All Features
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…
Bruce Weinberg
Science funding is intended to support the production of new knowledge and ideas that develop new technologies, improve medical treatments, and strengthen the economy. The idea goes back to influential engineer Vannevar Bush, who headed the U.S. Office of Scientific Research and Development during…
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…
Michael Hughes
The F-35 was billed as a fighter jet that could do almost everything the U.S. military desired, serving the Air Force, Marine Corps, and Navy—and even Britain’s Royal Air Force and Royal Navy—all in one aircraft design. It’s supposed to replace and improve upon several current—and aging—aircraft…
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…
Loic Sadoulet, Giovanni Tassini
Making the most of its position as an important seaport, Venice’s remarkable economic development during the Middle Ages relied on network effects, contractual innovation, and coordination among the players involved in long-distance trade. Companies today still exploit these mechanisms to succeed…
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…
Katina Sawyer, Christian Thoroughgood
In times of organizational crisis, some companies are able to right the ship, while others sink under the pressure.
Recently, Uber has been under fire for a bad corporate culture, which promoted, among other things, sexism and other forms of toxic behavior. This led to a four-month investigation…
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…
Mike Richman
The July 17, 2017, episode of QDL focused on some of the nitty-gritty of quality improvement, from the value of personal certifications to the opportunities of disruptive innovation, and to the fundamentals of risk management to the challenges of customer service. In case you missed it, here’s a…
Rick Barker
Operations and safety don’t always speak the same language, not because operations isn’t committed to keeping people safe at work or safety isn’t concerned with meeting operational goals, but rather because each area has its own methods, processes, and measures. This communication gap can increase…
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…
Pat Toth
Recently a segment on my favorite morning news program stopped me in my tracks. The young and attractive hosts (why are they always so young and attractive?) were demonstrating new appliances, among them a smart refrigerator. The fridge was equipped with all kinds of high-tech features including…
Dirk Dusharme
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…
Erin Connelly
For a long time, medieval medicine has been dismissed as irrelevant. This time period is popularly referred to as the “Dark Ages,” which erroneously suggests that it was unenlightened by science or reason. However, some medievalists and scientists are now looking back to history for clues to…
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…
Roger Lehman, Julius Koh
Lucy felt hollow and dissatisfied. She was a star performer and had just helped her team clinch a large government deal that they had been working on for months. At the celebration that evening, Lucy was forced to put on a smile and a dynamic front. She had good relationships with her team members…