Ed MaƩhews, MBA, Lean Master, CMQ\OE, & CSSBB SecƟon Chair ASQ SecƟon 0701 Welcome to another addiƟon of our eScope. I hope you find the informaƟon contained within this and all addiƟonal informaƟve. Happy New Year On behalf of the secƟon leadership team I want to wish everyone a happy New Year. SecƟon Refreshers Courses and Seminars Our secƟon has one of the richest educaƟonal programs around at a considerable low cost for our members. I encourage you to take a look at the courses that will be starƟng this month. Among the courses you will find: CQM/OE Prep/Refresher Course CQI/CQT Prep/Refresher Course CQA Biomedical Prep/Refresher Course For more informaƟon, visit our secƟon’s web site calendar (click here) or see the announce- ments in this eScope for more informaƟon Membership Dues Increase Last year ASQ approved an increase of membership dues to take effect January 1st, 2013. If you are a Full/Senior/Fellow and Associate the dues will increase $4.00 and students will see an $1.00. This is the first Ɵme that ASQ makes an increase since 2005. We are including in this issue of the eScope the full document posted explaining the reasons behind the dues increase. Members in TransiƟon If you or anyone you know is an ASQ member who is in transiƟon due to a job loss, you may be eligible to receive assistance from ASQ Headquarters on reduced dues. The reducƟon is temporary and is based on the length of your current membership. For more informaƟon or assistance regarding this benefit, please contact ASQ customer service at 800-248-1946. ASQ Re-CerƟficaƟon Last, but not least, the holiday season can bring a lot of acƟviƟes that may result in for- geƫng to check your cerƟficaƟons. CerƟficaƟons typically expire and are due for renewal De- cember or June. Please check your cerƟficaƟons to make sure you stay current with your cer- ƟficaƟons. For more informaƟon, see the recerƟficaƟon informaƟon on page 3. SecƟon Chair Update January 2013 Special points of interest: Free Monthly Dinner. All aƩendees are eligible for the drawing held at each monthly dinner meeƟng. Welcome NEW Members! Get informaƟon for a free Dinner MeeƟng (pg 2) ASQ recerƟficaƟon (pg 3) SecƟon Leadership Team (pg 15) Inside this issue: SecƟon Chair Update 1 eScope Update 2 Radical Thinking? Struc- tured InnovaƟon – The SegmentaƟon Principle 4 Membership Dues Increase 10 December 2012 Memories 14 eScope The official newsleƩer of the ASQ Orange Empire SecƟon 0701 Upcoming Events January 8, 2013 January Dinner MeeƟng January 9, 2013 EducaƟonal Seminar: Lean Six Sigma & Balanced Scorecard, Forrest W. Breyfogle, III February 12, 2013 Dinner MeeƟng February 22, 2013 Seminar—GMP March 12, 2013 Seminar—GMP
Transcript
Ed Ma hews, MBA, Lean Master, CMQ\OE, & CSSBB Sec on Chair ASQ Sec on 0701
Welcome to another addi on of our eScope. I hope you find the informa on contained within this and all addi onal informa ve.
Happy New Year
On behalf of the sec on leadership team I want to wish everyone a happy New Year.
Sec on Refreshers Courses and Seminars
Our sec on has one of the richest educa onal programs around at a considerable low cost for our members. I encourage you to take a look at the courses that will be star ng this month. Among the courses you will find:
CQM/OE Prep/Refresher Course
CQI/CQT Prep/Refresher Course
CQA Biomedical Prep/Refresher Course
For more informa on, visit our sec on’s web site calendar (click here) or see the announce-ments in this eScope for more informa on
Membership Dues Increase
Last year ASQ approved an increase of membership dues to take effect January 1st, 2013. If you are a Full/Senior/Fellow and Associate the dues will increase $4.00 and students will see an $1.00.
This is the first me that ASQ makes an increase since 2005. We are including in this issue of the eScope the full document posted explaining the reasons behind the dues increase.
