escope - asq orange empireasqorangeempire.org/wp-content/uploads/2016/09/2016-09-escope.pdf · ent...

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

Upcoming Dinner Mee�ngs

September 12 2016 (NOTE: Monday!!)ASQ Orange Empire and OCRAMonthly Dinner Mee�ng

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

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

Inside this Issue Pg.

Sec�on Chair Update 1

2016 Leadership Team 2

New Members 5

Educa�on Opportuni�es 8-9

Volunteer Opportuni�es 10

Editor’s Announcement:Call for Ar�cles

11

“Synergy "WOW" Factor!”Seminar

12

“Process Valida�on” Seminar

13

“Employing Audits forImproved SupplierPerformance” Ar�cle (Part 1 of 2)

14-15

Monthly Dinner Mee�ng 16-18

Upcoming Conferences 19-21

Monthly Recer�fied Members 6

ASQ is moving to ComputerBased Tes�ng

7

2017 Call for Nomina�ons for ASQ Sec�on 0701

3-4

September 2016

Sec�on Chair Update

Hello Quality Colleagues,

This month, our sec�on was joined by the Orange County Regulatory Affairs (OCRA) group at our dinner mee�ng. The night event was the result of about five months of prepara�ons by a team from both of our organiza�ons. My special gra�tude goes to both teams and Bob Mehta for represen�ng our sec-�on.

This mee�ng had a very interes�ng concept that I thought had very interes�ng prospects. Clinic #1, A Symbio�c Rela�onship between QA and Regulatory Professionals was a discussion group led by a panel of experts in the topic. Thisdiscussion format is a great way of sharing insights on topics such as the one in

this clinic. Sharing experience and knowledge is priceless to those that seek it. This is one of the greatvalues of being an ASQ member in our sec�on. We have some of the best experts in different indus-tries and I encourage you, to be part of this great synergy.

Helping and learning from each other is a win-win!

Coming up in November, we will join our sister sec�ons Los Angeles (0700) and San Gabriel Valley (0702) to bring you the Southern California Quality Conference. Topics that are in the works for thisconference include sta�s�cal tools, problem solving, project management and design of experiments. Another great event for you to benefit from great learning opportuni�es. Look inside this newsle�er for more details and how to register.

Before the year ends, our sec�on’s VOC Chair has an assignment to get informa�on from our members that can help us shape our programs and make sure that we are providing relevant topics to the differ-ent industries our members belong to. Over the last 10 years, there is a significant shi� from Aerospace and Automo�ve to the Bio-Medical industries. Please gather your thoughts and when the surveycomes out, please contribute with your feedback. It would be great if the survey has inputs in a doubledigit percentage that gives us a good representa�on of our sec�on. It would be great if we hear from YOU! I would welcome any feedback that you can give us, at any �me, but his survey has a strategic purpose to bring more value to our members.

Lastly, in our next mee�ng we will once again have opportunity to elect the officers for our sec�on. Dave Nagy would like to hear from you, if you are interested in becoming part of our Leadership Com-mi�ee. I encourage you to become involved and volunteer, even in suppor�ng roles that could give you the opportunity to learn some of the Leadership posi�ons and allow you to see if this is something that you would like to be part of.

See you at our next dinner mee�ng!

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

Dieter Eckstein, BSBM,CMQ/OE, CQA

- ASQ Orange EmpireSection 0701 Chair

eScopeSeptember 2016

SOCIAL MEDIA CHAIRAbel C [email protected]

MEMBERSHIP CHAIRVatsal [email protected]

AUDITING CHAIRThomas M. [email protected]

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]


2017 Call for Nomina�ons for ASQ Sec�on 0701

Please submit names of nominated individuals to Dave Nagy, Nomina�on Chair, at

[email protected] by September 20, 2016.

Sec�on officer nomina�ons from the general membership require the submission of a nomina�on pe��on signed by at least 10 vo�ng Sec�on members* and submi�ed in person, or by email to the addressee listed above no later than midnight on September 20, 2016.

Nominees and signers must be vo�ng members of ASQ.*

Below is a brief descrip�on of each posi�on that is open for nomina�ons. Each of these posi�ons is for a one-year term. Each posi�on is eligible for reelec�on; however, the Chair and Treasurer is limited to a maximum of two consecu�ve one year terms.

