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2014 ASQ San Diego Quality Conference

Building a Community for Quality

Conference Theme

2014 ASQ San Diego Quality Conference Theme


The quality community is comprised of three principal groups; local companies with a focus on quality, quality

professionals that serve those companies, and the supporting organizations like American Society for Quality. The vision

for this year’s conference is to bring these three parts of our quality community together to build relationships and

capability, to increase the impact of quality.

Companies desire an effective quality program and culture as the benefits include decreased cost,

improved product and service, and increased employee engagement.

The success of the quality programs within our local companies depends on the capability of the quality professionals

they employ. Attendees to this conference receive the very training needed for the local companies they work for or

desire to work for, preparing them both to be more successful.

ASQ San Diego section exists to serve our community and through facilitating and organizing this type of conference

helps to build relationships and increase everyone’s ability to succeed. ASQ can connect companies with highly qualified

quality professionals, develop training opportunities, and transfer knowledge and expertise to our quality partners. Our

goal is to help build a successful quality community. Building a conference that meets the needs of all three groups at

one event is truly magnifying value for all. It is a demonstration of what the quality profession is all about.

. 2014 ASQ San Diego Quality Conference


Conference Sponsors

HOST Sponsor:

HOLOGIC Inc, 6333 Sequence Drive, San Diego, CA

Hologic is a global leader in the development, manufacture

and marketing of rapid, accurate and cost-effective molecular

diagnostic products and services that are used primarily to

diagnose human diseases, screen donated human blood, and

ensure transplant compatibility.

Silver Sponsor: Eyes On, Inc.

Eyes On, Inc. provides consulting services on software process improvement and quality management systems primarily

for the medical device and pharmaceutical industries. Systems experience includes ERP, document management,

training, warehouse management, supplier management, calibration systems, and many others.

ASQ San Diego Quality Conference Planning Team:

It takes a team of individuals working together to make an event like this a success. Our team of volunteers has worked

for months to build an event that we hope you will enjoy and find especially beneficial. Please take a moment to thank

them for their effort.

Jeffrey Andersen Nancy Pasquan Brooks Carder Ed Perias

John Cassidy Elizabeth Rietow Loretta Curtin David Stifter

Geraldine Domingo Vivian Terry Tusa Enriquez Adriana Varvara

Nancy Maple Elayne Summers

We hope you enjoy the conference!

Mark Claywell, ASQ San Diego Conference Chair, ASQ/DON LSSBB, PMP, [email protected]

mailto:[email protected]


Friday, November 7

Registration: 7:30 a.m. – 9:00 a.m. in Atrium Continental Breakfast: 8:15 a.m. – 9:00 a.m. in Cafe

Conference Workshops: 9:10 a.m. – 5:00 p.m. in Learning Centers A and B

Track A – Learning Center A Track B – Learning Center B

Morning Sessions: 9:10 a.m. – 12:00 p.m.

Enlightened Project Management - Part 1 Joe Drammissi

Managing Supplier Performance Mark Lindsay

Networking and Lunch: 12:00 p.m. – 1:00 p.m. in Cafe

Afternoon Sessions: 1:10 p.m. – 5:00 p.m.

Enlightened Project Management - Part 2 Joe Drammissi

Visual Workplace Lisa Thompson

Saturday November 8th

Registration: 7:30 a.m. – 9:00 a.m. in Atrium Continental Breakfast: 8:15 a.m. – 9:00 a.m. in Cafe

Welcome and Announcements: 9:00 a.m.: Waterfall Café: Mark Claywell, Keith Boyle

Keynote Address: 9:10 a.m. – 10:00 a.m.: Waterfall Cafe: San Diego County Supervisor Dave Roberts

Mid-Morning Break - Networking: 10:00 a.m. – 10:30 a.m.: Atrium

Conference Sessions in Learning Centers A & B and Cafe

Track A – Learning Center A Track B – Learning Center B Track C – Cafe

Mid-Morning Sessions: 10:30 a.m. – 11:30 a.m.

