eScope - ASQ Orange Empireasqorangeempire.org/wp-content/uploads/2016/01/2016-10-eScope.… ·...

Upcoming Dinner Mee�ngs

October 11, 2016 (Tuesday)Monthly Dinner Mee�ng

November 8, 2016 (Tuesday)Monthly Dinner Mee�ng

December 13, 2016 (Tuesday)Monthly Dinner Mee�ng

Inside this Issue Pg.

Sec�on Chair Update 1

2016 Leadership Team 2

New Members 3

Re-Cer�fica�ons and Sec�on Offerings

4

ASQ is moving to ComputerBased Tes�ng

5

Educa�on Opportuni�es 6

Volunteer Opportuni�es 7

Editor’s Announcement:Call for Ar�cles

8

“Employing Audits forImproved SupplierPerformance” Ar�cle (Part 2 of 2)

9-10

Monthly Dinner Mee�ng 11-12

Upcoming Conferences 13-15

eScopeThe official newsle�er of the ASQ Orange Empire Sec�on 0701

October 2016

Sec�on Chair UpdateHi Colleagues!

October 2016!! Wow! We started the 3rd quarter of 2016 and the year startswinding down in a hurry! Before we say goodbye to 2016, our Sec�on Leaders are working on a few more ac�vi�es for you.

One of these will take place on November 4thand 5th when our Sec�on joined our sister sec-�ons 700 and 702 to bring you the 9th Annual Southern California Quality Conference (SCQC)in Cal Poly Pomona. The event will start withworkshops on November 4 and close with athree track conference on November 5th. Thetheme for the conference is Quality in the

Evolving World of Business. This promises to be a great educa�onal opportunity for our members. Have you registered already? If you havenot, I urge you to find out more informa�on using this link h�p://socalqualityconference.com and regis-ter before the a�endance limit is reached. The conference tracks are Management, Regulatory/Audits, and Lean, Six Sigma and CI Track. I hope to see you there!

Star�ng in 2017, we have an exci�ng change for you. A�er many years at the Double Tree Hotel, our sec�on has decided to find another home for our monthly dinner mee�ngs and main events. A�er a diligent project led by Ned Schneider and Bob Mehta that evaluated different poten�al venues, we

reached an agreement with the Irvine Wyndham Hotel to host ourmee�ngs star�ng next January 2017. Our sec�on is not a stranger to this hotel. Our ASQ Sec�on used to host its diner mee�ngs and seminars at this hotel nearly 10 years ago. The hotel has recently been renovatedand their dinner menu promise to be a good move just a few minutessouth of the 405 freeway. Personally, I think the traffic, parking and con-ference rooms will serve as a much improved venue for our members.We look forward to seeing you there in January 2017!

Last month, Thomas Neil decided to step down as the leader for our Volunteer Auditor Program. I per-sonally thank Thomas for his great contribu�ons to our Leadership Commi�ee and I wish him the best of luck with his busy auditor schedule. Thomas has been an exemplary member for our sec�on who has proven that the skills that we learn in our Quality Profession can transport us to new opportuni�es not only in our careers but in our lives. I remember Thomas a couple of years ago coming to ourmee�ngs and sharing his plans to become a Lead Auditor and relaunching his career as an auditor. Now, Thomas’ career is thriving once again and making a difference for companies he serves. Thomas, thank you once again and it is with great pride that I can say that I have had the privilege to work withyou.

If you are a Cer�fied Lead Auditor and are interested in leading our Volunteer Auditor Program, please email me your resume. This volunteer program is one with great synergies for our members as well asthe community of small businesses that our sec�on is able to assist with audi�ng services in exchange for our auditors to get a chance to accumulate audit experience.

Last, but not least, November is World Quality Month! Every yearASQ provides a pla�orm for Quality Professionals around the world to celebrate Quality and share success stories. Visit the website forthis year’s World Quality Month at www.worldqualitymonth.organd join us as we celebrate one of the most influen�al professions in today’s business world…QUALITY!

