October 19, 2017 Membership Meeting

State of the section, Elections and Focus Group

Dover Straits
890 East US Route 45
MUNDELEIN, Illinois 60060

 5:30 PM to 8:30 PM (CDT)

 

Come prepared to work.  

We’ll pick up the tab for dinner.

October is our annual free meeting.

Dinner is on us! Sign up here, so we can plan.

 

Members and non-members are always welcome.

Pre-Dinner Presentation 5:30 – 6:00 pm 

A Complete Approach to Supplier Quality Management. Edward Cook 

Dinner and Networking    6:00-7:00 pm 

Main Presentation   7:00 – 8:00 pm State of the section, elections and Focus group

5:30 – 6:00 PM: Pre-Dinner Presentation:

A Complete Approach to Supplier Quality Management by Edward Cook

This presentation will discuss how to utilize both a QMS and a Relationship Management Model to Address Industry Challenges and Changes.

  • As Supply Chain professionals, we embrace the idea that our outsourced processes are an extension of our business…
  • But what does that REALLY mean?
  • How do we translate this ideal into practical management of the supply base?
  • How do we monitor the performance of the supply base and our management of it?
  • How do we meet the challenges and changes in industry?

Ed Cook has been the Director, Supplier Quality Management at Hospira, a Pfizer Co., since January 2013, where his responsibilities are to manage the global Supply Chain program for medical device operations.  In this role he sets policy for and oversee Suppliers and third party manufacturing (TPM) organizations in the areas of relationship management, supplier quality engineering, incoming quality inspection supplier and TPM audit, and the supply chain quality management system (SC-QMS).

While at Hospira, Ed led a major remediation project (coined “Compliance Master Plan”) for cross-functional teams for purchasing controls, built a new SQ organization and increased staff from 4 to 22, and developed supplier qualification, monitoring and measuring, and a supplier management review process in addition to implementing unified SCAR, PPAP and Certification Processes.  He also led a major cross-functional improvement project to optimize Supply Chain Processes across the Supplier Management Lifecycle (LCM).

Ed served in various roles in and out of the medical field, including Plant QA Head for Husqvarna Outdoor Products; Head of QA/RA for Facet Technologies; Director of Quality, Molding Operations for Avail Medical Products; as well as QA Manager roles at several other companies.

Pre-Dinner Presentation 5:30 – 6:00 pm 

We all want our Section 1212 to be a more vibrant section and a section that serves your needs. Please help us help you.

The annual free meeting is election night (Chair Elect, Secretary, and Treasurer) and a chance to give YOUR FEEDBACK. Among other things, we will discuss venue preferences, how we can meet our section goals and how we can best serve our members. We will ponder the following four questions, and, with your help, identify the best answers:

  • What can we do to attract young talent?
  • What topics do you want to cover at quality forums and study groups?
  • What incentives can our section offer to get more people involved?
  • What other ideas do you have to improve the section?

 As a token of our appreciation, Section 1212 offers a free meal to all individuals who participate in the duration of the program.

Together we can create a vibrant section that utilizes the talents and imagination of all its members.  Bring your ideas to improve the section, ways to encourage greater participation, and feedback on what the section is doing well, so we stay on the right track.

The purpose of the section is to serve its members.  Your opinions matter to us, and we want to know what’s on your mind.   Section 1212 can truly live the values of Quality that it espouses.

 

 

ASQ 1212 Membership Meeting: September 21, 2017

Did you miss us over the summer?

Join us for our first Membership Meeting of the Fall.

5:30 – 6:00 PM: Pre-Dinner Presentation:

Case Study – Improving the Quoting Process for a Customer Engineered Electronics by Richard Gordon

With a new strategic focus on selling custom engineered solutions, the design and quoting team of an electronics manufacturer was struggling to keep up with the new volume of RFQs that they were asked to process. The additional work – and products – quickly led to bottlenecks and downstream effects that included delays, quality issues, and missed customer deadlines. As a result, they were at risk of losing clients to customer dissatisfaction.

