Dear ASQ Section Members,

It has been several weeks since the attack on the United States and we hope you are supporting our Presidents recommendation to let America continue to go about its regular business, even as the leaders of nations around the world are preparing to respond to the threats made to our way of life.

With that in mind, many of you chose to come to our rescheduled Section meeting on Wednesday the 26th which featured Ms. Barbara Moynier - Senior Food & Drug Investigator, Ozzie Schmidt, Supervisor – Medical Device Safety Unit and Susan Bond, Supervisor – Drug Safety Unit. These representatives from the California State Food and Drug Branch presented an extended 2-hour program on an "Introduction and Overview of the FDB".

Mr. Ozzie Schmidt began the evening by giving the overview on the agencies’ origin dating from the 1920’s when the Sherman Food, Drug & Cosmetic Law was introduced – predating the FDA. Their job is to protect the public health by regulating the medical device, food and drug industries and prevent the adulteration misbranding and false advertising of their products. Their team address 5 critical areas: Inspections, Education, Complaint Investigations, Core Science Support of government agencies and Service to Industry including free third party document review and device evaluations.

Ms. Susan Bond addressed the Drug and Consumer product section overview. She is concerned with the propensity of ethnic cultures using illegal sources for their drugs and herbal remedies. She detailed how people are not adequately protected when they obtain their medicines at swap meets or mini-markets, which is their custom in their homeland. Some compounds have been found to be ineffective and some dangerous to your health because the disease is not properly diagnosed and the wrong drugs are prescribed and used.

Ms. Barbara Moynier provided an interesting discussion on the use of "QSIT", "Quality System Inspection Technique" in a Regulatory Audit. This type of audit tool focuses on 7 key areas: Management, Design, CAPA, Production, Material, Equipment, and Documentation processes and controls. The process is a top down approach and requires you to Define, Document and Implement your Quality system compliant to the QSR’s. You must pass the "Establish" test; this involves reviewing your documentation, which defines your controls to verify if they meet the requirements of QSR, that you do what your documents describe and that there are records to substantiate that your activities are effective.

Overall, this was an excellent opportunity for all members of our Quality community to hear their advice on how to best prepare for, and participate in, a regulatory audit. The extended format provided plenty of time to speak with these experts in their field and we were very fortunate to have them spend the evening with us. We extend to them our sincerest thanks and have invited them to come back because ASQ Section 0703 would like to host another FDB training opportunity in the San Diego area soon.

Besides the 9th being our meeting night as outlined below, ASQ Section 0711 is sponsoring National Quality Month Workshops addressing Malcolm Baldrige Quality Award, Design of Experiments, and ISO 9000:2000 from 2:00 P.M. until 6:00 P.M. located at the La Sierra University, in Riverside. If these subjects interest you please visit our website and get more information on this event. See: http://www.asqsandiego.org/Education/EducationAug2001/OtherNLEvents.htm#1

The October "3 Hour Workshop" will complement the "ISO 9000:2000" theme and is scheduled for the 24th from 5:30 to 9:00 P.M. Details on the presenter and program will be forthcoming.

GDT $AVE$ YOUR COMPANIE$ LOT$ OF BIG DOLLAR$!

If your company wants to save money by reducing part rejects, scrap, or rework then your company’s (or your supplier’s) Design Engineers, Machinists, and Inspectors need to learn about Geometric Dimensioning & Tolerancing. ASQ Section 0703 is committed to sponsoring a comprehensive GD&T seminar tentatively scheduled for the week of December 10th. This intense 5-day course that will enable local Medical Device or commercial company’s design, manufacturing and inspection teams to gain the complete "Body of Knowledge" necessary to implement this important cost saving methodology.

This is to be presented by Michael A. Sandford. Mike is the principal of Technical Documentation Consultants of Arizona (http://www.tdcofarizona.com). His course will include lots of hardware, tooling, and functional gages which will lend a "hands on" demonstration of the concepts he will be exploring.

If you are interested in this valuable course, please check our "Education" website for more information at: http://www.asqsandiego.org/gd%26tseminar.htm

We have had several ideas on off site events including touring a local Winery or Brewery, a manufacturing company in Tijuana on a weekend, etc. If you would like to attend these or have ideas for other programs please feel free to email or contact any Board member with your suggestions so we can include spouses on some interesting excursions into Quality.

I had stated that the strength of our nation is the volunteers that give of their time for the betterment of their community. We are still holding out hope that one of you will find it in your heart to join our Board and lend us a hand in a capacity that you feel comfortable in. This could be the Treasurers, Koalaty Kid or other positions. You to can make a difference in our organization, please check your schedule and consider joining the Executive Board. If there is time in your schedule to devote several hours a month and you would like to help us build and define the future of your Section, then we invite you to join this diverse group of individuals serving as Committee Chairpersons.

See you at the Section Meeting on the 9th at the Ericsson building,

Don