All Features
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…
Paul Sloane
What happens when someone with a lot of experience leaves your office? She may have many years of technical, marketing, or customer expertise. How will her accumulated knowledge and know-how be captured and transferred to her successor?
In most organizations the process is haphazard. The employee…
Joseph A. DeFeo
Editor’s note: The author, in conjunction with Quality Digest’s Professional Development Curriculum, is offering a fee-based, two-part presentation on this topic on June 16, 2015 and July 28, 2015. These presentations are offered live and on-demand, and CEU are provided to those who complete both…
Thomas R. Cutler
As regulatory compliance expands with fast-changing, ever-growing requirements, safety and quality professionals are falling behind. Senior management, particularly among small and mid-sized manufacturers, delegates the function of safety and quality without fully comprehending the scope and…
Michael Causey
Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually unite to accomplish something pretty big after all.…
Paul Sloane
Some meetings serve simply to disseminate information. One person gives a presentation, usually in PowerPoint, and others listen and absorb some of the content. In its method this meeting is really an extension of a school class or university lecture. We will not dwell on this type of meeting here…
Bruce Hamilton
The last few weeks for me have been all things Shingo, including a presentation at the Shingo Institute’s International Conference three weeks ago in Provo, Utah, followed by four days of Shingo Institute workshops at Vibco in Richmond, RI. Questions at both events about assessing for enterprise…
Blake Eskin
The section of the MakerBot factory where the MakerBot Replicator Z18 gets made didn’t get much overhead light, so fluorescent tubes were hung above each workstation. The assembly line workers weren’t used to the brightness, however, and some switched them off.
Scott Hraska, manufacturing…
Patrick Stone
The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.
This is troubling. My first question: How are IRBs going to assure that clinical investigators will abide by requisite 21 code of federal…
Patrick Runkel
It’s usually not a good idea to rely solely on a single statistic to draw conclusions about your process. Do that, and you could fall into the clutches of the “duck-rabbit” illusion shown below.
If you fix your eyes solely on the duck, you’ll miss the rabbit—and vice-versa.
If you’re using…
Carrie Van Daele
After the economic downturn of 2009, when many workers were phased out, subject matter experts (SMEs)—people who held the most knowledge about companies’ products and processes—found themselves assuming more job duties. Feeling overworked and underappreciated, SMEs have been biding their time…
Brian Maskell
It is vitally important for lean people to know nothing when working on improvement. This sounds like a crazy idea, but it is another 100-percent turnaround from traditional management thinking.
To do this, it’s necessary to do three things: • Understand how lean thinkers go about radically…
Mika Javanainen
Standard operating procedures (SOPs) are woven into almost every facet of the manufacturing world to help employees and subcontractors complete their tasks safely and in compliance with regulations and standards. It sounds simple enough: Describe the processes in SOPs and verify that they are…