Members in Transi on
If you or anyone you know is an ASQ member who is in transi on due to a job loss, you may be eligible to receive assistance from ASQ Headquarters on reduced dues. The reduc on is temporary and is based on the length of your current membership. For more informa on or assistance regarding this benefit, please contact ASQ customer service at 800-248-1946.
ASQ Re-Cer fica on
Last, but not least, the holiday season can bring a lot of ac vi es that may result in for-ge ng to check your cer fica ons. Cer fica ons typically expire and are due for renewal De-cember or June. Please check your cer fica ons to make sure you stay current with your cer-fica ons. For more informa on, see the recer fica on informa on on page 3.
Sec on Chair Update
January 2013
Special points of interest:
Free Monthly Dinner. All a endees are eligible for the drawing held at each monthly dinner mee ng.
Welcome NEW Members! Get informa on for a free Dinner Mee ng (pg 2)
ASQ recer fica on (pg 3)
Sec on Leadership Team (pg 15)
Inside this issue:
Sec on Chair Update 1
eScope Update 2
Radical Thinking? Struc-tured Innova on – The Segmenta on Principle
4
Membership Dues Increase
10
December 2012 Memories 14
eScope The official newsle er of the ASQ Orange Empire Sec on 0701
Upcoming Events
January 8, 2013 January Dinner Mee ng January 9, 2013 Educa onal Seminar: Lean Six
Sigma & Balanced Scorecard, Forrest W. Breyfogle, III
February 12, 2013 Dinner Mee ng February 22, 2013 Seminar—GMP March 12, 2013 Seminar—GMP
Page 2 eScope January 2013
eScope Update By Dieter Eckstein
Improvement is a process, isn’t it? Well, I also think that im-provement is a journey in which we achieve growth from the experiences that we gather as we move along. We also leave imprints throughout the journey’s path and also with those that have joined us in the journey.
As a new member of ASQ over 10 years ago, I remember read-ing a column that got my a en on because of the insights ex-posed in its lines. I am referring to the “Radical Thinking?” col-umn which was part of the hard copy version of the Scope.
We are excited to bring the column back! This issue has the first ar cle from Mr. Akhilesh Gula , the author of “Radical Thinking?” I want to thank Mr. Gula for his column and hope that you find his ar cles valuable.
At our next dinner mee ng, we will make available index cards that you would be to return with any ques ons for the speakers that you didn’t have a chance to ask during the presenta ons. We will make an effort to have those ques ons answered and may pick some of them to share the ques on and answer in fu-ture eScope issues.
This will be another avenue for our members to maximize their benefits from dinner presenta ons and clinics.
Lastly, star ng with this issue, we are star ng another interac-ve column to give our members a chance to ask ques ons re-
garding improvement tools, management systems and standards, etc. The ques ons we receive will be reviewed them and an-swered by professionals in the corresponding areas in a future issue of the eScope. If members would like to keep their iden fy and company name’s anonymous, we will answer the ques ons keeping such informa on or any sensi ve informa on out. We will name this column the Improvement Compass. The objec ve of this column will be to point our members in the right direc on to remove roadblocks and shed light on subjects our members need help with.
I invite you to join me in this improvement journey of the eScope to bring you and our sec on members an informa ve, value-add type of newsle er. Feel free to contact me with com-ments, ques ons or a subject of interest that you would like to see in our eScope.
Welcome and congratula ons on making the im-portant decision to become a member of ASQ.
