Risk and Regulatory Compliance – 2018 Midwest FDC Conference

Risk and Regulatory Compliance

Don’t miss the 2018 Midwest FDC Conference

October 3, 2018 at Wojcik Conference Center – Harper College

Palatine, Illinois

Regulatory authorities have embraced science-based risk management.  As the supply chain becomes more complex, risk awareness and quality aspects in general become more important.
All countries involved in regulated industries should have quality processes for sourcing of materials, manufacturing, packaging, testing, storage, and distribution.  These quality processes provide rationale to understand risk, as well as to mitigate it through appropriate and robust controls.

Members:  $100  Non-Members:  $120

UTD – ASQ LSS Student Section Event

UTD – ASQ Student Event was held on Thursday 6th September 2018.

The event was held at UTD with 27 students in attendance. The event involved presentation about ASQs expectation from its Student Sections. A Q&A session followed.

Representing ASQ Dallas the following were in attendance:

  • Joe Sepulveda (Vice Chair – Nominations)
  • John Jennings (Vice Chair – Mentoring)
  • Bob Shelton (Lean Six-Sigma SIG – Chair)


Cowtown Quality Roundup 2018


Registration is Open



Add to Calendar


Friday, April 20, 2018

8:00 am – 5:00 pm


Radisson Hotel

Fort Worth North – Fossil Creek



Cost: $127 – a Great Value!

Includes: Continental Breakfast, Buffet Lunch, Afternoon Break


Memory Jogger, Door Prizes, CA$H Lotteries

Sorry… no early bird or multi-person discounts are available.

We give equivalent back in the 2-3 Lotteries valued $50 to $250


Immediate payment by credit card is the default…

for alternative payment methods contact jbreckline@att.net


For more details in including program choices, see or download flyer below…



ASQ BioMedical Division and FDA Medical Device Industry Coalition – Big Event – April 15, Dallas, TX

Big Event 2016 – Final Meeting Agenda Posting

Quality System Survival: Success Strategies for Production & Process Control,   and CAPA

Date and Time: April 15, 2016 from 8 a.m. to 5 p.m.

Location: Courtyard Dallas DFW Airport North/Grapevine, 2200 Bass Pro Court, Grapevine, TX 76051 USA.  Telephone (817) 251-9095

Every two years FMDIC, with the participation of ASQ Biomedical Division, hosts the “Big Event”, an educational forum for members of the medical device industry to gain more knowledge on how to best implement quality system practices in their organization to ensure product quality and safety, while meeting the requirements of the FDA regulations.  This year’s event focuses on Production and Process Control combined with CAPA, which remain key warning letter citations for many firms.  This event is an all-day seminar which will feature speakers from FDA, academia and industry giving their thoughts on how to best manage these processes in a manufacturing organization.

Because there is a limited capacity for this event, we recommend advanced registration. Click on the link below to register online and reserve your seat.  Be sure to contact the Marriott Courtyard Dallas – DFW Airport North Hotel to reserve your guest room, if needed, under the FMDIC, Inc. room block to receive a reduced rate as well. 

Registration Fee: Industry $300, Government with ID $200, and Student registration with ID $50. To register online, please visit https://www.123signup.com/register?id=pnrxz. As an alternative, send registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to FMDIC, Inc., to FMDIC Registrar, 4447 North Central Expressway, Suite 110, PMB 197 Dallas, TX 75205.

If you need special accommodations due to a disability, please contact Staci McAllister at least 7 days in advance at Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, email: Staci.McAllister@fda.hhs.gov.

FMDIC is a non-profit coalition, composed of key employees of the FDA offices in Dallas, officials from the Texas Department of Health, academic members as well as individuals from professional and trade associations representing the medical device industry, including ASQ and the ASQ Biomedical Division.  FMDIC was formed to promote communication, education and cooperation between the regulators and the regulated industry.

