Message From The Chair,	This Month's Meeting	Survey / Raffle	Saturday Workshop this month
Refresher Course Activities	This Month's Sponsor	Our Mission	Meeting Location

Message from the Chair

"With Deep Regret"

Don Griego, ASQ 703 Chair

Dear ASQ Section Members,

It is with deep regret that I notify you that I have received and accepted the resignation of 2 members of the Executive Board:

Ms. Leanne Kiviharju is resigning the Vice Chair effective 08-20-01. She has accepted a promotion to Associate Director, Regulatory Affairs at Gen-Probe. Unfortunately, these new responsibilities require her full time and attention.

Mr. Marc Monette is resigning the Webmaster Chair effective 08-25-01. He also has new job commitments, frequent travel, and family needs that do not leave him the time and dedication necessary to perform the task.

I want to express my sincere thanks to Leanne for her two years of excellent service to the membership, and Marc for initiating the latest website and email processes during his 90 days on the Executive Board. It was a pleasure working with them both and we will miss their dedication and creativity. Please join me in wishing them continued health, wealth and success in their new endeavors.

This unexpected turn of events leads me to make the following appointments:

I have asked our Treasurer, Mr. Hank Posters to accept the responsibilities of Vice Chair and he has graciously accepted the invitation to rise to the challenge this office brings. Hank will be helping us plan and implement our Section Management Process and define the metrics to measure and improve our Sections services.

I have asked Kim Niles to accept the responsibilities of communications chair by combining the Webmaster, Newsletter, and Booster positions. I have asked Emilito Ong to assist Kim.

I am asking all of you examine your schedules and consider serving on the Board in the capacity of the Treasurer. If there is time in your schedule to devote several hours a month to the office of the Treasurer 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.

You can contribute and make a difference within this organization by other means as well, whether you have ideas about what Workshop topics, Company Tours, or Meeting Programs you would like to attend, present or propose, contact the Chairperson of your area of interest and let them know your needs or capabilities. There are opportunities here for you. Help us accomplish our goal of being "Our members’ best resource for achieving professional and organizational excellence".

We had a great 3 Hour Workshop on Saturday August 25^th at the Ericsson building! The program was on "Geometric Dimensioning & Tolerancing" and presented by Michael A. Sandford. Mike is the principal of Technical Documentation Consultants of Arizona (http://www.tdcofarizona.com) and is an excellent speaker. His presentation complemented the 1 hour talk he gave at our Section Meeting on August 14^th and he brought lots of hardware, tooling, and functional gages which demonstrated the concepts he described "hands on".

In this expanded session, there were members in attendance from a variety of backgrounds and responsibilities including: Machinists, Design Engineers, Inspectors and Managers from Medical Device and Commercial businesses. We had the opportunity to actually learn some GDT basics and apply them to an actual test case.

These individuals contributed to an interesting dialogue on the importance of an educated team approach, each speaking from their particular viewpoint and responsibility.

The biggest revelation that we all had was the simplicity of the symbology and its application if a person understands the concepts. The biggest benefit we all could acknowledge:

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

ASQ Section 0703 is committed to sponsoring a comprehensive GD&T seminar tentatively scheduled for the week of December 10^th entitled "Geometric Dimensioning and Tolerancing 40 Hour Training Seminar". This intense 5-day course that will enable local company’s design, manufacturing and inspection teams to gain the complete "Body of Knowledge" necessary to implement this important cost saving methodology. If you are interested in this, please check our "Education" website for more information.

I invite you all to attend the Section Meeting on September 11^th when Ms. Barbara Moynier, of the California State Food and Drug Branch will be presenting an "Introduction and Overview of the FDB". The FDB regulates the Food, Drug and Cosmetic industries within the State of California and she has first hand knowledge I think you will find critical to your business.

We are inviting Ms. Moynier and her colleagues back on September 26^th from 5:30 P.M. to 9:00 P.M. for a midweek training opportunity. This 3 hour Workshop on "Regulatory Audits" will allow in depth discussion. Using the concepts of "QSIT", Ms. Moynier has extensive experience in the performance of Quality Systems audits of food, drug and medical device manufacturing companies to ensure that various internal controls are operating and is responsible to review their compliance to State, Federal and local regulations. She is familiar with Food manufacturing programs including "HACCP". Plan on attending this informative session. If you are interested in this, please check our "Education" website for more information.

Please remember to check your schedule and consider joining our Executive Committee. Our true strength in our organization is the volunteers that give of their time and dedication, working together to provide our membership with the best educational and networking opportunities available. You to can make a difference.

See you at the Section Meeting,

Don

This Month's Meeting

Meeting Date: September 11, 2001 (Second Tuesday); RSVP 9/10.

"An Introduction and Overview of the State of California Food and Drug Branch"

Presented By Barbara Moynier - Senior Food and Drug Investigator

Can you answer the following questions?

Who has the authority to enforce the Sherman Food, Drug, and Cosmetic Law, can request injunctions, and seize, or embargo goods?
What is the requirement for drug testing prior to going to market in the State of California?
Where can you attend low cost, informative Medical Device Education Seminars?
How can you get an independent 510(k) PMN Third-Party Review for minimal cost?

