The Long Island American Society of Quality Conference on

FOREWORD
The Long Island
American Society of Quality
Conference
on
CONTINUAL QUALITY
IMPROVEMENT
Monday, November 3, 2014
Guthart Cultural Center Theater
Hofstra University
ASQ is a global community of people dedicated to quality who share the ideas and tools that make our world work better. With individual and organizational members around the world, ASQ has the reputation and reach to bring
together the diverse quality champions who are transforming the world’s corporations, organizations and communities to meet tomorrow’s critical challenges. The Long Island section 303 ASQ has been at the forefront of preparing Quality Professionals since its inception in 1959. We have provided training to candidates preparing for ASQ professional certificates such as: The
Certified Manager of Quality/Organizational Excellence (CMQ/OE); Certified
Quality Engineer (CQE); Certified Quality Auditor (CQA); Certified Six Sigma
GreenBelt (CSSGB) and many other courses through the 'Siefer Institute' its
affiliate training institute.
Hofstra University located in Hempstead, Long Island is one of the top ranked
private universities in the country offering undergraduate and graduate programs taught by a research-active and professionally engaged faculty. The
Department of Information Systems and Business Analytics has been providing cutting-edge academic training in Information Technology, Business Analytics and Quality Management in an environment that combines excellence
in teaching and research with dynamic industry-university collaborations.
The Long Island ASQ (American Society for Quality) in partnership with The
Department of Information Systems and Business Analytics at Hofstra University presents its 2014 Fall Conference on “Continual Quality Improvement” (CQI). CQI is an ongoing effort to improve products, services, or processes. The results of these efforts are monitored so that incremental improvements can be achieved over a long and sustained period of time. This is
especially important since quality is increasingly becoming the distinguishing
factor in defining success or failure in today’s competitive global marketplace.
The philosophy of Dr. Edwards Deming, who many consider the father of the
modern quality movement rings true even today. He said that when people
and organizations focus primarily on quality, quality tends to increase and
costs fall over time. However, when people and organizations focus primarily
on costs, costs tend to rise and quality declines over time.
We welcome you to the conference.
Hempstead NY 11549
Dr. Samuel Prasad
Chairperson
ASQ Section 0303
[email protected]
631-368-8130
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Dr. Elaine R. Winston
Chairperson
Dept. of IS& Business Analytics
Hofstra University
[email protected]
516-463-5716
WELCOME
First and foremost we want to thank all the attendees and speakers today for
taking time out of your busy schedules to participate in this conference. Under
the direction of Dr Samuel Prasad of ASQ LI and Dr Elaine Winston of Hofstra
University, we have assembled this program with the goal of providing a wide
range of Continual Quality Improvement topics across Industry and Academic
domains.
We hope that you will learn something new today (e.g., new methods, new
tools) that can be leveraged in your organization or environment.
The feedback surveys that are in your program bags are essential to our
providing the best program(s) as possible. Please be sure to fill them out during the day and return at the end of the conference. We want to hear your
feedback regarding this program and recommendations for future programs so
we can provide excellent return on your investment.
On behalf of the ASQ LI Board of Directors and Hofstra University we appreciate the time and energy of so many folks to bring this program to you today.
Jeanne V. Ruggles
Conference Co-Chair
ASQ Section 0303
[email protected]
516-785-4563
Meegan Dowling
Conference Co-Chair
ASQ Section 0303
[email protected]
516-717-0057
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MORNING SESSION
7:30–8:30 AM
Breakfast & Registration
8:30–8:45 AM
Opening Remarks—Hofstra University
Elaine Winston
8:45–9:00 AM
Opening Remarks—ASQ Section 303
Samuel Prasad
9:00–9:45AM
How Can the Assessment Process Lead to Continuous Improvement?
David Feist
9:45–10:30 AM
The Technology of Quality
Mohan Ponnudurai
10:30–10:45 AM
Break
10:45–11:30 AM
The Issue of Reproducibility in Biomedical Research
& How a New Quality Guideline Initiated by the
ASQ Could Help
Ülo Palm
11:30–12:00 PM
Continuous Improvement, Innovation and Analytics
Mahesh Chandra
12:00–12:45 PM
Lunch
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AFTERNOON SESSION
12:45–1:00 PM
Vice Dean’s Address—Hofstra University
George Papaioannou
1:00–1:45 PM
Improving Design & Development in Safety Critical
Systems – Key Concepts from the
Aerospace Standards
Jim Hermann
1:45–2:30 PM
Using Engineering Processes & Systems to Drive
Development of Products that Delight Customers
Susan Stapleton
2:30–2:45 PM
Break
William Bagnasco,
Global Quality Systems Specialist
Sartorius Group North America
Mr. Bagnasco has been involved with the Pharmaceutical and Biotech industries for 13 years, with the last 4 years spent working in quality. William
holds a B.S. Degree in Management of Technology from SUNY Farmingdale.
