• Northridge, California, United States

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" 

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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. 

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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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Abstract

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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Abstract:

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

>>>Registration Link<<<

Abstract:

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. 

Graduate: 

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

Registration Link

Abstract:

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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September General Meeting 

Data OutliersAssessment and their Impact on Normality 

Thursday, September 21, 2017 6:00pm to 8:30pm 

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During this discussion an emphasis will be placed on using Minitab for both Box-Plot and Grubb’s Test to assess whether data points should be considered outliers or not. Various data sets will be presented and analyzed using the tools in Minitab to determine if outliers exist. A brief discussion of the current standards ASTM E178-08 “Standard Practice for Dealing with Outlying Observations” and ISO 16269-4:2010 “Statistical Interpretation of Data-Part 4: Detection and Treatment of Outliers” will be held. The talk will end with an example of how creating a single outlying data point can actually change the type of distribution from Normal to Log-normal, creating a concern and demonstrating the need for carefully assessing the impact of the analysis. The bottom line is that there is a thin line between outliers and choosing an alternative distribution (rather than normal) when dealing with data. 

Takeaways: 

Using statistical analysis tools to assess outliers 

ASTM E178-08 and ISO 16269-4:2010 standards discussion 

Outliers vs Alternative Distribution 

Please bring your questions, experiences, and other commentary to make this a more valuable experience. 

Expert: Larry BartkusLarry Bartkus was named ASQ Biomedical SCDG Speaker of the Year three times now for his informative and always humorous presentations. He is currently Sr. Distinguished Engineer Quality Systems for Edwards Lifesciences in Irvine. He is a Certified Quality Engineer and Six Sigma Master Black Belt with over forty years’ experience in the Quality profession. He holds a degree in Chemistry from Montclair State University in New Jersey. Larry has been guest speaker at the Society of Plastic Engineers, Society of Manufacturing Engineers, APICS, OCRA, American Statistical Association and ASQ. Larry has lectured at 12 different colleges and universities. He is a past Chairmen of ASQ Section 702 and has served on the Executive Board for over twenty years now. He was an instructor for several Refresher Courses including CQE, CQI, CBA and CQM. Larry has conducted seminars in Process Control, Statistical Sampling, Lean, Normality Assessment and Design of Experiments. 

Registration: https://www.eventbrite.com/e/data-outliers-assessment-and-their-impact-on-normality-tickets-37678548553 

Dinner (sandwiches or pizza) & soft drinks will be provided.Seating is limited to the first 40 registrants so sign up soon! Registration closes one day before the event on Sep 20. 

Member Early Registration $20 

Non-member Early Registration $30 

Walkins $35- Check only if seating is available 

Location: Boston Scientific, 25129 Rye Canyon Loop, Valencia CA 91355 

For more information Contact: Dora Derashan email dderashan@yahoo.com  

August General Meeting 

Knowledge Management for Organizational Excellence” 

Speaker: Dr. Melinda Sue Norin 

 Abstract:Dr. Norin will be sharing the value of Knowledge Management (KM) from different organizational perspectives. She will also be discussing examples of organizational successes and failures. Dr. Norin will expand our understanding of Knowledge Management beyond compliance with ISO 9001, introducing many useful and effective tools and techniques. 

Speaker Bio:Dr. Norin has consulted or trained more than 6,000 representatives from the City of Los Angeles, City of Santa Monica, the SCAQMD, IRS, FBI, Counties of Ventura, San Bernardino & Los Angeles, USC+LAC County Medical Center, Home Depot, DWP, LAUSD, Latham & Watkins law firm, the YMCA, Google, US Postal Service, Target, many retail outlets, hotels, aerospace, restaurants, banks, insurance organizations, media outlets and technology startups -- to name a few. 

During her 30 years of consulting, she has developed marketing strategies, tracking programs and government forms; she has created policies and procedures, introduced motivational tools, taught public speaking techniques, and guided organizations in creating many quality programs. 

For three consecutive years, Dr. Norin was named "Employee of the Year" while working with Commuter Transportation Services, now known as Metro. Dr. Norin earned a "Diamond Award" after consulting the LA County+USC Medical Center. The Los Angeles Unified School District Board of Supervisors surprised her with a 'Certificate of Recognition" during a televised Board Meeting after working with LAUSD management creating a marketing program for the students, faculty and staff at 300 schools. 

Dr. Norin's educational background and eclectic experience has allowed her to observe both quality performance and many quality organizations having diverse goals. She has also witnessed the setbacks when businesses remain unprepared to address challenges. 

Register Here: Click here for details and to register for the August General Meeting


July 18 General Meeting - ISO 15189 Medical Laboratories with Shaun Waters 

Register Here:  https://ticketbud.com/events/fa14bbce-61f8-11e7-a1c3-0b8ad0417518

Abstract:This presentation will cover the principles of ISO 15189, which applies to accreditation of medical reference laboratories. It will also emphasize the key concepts of ISO 15189: developing a quality management system, designing continual improvement projects, and utilizing root cause analysis to assess problems. The differences between ISO 9001 and ISO 15189 will be discussed to emphasize the specificity of ISO 15189 to medical laboratories. The cyclical process of earning and maintaining accreditation will also be presented in detail. 

Speaker Bio: Shaun Waters developed a year-long continuous improvement project as part of Genzyme Genetics’ College of American Pathologists (CAP) ISO 15189 accreditation process. The project was designed to determine the root cause of a recurring issue involving a pervasive contamination problem with specimens that were received from certain clients. Shaun presented the findings of his project to the CAP auditors during the final evaluation. Genzyme Genetics became the 2nd lab in the U.S. to achieve the ISO 15189 accreditation. 

Shaun graduated from UC Riverside in 1999 with a Bachelor of Science in Biochemistry. He began his laboratory career at Genetics Center in Orange, CA, where he worked primarily performing tissue culture for cytogenetics applications for 9 years. Shaun has been a CLSp(CG) licensed cytogenetics technologist for 15 years. He also earned his MBA from USC Marshall School of Business, while working full-time in the laboratory and attending the MBA.PM program in the evenings, specifically designed for working professionals. 

Shaun continued his cytogenetics career with Genzyme Genetics working as part of the team to earn ISO 15189 accreditation. He is currently working as a product manager for the Cytogenetics and Classical Media lines for Irvine Scientific, a tissue culture media company, in Santa Ana, CA.

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