All Features
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…
Jon Miller
Facilitation is the art of guiding but not leading, bringing learning but not lecturing, engaging but not directing. Coming from the Latin facilitar, meaning, “to make easy,” the role of the facilitator is not to do for others, but to bring out the ability of a group to accomplish a goal. There are…
Paul Leavoy
Courtesy of another controversy surrounding hazardous substances in children’s toys, China’s massive manufacturing sector is reliving a public relations disaster.
Four years ago, a nationwide recall on children’s toys containing lead paint—and manufactured in China—cast a pall on the integrity…
Akhilesh Gulati
Toyota’s name has been plastered in the headlines providing it the publicity no organization would wish for.
Historically, Toyota had achieved a global reputation for the production of very high quality vehicles. The Toyota Production System, or the Toyota Way, is being taught, learned, and…
Denise Robitaille
Ok, men. Leave the room.
Today, I want to discuss fulfilling customer requirements as they relate to one particular product: The bra. For those men who’ve not heeded the warning to leave, you may, by the end of this article have discovered, one of the perennial reasons for your spouse’s…
Robert Parsons
The AS9100C standard (also referred to as AS9100:2009 and AS9100 Rev C) has been published since January 2009. You are not alone if you are confused about the delay in being audited to this standard. Like you, most companies seeking registration to AS9100 are in the process of trying to figure out…
Paul Scicchitano
Some experts could barely hide their disappointment when the total number of ISO 9001 certificates recently failed to break the long-awaited million-certificate mark—as if it isn’t enough to have the world’s most widely used voluntary quality standard of all time.
With 982,832 third-party…
National Standards Authority of Ireland NSAI
(NSAI: Nashua, New Hampshire) — Even though no firm action was taken during the 2009 Climate Conference in Copenhagen, the U.S. administration has still pledged that the country will tighten carbon emission regulations. The most plausible possibility is what is referred to as a “cap and trade”…
The Un-Comfort Zone With Robert Wilson
On a summer weekend in 1977, my friend Tony and I made plans to go water-skiing. When he picked me up there were two people in the car that I did not know. He introduced his new girlfriend, Sue, and her brother, Bubba.
Bubba was the quintessential redneck. Within minutes of getting on the boat…
Miriam Boudreaux
When a quality management system (QMS) is implemented, results are evident immediately: reduction in warranty cost, reduction in rework, reduction in scrap, higher profit margins, etc. Would you agree that ISO 9001 and other quality initiatives such as lean, Six Sigma, and 5S can significantly…
Jennifer Simcox
One of the key additions to the R5 version of the telecommunications quality management system standard, TL 9000, is the addition of a risk management requirement. While the requirement is only a single sentence, it is followed by a bulleted note that adds guidance as to the intent. Managing risks…
