All Features
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.
The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted…
Grant Ramaley
Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region…
Chad Kymal, Gregory F. Gruska
During the early 1980s, GM, Ford, and Chrysler established the Automotive Industry Action Group (AIAG), a not-for-profit organization with the mission “To improve its members’ competitiveness through a cooperative effort of North American vehicle manufacturers and their suppliers.” In the late…
Jyoti Madhusoodanan, Knowable Magazine
A frog the size of a fingernail. A poncho-clad farmer leading his mule. A tree, some intertwining leaves, a silhouetted figure holding a pot. Such logos are stamped on labels of coffee, cocoa, mangoes, jeans, and myriad other products, certifying that the object for sale is in some way “sustainable…
Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new sustainable treatment plants. The International Organization for Standardization (ISO) and the Gates …
Jon Speer
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
If your…
James J. Kline
The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard. Although numerous articles and several books have…
Ryan E. Day
In the article, “ANSI’s Role in the Wide World of Standards,” (Quality Digest, March 12, 2019), we looked at where standards originate and how companies are involved in developing them. In this article, we’ll outline four points that can help your organization integrate standards into your…
Ronda Culbertson
The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new standards caught quite a few organizations somewhat flat-footed; particularly with the emphases on risk…
Harry Hertz
Recently I’ve seen some startling statistics from Gallup and Glassdoor about employee and customer engagement. I hope those statistics do not represent data from any organization you or I associate with. The actions of senior leaders, as well as setting the right focus on employees, can prevent…
Alexandra Killewald, Xiaolin Zhuo
Almost 70 percent of American mothers with children younger than 18 work for pay, but motherhood remains disruptive for many women’s work lives.
American women earn almost 20 percent less per hour than their male peers, in part because women disproportionately take responsibility for raising…
Brian S. Smith
Throughout my career, I have been a member of several trade organizations. I believe that standards have meaning, in every field. When I become a member of an organization, I endeavor to learn as much as possible.
For example, I belong to ASQ (American Society for Quality). I enjoy having…
Ryan E. Day
According to the International Labor Organization, around the world every day 7,600 people die from work-related accidents or diseases—that’s more than 2.78 million people every year. To address the issue, the International Organization for Standardization (ISO) has developed a standard, ISO 45001…
Tom Taormina
Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case…
Chad Kymal
When we think about IT security, we typically think about the large hacks that were reported in the press. When viewed as a whole, we can understand the magnitude of lost data. It’s no surprise that these hacks are what come to mind when we think about information security.
The table below shows…
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time.
Because of…
Ryan E. Day
I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up. You just benefited from at least seven U.…
Donald J. Wheeler
Managers the world over want to know if things are “in control.” This usually is taken to mean that the process is producing 100-percent conforming product, and to this end an emphasis is placed upon having a good capability or performance index. But a good index by itself does not tell the whole…
William A. Levinson
The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001 users can avoid most nonconformances by focusing on the clauses that are the most frequent trouble…
Laurel Thoennes @ Quality Digest
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?
1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Dirk Dusharme @ Quality Digest
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.
The goal of any honest pharmaceutical company is to make…
Graham Freeman
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
Wendy White
Starting a new facility in the food-processing industry is an enormous undertaking. There are thousands of things that must be accomplished, from hiring and training new staff to ordering and installing equipment. This scenario is a perfect example of “too much to do and not enough time to do it…
Richard Harpster
On Oct. 13, 2018, the Automotive Industry Action Group (AIAG) sponsored a webinar on the status of the AIAG Core Tools Software (AIAG CTS). John Cachat, AIAG project manager for the AIAG CTS project, was the presenter for the webinar. The presentation provided information on why the AIAG was…
Dirk Dusharme @ Quality Digest
We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context.
“The Gift of Being Small” This article by Quality Digest’s Taran March wonderfully illustrates how we…
