Registrar survey In response to Jim Parker's letter in the October 2000 issue about your registrar customer
satisfaction survey (July 2000), I would like to comment that I have personal experience with a registrar who did "strongly encourage" continuous improvement of a quality system. The registrar
consistently evaluated trends of various metrics and expected to observe fewer and fewer nonconformances as the quality system matured. The result was a more competitive company that, due to
quality system improvements, experienced fewer internal inefficiencies. In the end, is this not a key objective for an organization complying with the ISO 9000 series of standards?
--Jay Stahan
Quality Manager
Bemis Associates Cement life preservers? Scott M.
Paton's statement in his October 2000 First Word column that "The recent Firestone tire recall has nothing to do with the effectiveness of QS-9000" is correct. The effectiveness of QS-9000, or
any other quality standard, depends upon the people involved in design and manufacture. People design and produce safe and effective products; standards do not. However, the
argument that the registrar, Lloyd's Register Quality Assurance, has no share in the blame attached to the Bridgestone/Firestone tire recall could be questioned. Claims made by the registrar with
regard to inspections for certification are not known. Any report made by LRQA to Firestone is probably not publicly available. Once the cause of the problem is known, it will be possible for a
plaintiff to evaluate the assessment made by LRQA. Is it possible that LRQA certified critical parts of the quality management system (such as design, validation, or failure mode and effects
analysis) when they were not well-defined or well-documented? The responsibility for delivery of safe products ultimately rests with the manufacturer, but the promotion of
QS-9000 and advertisements for registrars may lead to an unwarranted feeling of confidence that certification is assurance that the quality management system is in control. If
QS-9000 is only designed to meet customer requirements, it may not be the quality standard that is needed. If certification only requires that suppliers be aware of customer requirements and that
they have a quality system that meets these requirements, certification may not be the proper means for determining the actual state of control of a quality system. A Food and Drug Administration
auditor who digs into the detailed performance of a medical device quality system and the products it produces must also be satisfied that safe and effective products are being delivered. --Mort Levin
Mort Levin Inc.
Quality and Regulatory Affairs Improving FMEAs I had the pleasure of reading Jim Bongiorno's article, "Improving FMEAs," in the October 2000 issue and was appeased but not necessarily happy to find out that others have continued
to experience the drawbacks and barriers that I am experiencing. Unfortunately, many companies and managers consistently view FMEA from a negative perspective and therefore do
not support it. The result is best defined by the old software acronym "GIGO," or garbage in, garbage out. What I really finding amusing is that when all is said and done,
those who did not support FMEAs are the first to have monumental expectations. I hope that articles like this one help convert or convince all employees, not just the lonely
quality and reliability engineers, of the potential gain that can be achieved by using a well-conducted FMEA. --Jorge García ANSI strategy News Digest in the November 2000 issue refers to ANSI and its national standards strategy. No mention is made of the
need for either ANSI or NIST to provide U.S. industry with an international standards comparison database, whereby industry can easily find other countries' standards equivalent to a named U.S.
standard and be able to peruse them from the database. In this day and age, with the resources of our country, this should not be that difficult. Wouldn't ANSI and NIST seem to
be the appropriate bodies? --Malcolm B. Lloyd |
