eScope SecƟon Chair Update November 2014 Inside this Issue

eScope
The official newsle er of the ASQ Orange Empire Sec on 0701
November 2014
Inside this Issue
Pg
Sec on Chair Update
1
Leadership Commi ee
2
Monthly Recer fied Members
3
The Improvement Compass—
Recalls, Recalls and More Recalls
4
ASQ Seminar—The Global 8D
Problem Solving Process
5
Upcoming Refresher Courses
6
7th Annual Southern California Quality Conference
7
Monthly Dinner Mee ng and
Clinics
8-9
Upcoming Events
November 8, 2014
7th Southern California Quality
Conference
November 11, 2014
Monthly Dinner Mee ng
November 20, 2014
ASQ Seminar—The Global 8D Problem Solving Process
December 9, 2014
Annual Dinner Event—Casino Night
SecƟon Chair Update
Hello everyone, welcome to our November Newsle er.
Anet Tanya Ant, CQA, CQE
Chair - ASQ Orange Empire
Sec on 0701
To deliver value to our sec on, we have a number of projects to help our members. One marquee program is our Volunteer Auditor Program. This program
helps some of our members get audit hours and experience in exchange for
providing audi ng services to companies with limited resources. During our last
Leadership Mee ng, we discussed the fact that we need at least three more
companies or audits to complete our goal for 2014. Therefore, if you know of a
company that may benefit from this volunteer service, please contact Dave Nagy
at [email protected]
Another program to help our members is the Boosters Commi ee. Babak
Baghei and Dave Nagy are both looking for opportuni es to connect companies
to ASQ resources to be er accomplish goals, objec ves, and to help resolve problems exist in organizaons. Don’t miss out on these opportuni es.
Are you into Social Media? We are currently looking for ways to enhance our communica on with
members using available social media such as LinkedIn. If you would like to be part of this exci ng new
chapter of our sec on, please
contact our Vice –Chair, Dieter
Eckstein to find out more details.
November is when ASQ celebrates World Quality Month
worldwide to promote the success of quality tools, methods
and teams. Throughout the
month, ASQ invites you to read
and share quality related success
stories. If you haven’t done so
already, visit the website and
see what quality professionals
like you are up to around the
world. If you would like to submit a success story, the deadline
is the November 24th, 2014.
Last, but not least...don’t forget
about our 2nd annual Casino
Night Sec on Social Event coming up next month. The event will give our members a chance to increase their odds by a ending a Sta s cs Clinic with a fun twist to compliment the evening. This event
will be held on December 9, 2014; save the date! Make it a date or bring a friend to be part of this
evening of games. Among the fun ac vi es, we will have seven gaming tables, featuring Blackjack,
Roule e, Texas Hold’em, Poker, Craps, and other pit games. Three hours of unlimited gaming and
defying the odds. To cap it off, we will have a raffle drawing with goodies.
Have a wonderful month and joy filled Thanksgiving Day. I am looking forward to seeing you at our
Monthly Dinner Mee ng on Tuesday November 11th at Double Tree Hotel, Santa Ana.
Best Wishes,
Anet Tanya Ant, CQE, CQA
Chair, ASQ Orange Empire Sec on 701
eScope
November 2014
Page 2
2014 Leadership Team
CHAIR
Anet Ant
TEL (949) 903-3274
ane [email protected]
eSCOPE EDITOR
Dieter Eckstein
TEL (949) 677-2751
[email protected]
VICE CHAIR
Dieter Eckstein
TEL 949 677-2751
[email protected]
CAREER MANAGEMENT CHAIR
Bob Mehta
TEL (949) 510-9138
bobasq1[email protected]
TREASURER
Briana Sallows
TEL (909) 910-8933
[email protected]
INTERNET CHAIR
Jay Mehta
TEL (949) 887-0577
[email protected]
SECRETARY/HISTORIAN
Laurie Pa on
TEL (949) 361-9301
laurie.pa [email protected]
MEMBERSHIP CHAIR
Steve Mar n
TEL (714) 270-4815
smmar [email protected]
EDUCATION CHAIR
Mark Lindsey
TEL (714) 273-2678
[email protected]
AUDITING CHAIR
Aaron Reddoch
[email protected]
CERTIFICATIONS/ RENEWALS
Cory Goral
TEL (949) 753-6333
[email protected]
CHIEF PROCTOR
Hassan Farah
TEL (909) 261-3517
[email protected]
PROGRAMS CHAIR
Dave Nagy
TEL (714) 883-9305
[email protected]
ARRANGEMENTS
Vatsal Patel
[email protected]
NOMINATING CHAIR
Dave Nagy
TEL (714) 883-9305
[email protected]
VOC CHAIR
Stan Themea
TEL (909) 714-4323
[email protected]
SECTION 7 REGIONAL DIRECTOR
Ed Ma hews (2014)
TEL (714) 686-6638
ed.ma [email protected]
SECTION 7
DEPUTY REGIONAL DIRECTOR
Vinay Goyal
TEL (714) 876-3927
[email protected]
We are looking for
difference makers!
Join our ASQ Team of Volunteers and help us
con nue to make the ASQ Orange Empire
Sec on 0701 one of the best! We are currently looking for volunteers for the following:

