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Representing the first international effort to formulate a quality management
system standard for the aerospace industry, the two-year-old AS9100 is beginning
to show its long-term value. The standard supplements ISO 9001 by addressing the
additional expectations of the aerospace industry. Already, reports along this
complicated manufacturing chain attest to–among other benefits–AS9100's
contribution to more consistent verification methods and fewer verification
audits.
Initially released in October 1999 by the Society of Automotive
Engineers in the Americas and the European Association of Aerospace Industries
in Europe, and shortly thereafter by standards organizations in Japan and Asia,
AS9100 was a cooperative effort of the International Aerospace Quality Group. As
such, it combines and harmonizes requirements outlined in the SAE's AS9000 and
Europe's prEN9000-1 standards. Recently, AS9100 was revised to align with ISO
9001:2000.
Tough economic times are upon us. The leaders of the Big Three automakers have to stoop to driving their own cars, our nation’s leaders have to separate themselves into two parties, and the people affected by the layoffs have to go home and lead their families through troubled times. Which do you think is the toughest job and requires more leadership?
We all accept the role as leaders of our families, churches, the neighborhood association, or perhaps the local school board. Those roles are more important to us as individuals than the roles played by Congress or the car manufacturers’ officers. It is a choice that we make personally, and this decision requires us to question not only our time commitment, but also the alignment of our personal belief system with that of the organization.
Registering to the appropriate quality management standard—and maintaining that registration—is probably the best way to ensure that your organization is serious about improvement. There are standards for practically every industry in the world, in manufacturing as well as service environments. The path to registration can be a long one; fortunately, there are professionals to make the journey a bit easier.
The following section contains two directories. The Registrar buyers guide will help you find the right company to register and audit your organization’s compliance to various standards. These organizations can ease your journey toward the successful implementation of standards for quality management, social accountability,
environmental management, FDA requirements, and others. This section also includes the ISO Standards Consultants buyers guide, which can help you find the right consultant to lead you through the often-complex registration process, particularly for ISO 9001, the world’s most recognized quality standard.
By Lorri Hunt, Denise Robitaille, and Craig Williams
Editors note: The following is an excerpt of The Insiders’ Guide to ISO 9001:2008 , which was published November 1 by Paton Professional.
As users get their first glimpse of ISO 9001:2008, the question on everyone’s mind is, “What, if anything, will our organization need to do differently?” ISO 9001:2008 focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. It should not result in an extensive change to existing quality management systems (QMS). The changes are minor in nature and address such issues as the need for clarification, greater consistency, resolution of perceived ambiguities, and improved compatibility with ISO 14001, which relates to environmental management systems ( EMS).
What does this mean for users? Requirements in the standard are frequently referred to as “shalls.” For the purpose of this amendment, ISO 9001:2008 provides improvements for users without adding to or removing any of the “shalls.”
IECQ QC 080000: The Standard for Lean-Green Compliance
Although not all manufacturers around the world understand the value proposition of a lean-green, process-based manufacturing program, there are more than 1,250 that do--those that are registered to the IECQ QC 080000 standard.
IECQ hazardous substance process management (HSPM) has proven to be an efficient, effective, and financially prudent way for manufacturers to demonstrate international compliance with hazardous- substance-free components, products, and related material requirements and legislation.
Adding a lean-green, process-based manufacturing program enhances this concept and adds even greater value.
When properly implemented, QC 08000 certification provides its management and stakeholders:
Excellence is a part of life, and we must strive for it, especially if our mistakes create problems for others. Mistakes are costly; they hit the bottom line. Some are costly enough to put us out of business.
The code word for a mistake-free state is quality. The process for achieving that begins long before gauges and calipers arrive on the scene. It’s a route with many stops, any of which can determine whether the final destination will be quality or the scrap heap.
The many stops look so routine and ordinary: choosing the right raw material, correct chemical formula, precise temperature, exact amount, specific tools, proper assembly procedures. The timely output of quality outcomes depends on each of these transactions. How can we ensure that they will all happen accurately and completely? The answer for me is visual thinking, which leads to visual devices and systems.
Visual devices ensure that each stop on the road to quality is executed perfectly, on time, and safely. A visual workplace doesn’t just minimize problems and mistakes; it can eliminate them completely for both final product quality and every transaction along the way.
Professional statisticians typically have powerful software at their disposal to perform advanced analyses and create slick graphs. But many professionals in the quality field don't enjoy that luxury. Faced with a limited budget, they must be resourceful with the software they already have. Besides, not everyone needs the capability to perform nonlinear regression with custom loss functions for maximum likelihood! Fortunately, many occasional data analysts already own a versatile software capable of providing most basic quality analyses -- Microsoft Excel.
Skeptical? I don't blame you. The following examples show how to apply Excel for the graphical analysis of quality data. The examples range from somewhat obvious to downright clever. As it turns out, Excel's capabilities are limited only by your creativity.
In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations.
ISO 13485--”Medical devices--Quality management systems--Requirements for regulatory purposes” is the standard for organizations engaged in the manufacture of medical devices. According to the most recent survey by the International Organization for Standardization ( www.iso.org/iso/survey2006.pdf ), there were a total of 8,175 current ISO 13485 registrations across 82 countries in 2006. Approximately 30 percent of all ISO 13485 registrations were issued in the United States, compared to only 6 to 7 percent of all ISO 9001 and ISO 14001 registrations. According to the survey, the 2006 total represents an increase of 3,110 (61%) compared to 2005, when there were 5,065 registrations across 67 countries and economies. Other major markets include Europe, Japan, Canada, Sweden, and Israel.
Quality improvement is a tough undertaking for even the savviest organization. There’s no need to go it alone, however. Quality system consultants and trainers can help keep you and your organization on the right path, and ensure that you’re current in your knowledge of best practices.
On the following pages, you’ll find our Consulting and Training buyers guide. This guide include hundreds of companies that employ experts in the Malcolm Baldrige National Quality Award program, statistical process control, Six Sigma, leadership training, quality system development, and certification, among others.
These directories are not meant to endorse or exclude any particular organization. Rather, they should be used as the starting point in the data-gathering process. Readers are encouraged to contact the companies directly for more information and to ask for—and check—references. Further information, including company descriptions (if provided to us) can be found on our web site at www.qualitydigest.com/content/buyers-guides.
A few years ago, we had a mysterious scratching sound in our attic. My 5-year-old daughter was terrified, and everybody’s sleep was being interrupted on a nightly basis.
“We need to do something about the noise in our attic,” I told my daughter.
“No!” she cried. “Don’t go into the attic. It’s too scary.”
I talked to my daughter, and it was obvious that the vagueness and seeming enormity of the problem terrified her. She didn’t understand the problem; thus it was overwhelming. In my daughter’s mind, the sound in the attic could be bats, snakes, ghosts, vampires, or big hairy monsters. I took my daughter’s hand and gave it a reassuring squeeze.
“I’m a little scared, too,” I told her. “But if we can learn more about the problem, I bet we can solve it.”
My daughter seemed dubious, but she agreed to help me investigate the situation. We went into the attic with a flashlight, stabbing the beam of light into the dark and dusky corners. It didn’t take long for us to figure out the nature of our problem. We saw tiny eyes and furry little faces staring at us.
“They’re just squirrels,” my daughter giggled. “They snuck into the attic.”