Intro to Lean Process Improvement

Henry Herz

Performance Metrics to Improve Operator Engagement and Accountability

Abe Chohan

ISO 9001:2015 Changes Manuel Marco

Lunch and Featured Speaker: 11:35 a.m. – 12:30 p.m.: Waterfall Cafe: Genero Crenshaw

Track A – Learning Center A Track B – Learning Center B Track C – Cafe


Optimal Training Marilyn Monda

Unique Device Identifiers Lisa Thompson

Expectations & Accountability Mike Oslovar

Afternoon Break - Networking: 1:40 p.m. – 2:00 p.m.: Atrium


Lose the Carrot and Stick, Substitute Leadership

Marilyn Monda

Medical Device Packaging and ISO 11607 -1/-2 Compliance

Jan Gates

Operational Excellence with Quality Systems

Bob Lane


Design for Operational Excellence Keith Boyle

Effective Use of SPC Bill Oakes

Quality Metrics Chris Holl

End of Day Panel Discussion, Closing Notes and Door Prizes: 4:10 – 5:00 p.m. Waterfall Cafe: Experiences with Risk Panel: Nancy Pasquan, Mark Claywell, and Keith Boyle



Keynote Address: Saturday November 8th

Keynote Speaker

San Diego County Supervisor Dave Roberts

Prior to his election to the Board of Supervisors in 2012, Supervisor Dave Roberts completed

two terms on the Solana Beach City Council and served as the city’s Mayor and Deputy

Mayor. He began his public service as a Commissioner for the Solana Beach Budget and

Finance Committee and Vice Chair for the Friends of the Solana Beach Library.

Dave is a former corporate officer for SAIC, a Fortune 500 company. He also founded, owns

and operates his own multi-state real estate management company.

In 2012, Dave became the first newly-elected supervisor in 20 years. He resigned from his

position as a senior manager for the Healthcare Information and Management Systems

Society, an international nonprofit organization. In that role, Dave drew upon his background

as an appointed health policy advisor in the Administrations of both President Barack Obama

and former President George W. Bush. Dave earned national recognition for reducing costs and improving the delivery of

Medicare, Medicaid and children’s health insurance coverage. Dave also worked for the U.S. Air Force at the Pentagon

and in Europe. He played a key role in developing TRICARE, the military's health insurance system.

Dave lives in Solana Beach with his family and has six children, ages 2 through 19. Dave earned his Eagle Scout Award in

1975. His oldest son, Robert, is an Eagle Scout who recently began training for the U.S. Air Force at Lackland AFB, Texas.



Featured Speaker: Saturday November 8th

Featured Speaker

3 Secrets to Communication That Get Acceptance, Buy-In & Commitment To Your Ideas,

Projects & Requests for Support (even if you’re not a manager or project leader)

Genero Crenshaw

Are your ideas, projects, or requests for support getting the response you desire?

Would you like to have more control or be more persuasive without being seen as a

("you know what you call them”)?

What if you could honestly say yes to both of those questions, how would you feel

about your work?

This presentation is designed to give systematic and predictable strategies and tactics

you can implement immediately to increase your ability to influence the decisions that

are important to you while being seen as a "good guy/girl" so that you get support and commitment for your ideas and

projects.

Genero Crenshaw is the managing partner of The Crenshaw Consulting Group. They help leaders rev up their careers,

ramp up their communication skills and raise the lid on their success. Over the past nine years their clients have

included Sony, HP, and General Dynamics to name just a few. The skill that their clients say has the most impact is the

ability to inspire and influence others to action with the spoken word.



Conference Workshop Descriptions: Friday November 7th

Enlightened Project Management – An Approach for the 21st Century Workplace:

Joe Drammissi

Full Day Workshop

The workplace, along with the workforce, is rapidly changing as we move into the 21st century. As project work is an

integral part of most organizations it makes sense that project management will be evolving to meet the challenges of

the new environment. Enlightened Project Management® addresses the issues that cause much of the stress and less

than optimal performance experienced by project managers and their teams. Most of the pain we experience as project

managers is self-inflicted and can be remedied by applying the tools and techniques of Enlightened Project

Management®. By becoming an Enlightened Project Manager you will not only significantly improve the performance of

your team but you will help to improve the workplace environment, making your organization more successful and its

employees happier and more productive.

Managing (Improving) Supplier Performance:

Mark Lindsay

Half-Day Workshop

This tutorial will be facilitated as a hands-on World Café setting. We will cover the body of knowledge outline on Supplier

Management based on the CMQ-OE Certification and focus on Supplier Performance Ratings.

Various examples of Supplier Performance Ratings will be shared with the participants along with soft copies of working

templates that they can modify and use at work. The participants will form into working groups as a World Café and

develop Affinity Diagrams to determine the key supplier issues that are common within and between the groups. We

will then develop Interrelationship Diagraphs to determine the key Drivers and Outcomes associated with the key

supplier issues. This gained and shared insight can be used as criteria to use on the participant’s own Supplier

Performance Ratings. Time permitting, we will discuss the next steps to deal with these issues.