Chair

Provides leadership and oversight to the member unit leadership. Prepares mee�ng agendas and is the presiding officer of Sec�on 0701 affairs.

Vice Chair

Performs du�es as directed by Chair in support of the organiza�on’s mission and goals. This posi�on does not ascend to the posi�on of Chair following the end of the first term.

Secretary

Documents business and maintain records. Serves as the official correspondent.

Treasurer

Oversees funds. Maintains accurate financial records. Reports on financial condi�on at �mes directed by the bylaws and policies and procedures.

For more informa�on, please contact Dave Nagy, Nomina�ng Commi�ee Chair, at [email protected] or 714.883.9305.

*Vo�ng members have their membership dues current: Full, Senior, Fellow, and Honorary members, as well as the primary contact from Site, Enterprise, and District and School memberships.


Nomina�on Pe��on Form for ASQ Sec�on 0701

Nominees and signers must be vo�ng members of ASQ.*

Sec�on officer nomina�ons for 2017, from the general membership, shall require the submission of a nomina�on pe��on, signed by at least 10 vo�ng Sec�on members* and submi�ed to Dave Nagy, Nomina�on Chair, at [email protected] by September 20, 2016.

*Vo�ng members have their membership dues current: Full, Senior, Fellow, and Honorary members, as well as the primary contact from Site, Enterprise, and District and School memberships.


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


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

Congratula�ons!Re-Cer�fica�ons

The following members have met therequirements to be recer�fied:

Gregory Woodrow

Matthew Gay

Scott Hay

WHY BECOME CERTIFIED?

In today’s world, where quality competition is a fact of life and the need for a workforce proficient inthe principles and practices of quality control is a central concern of many companies, certification is amark of excellence. It demonstrates that the certified individual has the knowledge to assure quality ofproducts and services. Certification is an investment in your career and in the future of your employer.

Check out the CertificationCourses offered in this

month’s eScope


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.


Certified Quality Engineer - Prep / Refresher Course

(Traditional Classroom & Webinar)

SESSIONS/DATES

14 sessions; Thursdays September 8, 2016 to December 1, 2016. 2 sessions TBD. No class during Thanksgiving week.

Will cover: Management and Leadership in Quality Engineering; Quality Systems Development, Implementation, and

Verification; Planning, Controlling, and Assuring Product and Process Quality; Reliability and Risk Management; Problem

Solving and Quality Improvement; Quantitative Methods; and Exam Tips

When

Thursday, September 8, 2016 6:00 PM - Thursday, December 1, 2016 9:00 PM

Pacific Time

Location

Alcon Laboratories

15800 Alton Parkway

Irvine, California 92618, USA

CLICK HERE TO REGISTER

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



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.

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

Pacific Time

LocationAlcon Laboratories

15800 Alton Parkway



Education OpportunitiesUpcoming Refresher Courses

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

• Breakfast Meeting Chair

• And more (e-mail for details)

Inquire within!


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!!


Synergy "WOW" Factor!Bring The "WOW" Factor! Into Your Business

and Earn Customer Loyalty for Life

Seminar

Presented by: Chris Alexander, Award-Winning Business-Building Strategist and Coach, Best-Selling Author, andProfessional Speaker

Seminar Date & Hours: Saturday, September10th, 2016 from 9:00 AM to 4:30 PM

(NOTE: Registra�on commences at 8:30 AM)

Synergy "WOW" Factor!, Bring The "WOW" Factor! IntoYour Business and Earn Customer Loyalty for Life

Have you ever said: "WOW", I just loved the way theytook care of me! That was easy; I could do business withthem again in a heartbeat?" If so, you have just experi-enced The "WOW" Factor! We have all had experienceswith brands, products, companies and people thatWOWed us. It was not by luck, fate, or by accident thatyou were "WOW"ed– it was a deliberate choice. To WOWyou is the primary purpose of an enlightened business; anenlightened business that thrives on consistent revenueincreases, and lowered costs. In today's turbulent marketplace, WOWing the customer is indeed a strategic com-pe��ve advantage. Now, more than ever we need to take care of our customers, or somebody else will.

Chris Alexander will show you how to bring The "WOW"Factor! into your business and build a community of cus-tomers loyal to your brand.

