November 15, 2012 Education Program: Competitiveness

Pre-Meeting Clinic (5:30 – 6:00 PM):  Competitiveness Part 1

Presented by Jack Dye

Help your businesses compete in the growing global marketplace. Ensure you have access to international markets, protection, and assistance if you have been adversely affected by imports. Keep abreast of competitiveness tools, techniques and initiatives including numerous Federal and State programs and resources, including grants and matching funds, currently available to help your company succeed. U.S. Department of Commerce – Programs helping all – including small & medium-sized enterprises: The U.S. Department of Commerce is committed to strengthening the international economic position of the United States and developing a public policy environment that advances U.S. competitiveness at home and abroad. Since it’s inception in 1903, the Department’s mission has been “to foster, promote, and develop the foreign and domestic commerce” of the United States by participating with other Government agencies in the creation of national policy, through the President’s Cabinet and its subdivisions; promoting and assisting international trade.  The Department has many bureaus and administrations that work together in securing the prosperity of U.S. companies and ensuring that we remain competitive in today’s global economy. The International Trade Administration: (ITA) is here to help your U.S. businesses participate fully in the growing global marketplace. It provides practical information to help you select your markets and products and ensuring that you have access to international markets as required by our trade agreements and safeguard you from unfair competition from dumped and subsidized imports.  The International Trade Administration: (ITA) is here to help your U.S. businesses participate fully in the growing global marketplace. It provides practical information to help you select your markets and products and ensuring that you have access to international markets as required by our trade agreements and safeguard you from unfair competition from dumped and subsidized imports.  The Trade Adjustment Assistance Program (TAA) for firms is a U.S. Department of Commerce program designed for manufacturers and service firms adversely affected by imports. This program offers up to $75,000 in cost-sharing funds for projects implemented to improve the business.  Applied Strategies International, Ltd (ASI) is a non-profit organization contracted to administer the program. Currently ASI has 141 active manufacturing clients receiving assistance, and ASI has assisted over 850 companies in various industries since it began administering the program.

Jack Dye

Jack Dye is Chief Engineer and Senior Program Manager at Applied Strategies International, Ltd. He has a B.S. Engineering from Michigan State University, Cognate in Business, Marketing, & Supply Chain Management. M.B.A. with distinction from DePaul University, Concentrations in Finance, Strategy, Execution, & Valuation. Previous career experience in automotive engineering & manufacturing, telecommunication engineering, and utility consulting.

Section Meeting  (7:30 – 8:30 PM): Competitiveness Part 2

Presented by Tom Babin and John Schaefer

Keep abreast of competitiveness tools, techniques and initiatives including numerous Federal and State programs and resources currently available to help you from Department of Commerce programs as well as other interagency programs. Made in America: The Next-Generation of Innovations,, manufacturing is a matter of fundamental importance to the economic strength and national security of the United States. More than any other industry, a globally competitive manufacturing sector translates inventions, research discoveries, and new ideas into better or novel products or processes. To be sure, there are many interrelated elements of an innovation ecosystem…but without manufacturing, the economy-building, job-creating power of innovation fades…Why Focus on Advanced Manufacturing: Manufacturing stands on the threshold of a major transformation. From the digitization of equipment, processes, and organizations to three-dimensional printing (or additive manufacturing) to materials with custom-designed properties, a whole host new design, production, and business capabilities are opening the way to new types of manufacturing-referred to, collectively, as advanced manufacturing. Advanced manufacturing entails more than making high-tech products. It also includes using new, often leading-edge machines and processes to make products that are unique, better, or even cheaper. Advanced manufacturing also facilitates rapid integration of process improvements, readily permits changes in design, such as new part features or substitute materials, and accommodates customization and cost-effective low-volume production. In advanced manufacturing, product innovation and process innovation are different sides of the same coin. Scientific discoveries, new ideas, and novel engineering approaches can be converted quickly into the seeds of new products and processes. Technology-intensive and dynamic, advanced manufacturing enterprises require high-skilled workers to perform at high levels and compete globally. Advanced manufacturing provides the path forward to revitalizing U.S. leadership in manufacturing, and will best support economic productivity and ongoing knowledge production and innovation in the Nation. The Nation’s long-term ability to innovate and compete in the global economy greatly benefits from co-location of manufacturing and manufacturing-related R&D activities in the United States. The loss of these activities will undermine our capacity to invent, innovate, and compete in global markets.

