1. BOSCON 2015
The Boston Quality ConThe Boston Quality ConThe Boston Quality ConThe Boston Quality Conferenceferenceferenceference
Challenges & Innovation
Tuesday, April 14, 2015
The Conference Center at Waltham Woods
Waltham, Massachusetts
www.asqboston.org
The American Society for Quality
Boston Section

2. Visit our web site at www.asqboston.org and participate in our monthly meetings.

3. Visit our web site at www.asqboston.org and participate in our monthly meetings.
What you will experienceWhat you will experienceWhat you will experienceWhat you will experience at BOSCON 2015at BOSCON 2015at BOSCON 2015at BOSCON 2015
BOSCON 2015 brings to you, under the theme
“Challenges and Innovation”, the experiences of
recognized professionals who will be presenting
advanced solutions from organizations like Philips,
Rockwell Automation, Harvard Business School, Shire,
Raytheon and many others, making this event “The
Boston Quality Conference”.
The following American Society for Quality Boston Section leaders, and many
additional volunteers, have worked together to make this event a success:
• Jim Saropoulos Chair Chair@asqboston.org
• Sarah Rauhut Secretary Secretary@asqboston.org
• Maryse Constant Treasurer Treasurer@asqboston.org
• Arnold Greenbaum Arrangements & Scholarship Chair
• Jim Turner Certification Chair
• David Manalan Communications Chair
• Gil Andrade Nominations Chair
• John Athanasiadis Awards & Recognition Chair
• Byron Mattingly Web Chair
• Alice Maina Special Projects
A special thank you to the Speakers, Sponsors and Exhibitors.
Also, remember that your survey responses are essential for us to improve our activities
and benefits for ASQ members.
Have a great time and enjoy your day.
Carlos E. DaSilva
BOSCON 2015 Chair
+1(978) 460 8625 or +1(978) 905-0342
Carlos.DaSilva@asqboscon.com

4. Visit our web site at www.asqboston.org and participate in our monthly meetings.
Track 1: Software & Security
9:00am - Fuzzing the Stack - Security Testing At All Communication Layers
All software information systems communicate at multiple levels (a protocol stack, generally described by
the 7 layer OSI model.) Whether you test at layer 8 (phishing) , layer 7 (GUI) or lower layers that use
Bluetooth, NFC or WiFi, or use waterfall or agile development, you will need to inject malicious input
(fuzzing) into the system in order to do security testing. Tools and mindsets to do this will be discussed. In
addition, the standard metric of code coverage is complicated by the use of open source code. Open
source code is used at all levels of programs from device control to user interface. While it should be
included in code coverage calculations, it is different from the code created for the project because it
often has known security vulnerabilities described in public CVE databases and those can also be tested
using input fuzzing.
Jim Weiler has been a developer for 30 years and an application security guy for over 10 years. Currently
he is the Application Security Architect for Starwood Hotels. He also started and has run the Boston
chapter of the Open Web Application Security Project (OWASP) for over 10 years and is the conference
director for the OWASP Boston Application Security Conference.
10:00am - Software Process Improvement: Factors for Success
The presentation is interactive utilizing SPI interview protocol to discuss and provide research results that
are applicable to software development.
Ann McDonald is the Quality Manager for Stinger Ghaffarian Technnologies at the Volpe Center for the
US Department of Transportation. Ann is working on special projects for the NextGen software for the
FAA. She is an ASQ CSQE, Certified Scrum Master, and was recently named one of 17 Subject Matter
Experts (SMEs) in Software Quality for the SGT Class of 2014 FSME's.
11:00am - Cybersecurity Challenges for Medical Device Manufacturers
This presentation will provide a discussion of cybersecurity threats and include information on complying
with the critical steps/recommendations included in the FDA guidance document titled "Content of
Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014.
Steve Rakitin is a software consultant with over 40 years of experience as a software engineer and
software quality manager. He has worked in the medical device industry for 25 years. He is a frequent
speaker on topics to medical device software. Steve authored the book titled "Software Verification &
Validation for Practitioners and Managers".

