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62nd ASQ NEQC CONFERENCE OCTOBER 23 – 24, 2018

Achieving and Sustaining a Culture of Excellence In a Global Environment

Jim Ryan PresidentJim Ryan Talks

Sanjay Patel CEOGuestBook

Harry Kenworthy PrincipalQPIC, LLC

Domenic Albert KalilExec. Trainer & Speaker Kiai Communications

PRE-CONFERENCE SeminarsOctober 22, 2018

Royal Plaza Hotel & Conference Center Marlborough, MA

Our Keynote Speakers

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Welcome to the 62nd NEQC Conference! NEQC’s conferences have a tradition of bringing together quality and industry professionals for a broad

perspective on system, process, people, and performance improvements.

This is our 62nd conference! The first NEQC conference was held in January 1948 at the Boston City Club. It was sponsored by five sections of ASQC. The second conference was held in Boston as well, in conjunction with the Second National ASQC Conference. We have enjoyed a long history of

success with ASQ, and this year, we are celebrating 70 years of service to area ASQ sections, quality professionals, and the North East Quality community.

For this 62nd conference, NEQC has assembled an excellent program for professional development with 5 educational seminars and a stimulating two-day conference with 32 topics. Our conference goal is to provide improvement and innovative tools and techniques that allow you to successfully implement your ideas in your workplace and for your career!This year’s conference theme is “Achieving and Sustaining a Culture of Excellence in a Global Environment.” NEQC is pleased to bring speakers and trainers to our conference to help professionals and practitioners find what it takes to improve performance in this ever-changing global economy. Our speakers are experts by whom you will be inspired, and their motivational messages will guide you on a path of innovative improvements of endless possibilities. Don’t miss it!! At this conference, you will enjoy:

Your NEQC Conference Committee: Jay Patel (Chair), Carol Beaucheson (Program Chair), Deb Hervieux, Helen Van Diver, Lucy Kahn, Jack Reardon, and Edwin May

We look forward to seeing you there!Sincerely,Jay PatelConf. Chair, NEQC Past Ch., ASQ Fellow CEO, Quality & Productivity Solutions, Inc. E-mail: jayp@qpsinc.com

Five special pre-conference seminars on Monday, October 22nd:

• Course 101: Medical Device Audit MDSAP and ISO 13485:2016 • Course 102: Using Internal Audits to Improve your Business • Course 103: Implementing Risk-Based Thinking Simplified • Course 104: What Customers Want: Uncover, Translate, Measure, & Deliver the ‘Impossible’ • Course 105: High-Performance Teams: Core Protocols for Psychological Safety and Emotional Intelligence

Four tracks each day, covering a wide variety of topics:

• Leadership • ISO • Process • Special

• Improvement • Tools • Excellence • Medical/Pharma

Four recognized keynote speakers:

• Mr. Jim Ryan – Jim Ryan Talks • Mr. Sanjay Patel – Guestbook • Mr. Harry Kenworthy – QPIC • Mr. Domenic Kalil – Kiai Communications

Local AttractionsMarlborough is within driving distance to many attractions including:

• Museums, Music, & Shopping in Worcester• Halloween Festivities and Museums in Historic Salem• Boston Harbor and Dinner/Sunset Cruises• Boston Aquarium and Quincy Market• White Mountains of New Hampshire • Tour the spectacular Fall Foliage of New England!

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Jim Ryan PresidentJim Ryan Talks

Tuesday, October 23, 2018 8:00 - 9:00 AM

TOPIC: 8 Characteristics of Happy PeopleJim Ryan’s career has evolved as his life has evolved. He started out as a foreign language teacher and guidance counselor in Bethpage, NY. After spending 14 years in education, he went on to become a financial planner. His experience in both the educational and business worlds have him firmly grounded in the real world. Jim is married and the father of three grown children. In the year 2000, Jim decided to give back to his community by volunteering in his local prison system, teaching a course in personal development.

