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September 2015
eScope The official newsle er of the ASQ Orange Empire Sec on 0701
Upcoming Events September 8, 2015 Monthly Dinner Mee ng
September 23, 2015 Biomedical Division Discussion
October 13, 2015 Monthly Dinner Mee ng
October 30, 2015 Quality Day
Inside this Issue Pg.
Sec on Chair Update 1
2015 Leadership Team 2
New Members 3
Monthly Recer fied Members 3
Educa on Opportuni es 4
Volunteer Opportuni es 5
Quality Day Conference 6
ReVella ons: Process Flow Char ng and Process Mapping
7
Design of Experiments Semi‐nar
10
Improvement Compass: ISO 9001:2015‐ No Documenta on Required?
12
Southern California Quality Conference
13
Monthly Dinner Mee ng 14
Sec on Chair Update
Hello Everyone, Welcome to our September Newsle er I hope you are enjoying the last days of summer. We are very enthusias‐
c about pu ng together a very robust professional educa onal and networking programs and events for you.
Mark your calendars for October 30, 2015, Quality Day! This is our signa‐ture all day event that occurs every other year with many of our sec ons most popular presenters. The list of Quality Day presenters will include: Chris Alexander, Roger Olson, Dave Nagy, Frank Adler, Larry Bartkus,
Akhilesh Gula , Pierre Servan and David Markovitz. Topics will include: Leadership and Team Building, Root Cause Analysis, Equivalency Tes ng (Hypothesis Tes ng), TRIZ (The Theory of Inven ve Problem Solving), ISO 9001/2015, Risk Analysis/ISO 9001/2015, Preparing Wri en Documents that Work, etc. More details will be available soon, so, stay tuned! Are you inter‐ested in volunteering the Quality Day? Please contact our Vice Chair Dieter Eckstein at ASQ0701Vice‐[email protected].
This month, there is another event for you: Free Half Day FDA & FSMA Compliance Work‐shop organized by ASQ Food, Drug and Cosme cs Division at the FDA Conference Room in Irvine on September 24, 2015 from 7:00 am un l 12:00 noon. For more informa on, you can reach out to Rosemarie Christopher at [email protected].
I also want to announce the event "Integra ng Company Acquisi ons", an industry round table discussion by ASQ Biomedical Division that will be held on September 23, 2015, 5.30 pm ‐ 8.30 pm at Alcon Labs Registra on Link: h ps://www.eventbrite.com/e/asq‐scdg‐event‐integra ng‐company‐acquisi ons‐best‐prac ces‐and‐lessons‐learned‐ ckets‐17929110452
ASQ is offering training on Supplier Management and Customer Sa sfac on on September 21‐25, 2015 in Nashville, TN, Louisville KY, & Cincinna , OH, October 5‐9, 2015 in Las Vegas, NV and Phoenix, AZ. If you want to learn ways to improve in both of these topics, resul ng in more effec ve programs and processes, here is the link to register: h p://links.communica ons.asq.org
Lastly, I want to announce that ASQ Sec on 1414 (Aus n, TX) is holding a Quality Conference on Nov 6, 2015. If you are interested in a ending, please visit the following website to regis‐ter: h p://asqaus n.org/2015/07/29/2015‐aus n‐conference‐registra on/
With informa ve clinic programs, as always, we will be welcoming you at the DoubleTree Hotel, Santa Ana on Tues Sep 8, 2015. Great chance to do networking and learning! I am looking forward to seeing you there.