November 2014 Professional Development Meeting

The November 2014 PD meeting will be held on Thursday the 20th.  Please REGISTER to let us know you will be in attendance.

Forrest Breyfogle, CEO of Smarter Solutions, Inc. (smartersolutions.com) will give both the PD dinner and the tutorial presentation.

Tutorial Topic: Creating Predictive Performance Reports using a Minitab Add-in


Most scorecard or process performance metrics provide a historical or lagging view of key performance indicator (KPI) measurements and/or process responses.  A more desirable statement for reporting reflects what would be expected in the future, if nothing were to change within the process.  With a futuristic understanding for all metrics throughout an organization, one could determine which measurements should be given improvement effort focus so that the enterprise as a whole benefits from this utilization of resources.

Described is a 30,000-foot-level form of reporting, which provides a leading-indicator report format.  A Minitab add-in will be used during the session to facilitate this predictive-performance form of report creation.  This Minitab add-in will be freely available to all attendees after the session.

Dinner Topic: Enhancing Quality’s Role by Resolving Common Executive Management                            Issues


Quality practitioners and organizations benefit when they demonstrate to executive management the benefits that they provide to the big picture.  One way of helping leadership is through addressing issues that are most important to them.

This presentation will describe how those in the Quality profession can help executives address the following challenges, which they often experience:

  1. Executive management receives a monthly 60+ slide PowerPoint deck or a huge excel file, which nets out the status of the organization’s performance metrics. This report, which took much preparation resource, has outdated information, can be difficult to interpret, and does not present information in an actionable format. Data are only historic and not presented in a timely fashion with prediction statements. Management would benefit if it had  reporting that it could access at any point in time  in order to have a high-level view to successfully “thin slice” its decision making process.
  2. Quarterly executive management reviews (EMR) are lengthy and questionable in value.  EMRs consume much resource for both executives and presenters.  Presentations could highlight the status of corrective and preventative actions (CAPAs), but an alignment with business performance metrics is often lacking.
  3. Resources are wasted in fighting fires, and the benefits of process improvement efforts seem questionable. Issues of the day that are supposedly resolved only reoccur.  Also, 100 million dollars in savings may have been reported from process improvement efforts, but nobody can find the money.
  4. Our organization is operating in silos where little regard is given to the big picture.  Performance goals are set by function; however, what is right for one function might not be the best for another function and/or the business as a whole.

 About Forrest Breyfogle

Forrest Breyfogle is CEO of Smarter Solutions, Inc. (smartersolutions.com), which he founded in 1992 after a 24 year career with IBM. He is a Professional Engineer and ASQ Fellow. He received the 2004 ASQ Crosby Medal for his book, Implementing Six Sigma and in 2011 was selected Quality Professional of the Year by the Quality Magazine. In 2012, he was awarded alumni of the year by Missouri University of Science and Technology and received the Leadership Award at the 2013 Lean & Six Sigma World Conference.

He has authored or co-authored 14 books on business management and Lean Six Sigma process improvement methodologies, which have integration with Business Process Management (BPM).

In his 2008 published 4-book series, an Integrated Enterprise Excellence (IEE) system is described that goes Beyond Lean Six Sigma and the Balanced Scorecard. His 2010 published book, Lean Six Sigma Project Execution Guide, provides a detailed step-by-step roadmap, which integrates Lean and Six Sigma tools applications for efficient and effective improvement project completion. His books are primary body of knowledge reference for the America Society for Quality (ASQ) Black Belt certification test.

He has spoken as a keynote and given many presentations at conferences throughout the world. He has been interviewed by several TV, radio, and publications about the application of Six Sigma. Among those that interviewed him include CNNfn & CNBC Power Lunch.

Smarter Solutions not only conducts training but also facilitates creation of the IEE enhanced business management system with BPM. This system effectively integrates predictive scorecards with analytically/innovatively determined strategies, resulting in defined projects and improvement opportunities that have a whole-enterprise benefit.