5. Visit our web site at www.asqboston.org and participate in our monthly meetings.
Track 2: Professional Development
9:00am - What's Happening with ISO 9001?
The ISO 9001 revision is making headway towards its 2015 release date. The standard hasn't experienced
a significant makeover since 2000, so the impending change is being greeted with both excitement and
trepidation.
Multiple changes are being proposed. The structure is markedly different. New concepts have been
introduced, requirements have been added and existing text has been shifted around.
This presentation will provide an overview of the status of the revision project, key changes that can be
expected and tips on how to prepare for the transition.
Denise Robitaille is a member to US TAG to ISO/TC 176, the standards developers responsible for ISO
9001 and ISO 9004 and the portfolio of QMS support standards.
For 20+ years, Denise has helped companies achieve ISO 9001 registration and derive benefit from their
management systems. She is recognized internationally as a speaker and trainer, and has worked in
numerous industries and government agencies.
She is the author of twelve books, including ISO 9001:2008 for Small and Medium-Sized Businesses. , The
Corrective Action Handbook, 9 Keys to Successful Audits, and ISO 9004: The Key to Sustainable Success.
(E-book).
10:00am - Leadership Development: A Requirement for Success
In many places, leadership is thought to be about position, title or roles. Leadership development applies
for everyone and in every situation for greater effectiveness, growth and greater impact. Talent, success
and educational background are not enough for success.
In order to become more effective and grow as an organization, we need bosses who lead, engineers who
connect, and team members who work together. We need subject matter experts who can equip others
and we need CEO’s who truly value their employees.
Leadership ability is the lid that determines a person’s level of effectiveness.
Kemi Sorinmade is the owner of the Growth studio, a business improvement and leadership development
firm based in Massachusetts. She is also a certified leadership development coach with the John Maxwell
team and she works with individuals, business owners and corporations by offering improvement and
leadership development strategies for more effectiveness and growth.
ASQ Boston Section Courses

6. Visit our web site at www.asqboston.org and participate in our monthly meetings.
11:00am - Global Leadership for New Economy
Effective leadership skills create right organizational values, direction, increased customer focus, robust
processes and promote performance excellence.
The presentation will cover:
- Acquiring the leadership skills necessary to champion global improvement
- Creating and promoting an environment of quality and productivity
- Deploying robust processes within an organization
- Communicating, empowering and motivating employees
- Focusing on organizational objectives and improving performance to realize the vision
- Fostering Management responsibility for Quality Management Systems
Jay P. Patel is CEO and founder of Quality & Productivity Solutions, a consulting and training firm
specializing in Lean Six Sigma, Project Management, Quality Systems, and Business Improvements. He has
25+ years of experience in management and quality and has held wide-ranging positions including Plant
Manager and Corporate Director of Quality. He has Bachelor and Master Degrees in Engineering and an
MBA. Jay is a RAB-Quality System Lead Assessor, an ASQ Fellow and has 10 ASQ Certifications.
He is a past chair of ASQ Worcester Section and has served as Chair of ASQ NEQC for six terms since
1998, besides serving NEQC conference during the last 14 years.
Track 3: FDA & Healthcare
9:00am - Value-Based Health Care
The presentation will cover the core concepts of value-based health care delivery. Health care value
represents the outcomes that are achieved relative to the cost by medical condition. The talk will cover
how to measure outcomes and costs, how to organize care delivery to achieve good outcomes at low
costs, and how to structure payments to providers to align their incentives to deliver high value care.
Derek Haas is principal of Affordable Futures, LLC and manager of the Chamber Health Coop. Before
founding Affordable Futures, he was a health care consultant to the Massachusetts Office of the Inspector
General. Previously, he worked on the staff of the White House Council of Economic Advisers, and for the
management consulting firm Bain & Company. He is a licensed health insurance broker, and has a MBA
and a BA from Harvard University.
10:00am – Deploying Quality Metrics
Health Authorities are increasingly interested in company-generated Quality Metrics to provide insight to
the safety and availability of our drug supply. This information can also be helpful in establishing
inspection priorities. Biopharmaceutical companies use a variety of measurement tools to monitor and
improve the quality of their operations. This presentation will share the evolution of metrics used by Shire
to monitor effectiveness of our Quality Systems and our approach for evaluating robustness of our
products manufactured both internally and externally.
Charlene Banard, Senior VP Quality at Shire. Charlene is a member of the Global Technical Operations
Leadership Team and is responsible for the global GMP and GDP Quality function. Prior to joining Shire,
she held quality roles in Gilead Sciences, Cell Genesys and Chiron Corporation (now Novartis). She has an
undergraduate degree in Biochemistry and a Masters in International Business.

