scope november 2011 - asq orange...
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The Official Newsletter of the ASQ Orange Empire Section November 2011
Section Chair Column - ASQ Letter from the Chair
Welcome to another addition of our e-Scope. We hope you find the information contained within this issue informative.
Quality Day preparations occupied most of our time during October so I would like to thank those who participated and help make it a success.
! !194 participants – thank you for joining us! !3 Sponsors – thank you for your support o Verify o Med Exec o Q Pluse! !Two Key Note speakers o Rob Bryant kicked off our session
talking about employee engagement o Chris Alexander during lunch break
continued with how employees can create an organization’s WOW factor
! !We had 11 speakers covering topics that participants found informative – thank you for sharing your knowledge.
o Phillip R. Rosenkrantz o Michael Scofield o Linda Howe Garriz o Heather Weishlow
o Rosemarie Christopher o John Hall o Bob Mehta o Dani Picciotti o Mark Lindsey o Roque Garcia ! !Career Coaches that helped members with
resume reviews and how to pursue job opportunities – thank you for your guidance to our participants
o John Hall o Heather Weishlow o Greg Johnson o Ken Gryske! !Our Leadership Committee and Program
Committee members did an outstanding job and I want to thank them:
o Dave Nagy – Program development o Luke Foo – A/V vendor arrangements o Anet Ant – Career track moderator o Steve Martin – Supplier track
moderator o Laurie Patton – Quality track moderator o Don Shannon – Registration moderator o Vinay Goyal – CVENT registration
moderator o Sharon Dalmage – Program binders
- continued on next page
SCOPE
Chair Column - continued from page 1
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o Bob Olevson – Quality Day finances moderator o Brian Sallows – Marketing Materials and Registration Materials o Susan Willis – identification and selection of gift items o Kevin Schuld – Marketing o Aaron Reddock – Sponsors o Margaret Benavides – Education Information table o Bob Metha – Hotel logistics o Ed Smith – Session Surveys! !Registration Table – awesome job keeping the line moving and continued help during the day with
surveys and other items! !Scott Fiedman! !Jay Metha! !Janice Loy! !Ed Smith ! !Ed Matthews Jr. ! !Betty Hickok! !Gitty Yasreb! !Erin Cummings! !Naydamar Morales! !Aretha Betancourt! !Letha Alvarez! !Janet Halpert
I apologize in advance if I missed anyone, it was a busy day and a few more individuals may have pitched in to make this a success.
We have posted the presentation materials on our web site. Use the Quality Day information box on the main page. After you reach the information page scroll to the bottom of the page where you will find the list of presentors which is a link to their presentation.
Best Regards,
Ed
Ed Matthews, MBA, Lean Master, CMQ&OE, & CSSBBChairman ASQ Section 0701
November 8 Dinner MeetingDoubletree Hotel, 201 E. MacArthur Blvd, Santa Ana
5:45pm Clinic # 1, 5:45pm Clinic # 2, entitled FDA’s unpredictable path: where is FDA “going?” A fresh perspective. The presenter (Jack Dhuwalia) was recently invited to address FDA’s senior staff including Dr. Jeff Shuren, Dir. CDRH, FDA, at a town-hall
meeting. Dr. Shuren gave “hints” of where FDA might be heading on these important issues - Jack will share what he learned. Uncertainly comes from FDA’s unpredictable review process from what we’re seeing for the last two years. Takeaways: • Specific ideas to make the 510(k) application
sound for getting it “cleared” quickly
• Where is FDA going for “implantable” products requiring 510(k)
• Why is FDA delaying so many applications?
5:45 pm, Clinic #2, Linda Garriz presents “Design of Experiments Simplified: The Power of Fractional Factorial Experiments”. You will learn the basics of
how to define and set up a factorial designed experiment and a fractional factorial screening experiment. This session provides an overview of Fractional Factorial Experiments and provides the necessary tools and knowledge to begin applying the concepts on your processes. By attending this session, you will… • Understand when and how to use fractional
factorial experiments to solve problems. • Learn how to design and run a fractional
factorial experiment without the need for specialized software.
• Understand confounding and how to avoid it.At 7:30 pm, the dinner topic Social Media in the Workplace: Know Your Rights! This presentation will focus on employee use of social media: whether employers can monitor what employees do on social media, and whether employers can fire employees for what they do on social media. Labor Attorney Laura Fleming will talk about privacy rights, First Amendment rights, anti-discrimination laws, lifestyle protection laws, and the National Labor Relations Act as they all relate to employee use of social media. You will learn answers to the following questions:
• What are the risks associated with employee use of social media?
• What are the “Best Practices” for social media policies?
• When can employees be disciplined for what they post online?
Jack Dhuwalia is experienced in the medical industry. He has been problem-solving in R&D, manufacturing and quality areas. He has addressed many 483s and Warning Letter items to resolve problems with the FDA; the results have been audited and verified by the FDA satisfactorily. Since 1992, he co-founded JD Consulting, a firm specializing in medical industry. He is very effective in conformance to FDA, ISO 13485 and other requirements. He has published several articles on CAPA, problem solving, productivity and communication. He has spoken on Root Cause Analysis and CAPA during FDA-OCRA events. He is a past member of the executive board of OCRA, a professional organization for quality/regulatory affairs and on the board for other professional associations. He is a six sigma black-belt and a certified HACCP auditor.