The Manufacturing Extension Partnership (MEP) is a catalyst for strengthening American manufacturing – accelerating its ongoing transformation into a more efficient and powerful engine of innovation driving economic growth and job creation. “MEP Centers make it possible for even the smallest firms to tap top-level manufacturing and business specialists. If you are in manufacturing, don’t miss this great resource.” 100 Best Resources for Small Business. Be aware of all the breadth of programs available, get access to SBA, export assistance, banks, trade organizations, and so many other kinds of resources that can help you grow your business. MEP centers are a key component in the U.S. manufacturing infrastructure. MEP’s mission is to provide small and medium-sized manufacturers with the help they need to succeed. MEP centers in every state work directly with local manufacturers to provide expertise and solutions tailored to each company’s critical needs. These are the people guiding and instructing U.S. companies on how to excel at manufacturing. Improve your operational excellence and competitive strategy:  Illinois Manufacturing Extension Center (IMEC). IMEC was established in 1996 to improve the productivity and competitiveness of Illinois’ small and mid-sized manufacturing firms. A non-profit economic development organization, IMEC is funded in part by the National Institute of Standards and Technology – Manufacturing Extension Partnership, the Illinois Department of Commerce and Economic Opportunity, and by fees for services paid by Illinois manufacturers. View IMEC Authored Content: From strategy white papers to capabilities profiles and success story newsletters, IMEC is a rich source of information for manufacturers looking to gain an edge on the competition. Content Partnerships with leading manufacturing publications provide Illinois manufacturers with access to best practices, tips and industry trends. Experienced staff based at eleven office locations throughout Illinois provide hands-on technical assistance and consulting services to help manufacturers innovate, contain manufacturing costs, streamline processes, and increase profits. They roll up their sleeves and get to know all facets of the business, providing solutions in areas ranging from process optimization to product innovation, quality improvement to technology integration. IMEC draws on the resources and capabilities of a network of manufacturing service providers. Alliances with state and national economic development programs, higher education institutions, specialty service providers, and the private sector ensure that IMEC is able to address critical manufacturing needs without duplication of effort. And, as part of a national system, IMEC is able to leverage the expertise of a field network of 2,000 manufacturing advisors from over 400 MEP centers. Our speakers, Manufacturing Specialist Dr. Babin and Business Development Specialist John Schaefer, will inform us about some of the Federal and State initiatives and resources available.

Dr. Thomas Babin

Tom Babin, IMEC team Manufacturing Specialist, is a Six Sigma Master Black Belt with a successful background of designing and implementing product and process improvements in highly competitive environments — domestic and international. Especially skillful at driving continuous improvements in efficiency, productivity, quality and reliability. Proven ability to identify, analyze and solve complex problems — designing workable strategies and leading successful solutions from concept to completion. Successful background of innovative leadership, project management, implementing leading-edge technology, and delivering excellent products on time and under budget — exceeding requirements and expectations. Tom is based in the Chicagoland region and works as part of high performance service delivery teams, drawing upon IMEC’s extensive state and national resources to help companies implement actions to improve their productivity and competitiveness. Tom has over 20 years of experience in manufacturing, product development, and service offering development in the telecommunications industry. He has held positions of increasing responsibility from staff engineer to director/fellow of the technical staff. He was Past Director, Motorola Solutions and earned a Bachelor of Science and Master of Science in Industrial Engineering and a PhD in Mechanical Engineering from the University of Illinois Urbana-Champaign.

