In PDF form:  http://web.archive.org/web/20040905113302/www.asqsf.org/asqsfmember/gate/eGate200409.pdf

 September 2004

The Newsletter of the San Francisco Section of the American Society for Quality

http://www.asqsf.org/

IN THIS ISSUE
September Monthly Activity
…………………….…………...1
Chairman’s Corner
…………………………………2
Recent Events
………………………….….…..3
Education Program
……………...……..…..….…...4
Executive Committee
…………………………………8
Executive Committee
Volunteers Needed!

Gate Publisher/Editor

If you have experience creating
newsletter and take this publication to a
higher level and are skilled at Microsoft
Word or Adobe InDesign, join our
group!

Placement Chair

Do you have a knack for finding jobs?
Are you surfing the web looking for
jobs? We are looking for a volunteer to
regularly search for quality jobs on the
web and be our point person for job
postings.

For more information on either of these
positions, please contact the section
chairman, Robert Hazemoto.

SF Section Monthly Activity

September 2004

Risk Management and
It’s Implementation –
Designing Out
Unacceptable Risk


6:00 - 6:30 pm Registration / Job Networking
6:30 - 7:30 pm Dinner
7:30 - 8:30 pm Program
DoubleTree Hotel
Burlingame, CA

To register, go online to http://www.asqsf.org

About the Meeting:

This presentation will be given by Barry Craner.

Barry Craner is Director of Quality Assurance for
Lipid Sciences, Inc., and currently also serves as
Co-Chair on the Board of Directors of the Northern
California Biomedical Discussion Group.

About the Presentation:

Barry Craner will build on his Risk Management
(RM) presentation given in May of 2003, and briefly
characterize several commonly used risk-
identification and risk-reducing methods, share
practical applications implementing several of the

Continued on page 2


recently enacted standards relevant not only to medical device risk management, but to
most other industries. This time, he will share two new concepts: a case study in which a
hazard analysis is taken to a more full application in RM, yielding recommendations not
only in design, but in manufacturing and procurement, and the US and European
rationales for requiring RM, as well. He will also provide examples of identifying product
and process hazards, evaluating the hazards for possible level of risk, and ways to
creatively brainstorm on reducing (mitigating) the risk. These concepts lend themselves
to multiple disciplines and industries, including product development, manufacturing,
procurement, including mechanical, electrical, software, and disposable products.

About the Speaker

Barry Craner is Director of Quality Assurance for Lipid Sciences, Inc., and currently also
serves as Co-Chair on the Board of Directors of the Northern California Biomedical
Discussion Group.

Barry has over twenty five years of experience in the management of scientists and
engineers in applications in medicine, aerospace, internet technologies, and medical
devices. He has written several design control systems for companies, and has
consulted in areas of reliability engineering, quality system development. He has audited
many medical device companies from first, second and third party perspectives. His
advanced degrees are in Cardiac Physiology and Business Management with a
Computer information Systems emphasis, and he has the equivalent of an electrical
engineering minor. He is certified in Quality Engineering, Reliability Engineering and
Quality Auditing by ASQ, and was on the founding team to create the Body of
Knowledge and examination questions for the new ASQ CQA-Biomedical Auditor
certification program.

Barry has delivered numerous papers and presentations since 1986 on topics, among
them such as calibration systems, management auditing, software quality assurance,
risk management, and managing contract design. He is a senior member of ASQ, past
chair of the San Diego Section of ASQ, and past Deputy Regional Director for the
Southern California ASQ Region, and has been nominated for the status of Fellow in the
American Society for Quality.


CHAIRMAN’S CORNER


Section Planning

The Executive Committee for ASQ San Francisco section is currently working on finalizing
the section plans for FY05. Please join us at our September dinner meeting – hope to see you
there.

Have a great day!
Robert Hazemoto

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eGATE In the spirit of continuous improvement, we have changed The Gate from a hardcopy mailer to
an electronic newsletter, The eGate. Why? Hard copy has proven to be slow and costly with costs associated
with the number of pages. Creativity and the number and size of articles were limited because of restriction
on the number of physical pages printed and mailed. Finally, the hard copy format is somewhat out-of-step
with modern business communication practices.

