All Features
Mike Richman
Protecting the health and well-being of consumers and the world at large is the quality industry’s highest calling. During the past several decades, as the manufacture of electronics and consumer goods has shifted away from North America and Europe, the need to confirm and ensure the safety of…
Pierre Huot
If a manufacturer were to ask its clients how they evaluated goods or services, the three most common metrics would be goods at a fair price, on-time delivery, and quality. Ask which could be most valuable and in all likelihood the most significant response would be quality. When included in the…
Dirk Dusharme @ Quality Digest
For most of us, food safety is a topic that, at best, only lurks at the edges of our brains. It rarely becomes something we really think about until we open up our refrigerator and try to figure out what’s growing in the back corner of the bottom shelf, or until we hear stories about people being…
Mike Richman
Yes, it happened again. According to a recent Associated Press story, drinking glasses produced in China, featuring comic and superhero characters, have been discovered to contain extremely high levels of lead. Excessive amounts of cadmium were revealed in the glasses as well.
This has been a…
A new year always brings new hope, new plans, and new perspectives. While looking ahead is the most direct route to progress, looking back is essential to understanding the present. After all, the past creates the consequences that will shape the future.
With this in mind, the editors of…
Thomas R. Cutler
Food safety standards are becoming increasingly stringent. Although government legislation has long been implemented, your customers may be driving an even higher standard of food safety through the Global Food Safety Initiative (GFSI) or Safe Quality Food (SQF) Institute, which require third-…
The QA Pharm
My definition of “specification” is rather simple: It’s a promise.
Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less…
Denise Robitaille
Election time is once again upon us. And, like a bumper crop of kudzu run amok, campaign ads have besieged local broadcasts with the tenacity of an unrelenting pestilence. My mailbox is equally stuffed with innuendo-laden campaign fliers. A horrific waste of paper.
The malicious tone of the…
Mike Richman
Did you know that World Standards Day (being celebrated today) and Earth Day both began in the year 1970? How about the fact that Oct. 14 was chosen as the date because that was the day in 1946 when the delegates of what was to become the International Organization for Standardization (ISO) first…
Andrew Reich
Looking for a new factory to work with in China can be daunting. With pressures from poor rice production on the rise and labor throughout China unstable, more China-based manufacturers are closing shop every day.
For these reasons I think it’s an opportune time to review the key aspects and goals…
Miriam Boudreaux
If you have ever wondered what the difference was between a gap analysis, an internal audit, or a pre-assessment, you might not be alone. When trying to figure out whether your company meets the requirements of a standard, such as one the International Organization for Standardization (ISO),…
Denise Robitaille
Trepanning is the process of drilling a hole in the skull. It was practiced as far back as 10,000 years ago. Archaeological artifacts lend credence to the lore that the process was used by some cultures to expel evil spirits. Apart from that occult-ish application, the process has been used for…
Robert Parsons
Finally, the long and arduous process that appears to be a requisite phase in the development of an international quality management system standard appears to be nearing an end. Though the AS9100:2009 and AS9101:2009 (checklist) have been available for quite some time, the aerospace industry has…
Sal Lucido
In Part I and Part II of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance called the “circle of compliance,” pictured in figure 1. I also showed how setting up key performance indicators (KPIs) that monitor performance to goals is a good way…
Oriel STAT A MATRIX
The status of nuclear power in the United States is finally changing. As of last month, there were 18 proposals under review by the Nuclear Regulatory Commission (NRC) for 28 new units in 14 states. This renewed interest in building nuclear power plants can be attributed in large part to the…
Xia Enyu
Industrial organizations face numerous compliance regulations such as management system certification, information security, corporate social responsibility compliance, and limiting the content of hazardous substances in products. Now they can add carbon management to the list. This task is one…
Denise Robitaille
As the universe of quality management systems expands, it’s interesting to observe the increasing variables that constitute the concept of applicability. Let’s take maintenance of records as an example.
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Twenty years ago, the records that were kept and the method of keeping…
Sal Lucido
In Part I, “Savvy Compliance Strategy Can Improve GMP,” we took a high-level look at a process for automating regulatory compliance management. The closed-loop process starts with documenting your processes, followed by monitoring or checking that the processes are being followed. Next, you…
Standards Council of Canada
The Bre-X gold scandal that rocked the Toronto Stock Exchange (TSX) during the late 1990s forever changed the Canadian mining sector. When millions in pension dollars were lost due to fraudulent and falsified test data, investors around the world were outraged.
It remains one of the most…
Thomas R. Cutler
There is no shortage of standards. There are standards that define how something should be made vs. those related to processes, such as ISO 9001. According to the International Organization for Standardization (ISO), standards that provide requirements or give guidance on good management practice…
Gene Rider
Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S. Consumer Product Safety Commission (CPSC) “small parts” standard, for example, are the result of…
Paul Scicchitano
The billowing cloud of volcanic ash spewing from Iceland may have been a major pain for air travel, but it also had a positive side. It served up a gentle reminder for me to find out what the heck is going on with AS9100 certification.
Faster than I could say Eyjafjallajökull, I was on the…
Almost two years ago, the management team of the Indiana Toll Road (ITR Concession Co. LLC) and the Chicago Skyway Bridge (Skyway Concession Co. LLC) decided that implementing a quality management system compliant with ISO 9001 would be a useful tool for driving continual improvement. The shared…
NIST
The following is a profile of one of the 2009 Malcolm Baldrige National Quality Award Winners. The Baldrige Award is the nation’s highest award for quality and is administered by the Department of Commerce through the National Institute of Standards and Technology.
AtlantiCare, a nonprofit…
Denise Robitaille
ISO 9001 makes multiple references to the need to understand customer requirements and to monitor the extent to which those requirements have been fulfilled. In fact, the scope of the standard clearly indicates that its focus is primarily on ensuring that an organization has the processes that…
