ASQ Section 1212 Newsletter, March 2017


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:

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


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.


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.


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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.

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