All Features
Dawn Bailey
When the recession hit during the early 2000s, Michael Garvey left his fast-paced life trading equities on the floor of the New York Stock Exchange to help save the “family farm,” a bronze foundry in Youngstown, Ohio.
Garvey said his parents and many other manufacturers got caught in the “perfect…
Michael Causey
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on patient needs when looking at high-risk devices.
If…
Jack Dunigan
What good is it? Often the mantra of the obsessively practical or the hopelessly cynical, a “what good is it?” response typically indicates disgust, disappointment, or disdain—maybe all three.
Obsessively practical leaders seem to become, well, obsessed, with efficiency. Every act, every task,…
Alex Morris, Jon Speer
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.
We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to meet design controls, and that you’re addressing…
Rob Harrison
There’s no doubt that the world becomes more interconnected and technology-centered as each day passes. Driverless cars have taken to the road in pilot projects in several countries; modes of communication are instant and global, whether they’re under 140 characters or above; and medical…
Paul Adams
I love my car. Recently, I had to get some major repairs done on it (luckily, they were covered by the warranty). Because it was going to take a while, they provided me with a loaner. This was a really nice car—only 1,200 miles, new-car smell, sunroof, super-quiet, drove like a dream. It made me…
Bruce Hamilton
June 11, 2015, marked the fourth anniversary of the passing of someone who, although not typically credited as a “lean” thinker, nevertheless had a profound effect on many lean implementers. Eliyahu Goldratt, or Eli, was an Israeli physicist whose Ph.D. thesis on queuing theory led him and many…
John Shook
We need to think about redefining work. Until we—anyone who wishes to bring about organizational change—redefine the actual value-creating work of the business, we haven’t made any changes that are meaningful.
You may be able to create wealth through a variety of business models or ways of…
Ulrich Wegner
The new ISO 9001, scheduled for publication in late 2015, introduces the term “knowledge.” As knowledge was not addressed by the previous version of ISO 9001, the depth of this topic and the approach to it are new.
The international standard ISO/DIS 9001:2015—“Quality management systems—…
Matthew Barsalou
I know that the customer should be involved when performing a root cause analysis (RCA) as the result of a complaint. However, in a meeting, the manager of problem resolution and statistical methods told our team that we should view customer-related problem resolution as a “shared journey of…
Jesse Lyn Stoner
Great leadership quotes inspire and guide us. They become part of our mainstream language and are instilled into our culture. We accept them as a reflection of the ideal, aspire to live them, and use them when teaching others about leadership.
But sometimes a quote takes root that sends us in the…
Philip Hewitt
Editor’s note: This week, Quality Digest Daily will be looking at some of the key technologies on display at the Coordinate Metrology Society’s annual conference (CMSC). The CMSC, taking place this year July 20–24 in Hollywood, Florida, is the gathering place for users, service providers, and…
Alan Nicol
Almost every conversation I’ve had with colleagues lately on the topic of process improvement or business performance improvement has centered on organizing working meetings or events to address and solve problems. “Events” seem to be growing in popularity. The problem is, they don’t work.
People…
Donald J. Wheeler
While the computations for a process behavior chart are completely general and very robust, the secret to using a process behavior chart effectively lies in the art of rational sampling and rational subgrouping. Rational subgrouping was the topic of last month’s column. Here we shall look at the…
Matthew E. May
No, this isn’t an opinion piece or in any way a critique. It’s more like a public service announcement for business professionals in the job market, looking for a strategy position with a market leader.
Like most regular users of LinkedIn, I constantly get pushed notices about “jobs I might be…
Clive Fraser
Editor’s note: This week, Quality Digest Daily will be looking at some of the key technologies on display at the Coordinate Metrology Society's annual conference (CMSC). The CMSC, taking place this year July 20–24 in Hollywood, Florida, is the gathering place for users, service providers, and…
Kelly Graves
Most everyone has read the maxim, “Plan your work and work your plan.” This is simple and effective advice—when it’s followed. Unfortunately, it can also be overwhelming when it comes to ensuring that everyone in the organization knows what the strategic plan is and how they can directly support…
Edward Herceg
Position feedback sensors for hydraulic or pneumatic cylinders have used one of three traditional technologies: magnetostrictive, variable resistance, and variable inductance sensors. Occasionally other sensor technologies have been used successfully in this application, but the focus of this…
Mike Richman
Editor's note: This week, Quality Digest Daily will be looking at some of the key technologies on display at the Coordinate Metrology Society's annual conference (CMSC). The CMSC, taking place this year July 20–24 in Hollywood, Florida, is the gathering place for users, service providers, and…
Quality Transformation With David Schwinn
“If we are to achieve a richer culture, rich in contrasting values, we must recognize the whole gamut of human potentialities, and so weave a less arbitrary social fabric, one in which each diverse human gift will find a fitting place.”
—Margaret Mead
This month’s article comes from the…
Gary Confalone
Editor’s note: This week, Quality Digest Daily will be looking at some of the key technologies on display at the Coordinate Metrology Society's annual conference (CMSC). The CMSC, taking place this year July 20-24 at the Diplomat Hotel in Hollywood, Florida, is the gathering place for users,…
Brian Maskell
T here are three ways in which a standard costing system is typically used in a manufacturing company:
1. Performance measurement 2. Decision making 3. Inventory valuation
From an accounting perspective, performance measurement and decision making are part of a company’s management accounting…
Annette Franz
How do we ensure that everyone in the organization is on the same page when it comes to customer experience?
I’m thinking about a quote I stumbled upon the other day from Edmund Wilson: “No two persons ever read the same book.”
Wow! Isn't that the truth?
Think about books you’ve read; think about…
Michael Causey
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. So it’s only fair to give equal space to something when they seem to get it right. Take the agency’s Unique Device Identification System (UDI).
Readers of this column…
Harry Hertz
Given the challenge, I can relate any three topics to each other. However, in the case of change management, social media, and CEOs, there’s a strong relationship that is reinforced by concepts in the Baldrige Excellence Framework. Two studies by Leslie Gaines-Roth et al. of Weber Shandwick, a…