THE EMERGING WORLD OF QUALITY

ASQ NORTH JERSEY SECTION 304
SPRING QUALITY CONFERENCE
2015
THE EMERGING
WORLD OF
QUALITY
Thursday, April 2, 2015
Hanover Marriott
Whippany, NJ
Route 10 East
Near I-287
Four Concurrent Tracks with
Sixteen Presentations
Visit our website at
www.springqualityconf.org
to initiate registration
The North Jersey Section 0304
of the American Society for Quality (ASQ)
Presents
“THE EMERGING WORLD OF QUALITY”
You are invited to attend the ASQ Spring Quality Conference where the Keynote
presentation will be given by Bob Miglani. There will be four concurrent tracks:
Best Practices, ISO 9001:2015, FDA Regulated, and Quality Approaches.
Note:
“Business Casual” dress code is encouraged!
(Bring your business cards.)
Date:
Thursday, April 2, 2015
Time:
7:20 am - 8:20 am
8:20 am - 4:00 pm
7:30 am - 3:00 pm
Registration and Continental Breakfast
Presentations
Exhibits
Message Board: 973-538-8811
Location: Hanover Marriott, 1401 Route 10 East, Whippany, New Jersey
• The hotel is off the EAST bound lanes on Route 10, 1/2 mile
west of the I-287 - Rte. 10 intersection
• If coming from I-287, take the Route 10 west exit. After driving 1/2 of a mile west, take Ridgedale/Cedar Knolls exit and
U-turn to Route 10 East. The first driveway is the Marriott.
Cost:
$350
Cancellations and no-shows will be billed.
If the registrant is unable to attend, you can:
• Send a substitute at any time, even at onsite registration
• Received a full refund, less $50.00 processing fee by March
16, 2015
• No refunds after March 16, 2015
Registration information: Visit our Website at www.springqualityconf.org.
Conference Chair: Lucy Kahn, lkahn3@verizon.net
Registration Chair: Steve Becker, swbecker3@comcast.net
Program Chair: Mike Parrillo, parrillosr@aol.com
Exhibit Chair: Wayne Merrifield, wamerrifield@gmail.com
0.8 RUs WILL BE EARNED BY ATTENDEES
“Special prizes will be raffled at the end of the last session for
free four (4) ASQ Certification Courses worth $690.00 each.”
Management reserves the right to make cancellations and changes without notice.
Keynote Speaker
Moving Forward Through Uncertainty and
Change in Business
Mr. Bob Miglani - Senior Director, External
Medical Affairs Pfizer Inc. USA and author
of several books and owner of small business
We live in times of profound change, uncertainty and
complexity. From changing customer needs to shocks
Mr.Bob Miglani
and random events occurring more frequently to
tougher global competition to increased complexity of regulations to the way we
work today – we are indeed operating in times of turbulence.
All of this can make us feel stuck, overwhelmed and stressed. As business
people, we need to find a way to move forward to grow our business and succeed
in creating value for our customers and colleagues.
In his compelling and inspirational talk, Bob shares his own journey about how
we can get unstuck and move forward so as to continue making a positive
contribution to the place we work, to those around us and in our lives. Through
unique story telling Bob shares his 3 secrets of learning to embrace the chaos in
business and in life.
About the speaker –
Bob Miglani is an accomplished executive at a Fortune 50 Company in NYC for
the last 22 years. He started his career as a sales rep knocking on doors in
Manhattan and worked his way up to many different areas of the company
creating, innovating and doing business in over 40 countries.
He grew up with humble means, helping his family run their Dairy Queen store
in a small town in New Jersey for the last 25 years.
Through his experience in small business, big business and in life, Bob has been
able to capture fun and inviting stories in his new book titled, Embrace the
Chaos. Which by the way, hit the Bestseller List only 4 weeks after being
published. Bob’s first book about the lessons he learned at the Dairy Queen
called Treat Your Customers, was published in 2006.
Today, through his writing and speaking Bob inspires countless others on living
a life full of meaning, prosperity and fulfillment. Please join me in welcoming
Bob Miglani.
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Track 1 – BEST PRACTICES
Moderator: Mel Downes
Principle-Centered Leadership
John F. Hedderich III, Executive and Acting Director of the US Army, ARDEC and
James Caiazzo, Manager Office of Strategic Management, U.S. Army , ARDEC
Abstract - An organization’s ultimate multiplier is the development of its leadership and
employees. Systems and processes require talented and committed people to make them
operate effectively and efficiently, regardless of the industry.
This session encompasses the design and implementation of the U.S. Army Armament
Research, Development and Engineering Center’s approach to “Leadership Development” in
growing and sustaining leaders to achieve its mission, “To empower, unburden and protect
the Warfighter by providing superior armaments solutions that dominate the battlefield.”
Over the years numerous leadership models have emerged based on trait, behavioral, contingency, transactional, and transformational theories, to name but a few. The U.S. Army has
developed a practical leadership development model which bridges the gap between these
theories and reality. The ARDEC has adopted this principle-centered model which defines
leadership as “the process of influencing people by providing purpose, direction, and motivation to accomplish the mission and improve the organization.”
The essence of this model addresses the three leadership attributes of character, presence,
and intellect, as well as the three competencies to lead, develop, and achieve. The model
places strong emphasis on character as embodied in the Army values of Loyalty, Duty,
Respect, Selfless Service, Honor, Integrity, and Personal Courage. The ultimate purpose of
this leadership model is mission accomplishment and workforce satisfaction. The ARDEC
continuously works to improve its leadership development process using the Army leadership principles embodied in its model as guidance along with feedback from Baldrige and
Shingo external assessments.
