All Features
Roy Swift
Certificates, certifications, badges, and licenses: What are they worth to the workforce? The last decade has seen huge growth in the number and variety of credentials, and this explosion has fueled a great deal of confusion among students, workers, job seekers, employers, and others.
Job seekers…
Olympus
Sponsored Content
Restriction of hazardous substances (RoHS) regulations help protect the public from dangerous or toxic materials in consumer products and electronics. Beyond public health and safety concerns, noncompliance represents significant potential costs, including fines, product recalls…
William A. Levinson
Some ISO 9001 users complain that the standard does not improve performance or deliver bottom-line results, while others are delighted by the standard as a framework for effective quality management systems. I pointed out previously that ISO 9001:2015 does not address, at least not explicitly, the…
Arun Hariharan
In my October 2013 column, “Standardize to Improve,” I dealt with business process mapping in detail. Business process management systems (BPMS) comprise the entire gamut of documenting process steps, assigning ownership to process owners, and often, process-compliance audits to check whether you…
Mary McAtee
True to my profession as an engineer, I am a total geek at heart and proud of it. Spending time in automobile museums always fascinates me. It excites me to see a prescient innovator from the past come up with an idea like headlights. The first ones were Limelight carbide models that had a nasty…
Peter Merrill
ISO 9001:2015 has significant structural changes that differentiate it from the previous standard. The new high-level structure is common to all ISO management system standards (i.e., quality, environmental, IT security) and enables us to start looking at integration of these systems. There is a…
Joe Bollard
As of Sept. 14, 2018, ISO/TS 16949 certificates are longer valid, which means automotive suppliers must certify to the new version, IATF 16949. Transition audits are underway and will continue into next year, but many companies still have a long way to go to prepare.
Let’s look at some of the…
Dirk Dusharme @ Quality Digest
Our Sept. 8, 2017, episode of QDL examined a different way to conduct clinical trials, discussed fixing problems before they occur, and in the aftermath of Hurricane Harvey looked at resources for building a more resilient and sustainable infrastructure.
“A Better Way to Design Clinical Trials”
A…
DNV GL
Sponsored Content
A new report by Jupiter Research says $8 trillion will be the price tag—within the next five years—of cyber attacks against businesses around the world. Hacks and other forms of digital theft are accelerating despite what would seem to be nonstop efforts by corporations to harden…
Mike Richman
On Friday, Sept. 1, 2017, QDL included news about the disaster in Texas and no apocalypse in retail, an interview covering a different approach to failure modes and effects analyses, a feature article on consumer views about for-profit social-benefit enterprises, and a great new Tech Corner demo.…
Amie Whittington
As discussed in my previous article, the Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under section 501(c)3. However, the IRS isn’t the only one monitoring your tax-exempt hospital. Other organizations have started policing these…
Mike Richman
There was a lot of ground to cover on this week’s show… fortunately we had drones (I mean, unmanned aircraft systems) to help us cover it all. Here’s a quick flyby:
“Girl Scouts Offer New Badges for Science, Technology, Engineering and Math” The Girl Scouts of the USA are now offering their…
John Flaig
Independence is an important issue in statistics, so I found the article, “Ethics, Auditing and Enron,” by Denis Arter and J. P. Russell, in the October 2003 issue of Quality Progress quite interesting.
In the second section of the article the QP editor asks, “Must auditors be independent?” to…
Chad Kymal
Globally, there are more than 68,000 organizations certified to ISO/TS 16949:2009 that will need to undergo a transition audit to the International Automotive Task Force (IATF) international automotive quality standard, IATF 16949:2016. As of April 2017, 181 of these audits have been completed,…
Ryan E. Day
What do cocoa, socks, and smartphones have in common? If you guessed risk of slavery in the manufacturing supply chain, you are correct. Does your organization have an international supply chain? Then it’s at risk. What are you doing to address the risks associated with modern slavery in your…
Dirk Dusharme @ Quality Digest
Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.
“Climbing Stairs Just Got Easier With Energy-Recycling Steps”
These stairs actually help you go up.
“The Curious Case of the Fidget Cube”
How a product…
William A. Levinson
Joseph Juran once warned1 that ISO 9001 standardizes mediocrity, and users often discover that it does not deliver outstanding or world-class results. This is not because of any inherent problems with the standard, but rather the manner in which organizations use it. If their goal is solely to “…
Sal Lucido
Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated process management system lies the unsung yet essential electronic form. You can avoid quality management…
Mike Richman
The dog days of summer are here, but the Aug. 4, 2017, episode of QDL offered lots of cool content. Let’s take a closer look:
“What Went Wrong With the F-35?” One expert calls the Lockheed Martin’s F-35 fighter jet an “inherently terrible airplane.” So why does the Air Force consider it warfighter…
DNV GL
Bribery and corruption are a $1 trillion drain on the global economy and a door-shutting event for companies unable to prevent rogue acts from destroying a company’s entire reputation. If you think about it, managing bribery is a bit of an oxymoron. How do you manage something that hasn’t happened…
AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.
Inadequate corrective actions
An FDA investigation was conducted from January to February 2017 at…
Elizabeth Gasiorowski Denis
Change is nothing new. Nobel laureate Bob Dylan sang that “the times they are a-changin’” back in 1964. The difference today is the pace of change. In his book, Thank You for Being Late: An Optimist’s Guide to Thriving in the Age of Accelerations (Farrar Straus & Giroux, 2016), Thomas Friedman…
Scott Gottlieb
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By…
Pam Bethune
Every company is in business to take risks.
Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to identify opportunities and take them when beneficial, but the amount of risk must be understood. Whether it’s…
Claire McCluskie
With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some uncertainty about the effect that one of the standard’s key changes might have on their business: computer…
