Our February Membership meeting features our annual FDA Update
To accommodate a larger group, our meeting is at:
401 Half Day Road, Buffalo Grove.
Pre-Meeting Presentation 5:30 – 6:00 pm
Dinner, Networking 6:00-7:00 pm
Main Presentation 7:00 – 8:00 pm
Reserve your spot by filling on Eventbrite by clicking here.
Click this link to access Peter Berg’s slide deck: Deploying 5S In A 3D World_15Feb18
DEPLOYING 5S IN A 3D WORLD by Pete Berg, Adello Biologics Process Improvement Leader:
Pete Berg will share with us how he’s bringing the 5S discipline into Adello Biologics. He’ll cover challenges, immediate and long term benefits, best practices and some watch-outs. He’ll also talk through some interesting change management scenarios as well as FDA (PAI) implications.
Peter (Pete) Berg attended the US Air Force Academy and served as a U.S. Air Force officer for 9 years. HIs core expertise is process improvement, change management, and leadership coaching. He’s a GE-certified Lean Six Sigma Black Belt, Master Black Belt and Oliver Wyman change management consultant. His 25-year career has placed him throughout the U.S., Mexico, Europe and Asia-Pacific. Petehas worked in the following fields: military, telecommunications, financial services, manufacturing, energy and bio-pharma where he led teams as large as 1,000 +, project portfolios in excess of $40M, and has facilitated 51 Kaizen events. Pete’s most successful projects valued in excess of $10M.
Pete’s passions: faith, family, weight-lifting and servant leadership. He’s proud to be married to wife, Connie, for 25 years, and of his sons Danny & Joey, 19 and 17, respectively.
Click this link to access Bill Weissinger’s slide deck: ORA Aligns for the Future 50 State Call
PROGRAM ALIGNMENT by FDA Chicago District Director, Bill Weissinger
Program Alignment is part of a larger plan to apply a risk-based strategy to site inspections, by matching specialists in the areas inspected to the industry inspected. As many of you may know, with the influx of imports, the administrative burden on the FDA for performing inspections is increasing at an exponential rate. Program Alignment will ensure that inspections are conducted efficiently and that time, which might be wasted with an inspector gaining familiarity with a particular technology, can be eliminated.
Bill will review the new organizational structure that enables Program Alignment, and discuss how the changes affect the regulators and regulatees alike. There will be time for Q&A too. Come with your questions, so you will know how to be successful during your next FDA inspection! If you are not from an FDA-regulated industry, the session will be a living example of how an organization’s structure can help facilitate better results.
Mr. William (Bill) Weissinger is the district director of the U.S. Food and Drug Administration’s Chicago office and also director of the Human and Animal Food 6 East (HAF 6E) program. The FDA Chicago District office coordinates FDA civil regulatory actions in the State of Illinois including inspections, investigations, recall audits and complaint handling. HAF6E oversees civil regulatory actions for all human and animal food for the states of Illinois, Indiana, and Michigan. Prior to his current role, Mr. Weissinger served as deputy district director where he assisted with day-to-day management of all district operations, both crisis-oriented and routine. He supervised the district’s emergency response functions, quality management, and facilitated district integration with state and local health departments via partnership and contracts. He joined FDA as an investigator in 2003. Prior to FDA, he was a Quality Control Manager for Vandervoort’s Dairy in Ft. Worth, TX. He received his master of science from the University of Georgia where he specialized in food microbiology, and a bachelor of science in biology from Purdue University.
Click here for Kam Gupta’s presentation: 2018FluidLeadershipASQ1212
The January membership meeting is at Dover Straits, 890 East US Route 45, Mundelein.
5:30 – 6:00 pmDinner
6:00-7:00 pm: Networking
7:00 – 8:00 pm : Main Presentation
Reserve your spot using the Eventbrite link here.