Warm Regards, Anet Tanya Ant, ASQ CQE, CQA Sec on Chair, ASQ Orange Empire 0701
Anet Tanya Ant, CQA, CQE Chair ‐ ASQ Orange Empire Sec on 0701
eScope September 2015
eSCOPE NEWSLETTER EDITOR Mike Chernobieff [email protected]
CAREER MANAGEMENT CHAIR Bob Mehta [email protected]
SOCIAL MEDIA CHAIR Jeffrey Snoddy [email protected]
MEMBERSHIP CHAIR Open Vinay Goyal (Ac ng Chair) [email protected]
AUDITING CHAIR Aaron Reddoch [email protected]
NOMINATING CHAIR Dave Nagy [email protected]
VOC CHAIR Stan Themea [email protected]
SECTION 7 REGIONAL DIRECTOR Ed Ma hews (2014) ed.ma [email protected]
SECTION 7 DEPUTY REGIONAL DIRECTOR Vinay Goyal [email protected]
CHAIR Anet Ant ane [email protected]
VICE CHAIR Dieter Eckstein ASQ0701Vice‐[email protected]
TREASURER Briana Jokerst [email protected]
SECRETARY Laurie Pa on laurie.pa [email protected]
HISTORIAN Hyung Kim [email protected]
EDUCATION CHAIR Mark Lindsey [email protected]
CERTIFICATIONS/ RENEWALS Cory Goral [email protected]
CHIEF PROCTOR Hassan Farah [email protected]
PROGRAMS CHAIR Ned Schneider [email protected]
ARRANGEMENTS Vatsal Patel [email protected]
2015 Leadership Team
Page 2
eScope Ad Rates
Ad Size Approx. 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, and mailed to ASQ, PO Box 14183, Irvine, CA 92614, with ad copy, in‐
structions for placement, and frequency. Contact eSCOPE Editor: Mike Chernobieff @
Email: [email protected]
eScope September 2015
Congratula ons! Re‐Cer fica ons
The following members have met the requirements to be recer fied:
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 your recertification packages to:
Alcon Laboratories A n: Cory Goral, M/C 122, CEE Lab
15800 Alton Parkway, Irvine, CA 92618
For more informa on email [email protected] or
Click here for more informa on Or View our training videos
If you have any ques ons, catch up with Cory Goral at our dinner mee ngs.
Rebecca Waggoner
Paul Carroll
Hamid Tamaddon
Edward Alluis
Elpidio Rafanan
Brian Bui
Welcome! New ASQ Members
Welcome and congratula ons on making the important deci‐sion to become a member of ASQ.
All new members are eligible for free admission to a dinner mee ng within 3 months of becoming a member. Please con‐
tact Vinay Goyal for a free dinner voucher at: [email protected]
Tracy Tieu
Janice Jocom
Flavio Parra
Jane J. Choi
Genaro Ramirez
Mariz Badawy
Dung Pham
Samantha Tran
Stephanie Garrison
Ryan J. Van Woerkom
Charlie J. Eich
Dante J Pestano
Ryan F. Olischefski
Yingbin Zhang
Linda Nguyen
Sarah Cameron
Dongmei Huang
Greg Rawlings
Luong N. Nguyen
Sinisa Petkov
Sharon Hahn
Rogelio Diaz
Shehreen Dheda
Lisa A. Strawn
Jeffrey P. Ryberg
Julie A. Reid
John R. Palomino
Robert James Bergstrand
Carolina Jaime
Nha Trang Bregman
Robert Brendle
Graham O. Cano
Joshua Bedwell
Philip White
Tracy Holmes
Amy Chan
Christopher Daughtry
Jeff Welch
Sedrick Simmons
Andhao Vu
Nancy J. Meade
Angelia Duncan
Mike Shahabi
David Tang
Katie Trzeciak
Nga Nguyen
Page 3
eScope September 2015
Page 4
Educa on Opportuni es Upcoming Refresher Course for December exam
ASQ Six Sigma Green Belt Certi-fication Exam Refresher Course
SESSIONS/DATES 10 sessions; Mondays from September 28, 2015 to No-
vember 30, 2015
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 28, 2015 6:00 PM - 9:00 PM
Pacific Time
Location Alcon Laboratories
15800 Alton Parkway, Irvine, California 92618, USA
CLICK HERE TO REGISTER
Page 5 eScope September 2015
Volunteering Opportuni es We are always looking for volunteers, but have an immediate need for the following posi ons.
For more informa on about any volunteering, please contact Dieter Eckstein @ 949 677‐2751 or email at ASQ0701Vice‐[email protected]
We are always looking for Clinic and Dinner speakers!! Breakfast Meeting Chair
Coordina on of speakers for seminars
Provide reports on cost and sa sfac‐on for each mee ng
Manages the registra on process for seminars
And more (e‐mail for details)
We are always looking for assistance with Dinner meetings, Clinics, and other events!
Inquire within!
Immediate Opening
eScope September 2015
An American Society for Quality Special Event
ASQ Orange Empire Sec on 0701 Quality Day Conference 2015: “ Crea ng & Sus-taining a Culture of Quality in the 21st Century”
Friday, October 30, 2015 (7:00 – 4:30 ) DoubleTree Hotel Santa Ana/Orange County Airport, California
***An Excep onal Day for an Excep onal Value***
Join your colleagues for a full‐day Quality Conference featuring workshops, keynote speak‐
ers, con nental breakfast, and lunch. Get informed from industry experts, network with
your peers, and get up‐to‐speed on the latest developments.