e-Media person for communica
ons via
social media (i.e. LinkedIn, Twi er, Facebook, etc.)

Programs and Dinner Mee
ngs Logis cs

Newsle
er (photographer, writers, research, and PR)

Historical (Catalog/Sort historical documents, create visual compila ons &
presenta ons of our sec on’s history,
document current events, etc.)

Clinic and dinner speakers
For more informa on contact Dieter Eckstein
@ Tel. 949 677-2751 or email at
[email protected]
eScope
November 2014
Page 3
Congratula ons!
Cer fica ons
The following members have met the
requirements to be recer fied
Khai Trinh
Thomas Culhane
Are your certifications due for renewal?
You can submit up to six months before and after the due
date. The recertification units must fall within the
recertification period.
Send you recertification packages to:
Alcon Laboratories
A n: Cory Goral, M/C 122, CEE Lab
15800 Alton Parkway, Irvine, CA 92618
For more informa on email [email protected] or
Click here for more informaƟon 
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email [email protected]
eScope
November 2014
Page 4
The Improvement Compass
Finding direcƟon!
#QualityIs...
By Dieter Eckstein, CQM/OE, CQA, BSBM
As the Global Quality Community celebrates World Quality
Month, the profound ques on of what is “Quality” came up.
The home page of the World Quality Day Website (h p://
asq.org/world-quality-month) has a list of entries submi ed
to the #Qualityis Contest a emp ng to define “Quality.” You
can vote for your favorite before November 19th.
plied into different areas and depending on the objec ve, the
defini on may have a different aim.
According the Merriam-Webster Dic onary, Quality is an adjecve. Many of us would probably disagree that it is a simple adjecve. The word is complex and that is why it is hard to define in
just one way. I think Quality is a verb because the word rarely
comes without an ac on.
Quality is an ac on word that can be used to dis nguish the
difference between acceptable and not acceptable. One can also
say that Quality is a culture that lives in companies that strive for
success and value.
Whichever it is the defini on you choose to apply, Quality is a
pillar in our society because without it, chaos will surely find its
way. It is a compass that helps us find the direc on to success
regardless of the industry, product or service. Quality is the
measuring tool that benchmarks those that are willing to “do it
right the first me” versus any that defy the odds for their existence. Quality is a fascina ng field that has created a plethora of
methods and philosophies that developed and nurtured companies such as the Ford Company, GE, Chrysler, Boeing, Apple or the
“mom & pop” shop that inspires the next conglomerate of the
world. I wish you a great Quality Month full of success and great
lessons to be learned for our colleagues around the world. Now…
Click Here to visit the website 
(1) De Feo, J.A., & Juran, J.M. (2010). How to Think about Quality. Juran’s Quality Handbook,
Sixth EdiƟon, pp. 5.
Source: hƩp://asq.org/world-quality-month/
In the Juran’s Quality Handbook, there is a sec on dedicated
to defining “Quality.” It defines Quality as “fitness for purpose.” (1)
But is it just that? We hear it everywhere, on the radio, we
see it in delivery or company trucks that claim their products
or services are superior to everyone else, it is hailed during
situa ons like the Ebola scare in Texas, the car manufacturer
failures, etc.
I don’t disagree with any defini on I’ve read in the webpage
or the Juran’s Quality Handbook, because quality can be ap-
Page 5
eScope
November 2014
ASQ Orange Empire Sec on Seminar
The purpose of this seminar is to introduce you to the (Global) 8D Problem Solving Process, one of the most widely used systema c and team-based problem solving processes, and to show you how you can use this methodology and some of the integrated problem solving tools to effec vely iden fy the underlying root cause(s) of a problem.
The 8D Problem Solving Process has become a standard in many industries as internal Correc ve Ac on Request (CAPA) Process and as Supplier Correc ve Ac on Request (SCAR) Process.
Topics Covered
* Understand the purpose and objec ves of each phase of the 8D Problem Solving Process
* Learn how to apply and u lize key problem solving tools in each phase of the 8D Problem Solving
Process
* Apply some of the problem solving tools and key learning points on a simple case study
* Use of assessing ques ons at the end of each phase of the 8D Problem Solving Process to ensure
