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Quality by Design and RMM: Helping Manufacturers Balance Quality and Speed to Market
Today’s drug development companies face a difficult challenge: balancing the need for product quality and safety while speeding time to market. Championed by the FDA, EMEA, and other global regulatory agencies, quality by design (QbD) represents a systematic approach to building quality into product and process design and development right from the start. QbD and rapid-detection RMM go hand-in-hand, because both share the same goals--to ensure a high-quality manufacturing process that is lean, efficient, and reliable.
Welcome to Quality Digest’s 2008 SPC Software Directory featuring 93 companies that responded to our requests for information. These companies produce or distribute software applications assisting with ANOVA, capability analysis, control charting, data mining, DOE, FMEA, gauge R&R, regression analysis, reliability analysis, and similar functions. If provided, descriptions of their products can be found at www.qualitydigest.com/content/buyers-guides . As with all Quality Digest guides, the 2008 SPC Software Directory is in no way meant to endorse or exclude any specific organization. Rather, it should be used as the starting point in the data-gathering process. Readers are encouraged to contact these companies directly for more information.
The United States spends 16 percent of its gross domestic product (GDP) on health care, more than any other nation. Although that investment has produced medical experts and breakthroughs envied the world over, a great majority of U.S. citizens are unhappy with the end results. When the nonpartisan Commonwealth Fund conducted a poll of U.S. health care consumers last year, 69 percent expressed strong dissatisfaction with the current health care system. In a 2007 survey, the same group found U.S. respondents twice as likely to support a complete overhaul of their system than those from Canada, Germany, the Netherlands, New Zealand, Great Britain, and Australia--all nations that spend half as much GDP as the United States on health care.
Delivering systemic change to a large institution requires more than sound organizational reengineering or optimizing the operating process. Change must be identified, energized, and directed. Potentially sympathetic but undecided hearts and minds must be won, and opposition, whether open or covert, must be understood, met, and overcome. Ultimately, most stakeholders must see change as not just possible, but preferable to the status quo. To paraphrase a slogan from President Obama’s campaign, large coalitions must be given change they can believe in. In that respect, regardless of what you think of his governing agenda—and thoughtful detractors are legion—it’s hard to argue with Obama’s success in campaigning for change he believes in.
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.
For some, Labor Day signals the end of summer as preparations for autumn and the accompanying holidays begin. As is customary in some locales, warm weather clothes, including one’s white wardrobe and shoes, are returned to the closet until next spring. Children and students go back to school, much to the delight of their parents, and hopefully to the excitement of their teachers.
Chances are one of the kids’ first assignments will be to draft a report on the activities of their summer vacation. Not to be left out of this assignment, I thought it appropriate that I pen a few lines about one of our recent trips. There were no death-defying rides on some monster roller coaster, no surfing in shark-infested waters or aerial descents with a parachute from a plane, just a sensible trip to Chicago for my wife and me.
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.
Real-time X-ray inspection systems have been used in quality assurance applications for more than 25 years. In electronics manufacturing, for example, X-ray inspection ensures the registration of drilled holes to internal pads of multilayer printed circuit boards. In electronic assembly applications, X-ray inspection ensures the quality of hidden solder bonds of surface-mounted components such as ball-grid arrays, as seen in figure 1 below.
Now real-time X-ray inspection is becoming an important tool for ensuring the quality of many medical devices. These devices incorporate a diversity of materials, including polymers, rubbers, steel, titanium, ceramics, and glass. Real-time systems employ fluoroscopic imaging devices to display the device’s X-ray image in a video format.
Enron. Worldcom. Tyco. Cendant. Bernie Madoff, once chairman of the NASDAQ, is now cooling his heels in jail. The ex-CEO of Comverse is arrested in Namibia, the CEO at United Healthcare is forced to step down, and Patricia Dunn of Hewlett Packard is charged in an ethics scandal. And, of course, AIG has no problem doling out millions in bonuses to the very people who drove the company and the country into a financial crisis. It seems that no matter where we look today, the erosion of ethics and basic moral principles of right and wrong have taken us to the point where trust in our institutions and the very systems that make our society work are in imminent danger of oblivion. Perhaps at no time during the last two or three decades has business ethics, or the lack thereof, been of such paramount importance to the well-being of our business entities and country.
In today’s business environment, any organization that wishes to exceed customer expectations and stay competitive needs a long-range strategic plan. This plan must be forward-looking, visionary, and achievable, while at the same time striving toward continuous improvement of the organization’s key business processes. The organization must, in effect, keep both hands on the wheel to move forward successfully. The hoshin strategic planning process in use at Hewlett-Packard Co. has been highly successful in meeting these requirements.
The hoshin process is, first of all, a systematic planning methodology for defining long-range, key, entity objectives. These are breakthrough objectives that typically extend two to five years with little change. Second, the hoshin process does not lose sight of the day-to-day business fundamental measures required to run the business successfully. This two-pronged approach provides an extended period of time for the organization to focus its breakthrough effort while continuously improving key business processes day to day.