The purpose of this session is to share how this approach to leadership development can be
applied to any private, non-profit, or government organization. The Army Leadership Model
is readily available to practitioners of leadership development and the general public.
About the speaker(s)–
John F. Hedderich III - John is the Executive Director of the Munitions Engineering &
Technology Center, U.S. Army Armament Research, Development and Engineering Center.
He provides guidance and direction to an engineering and scientific community. He is responsible for developing, directing and managing enterprise investment strategies to ensure stateof-the-art facilities, people and equipment, as well as the center’s extensive research, development and engineering efforts for fielding new ammo, munitions, and combat systems.
A career executive, he was appointed to the Senior Executive Service in the civilian government. His executive roles have included leading the development and execution of scientific and technology strategies for small, medium and large caliber weapons, ammunition, mines and countermine, non-lethal weapons and ammunition and special operations
gear. Additionally, John has managed ARDEC’s technology base and manufacturing technology programs, strategic planning, and portfolio and knowledge management.
John earned his bachelors of science degree in mechanical engineering from Fairleigh
Dickinson University in Teaneck, New Jersey. He also trained under Harvard’s University’s
Senior Executive Fellows Program, the Baldrige Leadership Team Knowledge, the Shingo
Approach to Operational Excellence, and the Leading the Organizations—Challenge of
Command program.
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James J. Caiazzo - Jim currently serves as Manager, Office of Strategic Management,
Strategic Management and Process Office, U.S. Army Armament Research, Development
and Engineering Center. His office facilitates corporate strategic planning to sustain and
improve enterprise and business performance. Jim provides multi-discipline corporate
advice and recommendations to senior leaders on enterprise planning and continuous
improvement initiatives, including, Baldrige, Shingo (Lean) and benchmarking for industry
best-practices.
As a Master Black Belt and lead instructor, he was responsible for teaching Lean Six Sigma
Workshops and consulting with project teams seeking Green Belt and Black Belt certification. His adjunct instructor activities have included teaching professional development
courses for the American Management Association, designing and teaching supervisor certification workshops and management courses at local colleges, and providing leadership
training to institutions in the corporate and non-profit sectors.
Jim holds a BS, Upsala College and a MS, in Management Science, Florida Institute of
Technology. He is a graduate of the Army Officer Candidate School, Fort Benning and
served his country as an infantry officer in the Vietnam Conflict.
Planning and Implementing Corrective and Preventative Actions
Mr. Michael Kochian
Client Manager, ER BSI Lead Assessor for BSI Americas
Abstract - The principle objective of this presentation is to demonstrate how organization
can achieve reliable and effective process for Control of Nonconforming Product. The regulatory requirements that impact the non-conforming product in the medical device industry, and why it is important to determine adverse effect prior to authorization of rework
instructions and when nonconforming product is corrected why verification for reliability
is important. The output of nonconforming report may need to be raised to Corrective and
Preventive Action investigation to be able to resolve the problem. When important steps are
not established in planning for nonconforming product procedure, and when these important steps are not properly investigated and documented in non-conforming report that leads
to non-conformance during internal and external audits. The importance of meeting the ISO
9001:2008 and ISO 13485:2003 Standard and Regulatory requirements for Control of
Nonconforming Product, and monitoring and measuring of process performance in determining process effectiveness to meet and exceed management expectations.
The objective of Corrective and Preventive Action presentation is to demonstrate how organization can achieve reliable and effective process based on effective planning and implementation. The importance of planning, implementing these internal procedures. Once the issues
have been reported internally or externally, and upon evaluation raised to Corrective and
Preventive Action investigation. The important steps involved in Corrective and Preventive
Action are stopping the spread of problems covered in containment action, and stopping problems from reoccurrence are covered in root cause analysis, corrective action, preventive
action, verification/validation of actions implemented, and effectiveness check. The importance of meeting the ISO 9001:2008 and ISO 13485:2003 Standard and Regulatory requirements for Corrective and Preventive Action, and monitoring and measuring of process performance in determining process effectiveness to meet and exceed management expectations.
About the speakerMr. Michael Kochian is the Client Manager, ER BSI Lead Assessor for BSI Americas
since 2007. His Achievement of Excellence in the delivery of world class BSI’s assessment
services to a portfolio of assigned clients specialized in the medical device industry. Expert
in assessment services for all client specific schemes, ISO 13485:2003, CMDCAS, MDD
93/42/EEC, JPAL, ISO 14971:2012, and activities involving design and development, man—3—
ufacturer in orthopedic implantable devices, active medical devices that are software, electro mechanical surgical instruments, IVD, and various types of active and passive devices.
Prior to joining BSI America’s, Mr. Kochian was Management Representative, Manager of
Quality Assurance and Regulatory Affairs at startup company 3TP LLC dba CAD SCIENCES, White Plains, NY (2004-2007). Spearheaded and provided leadership for a customer focused on quality management system. 3TP LLC is developer and maker of CAD
imaging software used by Radiologist and Oncologist for post-processing of MRI breast,
prostate, and CT-Lung.
Mr. Kochian was Quality Manager and Quality Assurance Engineer at DiSanto Technology,
Stamford, CT. (2001-2004). He spearheaded and provided leadership for a customer satisfaction focused quality assurance approach at DiSanto Technology, Inc. (maker of Knee,
Hip, Shoulder, and Spine implants/instruments w/Cobalt-Chrome, Titanium, Stainless
Steel, Rubber, and Medical Plastic materials used in Orthopedics Industry).