Audiences will learn:

* How to deliver World-Class customer experiences

* Make the buying experience magical!!

* To give and receive "WOW" experiences

* To build love and loyalty for your brand

* To exceed customer expecta�ons

* To earn respect and apprecia�on

* To build your charisma

Our speaker: Chris Alexander

Bio: Chris Alexander is the founder and president of Synergy Execu-�ve Educa�on, a highly effec�ve change management prac�ce spe-cializing in people centered change. He is an award-winning business-building strategist, professional speaker, and author of 9 business andpersonal development books. So far, Alexander’s largest audience hasbeen his two PBS TV shows, �tled “Crea�ng Extraordinary Joy” and “Joy in the Workplace.” His Synergy Programs have been implement-ed worldwide by many Fortune 500 companies, government agencies,nonprofit organiza�ons, and educa�onal ins�tu�ons. He has ad-vanced degrees in Organiza�onal Behavior and is an expert at building high-performance business teams focused on a shared des�ny.

Loca�on:

Brandman University

16355 Laguna Canyon Road, Room # 111ABCIrvine, CA 92618NOTE: Free Parking is available on Campus.

Walkup Registra�on and class sign-in begins at 8:30 AM September10th, 2016. Lunch will be provided.

Registra�on cost: ASQ Sec�on 0701 Members $225.00 & All Others $275.00

1.0 R.U. will be granted for par�cipa�on.

For more informa�on, contact Vatsal Patel at [email protected]

Early Registra�on:

Note: Please sign up early to ensure available sea�ng!

All registra�ons, even payment by check, will be made using the Cvent link or by going to h�p://www.asqorangeempire.org/ and select Calendar to find the event.

CLICK HERE TO REGISTERReceipts are provided by the electronic registra�on system to your email address.


Process Validation

Seminar

Presented by: Bob Mehta – ASQ Fellow and Co-Author ofthe Book Titled “Prac�cal Process Valida�on” Published by the ASQ Press in July 2016

Seminar Date & Hours: Saturday, October 8th,2016 from 9:00 AM to 4:30 PM

(NOTE: Registra�on commences at 8:30 AM)

FDA’s 21 CFR 820, ISO 13485 / ISO 9001, and other regula-tory bodies have specific requirements for process valida-�on, but o�en manufacturers don't completely under-stand requirements and don't fully implement them. Theconsequences can be audit findings from a No�fied Body or Inspec�onal Observa�ons on an FDA 483. In the past 10 years, Process Valida�on issues ranked within the top six of FDA form 483 findings. Process valida�on is defined as the collec�on and evalua�on of data, from the process design stage throughout produc�on, which establishes scien�fic evidence that a process is capable of consistent-ly delivering quality products. Through interac�ve discus-sion and breakout sessions for case studies, you’ll evalu-ate real-world process valida�on examples warning le�ers, and learn best prac�ces for the prac�cal applica-�on of process valida�on in medical device manufactur-ing.

The seminar will outline:

FDA, ISO, and global regulatory body requirements

Defini�ons

Overview of process valida�on requirements

Policies and procedures

Valida�on prerequisites

Installa�on (IQ), Opera�onal (OQ), and Performance (PQ) Qualifica�ons

Learning from experience

Our speaker: Bob Mehta

Bio: Bob Mehta is the Principal Consultant & Recruiter at GMP ISOExpert Services (www.gmpisoexpert.com) and provides consul�ng service in Pharma, Biotech, Medical Device, API, Food/Dietary Supple-ment, and Aerospace industries. Bob has over 26 years of experience,including as a Principal Consultant, in the Quality Systems, Trainingand Regulatory Compliance areas. Bob is a Fellow of American Socie-ty for Quality (ASQ) elected in November 2014. He haswri�en educa�onal ar�cles in the areas of Quality and Compliance for Medical Device & Manufacturing (MD&M), Pharmaceu�cal Technolo-gy, Quality Progress and Nutraceu�cal World publica�ons. He is anadjunct professor at Cal State Dominguez Hills and Cal Poly Pomonateaches courses on Risk Management, Total Quality Management, SixSigma Black Belt, and FDA's Quality System regula�ons. Bob authored the book “Implemen�ng and Audi�ng ISO/IEC 17025: A Prac�cal Guide” which published by ASQ Press on April 15, 2013 and it is oneof the best-selling books based on informa�on provided by the ASQ Headquarters in October 2014 and the book received 4.7 out of 5stars ra�ng on Amazon.com (based on 9 customer reviews) and a link is included below:

h�p://www.amazon.com/Implemen�ng-ISO-IEC-17025-Prac�cal-ebook/dp/B00C2XQK70

Bob has co-authored a book �tled “Process Valida�on” and the book is published by ASQ Press in July 2016.

