May 2016 Professional Development Meeting

Features

The next Professional Development meeting will be held on

Thursday, May 26, 2016.

Please REGISTER to confirm your attendance.

PD Presentation:  

The Two Big D’s: Data Analysis and Data Integrity

By Danny Aguilar

Data integrity has been a hot topic recently and has gained wide attention due to increased regulatory issues. This presentation emphasizes the importance of Data Integrity. It also explores the relevance of Data Analysis in the context of enhancing processes and quality system. Moreover, good documentation practices will also be covered.


Tutorial Topic:

Conducting a Robust Failure Investigation

By Danny Aguilar

This presentation focuses on methods and techniques to conduct robust and effective failure investigation. Additionally, a case study will be explored to gain a practical application of this tool and technique.


Danny Aguilar Bio:

As the Principal Consultant of Quality Eagle Consulting, Danny Aguilar brings over 15 years of experience and expertise in the areas of process improvement, quality auditing, compliance, quality engineering, six sigma, project management, etc. in the biological, pharmaceutical, biopharmaceutical, medical devices and automotive industries.

Academically, Mr. Aguilar holds the following degrees:

• BS Chemical Engineering – Saint Louis University, Baguio City Philippines
• MS Management Engineering – University of Bridgeport, Bridgeport, CT
• Master in Business Administration – University of Tampa, Tampa, FL

Additionally, Danny is a Senior Member of ASQ. He is an ASQ Certified Quality Engineer, ASQ Certified Quality Auditor and Johnson and Johnson Process Excellence Six Sigma Black Belt. His work experience includes working for Johnson and Johnson, Bausch and Lomb and Sanofi. In his spare time, Danny enjoys volunteering and film making.


PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).  PD Presentations are normally given between 5:30 and 6:30 PM: 45 minutes for the presentation and about 15 Minutes of Q&A at the end.

Interested in giving a presentation or tutorial at one of our future PD meetings?  Contact the ASQ Dallas Chair (asqdallaschair at gmail dot com).

ASQ Section 1402 Sponsored Online Video Classes

Features

The Dallas section 1402 is proud to announce the online class schedule for Fall, Winter and Spring.  These are on-line live video certification prep classes for your professional development at special ASQ Dallas discount rates.  Benefits are:

  • Expand your choices for certification prep.
  • No traveling to classrooms.
  • Participate from your desktop, laptop, or tablet.
  • Competitive rates.

Click here for more class schedule and registration information.

April 2016 Professional Development Meeting

The next Professional Development meeting will be held on

Thursday, April 28, 2016.

Please REGISTER to confirm your attendance.

PD Presentation:  

ISO 9001:2015 Revision – the “Highlights Reel”

By Mary McDonald

This presentation highlights the changes for the ISO 9001:2015 standard, including what the major changes are, and how you can prepare your organization for transition.

Mary covers the shift from Top Management to Leadership; the impact of Context on future audits and implementation; Risk-Based Thinking, internal communication, as well as the transition schedule.

She’ll also bring her real-world experiences to bear as a consultant helping organizations to transition smoothly, and as a registrar auditor assessing organizations ready to transition.


BIO: Mary McDonald is a seasoned Quality/Environmental/Health and Safety professional MaryMcDonald2016with over 30 years’ experience in implementing Management Systems around the world.  Her BS in Environmental Engineering and MS in Industrial Administration ensures that she can work form the factory floor to the C-suite with equal ease.  Her involvement in the US Technical Advisory Groups for both ISO 9001 and ISO 14001 since 1995 ensures that she is not only aware of WHAT the changes are, but WHY those changes were made. In addition to implementing ISO systems, Mary is a certified Lean and Kaizen facilitator and consultant, and is holds certifications in OHSAS 18001, RoHS, and industry-specific standards including TL 9000, AS 9100, and ISO/TS 16949.

She gives back to our profession through regular speaking engagements to ASQ sections and conferences, volunteering as a MBNQA Examiner (3 times) and writing articles for inclusion in industry publications.

Her husband and grown children live in Austin; Mary lives in various hotels, with occasional wardrobe swaps in Austin.

Tutorial Topic:

TBD

By Mary McDonald


PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).  PD Presentations are normally given between 5:30 and 6:30 PM: 45 minutes for the presentation and about 15 Minutes of Q&A at the end.

Interested in giving a presentation or tutorial at one of our future PD meetings?  Contact the ASQ Dallas Chair (asqdallaschair at gmail dot com).

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.

March 2016 Professional Development Meeting

The next Professional Development meeting will be held on

Thursday, March 24, 2016.

Please REGISTER to confirm your attendance.

PD Presentation:  

A Story of the Quest for Quality and the Malcolm Baldrige Award

By Roy Dale Crownover

Dale is President & CEO of Texas Nameplate Company (TNC) in Dallas, Tx.  He has received multiple awards and recognition for his visionary leadership of his company as well as the DaleCrownoverquality community in general.