Mr. Kochian has extensive industry background from Aerospace, Sikorsky Aircraft, UTC,
and Civil Engineering, Northeast Engineering Associates, and Finance, Master Card
International. He holds M.S., Mechanical Engineering, University of Bridgeport, 1991, and
B.S., Mechanical Engineering, University of Bridgeport, 1987. Attended Fairfield
University for MBS program, 1997
Build Performance on Strengths, a Counterintuitive Approach to
Continual Improvement
James August, CMQ/OE, CQA
Director of Quality Management, American Biltrite Inc.
Barbara August
Literacy Consultant
Abstract - High performing organizations know that continual improvement begins with
investment in their employees. This is because organizations that leverage the strengths of
their people produce empowered and engaged employees. This paper looks at the concept
of performance improvement, both for the individual and for the organization, through
building improved performance on top of individuals’ existing strengths.
There is a whole area of psychology devoted to this technique where it has been applied to
overcoming a variety of personal issues. But also, this approach can be used in training for
business performance improvement, as an adjunct to, and possibly in place of, trying to fix
performance deficiencies. In fact, there is a growing body of literature that indicates that trying to improve performance by fixing deficiencies is generally ineffective, or slow at best.
This psychology will be examined for use in educating and training in our organizations.
We present some of the tools and techniques for performance improvement that specifically work by building on individuals’ strengths. Then, the use of these tools is extrapolated to
the organizational level. These are techniques that we can use, and that we can pass on to
others with responsibility for generating performance improvement.
About the speakerJames August is a quality professional with over twenty years’ experience in commercial,
industrial and military/aerospace manufacturing. He holds a Bachelor of Engineering from
SUNY Stony Brook, a Masters in Materials Science from the same university. Currently, he
is Director of Quality Management for American Biltrite Inc. in Moorestown, NJ, and Ideal
Tape Co. in Lowell, MA. He is the ISO 9001 representative for ABI.
Jim is a Senior member of ASQ and is ASQ Certified both as Manager of Quality/
Organizational Excellence and as Quality Auditor. Mr. August was active in Quality New
Jersey from 1991 through 2007 serving as the Administrator for the QNJ Performance
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Excellence Network. He was a member of the QNJ Governor’s Award for Performance
Excellence Board of Examiners (Baldrige criteria) for twelve years, holding the responsibilities of Examiner, Senior Examiner and examiner process trainer.
He has been Adjunct Professor at Rutgers University, Raritan Valley Community College
and Middlesex County College. Jim is a member of ASCD and was a registered
Professional Development Provider in New Jersey. Jim is a frequent guest lecturer and presenter at regional university, ASQ and PSTC activities.
Barbara August is a literacy conslulatant. After 20 years teaching in diverse classrooms
in NY, CO, PA and NJ, Barbara had the opportunity to become one of New Jersey’s first
state Literacy Coaches – teaching teachers to teach literacy. She spent two years working
for the state before becoming a staff trainer in her home school district of Franklin Twp and
later in Milburn Public Schools and Livingston Public Schools where she was responsible
for the day-to-day administration and delivery of their programs.
Barbara August holds a Bachelors Degree in Education from Lehman College, a Masters in
Education from SUNY Stony Brook and she has been involved in primary education for
three decades. She is a Registered Professional Development Provider in New Jersey, a
member of IRA and NCTE, and holds a Supervisor’s Certificate from Rutgers. She is a regular presenter of professional development workshops at NJ and regional conferences.
A Practical Approach to Integrating Process Excellence Disciplines
within your Organization
John Crombie
Executive Vice President of Business Development with Juran Institute.
Abstract - “A Practical Approach to Integrating Process Excellence Disciplines
within your Organization”
The practical Back End of Product Development is normally remote and detached from
vague Front End activities. But through the transformation of Back End metrics into Front
End design requirements, you will be shown how to reduce wasted time and effort in the
Front End and uncover organizational needs and insights in the Back End.
Specifically:
• Integrating design for six sigma, six sigma and lean manufacturing practices into new
product development
• Fostering a lucrative connection between operations and research
• Capitalizing on your organizational strengths for increased efficiency
• Data capture and utilization strategies to improve cross-functional effectiveness.
About the speakerJohn Crombie is Founder of UpStart Product Development LLC., an end to end product realization company. He has developed innovative products for orthopedics and spine surgery,
plastic and reconstructive surgery, general surgery, women’s health procedures, diagnostic
medical software, consumer, recreational, and global emerging markets. He served in numerous technical roles as well as Innovation Facilitator, Process Excellence Master Black Belt,
and head of a corporate Design for Six Sigma department. John has developed several global new product development processes for organizations, including Johnson & Johnson and
Allergan. He is skilled in identifying next-generation product opportunities and recently
applied his unique tools and techniques to the China medical device market. Previously, John
was employed by Johnson & Johnson’s Ethicon and Ortho-Clinical Diagnostics, by Pfizer’s
Howmedica and Leibinger, and by several private organizations and startups. He is also very
active with Operation Smile. John holds dual Bachelors degrees in Physiology and
Mechanical Engineering and a Masters degree in Business Management.
—5—
Most notably, John has commercialized 70% of his 25 patents into new products spanning
across 6 companies and 25 years.
Track 2 – ISO 9001:2015
Moderator: Bob Spinosa
ISO 9001:2015 Key Changes (Sessions 1 and 2)
Lorri Hunt
US Expert to ISO TC176/SC2/WG24
(Group responsible for ISO 9001:2015 revision)
Lorri Hunt & Associates Inc.Kansas City, MO 64108
Abstract - The revision to ISO 9001 will bring an uncertainty to the known requirements
in the current versions of the standards.
