On-line CMQ/OE Exam Prepreparation



ASQ Certified CMQ/OE Exam
Online Class

Manager of Quality & Operational Excellence

– Presented by ASQ Section 1302 –

Instructor: Mr. Rick Pennington, CMQ/OE, CQE

 

Class dates: March 20 – May 7, 2017

(Class Enrollment Deadline: March 12, 2017)

CMQ-OE exam dates: May 5 – 21, 2017

(Exam Registration Deadline: April 7, 2017)

From the cozy comfort of your home!

Just Imagine: You can do all this…… without leaving town!

  • Attend an Online CMQ/OE 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

 

Here are the ways you can $Save$ BIG:

  1. Travel expense (flight, drive, gas, depreciation & maintenance)!
  2. Lodging and hotel bills
  3. Food and incidentals due to travel
  4. Tuition and registration: This 7-week online class will cost you only $400! Compare to $600+ price tag if you take the National ASQ prep-course which is self-study and does not include instructor and group interaction. (Note: price does not include Primer and recommended course material).

 

What to Expect

  1. Pre-exam to evaluate current knowledge of CMQ/OE BoK.
  2. Weekly readings from the primer and articles pertinent to CMQ/OE exam
  3. Weekly homework Modeled after CMQ/OE exam
  4. Weekly open-ended Questions as homework to prepare for the closed-book portion of CMQ/OE exam.
  5. Weekly Discussion Board: Communicate & interact with your instructor and your classmates
  6. Videos that reinforce learning course concepts and the CMQ/OE body of knowledge
  7. Opportunity to simulate the exam: A mini version (approximately 2.5 hours) of a mock exam will be available so you can practice taking the test under timed setting.
  8. You must order and pay for the required Primer (and other optional course resources). Links and approximate cost are available at the website. Allow 5-7 days for delivery.
  9. Recertification Units (RU) = 2.0 after successful completion of course. Signed certificate will be emailed.

 

Don’t lose out on this great opportunity!

Enroll in this class TODAY


The last day to enroll for class is:  Monday, March 12

 

Enroll here!                                         http://www.asq-1302.org/education-and-training/

 

Once enrolled, you will be directed to another page where you can make a credit-card payment.

Membership Meeting: March 16, 2017

4:00 – 5:00 Factory Tour – Plexus, 2400 Milbrook Dr., Buffalo Grove, IL

5:00 – 5:30 Dinner and Networking; Training Room, Plexus

5:30 – 6:30 Post- Dinner Presentation: Electronic Finished device manufacturing, Robin Dunham

Note: Please come 15 minutes before the event begins to sign in. Everyone needs to get a security badge prior to the factory tour.

For this ASQ NEI Section 1212 Event only, the ticket price is $14 through Eventbrite and $17 at the door.

If you wish to attend the meeting  and forego dinner, please sign up for the ticket titled “ASQ Section 1212 September Meeting WithoutDinner.” Dinner is free to unemployed members. If you wish to attend the meeting and are unemployed please sign up for the Event titled “ASQ Section 1212 September Meeting Courtesy Dinner.” Please be prepared to provide your personal membership number at the door.

Plant Tour:

Plexus Corp. (Plexus) and its subsidiaries are engaged in the electronic manufacturing services (EMS) industry. The Company delivers end-to-end solutions for customers in the Americas (AMER), Europe, Middle East, and Africa (EMEA) and Asia-Pacific (APAC) regions. The Company’s segments are AMER, APAC and EMEA. The Company’s customer-focused solutions model integrates product conceptualization, design, commercialization, manufacturing, fulfillment and sustaining solutions. The Company delivers solutions to its customers through its product realization value stream. The Company provides customer services to about 140 branded product companies in the healthcare/life sciences, industrial/commercial, networking/communications and defense/security/aerospace market sectors.

The Company’s product design includes various solutions, such as program management; feasibility studies; specification development for product features and functionality; Circuit design (digital, microprocessor, power, analog, radio frequency (RF), optical and micro-electronics); field programmable gate array design (FPGA); printed circuit board layout; embedded software design; mechanical design (thermal analysis, fluidics, robotics, plastic components, sheet metal enclosures and castings); test specifications development and product verification testing, and automated (robotic) production solutions and complex automation design. Its Design for Excellence (DFX) solutions encompass a range of specific design solutions, including design for test, design for manufacturability/assembly and design for fabrication. Its manufactured products fall into one of the categories in its assembly spectrum, including printed circuit board assembly, basic assembly, system integration and mechatronic integration.

