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
9-7-12

FAQs

 

Northeastern Illinois

Section 1212 Fact Sheet

2012-2013

ASQ website: www.asq.org

1212 website: www.asq1212.com

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 (james.sohn@yahoo.com) for more information.

Job postings can be found at our section’s website or on our LinkedIn discussion group ASQ NEI Section 1212 (http://www.linkedin.com/e/vgh/2236959/)

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 asq1212reservations@yahoo.com 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 twins0649@gmail.com 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 About.com, WherearewegoingChicago.com, BlogHer.com (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 http://www.theblacktortoise.com and http://www.oncealittlegirl.com.  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

Your Section Leadership

The Section Leadership Committee (SLC) is comprised of volunteers from your section.  Feel free to contact them using the email addresses listed below.

If you need help navigating our website, have questions or have an idea for improvement contact our webmaster Adela Crandell Durkee at  website@asq1212.com

If you want to submit something to the Newsletter, don’t know how to sign-up, are missing newsletters, or have questions about the newsletter contact Adela at newsletter@asq1212.com

2017 SLC
Name E-mail
Arrangements Glenda Piefer glenda.peifer@gmail.com
Assistant Arrangements Chair Dave Krasowski djkrasowski@yahoo.com
Auditing James Sohn james.sohn@abbvie.com
Auditing Assistant Peter Larson twins0649@gmail.com
Awards James Schlichting schlijp@sbcglobal.net
By Laws James Schlichting schlijp@sbcglobal.net
Chair elect James Sohn james.sohn@abbvie.com
Chair Jeff Wright* calainetp@hotmail.com
Education Edwin Rodriguez ER8472760550@GMAIL.COM
Education Assistant Kam Gupta citkam@gmail.com
Historian Jim Sohn james.sohn@abbvie.com
Membership/ Database Sandra Storli storli4600@sbcglobal.net
Nominating Regina Fullin rmfullin@gmail.com
Par (SMP) Virginia Gibbs virginiag920@aol.com
Past Chair Regina Fullin rmfullin@gmail.com
Placement David Norby dplmnorby@sbcglobal.net
Program Chair Mahendran Ravichandran r.mahen@gmail.com
Publicity Ravi Nadarajah Ravindrakumar ravi.kingcross@gmail.com
Re-Certification Merle Goddard merle_ goddard@baxter.com
Re-Certification Assistant Don Gatza don.gatza@abbott.com
Secretary Amit Dave amitbdave@gmail.com
Social Media Chair Michele Weir michele.weir@gmail.com
Standards Study Group Donna Nash qltypest@yahoo.com
Treasurer Joe Lierman J.lierman@lycos.com
VOC Assistant Maddy Bradford maddy_bradford@comcast.net
VOC Chair Martha Kadas mkadas@sbcglobal.net