John Schaefer

As a member of the IMEC team responsible for expanding business in the Chicago region, John develops relationships with area manufacturers, assesses their challenges as well as opportunities, and offers IMEC’s strategy, technology, and efficiency solutions to help them become more profitable and competitive. John has over 18 years of manufacturing management experience with responsibilities that included productivity and quality improvement programs, new product and new process design, supply chain development, inventory controls, facilities and facility planning, engineering, and OSHA / Health Life Safety. Immediately prior to joining IMEC, John was an independent consultant providing AEC and Energy Conservation services to commercial organizations. John earned a B.A. from Governors State University after undergraduate studies at Loyola University. His post-graduate education and training include Industrial Engineering, Computer Aided Drafting & Design, Architecture and Project Management. John is a Past Adjunct Instructor and is based out of the University of Illinois Chicago, Center for Advanced Design Research and Exploration (CADRE).

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Rocky Mountain Quality Conference 2013

 Date:              February 6-9, 2013

Location:      Arvada Center for the Performing Arts

                        6901 Wadsworth Blvd., Denver Colorado 80003

Earn a Minimum of 3.0 RUs!

25% Discount for Site and Enterprise Members

Special Discounts for Non-Profit and Government

 How to Raise Quality Awareness in a Down Economy

Featured Speakers Include: Volvo, CDOT, Covidien, St. Joseph’s Hospital, Minitab, SSD Global Solutions, QI Macros and Top Consulting Firms

Key Note Speakers

Joseph A. De Feo, President, The Juran Institute

Forrest W. Breyfogle III, President, Smarter Solutions, Inc. 

Six Informative Tracks

Leadership Development

Quality Tools

Product/Service Innovations

Healthcare/Medical Device/Biotech

Lean Government

Certification Preparation and Refresher Workshops

                All ASQ Tests are Available!

 Pre/Post Conference Opportunities (includes Lunch)
Gain additional RUs!

 Create-Learning Inc.

High Performance Quality Teams

ASQ Lean Enterprise Division Workshop

Sharpen your Lean Skills

System Service & Delivery, Inc. SSD Global Solutions
How the ISO 13053 for Six Sigma is Surprisingly “Lean”

The Best Priced ASQ Conference for 2013!

Conference Price Includes Meals, Materials and Networking Events

For Complete Details Visit:


Sponsorship Opportunities are Available 

October 18, 2012 Section Meeting: Innovation!

Presentation 1: Innovation EcoSystem, By William Beach

In today’s economy, innovation is more important than ever to survive and thrive. William Beach  director of the Heritage Foundation (a research and educational institution —a think tank) presents information from the Center for Policy Innovation (Heritage’s “think tank within a think tank”).  Units within creative companies and specific institutions that develop breakthrough ideas is the model for The Center for Policy Innovation. William Beach will focus on advancements, ideas, tools, and key forces needed to create an Innovation Ecosystem–an environment that encourages and promotes innovation. He will give an educational and inspirational synthesis of recent Innovation data, reports, and conferences/events in plain English! He will be highlighting research projects and recent findings, effective strategic planning and critical strategic goals, as well as the principles that promote innovation. Beach will comment on how today’s public policy problems affect/threaten innovation today and tomorrow. So, whether you’re a top-level executive or a person that wants your department or group to succeed, this will help you gain the latest innovation insights, strategies, and tools to position yourself for success!

Bill Beach

William Beach works for the Heritage Foundation, where he was inaugurated in April 2012 as Lazof Family Fellow. He is the think tank’s chief “number cruncher,” speaker/host for many conferences/events. Beach helps build analytical models as well as acquires them. Under Beach’s leadership, Heritage acquired one of the largest collections of privately held databases in the United States, as well as a variety of peer-reviewed analytical models. Together, these acquisitions allow the Center for Data Analysis (CDA) to produce some of the most sophisticated calculations done anywhere in the world. Because of his ability to distill complicated data into plain language with real-world examples, Beach is a reliable source for news reporters and a frequent guest on television and radio talk shows. He serves on the Economics Advisory Panel for ABC News.