The Company provides a range of aftermarket services, including complex repair, refurbishment and product support for products it manufactures. In addition, it also provides customized solutions for products it does not manufacture. Its aftermarket services offerings include screening, loaner program, part harvesting, in/out warranty repair, advanced exchange, part repair, upgrade, demo unit management, warranty redemption, recycling, part fulfillment, decontamination, destruction, part fulfillment with warranty redemption, complaint handling and part sales. Plexus offers fulfillment and logistics solutions to its customers in the forms of Direct Order Fulfillment (DOF), Build to Order (BTO) and Configure to Order (CTO).

Post-Dinner Presentation: Electronic Finished device manufacturing, Robin Dunham

Summary:

Presentation is an overview of Plexus and the process for manufacturing FDA regulated Finished Medical Devices.  It covers receipt of Raw Materials through Product release.  Circuit Board manufacture, assembly and Functional testing.  This is a short version of what Plexus presented at FDA headquarters 5 times since 2008.

 Bio:

Robin is a 13 years veteran in the Quality function at Plexus.  He is considered the expert in the application of the Circuit Board manufacturing standard [IPC] related to Soldering quality.  He is also in-house CAPA coordinator reporting on each CAPA status on a weekly basis.  He has been an ASQ member for 9 years.

 

Certified Quality Engineer (CQE) Refresher Class

Purpose

To help prepare our members for the June 2017 CQE Exam, the Northeastern Illinois Section (1212) will be providing a CQE Refresher class

What is a Certified Quality Engineer?

“The Certified Quality Engineer is a professional who understands the principles of product and service quality evaluation and control. This body of knowledge and applied technologies include, but are not limited to, development and operation of quality control systems, application and analysis of testing and inspection procedures, the ability to use metrology and statistical methods to diagnose and correct improper quality control practices, an understanding of human factors and motivation, familiarity with quality cost concepts and techniques, and the knowledge and ability to develop and administer management information systems and to audit quality systems for deficiency identification and correction.” borrowed from ASQ.org

Why would I want to become a CQE? Continue reading

“Root Cause Analysis to Address Health Concerns” by Kelly Rodkey

My daughter recently developed a skin condition that the pediatrician could not identify.  In her frustration, she declared, “Well I want to get a definitive diagnosis, not spend a year chasing around and guessing what it is!”

It reminded me that root cause analysis can be used to diagnose a medical condition.  Routine monitoring of human clinical chemistry can find an “out-of-specification” value in need of investigation.

As an example, Lee routinely got annual physicals.  Health insurance companies encouraged it and she thought it was a valuable investment as she realized she was no longer an invincible twenty-something.  At the office exam everything looked great, healthy weight and no major complaints.  She thought the insomnia, fatigue, joint pain, and trouble with concentration, were just a result of age and the hectic schedule of a working mother of three.  However, the routine lab work showed that Lee’s iron levels were quite low even though she took iron supplements since the birth of her then 10-year-old son.

It took multiple blood tests, fluid samples, and an upper and lower endoscopy to finally diagnose the root cause of the low iron level.  However, once clinicians identified the autoimmune disease, a  solution could be implemented… effectiveness is to be determined.

It would be nice if medical diagnoses could be swift and accurate, but as is often the case in industry, if the needed data are not available to identify the cause, then a well-planned investigation to collect more data must begin.

How will you manage your own health?  An annual physical allows the physician to monitor routine clinical chemistry values and to identify when something is trending out of specification.  Once the out of specification condition is identified, the investigation can begin.  With luck, the root cause can be quickly diagnosed, solutions can be identified and implemented, and the effectiveness of the solution can be evaluated… all with facts and data and not prolonged physician guessing.

Kelly Rodkey spent over 22 years in the healthcare industry at Abbott and Baxter in many quality roles, which encompassed testing and manufacturing, new product development, and clinical study report submissions.  In her most recent role as a CAPA Quality Approver, Kelly worked with investigation teams to ensure nonconformances were fully investigated, corrective and /or preventive actions were effective, and documentation narratives were understandable and fully supported.  She holds three ASQ certifications and has been a member of ASQ Section 1212 since 2009.

Newsletter, February 2017

Dear reader,

 Our next meeting is February 16, 2017

 

The February membership meeting is at

Arboretum Club

401 Half Day Road, Buffalo Grove.

Members and non-members are always welcomed.

There is no charge for people who wish to listen to the speakers and forego dinner.

Although walk-ins are welcome, we strongly urge you to pre-register.