Pre-Dinner Speaker, “Win-Win Negotiations”:
Spanning a career at the intersection of business and technology, Bruce has experienced and explored innovation, strategy, and leadership purposefully and variously. Hhe understands first-hand the business need for and benefits of innovation and strategy, as well as how to effectively implement both. He followed his passion by conducting groundbreaking research on the strategic practice of breakthrough Innovation across a wide cross-section of mature companies and industries.
Bruce is co-author of Serial Innovators: How Individuals Create and Deliver Breakthrough Innovations in Mature Firms (Palo Alto: Stanford University Press, 2012) as well as five book chapters and numerous publications on innovation. During his earlier technical career, he contributed to the first demonstration of the quantum well laser – now found in essentially all CD and DVD players – and explored the potential of advanced technology for defense applications. He serves on the Board of Directors of Midtronics, Inc. and the Advisory Board of JVA Partners, periodically consults on the topic of innovation for Procter & Gamble, and regularly presents to, leads workshops for, and advises various other companies.
Prior to joining Illinois BIS Bruce served as Associate Dean and Adjunct Professor in the top-ranked College of Engineering at the University of Illinois at Urbana‐Champaign. Earlier in his career he was Director of Advanced Technology for Motorola’s non-semiconductor components business, held research and corporate development positions of increasing responsibility at Amoco Corporation, and was on the research staff at MIT Lincoln Laboratory.
Bruce holds BS (with Highest Honors), MS and PhD degrees in Electrical Engineering from the University of Illinois at Urbana-Champaign and an MBA, with concentrations in finance and marketing, from the University of Chicago’s Booth School of Business.
Post-Dinner Speaker, “Fluid Leadership”
Make 2018 YOUR year.
We are in a new year, a new kind of national leadership, a new kind of economy and a new kind of mindset about work and life. The nature of conversations has changed. This is a fluid environment, thanks to the fast pace of changing technology and innovative applications of it; which only seems to accelerate with time.
As a quality professional, come explore your potential to lead and live your life the way you want, both at work and at home. Discover ways to realize your dreams and goals for 2018 and beyond, and the resources and enablers that will propel you towards what you want.
Fluid leadership is a powerful new concept that allows you to be fluid like water and still maintain your values and character that define you. Included in the presentation are other emerging leadership thoughts with focus on balance, creativity, and innovation.
This is an interactive presentation that will enable you to take home some points to ponder, some interesting work to follow up, and some tools to create the life you want, with follow up support.
Kam Gupta is an executive coach, quality professional, and management consultant. He speaks extensively on personal and professional leadership related topics, integrating coaching into management and quality consulting for greater effectiveness and sustainability of outcomes.
Kam is Education chair for the northeastern section of ASQ (ASQ1212.com). He has been an active member leader of ASQ national, regional, and local chapters. Kam is certified coach and past president of International Coach Federation (ICF), Chicago. He has represented ASQ in Mexico, Brazil and other countries furthering the understanding of quality leadership.
Kam holds MS (EM) from MSOE, Milwaukee. He has worked/ consulted with many companies, such as Eaton Corporation, Harley Davidson, Abbott, Inuit, and others.Kam Gupta”Planning for Quality in the New Year” Kam Gupta will lead a mini-coaching session with participants during the Main Presentation. Kam will surprise and entertain you with a lively exercise that will make you think.
From the cozy comfort of your home!
Just Imagine: You can do all this…… without leaving town!
- Attend an Online CQE Prep course and prepare for the exam
- No need to travel to another city for multiple weeks
- No need to lose time from work
- No need to lose family time
Brought to you by: ASQ Section 1302
Class dates: February 5 – April 2, 2018
(Class Registration Deadline: January 28, 2018)
CQE Computer-Based Testing Dates: April 6 – 22, 2018
(Exam Registration Deadline: March 9, 2018)
Computer-based exam testing dates: June 1 – 17, 2018
(Exam Registration Deadline: May 4th, 2018)
Here are the ways you can $Save$:
- No Travel expense (flight, drive, gas, depreciation & maintenance)!