Prior to joining Heritage in 1995, Beach held a variety of posts in the public, private and academic sectors. He served as a litigation economist with two Kansas City, Mo., law firms Campbell & Bysfield and Watson, Ess, Marshall & Enggas where he specialized in analyzing how antitrust legal remedies would alter product pricing and availability. Later, as an economist for Missouri’s Office of Budget and Planning, he designed and managed the state’s econometric model and advised the governor on revenue and economic issues. After a stint in the corporate headquarters of Sprint United Inc., Beach moved to the Washington, D.C., area to serve as president of the Institute for Humane Studies at George Mason University. A graduate of Washburn University in Topeka, Kan., Beach also holds a master’s degree in history and economics from the University of Missouri, Columbia.  He is a visiting fellow at Buckingham University in Great Britain.

Presentation 2:  The Innovation Solution:  Making Innovation More Pervasive, Predictable, and Profitable, By Praveen Gupta

While others talk about the known innovation problem, The Innovation Solution offers a well-researched, logical, and holistic understanding of the innovation process, taught for many years at several colleges and Universities. The 21st-century requires 21st-century solutions. In his presentation, Praveen Gupta provides an easy-to-understand powerful innovation framework for anyone interested in learning about innovation and striving for success at the personal or organizational level. More than that, it demonstrates that innovation skills can be taught and learned for pursuing one’s passion and growth.  Gupta has recognized that Innovation is a learned skill, and he has applied Einstein’s revolutionary work correlating innovation as a function of ones speed of thought to develop his overall framework. Known as Breakthrough Innovation (or Brinnovation), this framework has joined strategies for success, the rule of two, management techniques, measures, return on innovation, and a curriculum to jumpstart an innovation initiative and the powerful TEDOC method (Target, Explore, Develop, Optimize, and Commercialize). Gupta has designed the Brinnovation framework to make innovation more pervasive, predictable, and profitable.

Praveen Gupta

Praveen Gupta is the author of several books including Business Innovation in the 21st Century, The Innovation Solution, A Complete and Balanced Service Scorecard, and Stat Free Six Sigma. Praveen has worked at Motorola in pioneering the Six Sigma deployment method, and taught professionals worldwide. Praveen has done extensive work in teaching and achieving excellence, and is presently focused on teaching and deploying innovation. Praveen has written about 200 monthly columns on Excellence and on innovation.  Praveen is the Director of the Center for Innovation Science and Applications (CISA) at the Illinois Institute of Technology (a collaboration between industry and academia to further develop the science of innovation with global participation).

Praveen taught Operations Management at DePaul University’s MBA program. He teaches Business Innovation at Illinois Institute  pf Technology (IIT) and University of Illinois, Chicago. Besides teaching innovation, Praveen is president of Accelper Consulting (, a Management Consulting firm helping organizations achieve profitable growth through excellence and innovation. He has consulted with about 100 Start Ups to Fortune 100 companies.  Praveen often speaks at conferences or meetings internationally on the topics of Six Sigma, Process Excellence, Business Scorecard, and Business Innovation. He is the founding editor of the International Journal of Innovation Science launched in February 2009, and founding Chair of Business Innovation Conference starting since 2008.

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Value Added — ISO 9000 Certification, by Martin Palczynski

We had solid a presentation and discussion about ISO 9000 compliance at the September ASQ 1212 section meeting.  The presentation stimulated an important question: Is your company’s ISO 9000 certification compliance or illusion?

Many companies today require ISO 9000 certification of their suppliers, in order to establish a fundamental baseline of quality for the materials they will receive.  The ISO 9000 standard provides a solid framework to build upon, if the organization truly embraces the fundamentals.  Companies that leveraged this framework to its full benefit see and reap the benefits.  So do their customers.  Through the continuous improvement mindset Continue reading

Training available to you from the ASQ Learning Institute

Start planning your career training today! As the leading quality training provider for more than 65 years, ASQ offers essential career training in convenient and practical formats. The training listed below will make you more valuable to your current organization as well as the job market. Remember as an ASQ member, you can take advantage of member pricing on ASQ training. You can save up to $200 on the list price of these upcoming courses. Many of our courses also count toward recertification units (RUs). Register today!
Upcoming Instructor-led (Web-based) CoursesSeptember 2012 – LAST CHANCE TO REGISTER!