7. Visit our web site at www.asqboston.org and participate in our monthly meetings.
11:00am - Management Responsibility in FDA QSR
The FDA’s Quality System Regulation (QSR) prescribes a medical device manufacturer’s Quality
Management System (QMS). The presentation describes Management Responsibility by reviewing the
regulations, inspection methods, and Warning Letters.
There are five components to Management Responsibility. This presentation explains each of them. A
bonus checklist helps guide your effective implementation.
The presentation examines the requirements for management responsibility using FDA based information.
We look at the structure of regulation in 21 CFR §820.20 and its constituent parts. This section has many
defined terms that bear on implementation. The presentation examines and explains the terms.
The presentation draws on many sources to provide the understanding you need for an effective
implementation. One rich source is the preamble in which FDA-CDRH responded to suggestions and
comments about the draft regulation. The Quality System Inspection Technique (QSIT) guides
Investigators during an inspection. QSIT includes flow charts and narrative that the presentation
incorporates. Warning Letters represent problems that FDA Investigators uncovered during an inspection.
They provide an opportunity for you to learn from the mistakes of others.
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in
regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master Degree
in Mathematics. His professional experience relates to quality, reliability, and operations management.
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational
Excellence. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability
Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.
NOTES:

8. Visit our web site at www.asqboston.org and participate in our monthly meetings.
Track 4: System & Communications
1:30pm - Connected Enterprise - Improving Efficiency with Smart Sensors
This presentation will be an introduction to the next generation of Smart Sensors with IO-Link
communication technology. With IO-Link enabled sensors, the PLC has direct communication with the
sensors, providing real-time monitoring of sensor parameters for trending/diagnostics or giving ability to
remotely re-program sensors with multiple configurations to decrease downtime during changeovers. We
will explore the benefits and potential applications to enhance manufacturing lines, ultimately leading to
higher quality products.
Kentaro Sugimoto has 14 years of experience, focused on providing applications support and validating
products in customer applications across different industries. Kentaro began his career in 2001 at National
Instruments Japan. Now, he is a Project Quality Engineer at Rockwell Automation responsible for
validating next generation industrial sensors and safety devices. Kentaro has a Dual Bachelor Degree in
Computer & Systems Engineering and Computer Science from Rensselaer Polytechnic Institute, Troy, NY.
Kentaro brings with him a broad range of skills and certifications, like NI LabVIEW Programming; Teradyne
Catalyst/FLEX Programming; Cisco Certified Network Assistant; Audio Engineering; and is fluent in
Japanese.
2:30pm - Rethinking Quality!
- It's Time to Adapt -
- It's Time for a "New Adventure" in Quality! -
This presentation will share an evolutionary perspective with regard to how companies have evolved their
quality capability, and perhaps you can gain a perspective on your own operations (What’s working and
What’s not!), and where you might next evolve. The intent is to cause you to rethink your current
companies Quality practices, and adapt them to tomorrow’s needs. Your reality is you will be required use
less energy while achieving the desired result.
Hopefully, you will leave this session with new insight into how you could apply very basic Newtonian
based physics principles to the changes ahead. (No numbers… just physics principles applied to Business
and Change Management.). A few successful approaches to Software Quality, COPQ, Customer
Satisfaction Metrics and Supplier Quality Management in China will be shared.

9. Visit our web site at www.asqboston.org and participate in our monthly meetings.
John (Jack) Rabbitt is a member of ASQ Worcester Section. He has a BBA University of Mass, Amherst, an
MBA California State University, a PhD: The National Graduate School (NGS). He is a Certified Lean Six
Sigma Black Belt; and a Sr. Adjunct Professor – 15+ Years: Teaching graduate Master Degree level courses
in Quality Systems Management, Continuous Improvement, Hoshin Planning and more; and he authored
6 books on Quality Systems.
3:30pm - Defining Metrics and KPIs That Don't Harm a Company, but Improve It
Many forms of measurement on Quality, Time and Costs are all around us at work and outside of work;
mostly with the purpose of providing decision support information to do our jobs well and have our
organizations do well.
While this sounds fairly simple to do, the reality is that too often wrong conclusions are made, based on
inaccurate information or looking at the wrong information. Worse, poor selection of metrics to track and
review, likely will drive unintended negative consequences within a company, such as focusing on
improving a particular metric at the expense of the overall company health, success and achieving its
strategic goals.
This presentation covers the difference between metrics and KPIs (Key Process Indicators); who reports a
metric vs. who can influence it; and provides practical, straightforward, keys to success in defining and
making use of metrics and KPIs.
George Lane has over 20 years of experience in leading organizations and improvement projects in
Quality Assurance, Quality Engineering/6-Sigma, Quality Management Systems, New Product Introduction,
Operations and Supplier Quality. He has helped start-up companies reach commercial success and large
companies revitalize their key processes and systems.
George has a Masters’ Degree in Industrial Engineering/Operations Research from UMass-Amherst; a
Business Degree from The State University of New York and is a Senior Member of the American Society
for Quality.
Track 5: Innovation
1:30pm - Meeting the Challenges of Manufacturing in an Age of Outsourcing
Today we find challenges in hiring and retaining qualified help to set up, run and maintain the highly
technical manufacturing equipment used to produce everything from screw type fasteners to
pharmaceutical tablets or medical devices.
As an independent consultant working in these areas, Mr. Gillis sees the impacts on schedule, profitability
and market position as obstacles to having the right people in place and retaining them, presenting
continued challenges to meeting the needs of production and product development. This presentation
will focus on some of the issues that have surfaced and steps being taken to meet these challenges. In a
recent report from Boston Consulting Group, it is reported that companies with sales of $1 billion plan to
make 47% of their products here in the US in the next 5 years, up from 44% last year. We are seeing
resurgence in on-shoring and we need to be prepared to meet these challenges going forward.