Dale’s father, Roy Crownover, founded TNC in 1946. Dale has worked for this family-owned business since 1960. He started by sweeping floors, then working in the production areas, and assuming duties as President and CEO in 1989 at age 37. Dale’s father and mentor, passed away in 2008, leaving Dale with sole ownership of TNC.

Small Business Leadership Services and Current Responsibilities

“Dale” Crownover has held the positions of President and CEO of Texas Nameplate Company, Inc. (TNC) for 26 years. TNC is a 40-person, family-owned business located in Dallas, Texas that manufactures nameplates attached to products and equipment to educate and protect the safety of users. TNC serves a large and diversified customer base.

Dale’s visionary leadership for TNC has resulted in TNC and Dale receiving the following awards, recognitions and designations:

Service in State and National Professional Associations

  • 1990 -1995 President, South Ellis County Water Supply Corporation, Italy, Texas http://www.nonprofitfacts.com/TX/South-Ellis-County-Water-Supply-Corp.html
  • 1993-1994, Board of Examiners, Texas Award for Performance Excellence. http://quality-texas.org/
  • 1996-1998, Board of Overseer, Quality Texas Foundation
  • 1997-1999, Chairman of the Board, The Quality Texas Foundation
  • 2000-2001, Board of Examiners, Malcolm Baldrige National Quality Foundation
  • 2001-2004, Member, Board of Directors, Malcolm Baldrige National Quality Foundation http://www.baldrigepe.org/foundation/
  • 2001-2003, Panel of Judges, Malcolm Baldrige National Quality Award
  • 2003-2004, National Treasurer, American Society for Quality
  • 2004-2007, Chairman, Board of Director, Quality Texas Foundation
  • 2004-2007, Chairman, Board of Directors, Malcolm Baldrige National Quality Foundation
  • 2008-2010, Chairman, Board of Directors, Quality Texas Foundation
  • 2014-Present, Vice Chairman, Board of Director, Quality Texas Foundation. http://quality-texas.org/

Presentations and Publications

Education

  • 1997, BS in Business Management, LeTourneau University, at age 45

Tutorial Topic:

TBD


PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).  PD Presentations are normally given between 5:30 and 6:30 PM: 45 minutes for the presentation and about 15 Minutes of Q&A at the end.

Interested in giving a presentation or tutorial at one of our future PD meetings?  Contact the ASQ Dallas Chair (asqdallaschair at gmail dot com).

February 2016 Professional Development Meeting

The next Professional Development meeting will be held on

Thursday, February 25.

Please REGISTER to confirm your attendance.

PD Presentation:  

Process Quality and Security in Healthcare using Programmerless Programming,  an Evolution in Advanced Artificial Intelligence Technology

By Sam Chaffin, Unityware Chief Operating Officer and
Brian Stack, Unityware Sr. Scientist

Is modern software the enemy of quality and profit?

It may shock you to learn how much it would return to your bottom line by just
helping your people work together.

Dr. Deming said, “If we focus on the process, the result takes care of itself.”
What’s wrong with our approach to all our software today? Is one of the
problems that we always start with the result we want to achieve?
February 25, we want to talk about the process. With Unityware, our process
starts with:

Do you believe we can program a robot to do work? YES!

Then you can believe we can teach the computer to program AND DO THE
WORK.

unityware1

Unityware performs the work of software and is fast to implement – or change.

Sam Chaffin BIO

Sam, a registered professional engineer with BS Chemical Engineering and MS Industrial Engineering was recognized as an outstanding alumnus by College of Engineering, University of Arkansas in 2008. He has persistently solved challenges with his 48 years of experience in providing solutions for companies from Baxter Healthcare and Kimberly Clark to Wal-Mart. Mr Chaffin is known to solve the logistical problems that keep you awake at night.

Bryan Stack BIO.

Bryan Stack created system generating technologies, including one capable of generating itself. Patented under his name, the technology is an innovative mechanism for creating software and user documentation in under 2% of the time it would take the fastest technologies available. The patents are granted and recognized in countries around the globe. Stack  has built companies from the ground up including one he took public and another that was venture funded after securing industry luminaries as clients.

Tutorial Topic:

Introduction to ASQ Certification Process

By John Jennings

ASTCert0

ASQ certification (like the examples shown above) is a formal recognition by ASQ that an individual has demonstrated a proficiency within, and comprehension of, a specific body of knowledge. Nearly 180,000 certifications have been issued to dedicated professionals worldwide.

For many, the certification process remains something of a mystery. Frequently asked questions come up about how the exams are created, how they are scored, and how best to prepare for taking a test. This discussion will address these issues and more for those wanting to get one of the many certifications ASQ offers.

Invest in your career and your future with an ASQ certification. Gain an advantage over your competition and increase your potential for a higher salary.

John W. Jennings III BIO

John left the US Air Force in 1970, after serving four years.  Thereafter, John gained thirty-five years of experience in manufacturing as a Quality Technician, QA Engineer, Reliability Engineer, QMS Auditor, QA Manager, Quality System Manager and Director of Performance Excellence.  He continued his formal education part time and graduated from UTD (University Of Texas at Dallas) with a BSEE in Telecommunications (1992) and a MS in Engineering Sciences from UTD in Electronic Manufacturing (1996).

