November 2014 eScope The official newsleƩer of the ASQ Orange Empire SecƟon 0701 Upcoming Events November 8, 2014 7th Southern California Quality Conference November 11, 2014 Monthly Dinner MeeƟng November 20, 2014 ASQ Seminar—The Global 8D Prob- lem Solving Process December 9, 2014 Annual Dinner Event—Casino Night Inside this Issue Pg SecƟon Chair Update 1 Leadership CommiƩee 2 Monthly RecerƟfied Members 3 The Improvement Compass— Recalls, Recalls and More Re- calls 4 ASQ Seminar—The Global 8D Problem Solving Process 5 Upcoming Refresher Courses 6 7th Annual Southern Califor- nia Quality Conference 7 Monthly Dinner MeeƟng and Clinics 8-9 SecƟon Chair Update Hello everyone, welcome to our November NewsleƩer. To deliver value to our secƟon, we have a number of projects to help our mem- bers. One marquee program is our Volunteer Auditor Program. This program helps some of our members get audit hours and experience in exchange for providing audiƟng services to companies with limited resources. During our last Leadership MeeƟng, 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 CommiƩee. Babak Baghei and Dave Nagy are both looking for opportuniƟes to connect companies to ASQ resources to beƩer accomplish goals, objecƟves, and to help resolve problems exist in organiza- Ɵons. Don’t miss out on these opportuniƟes. Are you into Social Media? We are currently looking for ways to enhance our communicaƟon with members using available social media such as LinkedIn. If you would like to be part of this exciƟng new chapter of our secƟon, please contact our Vice –Chair, Dieter Eckstein to find out more details. November is when ASQ cele- brates World Quality Month worldwide to promote the suc- cess 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 sub- mit a success story, the deadline is the November 24th, 2014. Last, but not least...don’t forget about our 2nd annual Casino Night SecƟon Social Event coming up next month. The event will give our members a chance to in- crease their odds by aƩending a StaƟsƟcs 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 acƟviƟes, we will have seven gaming tables, featuring Blackjack, RouleƩe, 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 MeeƟng on Tuesday November 11th at Double Tree Hotel, Santa Ana. Best Wishes, Anet Tanya Ant, CQE, CQA Chair, ASQ Orange Empire SecƟon 701 Anet Tanya Ant, CQA, CQE Chair - ASQ Orange Empire SecƟon 0701
Transcript
November 2014
eScope The official newsle er of the ASQ Orange Empire Sec on 0701
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 Prob-
lem Solving Process December 9, 2014 Annual Dinner Event—Casino Night
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 Re-calls
Sec on Chair Update Hello everyone, welcome to our November Newsle er.
To deliver value to our sec on, we have a number of projects to help our mem-bers. 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 organiza-ons. 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 cele-brates World Quality Month worldwide to promote the suc-cess 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 sub-mit 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 in-crease 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.
2014 Leadership Team 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 cur-rently looking for volunteers for the follow-ing:
e-Media person for communica ons via social media (i.e. LinkedIn, Twi er, Face-book, etc.)
Programs and Dinner Mee ngs Logis cs
Newsle er (photographer, writers, re-search, and PR)
Historical (Catalog/Sort historical docu-ments, 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
1/8 Page 3.67” x 2.36” $35 $195 $350 Checks should be made to: ASQ Orange Empire Section, and
mailed to ASQ, PO Box 14183, Irvine, CA 92614, with ad copy, instructions for placement, and frequency.
SCOPE Editor: Dieter Eckstein 949-677-2751 or email [email protected]
Page 4 eScope November 2014
The Improvement Compass Finding direc on!
#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.
In the Juran’s Quality Handbook, there is a sec on dedicated to defining “Quality.” It defines Quality as “fitness for pur-pose.” (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-
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 adjec-ve. Many of us would probably disagree that it is a simple adjec-ve. 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 exist-ence. Quality is a fascina ng field that has created a plethora of methods and philosophies that developed and nurtured compa-nies 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 Edi on, pp. 5.
Source: h p://asq.org/world-quality-month/
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 sys-tema c and team-based problem solving processes, and to show you how you can use this methodology and some of the inte-grated 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) Pro-cess 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 on-al 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 Opera-
onal 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!
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 Compe-
tencies, 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
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, Pro-ject 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
Page 8 eScope November 2014
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 presen-ta 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
DINNER PRESENTATION
“A Community Hospitals Lean Journey: Success, Challenges and Reflec ons"
Presented by: Andrew V. Nguyen, MBA
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 devel-oping the Torrance Memorial Opera ng Sys-tem to create a holis c and sustained trans-forma 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 Toyo-ta 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 oper-a 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”.
CLINIC # 1
Management Responsibility – “Promo ng a Compliance Culture”
Presented by: James Wabby
A culture of compliance is evidenced by an organiza on working to-wards understood goals, with clear and consistent communica on, effi-cient monitoring and repor ng, and decisive ac on to inves gate non-conformi 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 dia-logue 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 coun-
sel to all aspects within the quality management system arena for medi-cal 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 health-care related laws and interna onal regula ons. James received his un-dergraduate and graduate degrees from Duquesne University and
received his Health Care Compliance Cer ficate from Seton Hall Univer-sity Law School.
He is a member of various regulatory and quality work groups including the ASQ Orange Empire Sec on.
CLINIC # 2
Supplier Oversight: Process Focus is Key
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 inven-tory 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 Assur-ance 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