proper execu on of each phase
About the Speaker: Frank G Adler, Principal & Managing Partner
Frank co-founded Opera onal Excellence Consul ng (OEC) in 2009 to follow his passion for Opera onal Excellence and to be able to work with individuals and organiza ons that share this passion.
He has over 20 years of interna onal execu ve leadership experience in General Management, mul site Opera ons & Supply Chain Management, Quality & Customer Support Management, and Operaonal Excellence & Lean Six Sigma. Frank holds a M.S. in Mathema cs and Physics from the Freie University Berlin (Germany)
and a Ph.D. in Applied Mathema cs and Industrial Economics from the Helsinki University of Technology (Finland).
WHERE
Brandman University
16355 Laguna Canyon Road, Room #110, Irvine, California 92618 USA
WHEN
November 20, 2014 8:30 AM -4:30 PM
Dress Code
Business A re
Fees
ASQ Sec on 701 Member: $169
(Discounted rate - $149, if registered by November 13)
Non-Sec on Member: $189
(Discounted rate - $169, if registered by November 13)
RSVP by Friday, November 13 for discounted pricing!
Register 
eScope
November 2014
Cer fied Quality Auditor (CQA)
Prep/Refresher Course
SESSIONS/DATES
9 sessions; Thursdays (was Wednesdays) 6 PM ‐ 9 PM from October 9, 2014
to December 4, 2014. Note: No Class during Thanksgiving week. Another
class session will be scheduled.
Note: An Online Instructor led version of this course is also being offered on
Saturday mornings. If interested, go to h p://www.cvent.com/d/
s4q5mw/1Q
Will cover: Cer fica on Overview, Audi ng Fundamentals, Auditor Competencies, Audit Prepara on, Audit Performance, Audit Repor ng, Audit Follow
-up & Closure, Audit Business Applica ons, Quality Tools & Techniques, plus
Tips & Strategies on taking the exam.
When
Thursday, October 9, 2014 6:00 PM - Thursday, December 4, 2014 9:00 PM
Loca on
Alcon Laboratories
15800 Alton Parkway, Irvine, California 92618 USA
Fees & Course Registra on
Employed Member Fee $350.00 for a limited me ($400.00 original price)
Nonmember Fee $500.00 for a limited me ($550.00 original price)
Unemployed Member Fee $200.00
CLICK HERE TO REGISTER 
Page 6
Cer fied Lean Six Sigma Black Belt ‐
Prep/Refresher Course
SESSIONS/DATES
14 sessions; Wednesdays from November 12, 2014 to March 4,
2015.
No sessions during the weeks of Thanksgiving, Christmas, and New
Year.
Will cover: Enterprise Deployment, Business Process Mgmt, Project Mgmt, Six Sigma Improvement Methodology & Tools (Define,
Measure, Analyze, Improve, & Control), Lean Enterprise, & Design
for Six Sigma. Plus, strategies/ ps for preparing & taking the exam.
When
Wednesday, November 12, 2014 6:00 PM - Wednesday, March 4,
2015 9:00 PM
Loca on
Alcon Laboratories
15800 Alton Parkway
Irvine, California 92618 USA
Dress Code
Business Casual A re
CLICK HERE TO REGISTER 
Page 7
eScope
November 2014
eScope
November 2014
Page 8
DINNER PRESENTATION
“A Community Hospitals Lean Journey: Success,
Challenges and Reflec ons"
Presented by: Andrew V. Nguyen, MBA
ASQ Orange Empire Monthly Dinner Mee ng
ASQ Orange Empire Monthly Dinner Mee ng
This is our regular monthly dinner mee ng program with two
clinics running concurrently, dinner, and an outstanding a er
dinner presenta on. You are welcome to come for the clinics
and a er dinner presenta on WITHOUT buying the dinner. In
fact, we welcome you. We will have accommoda ons for you.
This way you s ll earn the RU and take advantage of the presenta ons.
PRESENTATIONS
Clinic 1: Management Responsibility –
“Promo ng a Compliance Culture”
Presented by James Wabby
Clinic 2: Supplier Oversight: Process Focus is Key
Presented by Paul Mesmer
Dinner Presenta on: “A Community Hospitals Lean Journey:
Success, Challenges and Reflec ons"
Presented by Andrew V. Nguyen, MBA
WHEN
Tuesday, November 11, 2014 5:15 PM - 9:00 PM Pacific Time
WHERE
Doubletree Hotel Santa Ana/Orange County Airport
201 East MacArthur Boulevard, Santa Ana, California 92707 USA
RSVP or register by Monday November 10.
CLICK HERE TO REGISTER 
For decades Lean has been within Manufacturing/Supply Chain
opera ons and currently is evolving into Healthcare. The US
Healthcare is going through so many changes and now embracing
Lean philosophies to help address some key challenges. In this
discussion, you will see a local community hospital’s Lean journey.
We’ll cover what went well, what could be improved and what
they’ve learned along the way.
By a ending this clinic presenta on, you will get…