 To continue receiving The Gate, all you need to do is send your email address to Robert Hazemoto at
This e-mail address is being protected from spambots. You need JavaScript enabled to view it . If you are absolutely certain that you are already on the section’s email list, then
you’re all set. The eGate notification will automatically distribute to you.

 Privacy Note: Your email address is used strictly for SF Section notifications. Your email address or other
information will NEVER be visible to any other section member during distribution and will NEVER be
given to any other organization or person for ANY purpose.

By Robert Hazemoto

August 26th Genentech Tour

Thanks to the Genentech team for providing an excellent tour. The tour was very well done,
planned and executed. Paul Moran did an excellent job in guiding the ASQ San Francisco tour
group and taking the time to explain about the product, processes and the company culture. Paul
also made sure that all the questions were answered and attendees left with great customer
satisfaction. Special thanks to Rick Marlow for sponsoring our tour and making the event
happen!

Executive Committee Volunteers Needed!

Gate Publisher/Editor

If you have experience creating newsletter and take this publication
to a higher level and are skilled at Microsoft Word or Adobe
InDesign, join our group!

Placement Chair

Do you have a knack for finding jobs? Are you surfing the web
looking for jobs? We are looking for a volunteer to regularly
search for quality jobs on the web and be our point person for job
postings.

For more information on either of these positions, please contact
the section chairman, Robert Hazemoto.

ASQ SAN FRANCISCO SECTION 0604 SEPTEMBER 2004
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ASQ San Francisco Education Courses

by Dave Clark, Education Chair

Courses Offered by the San Francisco Section

A Full Program for All Certification Exams Coming in October

SF 104: Certified Mechanical Inspector Exam Review

Date: September 11, 2004 Time: 8:00 - 5:00
Fee: $90/$110 Location: TBD

This review course will cover the main topics that compose the Certified Mechanical Inspector
examination, namely: technical mathematics, blueprint reading, inspection tools and equipment,
inspection planning and technology, statistics, sampling and sampling plans. Sample problems
and question will be provided to help the student prepare for the exam. The required text is the
CMI Primer from the Quality Council of Indiana.

SF 106: Certified Quality Manager Exam Review


Date: September 11 & 18 Time: 8:00 -5:00
Fee: $275/$295 Location: St. Peter’s Church*


* 178 Clinton Rd. Redwood City, 94062
This twelve-hour course (8 hours on 9/11 and 4 hours on 9/18) will cover the eight major areas
of the body of knowledge covered in the Certified Quality Manager exam. It will include practice
and discussion of typical examination problems and answers. The instructor, Dave Clark, has
been trained and certified by ASQ to teach this course. The course fee includes a $155 text from
ASQ for the BOK. This text can only be purchased from certified instructors like Dave.

Certified Quality Auditor - HACCP Exam Refresher Course


Date: September 11 Time: 8:00 -5:00
Fee: $125 / $150 Location: Hope Lutheran Church*


*600 42nd Ave San Mateo, CA 94403

This one day course will focus on all seven steps of the process as well as on the ASQ BOK and
will be amplified by the instructor's experience and reference to the relevant regulations. The
instructor, Ken Stearns is a CQA-HACCP and works in an active HACCP facility. He has also
served in the past on the ASQ exam review committee and brings a special knowledge of the
goals of ASQ in this certification.

Certified Quality Auditor - Biomedical Exam Refresher Course

Date: September 18, 2004 Time: 8:00 -5:00pm
Fee: $125 / $150 Location: New Vision United Methodist Church

 *450 Chadbourne Ave. Millbrae, CA 94030

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This one day course will focus on the ASQ Body of Knowledge and will be taught by David
Crisp, a consultant with the CQA-Biomedical certification and with 20 years experience in the
Biomedical industry and 10 years in QA. He has many years experience in auditing and in
resolving problems identified by those audits and will use that experience to augment discussion
of the relevant regulations.