John taught Applied TQM (Total Quality Management) and SPC (Statistical Process Control) for Richland College’s Continuing Education classes for 2 years until they discontinued the program. He has taught refresher classes for the Dallas/Ft. Worth ASQ Section for CMQ/OE, CQT, CQIA, CQI, and CQE.

John is the Quality Assurance Manager for Bowhead Manufacturing, a part of UIC Government Services Division and the Bowhead Family of Companies, part of the Ukpeaġvik Iñupiat Corporation, an Alaska Native Corporation.

John has served as a senior examiner for the Texas Award for Performance Excellence, a member of the Board of Governors for Quality Texas and as a member of the board of examiners for Malcolm Baldridge National Quality Award. He is an ASQ Fellow and currently holds ASQ certifications as CQE, CRE, CSQE, CQA, CBA, CMI, CQT, CMQ/OE, CSSGB, and CSSBB. He is an Exemplar Global Certified QMS Lead Auditor and is certified by NARTE (The National Association of Radio and Telecommunications Engineers, Inc.) as an ESDC (ESD Control) Engineer.

PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).

January 2016 Professional Development Meeting

The next Professional Development meeting will be held on

Thursday, January 28, 2016

Please REGISTER to confirm your attendance.

PD Presentation:  

Emotional Intelligence – Part 1

By Elizabeth Lions

intelligenceEmotional intelligence is the ability to monitor one’s own and other people’s emotions to discriminate between different emotions and label them appropriately, and to use emotional information to guide thinking and behavior. According to Inc. Magazine, the higher the ranking title (such as CEO) the lower the emotional intelligence. Over time lack of emotional intelligence impacts behavior as well as promotions. If you are serious about climbing the career ladder, emotional intelligence is a must.

Join us for the first of a  two part series where Elizabeth will explain what emotional intelligence is, why it’s important and how to develop the skill. This course is beneficial in work situations or in your personal life.

 

Elizabeth Lions BIO

Elizabeth grew up in central New Jersey, about an hour from New York City. She studied psychology at the University of Maine. She is the Author of two books, ‘Recession Proof Elizabeth LionsYourself’ and “I Quit! Working for You Isn’t Working For Me”. Elizabeth is currently crafting her third book on leadership.

Elizabeth’s coaching practice is broken into two key areas: career management and leadership.

Elizabeth’s credentials are impressive. They include being quoted in U.S. World News Report, AOL Jobs, Australian Finance, Silicon India, CBS Money Watch, Yahoo, The Ladders, and Dice job boards. Her words have reached as far as the front page of the Philadelphia Tribune, PBS, CBS Money Watch, Dale Carnegie and John Tesh’s blog.

In 2013, her radio show for women entitled, “Leadership Lessons from the Lioness”, was created through Plaid For Women, along with her articles. A year later, she brought her leadership classes to Dubai.

Elizabeth’s client list includes executives from Fiserv, AT&T, Microsoft, Wells Fargo, eBay and Intel to name a few.

Today, Elizabeth can be found writing, coaching and collaborating with the who’s who of the Corporate America, as well as abroad. When she isn’t working, Elizabeth can be found traveling across state lines with her husband on their Harley Davidson motorcycle or in the yoga studio twisting for hours on end. To contact Elizabeth, please visit www.elizabethlions.com

 


Tutorial Topic:

Establishing the FaCS – SIG

By Sharon McNair

Often times the basic quality processes are deemed tedious and overlooked. It is these very steps that allow us to maintain and create a quality product or service.  Many who perform those task on a daily basis do not see the value in their work thus provide less than quality service.

Quality Management is faced with finding ways to create an environment in which employees feel engaged, connected to the success of the company.  The basic quality tools are pertinent to the success of a business and yet most employees do not see their value.  In creating FaCS -SIG we hope to create an environment where persons in the Food, Cosmetics and Supplement industries may learn ways to improve processes that exist and their significance.

Sharon McNair BIO

Sharon is a Quality Manager with Mannatech, Inc. In this role, Sharon oversee the quality systems providing all aspects of quality management, including auditing, and training.  Before joining Mannatech in 2003, Sharon worked for 5+ years for a diverse range of organizations, including Colgate Oral Pharmaceuticals, Idexx Veterinary Services and Argus Analytical Inc.

Sharon’s varied background in Dietary Supplements, Oral Pharmaceuticals and environmental industries provided the perfect foundation for quality management.  With more than 17years experience in the various industries, Sharon now focuses mainly on continuous improvement and cGMP compliance.

Sharon is an ASQ Certified Quality Auditor.  She is pursuing her Master’s degree in Quality Management at California State University Dominquez Hills, and received her Bachelor of Arts degree in Chemistry from Mississippi State University.

 

 

 

PD MEETING NOTE:

Normally, Professional Development (PD) meetings are always the fourth Thursday of every month.  There are no meetings in June, July, August (summer break) and December (after Thanksgiving).