 

Door prizes of wine, books and other great gifts are given out every month.

 

Register for the February Meeting by using the link below:

 

https://www.eventbrite.com/e/asq-section-1212-february-meeting-and-dinner-tickets-27442471170?aff=eac2

 

 

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Pre-Dinner Meeting:

Presentation Topic:   Taking the Mystery out of Computer System Compliance by Deb Bartel

The aim of this presentation is to increase the comfort level on the subjects of computer system validation and electronic data integrity by answering these questions:

  • What is Computer System Validation (CSV)
  • Why should you perform CSV
  • Which systems need to be validated
  • What are the steps of the CSV process
  • What do you need to do to ensure the integrity of electronic data

During Networking Dinner:

CGMP and Postmarketing Safety Reporting Requirements for Combination Products by Jesse Vazquez

Jesse Vazquez from FDA Chicago district office will be present at our meeting to answer questions that our members may have. Jesse is a Medical Device Specialist (Biomedical Engineer / Investigator) at the Chicago district office.

Post-Dinner Meeting: cGMP and post marketing safety reporting requirements for combination products by Mark D. Kramer, MS, RAC

Mark D. Kramer, MS, RAC, is President, Regulatory Strategies, Inc., (www.regulatorystrategies.net), a regulatory consultancy specializing in medical devices and combination products.  He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration

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Your Section Leadership

The Section Leadership Committee (SLC) is comprised of volunteers from your section.  Feel free to contact them using the email addresses listed below. If you need help navigating our website, have questions or have an idea for improvement contact our webmaster Adela Crandell Durkee at  website@asq1212.com If you want to submit something to the Newsletter, don’t know how to sign-up, are missing …

Read more.

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Membership Meeting February 16, 2017

Click the links (in blue) below to view the Slideshow presentations:

Kramer ASQ CGMP and Postmarket Safety Reporting 2-16-17

Praxis Computer System Validation 2017 02

Attention:

The February membership meeting is at

Arboretum Club

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 out the Eventbrite form at the end of this announcement.

Members seeking employment are eligible for the courtesy dinner.  Be prepared to show your membership number.


 

Pre-Dinner Meeting:

Presentation Topic:   Taking the Mystery out of Computer System Compliance

Many Quality Assurance professions are confident in their QA expertise for a wide array of topics, including manufacturing, laboratories, clinical trials, and QMS, but start to feel uncomfortable when computer systems are the focus.

The aim of this presentation is to increase the comfort level on the subjects of computer system validation and electronic data integrity by answering these questions:

  • What is Computer System Validation (CSV)
  • Why should you perform CSV
  • Which systems need to be validated
  • What are the steps of the CSV process
  • What do you need to do to ensure the integrity of electronic data

Biography: Deb Bartel is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.  She is a long-time leader of software quality and information system initiatives with over 25 years of experience in multiple industries, including pharmaceuticals, medical device, chemicals, and textile manufacturing.

Deb has great enthusiasm for applying practical, effective approaches to meet the quality and compliance challenges of the Life Sciences industry. She has been able to use LEAN, continuous improvement, and risk-based processes to reduce costs while maintaining compliance with both US and international regulatory agency expectations. Deb also has many years of experience managing international ERP, laboratory, pharmacovigilance, clinical, quality management, and financial systems projects in both regulated and non-regulated industries.

Since joining Praxis in 2007, Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.  She also leads a popular weekly webinar series on CSV and SQA topics such as Part 11, Annex 11, Cloud/SaaS in GxP, and Auditing Software Vendors.

Deb has BS-Information Systems and MBA degrees from the University of Wisconsin.  She holds ASQ certifications in quality auditing (CQA) and six-sigma processes (CSSGB) as well as a PMP from the Project Management Institute.

 

During Networking Dinner:

CGMP and Postmarketing Safety Reporting Requirements for Combination Products

Jesse Vazquez from FDA Chicago district office will be present at our meeting to answer questions that our members may have. Jesse is a Medical Device Specialist (Biomedical Engineer / Investigator) at the Chicago district office. He Conducts inspections of regulated industry including inspections related to product marketing applications. Investigates complaints of injury, illness, or death caused by a product regulated by the FDA. Trains and works with industry, State and local officials, consumers, and fellow colleagues on enforcement policies, methods, and interpretation of FDA regulations and their impact on public health. Combination products such as drug-coated devices, prefilled delivery devices, convenience kits and cross-labeled products, raise a variety of unique regulatory issues.  This presentation will focus on the current good manufacturing practice (CGMP) and very recently issued postmarketing safety reporting requirements for combination products.  We will review the underlying CGMP and postmarketing safety reporting requirements for drugs, devices and biological products, and the final regulations now in place that specify the additional requirements that manufacturers must implement for their combination products.  Key takeaways from each regulation including compliance timeframes, enforcement considerations and recommendations will also be addressed.

