• Northridge, California, United States

October Section Meeting: Challenges for Applying FMEA Tools into the MedicalDevice Development with speakers Jerry (Jinxing) Xiao and John Spanomanolis

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Location: Sign-in starts at 5:30pm at Lulu’s Restaurant, Banquet Room16900 Roscoe Blvd.Van Nuys, CA 91406

Abstract: The FMEA (Failure Mode and Effect Analysis) was initially formalized in 1949 by the U.S. military in MIL-P-1629. Since thattime, FMEAs have been successfully applied in various fields including the Apollo space program, civil aviation, environmentalprotection, the automotive, semiconductor and food service industries, the plastics sector, software, and healthcare. There are manystandards and guidelines published that cover the scope and general procedures for doing FMEAs or FMECAs, such as SAE J1739,AIAG, MIL-STD 1629A, IEC 60812. Since FMEAs are able to shift problem discovery earlier in the product development process,the early detection of failures helps reduce project risks and minimize the cost of changes. 

Since ISO 14971 is a standard for the application of risk management in the medical device industry, every medical devicecompany has to remediate risk management files (traditional FMEAs) into new templates. Many organizations hire qualityengineer consultants (also called risk management engineer consultants) to work on costly and time-consuming remediationactivities. 

This presentation will explore the major challenges of building these new FMEA templates and updating risk management filesfrom gaps between FMEAs vs ISO 14971, FMEAs vs cross-functional teams, FMEAs vs post market surveillance, and FMEA vsRisk management report annual reviews. 

In the end, a risk management software (RdPDM V3.0) program is introduced to show one unified FMEA worksheet for all types(etc. design, process, application, software, system) and all status (e.g. pre-market, post-market). The software allows you to exportFMEA worksheets into excel files and generate risk management files. It is able to visualize the gap between FMEA vs. customercomplaints and further push FMEA files updated in the course of RMR annual reviews. This software can save a significant amountof time and money when a FMEA needs to be updated or remediated (e.g. hazard, hazardous situation, harm, severity level, riskregion). 

By attending this presentation, you will: 

• Understand basic FMEA history, standards, success, and limitation 

• Realize challenges for applying FMEA into medical device development 

• Overview risk management software effectively and efficiently facilitates FMEA activities 

Speaker Bio:

Jerry (Jinxing) Xiao joined ASQ in 2007 and obtained his CQE, CQA, CSSBB and CRE from ASQ. He has worked successfully asa quality professional in China, Canada, and the U.S. During recent years, his quality practices focus on product development forthe medical devices in pre-market and post-market stages. Jerry has been involved with medical devices such as the Total ArtificialHeart, the Pacemaker, Implantable Cardioverter Defibrillators (ICD), Doctor Robot, Pumps (Insulin, Infusion), Ventilator,Orthopedic Products, Lead, Catheter from Johnson & Johnson, Medtronic, Philips healthcare, Abbott (St Jude Medical), BD,Zimmer Biomet, etc.Jerry (Jinxing) holds a Bachelor Degree in Engineering and a Master’s Degree in Quality Systems Engineering. He is the businessowner of RdQCC (Risk driven Quality Consulting Company LLC), located in San Diego, California. 


September Section Meeting: Public Speaking Tools & Techniques

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“Public Speaking Tools & Techniquest: Say What You Mean and Mean What You Say

Tuesday September 25 starting at 5:30pm at Marie Calendars in Northridge.

Abstract:The topic for ASQ on September 25 will explore both effective and ethical public speaking for allsituations. You will come away with specific tools you can use in planning every speaking opportunityand an understanding of how to effectively inform, persuade, inspire and entertain audiences from oneto a thousand. 

Speaker Bio:Lance Webster has 50 years of experience in communication, management, and coaching. He is anaward winning “Distinguished Toastmaster” and past Toastmasters District Director for the LosAngeles District that includes the San Fernando and Santa Clarita Valleys, Burbank and Glendale, anddowntown Los Angeles. Lance has been a Toastmaster for 18 years and has won awards for impromptuand inspirational speaking and speech evaluation, and regularly provides workshops for his fellowToastmasters. 

Lance is a Life Coach specializing in productivity, effectiveness, and communication, and has manyyears of experience in broadcast publicity and non-profit association management. He has worked forthe PBS network in PR, and is a media trainer for corporate and technical executives, celebrities andsports figures. He has taught PR and public speaking courses at colleges on the East and West coasts,most recently at UCLA and Pepperdine, where his focus was on the effective creation and use of acentral or core idea. 