Laura Fleming practices labor law at Stradling, a full-service law firm. Ms. Fleming represents a broad range of clients, from Fortune 100 companies to start-ups and individual executives. Her expertise includes all things employment-related: advice and counsel, personnel documentation, internal investigations, union arbitrations, government audits, and litigation defense. Ms. Fleming also speaks on a variety of topics, including diversity initiatives and social media in the workplace. Ms. Fleming is a graduate of Harvard University and Harvard Law School.
Linda Howe Garriz is Director, Quality Assurance Operations at the Irvine Technology Center of the Alcon Division of Novartis in Irvine, California. She received her B.S. in Mathematics/Economics from Allegheny College and her M.S. in Industrial Administration with an emphasis in statistical methods and analysis from Carnegie-Mellon University. She currently is an instructor for the Certified Quality Engineer, Certified Biomedical Auditor, and Certified Six Sigma Black Belt Refresher Courses for the Orange Empire Section of ASQ..
Leadership Team 2011
Welcome New Members
Jesse M. AdawagJack T. BogleDee D. BoslerCasey BrandLasaunta F. CruzBret DanielsDarrell Dragich
Yevgeniy FedotovJean-Michel GalmicheEverardo J. GarciaJung Hun HanFrank HiroyasuPeter HongMichael MarkantonisStephen R. MayfieldOrlando Mejorada-CastroQuang NguyenChristopher NonatoFrank NortonCharles OgbonnaJuan C. OsorioTeresa A. PorterLindsey RankMichael RedmondMelissa RoussakisTimothy RozemaEsmeralda SalgadoHessen SalvadorSammy Sam
Yasmine ShadRodrigo SuarezCory SullivanHann-Ping WangDavid WeiserMeng Xu
All new members are eligible for free admission to a dinner meeting within 3 months of becoming a member. Please contact Vinay Goyal for a free voucher at [email protected]
*****
Not receiving e-mail notifications of upcoming events? Call headquarters at 800-248-1946 and request the necessary changes, or e-mail them at [email protected]
Chair Ed Matthews C: (714) 686-6638 E-mail: [email protected]
Vice Chair Annette Ant C: (949) 903-3274 E-mail: [email protected] Laurie Patton E-mail: [email protected] Bob Olevson C: (714) 394-4883 E-mail: [email protected]
Programs Chair Dave Nagy W: (714) 883-9305 E-mail: [email protected]
Volunteer Audit Chair Dale Becker E-mail: [email protected]
Career Chair Sharon Dalmage E-mail: [email protected] Phone: (714) 808-4575
Arrangements Chair Briana Sallows E-mail: [email protected]
Publicity/Internet Chair Steve Martin W: 714- 985-3022 E-mail: [email protected]
Education Chair Margaret Benavides W: (714) 654-2479 E-mail: [email protected]
Certification/Renewals Karen Gaynor W: (949) 753- 6248 E-mail: [email protected] Examiner Hassan Farah C: 909-261-3517 E-mail: [email protected]
FinancialAuditing Chair
Darrell Moyer H: (562) 795-5990 E-mail: [email protected] Chair Don Shannon E-mail: [email protected] Regional Director Vinay Goyal W: (714) 876-3927 E-mail: [email protected]
Membership Chair Vinay Goyal W: (714) 876-3927 E-mail: [email protected] Outreach Chair Bob Mehta W: 949-510-9138 E-mail: [email protected] Regional Director, Region 7 Elias Monreal E-mail: [email protected]
SCOPE Editor Luke Foo W: (949) 743-9208 E-mail: [email protected]
Please contact the Leadership Team and tell us how to serve you better
Mail Recertification Packages to:Alcon Laboratories
Attn: Karen Gaynor QADC15800 Alton Parkway, Mail-stop 145, Irvine, CA 92618
Why Become Certified? In today’s world, where quality competition is a fact of life and the need for a workforce proficient in the principles and practices of quality control is a central concern of many companies, certification is a mark of excellence. It demonstrates that the certified individual has the knowledge to assure quality of products and services. Certification is an investment in your career and in the future of your employer.
Bolero Associates, LLCwww.boleroassociates.com 714-634-4441
Dave Nagy, PrincipalBolero Associates, a consulting company focused on increasing productivity, improving processes, and improving the bottom
line for our clients.
• QMS ISO 9001:2000, AS9100, and TL 9000
• Team Problem Solving and Decision Making
• Change Management - Achieve your vision
• Innovative Supply Chain Solutions
• Communication Development
• Leadership Development
• Baldridge & CA Quality Strategy Deployment
Get the leading-edge professional development you need with Cal State Fullerton’s wide range of certificate programs.