Context of the organization, risk-based thinking, relevant interested parties, external
providers. All of these are concepts or new terminology that are being introduced into ISO
9001:2015. With new concepts and new terminology comes the possibility for misinterpretation. In addition, many organizations associate new terminology and concepts with something
different they need to do in the organization. The level of change required on the revision will
vary organization to organization. This session will focus on understanding the changes, how
to use the standard itself to understand the new concepts and terminology, and suggest
processes your organization most likely has in place to implement the new requirements.
There are many sources for updates on the revisions to ISO 9001. ASQ is the administrator
of the technical advisory groups which develops the consensus positions for ISO 9001. This
presentation by one of the United States technical experts and a task group monitor to the
revision to ISO 9001 provides an opportunity for delivering information to users of the standards that is fact-based, adds value, and prevents incorrect information in the marketplace.
It will provide the most current information and insight into the potential impact these
changes will have to users.
The revision to the world’s most important quality management system is currently at the
Draft International Standard (DIS) stage. At the time of the conference, it is anticipated that
the Final Draft International Standard (FDIS) will be in the final stages of editing pending
distribution for ballot in July 2015.
The current information for transitioning to the revised standards is three years. An update
to the transition plans will be provided so attendees will know how to prepare in their organizations. This information will be provided based on any official published information
from the International Accreditation Forum (IAF).
Attendees at this session will take away the following critical information:
• Key changes to ISO 9001
• Current status of ISO 9001
• Updates on any confirmed transition plans for certified users
About the speakerLorri Hunt has been implementing quality management systems in diverse organizations such
as Honeywell, the Department of Energy, and small businesses since 1994. She is an active
member of the U. S. Technical Advisory Group to ISO Technical Committee 176. She currently serves as the head of delegation for ISO TC176/SC2. In this role, she is responsible for
overseeing the development of consensus positions for the United States related to ISO 9001
and 9004 and the supporting portfolio. She is a United States expert and Task Group Monitor
for the next revision to ISO 9001, which is currently planned for 2015. She also served as the
international Deputy Task Group Leader to the ISO 9001:2008 Amendment.
—6—
Lorri frequently contributes to quality publications and journals and is a co-author to The
Insiders’ Guide to ISO 9001:2008. She is a frequent speaker at conferences all over the
world and an Exemplar certified lead auditor.
ISO 9001:2015 – What’s New for Top Management? (Sessions 1 and 2)
Denise Robitaille
Member to US TAG to ISO/TC 176
Abstract - The revision to ISO 9001 is substantial, with a new structure, added and
revised requirements and introduction of new terms and concepts. The revision has generated both excitement and trepidation.
Some enhancements that permeate the entire standard are focused directly (or through
inference) at top management and its responsibilities. These include, among others, requirements relating to quality objectives, planning, risk, the role of the management representative and the management review process.
This session will focus on the intent of the requirements and how to achieve conformance
in a manner that creates value while enhancing the organization’s ability to meet its goals.
About the speaker• Denise Robitaille is a member to US TAG to ISO/TC 176, the standards developers responsible for ISO 9001 and ISO 9004.
• For almost 20 years, Denise has helped companies achieve ISO 9001 registration and
derive benefit from their management systems. She is an internationally recognized
speaker and trainer who has worked in numerous industries and government agencies.
• Denise is the author of ten books and 3 e-books, including ISO 9001:2008 for Small
and Medium-Sized Businesses , 9 Keys to Successful Audits, The Corrective Action
Handbook, and ISO 9004: The Key to Sustainable Success. (E-book)
Track 3 - FDA REGULATED
Moderator: Carl Perini
Proposed Changes to ISO 13485:2015
Bill Enos, Microbiology Team Leader
BSI
Abstract - ISO 13485 represents requirements for a comprehensive management system
for the design and manufacture of medical devices. Adopting ISO 13485 provides a practical foundation for manufacturers to address the medical device directives, regulations and
responsibilities as well as demonstrating a commitment to the safety and quality of medical
devices. While it continues to be as relevant as ever, ISO 13485 is now under review with
an updated version expected by the end of 2015. We will discuss the proposed changes to
ISO 13485:201X, key additions, and the potential timing of a final approved standard.
About the speakerBill Enos, Microbiology Team Leader, has been with BSI for 10 years and is currently the
BSI US Subject Matter Expert regarding ISO 13485 updates. His responsibilities include
auditing quality systems and review of design dossiers/technical files and other certification activities related to sterile medical devices (environmental controls, sterilization validation and release, biocompatibility, accelerated aging, package validations, tissue of animal origin, etc). He has developed training programs on biocompatibility testing, devices
containing tissues of animal origin and sterilization activities. Bill received his Bachelor of
Science degree in microbiology in 1993 from Western New England University. Bill is the
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ASQ NORTH JERSEY SECTION 0304 SPRING QUALITY CONFERENCE
“THE EMERGING WORLD OF QUALITY”
Track
Moderator
Room
Track 1 - Strategic Leadership
Mel Downes
Director, Fire Control Systems
& Technology
Weapons & Software
Engineering Center (WSEC)
Salon D
April 2, 2015
Track 2 - ISO 9001:2015
Bob Spinosa
QA Director,
Multi Packaging Solutions
Track 3 - FDA Regulated
Carl Perini
Corporate Quality,
Ashland Specialty Ingredients
Gallery
Hanover
Track 4 -Quality Approaches
Long P. Nguyen
Competency Dean, Reliability
Engineering Chief, Reliability
Management Office Quality Engineering
& System Assurance Directorate
Salon C
7:20 - 8:20
Registration - Continental - Breakfast - Networking
Keynote
8:20 - 9:20
Keynote Speaker: Bob Miglani “”Embrace The Change”“ Executive at a Fortune 50 Company in New York City, where he has been embracing change
for the last 21 years. A bestselling author of two books about business and personal development and someone who has knee deep experience in running small
businesses.