October 2014 Professional Development Meeting

The October 2014 PD meeting will be held on Thursday the 23rd.  Please REGISTER to confirm your attendance.

Ms. Maura Schreier-Fleming, President of Best@Selling at Dallas will give the PD presentation while Mr. David Heinzelmann of Eclipse Electronic Systems is the PD Tutorial speaker and will give the tutorial presentation .

Tutorial Topic:  Turtle Diagrams – Not Just An Auditing Tool


An auditing tool used by ISO and other auditors  – what is it, what is it used for, how to construct one, and other uses for Turtle Diagrams.

About David Heinzelmann

For the past two and a half years David Heinzelmann works as a Quality Systems Engineer at Eclipse Electronic Systems responsible for ISO 9001 Registration and quality improvement activities.  Prior to Eclipse David was a member of Microsoft’s Commercial Technical Support organization as a Quality Process Analyst and completed a celebrated 33 year career with Motorola.   David has a B.S. degree in Electrical Engineering from Valparaiso University, an MBA in Engineering and Technical Management from the University of Dallas, is a Motorola Certified Six Sigma Black Belt, and has completed ISO Lead Auditor Training.  While at Motorola, David gained a very broad experience in the area of product design, manufacturing, software test, and quality.  David launched a very successful business at Motorola offering Cellular Telephone Base Station – Handset interoperability testing.  While at Motorola he started an organization leading to the first use of software reliability modeling using system test results.   David is the holder of three patents and is the author of the booklet “Reliability and Maintainability Analysis of Redundant and Non-Redundant Systems.”   David also taught Applied Business Statistics as a part time professor at Texas Christian University.

David is passionate about quality and will use that passion to drive quality improvement in CTS through the CTSQ program.  David has a three part philosophy about quality.   First, quality is defined by the customer or end user of a product or service and not by the provider.  Quality must be driven by the Voice of the Customer (VoC).  Second, quality cannot be an afterthought it must be developed into the product, process, or service from day one.  Third, Quality is everyone’s responsibility.

David is originally from the northern suburbs of Chicago and is married with two daughters.  During is down time David enjoys playing golf, amateur photography, music (plays alto saxophone), keeping up with technology, cooking, and reading (Tom Clancy is my favorite author).

Dinner Meeting Topic:  Create Your Own Luck for Business and Quality Success


 Do you think only your talent and skill contributes to your success in business? Talent and skill are certainly important; however, there’s another tool you need to succeed in business. Your success can also be determined because of luck.  The luck Maura will be speaking about is the ability to create your own good fortune. This program will show you what you can do if you want increase your luck as a tool and improve your success as a quality professional

About Ms Maura Schreier-Fleming

Maura Schreier-Fleming, a Dallas-based sales and business consultant, is the President of Best@Selling (www.Bestatselling.com.) Maura works with business and sales professionals to sell more and be more productive at work.  Her presentations and consulting focus on the skills and strategies that immediately produce results in business today.  

She is the author of two books: Real-World Selling for Out-of-this-World Results and Monday Morning Sales Tips.  She is a contributing author to the 2012 National Speakers Associations book: Speak More!: Marketing Strategies to Get More Speaking Business and You Can Have It All:  Just Not All At Once!.  She is a sales expert blogger for Allbusiness.com.  An engineer by training, she has appeared on numerous radio shows from coast to coast to discuss selling and business.  She is a regular guest columnist on sales with the Dallas, Austin and Houston Business Journals.

 Maura founded her company in 1997.  Her clients include Fortune 500 companies from diverse industries including Fujitsu, UPS, Capital One Bank, Ebby Halliday Realtors, Thomas Lighting, JC Penney, Houston Texans, Fina and Oronite Chemicals. Maura speaks at trade association conferences across the country including Society of Government Meeting Professionals, SITE, PCMA, and many others.  

