All Features
Jim Benson
I am in the world’s epicenter of offshoring, Bangalore, India. We just spent several days running a Kaizen Camp and keynoting SolutionIQ’s sold-out Lean India Summit.
Not surprising, the Kaizen Camp surfaced many issues around offshoring or the perils of distributed teams, with which we often…
Michelle LaBrosse
We’ve reached the last month of 2014—can you believe it? This time of year offers many opportunities for getting together with family and friends, but it can also be a stressful time for many. With the approach of the year’s end also comes the pressure to meet end-of-the-year goals, coordinate…
Michael Causey
A
s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very…
Greg Fox
Greetings, fair reader. In the past, I've written several articles with practical tips related to Minitab graphs, such as how to discuss the sensitive issue of p-charts and Laney P' charts with your doctor; how to use a g-chart to monitor parenting success; and how to use a scatter plot to start…
Annette Franz
As you think about the customer experience, which impression has the most effect: the first one or the last one? Which one is the lasting impression?
Let’s think for a moment about the customer experience life cycle, particularly when the customer first becomes aware of your brand or products.…
Jack Dunigan
‘When you find him, come and tell me so I can worship him, too.”
Those were the now-famous words of Herod, the designated Roman ruler of Judea during the first century of the Common Era. This is not a religious c6340n, and neither is it a Christmas story. It is a leadership article, and if you…
Davis Balestracci
For those of you who are improvement practitioners, are you satisfied with the organizational results of your efforts? I have a feeling most of you would answer, “Far from it,” and would almost unanimously feel that you could be more effective.
There is justification for this. A recent…
Arun Hariharan
Starting with the board and the CEO, the pursuit of quality or excellence is the job of everyone in the organization. Everyone, regardless of seniority or functional role, needs to do their jobs right the first time, meet customer requirements, and figure out ways to continuously improve their…
Grant Ramaley
Medical device regulators around the world often have to assess the cost of a new regulation. Typically there is a study to determine the financial effect on industry and the public. This information is often supplied to lawmakers in their respective countries before they pass new legislation. In…
Ken Koenemann
As a business leader, you spend a lot of your time figuring out how to win. With good reason: The most crucial job of every executive is to align efforts at every level of the organization to deliver wins for the week, for the quarter, and for the year.
The people at the front end of the business—…
Annette Franz
I wrote about technology and the customer experience a couple times last year. After all, that’s what self-service is all about: technology, such as ATMs, online flight check-in, self-checkout grocery lanes, interactive voice response, online FAQs, knowledge bases, and more.
Technology is an…
ASQ
For the second time in three years, salaries in 2014 decreased slightly for quality professionals, who said their organization’s quality culture plays a key role in the overall satisfaction of their job and salary, according to Quality Progress magazine’s 28th annual salary survey.
In 2014,…
Mike Roberts
The life sciences are largely driven by innovation and growth. What lies beneath those two drivers is a world of complexity across the drug or device life cycle. It’s clear that those companies that can continuously and collaboratively ensure quality, meet regulatory compliance, and mitigate risks…
Alexandra Brown
My husband and I both like to run. I run about three miles once or twice a week—if the weather’s not too bad, and if I don’t have something else going on. Keith, on the other hand, runs half marathons.
Keith goes for long runs on the weekends for three to four hours at a time and shorter runs…
Robin Lawton
In this two-part series, we outline the action necessary to create organizational transformation in line with the “Culture of Quality” research report published in late 2014 by ASQ and Forbes Insights. We also explain in practical terms how to implement the three main actions leaders say are…
Andy Nichols
The international standard for quality management systems, known as ISO 9001, is currently being revised and is scheduled for release in late 2015. Are you ready for the changes? How do the changes affect you?
NQA, a globally recognized certification body, is preparing, and we’re sharing with you…
Christine Schaefer
In late October, longtime Baldrige examiner Miriam Kmetzo traveled to Suzhou, China, to attend and speak at the 6th Quality Forum for Academics and Innovation.
Kmetzo gave a presentation at a session that featured four quality award programs in the international arena: the Malcolm Baldrige…
Jeff Mazik
If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.
Although not much has changed in this final rule in regards…
Robin Lawton
A recent survey by ASQ and Forbes Insights found that leaders and quality management professionals from all sorts of enterprises agree on some quality culture fundamentals. One is that customer expectations and experiences are the ultimate criteria for determining what quality is and the degree to…
Margaret A. Hamburg
I recently wrapped up a jam-packed, five-day visit to China, a fascinating country with a dramatically growing economy and an increasingly significant effect on the products that U.S. citizens consume. Indeed, a key reason for my trip is the important and growing collaboration between the FDA and…
Bruce Hamilton
I recently participated in the AME conference in Jacksonville, Florida, a terrific rally for manufacturing excellence with the tongue-twisting theme, “Strategic Success Through People-Powered Excellence.”
I had a small role on a keynote panel that attempted to answer questions from attendees…
Matthew Barsalou
Have you ever received a customer complaint with blurry photos and a demand for immediate action, but insufficient detail to actually take that action? Or the customer, in his or her haste to get the complaint out, neglected to mention which part failed or to provide a clear description of what …
Rip Stauffer
A number of recent articles in quality literature (and in the quality blogosphere) have posited the death or failure of Six Sigma. More articles, from many of the same sources, discuss the outstanding success of current Six Sigma efforts in manufacturing, healthcare, government, and financial…
Gary Minks
Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent audit of a…
Clara Asmail
Additive manufacturing (AM) is hurtling into its wide and wonderful future. Right now heavy attention is being given to the promise AM offers to toy and fanciful trinkets makers or to heavyweights in the aerospace industry. Deservedly, there are great investments and enthusiastic anticipation in…