Inside perspec ve on a community hospital’s lean journey

See Lean in ac on in non-manufacturing / supply chain
se ng

Learn what worked and what could have been improved
Our speaker: Andrew V. Nguyen
As Manager of Organiza on Improvement
(Lean) at Torrance Memorial Medical Center.
Andy’s efforts have been focused on developing the Torrance Memorial Opera ng System to create a holis c and sustained transforma on of how we deliver pa ent centric
care, that consistently delivers value with
highest quality and less cost.
Andy has a strong passion for developing
people as much as processes. He has over 15
years of mul -industry experience in Toyota
Supply Chain opera ons to Healthcare organiza ons like UCLA
Health Systems and Torrance Memorial. He has worked for Toyota for over 10 years and received direct training from Sensei’s
from Japan and the United States. While at Toyota, he has been
fortunate to have been a Group Leader managing day to day opera ons and crea ng new supply chain warehouse solu ons for
Toyota de Mexico and Puerto Rico.
Andy is an alumnus of Pepperdine University with his MBA and
undergraduate degree in Management and Human Resources
from Cal Poly Pomona. The philosophies he has learned and tries
to exemplify from these two schools are “Learn by Doing” and
“Freely ye receive, freely ye give”.
Page 9
eScope
November 2014
CLINIC # 1
CLINIC # 2
Management Responsibility –
“Promo ng a Compliance Culture”
Supplier Oversight: Process Focus is Key
Presented by: James Wabby
A culture of compliance is evidenced by an organiza on working towards understood goals, with clear and consistent communica on, efficient monitoring and repor ng, and decisive ac on to inves gate nonconformi es and take correc ve and preven ve ac on as needed per
risk assessments and data trending. This presenta on will discuss the
importance of promo ng a culture of compliance and why companies
which promote a culture of compliance tend to have a decreased
amount of FDA 483s and/or MOH cita ons. Open discussions and dialogue will be included.
The presenta on will outline:

What is Compliance?

Establishing and Implemen ng a “Posi ve” Culture of Compliance

Management Responsibility

Establishing a Robust Quality Management System

Importance of Management Review and Quality Metrics

Why 483s occur

Lean CAPA Programs and linkage to management responsibility –
Challenges and Opportuni es
Our speaker: James Wabby
James Wabby is the Director of Quality Compliance and
Risk Management at Allergan Inc. in Irvine, California.
He has over 10 years experience of increasing quality
compliance and regulatory responsibili es within the
GxP regulated environment pertaining to Nutri onal,
Cosme c, Pharmaceu cal, Biologics, Medical Device,
and Combina on Product areas. He regularly provides
Allergan therapeu c franchise units compliance counsel to all aspects within the quality management system arena for medical devices and combina on products regarding product development,
audit programs, inspec on management, clinical trial execu on, supplier
management, regulatory affairs, CAPA, produc on controls as well as
conduc ng business opera ons in conformance with applicable healthcare related laws and interna onal regula ons. James received his undergraduate and graduate degrees from Duquesne University and
received his Health Care Compliance Cer ficate from Seton Hall University Law School.
He is a member of various regulatory and quality work groups including
the ASQ Orange Empire Sec on.
Presented by: Paul Mesmer
How many mes have we verified as part of a periodic audit,
that a supplier’s Quality Management System is sa sfactory,
only to later experience a significant “escape” into our inventory or to our customers? Whereas a sound quality system
provides the founda on for quality products and services, the
devil is in the details of the supplier’s processes that produce
those products and services.
By a ending this clinic presenta on, you will get:

Greater awareness of the cri
cality of supplier process
verifica on.

Ways to op mize u liza on of limited resources.

Approaches to Customer-Supplier teaming to achieve
be er quality.
Our speaker: Paul Mesmer
Paul is currently Director of Quality Assurance at L-3 Power Paragon in Anaheim,
CA. L-3 Power Paragon is the worldwide
leader in the engineering, development,
manufacture and integra on of power
conversion and distribu on systems for
defense, governmental and advanced
industrial applica ons. Paul is a Senior
ASQ Member, and ASQ CMQ/OE.