All new members are eligible for free admis-sion to a dinner mee ng within 3 months of be-coming a member. Please contact Steve Mar n for a free voucher at smar [email protected]
Ben Lascelles
Bhavna Mantha
Dally Dinh
Delilah Mar nez
Filomena M. Collins
Francisco Cervantes
Gene L. Rodriguez Jr
Gordon Robison
Jennifer Demmon
Jessica N. Ha
John S. Li le
Juan Hernandez
Kimberly Brown
Kris n Walle
Leah McKillip
Lorne R. Varney
Maria T. Panzarella
Michael N. Bock
Nicole Krause
Sameer Patel Afsaff
Page 3 eScope January 2013
Con nued from page 4
Cer fica ons
Congratula ons! The following members have met the
requirements to be recer fied
Carlos Moz
David Jackson
Keith Aleckson
Lynne A Marafino
Nat Doersam
Richard Regalado
Yolanda F De Guzman
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: Karen Gaynor QADC
15800 Alton Parkway, Mailstop 145
Irvine, CA 92618
For more informa on click this link
Recer fica on
Page 4 eScope January 2013
anneal the larger cas ngs. However, this advantage had also become a constraint. Running a large furnace is expensive. So the produc on folks usually waited for the furnace to be filled before firing it up. This, of course, created longer lead mes, especially for the increasingly smaller pieces and associated lot sizes that her customers were designing these days. While batching the many small cas ngs, for heat treatment, reduced the cost because of be er u liza on of the furnace’s capacity, it also increased the lead mes back to the customer. Based on what li le she knew about TRIZ, she started seeing contradic-
ons here: she could run many pieces quickly thus reducing the actual processing me, but in order to be able to bake many pieces in a short me, the cas ngs had to wait a long me before they could be treated in the oven –thus increasing the cycle
me. How could she use the segmenta on principle?
Segmenta on meant transi oning to micro-level; this means dividing an object or system into independent parts thereby making an object easy to move and or disassemble.
Applying this principle to her baking opera on would mean breaking down the large oven into smaller ovens. In essence,
Radical Thinking? Structured Innova on – The Segmenta on Principle
By Akhilesh Gula
Faced with increasing compe on and globaliza on where reverse engineering has become an everyday occurrence, Belinda real-ized that her company would have to em-
brace innova on as a strategy, if she was to stay ahead of compe on. It was not enough for her to introduce new prod-ucts every few years, where the cost of failure could be rather high. Rather, innova on had to become a way of life at her company; it had to get into its psyche! Easier said than done.
Belinda had heard about TRIZ, a structured form of innova-on, at an ASQ mee ng and found the concept interes ng.
A er learning more about this topic, she decided to try out one of the 40 principles: segmenta on. It was the first princi-ple and seemed doable.
During her research, Belinda learned that one basically starts with a problem statement, iden fies the contradic ons that prevent the problem from being solved, then looks through the available resources (both apparent and invisible) to help reach the ideal final results. TRIZ iden fies 40 princi-ples that give one ways to resolve the contradic ons and reach the ideal final result. She also learned that there are pa erns of evolu on and that segmen ng the system into smaller parts was one of the most useful pa erns of evolu on. This reminded her of the age-old adage, “Divide and conquer.” A clear example that came to mind was how the accoun ng firm she had been using, had recently segmented itself into four business units. This had allowed them to become smaller and more flexible while s ll big. Now that she thought about it, teams had been one of those persistent themes in the workplace during the past decade enabling flexibility and the ability to make decisions quickly. She, in fact, just introduced product teams in her workplace, and had already seen bene-fits.
This thought process increased her comfort level and Belin-da started wondering how she could deliberately apply the segmenta on principle into her organiza on. She wanted to step into the ‘TRIZ’ waters rather cau ously, not wan ng to make it another ‘flavor of the month’.
One of the problems that Belinda’s firm had been facing lately was the long lead- me in manufacturing and heat-trea ng cas ngs; customers had been threatening to take their business elsewhere. Fortunately, she had one of the larger furnaces in the area and had the skill set required to
Page 5 eScope January 2013
that would mean replacing the large oven with smaller ovens! That would be a substan al investment or would it? Belinda put together a team to study this aspect and discovered that the newer smaller ovens were not only not very expensive, but also much more efficient. It also meant breaking the process into two phases. She could pur-chase a couple of these smaller ovens and place them close to where the cas ngs were being made before being sent to the oven for fur-ther heat treatment. It would certainly cut the wait me. However, it would also give her a lot more advantages:
Local control
Size of the ovens could vary depending on the parts it was to be used for
If necessary, the small ovens could be moved to other areas based on demand for certain products
The warm up me for these smaller ovens was much shorter, thus cu ng the cycle me even further
Power consump on of these ovens was much lower than the large (and older) oven
Only the needed oven capacity would have to be pre-heated thus lowering u lity costs further
Belinda did not need to think any further. While this might not have been a game changer in the industry, it was certainly a game changer for her business. Her customers commended her for listen-ing to their concerns and started opera ng as ‘partners in crime’ in-volving them earlier on in the design stage!
