All Features
Michael Causey
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San…
Since the launch of the Patient-Focused Drug Development (PFDD) program as part of the fifth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) has worked intensively to explore ways to enhance the patient’s voice in drug development. Recently the FDA…
Karleen Bacoccini
This month, the International Automotive Task Force (IATF) published IATF 16949, the standard for automotive quality management systems. In this article I’ll provide background on the origins of this important industry standard, summarize the key changes from its predecessor, ISO/TS 16949, and…
Jesse Lyn Stoner
Larry was clearly angry. Carl had used his tools (again) without asking, and even worse, hadn’t returned them (again). Larry told me he had given Carl some “tough feedback.”
He told Carl that he was self-centered and insensitive, and in the future he needed to ask for permission before borrowing…
Michelle LaBrosse
Let’s say you’ve found the perfect mix of people to staff your new project. They get along great together. They’re all top performers in their respective fields. They’re all gung-ho to get going. But then something happens.
First, one starts showing up late to meetings. Then, someone else plans a…
Scott A. Hindle
In all walks of life, being wrong can come with a penalty. It’s also true that, if you’re lucky, you sometimes get away with it without anybody being the wiser. To understand what this means in relation to the capability indexes Cp and Cpk, read on.
Introduction
In part 3 of “Process Capability:…
Christine Schaefer
To entertain you, to grab your attention, and (of course) to advance your understanding of the Baldrige Excellence Framework, staff members who contribute to this blog have occasionally written some odd posts—or, at least, given them curious titles.
In case you’ve missed one or more of these, I’m…
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming…
Brian Lagas
Embracing sustainable and green principles is more than simply “a good thing to do.” Manufacturers are realizing the many practical short- and long-term financial benefits to implementing environmentally conscious improvements. Such practices helps organizations become more efficient, competitive…
Dave Page
Digital technologies have reached a tipping point. Enterprises are moving from a focus on process automation to entire business models built on and driven by digital technologies. The development and convergence of myriad digital technologies such as the internet, cloud, mobile, big data,…
Bruce Hamilton
I was lucky that the first boss I ever had (at age 13) had much to teach at a point when I had much to learn. Chris M. was a brilliant but illiterate Italian immigrant and fisherman who had built a landmark restaurant and marina on the bay in Ocean City, New Jersey. That was my first lesson: You…
Davis Balestracci
Client A came to me for a consultation and told me upfront his manager would allow him to run only 12 experiments. I asked for his objective. When I informed him that it would take more than 300 experiments to test his objective, he replied, “All right, I’ll run 20.”
Sigh. No, he needed either to…
Kade Moody
Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your organization, but I think for many healthcare systems, the answer is false.
If you have already started…
Andrew Maynard
In 2014, more than 32,000 people were killed in car crashes in the United States. In 2012, more than 2 million Americans visited the emergency room as a result of car crashes. An estimated 94 percent of the crashes that caused these injuries and fatalities are attributable to human choice or error…
Peter Bussey
Operational risk management (ORM) centers on environmental, health, and safety (EHS) risks that can cause accidents or incidents anywhere that work takes place, whether it’s a manufacturing plant, an offshore drilling platform, a mine, or a marine terminal. This article will discuss why and how…
Kevin Meyer
When many people go into the office, they start their day by chatting with some colleagues, checking their email, and surfing the net for a while. Then they start working on whatever project is due that day. Soon, however, they hear the sound of a new email arriving, which they promptly open,…
Sponsored Content
The new Geomagic Control X inspection product from 3D Systems offers a computer-aided design (CAD)-like interface and an improved workflow for Geomagic Control users. By including extended product manufacturing information support, users of popular CAD systems can now seamlessly…
Jeff Sanford
Since we at Humantech developed an entire software-as-a-service (SaaS) offering to help our clients streamline the ergonomics process, a recent article in the Harvard Business Review gave me the opportunity to reflect on how our clients successfully implement ergonomics from a process management…
Serguei Netessine
Big data is helping us learn much more about what drives sales in the digital environment. The traditional service sector, however, remains very much a “black box.” A physical sales environment, such as a clothing store or restaurant, is subject to even more intangible elements than e-commerce…
Thomas R. Cutler
Manufacturers’ waste-reduction initiatives are rarely as effective as they could be. When reducing waste, inventory is often the main target. But how do you right-size inventory in an environment of constant variability? In a word: kanban.
Electronic kanban signals keep product moving throughout…
Festo Didactic
Manufacturing in the United States and Canada is marked by negative stereotypes left behind from 1955. Repetitive and simplistic duties in grimy workplaces, without a chance to change or advance a career, are the images most people see when they imagine what it means to work in a factory. But, a…
GBMP
Ellis Medicine is a 438-bed community and teaching healthcare system serving New York’s capital region. With four main campuses, five additional service locations, more than 3,300 employees, and more than 700 medical staff, Ellis Medicine offers an extensive array of inpatient and outpatient…
NQA
For companies that are registered to more than one management system, integrating them makes a lot of sense. Combining your management systems provides greater benefit than running separate management systems in parallel. An integrated management system (IMS) can help reduce duplication and…
Taran March @ Quality Digest
I hate banks. I’ve hated them since I was a drifty teenager who had a volatile relationship with math and trouble coming up with the required documents proving my adultness. My first checking account had less to do with the paltry sum I owned than it did with running head-on into the vast and…
Paul Smith
It’s hard to turn the pages of any business or leadership magazine these days without coming across something about the value of storytelling. Whether it’s for leadership, marketing, sales, or some other purpose, the benefits of telling stories in business is well documented.
What’s more often…