He has been accredited by the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) and is currently working toward his Certified Associate in Project Management (CAPM) by the Project Management Institute.
William worked in the Pharmaceutical Industry for over eight years at Forest
Laboratories and held various positions in the Clinical Packaging Department. He is extremely knowledgeable in GMP’s and FDA regulations.
William currently holds the position of Global Corporate Quality Systems
Specialist at Sartorius Stedim Biotech. He has been with the company for
over 4 years and his responsibilities include overseeing the Vendor Qualification program, TrackWise Administrator, and managing the day to day operations of the ISO 9001 quality management system. William has experience in
implementing ISO 9001 quality management systems and is a certified lead
auditor for ISO 9001.
Abstract: The Importance of Supplier Qualification
2:45–3:15 PM
The Importance of Supplier Qualification
William Bagnasco
3:15–3:45 AM
Understanding Changes to ISO 9001 and
How They Can Affect Your Quality
Management System
Rick Calabrese
3:45–4:00 PM
Closing Remarks
Jeanne Ruggles
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What is supplier quality assurance? It is defined as the “confidence in a supplier’s ability to deliver a good or service that will satisfy the customer’s
needs.” This is achieved through an effective supplier qualification program.
This presentation will delve into how instituting a successful supplier qualification program will provide the customer with confidence that suppliers consistently adhere to high standards, and meet a specific set of quality requirements.
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Mohan Ponnudurai, BS, MBA
Industry Solutions Director
Sparta Systems
Story of a Personal Kaizen
Richard Lombardi
ASQ LI Section 303 Education Chair
Mohan is an Industry Solutions Director for Medical Devices, High Technology and
Discrete Manufacturing at Sparta Systems, Inc. with over 20 years' experience in
enterprise software, real-time systems and business applications for various industries. He has authored many articles and blogs about quality and compliance and
spoken at conferences as a thought leader and subject matter expert. He has a
Bachelor's degree in Engineering from McGill University, in Montreal, Canada and
MBA from University of Tampa, FL.
Abstract: The Technology of Quality
During this session you will learn about the technology trends and the quality management tools available to ensure and enhance the quality and safety of products
and services. Using these tools have enabled leading organizations to achieve 20%–
35% quality process productivity improvement. Moreover, these tools further increase value across the enterprise by providing visibility and traceability, lowering the
amount of recalls and ultimately increasing patient safety.
We gather again today, as we do each year, to listen to experts in their various fields speak about “Continual Quality Improvement”. The speakers today address ways we improve systems and processes that in turn improve
safety, research, customer satisfaction, and efficiency. These are all very
important tenets in the quality industry. These are the keys to our success,
and the requirements that help keep us in business. Billions of dollars each
year are spent by companies across the world to improve their operations,
we all know this. And those of us in the middle of these improvement projects work long and hard and anxiously look forward to the point in the process where we begin to see the impact it makes on the business (our
“Check” of “Plan, Do, Check, Act”). Next, we look for another business process to improve, so the company can save money, meet its deadlines, reduce waste, and so on. Do we ever stop at some point and say, “What about
me? Do I have time to improve myself”?
This month marks my 50th year on this “always-in-need-of-improvement
earth”. Like all major age milestones I have reached in my life, this one I feel
is a big one, the biggest. A light went on in my head that made me ask myself, “Am I prepared”? Am I adequately preparing for retirement? Am I prepared to pay for my kids’ college education? Am I prepared to compete in
today’s business world where I am up against those much younger than me
and are looking for the same job opportunities as I am? I need to compete. I
need to look beyond my comfort zones. After all, as Sidney Greenberg once
said, “A successful man is one who can lay a firm foundation with the bricks
that others throw at him”. I need to firm up my foundation, even if it’s a little
bit at a time; I need to know what I don’t know. This will be the year I begin
my own “Continual Quality Improvement”.