10. Visit our web site at www.asqboston.org and participate in our monthly meetings.
Charles (Chuck) Gillis has an undergraduate degree in the life sciences and has done graduate study
towards an MBA. He is a certified Master Black Belt and a senior member of ASQ.
As a founder of Work Stream Consulting, he has been able to bring these skills into play with many
diverse clients from Healthcare, Medical Device and Pharmacy to traditional Manufacturing situations. He
has also worked with his client base to develop their own continuous improvement efforts, raised the bar
on expectations, and returned a solid ROI for all project efforts undertaken using Lean Sigma
methodologies.
2:30pm - Challenges & Innovation: Process Control in a Low Volume Mix Environment
This presentation will discuss the identification of process risk and the application of process control
techniques focused on managing critical process parameters as opposed to critical product parameters.
Manufacturing processes that are common across many products can easily lend themselves to statistical
process techniques by applying normalization.
It is through the management of process risk with a focus on controlling critical processes that have the
most risk to outgoing quality, field reliability and mission success where the benefit of low-volume, high-
mix statistical process application can be realized.
Dana Crowe is an innovative senior technical leader and change agent, translating complex technical and
business issues into practical solutions. Currently, he works at Raytheon IDS - Andover providing
Integrated Joint Battlespace Technology Solutions for sea-, air-, and ground-based defense systems
applications. Dana is a certified Master Black Belt Six Sigma; Operational Black Belt; Design for Six Sigma
Black Belt; Lean, 5s Kaizen, Certified Raytheon Six Sigma Specialist and Coach.
3:30pm - Unique Lean-Six Sigma Model (DMADV) for Non-Manufacturing Groups to Drive
Innovation in the Front End of Business
In these challenging times, all groups within an organization must reengineer/innovate their processes to
improve efficiency and effectiveness for the company’s survival. The traditional Lean-Six Sigma model
DMAIC does not work for non-manufacturing groups (i.e. HR, Sales/Marketing, Finance, AR/AP, IT,
Purchasing/Supply Chain, Logistics, Maintenance and others). You should come out to this presentation to
learn about DMADV in order to improve all facets of an organization using DMADV and DMAIC.
Sean Anzuoni is from Quantum Leap Engineering Inc. (QLE). Prior to Quantum Leap Engineering Inc. Sean
specialized in improving businesses top line and bottom line in the world of Mergers and Acquisitions.
QLE specializes in training and in implementing Lean Manufacturing and Six Sigma Methodologies
(DMAIC, DMADV and DFSS-IDOV). In many cases, Kaizen methodology is used to accelerate the
implementation of the Lean-Six Sigma project. He has a master’s degree in engineering from Worcester
Polytechnic Institute and a graduate of the Business Management program from MIT’s Sloan School. He is
a Lean-Six Sigma Master Black Belt and a registered Professional Engineer (PE).