Jim has spoken all over the United States, inspiring tens of thousands to live to their potential. His greatest pleasure is opening listeners’ minds to the possibilities that exist for living happier, joyful lives. Jim is just as comfortable speaking to an audience of 1,000 as he is facilitating an intimate offsite executive retreat. Jim is the author of Simple Happiness, 52 Easy Ways to Lighten Up which has met with rave reviews. Thousands on Jim’s email list wait anxiously every Wednesday morning for his uplifting and sometimes challenging “Aha Moments.”

Sanjay Patel CEOGuestBook

Tuesday, October 23, 2018 1:15 - 2:15 PM

TOPIC: Gradually, then Suddenly. How Technology affects business.Sanjay Patel is a serial entrepreneur and founder and CEO of GuestBook, a hospitality enablement software platform. Since receiving his degree in information systems from Carnegie Mellon University, Sanjay has proven to be able to foresee opportunities new technologies have in business. He previously founded Perpetuating, a services company focused on the leading edge of technology, successfully taking the company from eCommerce, to business IT, to becoming one of the premiere companies in the mobility industry.

Perpetuating eventually grew into a mobile app and software development firm rated top 6 by Apple. It also completed mobile innovation and digital transformation for many Fortune 500 B2B and Top 50 B2C brands globally. Sanjay’s career has covered the intersection of technology, business and the arts.

Our Keynote Speakers

TOPIC: Enhancing Cultural Excellence through Increased Employee Engagement/OwnershipHarry is Principal and Manager of the Quality and Productivity Improvement Center (QPIC, LLC) and its Lean Government Center® subsidiary. He worked with Dr. W. Edwards Deming in 1983-85 on a series of 2-day seminars throughout the US, sponsored by MIT. He has spoken at over 90 conferences on Quality, Productivity, Lean, and Six Sigma, and has been published in several magazines including Quality Progress, Purchasing, and Government Finance Review, along with doing numerous webinars and podcasts. He also had working relationships with Dr. Joseph Juran and Dorian Shainin. Founder of the Connecticut Quality Council and Chair of CBIA’s (Connecticut Business and Industry Association) Manufacturing Council, Harry was a Malcolm Baldrige National Quality Award Examiner from 1989-1991 and has held a CT Professional Engineer license and a CQE designation.

Harry's book Lean Government NOW!  is an Amazon best seller and is currently submitted for evaluation for a Shingo prize. Although it's directed toward government, the book is a "how to" about training and implementing a Lean management system.

Domenic A. Kalil is a successful advisor and expert investment consultant in service to small family-owned businesses mainly in the Northeastern United States. Retired at 55 after spending 30+ years bringing Wall Street to Main Street, he received his Bachelor of Science degree from Boston University's School of Management in 1978 and an MBA from Babson College in 1986, our nation's top entrepreneurial educational institution.

Kalil is thriving in his current roles as executive team trainer, motivational speaker, healing arts sensei, instructor of creativity and innovation at Suffolk University’s Center for Entrepreneurial Studies, ’dream’ team-builder, and author. He is a co-founder of Our One World of Peace Movement.org, a fledgling non-profit organization devoted to the attainment of World Peace thorough our common languages of artistic works and music. The movement seeks to help, share, and give to others, setting a positive example to all of the global sojourners traveling across our worldwide expanse that protecting Our Planet from harm through the abolishment of all conflicts during and throughout our collective lives is one of our most important daily charges for establishing a unified World Peace.

Harry Kenworthy PrincipalQPIC, LLC

Wednesday, October 24, 2018 8:00 - 9:00 AM

Domenic Albert KalilExec. Trainer & Speaker Kiai Communications

Wednesday, October 24, 2018 1:15 - 2:15 PM

TOPIC: Dream Team-Building @ the Apex! Success through a Guided Group Meditative Journey

ASQ - NEQC 62nd Conference Program Tuesday, October 23, 2018

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Note: Seminar information can be found on our website www.neqc.org

8:00 – 8:30 REGISTRATION - REFRESHMENTS - EXHIBIT HALL

8:30 – 9:45OPENING REMARKS: Jack Reardon, ASQ NEQC Chair KEYNOTE SPEAKER: Jim Ryan, President, Jim Ryan Talks TOPIC: 8 Characteristics of Happy People