After 10 years of being an ASQ member and serving on the LI Section’s
Board of Directors, I began my “personal kaizen” by finally going after my
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own certification. I recently completed the Certified Manager of Quality / Organizational Excellence class and sat for the exam (results are pending). We
studied some of the works of Deming, Juran, and Ishikawa, employee empowerment, and the advantages of a Customer-Supplier Relationship. I learned
what a “Standard Deviation” actually is and how to calculate one! I learned
something NEW, and it felt GREAT (again, the exam results are still pending).
Never mind that I couldn’t wait to use this at work, I left each class stimulated
and excited because I was a little bit smarter than I was 2 hours before.
This piece is not meant as a plug for taking ASQ’s certification classes. It’s
about continuously improving the most basic component of any continuous
quality improvement project – you. Download a dictionary app from the App
Store, start taking guitar lessons, volunteer to teach religion at your church (go
back to church for that matter), or go for evening walks and take it all in, get
out of your comfort zone, and promise yourself to learn something new today.
Ülo Palm, MD, PhD, MBA
Senior Vice President and Global Head Branded R&D Operations
Actavis
Dr. Palm is currently Senior Vice President of Branded Drug Development &
Research Operations with Actavis in New Jersey. Before this, he was SVP
Clinical Operations & Biometrics with Forest Research Institute. Prior to this
role he was Vice-President of Clinical Operations and Therapeutic Area
Head Respiratory Clinical Development. He is a member of the Operations
Committee for TransCelerate BioPharma, Inc. (TCB), where he also leads
the Future Initiatives workgroup looking at new project opportunities for TCB.
Including Forest, Dr. Palm has 24 years of overall experience in the pharmaceutical industry with such organizations as Novartis, Schering-Plough and
Bayer. He is a Senior Member of the American Society for Quality (ASQ), as
well as being certified as a Manager of Quality and Organizational Excellence (ASQ-CMQ/OE).
Abstract: The Issue of Reproducibility in Biomedical Research and
how a new Quality Guideline Initiated by the ASQ could help.
The productivity of modern drug development has been steadily declining
over the last two decades. The total spend on biomedical research has
reached about $270 million globally, but the number of new drugs relative to
this investment has been going down steadily.
There are many reasons for the declining output of drug development, but
one of the main reasons is the lack of reproducibility of biomedical research
in general. Some people even claim that the majority of biomedical studies
cannot be reproduced. There is now mounting evidence that general quality
problems are a root cause for this issue. Indeed, there is no commonly accepted quality standard for biomedical research. A working group of the
ASQ FD&C has therefore developed new guidelines for "Best Quality Practices for Biomedical Research In Drug Development" which will be introduced in this session.
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Mahesh Chandra, DSc
Associate Professor of Information Systems & Business Analytics
Hofstra University
Jim Hermann, BA, MBA
Quality Systems Manager, Aerospace Group - Fluid Systems Division
Parker Hannifin Corporation
Dr. Mahesh Chandra is an Associate Professor in the Department of Information
Technology and Quantitative Methods, Frank G. Zarb School of Business. Hofstra
University, NY, USA. Dr. Chandra earned his M.Sc. in Operations Research at the
University of Delhi, India and his D.Sc. in Operations Research with a minor in Statistics from George Washington University, USA. He has published articles in Mathematics of Operations Research, Journal of the American Statistical Association,
Expert Systems with Applications, Journal of Management Development, Quality
Engineering, Annual Review of Communications published by the International Engineering Consortium, USA, and Quality Progress. Presently, Dr. Chandra is involved in research in the fields of Innovation, Business Ethics, Environmental Sustainability and Corporate Social Responsibility. Dr. Chandra is a senior member of
American Society for Quality.
Jim is the Manager of Quality Systems for the Fluid Systems Division (FSD) of
Parker Aerospace. He oversees the Business Quality Systems, Internal Audit,
Corrective Action and Third Party Registrations for five division facilities located
in the U.S. FSD designs, assembles, tests and repairs Fuel and Inerting Systems and components for Commercial, Business and Military Aircraft. Joining
Parker in 2006, Jim brings 30+ years of aerospace and industrial experience to
his role. He has held a variety of leadership and engineering positions with
Parker Aerospace, Smiths Aerospace, General Electric Aerospace, and Lockheed Martin. Jim has taught classes for the Long Island Chapter of the American Society for Quality (ASQ) and National University. He has spoken at the
local chapter of the National Contracts Management Association (NCMA) and
the SMTA/CALCE Symposium on Counterfeit Electronic Parts at the University
of Maryland. Jim holds a Master of Business Administration (MBA) with an
emphasis in Computer Information Systems from National University in San
Diego, California, and a BA in Economics from the State University of New
York (SUNY) at Oswego. He is an ASQ Certified Software Quality Engineer
(CSQE).
