In the previous article in this series (June 2001 issue), I introduced the concept of "Fusion
Management" as an integrating process among the numerous quality and business process improvement initiatives introduced during the last half-century. These various approaches to improvement
tend to fall into three major categories: documented management systems based on consensus standards or regulatory requirements (discussed in this article); statistical tools to measure and
control quality processes; and performance excellence models, often based on award criteria, to evaluate both the elements of a management system and the business results provided by that system.
Hierarchy of Business Processes
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In earlier times, craftsmen would design, manufacture and ensure the quality of their products. A much smaller marketplace paid for these products according to their
perceived value and the skill involved in their workmanship--their level of quality. The transformation of our economy from agricultural
to industrial during the late 19th century gradually brought about a definition of quality pertaining to mass production techniques. With the advent of larger
manufacturing complexes, workers performing similar tasks were grouped together and supervised by a foreman, who then assumed responsibility for the quality of
their work. Through the 1920s and 1930s, test and inspection functions grew in size and were eventually separated from production. Manufacturing was no longer
responsible for the quality of the product. During the 20th century, as life became more complicated, government refined the
notion that its citizens should be protected from the excesses of free enterprise. Little by little, laws, regulations, guidelines and consensus standards crept into our
lives, and a new mindset began to develop: the notion that government must set quality standards where the private sector has left a void or where the health, safety
and welfare of the citizens are at risk. For example, in the United States, the Department of Agriculture provides safeguards for the daily food supply; the Food
and Drug Administration protects against unsafe food, drugs, medical devices and cosmetics; and the Department of Labor is responsible for the occupational health and safety of workers.
After World War II, the needs of the Cold War led to more formal expansions of quality system requirements by the Department of Defense through its Military
Specification MIL-Q-9858, "Quality Program Requirements," published in 1959. Military, and then space, standards were soon followed by Good Manufacturing
Practices, issued by the FDA for pharmaceuticals and medical devices, and the Nuclear Regulatory Commission's regulations for nuclear power plants.
Industry's major problem with government-imposed quality is the perception of excessive levels of documentation required by regulators, whose mission it is to
ensure that industry has complied with the requirements. The pyramid above shows the typical structure of a documented quality management system, regardless of the
standard or regulation imposed. The primary means of enforcing these systems is a network of audits--by corporate auditors, regulatory agencies, prime contractors on
their suppliers, and third parties--to provide objective evidence that documented systems are in place, meet the requirements and are being followed.
Gradually, as global trade expanded, it became necessary to develop quality management systems that would be internationally accepted and enforced, thus
promoting free movement of goods across national boundaries. The International Organization for Standardization, with headquarters in Geneva, Switzerland, and
more than 100 participating countries, is the coordinating agency for cross-national standards. ISO 9001 is the central quality management document in the
international consensus standards system. Gradually, as part of conscious efforts to "harmonize" quality system standards and reduce the amount of documentation and
number of audits organizations must undergo, various governmental requirements have been replaced by ISO standards, and many industries have developed sector-specific standards based on ISO 9001.
The process of ensuring quality has multiple components, including design verification, process validation, process control and product testing, in addition to
the quality management system. If some components are skipped or improperly deployed, quality is diminished. An audit can usually tell if you have a documented
system and are following it; it cannot readily detect design or process control flaws. Hence, management systems represent an excellent base upon which to build
quality, but they do not, by themselves, ensure quality processes or products. Moreover, although they call for continual improvement, they provide neither the
tools for improvement nor the criteria for performance excellence. Hence, there exists a need for other approaches, which I will discuss in future articles. About the author Stanley A. Marash, Ph.D., is chairman and CEO of STAT-A-MATRIX Inc. E-mail smarash@qualitydigest.com . Fusion Management is a trademark of STAT-A-MATRIX Inc. ©2001 STAT-A-MATRIX Inc. All rights reserved. |