Registra on is only $55 for Sec on members ($65 non‐members) and includes:
Two general session keynote speakers
Three tracks with three 90‐minute workshops in each...9 workshop sessions (see Agenda
for more details)
Meals (con nental breakfast and sit‐down lunch)
Networking with colleagues
Ge ng informed about industry trends
Free ASQ Press books, etc.
Registra on deadline: Wednesday, October 28, 2015
Click here to register
Page 6
Page 7 eScope September 2015
“ReVellations”
Process Flow Charting and Process Mapping
by Jack B. ReVelle, Ph.D.
What is a process? A process is a series of se-quentially oriented, repeatable operations having both a beginning and an end and which results in either a product or a service. A product, of course, is something tangible, something you can see, taste, or touch. A service is something in-tangible, something that you can’t see, taste or touch, but which you know you’ve received. For example, training would be a good example of a service.
Well if that is a process, then what is a system? A system is a collection of processes arranged in a series and/or parallel and which together con-stitute a project, a program or an entire organiza-tion. The American Society for Quality, an or-ganization, is a system composed of many pro-cesses. An initiative such as starting to use new software is a project made up of a variety of pro-cesses. A program may be an on-going activity which is conducted periodically; but in any case whether it is a program, a project or an entire enterprise, it’s a collection of processes.
Having defined for baseline purposes what a process and a system is, let’s review what we can do to better understand these processes, these basic elements or components of an organ-ization. There are a number of different ways we can analyze a process. The most common and one of the most useful forms is a graphic called a process flow chart. A process flow chart is a series of geometric figures usually rectan-gles, circles, triangles or whatever arranged typi-cally from left to right, and from top to bottom, connected by lines with arrowheads to show the flow of activity from the beginning to the end of the process.
When a process is being created or an existing process is being analyzed, it is very useful to create a process flow chart so that everyone involved, that is all of the stakehold-ers in the process, can see exactly what is supposed to hap-pen from beginning to end without having to try to imagine it. Each of us, in our own minds may have a picture, a graphical portrayal of what the process flow looks like, but it may be different and the only way we can be sure we understand we have a common perspective or outlook on the process is by graphing it as a process flow chart, a line-ar or one dimensional process flow chart. I say one dimen-sional to distinguish it from the two dimensional graphic that we are going to talk about shortly called a process map.
Let’s talk about the creation of the process flow chart. Traditionally people have created process flow charts from the first step to the last step. I don’t, and the reason I don’t is because people are looking at processes when they are putting this flow chart together in the same way they look at them every single day. As a result, there is a high poten-tial for missing something. And so what I suggest people do as we bring them together as a process improvement team (PIT) in a room to work together to create a process flow chart is to start with the end in mind. We begin by defining what is the last step or the output of the process and then begin to ask the question sequentially, well “what has to happen just before that?” If we know we have a specific output or step we ask what must be the predeces-sor event or events that must take place to satisfy all the needs so that the step that we are looking at can take place. Thus, we work backwards from the last step to the first step, and keep going until someone says, “that’s where this whole thing begins.” And now we have defined from the end to the beginning of the process, graphed as a process flow chart.
Continued next page
Page 8 eScope September 2015
“ReVellations”
Continued…...
Some people might say well why do you want to do it that way, and the analogy I use is that is very effective is suppose if I were to ask you to recite the alphabet, and in reciting the alphabet you would go A, B, C, D, E, F, G,…without thinking, without any thought what so ever, you would recite the alphabet because you have done it hundreds, perhaps thousands of times, in your life time. But if I were to ask you to recite the alphabet backwards you would probably say Z and have to stop and think what happens before that, what letter precedes Z and what most peo-ple do I have discovered is to do it forwards and to find out what the letter is then come back and say that the letter before Z is this, and the letter before that is this, and so on. We find that in working the alphabet backwards it makes people look at the alphabet in a way that they have nev-er looked at it before, that is the interrelation-ships between the predecessor and the successor events.
The same psychology applies in dealing with our processes whether we are dealing with a process of building a home or dealing with accounts pay-able or whether we are developing a flow chart, understanding a process as it relates to training, or whatever the case may be. Establishing the process flow chart from the last step to the first step is a very strong and powerful way to help people understand what their processes actually look like.
