All Features
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…
John Flaig
The classic version of FMEA is an engineering tool for quality and reliability improvement through project prioritization. It was formally released by the U.S. government with MIL-P-1629 in 1949 and updated in 1980 as MIL-STD-1629A. The classic FMEA methodology has proven to be reasonably…
Brandon Henning
Today, consumer packaged goods (CPG) manufacturers are under intense pressure to deliver quality products while keeping costs down. The push to globalize to meet customer demand, coupled with increasing mergers and acquisitions, makes it almost impossible for CPG companies to cost-effectively…
Mike Richman
3D printing. The Internet of Things. Big data. Outsourcing. Reshoring. A graying workforce. The skills gap. The wage gap. For manufacturers, these factors and countless others are creating a revolution, albeit a quiet one, whose effects are still not fully understood. They will, however, be felt…
Greg Goodwin
Regardless of where you look across manufacturing industries, you’re likely to see that the knob on operational speed has been steadily turned up during the past decade. As trends such as increased automation, mobility, cloud solutions, the Internet of Things (IoT), and enterprise manufacturing…
William A. Levinson
Engagement, according to the Mercer report “Engaging Employees to Drive Global Business Success,” is a decisive competitive advantage, “a psychological state in which employees feel a vested interest in the company’s success and are both willing and motivated to perform to levels that exceed the…
Fred Schenkelberg
Control charts provide an ongoing statistical test to determine if a recent reading or set of readings represents convincing evidence that a process has changed from an established stable average. The test also checks sample-to-sample variation to determine if the variation is within the…
Chris Thorne
When we talk about how a company is perceived, we can talk about the numbers in terms of worth and wealth, or we can talk about how the customer perceives the worth of a business in terms of its enrichment or the value it adds to that customer’s life or to society in general.
Both measures…
Katie Takacs
Capture kids’ attention at a young age, and it can inspire their futures. You often hear kids say they want to be a doctor, athlete, lawyer, policemen, or fireman. They associate these jobs with prestige and the “cool factor.” But how often do you hear a kid say that she wants to work in…
Harry Hertz
Every year, I return from the Baldrige Program’s Quest for Excellence Conference energized and full of pride in the success that can be achieved by people working together. And every year, I try to synthesize what I’ve heard into some key themes that reflect the best practices of the United States…
Alexandra Brown
Being a hospital leader is more difficult than ever in today’s changing healthcare environment. It can be easy to stray off course while dealing with regulatory compliance and financial constraints. It’s vital that a leader remembers he is responsible for one of the most precious and fragile…
The QA Pharm
When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons.
1. Management doesn’t know what is required
Executive and senior management might not have regulatory experience. MBA programs may offer courses on quality, but…
Jacob Stoller
Editor’s note: The following is an excerpt from chapter 3 of the new book, The Lean CEO: Leading the Way to World-Class Excellence (McGraw-Hill Education, 2015), by Jacob Stoller. In this chapter, “West Meets East and the Unbelievable,” Stoller relates the events that led to the widespread…
Russ King
IEC 62304, the international standard that defines software development life-cycle requirements for medical device software, was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to…
Jeffrey Phillips
OVO Innovation has done a fair amount of innovation work in the banking and financial sector. I wouldn’t call us “experts” in that space, but we've spent time there, and we’re always interested in the new ideas that percolate in the industry.
It was with great interest that I read a synopsis of a…
Akhilesh Gulati
The dynamics of the healthcare environment are changing rapidly. Small primary care practices are confronting a host of regulatory, technological, and practice challenges, not the least of which is patient expectation and evaluation. The challenges are all exaggerated by social media, where…
Davis Balestracci
To celebrate Father’s Day in the United States (June 21 this year), I’m going to use this and my next column to honor my late dad by using a game he loved—golf—to teach some very basic statistics lessons. Some of these may have been lost on you previously, not through some fault of your own, but…
Matthew Barsalou
One seldom mentioned yet critical skill is the ability to bring well-presented information to management. I almost typed “data,” but that would probably be incorrect. Chances are you are not holding a presentation to show top management data; you are presenting data that has already been distilled…
Emily Ysaguirre
In any organization, it’s important to audit your processes. Conducting timely audits is the best way of determining the efficiency and overall health of your organization. However, an audit is typically a time-consuming process that requires extensive preparation.
Auditing ensures that you are…
Steve Young, Dean Solberg
Fermi National Accelerator Laboratory (Fermilab) in Batavia, Illinois, is the United States’ premier high-energy particle accelerator facility. Fermilab collaborates with scientists from around the world to perform pioneering research and operate particle accelerators, in addition to experimenting…
Patrick Runkel
I’ve never understood the fascination with selfies.
Maybe it’s because I'm over 50. After surviving the slings and arrows of a half a century on Earth, the minute or two I spend in front of the bathroom mirror each morning is more than enough selfie time for me.
Still, when I heard that Microsoft…
Maurice DeCastro
My son is all grown up now and studying hard at university. But when he was a small boy I remember having the same conversation with him every time he was naughty.
Me: “Reece, why did you do that?” Reece: “I don’t know.” Me: “But Reece, you know better than that.” Reece: “I know, Dad.” Me: “Well…
Matthew E. May
A significant portion of my strategic facilitation work is with internal functions, a click or two below corporate and business-unit strategy, which includes marketing, human resources, purchasing, and even internal strategy groups.
There’s good news and bad news in this. The good news is that…
Steven Stein
Supply chain quality is a hot topic these days. Suppliers may be considered third-party organizations, but they are also extensions of your organization. One aspect of managing supplier quality is dealing with shipments of nonconforming items, parts, or services from suppliers.
The following are…