Lance has spoken before groups ranging from Lions and Rotary clubs to the Los Angeles Chapter ofMENSA, and to a variety of broadcast industry organizations.

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August Section Meeting: Internal Process Audits

“Principles of Internal Process Audits with a Focus on the Differences between AS9100C andAS9100D"

Tuesday August 21 starting at 5:30pm at Marie Calendars in Northridge.

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This presentation will cover an overview of internal auditing, good auditing practices, and the majorchanges in AS9100D and how it may affect your next third-party audit.  

Lisa has been trained as a LeadAuditor for AS9100C, with additional training in the AS9100D transition. She is responsible for theInternal Audit Program where she is currently employed, and really enjoys performing thetask. Additionally, Lisa is the Section 0706 Audit Committee Chair this year.” 

Speaker Bio:Lisa Strawn originally joined the ASQ in 1979 as an "Associate" member. Her career has taken her tovarious positions such as Quality Inspector (with a focus on SPC); Quality Analyst, Quality Engineer,and Quality Manager. She holds ASQ certifications as a Certified Mechanical Inspector (CMI),Certified Quality Engineer (CQE), and a Certified Manager of Quality/Organization of Excellence(CMQ/OE). Lisa earned her Bachelor's Degree in Information Technology, Software Engineering, andgraduated with honors from the University of Phoenix. Currently working in aerospace at Eaton, Lisaworked on the team that led her facility to become certified to AS9100D last December. As the QualitySystems Engineer at Eaton, Lisa spends a great deal of time training internal auditors and using varioussoftware systems. 

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July Section Meeting and Dinner: Process Improvement in Higher Education

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July 17th starting at 5:30pm at Marie Calendar's Restaraunt in Northridge, California

Abstract: Over the last 40 years, the cost of Higher Education has increased much faster than other sectors of theeconomy. This increase in cost has not necessarily resulted in higher quality, as measured by industrymetrics and stakeholder’s evaluations. Higher education institutions have an opportunity to tailor andapply process improvement methods with proven success results in other industries. 

Lean, Six Sigma methodologies and management models such as Baldrige and ISO 9001 have enabledmany other organizations facing similar challenges in cost control and quality improvement. A widerange of stakeholders in higher education can benefit from a tailored application education sector(Students, Faculty, Administration, Community and others). This presentation highlights challengesand opportunities with the application of Process Improvement in higher education, and provides somesuccess story examples.

Speaker Bio: Kaveh Houshmand Azad (MSc., Lean Six Sigma Black Belt, ISO 9001 Lead Auditor Baldrige Examiner)is a Performance Excellence leader with comprehensive process improvement experience andknowledge in healthcare, engineering and higher educational Industries. Kaveh has led severalorganizational excellence journeys over the last 15 years and is currently the Director of OperatingSystem at Keck Medicine of USC. He is also an adjunct faculty with David Nazarian College of Businessand Economics at California State University Northridge. 

Kaveh is a member of Board of Examiners for Baldrige National Performance Excellence Program, andhas presented at several conferences, including ASQ World Conference of Quality and improvement.

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June Section Meeting & Dinner - "Leveraging the QA Function to Ensure Risk-Based Compliance" 


Abstract: Southern California Edison's (SCE) Quality Assurance teams provide a valuable service to the organization’s continued drive to meet all regulatory obligations. With services ranging from controls design reviews, compliance reviews, and controls testing, QA is best positioned to provide SCE leadership with the information needed to manage compliance risk. With SCE’s shift to a risk-based compliance program, QA is even more critical to the company’s compliance efforts. This discussion with present SCE’s QA program, how its role has shifted over the years, and the vision for QA’s role in the future.” 

Speaker Bio:Jeff Balaban is currently the Quality Assurance Manager at Southern California Edison’s Ethics & Compliance organization responsible for assessing SCE’s compliance posture and risk. Jeff has over 35 years’ experience in Information Technology, Quality Assurance, process management, and regulatory compliance. Jeff has managed QA teams for the past 2 decades, holds a B.S. in Business & Management and has attained various industry certifications including ASQ’s CMQ/OE, CQA, and CSQE. 


