice. They are from Epictetus (55–135 AD), Marcus Aurelius (121–180 AD), and George Pólya (1887–1985). Epictetus and Aurelius are two famous Stoic philosophers of the past, and Pólya is a famous Hungarian…
Thomas R. Cutler
Two words no manufacturing organization wants to hear: product recalls. By their very nature, product recalls are unpredictable events.
The cost to a company transcends potentially expensive litigation and settlements. Product recalls and the effects that product failures have on companies that…
DNV GL
According the International Organization of Standardization (ISO), there are more than 300,000 certifications to ISO 14001 in 171 countries around the world, making it the most relied-upon symbol of environmental stewardship and sustainable business practice. True to its core tenant of continual…
Katherine Watts
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling spending in the Medicare program. It’s a question we’ve wrestled with for almost 20 years and a challenge we…
Jim Benson
If you are reading this, you are likely human. Congratulations; I’m human, too.
Everyday we all wake up and wonder what the day will bring. We wonder who we will meet, what conversations we will have, and what we will do.
We all want to do things
In business we have processes, we have…