11. Visit our web site at www.asqboston.org and participate in our monthly meetings.
Track 6: Risk Management
1:30pm - The ISO 9001:2015 - Changes, Challenges & Opportunities
Over one million organizations are certified according to the requirements of ISO 9001 worldwide,
especially in Europe. An ISO certification creates trust between customers, partners and suppliers, it drives
the companies to improve continuously.
For September 2015, a revision of the ISO 9001:2008 is announced. The current draft, which is in the
review phase, shows many differences compared to the version of 2008. These changes mean various
challenges to companies, which want to get a recertification. One modification concerns the process-
oriented approach, which will be an explicit requirement. Another is the risk-based approach, which
requires that the companies plan and realize measures to treat risks and chances. The presentation will
address the changes and the associated challenges to give a good overview and show that the new ISO
9001:2015 offers the chance to improve an organization.
Christoffer Rybski: After studying industrial engineering with a focus on mechanical engineering,
Christoffer started work at the Fraunhofer Institute for Production Systems and Design Technology (IPK) in
Berlin, Germany as a research assistant in the field of quality management. His work focuses on the topics
of risk management, quality management and process management. In particular, the technical risk
management, its methods and processes, and linking between standards such as the ISO 9001 and ISO
31000 are of strong interest for the business field of quality management. This includes the challenges of
the new ISO 9001:2015.
2:30pm - Risk Management Update for Medical Devices and Everybody Else
While medical device manufacturers are dealing with ISO 14971, there are plenty of other standards and
guidance in the world to serve everyone else. For example, ISO 31000 and ISO 27005 standards were
issued over 6 years ago, yet have not received the ‘fame’ of ISO 14971. We also have IEC Technical
Reports 80002-1 and 80001-2-1 which provide further details on applying Risk Management to Medical
Device Software and Networks, above and far beyond the basic requirements of ISO 14971. However,
these are not in widespread use, despite their value. This presentation will address:
- An update on which ISO 14971 to use, and why
- A summary of why and how to use IEC/TR 80002-1 and 80001-2-1
- How the rest of the world does risk management: ISO 31000 and ISO 27005.
Glen Emelock brings over 30 years of experience in health care product development, quality, risk
management and regulatory affairs. Since 1996, he has been the Senior Partner with The CRO Group, Inc.,
specializing in clinical studies, risk management, regulatory affairs, product approvals, and quality systems
– most recently for consumer/OTC, mHealth and wearable health products. Prior, Glen was the first
Director of Notified Body North American Operations for TÜV Product Service, responsible for
establishing and implementing ISO 9001, ISO 13485, and EU Directive/CE Marking certifications from 1993
to 1996, and he has been an accredited Notified Body/CMDCAS lead auditor for NSAI, National Standards
Authority of Ireland since 2003, and Senior Product Software Reviewer since 2010.

12. Visit our web site at www.asqboston.org and participate in our monthly meetings.
Glen has a Masters in Biomedical Engineering from Rensselaer, and a B.S.E.E. from Union College. He is a
past chair of the AAMI Annual Meeting Sessions on Medical Device Software Development and
International Regulations, and has been a frequent speaker for AdvaMed, RAPS and ASQ/NEBG.
3:30pm - Business Quality Risk Management Analysis
As many organizations attempt to squeeze a competitive edge from every activity, the evaluation and
management of business risk becomes more important. Organizations that use ISO 9001 as a QMS
standard can look forward to new requirements in 2015 that will heighten the need and importance of an
effective risk management process. As with any discipline, it may be difficult to identify those areas where
a formal approach to analyzing risk is warranted. Further, it is not clear what tools are best suited for
performing those analyses.
This presentation will review some key risks associated with business operations for product development,
sales, material procurement, planning, IT, production, quality control and shipping. A four case approach
to risk evaluation is developed using quadrant analysis, and financial calculations supported by technical
assessments allow risks to be quantified and permit risk comparisons, even across business units of widely
divergent resources.
James August is a quality professional with over twenty years of experience in industrial and
military/aerospace manufacturing. He holds a Bachelor of Engineering from SUNY Stony Brook, a Masters
in Materials Science from the same university and has completed post graduate work at the Colorado
School of Mines. Currently, Jim is Director of Quality Management for American Biltrite Tape Products
Division where he is their ISO 9001:2008 representative.
James August is a senior member of ASQ with the Princeton and South Jersey sections. He is an ASQ
Certified Quality Auditor since 1993 and a CMQ/OE since 2008. He also is a member of ASCD and a
Registered Professional Development Provider (for education) in New Jersey.
Jim August is a regular contributor to ASQ section programs both as a speaker and also as a trainer for
CMQ/OE and CQE certification refresher courses.
NOTES:

13. Visit our web site at www.asqboston.org and participate in our monthly meetings.
Exhibitors at BOSCON 2015
Advertisement

14. Visit our web site at www.asqboston.org and participate in our monthly meetings.