Abstract: Continuous Improvement, Innovation and Analytics
Companies all over world have been practicing continuous improvement and innovation for several decades. Continuous improvement results in reduction in costs,
and operational control; innovation is key to offering a steady stream of products
and services that result in customer acquisition and retention. The focus of this
presentation is on the role of analytics both in continuous improvement and innovation for sustainable business growth.
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Abstract: Improving Design and Development in Safety Critical Systems
– Key Concepts from the Aerospace Standards
The Aerospace Industry has been going about improving itself over the past 30
years by focusing on revising and issuing standards which have been used
extensively to design, build and certify both integrated systems for new aircraft
and the aircraft itself, (e.g. ARP 4754A, DO 178C, DO 254, etc.). Key concepts from these standards, such as Process Assurance, Independent Validation and Verification have been applied with a focus on safety critical systems,
resulting in some of the safest aircraft in history. This talk will explore these
concepts and techniques and discuss their potential for application to other
safety critical industries such as Medical Devices, and Pharmaceuticals.
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Susan Stapleton, BS, MS
Vice President of Engineering Processes and Systems
Veeco Instruments
Susan is the Vice President of Engineering Processes and Systems for Veeco
Instruments, Inc., headquartered in Plainview, NY. In her role, Susan is responsible for the systems and processes that are used by engineers and technologists in new product development and product improvement efforts across the
company’s worldwide locations. Ms. Stapleton has more than 25 years of product engineering, design and development experience on complex, high-tech
equipment, in positions ranging from Manufacturing Engineer and Design Engineer, to Sr. Director of Engineering, leading a large group of engineers in diverse disciplines. The products that she has developed have been based on a
wide range of technologies, from helium-based mass spectrometry to ion beam
etching and deposition. Ms. Stapleton has earned a Bachelor’s of Science from
the Massachusetts Institute of Technology in Mechanical Engineering, as well
as a Master’s of Science in Biomedical Engineering from the University of Virginia, and a Master’s of Science in Technology Management from The University of NY at Stony Brook.
Abstract: Using Engineering Processes and Systems to Drive Development of Products that Delight Customers
It takes more than great ideas and smart people to have successful new product development programs. Really understanding what the customers need,
and then developing the product to meet or exceed those needs, on time and
within budget, while managing technical, market and other risks, is crucial, but
not easy! Arming the development team with strong, but flexible, processes to
help guide their actions and decisions during the design and development cycle can help to ensure the best outcome for product development programs.
This session will discuss the use of a tailor-able, “living”, Product Life Cycle
(PLC) process, as well as related processes, systems and training, to bring
continuous learning and improvement to new product development.
David Feist
ANSI-ASQ Accredited Board
David is an accomplished Quality Professional, experienced in multiple disciplines of International Business, manufacturing, process mapping, organizational effectiveness, Emergency management planning for business continuity, Six Sigma Quality Improvement Methodologies and Total Quality Management and software development. He is the former owner of China Sourcing,
Inc, an Asia-Pacific manufacturer of Industrial Products sold throughout US
industry with over 20 years of experience in Project Management and largescale project implementation. He is a consultant Laboratory Systems
(Environmental, Water Quality, Destructive and Dimensional) on manufacturing, international product teams, project management, software validation and
Project Management He is a Lead Assessor for A Class and L-A-B
(Laboratory Accreditation Bureau) registrars in both ISO/IEC17025:2005 and
DoD ELAP (Environmental Laboratory Accreditation Program). He was Lead
Assessor for the L-A-B’s DoD ELAP qualification assessment, overseen by
NAVSEA (Naval Sea Systems Command). Mr. Feist established and ran 13
testing laboratories globally, guiding them through the ISO/IEC17025 registration process. He has conducted over 95 accreditation assessments to the
ISO 17025:2005 standard, including 10 DoD ELAP assessments. He has
been technical witness to qualify 3 environmental (NELAP) assessors for
Environmental Laboratory Accreditation. He has led multiple training classes
for private clients, qualifying them for Internal Assessment of Laboratories,
along with Process Improvement. He currently serves on the T-A-G
(Technical Advisory Group) as a Technical Lead for the L-A-B with oversight
for both their ISO 17025 and DoD ELAP accreditation processes.
Abstract: How Can the Assessment Process Lead to Continuous Improvement?
