All Features
Timothy Lozier
There’s been a shift in how companies view quality and compliance, and as a result, businesses are looking for a more comprehensive method for measuring operational efficiency. Risk management processes are proving to be an effective option for this. ISO 9001:2015 now promotes risk-based thinking…
Dawn Bailey
Dorothy: Now which way do we go? Scarecrow: Pardon me, this way is a very nice way. Dorothy: Who said that? Toto barks at the scarecrow. Dorothy: Don’t be silly, Toto. Scarecrows don’t talk. Scarecrow: [points other way] It’s pleasant down that way, too. Dorothy: That’s funny. Wasn’t he pointing…
Mark Esser
The nefarious Major Uncertainty has kidnapped Monsieur Kilogram, putting the world’s measurements of mass in jeopardy. As the world spirals into “Mass Hysteria,” the remaining SI Superheroes, champions of the metric system, leap into action to save the day, and hopefully Monsieur Kilogram as well…
The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages.
When manufacturing problems…
NIST
Let’s say you’re a biotechnologist working to develop new medicines or a better test for forensic analysis. You might find yourself frequently using absorbance spectroscopy, a technique that allows researchers to identify even small amounts of a substance (such as DNA) or an antibody based on how…
Mark Esser
Maintaining a social media account involves keeping track of the many random celebrations that can provide an excuse to post a story that otherwise might not have a timely hook. National Peanut Butter Day (Jan. 24 for the uninitiated) is just such a day.
While NIST chemist Carolyn Burdette spent…
Kevin McKinley
Walking the snowy streets of the small Swiss town of Davos, it was impressive to know that 40 heads of state and 2,500 leaders from business and society were there to talk about some of the most important global challenges facing us today.
In the main congress hall, I saw and met leading…
Chad Kymal
ISO 9001:2015, ISO 14001:2015, and ISO 45001:2015 establish clear expectations for top management. Not only are executives accountable for the effectiveness of these respective systems, they also have specific tasks ranging from establishing objectives to supporting relevant managers in their…
Lawrence Livermore National Laboratory
Although the most common method of metal 3D printing is growing exponentially, moving forward from producing prototypes to manufacturing critical parts will be possible only by reaching a fundamental understanding of the complex physics behind the process, according to a new paper written by…
Grant Ramaley
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member countries: the…
NIST
Flu season typically peaks between December and February, but by the time the winter holidays roll around, many of us will have already waited in line at area clinics, grocery stores, and pharmacies to get our annual flu shot. The Centers for Disease Control reports that U.S. vaccination efforts…
Miriam Boudreaux
Before 2015, many of us rode one of the largest waves of success in the history of the oil and gas industry. Everything was booming—companies, salaries, bonuses, cities, services, etc. Then 2015 came and crashed the party, leaving us all a bit uncertain.
Now, entering 2016, you may have some your…
Christine Schaefer
A question for devotees of the Baldrige Excellence Framework: Do people who passionately promote continuous improvement within organizations also tend to make New Year’s resolutions to improve their own well-being?
Seriously, I’m wondering if those who fully appreciate the framework’s value in…
Grant Ramaley
On Dec. 23, 2015, a vote was taken among 78 nations with accreditation bodies that are part of the International Accreditation Forum (IAF). From the vote it was determined that a new international database for quality management system (QMS) certifications should be created.
The intent of the…
Mike Micklewright
I’ve made the point many times that the quality function and the lean/continuous improvement/kaizen function within an enterprise are really one and the same. Treating them as separate value streams with their own documentation, procedures, and goals is wasteful, short-sighted, and disrespectful…
TÜV SÜD America
Sponsored Content
Company managers have a lot on their plates. It’s a tall order to handle daily operations, inventory, staffing needs, training, deadline and quota expectations, and a bevy of other duties. The best managers know enough to delegate certain responsibilities which can help maintain…
Dawn Bailey
Losing can actually have its benefits. For Baldrige users, however, it’s a common saying that everyone is a winner who takes that first step.
The most important reason for using the Baldrige Excellence Framework is not to win an award but to improve financial and business performance, says Joseph…
Christine Schaefer
Being a Baldrige examiner: What is the experience like? Some have compared the work—especially during the final phase of an evaluation—to being in a rigorous MBA program. Others may find it’s like being part of a dispersed but highly engaged task force, as teams collaborate online and on the phone…
Peter Holtmann
The auditing profession is changing. Auditors are getting older. Technology is changing the way auditors work. Companies now work 24/7 around the globe, speaking different languages and integrating different cultures, forcing auditors to adapt to a new work reality. How is all this affecting the…
Craig Cochran
ISO 9001 might be the most confusing document in business history. I first became aware of the standard in the late 1980s when my manager handed it to me and said, “See if you can figure this thing out. Our plant has to get certified.”
I took the document back to my desk and attempted to read it…
Jeffrey Eves
Sponsored Content
In 1996, the International Organization for Standardization (ISO) first released the ISO 14000 family of standards, which provided tools for organizations wanting to manage their environmental responsibilities. In the years since, ISO 14001—“Environmental management systems—…
The QA Pharm
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the…
TÜV SÜD America
As we near the end of 2015, the pilot phase of the International Medical Device Regulators Forum’s (IMDRF) Medical Device Single Audit Program (MDSAP) is approaching its third and final year. In this article, we’ll provide a review of the pilot study’s progress since its inception two years ago,…
Mika Javanainen
With more than one million certifications issued, ISO 9001 is the world’s most widely adopted framework for quality management systems, helping companies achieve conformity of products and services to meet customer expectations and regulatory compliance. The ISO 9001 standard has become synonymous…
Donald J. Wheeler
When industrial classes in statistical techniques began to be taught by those without degrees in statistics it was inevitable that misunderstandings would abound and mythologies would proliferate. One of the things lost along the way was the secret foundation of statistical inference. This article…