Tuesday June 19, 2018, 5:30-8:00PM, at Marie Calendar's Restaurant - 19310 Business Center Drive, Northridge, CA 91324

Beyond Internal Metrics, Customer Focused Medical Device Management Reviews Speaker: Monica Daneshrad

Tuesday, May 15, 2018, at Ali Baba Restaurant, 17513 Chatsworth Street, Granada Hills, CA 91344, 5:30pm 

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Abstract: The management review cadence evaluates the efficacy of the quality system against key performance indicatorsor metrics established by leadership. Timeliness of activities such as customer feedback, training, and internalaudits are reviewed robustly; however, there is still an opportunity to actively address the needs of the customer.Understanding the needs of the customer allows the company to deploy resources and solutions to reportedcomplications of breast implants and cardiac ablation procedures. The tools that allow for this understanding arebased upon the Law of the Market and the Law of Focus. Information from different channels can be aggregatedvia quality management tools such as affinity diagrams, interrelationship digraphs, and impact effort matrices.Links between various ailments and product design have been found, using these tools. Information from availablechannels of customer communication can be leveraged to further reduce reporting of signals due to productimprovement.

By attending this clinic presentation, you will:

  • Understand the current state of medical device management review body of knowledge. 
  • Apply certain quality management tools to further understand product issues and impactful solutions.

Speaker Bio: Monica Daneshrad is a Senior Quality Engineer currently employed in the medical device division at Johnson &Johnson in Irvine. She has accrued eleven years of experience in the quality systems field having worked atcompanies such as Siemens and Allergan. She has implemented and led process improvement initiatives inDocument Control and Internal Standards. She currently supports management reviews for 7 Johnson & Johnsonbrands. 

Monica holds a Bachelor’s of Science in Biology/Spanish with a minor in English from Loyola MarymountUniversity. She has the following ASQ Certifications: Yellow Belt, Green Belt, Black Belt, and Manager ofQuality/Organizational Excellence. She holds a Project Management Certificate from UC Berkeley and is anMSQA Candidate at California State University-Dominguez Hills.

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March General Meeting 

European Union (EU) Environmental Compliance: An overview of RoHS and REACH

Speaker: Randy Flinders 

 Tuesday, March 20, 2018, at Ali Baba Restaurant, 17513 Chatsworth Street, Granada Hills, CA 91344, 5:30pm

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No longer on the fringe of product development, environmental compliance requirements have becomemainstream and expanded significantly in recent years. With global product environmental requirements beinglargely driven by EU regulations such as the RoHS (Reduction of Hazardous Substances) directive and theREACH (Registration, Evaluation, Authorization and Restriction of Chemicals) laws, it is very important formanufacturers of electronic equipment to understand their obligations under these regulations and the bestpractices for meeting those obligations.

By attending this presentation, you will: 

  • Become familiar with the basic requirements of the EU RoHS and EU REACH regulations. 
  • Learn about recent changes to the regulations and how those changes impact the compliance status of yourproducts. 
  • Learn why the incorporation of EU RoHS into the CE marking scheme and the publication of EN 50581 hasturned RoHS compliance into a Quality Assurance endeavor – not an engineering one. 
  • Discuss best practices for implementing a cost-effective, risk-based product compliance process.
Speaker Bio
Randy Flinders has over 25 years working in product certification and compliance and holds a BSEE from ITTTechnical Institute as well as a Certificate in Electromagnetic Compatibility from the University of Missouri-Rolla.Randy is currently Senior Manager of Product Support and technical lead for GreenSoft Technology, a Pasadena,California-based environmental compliance services and software company.

Randy serves as a member of several IPC standards development committees, including the 2-18 committee, the2-18b (IPC 1752) committee, the 2-18j (IPC 1753) committee, as well as the 2-18h (IPC 1755) and E30 (IPCconflict minerals white paper) committees. Additionally, Randy is also a delegate on the IEC TC-111 U.S. NationalCommittee, and a named expert on the IEC 62474 committee validation and maintenance teams, as well as on theIEC 63031 standard committee. Randy has been awarded the "Distinguished Committee Service Award" for hiscontributions to the development of IPCs 1752A data exchange standard and has also been recognized for his pastwork with the IEEE Electromagnetic Compatibility society and IEEE Product Safety Society, where he served asChair of the Orange County chapters of both the IEEE EMC and Product Safety societies.

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February General Meeting 

Continuous Improvement in a "We" Organization

Speaker: Tim Higgins

 Tuesday, February 20th, at Two Guys from Italy, Granada Hills.

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Discuss the differences between a “Me” organization and a “We” organization and how that impacts performance and improvement. Identify the necessary prerequisite conditions for constantly and forever improving the system of production and service. During the session we will examine the inadequacies of the prevailing style of managing organizations, review the constraining trap of the thinking underlying the “Me” organization, and initiate seeing with new eyes to reveal possibilities invisible to those trapped in the prevailing thinking.

Speaker Bio:

Employed 29 years with Rocketdyne, Tim has for the last 8 years worked as a NASA Safety and Mission Assurance specialist assigned to Rocketdyne. 