A real world Assessor to International Standards, Mr. Feist will discuss the
Assessment Process, and how it can help your continual improvement efforts.
Failure and successes will be discussed, along with tactics for a successful
program.
Why Assessment?
What are the benefits?
Isn’t this just another program for us to pay for?
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Board of Directors
July 2012—December 2014
Rick Calabrese, BS, MS
Global Corporate Director of Quality Systems
Sartorius Group North America
Rick has been involved with quality in the pharmaceutical industry for more than
30 years. He holds a BS in Geology and MS in Industrial Management, both
from SUNY Stony Brook in NY. Rick is currently the Global Corporate Director of
Quality Systems for Sartorius Stedim Biotech and is responsible for overseeing
the quality systems for all global operations. He has also worked for global pharmaceutical companies like Shire and Forrest Laboratories. Rick is involved with
contributing to the improvement of quality by being involved with several nonprofit
quality organizations. Rick is also one of the authors of a technical report published by ASQ called “Best Quality Practices for Biomedical Research in Drug
Development” June 2012. He has also sat on the board of directors for ANAB,
the notified body for ISO in the United States. Rick is also the current co-chair for
the RX-360 Supplier Led Initiatives Committee and is also a standing committee
member on the AOG.
Section Chairman
Samuel Prasad
Treasurer
Kerry Donelan
Secretary
Recertification Chair
Devon Watkis
Education Chair
Nomination Chair
Richard Lombardi
Abstract: Understanding Changes to ISO 9001 and how they can affect
your Quality Management System
Over one million organizations around the world are certified to ISO 9001. ISO
9001 is also the basis for many more companies that have developed an in
house quality management system. While the core concepts of ISO 9001 are still
of value, changing social, economic, industry and regulatory practices cause periodic evaluation of it to ensure it fully meets current needs. By the end of 2015 a
new revision of ISO 9001 will be published. The draft standard has been written
using the new high level structure according to Annex SL which is common to all
new management systems standards. This will allow easy integration when implementing more than one management system.
Membership Chair
Owen Ramsay
Chief Proctor
James Anderson
While the standard is still currently under the review process it is possible that it
may deviate slightly from what will be covered in this presentation. It is recommended that each organization stay involved with updates to the review process
through the ASQ website. Copies of the current draft standard can also be purchased there.
Student Quality Club
MaryEllen DeCicco
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Newsletter Editor
Kasmore Rhedrick
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Board of Directors
July 2012—December 2014
MESSAGE FROM THE CHAIR-ELECT 2015
Communications Chair
Jeanne Ruggles
Audit Chair
Meegan Dowling
Website Chair
Larry Goldstein
Program Chair
Arrangements Chair
Mary Sansone
VOC Chair
Kelvin Campbell
Ethics Chair
Rick Calabrese
As ASQ LI section 303 Incoming Chair for 2015 I am excited and humbled to
take the place of Dr. Samuel Prasad who has provided such a tremendous
platform on which to continue our ASQ mission. The depth and breadth of our
Speakers today is a testament to the entire ASQ Board of Directors in concert
with the partnership of Hofstra University to provide you with a valuable and
informative experience. Continual improvement takes on many forms and
may be done smoothly, incrementally or at times rather quickly. Whether you
are new to Continual Improvement practices or a veteran of many years there
will undoubtedly be some key take-aways that you can apply to your own professional pursuits based on the experiences and lessons learned of our
Speakers today. So keep an open mind, ask questions, provide input, and
stay engaged as we hear from experts from both Academia and Industry and
bring what you learn here with you to advance the field of Quality in the future.
Jeanne V. Ruggles
Quality Manager
Veeco Instruments
Plainview, NY 11803
NEQC representative
Mahesh Chandra
Placement Chair
Rupal Doshi
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Publicity Chair
Dave Feldman
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American Society for Quality
Long Island Section 0303
366 North Broadway, Suite 410
Jericho NY 11753
We are the Long Island chapter of ASQ (American
Society for Quality), section 303. We are a professional organization dedicated to the progress of quality
practices in all industries on Long Island. Our members come from industries such as health care, pharmaceutical, cosmetic, construction, aerospace, engineering, and much more. We offer a variety of educational programs, courses, seminars, job postings and
professional articles related to the area of quality assurance and quality systems.
Our mission is to increase customer satisfaction by
providing educational and networking resources desired by section members, organizations and the community. Use quality principles, systems and technology to optimize their effectiveness in a modern global
society.
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