Session A
9:30 - 10:30”
John F. Hedderich III Executive and
Acting Director of the US Army, ARDEC
James Caiazzo Manager Office of
Strategic Management U.S. Army, ARDEC
Principle-Centered Leadership
Lorri Hunt
Lorri Hunt & Associates Inc
US Task Group Leader TC 176
ISO 9001:2015 Key Changes
10:30 - 11:00
Session B
11:00 - 12:00
Break - Networking - Exhibitors
Michael Kochian
BSI - Client Manager
Planning and Implementing
Corrective and Preventative Actions.
John Freije
Principal Medical Device Consultant at
Freije Quality Engineering, LLC
Going beyond the Audit in a Medical
Device Regulated Industry
Lunch - Networking - Exhibitors
James & Barbara August
Director of Quality Management, American
Biltrite Inc & Literacy Consultant
Build Performance on Strengths, a counterintuitive approach to continual improvement
Denise Robitaillie
Past Vice-chair to USTAG to
ISO/TC 176 (ISO 9001:2015)
ISO 9001:2015 – What’s New for Top
Management?
2:45 - 3:00
Session D
3:00 - 4:00
Kevin L. Ong, Ph.D., P.E.
Senior Managing Engineer - Biomedical
Engineering Practice Exponent®, Inc.
Using Design Control to Manage
Product and Business Risk
Lorri Hunt
Lorri Hunt & Associates Inc
US Task Group Leader TC 176
ISO 9001:2015 Key Changes
12:00 - 1:45
Session C
1:45 - 2:45
Jim Shore
ASQ Regional Director for
New England Area
Hands-on Kanban How to Reduce Inventory
Bill Enos
BSI Expert on the
Development of 13485:2015
Proposed Changes to ISO 13485:2015
Elizabeth Bononno
Director, User Experience Design
Siemens Healthcare Diagnostics Inc, Flanders, NJ
Usability Engineering in the Highly Regulated
Medical Device Industry
Susan L.K. Briggs
Chair, U.S. TAG to ISO TC 207 on
Environmental Management
Changes coming for ISO 14001:2015,
Environmental Management Systems
Break - Networking - Exhibitors
John Crombie
UpStart Product Development LLC
A Practical Approach to Integrating
Process Excellence Disciplines within
your Organization
Denise Robitaillie
Past Vice-chair to USTAG to
ISO/TC 176 (ISO 9001:2015)
ISO 9001:2015 – What’s New for Top
Management?
Steven Walfish
Staff Statistician at Becton Dickinson
Tying Risk to Statistical Tools for
Validation in an FDA Regulated
Industry
Allen Gluck Member of ISO/TC 262 (ISO 31000
Risk Mgm Standard), TC 176 (ISO 9001 TAG) &
Presiident ERM31000 Training and Consulting
How to Augment ISO 9001:2015 Using ISO 31000
Risk Management
4:00 - 4:30
Management reserves the right to make cancellations and changes without notice.
Conference Chair: Lucy Kahn
lddy@aol.com
Registration: Steve Becker
http://asqnorthjersey.org/
—8—
Backup TBD
Program Chair: Michael A. Parrillo
parrillosr@aol.com
Website: Mark Ellis
http://www.springqualityconf.org/
—9—
co-author of the book “Revisions to the Ethylene Oxide & Radiation Sterilization Standards
- Gap Analysis (2009)”, co-author of “Expert Commentary on BS EN ISO 11137-1:2006
+A1:2013 (2014), and author of “Packaging Validation – Issues to Consider” (1999).
Using Design Control to Manage Product and Business Risk
Kevin L. Ong, Ph.D., P.E.
Senior Managing Engineer - Biomedical Engineering Practice, Exponent®, Inc.
Abstract - The FDA provides oversight in the life sciences industry through inspections
and audits of manufacturers, vendors/suppliers, etc., to ensure the site’s compliance with
quality systems. These quality systems provide a framework for manufacturers to achieve
quality requirements for designing, manufacturing, packaging, labeling, storing, installing,
and servicing of their products. This presentation will discuss when, why, and how these
inspections are conducted, as well as the elements of a quality system that the FDA focuses
on. There will also be discussion of the various levels of feedback that is provided to the site
and their implications. This presentation will also review FDA data on inspections and warning letters from 2009 to 2013, with specific discussion of what quality system citations are
commonly issued. This information will help guide the life sciences industry on what areas
companies could improve on to minimize risk during design and manufacturing of their
products.
About the speakerKevin Ong’s practice focuses on providing engineering and scientific consulting services related to product liability and intellectual property litigation matters. He also provides
product design and development consulting services to the medical device industry. Dr.
Ong’s background is in the product design evaluation and failure analysis of medical
devices, with a focus on evaluating how patient, surgical, and design factors influence performance. He has experience with orthopaedic, spine, fracture fixation, cardiovascular, and
diagnostic medical devices from the perspectives of product liability, intellectual property,
regulatory compliance, design verification and validation, product development, epidemiology, health economics, and technology assessment.