Though Rocketdyne and then NASA provided him various assignments, Tim followed his bliss by messing with the frontal lobes of those trapped in the prevailing style of management. Certified to teach Six Thinking Hats, Lateral Thinking, and Problem Solving / Decision Making, he conducts training and consults Rocketdyne and NASA teams on cause investigation, analysis and intervention. He conducts discussions of The New Economics with both local participants and participants from the US, Canada, the UK and the Australia. He is a member of the In2InThinking Network Board of Directors. 

He spends five days a week playing o jogo bonito and every day enjoying his soul mate Brazilian wife. He and his son occupy themselves by wandering galleries, museums, and historic buildings. They also cooperate with others in earnest attempts to play soccer in a manner that lives up to its moniker, the beautiful game. 

Especially fascinated with books describing the downright weird behavior of both the atomic particles of the universe and the people in it, Tim has a Masters in English, and a rather substantial collection of Brazilian soccer jerseys.

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January  General Meeting

Introduction of Officers and STEM Apprenticeships: Shaping a Quality Culture

Speaker: Rosemarie Christopher

Tuesday, January 16th, 5:30 pm to 8:30pm at Mandarin King Restaurant, 17092 Devonshire Street, Northridge, California 91324

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Adopting apprenticeships for STEM jobs in Quality and Compliance improves the rate of success of new hires. Strategies and tools for attracting, developing, and retaining top talent that include on the job online and/or classroom learning, together with on the job training and mentorship can help to shape a culture of Quality in the organization. By attending this presentation, you will ‘get’… 

 • Apprenticeships build; maintain and retain skilled talent through consistent processes 

 • Gear Apprenticeships to the Millennial workplace and career values = Success 

 • CQIA & Other Industry recognized Certifications = Validation of the OJL/OJT Model 

 • YOU, the ASQ Quality Professional a GREAT Mentor = Professional Development

Speaker Bio:

Rosemarie Christopher holds board member positions in various quality and regulatory organizations such as the American Society for Quality (ASQ) Food, Drug and Cosmetic (FDC) Division as Membership Chair, Regional Councilor Chair, National Discussion Group Chair. Rosemarie also serves as Region 7 Deputy Regional Director and San Fernando Valley Section Career Development and Education Chair; the USC School of Pharmacy as a member of the Board of Councilors and Executive Committee Chair of the Life Industries Council (LInC); the Orange County Regulatory Affairs Discussion Group (OCRA-DG) as a member and sponsor. As President and CEO of MEIRxRS, a family of 3 unique companies that recruit and place scientific, technical, engineering and math/physics professionals, Rosemarie has over 28 years of experience with executive search and staff augmentation with mid-senior level STEM trained and experienced professionals. Rosemarie has a strong understanding of, and is a Speaker/Presenter on STEM apprenticeships; on the job learning; and employee retention in the multi-generational project by project workplace. 


Northampton County Community College - AA , Bethlehem, PA 

University of CA –Los Angeles –BA Anthropology – Los Angeles, CA 

University of Southern CA- MA –Corporate Communications – LA, CA 

Goldman Sachs 10K Small Businesses – Executive MBA – LA, CA

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October General Meeting 

Case Study: Using DMAIC on a Green Belt Project in Manufacturing Services” 

Speaker: Mayet Mendoza, CSSBB 

Wednesday October 17, 2017 6:00pm to 8:30pm, Mandarin King Restaurant, Northridge, California

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The DMAIC six sigma model for process improvement stands for Define, Measure, Analyze, Improve and Control. 

In this case study, the presenter goes through a number of tools and methods and how they were applied in each step. 

Define: Identify the issue causing decreased customer satisfaction.

Measure: Collect data from the process.

Analysis: Study the process and data for clues to what is going on.

Improve: Act on the data to change the process for improvement.

Control: Monitor the system to sustain the gains. 

Speaker Bio: 

 Mayet Mendoza, CSSBB, Continuous Improvement Manager at Vinyl Technology Inc. 

Mayet is a business process excellence leader and ASQ-certified Six Sigma Black Belt. She has leveraged Lean principles for more than 9 years to deliver superior global service and support across multiple industries including high-end electronics, telecommunications, software consulting and manufacturing. She is keen to one day add the healthcare/biotech industries to that roster. 

At her current role, she has managed kaizen projects, ranging from rapid facilitation to medium and large size projects in Production Operations with a total estimated $1.6M in Labor/Material cost savings to date. She has mentored green belt teams and has used DMAIC and PDCA methodologies extensively. 

She has a BS degree in Industrial & Systems Engineering from the University of Southern California.

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