All Features
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…
Dirk Dusharme @ Quality Digest
In our July 7, 2017, episode of QDL we look at apprenticeships, the Antikythera mechanism, and risk-based thinking in operations.
“Demand-Driven Education to Close Skills Gap”
Speaking at the National Association of Manufacturers Summit in Washington, D.C., Secretary of Labor Alexander Acosta and…
Amie Whittington
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (dual status). The…
Tim Lozier
The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it.
The biggest question often asked is, “I’m aware my company needs to pay great attention to the detail of risk, but…
Intertek
Sponsored Content
As widely useful and broadly applicable as it may be, the ISO 9001 standard covering general requirements for quality management systems (QMS) cannot address all stakeholder needs in every sector. Component functions and operations of discrete industries often require additional…
Intertek
Sponsored Content
For organizations within the aerospace sector, certification to the AS9100 family of standards—including AS9110 for aerospace maintenance, repair, and overhaul (MRO) organizations; and AS9120 for aerospace warehouse and distribution operations—is a necessity for doing business.…
Intertek
Sponsored Content
Organizations that build, supply, design, or maintain products, parts, or services for the aerospace industry generally must be certified to the AS9100 family of standards (including AS9110, which is specifically for aerospace maintenance, repair, and overhaul [MRO] organizations…
Michael Ray Fincher
To meet the 2018 deadline for becoming certified to ISO 9001:2015, organizations are scrambling to overhaul their quality management systems. One major revision to ISO 9001 is the requirement to identify, evaluate, and address risks. Unfortunately, a tool most appropriate for these actions has…
William A. Levinson
‘We’ve always done it that way” explains why many suboptimal and even obsolete methods are taken for granted. The range chart for statistical process control (SPC) is, for example, somewhat inferior to the sample standard deviation chart, and it is almost certainly a holdover from when all…
Chad Kymal
In the 1990s, Omnex worked with Ford Motor Co. to develop the Ford quality operating system methodology, which with maturity and broad experience has evolved into Omnex’s business operating system (BOS) process.
The quality operating system promised and has delivered the following: • Cross-…
Mike Richman
The June 16, 2017, episode of QDL included my hot take on Hexagon’s ginormous user conference as well as interviews with two of our favorite guests, Chad Kymal of Omnex and Kelly Graves of Internal Business Solutions. Take a look:
“Field Report: Hexagon Live 2017”
I and more than 3,000 of my…