Once the process flow chart has been created and everyone is satisfied, yes this truly reflects the order in which the events take place with regard to predecessor and successor events, the next step is to create a process map. Recall that earli-er I said a process map is created in two dimen-sions. We are going to use exactly the same steps we had in the process flow chart, except now, instead of just having the flow go from left to right we initially start out by saying, who are
the people or what are the positions or what are the depart-ments or the trades or the functions that are involved in the process and we will list them vertically down the left hand side from top to bottom. For example, it might be depart-ment A, B or C; person X, Y, Z, or the trades like concrete, plumbing, framing and the like. And what we do then, is to take the blocks and the rectangles we created in our pro-cess flow chart and associate them with the various func-tional areas or departments, or persons, or trades listed down the left hand side, and so what you see is a series of boxes being built from left to right and also moving up and down the vertical axis we have created on the left hand side of our process map. In so doing we see what could look very much like a saw-tooth effect with blocks going up, down, and across. In doing this, we end up with a view of the hand offs from one person to another, or one func-tion to another, or from one trade to another, so that we can see where queues are being built and the potential for ex-cess work in process is being built up between the various areas of responsibility that we have listed down the left hand side. In so doing, it gives us a very clear, visual pic-ture of some of the things we might want to be consider doing in terms of reordering the various steps to minimize the total number of handoffs that are going to be occurring as a part of this process. Recognizing that every time there is a hand off, there is a very strong potential for an error, an over sight, something left out, a build-up of a queue, the creation of a bottle neck, or the like.
In creating our process map we gain tremendous insights into what we can do to cause continuous improvement in our processes. Remember, the order or the way the steps are arranged may have been absolutely vital at one time, but with changes in technology, changes in people, chang-es in responsibilities, what we are doing today, while it may have been absolutely the right way once, may no longer be valid and we need to periodically assess or re-view our processes. The use of a process map is an excel-lent way to do that.
Continued next page
Page 9 eScope September 2015
“ReVellations”
Continued…...
Now, supplemental to what I have already said, in addition to looking at the process flow chart and process map, in terms of the sequence and the hand offs we can also use the process flow chart and the process map to access cycle time and to assess value added versus non value add-ed events or steps in the process. The technique I like to use is to ask everyone that’s in the room to assess the extent to which the process that was just evaluated using a process map or process flow chart requires. That is, does it take three hours, five days, 10 weeks, whatever it may be. When we achieve agreement there may be some discussion such that we end up saying six to eight hours or six to eight weeks, or whatever the final range may be. Then we go through and evaluate each individual step, how long does this first step take, well how long does this second step take and when we have gone all the way through that we sum up the total of all the indi-vidual steps and compare that to the estimate that the group has already made of the overall pro-cess. What we frequently find is that the sum of the individual steps is only 20 – 30 % of the overall total. That, very quickly presents an im-age of a lot of lost time, wasted time, time that is costly, time that could be used for other im-portant purposes that is being thrown away. If, for example a process is estimated to take six weeks and we sum up the individual components and it takes a week and a half, it’s obvious that we have got some time (read as costs) that we can save the organization. What needs to be done, where are the barriers, the bottle necks in the process that we can study, where can our de-partments or people can share responsibility?
One last aspect of process analysis that we need to go over is “as is” versus “should be.” When we create the first process flow chart or process map of a process as it exists today, we refer to that as the “as is” process, i.e., the status of a
process as it is currently operating; it gives us a baseline to create the new process, the revised process that we call the “should be” process. Then the PIT working together as a group, observes on the wall chart it has created the “as is” process. Having noted the weak points in the “as is” pro-cess, it is at this point they create the “should be” process. The “should be” process is created subsequent to the crea-tion of the “as is” process map. Then the PIT begins to build a bridge from the “as is” to the “should be.” The bridge is supported by a series of steps that is Step 1, 2, 3, 4 and the like that they must go through to change the pro-cess from the way it is “as is” to the way it “should be.”
A good example of that would be the creation of an inter-state or super highway where conventional surface roads exist. During the period of years of effort on the part of the crews, traffic still has to flow and so to move from the “as is” surface streets to the “should be” super highway the designers have to go through a series of steps that includes closing down and opening various components of the roads so as to permit as much as possible the traffic flow that never stops. In using this approach we find that it graph-ically provides us with an image of what we need to do to move from the “as is” process map to the “should be” pro-cess map. These are thing we might have otherwise over looked.
