The lay public doesn't generally understand that international consensus standards represent a set of minimum
requirements, not the optimum or the maximum. To achieve a national or global consensus, all of the involved member bodies must have input into the process, and a significant proportion of the
voting members (typically 70 percent to 90 percent) must approve the standard. Because the level of sophistication in many parts of the world can vary significantly, as do
practices within specific industries, and because each body tries to protect its own interests, the resulting standard is by definition shaped by the lowest common denominator. ISO 9000 is one of
these standards. Hence, the Sept. 8 USA Today article dealing with the recall of 6.5 million Bridgestone/Firestone tires ("Quality Auditor OK'd Decatur Tire Plant"), which refers to
this international standard as a "rigid quality standard," is misleading. ISO 9000 is not rigid, and it defines the lowest acceptable level of a quality system.
Furthermore, QS-9000 (which the article indicates is "the automotive subset of ISO 9000") is in fact a higher-level requirement than ISO 9000. QS-9000 includes all of ISO 9000's
requirements, plus additional requirements designed to ensure that the automotive industry operates at a level higher than that set by ISO 9000's minimum requirements. Similar approaches are
being applied by the telecommunications industry (TL 9000) and the aerospace industry (AS9100). The article also reports that "many automakers are switching to a German
quality standard." Although the article doesn't cite the particular standard, my guess is that the reference is to VDA 6.1, which--like QS-9000--is an add-on to ISO 9000. VDA 6.1 does
contain some requirements that go beyond QS-9000. However, a consensus has been reached between these two standards that will result in ISO/TS 16949, which incorporates the automotive industry
add-ons from the United States, Germany, France and Italy. The article further states that "A plant making life preservers of cement could get certified." This
statement is, of course, a half truth. If a customer specified that it wanted to purchase cement life preservers, the plant could get certified for making them. The real issue is the need to
clearly distinguish between product certification and system certification. The process of ensuring quality has multiple components. If some of the components are skipped or improperly deployed,
our confidence in the quality of the product is diminished. Some of the critical components of the quality process include design verification, process validation, process control, product
testing and product certification, in addition to the quality management system (ISO 9000 or QS-9000). An audit can usually tell if you have a documented system and are following it. It cannot
readily detect design or process control flaws. A second article in the same issue of USA Today reports that "An internal company memo dated January 9 showed that tread
separation incidents cost the company $3 million in 1999, and that Decatur-made tires caused a disproportionate 62 percent of that, or $1.8 million. That was 4.5 times as much as the next-worst
plant…" The question is, should the quality system permit a time lapse of seven months (January to August) before the company reacts? More important, should the quality
management system have identified the severity of the problem even earlier than January 2000? According to the article, "The bad Decatur tires mainly were produced in 1994-1996, coinciding
with a strike there." The updated version of ISO 9000 (ISO 9001:2000) contains expanded requirements for measurement, analysis and continual improvement. Many of these
requirements are in ISO 9001:1994; however, some are not. The increased emphasis in ISO 9001:2000 on process validation, monitoring customer satisfaction, measuring and monitoring processes,
analysis of applicable data to provide information and planning, and managing the process for the continual improvement of the quality management system might have resulted in an earlier
awareness and action on Bridgestone/Firestone's part. Standards development is, by necessity, an evolutionary process. The ISO 9000 development process had reserved certain
requirements for introduction at a later date because not all of the world standard bodies were prepared to adjust to some of the requirements. These are now being added to the year 2000 revision
of the ISO 9001 standard, and they will be introduced into most organizations during the next three years. However, high-tech industries--particularly where reliability and safety are prime
requirements--have always recognized that their goal is not to achieve the "lowest common denominator" but to use standards as the starting point from which they must proceed, utilizing
continual improvement methods to propel their enterprises to excellence. Many executives have learned the hard way--very often as a result of product recalls--that constant
attention to improving business, quality and regulatory processes is far less expensive and yields far greater returns on investment than most alternative approaches they might be considering.
Leadership that fully commits to a business excellence model such as Six Sigma is far less likely to be on television apologizing for performance deficiencies. About the author Stanley A. Marash, Ph.D., is chairman and CEO of STAT-A-MATRIX Inc. and past chairman of the World
Quality Council. Call him at (732) 548-0600 or e-mail smarash@qualitydigest.com . ©2000 STAT-A-MATRIX Inc. All rights reserved. |