Dieter Eckstein, BSBM, ASQ CMQ/OE, CQASec�on Chair, ASQ Orange Empire 0701

Dieter Eckstein, BSBM,CMQ/OE, CQA

- ASQ Orange EmpireSection 0701 Chair

eScopeOctober 2016

SOCIAL MEDIA CHAIRAbel C [email protected]

MEMBERSHIP CHAIRVatsal [email protected]

AUDITING CHAIROpen

NOMINATING CHAIRDave [email protected]

VOC CHAIRReepak [email protected]

SECTION 7 REGIONAL DIRECTOREd Ma�hews ed.ma�[email protected]

BREAKFAST MEETING CHAIROpen

CHAIRDieter [email protected]

VICE CHAIRVinay [email protected]

TREASURERCory [email protected]

SECRETARYLaurie Pa�on laurie.pa�[email protected]

HISTORIANHyung [email protected]

EDUCATION CHAIRMark [email protected]

CERTIFICATIONS/ RENEWALSSue [email protected]

CHIEF PROCTORHassan [email protected]

PROGRAMS CHAIRNed [email protected]

ARRANGEMENTSOpenVatsal Patel (ac�ng)[email protected]

eSCOPE NEWSLETTER EDITORGi�y [email protected]

CAREER MANAGEMENT CHAIRBob [email protected]

2016 Leadership Team

We are always looking forClinic and Dinner speakers!!

If you would like to share yourexperience at a future dinner

mee�ng, please contact Vinay Goyal at

[email protected]

or Ned Schneider, Program Chairat [email protected]

for more informa�on.

eScope Ad Rates

Ad SizeApprox.Inch Size

1 Issue 6 Issues 12 Issues

Full page 8.5” x 11” $200 $1,100 $2,000

1/2 Page 7.5” x 4.91” $110 $605 $1,100

1/4 Page 3.67” x 4.91” $70 $385 $700

1/8 Page 3.67” x 2.36” $35 $195 $350

Checks should be made to: ASQ Orange Empire Section, andmailed to ASQ, PO Box 14183, Irvine, CA 92614, with ad copy.

Instructions for placement, and frequency,Contact eSCOPE Editor: Gitty Yasreb @Email: [email protected]

eScopeOctober 2016

Welcome!New ASQ MembersWelcome and congratula�ons on making the important

decision to become a member of ASQ.

All new members are eligible for free admission to a dinnermee�ng within 3 months of becoming a member. Please

contact Vatsal Patel for a free dinner voucher at:[email protected]

Louvella Batan

Luke Hansen

Marcelino Cruz

Marcella McSorley

Matofa Fautua

Meng Hsuan Lin

Michelle Le

Mike Lee

Min Kyung Song

Muntaqab Mohiuddin

Robin Auerbach

Rosanne Nolan

Sameer Gupta

Shefali Bhatt

Sunil Chaudhari

Tenari

Thao Lieu

William Macias

William McGarry

Wilma Galindo

Do

Chavez

Alisen Wilkinson

Angela Miyamoto

Angie Amoraseth

Asad Jaleel

Cheng Dodd

Christina Cayuela

Christine Molina

Dave Bailey

David Orellana

Fay Farmand

Fleur Robert-Barrillon

Frank Vo

Grace Michaels

Hao Tran

Hitalo Valladaresq

Jesse Chou

Jihong Deng

Jocelyn Alvarado

Jonathan Lux

Juan Hernandez

Kamila Granadino

Ken Hashimawari

Loong SangYong

November is World Quality Month!

Visit the website for this year’sWorld Quality Month at

www.worldqualitymonth.org

eScopeOctober 2016

Re-Cer�fica�ons

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. There is now an online RU Recertification Journal availa-ble! The RU journal allows logging in your points as you earn

them over the three year period.

h�ps://asq.org/cert/myru

You can s�ll send your recertification package to:

Alcon Laboratories, Inc.A�n: Sue Knight, M/S 145

15800 Alton Parkway, Irvine, CA 92618-3818

For more informa�on or ques�ons, please email [email protected] or

Click here for more informa�on

WHY BECOME CERTIFIED?