Our objective was to develop a robust quoting process to ease capacity constraints and improve reliability of the manufacturing of these custom engineered products. In addition, we developed quote and order segmentation and prioritization processes to ease throughput by focusing on strategic clients and products. We will be sharing with the group highlights of our 18 week journey with the client including the approach we used to develop a more robust quoting process that will ease capacity constraints and improve reliability of the manufacturing of custom engineered products while ensuring alignment with corporate strategy.

Richard Gordon is a Senior Consultant in Centric Consulting’s Chicago office. He holds ASQ certifications and a Six Sigma Black Belt and Quality Engineer as well as a Project Management Professional. With experience in financial services, manufacturing, distribution, and insurance, Richard provides consulting expertise in the areas of revenue growth, operational performance improvement and customer relationship management. His emphasis is on growing revenue and improving experiences within multiple distribution channels.

 

6:00 – 7:00 PM: Dinner and Networking

7:00 – 8:00 PM: Main Presentation features your entire Section Leadership Committee

You will learn about ASQ, what it has to offer its members, and get an opportunity to meet and greet with your Section Leadership.  You will learn about the various services your section can provide to you, and how you can get involved in ASQ and build your career to new heights.  After this presentation, and learning about the various roles available at ASQ 1212, your section will be accepting nominations for officers to introduce on next year’s slate of candidates.  This is your opportunity to get involved and become part of something greater!

 

Career Opportunity: Specialist,Post Market Surveillance

Specialist,Post Market Surveillance

Perm – $70K – $80K – Depends on experience.

JOB SUMMARY:

Responsible for receiving, reviewing and processing all product inquiries for complaint evaluation as required by applicable regulations, standards, and company policy. This position requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211). Helps provide customer support and serve as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints. This role also partners with Quality Engineering on product investigations and trends.

ESSENTIAL/PRIMARY DUTIES:

  • Responsible for receiving, reviewing and processing all product inquiries for complaint evaluation as required by applicable regulations, standards, and company policy.
  • This position requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211). Helps provide customer support and serve as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints. This role also partners with Quality Engineering on product investigations and trends.

EDUCATION and/or EXPERIENCE:

  • Associates Degree preferred One (1) or more years’ quality assurance experience, or an equivalent combination of education and experience may be substituted
  • Requires strict attention to details, careful risk assessment, strong customer service, effective communication, and strong data entre.

Randstad Life Sciences

Four Parkway North, Suite 120

Deerfield, IL 60015

T 847.527.6107

C 815.721.5833

paul.zeman@randstadusa.com

lifesciences.randstadusa.com

Talent Acquisition | Outsourcing & FSP | Consulting | Direct Hire 

Follow Randstad Life Sciences on: LinkedIn, Twitter and Facebook

Connect with me on LinkedIn: https://www.linkedin.com/in/pzeman2

Membership Meeting: June 15, 2017

 

The June membership meeting is at Dover Straits

890 East US Route 45, Mundelein

 

Pre-Meeting Presentation 5:30 – 6:00 Companion by Minitab and Minitab 18 by Jeff Harding

Dinner & Networking 6:00 – 7:00 PM

Main Presentation 7:00 – 8:00 PM Standard work is a verb: The Quality Perspective by John Allwood

 

Pre-Meeting Presentation – Companion by Minitab and Minitab 18 by Jeff Harding

Macro view – Why Projects Fail

Minitab’s Response – Companion by Minitab

What’s New with Minitab 18 – Add functionality and features in the newly released version

 Bio: I am Jeff Harding the Regional Sales Manager for Minitab representing the states of Illinois, Wisconsin, Minnesota, and Iowa.  We recently opened an office in downtown Chicago in September where I am officed along with 6 other Minitab representatives and growing!  Our goal is to be closer to our customers to provide a better resource and support our customers.  I started with Minitab when they opened the office here in Chicago but I have a background of over a decade in software and technology sales.  My goal is to be a consultant to my customers to help them achieve their project goals through Minitab.

Main Presentation – Standard work is a verb: The Quality Perspective by John Allwood

In this presentation (based on the book, “Standard Work is a Verb: A Playbook for LEAN Manufacturing”) John demonstrates how Standard Work is a driving component in LEAN as well as its historical presence in the LEAN movement. He shows us what it looks like in practical applications and how Standard Work can be used to impact modern Quality concerns such as Quality at the Source; Continuous Improvement; Root Cause Corrective Action; etc. John provides specific examples of how he uses Standard Work to address such concerns successfully.