9:45 – 10:00 BREAK - EXHIBIT HALL

TRACKTRACK 1 LEADERSHIP

TRACK 2 ISO

TRACK 3 PROCESS

TRACK 4 SPECIAL

10:00 – 11:00 11A Anthony Osimo Ryann Leaming

Navigating the 7 C's: The Guiding Principles to Successful Front-Line Leadership

12A Jack Reardon

ISO 9001:2015 Registration Journey

13A Steve Reilly

Managing Supplier Excellence: Through Involvement, Audits, and Monitoring

14A Richard Harpster

ABCs of Implementing Risk-Based Thinking for ISO 9001, 13485, AS9100D, and IATF

11:15 – 12:15 11B Jeff Robinson

Leadership and Management Fundamentals in a Quality Environment

12B Rupal Patel

Managing QMS Audit Program for Continual Improvement

14B James AugustKirsten Smith

Leading Effective Improvement Teams

12:30- 2:15 LUNCH & KEYNOTE SPEAKER: Sanjay Patel, CEO, Guestbook TOPIC: Gradually, then Suddenly. How Technology affects business.

2:30 – 3:30 11C Ed May

Making Your Supply Chain Faster, Better, and Cheaper

12C Bill Levinson

ISO 14001 and Bottom Line Performance

13C Jorge Luis Romeu, Ph.D.

Teaching New Quality Applications to the Next Engineering Generation

14C Mark C. Hehl

Amusing Confessions of an International Consultant

3:45 – 5:00 11D Domenic Kalil

'Dream' Team-Building @ the Apex!

12D Denise Robitaille

ISO 9004 and Sustained Success

13D Richard Kasperowski

Power Games for High-Performance Team Culture, Psychological Safety, and Emotional Intelligence

14D Cher Nicholas, Ph.D.

Emerging Tool for the Quality Professional: Human Factors Engineering

5:30 - 8:30 Anniversary Dinner & Entertainment—Celebrating NEQC’s 70 Years ASQ Transformation and Future of Quality by John Conner, Region 1 Director

13B Paul Washburn

Process Audits & Achieving QMS Objectives

ASQ - NEQC 62nd Conference Program Wednesday, October 24, 2018

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8:00 – 8:30 REGISTRATION - REFRESHMENTS - EXHIBIT HALL

8:30 – 9:45 OPENING REMARKS: Jay Patel, NEQC Conference Chair

KEYNOTE SPEAKER: Harry Kenworthy, Principal, QPIC

TOPIC: Enhancing Cultural Excellence through Increased Employee Engagement/Ownership

9:45 – 10:00 BREAK - EXHIBIT HALL

TRACK TRACK 1 IMPROVEMENT

TRACK 2 TOOLS

TRACK 3 EXCELLENCE

TRACK 4 MEDICAL/PHARMA

22A Bill Levinson

Culture: A Decisive, and Almost Free, Competitive Advantage

23A Rosanne Wheeler-Flint Tim Belliveau Shannon FlanaganLeveraging your QMS to Support Customer Experience Excellence

24A Tanvir Mahmud

Risk Management at a Glimpse for Pharma, Biopharma, and Medical Device

11:15 – 12:15 21B Rita Schiano

Practices for a Positive Workplace

22B Andy Moysenko

Causal Loop Diagrams: A Quality Tool

23B Janice Sioui

The Power of Will: Creating Motivation to Accept and Embrace Change

24B Jay Patel

Design Controls for ISO 13485:2016 and FDA QSR

12:30- 2:15 LUNCH & KEYNOTE SPKR: Domenic Kalil, Exec. Trainer, Kiai Communications TOPIC: Dream Team Building @ the Apex!: Success Through A Guided Group Meditative Journey

2:30 – 3:30 21C Demetrios Venetis

Lean Transformation with Employee Involvement – Hands-On Workshop

22C Richard Bivins

Supply Network Excellence

23C Mark Altman

The Motivational Interviewer; Human Behavior Change: Desire, Ability, Reason, & Need