  • Supplier Management for the Medical Device Industry

October 2012

  • Measuring Process and Organizational Performance

November 2012

  • Process Validation for Medical Device

Upcoming Instructor-led (Classroom-based) Courses

October 2012 – Memphis, TN

  • ISO 13485 Lead Auditor Training (RABQSA Certified)
  • Practical Measurement Uncertainty

November 2012 – San Antonio, TX

  • Auditing for Improvement
  • Internal Auditor Training for AS9100
  • ISO/IEC 17025 Lead Assessor Training

Visit The ASQ Learning Institute™ for a list of all courses ASQ has to offer.

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Minutes of September ISO Support Group Meeting

Six members attended the meeting on September 6, 2012 at the Dover Straits in Mundelein:   Dave Spengler, Regina Fullen, Ron Bateman, Bill Sherman, Jan Agostinelli
and Dave Taylor. We talked about another place for our meeting. Please let me know if you have a suggestion of a restaurant that would accommodate our 4 to 10 member group, has a private dining room, and a menu of entries under $15.

Continuing our study of ISO 19011 2011 Guideline for auditing Management Systems, we reviewed sections 6.4.7, “Generating Audit Findings”, 6.6 “Completing the Audit” and 6.7 “Conducting he Audit Follow-up.” We then rated the sections of the standard about how effective it would be in providing a good audit. T

In the Round Robin review:

Ron Bateman described a conversion in the oil business away from ISO 9000 to API (American Petroleum Institute) QI. This is a standard like TS 16949 automotive standard. Customer audits inundate his ompany now. One audit lasted 10 days. He shared some comprehensive checklists used for these audits and discussed the company’s strategy for reacting to the findings. In addition the industry is doing employee safety audits that are much more comprehensive than OSHA.

Bill Sherman reported that FDA is sending him on “road trips where he spends two days or more calling on regulated companies in places like Galesburg and Rockford. Unfortunately several of the companies he are now out of business.

Dave S said his company is having problems with soldering. Also some customers are asking for third-party audits of tests conducted for PPAPs.

Dave T reported he will conduct an internal audit at an electronics company next week.

Our next two meetings will be held at 6:00 on Thursday Oct 4 and Nov. 1, 2012. We will continue our study of ISO 19011:2011 Guideline for auditing Management Systems.

We are still experimenting with locations. The October meeting will be held at Adinas on Route 45, just SE of Dover Straits. Phone (847-918-9060)

As always, a gratifying, tasty meal will be served for $5.00 (free for members searching for a position), the balance being funded by ASQ section 1212 Northeast Illinois. The public is always invited and we welcome your questions about ISO or other standards. Let me know if you have particular subjects to discuss. Contact Dave Taylor at if you have any questions or need directions.

Dave Taylor



Northeastern Illinois

Section 1212 Fact Sheet


ASQ website:

1212 website:

What is ASQ?  

The American Society for Quality (ASQ), headquartered in Milwaukee, Wisconsin, USA, is the world’s leading authority on quality since 1946. The 104,000-member professional association creates better workplaces and communities worldwide by advancing learning, quality improvement, and knowledge exchange to improve business results. By making quality a global priority, an organizational imperative, and a personal ethic, ASQ becomes the community for everyone who seeks technology, concepts, or tools to improve themselves and their world.

What are sections?

More than 250 volunteer-run local ASQ sections in the United States, Canada, Mexico, and Costa Rica allow you to meet and learn the business of quality from people in your community. The International Chapter is available for members primarily outside North America or where local sections do not yet exist. One Geographic section membership is included in your membership and may provide the following opportunities.

  • meetings
  • a newsletter
  • online information
  • educational courses, seminars, and conferences
  • certification exam preparatory programs

What are forums and division?

