BOSCON 2015 final program B

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

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 [email protected]

• Sarah Rauhut Secretary [email protected]

• Maryse Constant Treasurer [email protected]

• 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

[email protected]


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".


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


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.


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:


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.


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.


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).


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.


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:


Exhibitors at BOSCON 2015

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