Bio: John Allwood was introduced to the Toyota production system while working at Tuthill Pump, Alsip Illinois in the 1990’s. That is where he met Bob Pentland, who is featured in Chapter 8 of Womak’s “LEAN Thinking” book. In 1998 Bob was brought in as the company’s LEAN consultant, and shortly thereafter, Tuthill Corporation began a ten year transformation to The Tuthill Business System; this under the watchful eye of Mr. Pentland.

John was appointed Tuthill Pump’s Change Agent early in the journey, and served as such for the next eight years. He then transitioned into serving as Product Line Manager over and entire value stream including 5 machining cells and an assembly cell. After that, John took his LEAN show on the road, serving in engineering and management positions and found that LEAN was not very well understood from the Standard Work perspective, apart from the company where he had spent the previous decade. John also encountered and received training in several “LEAN interpretations”, all of which conspicuously lacked in the focus on Standard Work. John has had to come up with creative ways in which to practice LEAN and promote Standard Work upstream as the opportunity has presented itself.

Over the years, John has also developed a strong sense of what it takes for an organization to make the transition to an enterprise that is BEing LEAN instead of just DOing LEAN things. The failure modes that have gotten in the way of change have provided as many valuable lessons as the successful endeavors have. The one thing that John has learned over the years is that DO-ing leads to BE-ing and that activity is the best medicine for dealing with the fear of change. This has led him to write the book, “Standard Work is a Verb: A Playbook for LEAN Manufacturing”.

To learn more, visit www.standardworkisaverb.com

Membership Meeting: May 18, 2017 with presentation slide deck

Click the link (blue) below to view the presentation slide deck.

2017 – ASQ1212 – Recertification – 2017-05-18

The May 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 below:

Pre-Meeting Presentation – Recertification process by Don Gatza

Don Gatza will explain the recertification process. He looks forward to assisting you with your customized package for submission. Bring your packages to be reviewed!   Recertification only takes a few minutes to do ‘on the spot’.

Plan to join us to gain knowledge on how to develop a personal process improvement for your recertification efforts.

Main Presentation – ASQ Exam Development Process by Martin Palczynski

ASQ has a rigorous method for the development of a Body of Knowledge, the associated exam questions and final exam for a given certification.  This process uses a number of workshops, SMEs from within the certified pool, and feedback from a survey sent out to the certified pool to establish the foundation of current industries and refine the data into key knowledge points.  This discussion will highlight the key steps in the process and where and how certified members can participate.

Bio: Martin has been the CSQE exam liaison for the past year and has participated in many of the workshops from the current review cycle.Martin has been in the quality realm for approximately 18 years, with an overall industry experience of 27 years, working for Motorola, Rockwell Automation and HERE Technologies.  His focus has been in the areas of software development and software quality, with focus on quality program management, quality culture, auditing, and process Improvement.  He currently holds the CQE, CSQE, CQA, and CSSGB certifications.

April 2017 Newsletter

 

 

Register for the April Meeting by following the link to Eventbrite here.

 

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

 

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Membership Meeting, April 20, 2017

The April 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 

 

 Innovative and Integrated Supply Chains in the 21st Century

 

Dr. Manu Vora, Chairman & President, Business Excellence, Inc., USA

Fulbright Specialist, U. S. Department of State’s Bureau of Educational and cultural Affairs

Innovative Supply Chains Principles (Pre-Meeting)

In the global economy, supply chain management is a challenging task. Most global companies are managing multiple

supply chains, and depend on those operations to not only deliver goods on time, but to tailor and respond to divergent customer and supplier expectations, as well as manage rising pressures from global competitors. Dr. Vora will share innovative and integrated supply chain management principles by integrating total quality management principles based on the US Baldrige Performance Excellence Program.

Innovative Supply Chains Practices (Post-Dinner Meeting)

Global competition is driving companies to take a closer look at their quality management systems within their supply chain. Global supply chain quality is an ongoing process, not an event, and therefore requires a comprehensive plan that becomes a part of an organization’s culture and intertwined with manufacturing processes.

Read more.