ASQ’s forums and divisions are sources of concentrated information that will help you in your job. It is a place to go when you have a question, or need a specific type of conference, course, book, or paper. It can help you with questions like: ‘How can I…

      • Learn more about…
      • Get started in creating…
      • Find someone I can talk to about…
      • Find a speaker on the subject of…

It provides you with informative tools for your field of interest, involves you via collaborative and networking events, and inspires you to try new and innovative ways to improve yourself, your community, and your world!

What is the History of ASQ? Section 1212

Formerly known as American Society for Quality Control (ASQC), ASQ was founded in 1946 as the result of a merger of several local quality societies that had formed after wartime statistical quality control classes.

What are the Products and Services of ASQ Section 1212?

ASQ offers several types of membership, certifications, courses, and conferences to advance its mission. In addition, it is involved with several quality-related initiatives such as the American Customer Satisfaction Index, Malcolm Baldrige National Quality Award, and Koalaty Kid.

Section 1212 offers our members opportunities to learn more about their profession through the sharing of information and ideas. The section accomplishes this with our ISO Support Group, the Section Leadership Committee meeting and the monthly General Membership Meeting.

We also provide continuing education opportunities with classes and workshops that can be presented in-house or off-site.

We provide social networking through our Linked In page: ASQ NEI Section 1212

What are Major Events?

The World Conference on Quality and Improvement– held annually in May.

Plus there are many divisional, regional, and special interest conferences held throughout the year.

Does ASQ offer Career Services?

ASQ offers a variety of career services for quality-related professionals, as well as employers, including an online job service, resume service, and an annual career fair.

Section 1212 offers career services including placement information and offer pre-meeting clinics on resume writing and interviewing skills periodically.  Contact Jim Sohn ( for more information.

Job postings can be found at our section’s website or on our LinkedIn discussion group ASQ NEI Section 1212 (

What are the Membership Eligibility Requirements?

Anyone interested in quality!

Are there Membership Dues?

ASQ:  $135 annually; 1212 section:  included in your ASQ dues!

How many  Members does ASQ have?

ASQ:  over 100,000 members worldwide.  1212 section:  Over 750 members and growing!

When are the Section Meetings?

General Membership Meetings for ASQ1212 are typically held the third Thursday of every month at 5:30 p.m. at the Arboretum Club. (0.6 RUs per program)  The meeting format is typically a dinner meeting preceded by topic-specific quality clinics. The main presentation begins at 7:30 p.m. Please contact Dave Krasowski at for more information about section meetings or to make a reservation for the next meeting. There is a $25.00 fee for dinner, but the price is waived for those members searching for a position.  Please go to Monthly Section Meeting Programs for more information about this month’s section meeting. Go to Meeting Venue & Schedule to see the calendar.

Section Leadership Committee Meetings are held the second Thursday of the month at the Dover Straits Restaurant. Please contact Peter Larson for more information.

All members are encouraged to attend both general membership meetings and section leadership committee meetings.

ISO Support Group meetings are held the first Thursday of every month. Please see the tab for ISO Discussion for more information on the place, time, and standard under discussion.The public is always invited and they welcome any and all questions about Quality Management Standards. There is a small fee for dinner, but the price is waived for members who are searching for a position.

What do Meetings Costs?

Section Meeting Dinner: $25.00                 ISO Support Buffet: $ 5.00

Can I Volunteer?

You can also get involved by becoming a 1212 section volunteer. As a volunteer, you can enhance your leadership skills, increase your visibility in the quality community, and publicly develop and support the quality movement. You also collect re-certification units that can be used when renewing your ASQ certifications.