Dr. Ong completed his Ph.D. in 2003 and B.S. (summa cum laude) in 1998, both from
Cornell University. He is also a Licensed Professional Engineer in Pennsylvania and New
York. He has written one book, eight book chapters and authored over 60 journal articles
and 190 conference abstracts, and also serves on the editorial board of The Journal of
Arthroplasty. Dr. Ong has also received four awards from the American Association of Hip
and Knee Surgeons and British Orthopaedic Research Society for his research. He also
holds a Visiting Research Professor appointment at the Drexel University School of
Biomedical Engineering, Science and Health Systems, Philadelphia, PA.
Usability Engineering in the Highly Regulated Medical Device Industry
Elizabeth Bononno
Director, User Experience Design
Siemens Healthcare Diagnostics Inc, Flanders, NJ
Abstract - In the medical device arena, there are FDA and ISO standards driving Usability
Engineering. These regulations drive UX practices that are closely linked to Risk
Management and ensuring our Quality process mitigates Use Errors. IEC62366-1 and the
FDA Draft Guidance, Applying Human Factors and Usability Engineering to Optimize
Medical Device Design are some of the key
standards. This discussion will focus on creating a UX process that addresses industry standards, prevents user error, improves quality early in the design process and more importantly provides a delightful user experience.
— 10 —
About the speakerI joined Siemens Healthcare Diagnostics in 2004 and lead the User Experience Design
Team for the Central Laboratory Business Unit. I work out of the Flanders, NJ office where
a portion of the R&D and Manufacturing teams are located.
I have a BS in Biology from East Stroudsburg University, Pennsylvania. I spent the first 9
years of my career in Corporate Marketing for high tech direct marketing companies Data
Tech and LTS Systems Group in NYC. I went on to work for Block Scientific in
Englewood, NJ (a Diagnostics re-seller) as Director of Marketing before being recruited by
DPC as a Technical Marketing Specialist within the R&D Team.
As part of Siemens, I joined the Global Marketing team heading up Product Health and then
returned to Flanders R&D to head up the User Experience Design Team. This past year I
began leading the CAI Business unit’s User Experience Center of Excellence.
Our goal is to bring product development closer to our customers. We do this by iterating
product design with customers from start to finish. We not only want to prevent misuse of
medical devices by customers, but create products that exceed customer expectations and
are delightful to use. The best part of my day is when I can show colleagues in R&D why
a device needs to work the way a customer would use it.
It is also my sincere pleasure to be chair of the Diagnostic Division’s Diversity & Inclusion
Council since September 2004. I enjoy working with 12 of the Diagnostic Division’s sites
to foster an environment that ensures every voice counts.
When not working I enjoy spending time with my husband, four kids, two dogs and four
chickens!
Tying Risk to Statistical Tools for Validation in an FDA Regulated
Industry
Steven Walfish
Staff Statistician at Becton Dickinson
Abstract - The regulatory framework for statistical methods is vague with the onus on the
manufacturer to demonstrate acceptable statistical practices. The 21 CFR 820.250 Statistical Techniques has two clauses that focus on the establishment and maintenance of
valid procedures without any guidance to what is considered valid. The first states “Where
appropriate, each manufacturer shall establish and maintain procedures for identifying valid
statistical techniques required for establishing, controlling, and verifying the acceptability
of process capability and product characteristics. “ The second focuses on sampling plans
stating “Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling
methods are adequate for their intended use and to ensure that when changes occurs the
sampling plans are reviewed. These activities shall be documented.” The Preamble to 21
CFR 820 in Comment 160 tries to clarify the intent, but only adds more confusion. “…FDA
emphasizes that the appropriate statistical tools must be employed when it is necessary to
utilize statistical methodology. FDA has seen far too often the misuse of statistics by manufacturers in an effort to minimize instead of address the problem. Such misuse of statistics
would be a violation of this section.”
So what is the expectation of the regulatory authorities? The intention should be that all statistical methods and techniques be justified by tying it to the risk level. Most companies fail
to tie the product risk, failure mode risk and risk of harm back to the sampling strategy and
statistical methods employed for validation.
This presentation will present statistical tools that will help to justify validation activities.
We will cover validation scope, statistical tools and design verification techniques.
— 11 —
About the speakerSteven Walfish is a Staff Statistician at Becton Dickinson (BD) in Franklin Lakes, NJ.
Mr. Walfish is responsible for non-clinical statistical support for operations, quality and
product development. Prior to joining BD in 2012, Mr. Walfish was a Statistician at GE
Healthcare in Waukesha, WI responsible for global statistical support. Prior to joining GE
Healthcare, Mr. Walfish had a statistical consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing
Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human
Genome Sciences in Rockville MD.
Mr. Walfish brings over 25 years of industrial expertise in the development and application
of statistical methods for solving complex business issues including data collection, analysis and reporting.
Mr. Walfish has been an invited lecturer at Medical Design and Manufacturer (MD&M),
Institute of Validation Technology (IVT) and Advanstar conferences. Mr. Walfish has been
a speaker at ASQ Division and Section conferences. He is also an editorial board member
for BioPharm International, and a regular contributor to the magazine.
Mr. Walfish is the secretary for TAG69, senior member of ASQ, a certified quality engineer
and past chair of the Biomedical Division (2006-07). Mr. Walfish holds a Bachelors of Arts
in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers
University and an Executive MBA from Boston University.
Track 4 – QUALITY APPROACHES
Moderator: Long P. Nguyen
Hands-on Kanban - How to Reduce Inventory
Jim Shore
ASQ Regional Director for New England Area
Abstract - How to successfully implement Kanban which will reduce your overall inventory by 40% and increase your inventory turns to 24
See how to use interactive training techniques to train people
About the speakerJames Shore has 25 years of quality and supplier management experience working in
medical devices, semiconductor, aerospace and defense (Nypro, Boston Scientific, Aspect
Medical, ACMI Gyrus, Brooks, and Raytheon). Prior to joining Nypro, Jim was the
Operations Manager at Dynisco Plastics, responsible for the implementation of the global
material replenishment program (eKanban) and the operations and manufacturing of a new
product line (Vertex).