h�p://asq.org/quality-press/display-item/index.html?item=H1513

Loca�on:

Brandman University

16355 Laguna Canyon Road, Room # 111ABCIrvine, CA 92618NOTE: Free Parking is available on Campus.

Walkup Registra�on and class sign-in begins at 8:30 AM October8th, 2016. Lunch will be provided.

Registra�on cost: ASQ Sec�on 0701 Members $225.00 & All Others $275.00

1.0 R.U. will be granted for par�cipa�on.

For more informa�on, contact Vatsal Patel at [email protected]

Early Registra�on: Note: Please sign up early to ensure available sea�ng!

All registra�ons, even payment by check, will be made using the Cvent link or by going to h�p://www.asqorangeempire.org/ and select Calendar to find the event.

CLICK HERE TO REGISTERReceipts are provided by the electronic registra�on system to your email address.


Employing Audits for Improved SupplierPerformance

(Part 1 of 2 - to be continued in Oct. eScope ...)

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

According to the FDA, 21 CFR Part820.50 (Purchasing Controls) con-�nues to be a significant concern, with the agency issuing Form 483Observa�ons and Warning Le�ers ci�ng con�nued viola�ons by de-vice manufacturers. As shown inbelow, in 2015, FDA issued a totalof 1,002 Forms 483 (between

10/1/2014 and 9/30/2015) and frequency of “PurchasingControls” element was third highest and a total of 139.Below is a list of top five CFR Reference Numbers from 21 CFR Part 820 and frequencies of the findings.

Not only medical device manufacturers have issues with“supplier controls” element but many of their suppliersdo not meet all requirements included in ISO 9001:2008and ISO 13485:2003 sec�on 7.4 �tled “Purchasing.”

As many of our ASQ Sec�on 0701 members know that my company GMP ISO Expert Services has been providing con-sul�ng services to medical device, drug, dietary supplement clients for the top 5 frequencies listed in the table above. Notonly that but as Process Valida�on is always included in the top seven frequencies, I decided to co-author a book �tled “Prac�cal Process Valida�on” and it is scheduled to be pub-lished by the ASQ Press in June 2016. As we know, suppliersproviding non-conforming material are directly related to anincrease in medical device recalls, which increases the needfor effec�ve quality processes to mi�gate risk. With the FDA's increased vigilance, how can device manufacturers be�er po-si�on themselves to achieve and sustain compliance? The answer lies in the establishment of an effec�ve purchasing control procedure that places significant emphasis on supplier controls and the establishment of a value-added supplier au-dit program.A value-added supplier audit program can help organiza�ons mi�gate business and regulatory risk while reducing the Cost of Poor Quality (COPQ).

When intelligently designed, a value-added supplier audit pro-gram can provide great benefits to a device manufacturer. Establishing a value-added program begins with the under-standing that the program fundamentals expand beyond thephysical performance of supplier audits.

Cite Reference Short Long Descrip�on FrequencyId Number Descrip�on

3130 21 CFR Lack of or inadequate Procedures for correc�ve and preven�ve ac�on have not 377 820.100(a) procedures been [adequately] established. Specifically, ***

14713 21 CFR Lack of or inadequate Procedures for receiving, reviewing, and evalua�ng 294820.198(a) complaint procedures complaints by a formally designated unit have not been

[adequately] established. Specifically, ***

479 21 CFR Purchasing controls, Procedures to ensure that all purchased or otherwise 139 820.50 Lack of or inadequate received product and services conform to specified

procedures [requirements have not been [adequately] established.Specifically, ***

546 21 CFR Lack of or inadequate A process whose results cannot be fully verified by 134 820.75(a) process valida�on subsequent inspec�on and test has not been [adequately]

validated according to established procedures. Specifically, ***

630 21 CFR Lack of Wri�en Wri�en MDR procedures have not been [developed] 129803.17 MDR Procedures [maintained] [implemented]. Specifically, ***

Continued next page ………

Employing Audits for Improved SupplierPerformance

Continued from previous page ……...