In today’s world, where quality competition is a factof life and the need for a workforce proficient in theprinciples and practices of quality control is a centralconcern of many companies, certification is a markof excellence. It demonstrates that the certified indi-vidual has the knowledge to assure quality of prod-ucts and services. Certification is an investment inyour career and in the future of your employer.

* Monthly Dinner Meetings

Held the second Tuesday of each month (unless otherwiseannounced), dinner mee�ngs provide an opportunity to

a�end informa�ve presenta�ons, network with fellow local quality professionals, and earn credits toward your

recer�fica�on.

* Educational Seminars

Held periodically throughout the business year, seminarsprovide an all-day seminar on a topic of interest to our

sec�on members.

* Refresher Courses

Courses are held based upon the ASQ cer�fica�on exam schedule and provide a great overview of the informa�on you

will need to pass the exam at a great value to sec�on members. See the sec�on website and eScope for upcoming

offerings.

* eScope Publication

Published monthly, the eScope provides members withinforma�on about sec�on events as well as per�nent ar�cles.

* Volunteer Audit Program

Offering sec�on members the opportunity to gain audit experience by performing audits for local companies.

* Career Opportunities

Visit the sec�on website for career opportuni�es targeted to the Orange Empire membership … and so much more!

Check out theCertification

Courses offered inthis month’s

eScope

eScopeOctober 2016

ASQ is moving to Computer Based Tes�ng

(effec�ve for the October 2016 exams)

Benefits to ASQ Members

⇒ An increase in annual exam administra�ons from two to six

⇒ The availability of days in which to take the exams, increasing from four per year to 102

⇒ The convenience of retes�ng, reducing �me from 6 months to 2

⇒ An increased number of tes�ng loca�ons, from 350 to 8,000

⇒ And faster test results, from 10 days to 0-4

Frequently Asked Ques�ons

What is Computer Based Tes�ng

Computer-Based Tes�ng (CBT) is an efficient way to provide a secure, consistent environment for cer�fica�on and licen-

sure while significantly enhancing the candidate experience. Tes�ng is done in a secure proctored tes�ng center at a per-

sonal computer worksta�on.

How will this change affect me?

The applica�on/approval process will not change however, customers will be required to take an addi�onal step a�er be-

ing approved to schedule their tes�ng appointment with Prometric.

When will customers be able to schedule their exam appointment with PrometricA�er being approved for ASQ Cer�fica�on, customers can schedule their exam at the nearest Prometric Tes�ng Center.

Can customers choose to take a paper and pencil exam?No, beginning with the October exam window (September 1-October 15, 2016) all exams will only be offered via CBT.

(Excep�ons include Special Administra�ons and Translated exams which will roll out via CBT in 2017.)

(Source: ASQ.org)

For more informa�on please check the ASQ.org website: h�p://asq.org/cbt/

The delivery method for ASQ Certification exams is changing from paper andpencil, to Computer Based Testing. Candidates will take ASQ Certification examsat a Prometric testing facility where the test will be delivered via computer in aPrometric proctored, secure environment.

With thousands of testing sites and seats, test takers have a wide choice of datesand locations from which they can select.

eScopeOctober 2016

Six Sigma Green Belt Certification Exam Refresher Course

SESSIONS/DATES

10 sessions; Mondays from September 26, 2016 to November 28, 2016

Will cover: Lean Principles, Design for Six Sigma,, Project Mgmt Basics, Team Dynamics, Six Sigma Improvement

Methodology & Tools (Define, Measure, Analyze, Improve, & Control)… Plus: Basic Statistics preparation, TI-30X II

statistical calculator usage, strategies/tips for preparing & taking the exam.