- No Lodging and hotel bills
- No Food and incidentals due to travel
- Low Tuition: Tuition for this 8-week online class is only $500! Compare to nearly $700+ price tag for the National ASQ prep-course, which is self-study and does not include instructor and group interaction. (Note: The $500 tuition does not include Primer and recommended course material. See registration site for details).
What to Expect
- Weekly readings from the primer, handbook, test samples, and articles pertinent to CQE exam
- Weekly homework modeled after CQE exam
- Weekly Discussion Board: Communicate & interact with your instructor and your classmates
- Videos that reinforce learning course concepts and the CQE body of knowledge
- Opportunity to simulate the exam: A sample version (approximately 5.5 hours) of a mock exam will be available so you can practice taking the test under timed setting.
- You must order and pay for the required Primer and other required course resources. Links and approximate cost are available at the website (shown below) . Allow 5-7 days for delivery.
- Recertification Units (RU) = 2.0 upon successful completion of course. Signed certificate will be emailed.
- Weekly Google Hangouts with instructor: optional video conferencing to ask any questions you may have.
(Hangouts allows conversations between two or more users. In 2016 Google upgraded Hangouts to 25 concurrent users in HD video for Work/Education.)
Don’t lose out on this great opportunity!
Class registration deadline: Sunday, January 28, 2018
Register for class here! http://www.asq-1302.org/education-and-training/cqe-test-prep/
Once registered, you will be directed to another page to make a credit-card payment.
Meet Your Course Instructor
Mr. Robert Anderson-Ludrick is an adjunct professor at Bellevue University, in Bellevue, Nebraska. He teaches Statistics, Business Modeling, and Quality Management in the business school. He is President of Project Deep, Inc., a non-profit corporation specializing in educating and sponsoring students for experiential internships. Robert is retired from corporate business where he served in numerous management, industrial engineering, quality, and continuous improvement positions over a 45 year career. He is a senior member of ASQ, and has participated in workshops for writing the ASQ Black Belt and Master Black Belt exams. Robert currently serves as the Chairman of the local 1302 chapter and is a member of the Omaha Lean Consortium. Robert graduated from the United States Military Academy at West Point, served in the US Army, and has an MSIE degree from Texas Tech University.
Robert holds the following certifications:
ASQ Certified MBB, CSSBB, CQE, CQM/OE, CA, Lean Sensei.
I started my career as plant metallurgist in the metal casting industry. Just as many other quality professionals, my quality journey actually commenced with reviewing non-conforming products, process variations and variables, and customer complaints. To some degree, it is a bit ironic that many of us began quality journeys with task that involve“lack of quality”. I have to be honest here; I did not know much about quality when I started. In time, I started to learn acronyms such as PFD, FMEA, CP, PPAP, C&E, RCA, CAPA, PDCA, COQ, TOC, and on and on.
A few years ago, I was sitting in one of the quality training classes offered by American Foundry Society. One of the teachers was Ted Schorn, who was VP of Quality and Technology at a large manufacturing firm in Indiana. I was amazed not only by the content of the class but also by Ted’s knowledge on quality history, quality gurus, quality philosophies, and quality anecdotes. So inspired by him, during a class break, I asked Ted for career advice in quality arena. Ted replied, “You should start with the Certified Quality Engineer Handbook and try to get the CQE certification.” A year later, I received my certification. The preparation for the certification helped me put together the “puzzle pieces” of my quality skills and knowledge. Ever since, I have been blessed with opportunities to lead quality initiatives, manage Quality Management Systems, and now head a quality department consisting of ten quality professionals. To this day, I still find new meanings to the classic quality tools, concepts, and philosophies. Looking back, my quality journey can be distilled into the following:
- Base quality on data or fact-driven decisions
- Rely on a structured process
- Involve the team
- Cultivate a quality culture
Let me try to elaborate. The first a few years of my career taught me the importance of making informed decisions based on data / fact. Later on, the CQE journey enlightened me about a structured process and prepared me for developing, implementing, and maintaining such a process. However, it was not until the very recent years did I realize that it is not quite enough just being respectful of data and having a structured process. One has to recognize that systems needs to be maintained and continuously improved upon by the team, who are collectively responsible and committed to a common goal for which they hold themselves accountable. For any quality system to be effective in a long run, the quality leader must actively involve the whole team, by which I mean everyone from production floor to middle management all the way to the very top. Since each team member has his or her own priorities, the leader must make sure the quality message is simple, clear, and right to the point. The message needs to be communicated by all means (e.g., via process controls, audits, trainings, meetings, emails, etc.) to all interested parties (e.g., the suppliers, internal teams, the customers, etc.) on regular basis until it becomes the quality culture, or part of the DNA of the company.