21 CFR Part 820 - Subpart E Purchasing Controls

Each manufacturer shall establish and maintain proce-dures to ensure that all purchased or otherwise receivedproduct and services conform to specified requirements.

• (a) Evalua�on of suppliers, contractors, and con-sultants. Each manufacturer shall establish andmaintain the requirements, including quality re-quirements that must be met by suppliers, contrac-tors, and consultants. Each manufacturer shall:

1. Evaluate and select poten�al suppliers, con-tractors, and consultants on the basis oftheir ability to meet specified requirements, including quality requirements. The evalua-�on shall be documented.

2. Define the type and extent of control to be exercised over the product, services, suppli-ers, contractors, and consultants, based onthe evalua�on results.

3. Establish and maintain records of accepta-ble suppliers, contractors, and consultants.

• (b) Purchasing data. Each manufacturer shall es-tablish and maintain data that clearly describe orreference the specified requirements, including quality requirements, for purchased or otherwisereceived product and services. Purchasing docu-ments shall include, where possible, an agreementthat the suppliers, contractors, and consultantsagree to no�fy the manufacturer of changes in the product or service so that manufacturers may de-termine whether the changes may affect the quali-ty of a finished device. Purchasing data shall be approved in accordance with 820.40.

One of the terms employed by the FDA throughout theQSR is "establish." According to the FDA, establish means"define, document (in wri�ng or electronically), and im-plement." In support of establishing an effec�ve value-added supplier audit program for improving supplier per-formance, not only is a�en�on to detail important, but


documen�ng the en�re process in wri�ng an implementa�on should be considered a mission cri�cal task.

Addi�onally, the trend in the agency's issuance of warning le�ers for failure to comply with 820.50 can easily be reversed if device manufacturers establish adequate procedures andcontrols for purchasing and supplier management. Warningle�ers, such as following one issued on February 9, 2012, highlight the need for device manufacturers to establish effec-�ve procedures and actually employ them for assuring the quality of products purchased.

Warning Le�er Excerpt – C. R. Bard 7/13/2015

" Failure to establish and maintain procedures to ensure thatall purchased or otherwise received product and services con-form to specified requirements, as required by 21 CFR 820.50. In par�cular, 21 CFR 820.50(a) requires that each manufactur-er establish and maintain requirements, including quality re-quirements, that must be met by suppliers, contractors, andconsultants.”

Continued in October eScope ………

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]


ASQ Orange Empire and OCRA(Orange County Regulatory Affairs)

Monthly Dinner Meeting

A monthly dinner mee�ng program with two clinics running concurrent-ly, dinner, and an outstanding a�er dinner presenta�on. You have an op�on to pay for event including dinner or a�end a clinic and/or a�er

dinner presenta�on WITHOUT paying for dinner. This way you s�ll earn the RU and take advantage of the presenta�ons.

PRESENTATIONS

Clinic 1: A Symbio�c Rela�onship between QA and Regulatory Professionals - Sharing Insights and Panel Discussion

Presented by:Dinamarie Stefani, Director Quality Assurance at Abbo� Medical Op�cs

Ophelia Biggs, Associate Director Regulatory Affairs at Abbo� Medical

Op�cs

Rosanne Yetemian, Associate Director Regulatory Affairs at Abbo�

Medical Op�cs

Clinic 2: Social Responsibility: A Real and PermanentForce in Business

Presented by: Dick Gould, ASQ Fellow

Dinner Presenta�on: Supply Chain Management –“Challenges and Opportuni�es”

Presented by: James Wabby, Director Regulatory Compliance, Allergan

WHENMonday, September 12th, 2016, 5:15 PM - 9:00 PM

Please note: Dinner mee�ng for September 2016 is on a Monday.