 

Post-Dinner Meeting:

Combination products such as drug-coated devices, prefilled delivery devices, convenience kits and cross-labeled products, raise a variety of unique regulatory issues.  This presentation will focus on the current good manufacturing practice (CGMP) and very recently issued postmarketing safety reporting requirements for combination products.  We will review the underlying CGMP and postmarketing safety reporting requirements for drugs, devices and biological products, and the final regulations now in place that specify the additional requirements that manufacturers must implement for their combination products.  Key takeaways from each regulation including compliance timeframes, enforcement considerations and recommendations will also be addressed.

Mark D. Kramer, MS, RAC, is President, Regulatory Strategies, Inc., (www.regulatorystrategies.net), a regulatory consultancy specializing in medical devices and combination products.  He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration, culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. Mark began his career in engineering and clinical/regulatory affairs positions in the medical device industry. He joined FDA’s Center for Devices and Radiological Health (CDRH) as a lead reviewer in the Pacing and Electrophysiology Devices Branch, and from 1990-1995 served as Chief of the Urology and Lithotripsy Devices Branch. He then went to the private sector, serving in both consulting and in-house corporate regulatory affairs capacities. Mr. Kramer returned to FDA in 1998 as Chief of CDRH’s Anesthesiology and Defibrillator Devices Branch until his appointment as Director, CDRH Staff College in 1999. He then served as Director of the Agency’s Combination Products Program from February 2002 until the establishment of the Office of Combination Products in December 2002, where he served as Director until April 2007.  As OCP Director, Mark led the development of policies, procedures and processes to ease the assignment, premarket review and postmarket regulation of combination products.  From 2007-2010, Mark was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare.  Mark served on the Board of Directors of the Regulatory Affairs Professional Society (RAPS) from 2009-2014, served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.  Mark can be reached at kramer@regulatorystrategies.net.

Membership Meeting January 19, 2017

The January membership meeting is at Dover Straits, 890 East US Route 45, Mundelein.

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 out the Eventbrite form at the end of this announcement.

Members seeking employment are eligible for the courtesy dinner.  Be prepared to show your membership number.

Pre-meeting:

Title Human Factors and Implications for Medical Device Design

Abstract:  Human factors engineering encompasses the science and methods used to make products and services easy to use, and in the case of medical device design, safe to use.  This presentation provides an overview of human factors engineering, with examples of how evolving product designs can improve user experiences.  A quality system that is “fit for use” can only be evaluated as such when it is usable by the target population.  Usability takes on even greater importance when the system is a medical device because operator mistakes can have severe consequences.

Biography:  Ed Halpern, PhD, is a Principal Human Factors Research Engineer, focusing on medical combination products that are self-administered by patients.  He joined AbbVie in 2014 after 6 years at Baxter Healthcare, where he worked as an Engineering Specialist of Human Factors, focusing on the human factors design and evaluation of Large Volume Pumps for administering medications in hospitals and of dialysis devices for use in the home by patients suffering from kidney failure.  Prior to that, Ed spent 10 years at Motorola as Distinguished Member of Technical Staff with a focus on automatic speech recognition technologies and services and on wireless network management software tools. Prior to Motorola, Ed spent many years at Lucent Technologies/Bell Laboratories as a human factors engineer, researching and designing user interfaces for new enterprise telephone services and forward-looking technology platforms and applications.  Ed has a BS in Economics and a PhD in Instructional Systems Technology, both from Indiana University.

Main meeting:

Title: The Food Safety Modernization Act Review and Readiness

Abstract:

  • Review key parts of FSMA
  • Discuss areas of possible impact to food industry
  • Identify significant issues and questions for the future
  • Provide suggestions on how to prepare for the new regulatory environment

Biography: Loralyn (Lori) Ledenbach is a Principal Scientist in the Kraft Heinz Company Food Safety & Microbiology department, and has been with the company for over 36 years.  Over the years, Lori has worked on new method development and product category support for: salad dressings, pizza, and natural and pasteurized process cheese.  She is one of the internal process authorities for pasteurized process cheese products, and co-developed the Better Process Control School for Process Cheese standard curricula.  From 2007-2015, she was the lead for Kraft Foods global HACCP team, and now leads the newly merged Kraft Heinz Company North American HACCP team. She was an active participant in industry working groups to provide comments on the FSMA proposed rules, and was busy in 2016 conducting training sessions for the Food Safety Preventive Controls Alliance (FSPCA).  She has already trained over 140 Preventive Controls Qualified Individuals.  She graduated with a B.S. degree in Biological Sciences from Northern Illinois University and a M.S. degree in Food Science from University of Illinois.