Page 10 eScope September 2015
American Society for Quality
Orange Empire Section 0701
Robust Design of Experiments (Taguchi Methods)
Presented by: Jack B. ReVelle, Ph.D.
Seminar Date & Hours: Saturday, October 17th, 2015 from 9 AM to 4:30 PM
(NOTE: Registration commences at 8:30 AM)
Location: Brandman University 16355 Laguna Canyon Road, Room # 111ABC Irvine, CA 92618 NOTE: Free Parking is available on Campus.
Registration at 8:30 AM. Lunch will be provided.
Cost if Registered by October 10th: ASQ Section 0701 Members $149.00 & All Others $169.00
Cost after October 10th: ASQ Section 0701 Members $169.00 & All Others $189.00
All registrations, even payment by check will be made using the Cvent link or going to http://www.asqorangeempire.org/ and select Calendar to find the event.
Receipts are provided by the electronic registration system to your email address.
1.0 R.U. will be granted for participation.
For more information, contact Nora Abanes Dowell at [email protected]
Page 11 eScope September 2015
Jack B. ReVelle, Ph.D.ReVelle Solutions, LLC
A Consulting StatisticianProviding Training, Advice & Assistance
Integrated Product andProcessDevelopment
Quality Function Deployment
GOAL/QPCASIHybrid
Design of Experiments
TaguchiShaininClassical
The Sevens7-QC7-MP7-SUPP7-CREATE7-MISC7-TEAM7-LSS
Baldrige PE Awards ISO 9001 Lean Six Sigma
State Continuous Strategy PlanningQuality Process and Deployment
Awards Improvement Excellence System
Locally - BasedNationally -
ContractedInternationally -
Available
P.O. Box 10315Santa Ana, CA 92711-0315Phone: (714) 289-1664Cell: (714) 393-7672
E-mail: [email protected]
Fellow : ASQ, IIE, IAEJudge : USA Today Quality Cup
AZ Governor’s Award for QualityAwardsCouncil : CA Governor’s Award for QualityExaminer : Baldrige National Quality Award
aka The Wizard of Odds
eScope September 2015
The Improvement Compass Finding direc on!
ISO 9001:2015 - No Documentation Required?
By Dieter Eckstein, ASQ CMQ/OE, CQA, BSBM
As a quality manager, when I first heard about the new
revision of the ISO 9001 standard did not require
“documented procedures,” I was VERY concerned.
The first thought that came to mind was “Great!! One
more excuse for those managers that don’t see the value
of a documented procedure, even when their life de‐
pends on it!”
Well, it isn’t that bad! We can survive this!
I personally liked it when the ISO 9001 Standard included
that a “documented procedure” was required when in its
absence, nonconformances would likely happen. When
this changed, there were some places where I could not
get the supervisor to write a procedure or instruc on be‐
cause he heard it through the grape‐vine that this re‐
quirement was omi ed in the 2008 revision. It would
have been great if the reasoning why this change hap‐
pened would have been explained on the same grape‐
vine!
In the new 2015 revision, we have some changes in what
is a “document,” how and when it is required.
During the 2015 World Conference on Quality and Im‐
provement (WCQI), I a ended the presenta on “ISO
9001:2015 ‐ Going Beyond Quality” by Mr. John DiMaria.
His presenta on was from an auditor’s perspec ve. In his
presenta on, Mr. DiMaria cited content from the ISO
9001:2015 DIS in one of his slides (figure 1) which summa‐
rizes the new requirements for documenta on.
There is no specific requirement for a quality manual or a
“documented procedure,” as we have been used to in the
past.
However, he explained how this makes sense by making
references of audits where the employees are not familiar
with an applicable procedure and in cases they are not
aware that there was such a procedure. Thus, why have
it? It is NOT necessary!
Typically when a “documented” procedure or work instruc on is
necessary, the document doesn’t just sit in a folder or at docu‐
ment control. They are referenced to achieve consistency, effec‐
veness, efficiency and reliability of a process or product.
Mr. DiMaria suggested that we used our “Lean” thinking and pair
it with the “risk based thinking” to iden fy if a document is need‐
ed. He pointed how the ISO 9001:2015 DIS explains that required
document should be “necessary to support the opera on of pro‐
cesses” to achieve the desired results.