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)

(ASQ Sec�on 0701 and OCRA Member) Complimentary(Non-Member) $10.00

Clinic 1 or Clinic 2 and Dinner Speaker (no dinner meal)(ASQ Sec�on 0701 and OCRA Member) Complimentary

(Non-Member) $10.00

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

original price) (Non- Member) $45.00 for a limited �me ($55.0 original price)

RSVP byThursday, September 8, 2016 for discounted pricing and Fish and Beef dinner

selec�ons.Online registra�on closes at 12:00 pm on Monday, September 12, 2016.


DINNER PRESENTATION

Supply Chain Management –“Challenges and Opportunities”

Presented by: James Wabby

Throughout a product’s lifecycle, there are myriad of challengeswhich arise within supplier management and companies around theworld are discovering a powerful new source of compe��ve ad-vantage. It's called supplier quality management and it encom-passes all of those integrated ac�vi�es that bring product to market and create sa�sfied customers for the long term. This presenta�on will discuss the importance of promo�ng a robust supplier quality management program throughout the product’s lifecycle and whycompanies who have implemented a robust program will have adecreased amount of FDA 483s and/or MOH cita�ons. Open discus-sions and dialogue will be included.

The presenta�on will outline:

♦ Vital Important of Quality Management Systems

♦ Global Regulatory Landscape across various products

♦ Supplier Quality Management Programs: Challengesand Opportuni�es across various products

♦ Purchasing Controls and Regulatory Inspec�ons

Our speaker: James Wabby

James Wabby is the Director of RegulatoryIntelligence and Compliance at Allergan inIrvine, California. He has over 10 years ofexperience in increasing quality complianceand regulatory affairs responsibili�es within the GxP regulated environment pertainingto Nutri�onal, Cosme�c, Branded Pharma-ceu�cal, Generic, Biologic, Medical Device and Combina�on Product areas. He regular-ly provides Allergan therapeu�c franchise units compliance counsel to all aspects with-in the quality management system arena formedical devices and combina�on products regarding acquisi�ons, dives�tures, product

development, regulatory affairs, risk management, audit programs, inspec�on management, clinical trial execu�on, materiovigilance, supplier management, CAPA, produc�on controls as well as con-duc�ng business opera�ons in conformance with applicable health-care related laws and interna�onal regula�ons.

James received his undergraduate and graduate degrees from Du-quesne University and received his Health Care Compliance Cer�fi-cate from Seton Hall University Law School. He is a member of vari-ous regulatory and quality work groups including RAPS, OCRA andthe ASQ Orange Empire Sec�on.


CLINIC # 1

A Symbiotic Relationship between QA andRegulatory Professionals -

Sharing Insights and Panel Discussion

Presented by:

Rosanne Yetemian, Ophelia Biggs, & Dinamarie Stefani

Effec�ve cross-func�onal collabora�on is an essen�al trait of a successful medical device company. In what ways do QA and Reg-ulatory professionals contribute to this essen�al trait? The panel-ists for this clinic will reveal insights in answering this ques�on, and describe methods in how to shi� from a specialist in few aspects of QA or Regulatory to a generalist with broad understandings of thebusiness.

By a�ending this clinic, you will gain:

♦ A prac�cal understanding in how to build on your exis�ng knowledge and exper�se in QA or Regulatory to bring greater value to your organiza�on while growing in your career.

♦ You will also learn how QA and Regulatory professionalswork together to support the development, manufactur-ing, and marke�ng of medical devices.

About our speaker: Rosanne Marie Yetemian, PhD, MSRS, RAC

Rosanne Yetemian, PhD, MSRS,RAC is an Associate Director, Reg-ulatory Affairs, for the Abbo� Vi-sion business. She earned her PhDin Gene�c, Molecular, and Cellular Biology from the University ofSouthern California (USC) KeckSchool of Medicine as well as aMasters in Regulatory Science fromthe USC School of Pharmacy. She isresponsible for overseeing US, EU,

Canadian and interna�onal regulatory approvals and works cross-func�onally to develop innova�ve regulatory strategies for Ab-bo�'s cataract division of medical devices, including both PMA and 510k products. She par�cipates regularly in business development projects and developed a process for regulatory affairs due dili-gence assessments at Abbo�. She also guest lectures on medical device regula�ons and regulatory affairs at USC.