When

Monday, September 26, 2016 6:00 PM - Monday, November 28, 2016 9:00 PM

Pacific Time

Location

Alcon Laboratories

15800 Alton Parkway

Irvine, California 92618, USA

CLICK HERE TO REGISTER

Education OpportunitiesUpcoming Refresher Courses

Exam Dates: Computer Based Testing Date Window is December 1 - December 17, 2016

Certified Quality Auditor - Prep / Refresher Course

(Traditional Classroom & Webinar)

SESSIONS/DATES

Traditional Classroom Course of 9 sessions; Wednesdays 6 PM - 9 PM from October 12, 2016 to December 7, 2016.

Note: No Class during Thanksgiving week. Another class session will be scheduled.

Note: A Live Online Instructor led Webinar will simultaneously be offered during the Traditional Classroom Course.

Students can attend to participate in either one or both.

Will cover: Certification Overview, Auditing Fundamentals, Auditor Competencies, Audit Preparation, Audit Performance,

Audit Reporting, Audit Follow-up & Closure, Audit Business Applications, Quality Tools & Techniques, plus Tips &Strategies on taking the exam.

When

Wednesday, October 12, 2016 6:00 PM - Wednesday, December 7, 2016 9:00 PMPacific Time

LocationAlcon Laboratories

15800 Alton ParkwayIrvine, California 92618, USA


eScopeOctober 2016

Volunteering Opportuni�esWe are always looking for volunteers, but have an immediate need for the following posi�ons.

For more informa�on about any volunteering, please contact Vinay Goyal or email at [email protected]

• Arrangements Chair

• Auditing Chair

• Breakfast Meeting Chair

• And more (e-mail for details)

Inquire within!

eScopeOctober 2016

EDITOR’S ANNOUNCEMENT:

Newsle�er Contribu�ons Wanted!!

The ar�cles should contain the following as much as possible:

• Defini�on of the Opportunity (Do NOT disclose proprietary informa�on)

• Team forma�on and Management support (Team coopera-�on/accountability, Project Champion, etc.)

• Project management techniques used (Gan� Chart, Frequen-cy of team mee�ngs, �meline management, how were re-source & technical challenges addressed, etc.)

• Lean and/or Six Sigma Methodologies used (DMAIC, DFSS,etc.)

• Lean and Six Sigma Tools used (QFD, 7 QC Tools, Process Ca-pability/SPC, GR&R, Hypothesis Tes�ng, ANOVA, DOE, etc.)

• Project Results: Savings, new business market opportuni�es, Product or Process quality improvements (Incr. % Yield, im-proved CTQs, Improved Throughput, Reduced Waste, etc.)

• Lessons Learned

For more informa�on, submi�als, or comments about newsle�er ar�cles,

please contact Gi�y Yasreb (Newsle�er Editor) via email: [email protected]

Send your ar�cle today!!

Our ASQ Sec�on 0701 Leadership invites you to be a contributor to our newsle�er by wri�ng an ar�cle that would be of interest and value to other members. Maybe you can describe a work-related issue or opportunity thatwas resolved using Six Sigma, Lean or other Quality methodologies.

According to feedback, we believe our readers will be interested in whattheir peers are doing with the tools and training that ASQ provides.

If chosen for publishing, you will earn 1.0 RU!!

eScopeOctober 2016

Employing Audits for Improved SupplierPerformance

(Part 2 of 2 - Continued from Sept. eScope)

By: Bob Mehta - ASQ Fellow and Principal Consultant atGMP ISO Expert Services

Value-Added Supplier Audit Program

There are many reasons for or-ganiza�ons to establish a value-added supplier audit program.Granted, sustaining regulatorycompliance is a salient require-ment; however, there are otherfactors organiza�ons need to con-sider when establishing an ap-proach to value-added supplier

audits. For example: (a) preserva�on of brand equity; (b) ensuring values and strategy are clearly understood bythe supplier; (c) establishment of consistent prac�ces among suppliers; (d) achieving supplier return on invest-ment (ROI) goals; and (e) providing supplier oversight, soefficiency and con�nuous improvement targets can be achieved.