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“The SWOT Approach to College Enrollment” by Kelly Rodkey

As my family navigates the college search, application, and selection process for our second child, I yearn for a tool to distill the 4000+ degree granting universities into a handful for consideration.

I sought out the SWOT (Strength Weakness Opportunity Threat) Analysis as my salvation.  I quickly realized all the facts and data were available for these schools, so what I really needed was selection criteria for differentiation.

Strengths related to available field of study, admission criteria test scores, size of student body, public or private institution, scholarship availability, geographic location, and even academic reputation.

Weaknesses related to available field of study, admission criteria test scores, size of student body, public or private institution, scholarship availability, geographic location, and academic reputation as well.

Read more.

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Click “Read more” to see a complete listing of the SLC

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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Join our group on LinkedIn

 

Membership Meeting, April 20, 2017

The April 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 below:

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

 Innovative and Integrated Supply Chains in the 21st Century

 

Dr. Manu Vora, Chairman & President, Business Excellence, Inc., USA

Fulbright Specialist, U. S. Department of State’s Bureau of Educational and cultural Affairs

 

Innovative Supply Chains Principles (Pre-Meeting)

In the global economy, supply chain management is a challenging task. Most global companies are managing multiple

supply chains, and depend on those operations to not only deliver goods on time, but to tailor and respond to divergent customer and supplier expectations, as well as manage rising pressures from global competitors. Dr. Vora will share innovative and integrated supply chain management principles by integrating total quality management principles based on the US Baldrige Performance Excellence Program.

 

Innovative Supply Chains Practices (Post-Dinner Meeting)

Global competition is driving companies to take a closer look at their quality management systems within their supply chain. Global supply chain quality is an ongoing process, not an event, and therefore requires a comprehensive plan that becomes a part of an organization’s culture and intertwined with manufacturing processes.  Dr. Vora will share practical examples of integrating quality management into supply chain management via the ASQ’s Global State of Quality Research with insights from 2,000 respondents in 22 countries. The senior leaders and quality professionals worldwide offers actionable insights that supply chain experts can use to identify quality gaps within their processes and bridge them. The Baldrige Program empowers organizations to accomplish their mission, improve results, and become more competitive.

 

Biography

Dr. Vora received his B.Tech. (Honors) in chemical engineering from IIT (BHU) in 1968, M.S. ( 1 9 7 0 ) and Ph.D. (1975) in Chemical Engineering from Illinois Institute of Technology, Chicago, and MBA with Marketing Management (1985). He is a Past Vice President of ASQ, ASQ Fellow, and Certified Quality Engineer. He is a sought-after speaker on business excellence and quality management with over 620 presentations globally and published over 60 articles in professional journals and proceedings. Since 2012 he has written 50 blog posts as an ASQ Influential Voice. In 2013 he delivered two TEDx Talks including TEDxIITBHU Talk on Leveraging Social Responsibility to Unite the World”. He received Tata Scholarship for graduate work in US.

Dr. Vora is the Chairman and President of Business Excellence, Inc., a global quality management firm with over 41 years of leadership experience in guiding Fortune 500 companies with the US Baldrige Performance Excellence framework. For over

24 years as an Adjunct Faculty he has taught Operations Management courses at various business schools globally. He offered “Project Management for Organizational Excellence”, a GIAN course approved by the MHRD-GOI in August-September 2016 at IIT (BHU). He is connected with 80 educational institutes world-wide. Since 2013 he has taught soft skills using technology to 675,000 people.

Since 2004, he is a Senior Examiner for the Asia Pacific Global Performance Excellence Award Program. Dr. Vora is bestowed with 5 medals from ASQ. He received 2015 BHU Distinguished Alumnus Award, 2015 & 2000 Paul Harris Fellow Medal from Rotary International, 2012 IIT Chicago Alumni Medal, 2011 Ellis Island Medal of Honor, and 2010 US President’s Volunteer Service Award. Since 1989 he is the Founding Director & President of Blind Foundation for India and his team has raised over $4 million to serve one million blind people in India.

 

“The SWOT Approach to College Enrollment” by Kelly Rodkey

As my family navigates the college search, application, and selection process for our second child, I yearn for a tool to distill the 4000+ degree granting universities into a handful for consideration.