24C Rajesh Kasbekar

World Class (Harmonized) Medical Device Single Audit Program Management System

3:45 – 5:00 21D Jenn Atlas from Minitab

22D Scott Marchand Davis

Office 5S

23D Robin Goldsmith

Don’t Let ‘Quality Requirements’ Reduce Quality

24D Barbara Butrym

ISO 13485:2016 – Understanding QSIT for Compliance to FDA QSR

�Supplier Quality Management – Process Validation Assessment

Dimensionality Reduction Techniques

10:00 – 11:00 21A Angelo Scangas

Course 101: Medical Device Audit MDSAP & ISO 13485:2016 Seminar

Course 102: Using Internal Audits to Improve your Business

Course 103: Implementing Risk-Based Thinking Simplified

Course 104: What Customers Want; Uncover, Translate, Measure, and “Deliver the Impossible”

Course 105: High-Performance Teams: Core Protocols for Psychological Safety and EI 

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Achieving greatness with your team is completing projects on time and in budget, sharing a vision, using the best ideas and acting on them, and resolving conflicts quickly and productively. In this course, you’ll learn how to create trust on a team, stay rational and effective, and move quickly toward your team’s vision and goals.

Richard Kasperowski is a speaker, trainer, coach, and author focused on high-performance teams. Richard is the author of The Core Protocols: A Guide to Greatness

This will cover the theory of medical device regulations in all the major markets in the world, which includes the US, the EU, and Canada, as well as regulatory systems in Asia and Latin America. We will also cover mobile device requirements with specific focus on the FCC part 15 and part 18 requirements in the US and the ICES requirements in Canada, as well as the material Proposition 65 requirements from California which have become very important these days. The teams will be split into several groups in between sessions to compete against each other in fun activities that reinforce the learning and give insights into how to make decisions that include a healthy trade-off between business needs and regulatory requirements.

Raj Kasbekar is Global Vice President of Regulatory, Quality Systems and Clinical Affairs at Kaz USA, Inc., a Helen of Troy Company. Helen of Troy is a $1.6 billion company with leading brands such as Vicks, Braun, Honeywell, Revlon, Dr. Scholl’s, and products that are sold globally.

The recent revision of ISO 19011 has sparked renewed interest in the value and purpose of internal audits. Sometimes seen as an onerous activity to fulfill ISO 9001 (or comparable standard) requirements, the benefits to be derived often get lost.

This one-day workshop will revisit the benefits of the internal auditing process, focusing on improvements that may be realized through utilization of the guidance found in ISO 19011:2018. Students will also learn how to conduct effective audits and learn the relationship of auditing to other QMS processes.

Denise Robitaille is the author of thirteen books, including: ISO 9001:2015 Handbook for Small and Medium-Sized Businesses. She is also Chair of PC302 – the project committee responsible for the revision to ISO 19011, an active member of USTAG to ISO/TC 176, and technical expert on the working group that developed the current version of ISO 9004:2018.

With the publication of ISO 9001:2015, ISO 13485:2016 and IATF 16949:2016, and the standards’ emphasis on the importance of Risk-Based Thinking, many companies are being challenged with the task of successfully implementing Risk-based Thinking. The most common problem they face in their struggle to implement Risk-based thinking is they don’t know what it means to properly implement Risk-based Thinking. The key factor driving this lack of understanding is that by design the standards are non-prescriptive to varying degrees of what proper implementation of Risk-based Thinking is.

Richard Harpster is the president of Harpco® Systems Inc., which he founded in 1987. Harpco® Systems specializes in providing software, training, and consulting for Risked Based Product Lifecycle Management (RBPLM™).

Outstanding success is based on having an unambiguous way to avoid asking the wrong questions of the wrong people so you can drive improvement and design in high-ROI areas. This session shows you how to do that, applying a new VOC system of such unexpected simplicity, speed, common sense, and powerful results that you’ll wonder why you didn’t know about it before.

