All Features
The QA Pharm
You would think that the corrective and preventive action (CAPA) system would be a business enabler—a disciplined approach to permanently resolving problems once and for all. Unfortunately, the way most CAPA systems are designed and used, it is more of a stumbling block. The system gets so chock…
Tom Kadala
When you need an address, definition, or information about anything on Earth, friends will tell you to “Google it.” However, what if your smart device or robot needs to look something up? As part of the Internet of Things, it may well have to. For them, “googling” may help narrow some choices, but…
Larry Goldman
I’ve entered a phase I think of as “app fatigue.” I now use my smart phone mainly as, well, a phone. Sure, I take advantage of the handy tools like messaging, maps, Internet, weather, music, and LinkedIn, but I can’t recall the last time I crawled around iTunes looking for some new time-saving or…
FDA
Have you sometimes wondered if that “wild caught” salmon actually came from an aqua farm? Or if the “U.S. catfish” in the display case might have been born and raised in Vietnam? Is that “red snapper” actually red snapper and worth the premium price?
Scientists at the U.S. Food and Drug…
MIT News
According to a 2013 United Nations report 2 to 5 percent of all international trade involves counterfeit goods. These illicit products—which include electronics, automotive and aircraft parts, pharmaceuticals, and food—can pose safety risks and cost governments and private companies hundreds of…
Dan North
Once upon a time there was a restaurant. It was a good restaurant with a good reputation. It served quality food at a reasonable price. The service was excellent, and it became very popular.
One day a group of diners came to the restaurant and started ordering food. Dish after dish they ordered,…
Teresa Tarwater
When the topic of standard operating procedures (SOPs) comes up, most people immediately fall into one of two camps: lovers and haters. For every quality manager, auditor, process consultant, training director, and COO who views clear SOPs as the bedrock of efficiency and organizational success,…
Paul Naysmith
It was yesterday, a glorious sunny distraction of a day, and while alternately admiring the world outside my window and reading the latest issue of CQI’s Quality World, I came across a plea for help. In the letters section, a reader implored the editor to “help the large number of service…
Matthew E. May
Everyone, in any endeavor, gets stuck at some point. All of a sudden, or so it seems, things aren’t going right. Or even going anywhere.
Writers get writer’s block. Athletes suffer from losing streaks. Running a business is no different; what was working well yesterday isn’t working today. You…
MIT News
With the advent of “inherently safe” robots, industrial designers are changing their ideas about the factory of the future. Robots such as ABB's Frida and the Baxter robot from MIT spinoff Rethink Robotics are working “elbow to elbow with people,” says Julie Shah, an assistant professor in MIT’s…
American Customer Satisfaction Index ACSI
Just when we thought it was a safe bet that the economy was improving and consumer demand getting stronger, customer satisfaction with the travel sector takes a hit. Not a single hotel chain improves in guest satisfaction, and Best Western tumbles 6 percent. Among airlines, JetBlue, Southwest, and…
Jack Dunigan
The expectation that leadership can be a singular role is unrealistic. We wear a lot of hats. We manage, we motivate, we correct, we monitor, we inspire, we facilitate, we coordinate, we focus, we bark, we growl, we whisper, we articulate, we define, and we execute.
A couple of posts ago I wrote…
Russell Harley
Some people see project management as a roadblock to speedy delivery of critical projects. This is reinforced by the number of processes and documentation that can be involved in a project. After all, when a company is trying to meet market needs or break into trends, the last thing they need is a…
Michelle LaBrosse
“Sometimes your joy is the source of your smile, but sometimes your smile can be the source of your joy.” —Thich Nhat Hanh
My morning was what you could call “less than stellar.” Besides my neighbor’s car alarm going off intermittently throughout the night, I got up to discover my bike lock was…
Grant Ramaley
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this.
There just aren…
Sonal Sinha
Traditionally, brick and mortar stores have been the primary, and often only, way for companies to sell their products. But with the advent of e-commerce, mobile commerce, and social media, companies have the power to reach consumers through multiple sales channels, across geographical markets,…
Paul Leavoy
You’re a corporate quality director at a multisite enterprise with operations spread across the country or around the globe. At some point, you’re going to face the question: How do I keep my local quality leaders engaged, and on the same page?
It’s a question we’d be excused for thinking is only…
Mika Javanainen
It is human nature—people aiming for a goal typically look for the path of least resistance. And when staffing cutbacks and slashed budgets redefine “normal” modes of operation, it is only natural that employees are looking more fervently for efficiencies and ways to circumvent any process that…
Joel Smith
A couple of years ago, I wrote a blog post titled "What I Learned From Treating Childbirth as Failure" that conveniently ended up getting published the day before my daughter was born. You should read it first, but to summarize, it demonstrates how we can predict the odds of an event happening…
Lynda Chervil
Just as intended, the 44th annual celebration of Earth Day will prompt talk about our environment, our impact on it, and what we can do to better live in harmony with it. More of us are realizing that, if we all do what we can every day, collectively we will make a tremendous difference.
People…
Dan Nelson
The process approach is a concept crucial to proper quality management. This concept is not new. In fact, it’s how ISO 9001 was designed to work from the very beginning.
A process approach allows businesses to realize the full benefit of a management system by viewing and managing real processes…
Annette Franz
Do you really know who your customers are? Do you take a 30,000-foot view or a more granular, zoomed-in view in understanding and describing them?
I did several workshops this week on personas and journey mapping. The two are intimately intermingled, and that’s an important point to remember.
But…
John Millican
What could go wrong? As an information security manager, I am often asked that question. But, there are two ways it is asked.
The first is my preferred way. It is a genuine effort to identify and evaluate the risk associated with the item at hand. That is a conversation I want to have. That is a…
Mark Schmit
This is a story about U.S. manufacturing, honoring heroes past and present, and teaching children in ways that textbooks and rote regurgitation cannot. This is a story about why I am optimistic about the future.
This is also a story about Kylan. He’s 8. Before I tell his story, though, I need to…
Nick O’Donohoe
Wayward and capricious, the wind has long been used as a metaphor for constant change. Wind turbine engineers deal with that changeability every day, along with a host of other challenging factors.
Turbines must operate in desert sandstorms and corrosive saltwater. The ambient temperature at the…