Once again, the ISO 9001:2015 standard is making bold changes.
We had seen the wri ng on the wall from the previous revision,
so we can’t complain at “Who Moved Our Cheese!” We have to
adapt to the risk based thinking and work in the premises of de‐
termining if a process really can be successful without a docu‐
ment governing its requirements.
As the move forward to implement the new 2015 revision, I can
see that we will need to strategize on how these changes can
help us improve our organiza ons.
Less documenta on can make for a lean management system
that focus on what is “important” to have successful processes.
As we deploy our internal audits, we should give it some thought
on how to evaluate what policies, procedures, work instruc ons
are truly needed and which do not add any value.
Mr. DiMaria asked the ques on at a different point in his presen‐
ta on of how many of us determined the ROI of our manage‐
ment systems? The room got very quiet! No‐one raised their
hand. I wondered a er the presenta on how I can find the ROI of
procedures, work instruc ons or other documents? What oppor‐
tuni es do we have to quan fy the benefit of less documents to
govern our management systems? Can we use the Cost of Quali‐
ty Principles to find the ROI and how necessary documents can
be to our organiza ons? How will regulatory bodies that are doc‐
ument heavy allow for these changes? Will they?
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eScope September 2015
Page 13
eScope September 2015
ASQ Orange Empire Monthly Dinner Mee ng
This is a special mee ng program with two clinics running concur‐rently, 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.
PRESENTATIONS
Clinic 1: Global Supplier Quality Assurance Presented by: Phil Johnson
Clinic 2: Upcoming changes to the ISO 14971 Risk Management standard
Presented by: James (Rusty) Lusk
Dinner Presenta on: FDA and Global Regulatory Expecta ons for the Use of Sta s cs in Valida on Processes
Presented by: Marlene García Swider
WHEN Tuesday, Sep 8th, 2015, 5:15 PM ‐ 9:00 PM
WHERE DoubleTree Hotel Santa Ana/Orange County Airport
201 East MacArthur Boulevard, Santa Ana, California 92707
FEES Clinic 1 or Clinic 2 ONLY (no dinner speaker or meal)
(Sec on 0701 or OCRA Member) Complimentary (Non‐Member) $10.00
Clinic 1 or Clinic 2 and Dinner Speaker (no dinner meal) (Sec on 0701 or OCRA member) Complimentary
(Non‐Member) $10.00
Full Package ‐ Clinic 1 or Clinic 2, Dinner, and Dinner Speaker (Sec on 0701 or OCRA Member) $30.00 for a limited me ($40.00
original price) (Non‐Member) $45.00 for a limited me ($55.00 original price)
RSVP by Friday, Sep. 4, 2015 at 11:15 AM for discounted pricing and Fish
and Beef dinner selec ons.
Online registra on closes at 12:00 pm on Tuesday, Sep 8, 2015.
CLICK HERE TO REGISTER
DINNER PRESENTATION
FDA and Global Regulatory Expectations for the Use of Statistics in Validation Processes
Presented by: Marlene García Swider, Ph.D., CQM, LOS‐DO FDA Quality Manager
FDA’s globaliza on has fundamentally altered the economic and security landscape and demands in the way the agency fulfills its mission. Over the next decade, FDA plans to transform from a pre‐dominantly domes cally‐focused agency opera ng in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment. FDA already works to increase transparency and accountability in the supply chain, de‐velop be er enforcement and regulatory tools, encourage greater responsibility by industry, and collabora on with interna onal regu‐latory counterparts. These efforts include valida on of the manufac‐turing processes.
Sta s cs are useful during process design, process qualifica on, and con nual process verifica on. FDA recommends that a sta s cian or person with adequate training in sta s cal process control tech‐niques develop the data collec on plan and sta s cal methods and procedures used in measuring and evalua ng process stability and process capability. Procedures should describe how trending and calcula ons are to be performed and should guard against overreac‐
on to individual events as well as against failure to detect unintend‐ed process variability. Produc on data should be collected to evalu‐ate process stability and capability. The quality unit should review this informa on.