SF 110: Certified Six Sigma BB Exam Review


Date: September 18 & 25 Time: 8:00 -5:00
Fee: $150/$200 Location: The Vintara Corp.*


*Vintara is at 1970 Broadway, Oakland, CA 94612-2212

This refresher course provides an overall coverage of the key technical aspects of the CSSBB
exam. The course will cover the body of knowledge for the exam, strategies for taking the exam,
and a review of problems similar to those that will be encountered on the exam. It is
recommended that the participants purchase the CSSBB Primer from the Quality Council of
Indiana (800.660.4215, www.qualitycouncil.com) prior to the course.

Six Sigma Practitioners Overview

Date: October 9, 2004 Time: 8:00 -5:00pm
Fee: $125 / $150 Location: Vintara*

*Vintara is at 1970 Broadway, Oakland, CA 94612-2212

This one day course presents an overview of the important steps in the Six Sigma process,
highlighting key milestones and use of the proper tools and techniques in the process. Ideal for
those just getting started in Six Sigma or for current practitioners who want to understand the
overall plan.

SPC for Biomedical and Medical Device Applications

Date: October 23, 2004 Time: 8:00 -5:00pm
Fee: $125 / $150 Location: Vintara*, Oakland

*Vintara is at 1970 Broadway, Oakland, CA 94612-2212

A one day course that will focus on Statistical Process Control (SPC), problem solving methods,
and sampling plans for incoming and in process control. The course is applicable all industries
with emphasis on implementation of the appropriate SPC tools, as well as topics such as standard
error, confidence limits, and statistical significance.

Value Added Auditing

Date: October 30, 2004 Time: 8:00 -5:00pm
Fee: $125 / $150 Location: New Vision United Methodist Church

*450 Chadbourne Ave. Millbrae, CA 94030

ASQ SAN FRANCISCO SECTION 0604 SEPTEMBER 2004
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This course will focus on conducting "effectiveness" audits to ISO 9000-2000 while identifying
the step-by-step methods and tools / techniques to use for planning and conducting the audit. The
instructor will be Robert Trietley, Jr. who is a full-time auditor and CQA.

*Note: Lower fees are for ASQ members. For more information, contact Dave Clark at
This e-mail address is being protected from spambots. You need JavaScript enabled to view it . On-line registration is available at www.asq-sf.org/. Please try to
register at least 10 days prior to course date.

On-Site Courses

Most of the San Francisco ASQ courses can be taught at your site at economical group rates. On-
site courses can be customized to your organization’s terminology and examples. This
customized approach can maximize your employee’s learning and optimize your training
investment. Please contact Dave Clark for on-site course information.

Permanent Site for Education Courses and Exams Is Needed
Keep Your Eyes Open for Available Space


by Dave Clark, Examining Chair

For a long time we have been talking about the need for a permanent site for our education
courses. Recently I learned that from time to time we have had to send some of our certification
exam attendees to locations in other sections because our available site is not large enough to
accommodate all of our members who want to take the various exams. It has also been
mentioned that one of the drawbacks to attendance at our education courses is lack of a specific
facility.

 Just last week as I was driving along a city street, I noticed a large building marked
Auditorium, and it occurred to me that such a place might be large enough to accommodate our
needs. As it so happens, they do not rent. But this effort started my looking around to see what is
available. I ask that each one of you living or working on the peninsula, from Sunnyvale to San
Francisco, keep an eye out for similar buildings or organizations with buildings or space. When
you are out during lunch or shopping or whatever, be aware of the following places that we
might use (rent). Pay special attention to schools, churches, libraries, etc. a building generally
open to the public, possibly non-profit as we are also a non-profit group.

For Education Courses:

 The site should have a room or area to seat up to 12 people. It would be a plus if the site has
some equipment like a flip chart or white board or blackboard and possibly an overhead
projector / screen (but the section could provide the latter as we have both). The site should be
generally available on Saturdays from 8 AM to 5 PM.