When intelligently designed, a value-added supplier auditprogram can provide great benefits to a device manufac-turer. Establishing a value-added program begins with theunderstanding that the program fundamentals expandbeyond the physical performance of supplier audits. Sup-pliers with a cer�fied Quality Management System (QMS), in accordance with ISO 9001:2008 or ISO 13485:2003,have the basic system elements in place. Cer�fica�on allows device manufacturers to focus on process-specific audits which inherently provide more value. However,Trautman cau�ons manufacturers against relying solely on ISO cer�fica�on by third par�es as evidence that sup-pliers have the capability to provide quality products orservices.

In any event, these are the key elements that should beconsidered for inclusion in a value-added supplier auditprogram:

* A well-wri�en supplier quality agreement delinea�ng responsibili�es and expecta�ons

* A supplier ques�onnaire that focuses on business and

technology

* Supplier scorecards that are performance-centric

* Supplier on-site assessment checklist

* Supplier sta�s�cal data program in support of reduced incoming inspec�on

* Crea�on of supplier categories premised on risk (business and regulatory)

Device Industry Trends in Audi�ng

The device industry con�nues to employ three categories of supplier assessments: (a) supplier selec�on/qualifica�on au-dits; (b) supplier surveillance audits to ensure conformance torequirements is being sustained; and (c) for-cause audits,when supplier non-conformances nega�vely influence fin-ished-device performance. Because of the expense associatedwith performing supplier audits, device manufacturers are in aconstant cost-containment ba�le. The trade-off lies in con-taining costs associated with supplier oversight while reducingcosts associated with COPQ. It has never been economicallyviable to perform on-site audits on all of a device manufactur-er's suppliers, nor is it value-added.

Another trend influencing the medical device industry is sup-pliers wan�ng to be paid for entertaining audits. Device man-ufacturers invest a significant amount of �me and money se-lec�ng, approving, and incorpora�ng purchased components into finished medical devices. Considering the expense of vali-da�on and the regulatory ramifica�ons associated with the changing of cri�cal component suppliers, it is seldom econom-ically viable to replace suppliers charging for audits. A suppliercharging for an audit is an expense that must be considered inadvance.

Focused Versus QMS Audits

Focused and QMS audits provide value depending upon theapplica�on. If a supplier has a cer�fied QMS, then the ele-ments of an effec�ve quality system are already in place. However, if a poten�al supplier does not have a cer�fied QMS, performing an ini�al audit of the supplier's quality sys-tem is considered prudent and categorized as value-added.Considering the costs associated with device valida�on, it is too risky to proceed with a business rela�onship without first kicking the �res. However, if the supplier has a cer�fied QMS, a focused audit is probably the correct path to travel. A fo-cused audit can be employed to assess technical capabili�es, capacity and supply chain.

Continued next page ………

Employing Audits for Improved SupplierPerformance

Continued from previous page ……...

Audit Need and Frequency

Audit need versus frequency is one of the significant driv-ers for a value-added supplier audit program. It makeszero sense for device manufacturers to a�empt to audit 100% of their supplier bases. Conversely, not audi�ng suppliers or failing to establish a program for supplieroversight will in all likelihood result in an increase in theCOPQ and poten�ally invite regulatory ac�on from the FDA. A value-added supplier audit program should begoverned by audit need, premised on supplier risk. Forexample, cri�cal suppliers, such as a steriliza�on facility, should warrant an annual assessment. For the supplier ofa poly/Tyvek pouch (sterile barrier), once every threeyears may be appropriate. The key is for the device manu-facturer to adequately define need and frequency. Re-gardless of the approach, the FDA will want to see evi-dence of program effec�veness.