I sought out the SWOT (Strength Weakness Opportunity Threat) Analysis as my salvation.  I quickly realized all the facts and data were available for these schools, so what I really needed was selection criteria for differentiation.

Strengths related to available field of study, admission criteria test scores, size of student body, public or private institution, scholarship availability, geographic location, and even academic reputation.

Weaknesses related to available field of study, admission criteria test scores, size of student body, public or private institution, scholarship availability, geographic location, and academic reputation as well.

As I focused strengths and weaknesses of the internal environment, such evaluation became only one part of the whole.  I focused on the opportunities and threats of the external environment and, in this case, those affected by the perceptions of a teenager trying to plan for the rest of her life.

Will it matter how good the food is in the cafeteria, how far one has to walk to get to class, how many flights of stairs are beautifully incorporated into the treks across campus, how many people from high school are going to the same university, how good/poor the lighting is in the dormitory, how nice the professor was during the interview, the strength of campus safety measures, how close the university is to civilization (as defined by a teenager), etc.,?

SWOT looks at how a firm fits to the current reality, so it is a preliminary indication of current competitive position.  Reality for a teenager may change rapidly.

SWOT analysis should be based on objective data that allow past-to-current-to-probable future comparisons of the marketplace, competitors, products and services, and company performance.  SWOT can help narrow the field in the college search using institutional facts and data.  However, as selecting a university to commit to for about four years of her life requires identifying where she is most comfortable, it seems that no quality tool can help characterize the highly subjective and emotional traits that will make a particular university the right fit for my child.

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.

2017 Mini-Course from our Wisconsin sister-section

An Interrelated Look at ISO 9001:2015 

AND

Leadership Through The Eyes of ISO 9001:2015

 

ASQ Section 1216  La Crosse – Winona 

Tuesday, April 4th, 2017 4:00-7:30pm 

WTC Lunda Center, La Crosse, WI 

$25 Members and Guests $10 Students 

 

 

 

 

Register online at http://asq1216.pingg.com/AsqSection1216Mini by March 27. 

  

Presented By: Robert Freeman 

Where is your organization in implementing ISO 9001:2015? Whether you implemented immediately or are still in the process of evaluating your systems, our mini conference will give you a new take on the changes and how to improve your systems.

Bio: Robert Freeman is president of Practical Perspectives in McKinney, TX. He is a U.S. technical expert on the next revision of ISO 9004 and is a member of the U.S. Technical Advisory Group (TAG) to ISO Technical Committee (TC) 176. Freeman is a senior member of ASQ, a registered lead auditor for ISO 9001 and an ASQ-certified quality improvement associate.

An Interrelated Look at ISO 9001:2015 

Join us to explore the relationship of strategic direction and purpose of the management system, gain an understanding how to address requirements that lack an expectation for documented information and what maintained and retained documented information means and how to apply it effectively, learn the application of risk-based thought, understand competence versus organizational knowledge and transitioning to a business-centric management system.

Leadership Through the Eyes of ISO 9001:2015 

While some of us were losing sleep over the risk-based thinking requirements ISO 9001:2015, others realized that the role of leadership was equally critical in the implementation of the new standard. Learn how the new standard more clearly addresses the role of leadership in the organization’s management system, the importance of understanding an organization’s purpose and strategic direction within the context of the management system. Invite your leadership to join the discussion and learn about their new role.

Agenda: 

4:00-4:15 networking and registration

4:15-5:30 An Interrelated Look at ISO 9001:2015

5:30-6:00 dinner

6:00-7:30 Leadership Through the Eyes of ISO 9001:2015

Dinner: 

Dinner will be a choice of Chicken Marsala or Asparagus Gnocchi served with couscous and an assortment of roasted seasonal vegetables.

The Lunda Center is highlighted in blue. Parking for the Lunda Center is available in lot L.

ASQ Section 1212 Newsletter, March 2017

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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

Follow this link to register:  https://www.eventbrite.com/e/asq-section-1212-march-plant-tour-meeting-and-dinner-tickets-27442622623

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 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.

 

Read more.

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“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.

Read more.

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Click “Read more” to see a complete listing of the SLC.

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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