For an Exam Site:

 The site should be either one large room or two medium sized classrooms (or even conference
rooms) with seating for 25 people at tables / chairs. This means that, given two people to each
table, we should have access to 6 - 12 tables and 25 chairs. The site must be available on the
following 4 specific Saturdays in 2004: March 6, June 5, Oct. 16, and Dec. 4.

 The locations should be easily accessible from major highways and roads.

It would also be great if you could find out about other groups that might be using the facility
at the same time that we would use it because as you can imagine, noise is a concern especially
when taking an exam. You should also estimate the number of signs that will be necessary to

The eGATE, the newsletter of the San Francisco Section of the American Society for Quality.
SEPTEMBER 2004 -6 -


direct the attendees to the right room and how much set-up will need to be done to prepare the
room for use.

 I would like each one of you to look at you own company first to see if they can make their
facilities available since an employee always has more "pull" than a stranger. If you believe that
it is important to have a "permanent site" for our courses and one large enough to accommodate
our members, then I ask you to be our "eyes". If you find a suitable site, please contact me at

(650) 726-3133 or at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
On-Line Registration Is Here

That's right - our much awaited on-line registration process is now a reality. Just go to our
website and pull down the Education menu. All courses have a Register On-Line button that will
save you the hassle of writing and mailing the check and save us the handling and cashing of it.
Take advantage of this quick, efficient way to register. See you at the courses!


ASQ SAN FRANCISCO SECTION 0604 SEPTEMBER 2004
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San Francisco Section
1040 Grant Rd., Suite 155, PMB#330
Mountain View, CA 94040

www.asqsf.org

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DATED MATERIAL
THE eGATE, September 2004

San Francisco Section of the American Society for Quality
Officers and Committee Chairs, 2004-2005

Chairman Programs Chair Placement Chair
Robert Hazemoto Pinakin Bhatt (Open)
650-638-5263 510-487-2913
hazemorn@appliedbiosystems This e-mail address is being protected from spambots. You need JavaScript enabled to view it Examining Chair
.com Dave Clark
Arrangements/Operations 650-726-3133
Chair-Elect Chair This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Jason Jegge Jonathan Briggs
408-830-5900 ext. 107 This e-mail address is being protected from spambots. You need JavaScript enabled to view it Chief Proctor
Fax: 408-830-5910 Jim Santos
This e-mail address is being protected from spambots. You need JavaScript enabled to view it Education Chair Stellartech Research Corp.
Dave Clark 408-331-3145
Treasurer 650-726-3133 Fax: 408-331-3101
Doug Ford This e-mail address is being protected from spambots. You need JavaScript enabled to view it This e-mail address is being protected from spambots. You need JavaScript enabled to view it
650-306-8294
This e-mail address is being protected from spambots. You need JavaScript enabled to view it Boosters/Membership Nomination/Teller
Dave Clark Robert Hazemoto
Secretary 650-726-3133 650-638-5263
Kim Martinez This e-mail address is being protected from spambots. You need JavaScript enabled to view it hazemorn@appliedbiosystems
This e-mail address is being protected from spambots. You need JavaScript enabled to view it .com
Certification/Recertification
Recent Past Chair Emma Popek Internet Liaison
Thom Faris 925-948-2664 Robert Hazemoto
650-623-8807 This e-mail address is being protected from spambots. You need JavaScript enabled to view it 650-638-5263
This e-mail address is being protected from spambots. You need JavaScript enabled to view it hazemorn@appliedbiosystems
Auditing Chair .com
Thom Faris
650-623-8807 eGATE Publisher/Editor
This e-mail address is being protected from spambots. You need JavaScript enabled to view it (Open)

Region 6 Director
Frances Hill
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Silicon Valley Chairman
Douglas Hoffman
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Redwood Empire Chairman
Keith Fischer
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Golden Gate Chairman
Larry King
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Sacramento Chairman
Peggy Romary
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

The eGATE, the newsletter of the San Francisco Section of the American Society for Quality.
SEPTEMBER 2004 -8 -