Evalua�ng Risk

Performing supplier audits can be expensive. Employingtrained auditors, managing an extensive list of suppliers,�me associated with pre- and post-audit ac�vi�es, and the cost of travel can quickly become problema�c even for the most cost-conscious organiza�ons. That is why it is extremely important to include the assessment of risk aspart of the program. Crea�ng risk categories, performing risk analysis, focusing on risk reduc�on, and when appro-priate, iden�fying levels of risk assessment are important features associated with a value-added supplier auditprogram.

Third-Party Audits

Third-party audits, the use of consultants as an extensionof a device manufacturer's value-added supplier auditprogram, can be a blessing or a curse. Outsourcing suppli-er audits can result in an immediate and o�en substan�al savings to device manufacturers. However, there is alsosignificant trust involved when outsourcing supplier au-dits. Auditor competency will influence the overall effec-

eScopeOctober 2016

�veness of third-party audits. Auditors lacking experience toassess compliance against applicable regula�ons, standards, and industry guidelines or lacking technology-specific compe-tency, regardless of creden�als, affect the performance of op�mum audits resul�ng in missed opportuni�es for driving supplier correc�ons and improvements.

Summary and Conclusion

Considering the current regulatory climate and the need fororganiza�ons to focus on factors reducing the COPQ, imple-men�ng an effec�ve value-added supplier audit program be-comes a fundamental requirement for device manufacturers.It will never be prac�cal to ins�tute a program requiring a 100% performance of on-site supplier audits, nor will it beacceptable not performing some level of supplier assess-ments. The solu�on is to develop and implement an appropri-ate tool set that supports a value-added approach. Audit type,frequency, and the employment of third-party auditors willinfluence the cost of any audit program. However, the goal of the program should be to reduce the COPQ. An effec�ve value-added supplier audit program will significantly reduce the COPQ ensuring: (a) suppliers maintain a QMS; (b) supplierssustain compliance to applicable regulatory requirements;and (c) suppliers manufacture and/or supply a quality productor service.

About: Bob Mehta

Bob Mehta is a Fellow of ASQ and principal quality systemsconsultant at GMP ISO Expert Services(www.gmpisoexpert.com), a Los Angeles-based consul�ng firm helping U.S. and interna�onal clients in the pharmaceu�-cal, biotechnology, IVD, dietary supplement/food, and medicaldevice industries. Bob has more than 25 years' experience inthe fields of quality assurance, quality control, supplier man-agement, and risk management. He has helped clients withremedia�on and implementa�on of risk-based quality systemsand supplier audit programs in a variety of FDA regulated andISO cer�fied industries. He has published number of ar�cles published in the MD&DI, Quality Progress, Nutraceu�cal World, and Pharmaceu�cal Technology publica�ons. Bob is the author of the book �tled “Implemen�ng ISO/IEC 17025:2005” and has co-authored a book �tled “Prac�cal Pro-cess Valida�on” that is published by ASQ Press in July 2016. He serves on the commi�ee of the Industry Board of Advisors for Medical Device Industry Educa�on Consor�um (MDIEC). He teaches master level quality assurance courses at local univer-si�es, teaching Six Sigma Black Belt at Cal Poly Pomona in ad-di�on to teaching ASQ cer�fica�on courses. He can be reached at (949) 510-9138 or [email protected]

eScopeOctober 2016

ASQ Orange Empire Monthly Dinner Meeting

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. You can earn 0.3 RU’s per presenta�on for a total of 0.6 RU’s.

PRESENTATIONS

Clinic 1: The Importance of Understanding Type I and Type IIError in Sta�s�cal Process Control Charts

Presented by: Dr. Phil Rosenkrantz

Clinic 2: Visual Mind Mapping : Crea�ve Problem Solving

Presented by: Linda Krall

Dinner Presenta�on: "Preven�ve Ac�on through Risk-Based Thinking"

Presented by: Dr. Catherine L. Mar�n

WHENTuesday, October 11, 2016, 5:15 PM - 9:00 PM

Please note: Dinner mee�ng for October 2016 is on a Tuesday.