She had just begun to understand the TRIZ approach to ‘structured innova on’, and the first principle she’d implemented had led to so much benefit. She wondered what the complete approach would do, especially if she could get the ‘structured innova on’ psyche ingrained into the culture of the company. Belinda understood that culture change takes me and that, as another age-old adage comes into play, she would have to “lead by example.” Perhaps she would en-gage someone to train a few people within her organiza on. Perhaps she would research some more and try to use another principle.
She did not want to rush into it. She wanted it to succeed. She wanted to think whether to take a slow approach or to just commit and dive in; a er all she had drunk the Coolaid and had her first vali-da on of proof of concept, so was convinced.
PS: Some of you might realize that what she did is also a concept to TOC (Theory of Constraints) and that all these concepts come togeth-er, depending on the situa on . . .
What would you suggest?
About Akhilesh Gula :
Principal of Pivot Management Consultants— He has 16 years of experience in team leadership, and coordina on, problem solving, lean manufacturing and kaizen events, process and produc vity improvement. Experienced in a wide
variety of industries: ship building, oil and gas, aerospace, insurance, healthcare, distribu on, hi‐tech and manufactur‐ing. MBA, MS, BS, California Quality Award Examiner, Senior Member ASQ, Past Chair (1993‐1994)ASQ Sec on 0702, Founding member Inland Empire Council for Excellence (S. California). Experienced trainer. Can arrange for ETP funds.
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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: Dieter Eckstein 949-677-2751 or
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 Member) $45.00 for a limited me ($55.00 original price)
RSVP by Friday, November 9 at 2:00 PM for discounted pricing and
Fish and Beef dinner selec ons.
View Event Summary
View Event Agenda
RSVP / REGISTER Monday, January 7, 2013
Clinic # 1 DMAIC Dissected: M ‐ Measure
Presented by: Kathleen Gonzalez We will review the M or Measure phase of the DMAIC pro-cess.
By a ending this clinic presenta on, you will . . .
Know the basic, but key ques ons that need to be ad-
dressed in the M phase.
Know key points regarding the mapping process to estab-
lish failure modes; understand how to define & validate the measurement system; and determining ini al process capability.
Understand the tools in your toolkit used in this phase of
DMAIC
About our speaker: Kathleen Gonzalez Kathleen is an engineer and quality profes-sional for the last twenty five years in mul -ple industries – aerospace, construc on, oil refinery pumps, and plas cs packaging.
She has both a Bachelor’s degree in Me-chanical Engineering and a Master’s of Sci-
ence in Engineering & Produc on Management from Loyola Marymount University. She is cer fied in Team Facilita on, TQM, Concurrent Engineering, and Taguchi methods. She has earned her Six Sigma Black Belt from Flowserve and trained over 500 people in Yellow Belt training. She has been an ISO MR and Lead auditor for the last twelve years. Through ASQ, she has also earned her ASQ-OE/QM and CQE.
Dinner Presenta on Enhanced Roadmap for Lean Six Sigma Project
Selec on and Business Execu on: The Integrated Enterprise Excellence (IEE) System
Presented by Forrest W. Breyfogle III To maximize an organiza on’s compe veness, move-ment needs to be made toward achieving the 3 Rs of busi-ness; i.e., everyone doing the Right things, and doing them Right, at the Right me. The described predic ve organiza-
onal performance measurement and improvement system accomplishes this objec ve through an orchestra on tech-nique that addresses today’s business challenges. This sys-tem provides an integrated methodology where organiza-
ons can “look out its windshield” and, if they don’t like what they see, can make adjustments through targeted improvement efforts that posi vely impact the business as a whole.
By a ending this presenta on, you will be able to…
Describe issues with current process improvement
efforts and how to overcome these shortcomings.
Create predic ve scorecards.
Describe an enhanced system where business metric
improvement needs pull for projects that benefit the business as a whole.