So far, it has been a great journey for me.
Naiyu earned his PhD in Materials Science and Engineering from University of Alabama at Birmingham. He started his career as a Metallurgist, then served as a Supplier Quality Manager, and currently is a Director of Quality in the manufacturing industry. He has been a CQE from ASQ since June 2015. He is a Senior Member of ASQ. In his spare time, Naiyu enjoys playing soccer with friends, reading, and traveling.
The Illiana Section will join the Statistics Division for a Free Webinar: Introduction to ANOVA – January 16, 2018 at 7:00PM CST
Analysis of Variance, or ANOVA, is a fundamental tool in Statistics and Quality. It plays a critical role in analyzing data from designed experiments and forms the foundation of gauge R&R studies. This presentation focuses on the basics. The one-way ANOVA table is introduced, and a graphical interpretation of its components is provided. The situation is then complicated by adding a second factor leading to the two-way ANOVA table. Hypothesis tests for the importance of each factor are explained in terms of comparing the predictive ability of two models. Interactions are discussed.
NIST Standard Reference Materials will form the context of the discussion, to which ANOVA models naturally apply. However, the data presented in the examples will be simulated for pedagogical purposes. The session will be planned to last 30 to 40 min to leave time for questions. Software for performing the requisite calculations will not be covered.
Adam Pintar is a Mathematical Statistician at the National Institute of Standards and Technology (NIST), where he has worked since 2010 and focuses on applying statistical models and tools to scientific and engineering problems. His education history includes degrees in Mathematics from Pittsburg State University in Kansas and Statistics from Iowa State University. He is a member of the American Statistical Association and a senior member of the American Society for Quality.
Please reserve your seat by end of business day on Monday, January 15th, 2018 at the following link: Reserve your webinar seat now.
From the NEI Section, ASQ 1212, we wish you a very Happy New Year. We are positive that 2018 is going to be a staller year for you personally and professionally. We are planning to do our part. On the Educational front, we plan to explore bringing several learning opportunities for various certification exams as well as personal growth.
Plan: To start the year, we plan to offer Certified Quality Auditor (CQA) certification review course and Certified Manager of Quality and Organizational Excellence (CMQ/OE) review course in the first quarter of 2018.
The exam windows and the deadline to apply for the two exams are as follows.
- CQA Exam Window: April 6 through April 22, 2018 (Computer based testing or CBT). The last date to apply is March 09, 2018. To learn more about the process and Body of Knowledge and eligibility, please visit: https://asq.org/cert/quality-auditor
- CMQ/OE Exam Window: May 4 through May 20, 2018 (CBT). The last date to apply is April 6, 2018. To learn more about the process and Body of Knowledge and eligibility, please visit: https://asq.org/cert/manager-of-quality
Please let Kam know if you want to take any of the above courses, by meeting once a week during late Jan through March 2018,
Register by January 12, 2018 via email: email@example.com
Venue: We are looking at the right venues to teach these courses. If your company is willing to offer its conference room, or training room in the afternoon to evening hours, once or twice a week, please let me know at your earliest. That will help our members in keeping their training financially relevant.