Visual Workplace:

Lisa Thompson, Hologic Inc.

Half-Day Workshop

Most people do not understand the tremendous power of a visual workplace and may not even understand that they are

impacted by a visual workplace every day. It is often treated as just another form of improvement effort, whether lean

or Six Sigma. Visual workplace is not merely the posting of signs or taping borders around equipment or tools. It is a

self-ordering, self-explaining, self-regulating, and self-improving work environment. There is a specific purpose for it and

those who write it off as “just making things pretty” are missing out on another opportunity for improvement.



Conference Session Descriptions: Saturday November 8th

The following are all ~45 minute presentations:

Introduction to Lean Process Improvement:

Henry Herz

Lean is a process improvement methodology developed by Toyota over fifty years ago, and successfully applied ever

since. The focus of Lean is to shorten lead times, lower costs, and reduce mistakes through the reduction or elimination

of wasteful process steps.

This presentation will provide a high-level introduction to the following Lean topics: History of Lean, Benefits of Lean,

Attributes of a Lean Enterprise, Principles of Lean, Value, Value Stream Mapping, Waste, 5S, Flow, Pull, Mistake Proofing

and Kaizen Events.

Performance Metrics to Improve Operator Engagement and Accountability:

Abe Chohan

This presentation will discuss case studies on aligning operator-level metrics to company objectives. A team-based

approach to developing and managing metrics that ensure operator engagement, performance and avoiding negative

consequences will be described.

ISO 9001:2015 Changes:

Manuel Marco

As over 1.1 Million organizations around the World have been certified to the ISO 9001 standard, there is a tremendous

anticipation to the upcoming changes of the ISO 9001 standard. This presentation will provide an update on the current

changes and status of the 2015 revision of ISO 9001.

Optimal Training:

Marilyn Monda

Be the best you can be by learning how to coordinate your professional development with a Learning Management

System (LMS). LMS systems and criteria for their evaluation will be discussed and your top level professional goals will

be explored.

Unique Device Identifiers:

Lisa Thompson

As a medical device manufacturer, Hologic, Inc. is required to comply with the FDA’s guidance on UDI (Unique Device

Identification). Some of the products we manufacture are Class III products which required us to apply barcodes to our

outer packaging by September 24, 2014. This one-hour session will focus on how we initiated, planned and executed the

activities required to meet the FDA’s deadline. This discussion will be beneficial for anyone who is required to adhere to

this guidance and who is either currently in the process of compliance or has not yet started their UDI journey.

Expectations & Accountability: A ‘How To’ Guide:

Mike Oslovar

One of the more difficult tasks that a manager may have to conduct is to hold an employee accountable for some sort of

misconduct in the workplace. There is little doubt these conversations are difficult not only for the employee, but the

manager as well. This presentation is a practical set of guidelines that will bring structure to these situations and help

the manager navigate through these difficult situations.

Lose the Carrot and Stick, Substitute Leadership:

Marilyn Monda

Motivate, achieve results, and advance your corporate culture. Understand how to live your leadership legacy using

intrinsic and extrinsic motivation in this highly interactive session.

Medical Device Packaging and ISO 11607 -1/-2 Compliance:

Jan Gates

This talk focuses on getting ready for an ISO 11607-1/-2 audit – Packaging for Terminally Sterilized Medical Devices,

through a packaging development process in a company. There are over 115 “shall” statements in the two documents.

How do you make sure all portions are covered in a reasonable, sensible manner? Insights into where the necessary

documentation might exist and how to find gaps that may be present will be presented.

Operational Excellence with Quality Systems – Why there is no alternative:

Bob Lane

Quality is Operational Excellence – Why There Is No Alternative - is a fun, fact filled presentation that explores why

Quality is your key to success. The audience will learn how to establish their company’s competitive advantage with

Quality at the forefront. Simple, proven operational steps to achieve success with Quality will be the catalyst for

knowledge sharing.

Discussions exploring the range and magnitude of Quality problems and their business impacts will be countered with

solutions that make sense. All participants will walk away with a refreshed perspective on how synchronous Quality and

continuous improvement are. The presentation will conclude with “Stories to Remember”; case studies of world class

results.

Design for Operational Excellence – Taking you and your organization beyond the Lean and

Six Sigma improvements and into sustainable dramatic business improvements:

Keith Boyle

You are making an investment by attending this ASQ Quality Conference. This investment is in your organization’s

success and the return is knowledge. This knowledge is in the form of how other companies have applied continuous

improvement but then when you revisit your benchmarking partners you realize that they have not been able to sustain

the gains. Continuous improvement is much more that eliminating waste, it’s about the design process to prevent waste

from being produced.