September 20 Pre-Meeting Clinic: “What’s New in ASQ”

This month’s pre-meeting clinic is a team presentation by three inspiring Section 1212 leaders on the Section Leadership Committee.  Building on Section 1212’s award-winning performance in “President’s Race to Retain,” Section 1212 is extending its reach to by accommodating the needs of younger Quality professionals.  The theme of their presentation, “What’s New for ASQ 1212’s Membership” will explain how Section 1212 intends to be a lead by example in spreading the word about ASQ and its benefits to young quality professionals.  Ann Blosser will discuss her plans to reach out to early-career Quality professionals through training opportunities.  Adela Crandell is excited to share her summer project: the newly refurbished ASQ1212 website.  She will show you how to navigate and how to sign yourself up for automatic updates and theASQ 1212 newsletter.  Time permitting, Adela will demonstrate just how easy it is submit a Quality Article for publication and get CUs towards re-certification. Gina Kotz will describe efforts that are underway to allow younger members who have family responsibilities to reach the section meetings remotely.  Don’t miss this information, as it is News you can Use!

Ann Schrier-Blosser

Deborah “Ann” Schrier-Blosser is a professed daughter of the Motor City. She was born near Detroit and loved manufacturing since the moment she first saw a moving assembly line on TV as a child. After leaving high school, her first real job was as Assistant to the Quality Manager at a die casting company.  Since that time, she became a true adherent to the Quality field.  Ann’s two passions in life are Quality and Education, since nothing in her opinion is more important in life than striving to learn and grow. She believes that the more we learn the, better we can impact and improve lives. Her hope is to spread her excitement about Quality and learning to everyone.  She is presently employed in a QA role at Zebra Technologies.

Gina Kotz

Gina Kotz has a B.A. in English and Spanish and is employed as Lead Technical Writer for the PACS product at GE Healthcare, where she creates supporting documentation for numerous software product rollouts.  She is a Certified Software Quality Engineer at ASQ, and recently came to the role of Virtual Attendance Coordinator for Section 1212 while the Section was contemplating ways to reach our membership, and she gladly volunteered.  Gina states that she appreciates a challenge, and enjoys spending time with her family, watching movies, and playing Frisbee golf.


Adela Crandell

Adela Crandell is a Wife/Mom/G-mom, Writer/Reader, Regulatory Affairs Professional, Quality Assurance Expert, Microbiologist/Chemist, Pest Control Specialist, Trained Tongue, Seamstress, Organizer, TV Watcher, Cook, Gardener, Bicycle enthusiast, Swimmer, Yoga practicer, Environmentalist, Techno-geek, arm-flailing Zumba dancer, and much, much more. Adela gave up nearly 30 years of corporate leadership in pharmaceutical manufacturing to find her way as a free-lance writer and consultant.  You can find her published works syndicated by,, (Voice of 2011 honoree,) PKA Advocate, and TribLocal.  Her soul is infused with health, science and quality principles, so you will see that side of her peaking through in all that she writes.  Visit her at and  She asks that you cross your fingers for her:  her first novel is in the “read” pile with a major publishing house.

Thursday September 20, 2012 7:30-8:30 P.M. Main Presentation: FDA Mandated Quality Management Systems: Implementation and Challenges, Hugh G. Grimes and Dr. James Capone

Joseph M. Juran in 1987 published the “Cost of Poor Quality” and developed “Juran’s trilogy,” an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control and continuous quality improvement. These functions constitute a Quality Management System (QMS).

In the early 1990s, many ISO industries adopted the QMS approach to meet the needs of their customers.  Whether you work in a regulated or non-regulated industry, effective use of a QMS helps conduct business in a smooth and efficient manner. Come hear answers to the following questions:  When building a quality management system, what are the essential elements, and how do you make these elements connect in a meaningful way?  How does an effective quality system interact with business functions outside its scope?  What are the common gaps in a quality system, and how are they minimized?

Mr. Grimes and Dr. Capone were part of and assisted companies regulated by FDA CDRH when this was mandated for implementation by 21 CFR Part 801 in 1997.  Ten years later, in 2007, FDA mandated (by ICH Q10 guideline) the implementation of QMS for Pharmaceuticals, drug substances, drug products including biotechnology and biological products, i.e. companies regulated by CDER/CBER/CVM.  Now all FDA regulated companies are required to embrace these fundamental principles in one form or another. They will discuss their experiences in the implementation of these QMS and some of the challenges we encountered along the way.