 

Newsletter December 2016

Our next meeting is December 15, 2016

The December membership meeting is at Dover Straits, 890 East US Route 45. Mundelein. Reserve your spot using the Eventbrite link below.

Members and non-members are always welcomed.

There is no charge for people who wish to listen to the speakers and forego dinner.

Although walk-ins are welcome, we strongly urge you to pre-register.

Pre-meeting starts at 5:00 PM followed by Dinner and Networking at 6:00 PM

Pre-Meeting Presentation 5:30 – 6:00 pm Navigating ASQ Section 1212 Website.

Dinner, Networking           6:00-7:00 pm

Main Presentation             7:00 – 8:00 pm  Gemba Walks

Door prizes of wine, books and other great gifts are given out every month.

 

November Raffle winners:

Dave Norby, Peter Larson, Glenda Phifier

 

Register for the December Meeting by using the Eventbrite button below or on the website.

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Eventbrite - ASQ Section 1212 December Meeting and Dinner

ASQ 1212 Section Meeting December 15, 2016

Register by clicking on the Eventbrite link below: Join us on Thursday, December 15, starting at 5:30 p.m. at Dover Straits restaurant for our annual Quality Celebration, where we will have fun (and gifts) exchanged for all participants! Please bring a wrapped “White Elephant” gift with you, and we will have some seasonally appropriate fun. (Please, don’t spend any money; …

Read more.

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Message from the chair

It is December, and we will be celebrating the holidays, and our December section meeting pays homage to the holiday tradition with our annual “White Elephant” gift exchange, where we share something to re-gift. This is a reminder of how fortunate we are to have enough to share with others. Also part of our Quality Celebration is a focus on …

Read more.

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Quality Engineer opening at Ameda, Inc.

Ameda, Inc. 485 E Half Day Rd., Suite 320 Buffalo Grove, IL 60089 HR Manager: Lois Lloyd. 847-964-2627 Lois.lloyd@ameda.com Job Title:  Quality Engineer – Supplier Management We are seeking an experienced, high caliber, Quality Engineer – Supplier Management responsible as the key liaison between operations, engineering, quality, suppliers and the customer.  This position is responsible to ensure the overall specifications, …

Read more.

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Your Section Leadership

Please click below to see your leadership and their contact information:

Read more.

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ASQ 1212 Section Meeting December 15, 2016

The December membership meeting is at Dover Straits, 890 East US Route 45, Mundelein.

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 using the Eventbrite link below.

Eventbrite - ASQ Section 1212 December Meeting and Dinner

Join us on Thursday, December 15, starting at 5:30 p.m. at Dover Straits restaurant for our annual Quality Celebration, where we will have fun (and gifts) exchanged for all participants! Please bring a wrapped “White Elephant” gift with you, and we will have some seasonally appropriate fun. (Please, don’t spend any money; feel free to re-gift something that might be useful to someone else at our gathering.)

In the Spirit of the Season for Giving, we also use our December meeting to bring special focus to a charity that lives the giving spirit year-round. This year, we feature two local charities.   Social Responsibility is important for those of us in the quality field. and why it is important, as people in the Quality Field.

Come join us for fun and festivities.

Message from the chair

It is December, and we will be celebrating the holidays, and our December section meeting pays homage to the holiday tradition with our annual “White Elephant” gift exchange, where we share something to re-gift. This is a reminder of how fortunate we are to have enough to share with others.

Also part of our Quality Celebration is a focus on those less fortunate. Our December program includes a focus on charitable organizations. We encourage you to show your support for these organizations, which, like ASQ are not-for-profit, but who focus on a different type of impact.

Lastly, thank you for your support to make my experience as section Chair in 2016 a memorable period in my life. It has been a pleasure to serve Section 1212, and I have learned so much over the past year. I know that I held this office imperfectly, so I thank you for your understanding. I am also grateful for the very capable and charming Jeff Wright, who will succeed me in January. Please welcome him with as much support as you showed me!