WHEREDoubleTree Hotel Santa Ana/Orange County Airport

201 East MacArthur Boulevard, Santa Ana, California 92707

FEESClinic 1 or Clinic 2 ONLY (no dinner speaker or meal)

(0701 Member) Complimentary(Non-0701 Member) $10.00

Clinic 1 or Clinic 2 and Dinner Speaker (no dinner meal)(0701 Member) Complimentary

(Non-0701 Member) $10.00

Full Package - Clinic 1 or Clinic 2, Dinner, and Dinner Speaker(0701 Member) $30.00 for a limited �me ($40.00 original

price) (Non-0701 Mem-ber) $45.00 for a limited �me ($55.00 original price)

RSVP byFriday, October 7, 2016 at 11:15 AM for discounted pricing and

Fish and Beef dinner selec�ons.

Online registra�on closes at 12:00 pm on Tuesday, October 11, 2016.


DINNER PRESENTATION

Preventive Action throughRisk-Based Thinking

Presented by: Dr. Catherine Martin

This session describes Risk-based thinking that enables an organiza-�on to determine the factors that could cause its processes and its quality management system to deviate from the planned results, toput in place preven�ve controls to minimize nega�ve effects and to make maximum use of opportuni�es as they arise. The appropriate combina�on of risk-based methods is presented that links the riskmanagement strategy to the quality management system preven-�ve ac�on strategy to trigger performance improvement efforts.

Learning outcomes by a�ending this presenta�on:

♦ Define and interpret the ISO9000:2015 standard that re-quires the organiza�on to understand its context and de-termine risks as a basis for planning. The Standard repre-sents the applica�on of risk-based thinking to planning andimplemen�ng quality management system processes.

♦ Define the concept that one of the key purposes of a quali-ty management system is to act as a preven�ve tool .

♦ Define, describe and apply risk-based methods, techniquesand tools for preven�ve ac�on to con�nually reduce cost of poor quality.

Our speaker: Catherine Mar�n

Dr. Catherine L. Mar�n holds a Masterof Science Degree in Quality SystemsManagement from Na�onal Graduate School in Falmouth, Massachuse�s and Doctor of Business Administra�on in Quality Systems Management fromNa�onal Graduate School in Falmouth, Massachuse�s. She was the ASQLA Chair in 2014, 2015 and is cer�fied as a Quality Auditor (CQA) and Quality Engi-

neer (CQE) by the American Society of Quality.

Catherine’s diverse background gives her a unique view of qualityfrom several industries and an opportunity to study the best prac-�ces and winning strategies of these industries to improve perfor-mance. Her professional experience includes working or consul�ng in aerospace, defense, biotechnology and healthcare. Catherine iscurrently a Senior Principal Quality Engineer at Raytheon. Catherineis an ASQ Instructor for Cer�fied Quality Engineer (CQE) courses. She is an avid follower of the Galloway Run Walk method, enjoyscooking and loves to be outdoors.

eScopeOctober 2016

CLINIC # 1

The Importance of Understanding Type Iand Type II Error in Statistical Process

Control ChartsPresented by: Dr. Phil Rosenkrantz

Sta�s�cal methods that involve sampling of any kind are subject to two kinds of sampling error: Type I error is when your sample ortest leads you to conclude a process is bad but it is really accepta-ble (a.k.a “producer’s risk” or a “false alarm”). Type II error is whenyour sample or test leads you to conclude that a process is oper-a�ng OK but it is really not (a.k.a “consumer’s risk” or “failure to detect”). Wrong conclusions lead to incorrect ac�ons. In the world of quality the bigger concern is almost always Type II error such asthinking a part, batch or process is good when it is really not. How-ever, a major excep�on to this thinking is found in the use of sta�s-�cal process control (SPC) charts where Type I error (false alarms) can cause people to hunt for problems that don’t exist which de-stroys user confidence and damages the implementa�on of SPC very quickly. In my consul�ng experience this is a common prob-lem that is largely misunderstood. The major culprits are usuallythe decision rules being used to alert that the process is out-of-control.