About our speaker: Dr. Marlene Garcia Swider
Dr. Marlene Garcia Swider has served in the FDA for more than 28 years in different ca‐paci es. Most recently, she serves as Quality System Manager for Los Angeles District Office, FDA. She holds a Bachelor in Science, a Masters in Health Service Administra on, and a doctorate in Organiza onal Management. She is also a professional public speaker and published author. Her private presenta ons focus on current FDA policies and medical regulated products. No endorsement by the
Food and Drug Administra on is intended or should be inferred as these are solely based on previous presenta ons, public informa on, and personal literature research He is passionate about the power of human poten al and the extraordinary Synergy that comes from working together toward a shared des ny.
His favorite quote is: “It’s amazing what can be accomplished when nobody cares who gets the credit.”
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eScope September 2015
CLINIC # 1
Global Supplier Quality Assurance
Meeting the demands of the regulators and maintaining quality and fiscal con-
trols Presented by: Phil Johnson
The increase in use of suppliers and contract manufacturers by legal manufacturers requires more diligence and monitoring to ensure a con‐sistent supply of products, where costs are contained within an increas‐ing demand for quality. As more manufacturers outsource at a global level, efficient and regulatory compliant supplier and purchasing con‐trols are essen al.
By a ending this clinic presenta on, you will
Understand the current regulatory environment and observa on trends for supplier management
Iden fy changing regula ons and standards for supplier quality assurance
Consider the importance of taking a risk based approach to selec‐on and monitoring of suppliers and the need for performance
metrics for suppliers and materials/products
Iden fy with your suppliers as strategic partners and not just as commodity suppliers
Be able to op mize resourcing and organiza onal needs for suppli‐er quality assurance
About our speaker: Phil Johnson
Phil is an experienced regulatory and quality based professional who has worked in the Medi‐cal Device, In‐Vitro Diagnos c and Pharmaceu cal Industries for over twenty five years. His core exper se is in quality systems for Medical Devic‐es, IVD’s and Pharmaceu cals. This has included the wri ng, implementa on and maintenance of corporate Quality systems, audi ng of external suppliers and manufacturing/distribu on sites and due diligence audi ng. This involves provid‐
ing strategic regulatory, quality and management consul ng to a range of companies from start‐ups to major corpora ons.
Phil is a Senior Director with Quin les Quality & Compliance Services. As third party service providers they are ac vely engaged in supplier quality programs for both pharmaceu cal and device manufacturers. This in‐volves either managing the supplier audi ng role completely or provid‐ing strategic and audi ng support to corporate audi ng teams. Quin les are able to observe the impact and trends of observa ons made by reg‐ulatory agencies and No fied Bodies for supplier management at manu‐facturer and supplier sites. This informa on is used to provide industry benchmarking and ensuring appropriate resources are applied at manu‐facturers to create sustainable supplier management.
CLINIC # 2
Upcoming changes to the ISO 14971 Risk Management standard
Presented by: James (Rusty) Lusk
ISO 14971:2012 Risk Management standard is here, but is it a change from the 2007 version, and is it even relevant to my busi‐ness?
By a ending this clinic presenta on, the speaker will answer the following ques ons and more:
Is there a difference between ISO 14971:2007 and ISO 14971:2012?
Is there a difference between ISO 14971:2007 and the EN ver‐sion?
If our Risk Management system is based on EN ISO 14971:2007 are we are already opera ng under the 2012 standard?
Which should I need to implement: the ISO or EN 2012 edi on?
Do I need to implement the “2012” edi on when I make chang‐es to my device or design a new product?
If I distribute product only in the US, why do I care about ISO 14971?
About our speaker: James (Rusty) Lusk .
James (Rusty) Lusk has over 35 years of experience in regulated and non‐regulated industries ranging from early‐stage development to Fortune 100 companies. He has held senior man‐agement posi ons in disciplines such as Regulatory, Quality, Clinical Programs, and New Business Development. He is currently a Principal with Quality Sys‐tems Interna onal; a mul discipline consul ng company serving ISO and
FDA/Healthcare regulated industries. He is also co‐founder of LifePulse, LLC, an early‐stage medical device company and co‐inventor of a non‐invasive device intended to delay or reverse cardi‐ovascular disease and improve quality of life.
He is currently an ac ve member of Orange County Regulatory Affairs (OCRA) Discussion Group, a nonprofit organiza on with the mission of educa ng the regulatory professional, having held vari‐ous posi ons to include President.
Educa on:
MBA from Pepperdine University, BS, Biological Sciences from The University of California, Irvine, AA ‐ Electronics from Orange Coast College
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