Jim serves on the Board of Directors for the American Society for Quality (ASQ),
Biomedical ASQ Division (NEDG), and American Welding Society (AWS). In addition,
Jim is the Region Director of New England for ASQ.
His professional ASQ certifications include:
• Certified Six Sigma Black Belt • Certified Quality Manager/Operations Excellence
• Biomedical Auditor • Quality Auditor • Mechanical Inspector • ASQ Senior Member.
He also is a Certified Welding Inspector from AWS and obtained the Lean Bronze certification from the Association for Manufacturing Excellence.
He is a veteran of Operation Desert Storm (1991), having served in the United States
Marine Corps for more than 15 years
— 12 —
Going beyond the Audit in a Medical Device Regulated Industry
John Freije
Principal Medical Device Consultant at Freije Quality Engineering, LLC
Abstract - Maintaining compliance in a FDA Regulated Industry is challenging enough
within your own organization. How does one go about maintaining compliance when the
operations are outside of your control? Comment 105 of the Preamble to the 1996 Quality
System Regulation states:
“The capability of the product or service suppliers should be reviewed at intervals consistent with the significance of the product or service provided and the review should demonstrate conformance to specified requirements.”
It’s not feasible to be at your supplier’s facility every day to observe production nor does
this foster a strategic alliance built on trust with your supplier. Incoming inspection is only
a portion of ongoing monitoring activities that must be conducted and is after-the-fact.
Audits give us an initial and intermittent assessment of the supplier’s quality system, but are
not conducted at a frequency that gives us assurance our supplier is continuously meeting
our specified requirements, including quality requirements. Similar to Management Review
of your internal processes, your key or critical suppliers should partake in frequency-based
quality evaluations commensurate with product risk. Including your suppliers in your
Management Review gives more assurance you are compliant with 21 CFR 820.70 (a)(2).
The topic of this presentation “Going beyond the Audit in a Medical Device Regulated
Industry” will prepare quality professionals to go beyond the bare minimum of 21 CFR 820
by implementing and maintaining a Periodic Supplier Quality Evaluation (PSQE).
Presentation Objectives:
• Taking a proactive stance on monitoring component and device characteristics during
production that is outside of your control
• Implementing a tool to help meet requirements with regards to monitoring and controlling of process parameters for component and device characteristics for outsourced
product
• Benefits of implementing a Periodic Supplier Quality Evaluation
• Increased communication and strategic alliance with critical/key suppliers
About the speakerJohn Freije, CQE, CMfgT is the President and Principal Consultant at Freije Quality
Engineering, LLC. In this capacity John works with medical device companies and suppliers to medical device companies to develop and implement Quality Systems that exceed the
expectation of ISO 13485 and FDA’s Quality System Regulation 21 CFR 820.
John brings to the table over 30 years’ experience working for the government and the private sector, with over 22 years in the medical device and pharmaceutical industries. Prior to
becoming a consultant, John held several positions with increasing responsibility at Roche
Diagnostics, Eli Lilly & Co., Raytheon Technical Services, and the US Army.
John currently holds the position of Vice-Chair DGs for the ASQ Biomedical Division.
14001:2015, Environmental Management Systems
Susan L.K. Briggs, Chair, U.S. TAG to ISO TC 207 on Environmental
Management, Convener, ISO TC207/SC1/WG5 on Environmental
Management Systems, Reading, MA 01867
Abstract - Since its origination in 1996, more than 250,000 organizations in 155 countries around the globe have adopted the International Organization for Standardization
(ISO) standard on Environmental Management Systems, ISO 14001, with uptake continu— 13 —
ing to grow. The standard underwent revision in 2004; however changes were limited to
clarifying the original requirements. During this period, new developments have arisen in
the field of environmental management and stakeholder expectations have evolved, resulting in strong international support for substantive changes to ISO 14001. This revision has
been undertaken to ensure the standard continues to be relevant over the next two decades.
A study completed in 2010 by TC 207/SC1, Future Challenges for EMS, made 25 recommendations to address the evolving developments and expectations. In addition to the technical changes resulting from these recommendations, changes in design and layout of the
standard have occurred in response to the ISO mandate to impose a common structure and
minimum set of requirements on all management system standards (MSS).
The working group responsible for revising ISO 14001, TC 207/SC1/WG5, has been meetings since early 2012 drafting the new standard, and plans to issue the revision in mid-2015.
Early accomplishments in the redrafting of ISO 14001 include:
• Existing EMS requirements have been restructured and in most cases rewritten to conform to new ISO directives on Management System Standards.
• Established requirements for six new clauses imposed by the ISO MSS mandate;
‘Understanding the organization and its context’, ‘Understanding needs and expectations of interested parties’, ‘Leadership and Commitment’, ‘Actions to address risks
and opportunities’, ‘Performance Evaluation’ and ‘Continual Improvement’.
• Proposed revisions to enhance requirements on strategic environmental management
in support of sustainable development, legal compliance, environmental performance
improvement, external communication, supply chain and the lifecycle of products/services.
This presentation will provide an overview of the new requirements and outline the transition process for organizations seeking to have their systems certified to the new standard.