The notion that we should listen to “the voice of the customer” is well meaning, but an insult to our intelligence. Everyone knows there is no such thing as the customer. This necessarily means there must be more than one voice to listen to. Yet we can make potentially fatal assumptions about (1) who “the customers” really are, (2) what questions to ask, (3) how to prioritize their answers, and (4) how to define and measure success.

Robin Lawton is an internationally recognized author, executive coach, and expert in creating rapid strategic alignment between enterprise objectives and customer priorities. Rob has directed strategic and operational improvement initiatives since 1985. His fourth book, published in 2017, is Mastering Excellence: A Leader’s Guide to Aligning Strategy, Culture, Customer Experience & Measures of Success.

Pre-Conference Seminars Oct 22, 2018 from 9am to 5pm

(Additional seminar details on our website: www.neqc.org)

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Net Fees: $____________ HOTEL ACCOMMODATIONS: You are responsible for making your own reservations. Please contact the Royal Plaza directly for directions and special hotel rates for registration. You can log onto our website - www.neqc.org - for hotel details. Other local hotels are: Embassy Suites, Hampton Inn, Holiday Inn and Marriot Courtyard, all in Marlborough.

PAYMENT INFORMATION (Note: Confirmations will be made by email only) Checks payable to: ASQ NEQC. Advance registration must be accompanied by payment in full. Note: ASQ NEQC Tax ID No. 39-0912502 (Corporation) NOTE: Only cancellations made 14 days in advance of the event can be refunded. A 10% cancellation-processing fee will be charged for all cancellations. Substitutions can be made at any time.

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To Register, use one of the following: 1. Visit our Web site: www.neqc.org 2. Email form, with credit card information (see bottom of form) registration@neqc.org 3. Mail and enclose check payable to ASQ NEQC ASQ NEQC Administrator c/o Quality & Productivity Solutions 28 Lord Road, Suite 205 Marlborough, MA 01752

62nd Conference Registration FormPlease complete a separate form for each attendee.

Event Attending

(X)Event Date Title Fee

Oct 23-24, 2018 Conference - 2 days (8 AM to 5 PM) Code: 100 $600

Oct 22, 2018Seminar: Pre conference (9 AM to 5 PM) Code: 101 to 105Seminar Name:Course Code:

$400

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North East Quality Council One Sunny Hill DriveOxford, MA 01540

NON-PROFIT ORG. U.S. POSTAGE PAID

WORCESTER, MA 01613 PERMIT NO. 698

IMPORTANT COMPANY MAIL: If this person is no longer with this Company, please forward to yourOrganization’s Director of QualityOr Director of Operations.

For Further Registration and Exhibit Information: Website: www.neqc.org E-Mail: registration@neqc.orgPhone: 508-786-0777

Please Circulate This Brochure to All Management and Operations Professionals!

ISO 9001:2015 Tools for Transformation Innovation Risk ManagementISO 13485 Emotional Intelligence Process Leadership ISO 14001 Continual Improvement Improvement Internal Audits Lean Six Sigma Medical Devices Change Management Core Protocols

Reasons You Need to Attend This Event: ❖ Maximum Information at Minimal Cost to You—o Discounts Available: Room block rate of $134/night if booked by

Sept. 21st at www.RPlazaHotels.com❖ 32 Sessions, 5 Pre-Conference Seminars, and 4 Keynote❖ Programs for Everyone in Any Industry - Beginners to

Advanced, Auditor to Executive Leadership❖ A Beautiful, Central New England Location; the Perfect Time

to Enjoy Fall and the Boston Harbor❖ Opportunities in Networking and Access to Experts for Ideas❖ Case Study Workshops & Presentations❖ Success Stories to Share for All Types of Industries!

A Sampling of this Conference Topics Include:

WANT TO BE A SPONSOR & EXHIBITOR?

Contact Jay Patel at jayp@qpsinc.com

Conference details are available at neqc.org and on

the Whova app

Silver Sponsors Conference Sponsors

Minitab Inc www.minitab.com

Quality & Productivity Sol., Inc. www.qpsinc.com