About our speaker: Forrest W. Breyfogle III
Professional Engineer and ASQ Fellow, who received the 2004 Crosby Medal for his book, Implemen ng Six Sigma.
Selected as the Quality Professional of the Year by the Quality Magazine for 2011. Awarded alumni of the year
award in 2012 by Missouri University of Science and Tech-nology.
Authored or co-authored thirteen books. In his recent five-book series, an Integrated Enterprise Excellence business management system is described, which addresses many of the issues of the day. Has wri en over 150 ar cles.
Has been interviewed by several TV (e.g., CNBC Power Lunch), radio, and publica ons.
Awarded best presenta on at Interna onal Lean Six Sigma Conference.
Founded Smarter Solu ons in 1992 a er a 24-year career at IBM. Smarter Solu ons not only conducts training but also facilitates crea on of a no nonsense business management system that effec vely integrates predic ve scorecards with analy cally/innova vely determined strategies, resul ng in defined projects that have a whole-enterprise benefit.
Page 7 eScope January 2013
Clinic # 2 An Example of a Prac cal Applica on of Design of Exper‐
iments (DOE)
Presented by: Bob Mehta and Jay Mehta
Design of Experiments (DOE) is used to drama cally improve product and process innova on, effec veness, and efficiency. DOE is the scien fic ap-proach used by researchers to build empirical mathema cal models of prod-uct and process performance. These models are formulas that are used to op mize product and process performance while significantly reducing costs. DOE is considered the most powerful Six Sigma Tool.
Recent industry trends show there is an increase in the number of con-sumer/pa ent safety related issues due to poor design of product. In order to bring the product to market faster or due to a lack of understanding of design of experiment principles, adequate me is not spent to apply design control methods. Did you know that you are knowingly or unknowingly using design of experiments for a variety of tasks in your everyday life? DOE can consist of preparing a meal from scratch to baking cookies. This presenta on will show the applica on of design of experiment principles to barbequing tender, juicy meats.
The presenta on will outline:
History of design of experiments
Iden fying factors that impact the quality of your finished product
Iden fying levels of your experiment
Conduc ng experimenta on to find an op mal recipe
Having an independent source validate an op mal recipe
Benefits of using design of experiments
About our speakers: Jay Mehta and Bob Mehta
Jay Mehta is a Quality Engineering Technician II and works for Covidien Neurovascular in Irvine. Jay possesses a B.S. in Quality Assurance (BSQA) from Cal State Dominguez Hills. As a part of the BSQA program, Jay completed courses on de-sign of experiments (Quality Systems Failure Analysis), relia-bility, and measurement science. Jay possesses four ASQ cer fica ons including Cer fied Quality Improvement Asso-ciate (CQIA), Cer fied Quality Process Analyst (CQPA), Cer -
fied Quality Inspector (CQI), and Cer fied Quality Technician (CQT). Jay currently serves as Internet Chair for Sec on 701.
Bob Mehta has wri en educa onal ar cles for the Quality and Compliance areas in the eScope and has published ar cles in Medical Device and Manufacturing (MD&M) and Nutraceu cal World. He is a GMP/ISO consultant at GMP ISO Expert Services (www.gmpisoexpert.com) for the pharma, biotech, medical device, and food/dietary supplement indus-tries. Bob has over 22 years of experience in Quality Assurance, Quality Control, Supplier Quality, and Regu-latory Compliance areas. He is an adjunct instructor at Cal State Dominguez Hills, North Orange County Com-
munity College, University of Redlands, and UC Riverside and teaches courses on Risk Management, Project Management, and FDA's Quality Systems.
Bob possesses MSQA, MBA, and B.S. (Chemistry) degrees and 7 ASQ cer fica ons - CSSBB, CQE, CRE, CSQE, CBA, CPGP, and CQA. Bob currently serves as Career Chair for Sec on 701.
Page 8 eScope January 2013
Bolero Associates, a consul ng company focused on increasing produc vity, improving processes, and improving the bo om line for our clients.