 She has been a sales professional for over 30 years. She began her career as a sales engineer for Mobil Oil, and became Mobil’s first female Lubrication Engineer in the U.S. She sold industrial lubricants for applications used in such diverse industries as steel mills and nuclear power plants.  After moving to Texas, she worked for Chevron where she was recognized as one of the top five salespeople in the country.  She produced over $9 million in sales with $2 million in profit her final year at Chevron.

 A member of the National Speakers Association (NSA) while also active in IEEE (Institute of Electrical and Electronics Engineers), Maura received her M.S. from Georgia Tech in Textile Engineering and a B.S. from Cornell University in Textile Chemistry.

September 2014 Professional Development Meeting

The September 2014 PD meeting will be held on Thursday the 25th.  Please REGISTER to confirm your attendance.

Ms. Amy Gow is the Spark 101 Coordinator at Perot Museum of Nature and Science and will give the PD Dinner Meeting presentation while Mr. Peter Wright, CEO of Alternate Systems is the PD Tutorial speaker and will give the tutorial presentation.

Tutorial :

About Mr. Peter Wright:

Peter Wright is the CEO of Alternate Systems, a calibration and research lab specializing in material analysis, coating measurement, temperature and electronics, and is a member of the board of The St. Luke’s Foundation. His work is internationally peer-reviewed in X-ray fluorescence measurement and he has led research and development projects at Sandia National Laboratories and Los Alamos National Laboratory. He is currently working on developing leaders both inside and outside his organization.

Mr. Wright has completed Leader’s Roundtable at Bell Leadership Institute in Chapel Hill, North Carolina, and continues participation in the Roundtable alumni program. He has also completed programs in technical professionals and organizations at the Sloan School of Business at MIT, in start-ups at Babson College, and in financial management at SMU. Mr. Wright’s undergraduate work was at The University of North Carolina at Chapel Hill.

Dinner Meeting Topic:  Sparking Future Scientists


The Perot Museum of Nature and Science strives to be an extraordinary resource and catalyst for science learning through highly innovative and accessible experiences.  We want to inspire all students from cradle to career through active and hands-on learning.  The Perot Museum is focusing on professional development for STEM (Science, Technology, Engineering and Math) teachers to prepare and inspire the future scientists and community leaders of tomorrow.  Amy will talk about the STEM needs in North Texas and how education, business and non-profits can work together to bridge the STEM gap.  She will give an overview of the exhibits, programs and ways to engage.

The Perot Museum of Nature and Science is Dallas’ newest museum in Victory Park, near downtown Dallas.  Bursting with interactive exhibits that appeal to all ages, educational experiences around every corner give the Museum the opportunity to live our mission of inspiring minds through nature and science.  Our roots date back to 1936, with the opening of the Dallas Museum of Natural History in historic Fair Park, which would later merge with the Science Place and the Dallas Children’s Museum in 2006 to create the Museum of Nature and Science.  The Museum of Nature & Science in Fair Park which houses our historic wildlife dioramas and active paleontology lab will remain a part of the Perot Museum, giving visitors the chance to see not only our new Museum in Victory Park but also our historic Museum in Fair Park.

About Ms Amy Gow

Amy Gow has a passion for education, especially in relation to STEM equity.  As the Spark 101 Coordinator at the Perot Museum of Nature and Science, she is excited to be a part of an innovative program that will engage, connect and inspire all students for success in college and career pathways.  She brings with her experience as the Program Director for Design Connect Create!  Physics Camp for Young Women, and as a National Alliance for Partnerships in Equity (NAPE) STEM Consultant.  Amy has a BS in Electrical Engineering from Rice University.  She began her career as a Hardware Design Engineer with E-Systems (now Raytheon) and later went into sales and marketing with Texas Instruments as a Field Application Engineer.  She is a past President of the Hockaday Parents’ Association and former Trustee of The Hockaday School.  She is a member of the Advisory Boards for the Hillcrest Academy of Engineering and the Rice Engineering Alumni – DFW.