Areas of focus include:
Assure YourCompetitive Excellence
� Business Intelligence� Engineering� Green and Sustainability� Information Systems� HR & Leadership� Project Management� Six Sigma� Custom Workforce Solutions …and much more!
CALIFORNIA STATE UNIVERSITY, FULLERTONUniversity Extended Education
7822-3
www.CSUFextension.org/quality
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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: Luke Foo 949-743-9208 or [email protected]
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Worldwide services for the Pharmaceutical, Medical Device, Biologics, Diagnostics and Biotech industries
Clinical Research Regulatory Affairs
Quality Assurance & Compliance Medical Affairs
800.507.5277 I www.meirxrs.com I [email protected] 100 N. Brand Blvd I Suite 306 I Glendale I CA I 91203
Professional Development Courses
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Congratulations to the following members who have sent in their recertification packages:
Congratulations!Gary McMullin has won the drawing for a free dinner at the monthly ASQ meeting held at the Doubletree Hotel every 2nd Tuesday at each month. Please join us at the next meeting, and you too may win a chance for a free dinner!
Matthew Bazydlo
Richard Clark
James Deshefy
Ronda Elliott
Dieter R. Eckstein
James Brebner
Upcoming ASQ Event - Mark Your Calendars!DECEMBER 13th SOCIAL DINNER... Enjoy a magical evening with David Chen. Bring your family and friends for an evening of fun.
5:30 p.m. Registration5:45 – 6:30 – Hors d’Oeuvres & socializing
6:30 – 7:30 p.m. Dinner7:30 p.m. – 9:00 – A Magical Evening show9:00 p.m. – final announcements and close
Fees for ASQ Section 0701 Members:$0 (free!) for clinic and/or dinner presentation only (no dinner meal). RSVP requested by Early RSVP Deadline.$30 with RSVP before Early RSVP Deadline. Includes for clinic, dinner meal, and dinner presentation.$40 at the door. Includes for clinic, dinner meal, and dinner presentation.Fees for all others:$45 with RSVP before Early RSVP Deadline. Includes for clinic, dinner meal, and dinner presentation.$55 at the door. Includes for clinic, dinner meal, and dinner presentation.
Shayan Babibi
Phong Vo
David Jackson
Thomas A. Culhane
Brent W. Duggleby
Christopher A. Karner
Marcelo Trevino
EDUCATION
On-line Course - You can attend from anywhere as long as you have computer, internet connectivity
and a phone line
Certified Quality Inspector / Quality Technician Refresher Course
SESSIONS/DATES9 On-Line sessions total: Saturdays from 9:00 am to 11:30 am on Dec (2011) - Dec 3, Dec 10, Dec
17, Jan (2012) - Jan 14, Jan 21, Jan 28, Feb (2012) - Feb 4, Feb 11, Feb 18
Will cover: Inspection & Test techniques and Methods,
Metrology, Calibration, GD&T, Basic Statistics, Statistical Process Control, Capability Analysis,
Acceptance Sampling, etc. Also covers strategies/tips for preparing & taking the exam
FeesEmployed Member Fee $400.00 for a limited time
($500.00 original price)
Nonmember Fee $450.00 for a limited time
($500.00 original price)
Unemployed Member Fee $300.00 for a limited time
($400.00 original price)
On-line Registration http://www.cvent.com/d/dcqmjd/1Q
Certified Quality Inspector / Quality Technician Refresher Course
SESSIONS/DATES9 sessions total; 7 sessions Tuesdays Nov 29, 2011 to
Jan 31, 2012 at NOCCCD, 2 session on Feb 7 and Feb 14, 2012 at Alcon Labs Irvine and 1 session On-line TBD from 6-9 PM (No class on Dec 20, 27 and
Jan 3)
Will cover: Inspection & Test techniques and Methods, Metrology, Calibration, GD&T, Basic Statistics, Statistical Process Control, Capability Analysis, Acceptance Sampling, etc. Also covers strategies/tips for preparing & taking the exam
When:Tuesday, November 29, 2011 - Tuesday, February 14,
2012 6:00 - 9:00 PM (Pacific Time)
LocationNorth Orange County Community College, 1830 W.
Romneya Drive, Anaheim, CA 92801 USA
FeesCourse Registration
Fee $350.00 Before November 21, 2011 (After Nov 21, 2011 : $400.00 )
Unemployed Member Fee $200.00 (with proof)
On-line Registration http://www.cvent.com/d/7cqm4y/4W
Questions: Call Vinay Goyal (714)-876-3927 or email: [email protected]
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HIGHLIGHTS FROM QUALITY DAY 2011
Chris Alexander - Keynote Speaker
John Alexander - Clinic Speaker on Career Transition
Some attentive attendeesMichael Scofield - Clinic Speaker on Quality
in Data Visualization
HIGHLIGHTS FROM QUALITY DAY 2011
Workshop attendees Keynote Speaker Rob Bryant
Heather Weishlow workshop on Creating a Stellar Job Search Plan
Dr. Phil Rosenkrantz giving a clinic on Six Stages of Quality System Implementation