QMS ISO 9001, AS9100, and TL 9000 Team Problem Solving and Decision
Making Change Management - Achieve your
vision Innova ve Supply Chain Solu ons Communica on Development
CQI / CQT Exam Prep Course S B : Orange Empire Sec on 0701, ASQ
E D : March 2, 2013 E A D : January 11, 2013
Note: If you intend to take the exam, addi onal registra on is required; Registra on for this class does not automa cally register you for the exam. To register for the exam, go to h p://www.asq.org
L : North Orange County Community College District, 1830 W. Romneya Drive, Anaheim, CA 92801, Room 610 Between the 91 and 5 Fwys on Euclid Ave (go west on Romneya). There is a parking fee: $2.00 per day.
C F : $400 for Members ($200 if Unemployed Member) $550 for non-Members ($50 discount if registered at least 1 week before class)
T : 6:00 p.m. – 9:00 p.m.
S /D : 9 Sessions Jan. 7 to Feb 25, with 3 dates on‐line to be announced. Will cover: Inspec on & Test techniques and Methods, Metrology, Calibra on, GD&T, Basic Sta s cs, Sta‐
s cal Process Control, Capability Analysis, Acceptance Sampling, etc. Also covers strategies/ ps for pre‐paring & taking the exam (One addi onal class TBD)
R B : Quality Council of Indiana CQI or CQT Primer, Latest Edi on with solu ons (Required)
T C : $100.00 for either CQI or CQT Primer/Solu on Text To be purchased by the student directly through the Quality Council of Indiana @ 1‐800‐660‐4215 or at www.qualitycouncil.com prior to the first class I : Milt Krivokuca ([email protected] ) Bob Mehta ([email protected] ) Mark Lindsey ([email protected] )
E : Open through Monday, January 21, 2013
N : Class fees must be paid no later than the 3rd session and no refunds will be made a er the 3rd session. Minimum class size is 8 students. T R (2 O ): 1. To register on-line for the class go to h p://asqorangeempire.org/calendar/ 2. Or, fill out Registra on Form below using your credit card or make check payable to “ASQ Orange Empire Sec on 0701” and mail both to: Attn: Milt Krivokuca, 9 Olympus, Irvine, CA 92603
CQI / CQT Exam Prep Course—Exam Prep Course Mail‐In Registra on Form
(Make addi onal copies of Registra on Form as needed for mailing.)
S N : ______________________________________________________________________________
W P : ____________ H P : _________________ E :____________________________
A : _____________________________________________________________________________________________
If paying by credit Card: Type of Card: Master Card Visa Charge Amount: ______________________________________
Cardholder Phone Number (if different): _______________________________________________________________________
Page 12 eScope January 2013
Cer fied Manager of Quality & Organiza onal Excellence Course & Exam Prep Sponsored By: ASQ Orange Empire Sec on 0701 Exam Date: March 2, 2013 Exam Applica on Deadline: January 16, 2013 EXAM REQ’T: Completed Project(s) required to take cer fica on exam but not required to par cipate in the course to receive an overview & earn 3.6 CEUs/RUs. See www.asq.org for more informa on on exam. Loca on: Alcon Laboratories, located at 15800 Alton Parkway, Irvine, CA. Exit 405 Freeway at Sand Canyon, go right on Alton Parkway ¾ mile to Telemetry; turn right into Alcon parking lot. Turn le to employee entrance parking lot. Use Employee Entrance. Room as signment will be made on the first night.