The State of California Food and Drug Branch (FDB) is a publicly accountable organization, responsible for protecting and improving the health of all California residents by assuring that foods, drugs, medical devices, cosmetics and certain other consumer products, are safe, effective, are not adulterated misbranded nor falsely advertised.

The FDB Team is leading the way into the 21st century by redefining the standards for Food and Drug program excellence through dynamic, scientifically-based, cost effective, outcome-oriented public health protection programs, and is dedicated to be a globally recognized model for food, drug and medical device safety program excellence. They are interested in fostering industry growth and technological innovation, by creating a fair and scientific-based regulatory environment that attracts responsible industry to California, and assures public health protection for all users of California-produced devices.

Come and find out how the California Food and Drug Branch facilitates the growth and vitality of California food drug, cosmetic, industries and protects the health of California citizens by:

Employing effective industry and consumer education to provide understanding of the public health basis for regulatory requirements.
Providing uniformity of enforcement of regulatory requirements to prevent unfair competition.
Utilizing leading edge technology to perform scientific-based investigations.
Encouraging businesses to voluntarily correct deficiencies.

Speakers Biography: Barbara Moynier

Barbara Moynier has a M.S. Degree, in Nutritional Sciences and a Bachelor’s Degree in Foods and Nutrition both from San Diego State University. Ms. Moynier completed Peace Officer’s Safety Training and began working for the State of California, Department of Health Services Food and Drug Branch since 1988. She is a Senior Food & Drug Investigator working mainly in the Medical Device Safety Section.

Ms. Moynier is a Registered Dietitian, Member of the San Diego Nutrition Council, Member, AIDs Health Fraud Task Force of California and Member, Consumer Health Fraud Task Force. Her background includes Nutrition Instructor at Mesa Community College and is a Guest Lecturer at SDSU and was a Research Assistant working on a National Institute of Health Grant at SDSU.

Using the concepts of QSIT, Ms. Moynier has extensive experience in the performance of Quality Systems audits of food, drug and medical device manufacturing companies to ensure that various internal controls are operating and is responsible to review their compliance to State, Federal and local regulations. She is familiar with Food manufacturing programs including HACCP.

Menu:	To be announced.
Agenda:	Registration: 5:15 - 6 pm; Dinner: 6pm - 7pm; ASQ Announcements 7pm Speaker Presentation follows.
Price:	The price of the meal is $12.00 with reservation made by 10am the day before the meeting and $15.00 if made after. Non-members add $3.00.
RSVP / Registration:	By 10am the day before the meeting. Two ways to register as follows: Email: jackodelljr@yahoo.com or leave a message at the phone number for dinner reservations at 619-338-4336.
Location:	We meet in the Erricsson Building located in Mira Mesa at 6455 Lusk Boulevard, San Diego, CA 92121; Their phone: 858-332-5000; Map.
Parking:	Plenty of free parking
Dress Code:	Business casual

Upcoming Refresher Course Activities

Type & Details Link	Contact	Start Date	Schedule	Cost	Location	Evening	Duration
CQA	Tony Duarte	17 Sep. 2001	On schedule	$150	TBA	Monday	9/17-11/19
CRE	George Durgin	18 Oct. 2001	On Schedule	$200	TBA	TBA	15 Weeks + 1 Sat.
CQE	George Durgin	07 Nov. 2001	On Schedule	$200	TBA	TBA	20 Weeks

This Month's Sponsor

The ASQ San Diego chapter 703 is now accepting paid advertisements on our website. Contact Don Griego to support our newsletter. This space will be viewed by thousands of loyal happy Quality professionals over many years to come, pleased that your company sponsored such a worthy cause.

Survey / Raffle

Those that respond to any of the following questions will be entered into a raffle drawing. If the winner is present during the meeting the prize will be doubled. Respond by emailing your comments to kim.niles@znet.com

This is the third completely on-line version of our newsletter you are viewing. Your suggestions and feedback are greatly appreciated. What do you think of it?
The welcoming photo of our chair is meant to provide a warm fuzzy feeling to our members that this volunteer organization really does consist of real people. Our Chair is concerned about it having an adverse affect? Should the photo stay or go?
We are in need of additional high caliper, Quality oriented volunteers to assist as officers (especially Treasurer). Are you interested in assisting in some way or can you recommend another member who might be?
Are you able to receive html newsletters? If so, would you prefer it to the text version you are receiving?
Of all the possible Quality oriented meeting topics we could have (i.e. Auditing, Benchmarking, Reliability, Six Sigma, TQM, SQC, SPC, DOE, Guru's, History, Human Factors, Software Quality, Probability & or Statistical Techniques, Service Quality, Regulatory Affairs, ISO, Medical Quality, V&V, Corrective &Preventative Action, GD&T, Dimensional Metrology, Project Management, ASQ Certifications, Quality Related Software, 8D, 7Steps, 5S's, Shainin Techniques, etc.), what would interest you enough to motivate you to attend a meeting?
In addition to the meeting topic, are there other motivating and or limiting factors that determine your meeting attendance?

Our Mission

San Diego Section 703 will continue to provide Quality Forums and educational opportunities for members by recruitment, training, and retaining a motivated and enthusiastic volunteer team.

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