This presentation will take you through the 4 Concepts of Design for Operational Excellence:

Defining what Operational Excellence looks like

Creating the Roadmap to plot the Journey

Knowing when you have Arrived

How do we get there Faster?

Keith will share the details of these concepts from some of the companies he has worked with in Design for Operational

Excellence while creating sustainable dramatic improvements in operational performance.

Effective Use of SPC:

Bill Oakes

Beyond the nuts and bolts of setting up SPC charts and calculating limits, it is important to understand how SPC can be

used efficiently and effectively to control a variety of processes where the outcomes are measured. In this session we

will look at some practical lessons in SPC implementation and use.

Quality Metrics:

Chris Holl

Measurement is an essential component of project management and process improvement, but rolling out a metrics

program has many challenges for both team metrics and corporate metrics. The presenter will share his failures and

successes in implementing company-wide metrics while serving as Intuit's Corporate Software Metrics Leader. These

lessons are about metrics and technology, but mostly about people. The key ingredients of a successful metrics program

are to fully engage stakeholders at all levels as vested owners by aligning measurements with their goals, providing easy

access to the metrics, and having full management support.

Panel Discussion – Experiences with Risk:

Nancy Pasquan, Mark Claywell, Keith Boyle

This interactive panel-audience discussion focuses on the panel member’s experiences with Risk over a diverse range of

industries. A Q&A period will provide audience members an opportunity to raise various questions and concerns

regarding this topic.



Speaker Biographies

Joe Drammissi

Joe Drammissi, MSPM, PMP, PMI-ACP, CSM is a project management trainer and consultant with over 23 years’

experience in design engineering, project and program management in both commercial and defense related industries.

Joe is a co-founder and principal at Paceline Consulting Group LLC, a project management training and consulting

organization. Joe teaches project management at UCSD Extension and PMP Exam prep classes for the Project

Management Academy. Joe is an active member of PMI-San Diego and is currently the VP of Professional Development

at PMI-SD.

Mark Lindsay

Mark Lindsey is the Education Chair for ASQ 0701 and works at the Disneyland Resort as a Manufacturing Engineer

supporting Safety and Quality. He has previously worked in other industries (Aerospace/Defense, Electronics, and

Manufacturing) during the last 30 years. He teaches many of the ASQ Certification Refresher Courses for ASQ 0701 and

has delivered presentations at numerous ASQ events at the Section, Division, and the National level.

Lisa Thompson

Lisa has 16 years of experience with Hologic with 10 years working in continuous improvement. In 2008, she was tasked

with creating a Corporate Continuous Process Improvement Program to manage a portfolio of process improvement and

business systems initiatives across the organization. In 2009, Operational Excellence was introduced, and Lisa was

identified as one of the original Lean Champions to spearhead this effort. Lisa has a Lean Six Sigma Black Belt certification

from UCSD and a Master of Science in Global Leadership from USD.

Henry Herz

Henry Herz is a partner at Lean Business Solutions. He is a certified Lean Six Sigma Black Belt, with over 20 years’

experience creating and leading software development and professional services teams. He has participated in SEI CMMI

and other process improvement initiatives at several firms. Henry earned a B.S. degree in Operations Research (OR) &

Industrial Engineering from Cornell, an M.S. in OR from George Washington U., and an M.A. in National Security Studies

from Georgetown U. He has Project Management Professional (PMP), Certified Scrum Master, ITIL, MCP, and

International Business certifications.

Manuel Marco

Manuel Marco has been involved with Management System Certification since 1993 in Europe, North America and Latin

America, where he has held different management positions. Manuel has been qualified as Lead Assessor for ISO/IEC

20000-1, ISO 9001 Lead Assessor, QS-9000 and ISO/TS 16949, and Assessor for ISO 14001. He has also been qualified as

Lead Evaluator for the Carnegie Mellon eSourcing Capability Models for Service Providers (eSCM-SP) and Clients (eSCM-

CL). Manuel is a senior member of ASQ. Currently, Manuel is the Western District Manager of DNV Business Assurance in

North America.

Marilyn Monda

Marilyn Monda is an executive-level management consultant and Business Process Improvement (BPI) professional with

over 30 years’ experience. A seasoned Master Black Belt, facilitator, statistician and CEO of Monda Consulting, LLC;

Marilyn has delivered millions in direct benefits in manufacturing, ERP/SAP, R&D, marketing, sales and HR functions. A

change management leader, Marilyn has a proven track record in global strategy execution and project management.