Future: We will also plan to offer other courses as the year moves on. Some of the courses may include Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE), Six sigma related and others based on what our members want. (A survey will follow in February) See complete list of ASQ certifications: https://asq.org/cert/catalog
First Annual Virtual Conference
Thursday, April 19, 2018: 8:30AM-12:00noon ET
CALL FOR PAPERS
Conference Theme: Aspire to Inspire, Influence, and Engage Others by Improving Your Personal Skills Toolbox
Soft skills are increasingly becoming the hard skills of today’s professional workforce. It’s just not enough to be highly trained in technical skills, without developing the softer, interpersonal, and relationship-building skills that help people to communicate and collaborate more effectively.
These people skills are more critical than ever as organizations struggle to find meaningful ways to remain competitive and increase productivity. Teamwork, leadership, and communication are underpinned by soft skills development. Since each is an essential element for organizational and personal success, developing these skills is very important and does matter… a lot!
Join us online in April 2018 as we offer our first virtual conference. Our theme, Aspire to Inspire, Influence, and Engage Others by Improving Your Personal Skills Toolbox, is an effort to help highlight the need for soft skills development among Quality and other professionals. Our goal is to provide conference participants with a jam-packed morning of useful knowledge and plenty of takeaways that can be readily applied in any work setting. Continue reading
“There they go again…*another* certification/award/achievement/promotion/degree/etc.!” Sound familiar? Does this sentiment (of envy?) resonate with you whenever a peer or former (or even current) colleague makes good in some way?
It doesn’t have to be that way—it can actually be YOU, too—if you are deliberate enough to make it so.
Several years ago, when our daughters were young grade-schoolers, I dedicated myself to growing my communication and leadership skills with a membership in Toastmasters. I never regretted it for a moment. I met some of the most interesting people, many of whom I still keep in contact with today. How did that happen? I decided to make the time, instead of making excuses. With a commitment of about one or two hours a week, I carefully planned my Toastmasters goals. I had a “five year plan”, and I completed it a few months early, even. I earned the Distinguished Toastmasters certification, the highest achievement a Toastmaster can earn. Without those seemingly small investments of time each week, I would not have reached my goal of communication and leadership excellence.
Earning an ASQ Certification, the CSQE designation (Certified Software Quality Engineer), stood as another goal I set for myself. I studied well for the CSQE certification exam, or so I thought—and then, to my surprise, I was one of the 50% of people who fail that (very difficult) exam on the first try. But that temporary setback didn’t discourage me. In fact, it only spurred me on to try again. I kept on dedicating a few hours each week to my goal—pass that exam. I literally quadrupled my efforts. I managed to find not one, not two, but four question banks. I not only took practice exams by area of knowledge, I also took practice exams that lasted four hours—the timeduration of the actual CSQE exam. I also read, re-read, and studied cover to cover (much more closely this time!) Linda Westfall’s Certified Software Quality Engineer Handbook.
So what’s the big deal about these stories? Why should you care?
They are achievements born from an often underestimated and overlooked personality trait: Persistence. Without persistence (and a healthy “can-do” attitude), goals remain just that: Goals. Goals Never Met. Think of something you really hope to achieve: Whether you aspire to be a More Excellent friend, spouse, parent, grandparent, or even a better leader or colleague, or if you are working on a professional certification, advanced degree, or your undergrad degree, it’s all the same: If you are persistent enough to make the time for it, odds are that you can achieve it.
The next time you think about what Excellence means to you, remember that we all get the same number of minutes and hours in each day. It is what you choose to do with your time (and what you choose to do with time that might be spent unwisely) that makes all the difference.
There’s no need to wait until January 1, either. It’s time to book some regular “quality time” with Your Goals. They are calling you to achieve them!
is a technical writer in healthcare and technology with 17+ years of experience. Her passions include networking, process improvement, technical writing, and regulatory compliance. By night, Gina blogs, speaks, teaches, volunteers and helps others find their voice, tools, and resources to pursue their life’s dreams. She enjoys frisbee golf, travel, foreign films, reading, and spending time with her family and their two dogs and one cat. She is thrilled to be a part of the ASQ community. Ms. Kotz can be reached at LinkedIn: www.linkedin.com/in/ginakotz or firstname.lastname@example.org.