About the speaker- Career Highlights related to ISO Standards
Susan Briggs is the Chair of the US Technical Advisory Group to ISO/TC 207 on
Environmental Management, ANSI’s national standards body developing and promoting US
consensus positions on environmental issues and leading the US delegation in negotiations
of global environmental standards in the technical fields of management systems, labeling,
life-cycle assessment and greenhouse gases. She has been a member of the US TAG since
2000, leading the subcommittee on Environmental Management Systems since 2005.
She is now serving as the Chairperson of the international working group that is revising
ISO 14001, the Environmental Management System standard.
Her past affiliations include being a member of the Joint Technical Coordination Group
Task Force on Management System Alignment, and serving on the ANSI-ASQ National
Accreditation Board Accreditation Council overseeing the certification processes in the
U.S.
Professional Career - Susan Briggs has spent 15+ years implementing environment,
health, safety and quality management systems in National Laboratories, research
institutions and aerospace/defense companies.
Her most recent work experience as Director of Environment, Health and Safety at Textron
Systems Corporation, included responsibility for health and safety of 5,500 employees,
development and implementation of EHS management systems, disaster recovery and business continuity programs, and protection of the environment at twelve manufacturing companies in the US, England and Australia.
Previously, she was the Deputy Manager for Environment, Health, Safety and Quality at
Battelle, a global science and technology enterprise managing large R&D laboratories for
— 14 —
the Department of Energy where she led operational improvement initiatives including ESH
Management System implementation, behavior-based safety programs, and human performance improvement for high reliability organizations. Her environmental work on
Battelle’s EMS programs was recognized by DOE-Office of Science as ‘Best in Class’, and
was conferred the ‘Closing the Circle Award’ by the White House. Prior to joining Battelle,
she worked at Brookhaven National Laboratory as Environmental Project Manager responsible for implementing the first certified EMS at a national laboratory.
Susan’s early career was spent in academia on a research team at Harvard University School
of Public Health, studying the health effects of air pollutants in six cities across the US.
Contributions from her work on the Harvard Air Pollution Health Effects Study include
publications and formed the technical basis for the US EPA National Ambient Air Quality
Standards for particulate matter.
Susan L.K. Briggs holds a Bachelor’s degree in natural science from Harvard University.
How to Augment ISO 9001:2015 Using ISO 31000 Risk Management
Allen Gluck Member of ISO/TC 262 (ISO 31000 Risk Mgm Standard),
TC 176 (ISO 9001 TAG) & President ERM31000 Training and Consulting
Abstract - The advent of ISO 9001:2015 will raise many questions about risk, its man-
agement and its relationship to ISO 31000. As an SME on the ISO 31000:2009 Risk
Management Principles and Guidelines, Allen will demonstrate how this document will
rapidly become the quality management professionals best friend in assisting with the
implementation of risk-based thinking for quality management systems.
About the speakerAllen Gluck, holds a Master’s Degree in Leadership from Bellevue University, Nebraska.
He is an official member of both the ISO/TC 262 (ISO 31000 Risk Management Standard)
and TC 176 (ISO 9001 Quality Management Systems Standard) Technical Advisory
Groups. Mr. Gluck is a validated, certified lead trainer for the ISO 31000 Risk Management
Standards and Guidance document. Allen is also an adjunct professor at Manhattanville
College in Purchase, NY, where he teaches the first risk management course in the Unites
States, based on ISO 31000. Allen has over twenty five years of experience in public speaking and adult training and education. As President of ERM31000 Training and Consulting,
Allen provides risk management training and consulting across the United States.
— 15 —
2015 CONFERENCE COMMITTEE
CHAIRMAN
REGISTRAR
Lucita Kahn
Stephen W. Becker
PROGRAM CHAIR
PUBLICATION AD HOC
Mike Parrillo
Mulraj Ved
PUBLICITY
John Ackerman
Matt Benning
Carl A. Perini
ASSISTANT PUBLICITY
AWARDS CHAIR
EXHIBITOR CHAIR
SIGNS, SURVEYS,
SATISFACTION
MEASUREMENT
WEBSITE
Wayne Merrifield
Wayne Merrifield
US Army ARDEC
ASQ Immediate Past
Section Chair
ASQ Section Chair
National Manufacturing
Co.,Inc.
US Army ARDEC
Avon Products
Global Corporate Quality,
Ashland Specialty
Ingredients
GlyEco
GlyEco
Ed May
Mark Ellis
Consultant
Consultant
2015 EXHIBITORS Please see our website www.springqualityconf.org for updates.
ASQ NJ SECTION
SGS – CTS US
ASQ NJ EDUCATION
US ARMY ARDEC
ASQ ELEC/COMM
TEC-EASE, INC
GHR ASSOCIATES
NATIONAL QUALITY
ASSURANCE (NQA)
QUANTUM LEAP
ABS
MINITAB, INC
ETQ
SGS – SSC
QUALITY &
PRODUCTIVITY
SOLUTIONS
NORTH JERSEY SECTION 0304 SITE MEMBERS
ACTAVIS ELIZABETH LLC
BEACON CONVERTERS, INC.
MEDTRONIC INC.
NEWARK BETH ISRAEL MEDICAL CENTER
SPARTA SYSTEMS, INC.
TRUMPF PHOTONICS INC
US ARMY ARDEC
Elizabeth
Saddle Brook
Eatontown
Newark
Hamilton
Cranbury
Picatinny Arsenal
NORTH JERSEY SECTION 0304 ENTERPRISE MEMBERS
ANSELL HEALTHCARE LLC
BD
HONEYWELL
Iselin
Franklin Lakes
Morristown
— 16 —
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North Jersey ASQ Spring Quality Conference –
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North Jersey Section 304 - Spring Quality Conference
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