Abe Chohan

Abe is an experienced operational and academic leader with a true passion for continuous improvement. He currently

serves as VP of Operations for Inova Diagnostics, a Werfen Company, and as a Director on the Board of San Diego Youth

Symphony & Conservatory, a non-profit organization.

He has a BS in Chemical Engineering from the University of Rochester, an MBA from SUNY Buffalo and a Lean Six Sigma

Black Belt from UCSD. He has previously worked in the Chemicals, Pharmaceutical and Aerospace industries, ranging

from start-up to Fortune 500 organizations, as well as adjunct professor at the University of Phoenix.

Mike Oslovar

Mike has held positions of leadership in software systems development, quality assurance, configuration management,

systems integration and systems management since 1983. Mike has been an adjunct professor in the Fermanian School

of Business since 2005, and has taught courses in Technology Implementation, Operations, and Contemporary

Leadership. Currently Mike is the Manager of Device Software Quality at Hospira Corporation, where he oversees the

conduct of various product assessments and system audits. Prior to joining Hospira, Mike was the Director of Quality

Assurance for Patient Safe Solution, manufacturer of a bedside medication Safety system, Financial Profiles, a financial

planning company, and Syntricity Inc., which developed yield analysis software for the Integrated circuit manufacturing

industry. He also spent four years as Director of Quality Assurance and Technical Support for OrderFusion, a B2B

eCommerce software supplier. Mike holds a Master’s of Science degree in Systems Management from the University of

Denver, and Bachelor of Science degree from the United States Naval Academy.

Jan Gates

Jan Gates has more than 30 years’ experience in package engineering with foods, pharmaceuticals, detergent, and

medical devices, most recently with Abbott Vascular. Her work includes individual contributions and leading teams for

packaging material and systems design/development to meet regulatory, product protection, and customer use

requirements with production optimization, validation, and minimal packaging. Jan also has worked with AAMI, ASTM,

and ISO committees developing industry standard test methods and guidance documents.

Bob Lane

Bob Lane is the Founder and President of LaneOPX a Professional Services, Training and Education Company. LaneOPX

(www.laneopx.com) works closely with manufacturing firms across multiple industry sectors to improve operational

efficiencies and implement sustainable results. Bob is recognized for turning around organizations and leading

companies to success. He is an expert in lean operations, global supply chain management, and building organizations.

Sony, Textron, Biotix, GP Strategies, Nexiant, RTI Electronics, ViaSat and General Atomics represent a sample of the

companies that have benefitted from Bob’s body of knowledge.

http://www.laneopx.com/

Keith Boyle

Keith Boyle, P.E., is an internationally recognized performance professional and principal consultant with Quality &

Productivity Resources (QPR) – a consulting company assisting organizations to achieve performance excellence. He is a

renowned instructor and facilitator, an ASQ Certified Six-Sigma Black-Belt, Certified Master Black-Belt and recognized

Lean Sensei. He has trained and coached hundreds of Six-Sigma Black-Belts and Green-Belts and facilitated successful

Lean and Six-Sigma deployments and transformations at major national and international organizations. He is a Baldrige

National Quality Award Senior Examiner and a past member of the California Quality Award board of examiners.

Bill Oakes

Bill Oakes is the interim Chair of the Palomar section and is a Senior Staff Quality Engineer at Qualcomm. He holds 4

certificates from ASQ, a BS in Engineering from Harvey Mudd College and an MS in Systems Management from USC. For

the past 7 years Bill has worked with a Qualcomm display manufacturing plant in Taiwan on effective use of SPC and

various methods of demonstrating process capability.

Chris Holl

Chris Holl led Intuit's software engineering metrics program for five years; learning which approaches work and which

fail. In this presentation he will share some of the successes and failures in deploying both local group metrics and

corporate metrics and the benefits for all stakeholders.

Nancy Pasquan

Nancy is an ASQ Certified Software Quality Engineer (CSQE) and Certified Biomedical Auditor (CBA). She holds a BS in

Computer Science and has 30 years of experience working with software across a wide variety of (mostly) regulated

industries including military, aerospace, pharmaceuticals, and medical devices. She has been conducting formal and

informal supplier audits for over 15 years and certification audits for the past 2 years. An active volunteer for ASQ, SSQ

and DIA, Nancy travels whenever the opportunity arises and works as chief cook and bottle washer for her consulting

company, Eyes On, Inc.

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