The goals of this presenta�on are to:

♦ Provide a brief review of the concepts of process controland process capability

♦ Explain Type I and Type II error with colorful examples

♦ Give examples of Type I and Type II error for common deci-sion rules

♦ Illustrate how the improper use of decision rules createsexcessive Type I error and creates mistrust in the use of SPC

♦ Suggest simple approaches for reducing Type I error in SPC

About our speaker: Dr. Phil Rosenkrantz

Dr. Phil Rosenkrantz is Professor Emeritusof Industrial & Manufacturing Engineering atCal Poly Pomona where he has been teach-ing and consul�ng for 34 years and served as Department Chair from 1990-1997. Hewas also founding Coordinator of the MSQAProgram at CSU Dominguez Hills from 1986-1989. Phil was an engineering supervisor forGeneral Motors prior to entering academia.Educa�onal background includes Doctor of Educa�on in Organiza�onal Leadership from

Pepperdine University; MS in Sta�s�cs from UC Riverside; MS in In-dustrial Administra�on from Purdue University; and B.S. in Mechani-cal Engineering from Ke�ering University (formerly GMI). P.E. (California). 2005 Recipient of the Simon Collier Award. George P.Hart Award for Outstanding Faculty Leadership 1999. OutstandingTeacher Award for the College of Engineering 2012. Phil has beenac�ve in ASQ and ASEE (American Society for Engineering Educa�on). Over the years Phil has been a volunteer with the Boy Scouts ofAmerica (8 years), the Board of Directors of Eastside Chris�an Schools (27 years), and U.S. Forest Service (20 years).

CLINIC # 2

Visual Mind Mapping :Creative Problem Solving

Presented by: Linda Krall, speaker + author

Visual (mind) mapping is a widely u�lized tool for maximizing the brain’s poten�al, summarizing informa�on for presenta�ons/speeches, thinking through complex problems, quickly iden�fying and understanding the structure of a subject, making associa�ons and connec�ons suppor�ng memory and recall. Besides benefi�ng the individual it allows one to tap into the collec�ve crea�vity of their team!

By a�ending this presenta�on, you will gain a be�er understanding of:

Your brain and crea�vity, whole brain thinking techniques of visual (mind) mapping and prac�cal applica�ons for professional and per-sonal development, including: Project Management, ManagingMee�ngs, Presenta�on Power, Brainstorming, Wri�ng and Learning Skills.

About our speaker: Linda Krall

Linda Krall is author of The Wild IdeaClub published by Career Press (Best inBusiness Finalist, SDBA) and recentlydistributed in Malaysia and Korea. Hernewest �tle by Walter Foster Publishing is Ar�sts Block Cured: 201 �ps to un-leash your crea�vity!

O�en described as a “crea�vity catalyst” Linda sketches concepts and ideas in real-�me that bring to life new insights for innova�ve products, campaigns and services. She has worked on global brands such as PepsiCo, GlaxoSmithKline, Kra� Foods, Duracell, Cadillac and Target.

Linda’s high energy as a facilitator and illustrator enhances mee�ng effec�veness, fosters posi�ve group dynamics and is engaging, em-powering and fun!

She presented at the U.S. Treasury, American Psychological Associa-�on and QRCA’s Na�onal Conference. Locally you may have seen her onstage at Segerstrom Hall for the first TEDx Orange Coast.

Linda is a Pi�sburgh, PA na�ve and graduated from The Pennsylva-nia State University with a B.S. in Educa�on. For fun she can be seen hanging around the Harley-Davidson motorcycle crowd or cheeringon her favorite sports teams!

eScopeOctober 2016

Upcoming Conferences

Pre-Conference: CLICK HERE TO REGISTER

Conference: CLICK HERE TO REGISTERIf you have any questions, please contact: Vinay Goyal at [email protected]

eScopeOctober 2016

Upcoming Conferences

For more information about below conferences, please check the ASQ.org website!

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