Hugh G. Grimes

Mr. Grimes is a consultant with cGXP Consulting.  He has been actively involved in drugs, medical devices, and biologics for thirty-two years. His work experience includes the research, development and manufacture of same as well as extensive management responsibility for validation, quality systems and regulatory affairs.  His twelve years of independent consulting have involved him in the strategic development of GMP/GLP/GCP/ ISO quality systems, training in all facets of academic/compliance topics, and product approval submissions.    Mr. Grimes specializes in the development of all facets of the quality system including test method and process validation for both domestic and international manufacturers particularly in response to FDA/EU actions/observations.  As such, Mr. Grimes bridges the gaps between Management, Quality/Regulatory Compliance, and Technical Expertise.

Emphasis has been on the technical aspects of chemical, biological, and microbiological test methods and processes.  This included design and process validation along with analytical method validations and characterizations including test methods, compendial methods, and immunochemistry. Assisted in the development of appropriate quality systems, as determined by audit or in response to regulatory actions. International in scope and providing FDA quality systems and regulatory support from start-ups to the largest healthcare corporations.

  • Develop master validation plans and validation master plans for all aspects of the device pharmaceutical manufacturing operation.
  • Review, audit and help prepare FDA/CE/USP submissions, i.e., NDA, aNDA, 510(k), PMA, CE Mark.
  • Develop site-specific training for design controls, risk assessment, design of experiments, executive level training to the Quality System Regulations [21 CFR Parts 211 and 820]
  • Develop procedures for general laboratory and microbiological controls for the pharmaceutical and device quality laboratory.
  • Develop procedures for method characterization, validation, and method transfer consistent with compendial and non-compendial test methods.
  • Design Validation and Verification protocol development and execution
  • Test Method, Process, and Cleaning validation protocol development and execution.
  • Develop and implement Clinical protocols.
  • Instrument/Equipment/ Facilities/ Utilities Characterization and Qualification.

In general, led assessment, negotiation, development, implementation of Quality System Improvement Plans (QSIP), and managed the execution of highly acclaimed adult-based training for numerous corporations.

James J. Capone, Ph.D.

Dr. Capone has been actively involved in drugs, medical devices, and biologics for over thirty years. His work experience includes the research, development and manufacture of same as well as extensive management responsibility for microbiology, quality systems and regulatory affairs.  His fifteen years of independent consulting have involved him in the strategic development of quality systems and product approval submissions.    Dr. Capone specializes in the development of all facets of the quality system including test method and process validation for both domestic and international manufacturers particularly in response to FDA actions.

Emphasis on the technical aspects of microbiology and sterilization, design, and process validation along with analytical method validations and characterizations including test methods, compendial methods, and immunochemistry. Assists in the development of appropriate quality systems as determined by audit or in response to a regulatory action. International in scope and providing FDA quality systems and regulatory support from start-ups to healthcare corporations with sales in excess of $ 7 Billion annually.

  • Develop master validation plans and validation master plans for all aspects of the device pharmaceutical manufacturing operation.
  • Review, audit and help prepare FDA submissions, i.e., NDA, aNDA, 510(k), PMA.
  • Develop site-specific training for design controls, risk assessment, design of experiments, executive level training to the Quality System Regulations [Parts 211 (Drugs) and 820 (Devices)]
  • Develop procedures for general laboratory and microbiological controls for the pharmaceutical and device quality laboratory.
  • Develop procedures for method characterization, validation, and method transfer consistent with compendial and non-compendial test methods.
  • Design Validation and Verification protocol development and execution
  • Process validation protocol development and execution.

Strategic Quality Life Plan and Deployment

by Adela Crandell Durkee

Do you ever consider applying a Strategic Quality Plan and Deployment for your personal life?  Consider what is most important in your life.  Is it family, faith, career, or security?  How do you go about nurturing and supporting all the things that are most important?

Make a Quality Plan, starting with your personal missions statement.  One way to do this is Continue reading