Course Fee: $400 members plus cost of textbooks $550 for non-Members $350 members if registered 1 week before class. $200 with Proof of Unemployment Time: 6:00 p.m. – 9:00 p.m. Sessions/Dates: 9 sessions total: Mondays from January 7, 2013 to February 25, 2013 1 TBD Will cover: Leadership, Strategy Development & Deployment, Quality Management Tools, Customer Focused Organiza ons, Supplier Performance, Management, & Training/Development. Plus, strate- gies/ ps for preparing & taking the exam. Reference Books: Cer fied Quality Manager of Quality/Organiza onal Excellence Handbook (Required) The Memory Jogger 2 (Recommended - Pocket Guide of Quality & Planning Tools) Text Cost: Students to purchase prior to class. CQM/OE Handbook $99.00 available from ASQ Quality Press at
h p://qualitypress.asq.org Item#H1264 or call 800‐248‐1946. The Memory Jogger 2 $16.95 available from GoalQPC at h p://www.goalqpc.com or call 800‐643‐4316
Instructors: Eliot Dratch (Contact at 949-267-7731or [email protected]) Mark Lindsey (Contact at 714-273-2678 or [email protected]) Bob Mehta (Contact [email protected]) Enrollment: Open through January 28, 2013 Note: Class fees must be paid no later than the 3rd session and no refunds will be made a er the 3rd session. Minimum class size is 8 students. To Register (2 Op ons): 1. To register on‐line for the class go to h p://asqorangeempire.org/calendar/ 2. Or, fill out Registra on Form below using your credit card or make check payable to “ASQ Orange Empire Sec on 0701” and mail both to: A n: Mark Lindsey, 1035 E. Tularosa Ave, Orange CA 92866‐2839 Note: To register for the Exam, go to h p://www.asq.org
Cer fied Manager of Quality & Organiza onal Excellence Course —Exam Prep Course Mail‐In Registra on Form
(Make addi onal copies of Registra on Form as needed for mailing.)
S N : ______________________________________________________________________________
W P : ____________ H P : _________________ E :____________________________
A : _____________________________________________________________________________________________
If paying by credit Card: Type of Card: Master Card Visa Charge Amount: ______________________________________
Cardholder Phone Number (if different): _______________________________________________________________________
Page 13 eScope January 2013
CQA - Biomedical Exam Prep Course S B : Orange Empire Sec on 0701, ASQ E D : March 2, 2013 E A D : January 11, 2013 EXAM REQ’T: Completed Project(s) required to take cer fica on exam but not required to par cipate in the course to receive an overview & earn 3.6 CEUs/RUs. See www.asq.org for more informa on on exam
L : Alcon Laboratories, located at 15800 Alton Parkway, Irvine, CA. Exit 405 Freeway at Sand Canyon, go right on Alton Parkway ¾ mile to Telemetry; turn right into Alcon parking lot. Turn le to employee entrance parking lot. Use Employee Entrance. Room assignment will be made on the first night.
C F : $400 Members ($350 if registered before class) $200 with Proof of Unemployment. $550 for Non members ($500 if registered before class)
T : 6:00 p.m. – 9:00 p.m. 3.3 R.U.s will be given for the course. S /D : 11 sessions total; Wednesdays Jan 2, 2013 to February 27, 2013. 2 Sessions TBD
Will cover: Food, Drug, & Cosme c Act, Quality System Regula on, Medical Device Direc ve, ISO 9000:2000, ISO 13485, Audit Requirements, QSIT, Domes c and Interna onal Standards and Guidelines, Steriliza on, Biocompa bility, Environmental Control, So ware, Laboratory tes ng, etc. Also covers strategies/ ps for preparing & taking the exam
R B : The Biomedical Quality Auditor Handbook, ASQ Quality Press (Order #H1171) Member Price - $66.15; List Price - $ 110.25 The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edi
on (e-Book) Member Price - $57.00; List Price - $ 95.00 Arter, Dennis R., Quality Audits for Improved Performance, 3rd ed., ASQ Quality Press, 2003 (Order
#H1180) (or any quality system audit textbook as reference)
I : Various; Instructors are selected based on their subject-ma er exper se.
E : Open through January 23, 2013 N : Class fees must be paid no later than the 3rd session and no refunds will be granted. T R (2 O ): 1. To register on-line for the class go to h p://asqorangeempire.org/calendar/ 2. Or, fill out Registra on Form below using your credit card or make check payable to “ASQ Orange
Empire Sec on 0701” and mail both to: A n: Katrina Dayman, 15800 Alton Parkway, M.S. 122, Irvine, CA 92618 Note: To register for the Exam, go to h p://www.asq.org
CQA ‐ Biomedical Exam Prep Course—Exam Prep Course Mail‐In Registra on Form
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