About our speaker: Ophelia Biggs, RAC

Ophelia Biggs, RAC is an Associate Direc-tor of Regulatory Affairs for the Abbo� Vision business. She earned her Bachelorof Science degree in Biology from theAteneo de Manila University (QuezonCity, Philippines). Ophelia provides divi-sion-wide regulatory direc�on to product development by overseeing global(including US and EU) regulatory strate-gies and approvals for Abbo� Vision's Cataract and Consumer Eye Health busi-

ness units. Her por�olio scope includes a wide array of PMA and 510k products (including intraocular lenses or IOLs, phacoemulsifica-�on systems, ophthalmic viscosurgical devices, IOL inser�on sys-tems, and mul�purpose solu�ons). She par�cipates in external working group discussions on ANSI dra� standards for IOLs and in AdvaMed working groups for dra� FDA guidance documents.

About our speaker: Dinamarie Stefani, MBA, ASQ-CBA, RAC

Dinamarie Stefani, MBA, ASQ-CBA, RACis Director, Quality Assurance, and Man-agement Representa�ve for the Abbo� Vision business. She earned her Bachelorof Science degree in Biomedical and Clini-cal Engineering from California StateUniversity, Long Beach as well as an MBAfrom Webster University. She is in theprocess of comple�ng her Masters of Science in Jurisprudence with an empha-sis in Pharmaceu�cal and Medical Device

Law and Compliance from Seton Hall University Law School. Herexperience spans across 20+ years in the pharmaceu�cal and medi-cal device global space including roles in R&D-preclinical and clinical,IT, and QA-compliance and opera�ons. As a servant leader, she par�cipates regularly in STEM-related events to foster excitementand encouragement of our youth and young adults to pursue STEM-based academics and careers.

This month is our special meeting combinedwith Orange County Regulatory Affairs

(OCRA) group. Like our regular monthlydinner meeting program, this months programhas two clinics running concurrently, a dinner,and an outstanding after dinner presentation.


CLINIC # 2

Social Responsibility: A Real andPermanent Force in Business

Presented by: Dick Gould, ASQ Fellow

All industries are now, or will be affected by disciplines of Social Responsibility, as defined in ISO 26000, Guidelines for Social Re-sponsibility. How does this relate to the role of QA/RA profession-als in their organiza�ons?

Dick has been involved with ASQ’s Social Responsibility (SR) ini�a-�ve from its earliest days. He has been a champion of communi-ca�ng SR concepts to quality professionals across all industry disci-plines, and has contributed SR content to ASQ’s Body ofKnowledge (BOK). He has been instrumental in bringing SR frombeing a mere topic of conversa�on among quality folks to a formal-ly recognized technical community of professionals within ASQ.

By a�ending this clinic presenta�on, you will learn:

♦ An informa�ve introduc�on to Social Responsibility and its core subjects and principles.

♦ The rela�onship of quality professionals to Social Respon-sibility in any business or industry sector.

About our speaker: Richard A. (Dick) Gould

Richard (Dick) Gould provides training invarious aspects of supply chain manage-ment. Prior to re�rement from corporate life, Dick served organiza�ons that pro-duced surgical instruments, sterile disposa-ble medical products, medical devices andimplants; defense contract radar and ord-nance systems; magne�c recording media; electronic components, and data storagemedia and devices.

Dick is a Fellow of the American Society for Quality (ASQ), a pastmember of the Society’s Board of Directors, a charter member andpast chair of the Customer-Supplier Division, and past chair of Or-ange Empire Sec�on 0701. He holds ASQ cer�fica�ons as Manager of Quality/Organiza�onal/Excellence, Quality Engineer, and Quality Auditor. He has degrees in industrial management from North-eastern University and liberal arts from Vanguard University ofSouthern California.

Dick is an ASQ Learning Offerings instructor of the courses Intro-duc�on to Supplier Management; Audi�ng for Improved Supplier Performance and Handling Supplier Non-conformances.

* 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!


Upcoming Conferences

To register, log into:

h�ps://www.eventbrite.com/

• Search by SCQC• For Conference select #SCQC2016 and• For Workshop select #PRESCQC2016

If you have any questions, please contact: Vinay Goyal at [email protected]

To register, log into:

h�ps://www.eventbrite.com/

• Search by SCQC• For Conference select #SCQC2016 and• For Workshop select #PRESCQC2016

If you have any questions, please contact: Vinay Goyal at [email protected]


Upcoming Conferences

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