Gauge R&R by Rachel Dowell

The company I work for produces a disposable used with a medical device. In optimizing the design, we found that we lacked a test designed to detect a defective part.

The design team tried many test methods and finally decided on a functional test. They created specifications using a manufacturing DOE (Design of Experiments) output and wanted to transfer the test method to the plant. This was where Quality stepped in to ask for a gauge R&R (Repeatability and Reliability.) The design team saw this exercise as needless busy-work and too academic for their purposes, so they pushed back on the need for the test. Continue reading

Don’t miss ASQ in 3-D! December Double Days

Invite someone to start their own ASQ journey!

Invite someone on the ASQ journey today.

December Double Days ends December 31, 2012
This is your chance to get DOUBLE ASQ BUCKS when you recruit a new ASQ member during December Double Days! Not only will this opportunity impact the career of a friend or colleague, but it will also help build your personal network for sharing best practices.

It is easy to do! Just click here.

Have the person(s) you are referring enter your member number and name on the “Member Referred By” area of the ASQ online or print membership application.
SPECIAL OFFER: During the month of December, for every person you refer who becomes an ASQ member, you will receive 10 ASQ Bucks (1 ASQ Buck=$1 USD).

* All online or faxed new member applications must be sent by midnight on December 31, 2012. Applications that are mailed must be postmarked by December 31, 2012.

To update your contact information, or if you have questions for ASQ, please email help@asq.org.

If you no longer wish to receive promotional emails for ASQ Membership, please unsubscribe here.

Or, sign in at asq.org to update your complete email subscription preferences.

ASQ CUSTOMER CARE CENTER:
Phone:
United States and Canada: 800-248-1946
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All other locations: +1-414-272-8575

Mail:
American Society for Quality
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ISO November Meeting Minutes by Dave Taylor

Minutes of November ISO Support Group Meeting

Five members attended the meeting on November 1, 2012 at the Adinas in Vernon Hills:  Dave Spengler, Bill Sherman, Jan Agostinelli, Regina Fullen, and Dave Taylor.

We decided to meet at The Adinas in the foreseeable future.

We read ISO 19011:2011 Guideline for auditing Management Systems, and finished the main body of the guidelines.. We then rated the sections of the standard as to how effective it would be in providing a good audit. The ratings are recorded by Dave Spengler.

The next meeting, we will continue to review the annexes to the guidelines.

In the Round Robin:

Bill Sherman is now certified to Level One FDA auditor. Congratulations!

Dave Spengler is currently working on compliance to brazing standards. He is also revising the BOM requirements for Special Processes.

Regina has successfully passed the Certified Manager of Quality exam. Also Congratulations!

The next meeting will be held on January 3, 2013. We cancelled the December meeting being cancelled due to a conflict with the Sectional Leadership Council.

We will review the annexes to the guidelines of ISO 19011:2011 Guideline for auditing Management Systems. The meetings will be held at Adinas on Route 45, just SE of Dover Straits. Phone (847-918-9060)

As always, a pleasantly 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.

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The Power of Nothing, by Adela Crandell

Maybe it’s because of all those Black Friday and Cyber Monday sales ads. Or Cyber-Monday e-mails for 70% off all my purchases. Maybe it’s just my long commute and plenty of time to let my mind wander. Maybe my friend Bob is right, I have a mind stuck in beta wave mode. Anyways, I’ve been pondering zero lately. Yes, zero, as in 0, nothing, zed, nil, nada, zilch. Without zero, our lives would be sooo different. No 70% discount for one thing.

Counting seems natural. We must keep track of things: children, sheep, shoes, pennies, friends, enemies… If I have none of those, well, life is simple; nothing to keep track of, nothing to count. Counting starts with 1, not 0. We take zero for granted, but it wasn’t always so, especially in the western world. Stop and think a moment about trying to calculate that 70% sale using Roman numerals. Next to impossible. Wait, not next to. Impossible. Continue reading

December 13, Section Meeting: Global State of Quality and Global Quality Adventures (7:30 – 8:30 PM)

Prozessphasen CIP = Continuous Improvement Pro...

Prozessphasen CIP = Continuous Improvement Process PR = Process Reengineering (Photo credit: Wikipedia)

ASQ is partnering with APQC to collect and study data on the global state of quality. APQC is a leader in research, benchmarking, process improvement developments and knowledge management. This project will aggregate data, trends, and analysis on the global state of quality. Download The ASQ Global State of Quality Research brochure for more information. ASQ is looking for partners to join in pioneering research and reporting on quality, performance excellence, and continuous improvement developments and opportunities around the world. To take part in the study, visit http://www.asq.org/globalresearch. Initial results will be unveiled in May 2013, at ASQ’s World Conference on Quality and Improvement in Indianapolis.

Global Quality adventures: – a great presentation for seasoned globetrotters and armchair travelers alike! An amazing opportunity! Paul Borawski (ASQ CEO) and John Fowler (ASQ Director) have traveled the world, and they’ve seen the same quality problems everywhere, as well as some creative solutions.  These stories, this passion for quality, energy, wisdom, and enthusiasm will be contagious, inspiring, and re-energizing.  See a most invigorating blend of best practices that will inspire you with ideas for your business – from one story to the next. Motivational. Inspirational. WOW!

John T. Fowler joined ASQ Global as managing director in November 2010. Fowler will expand ASQ’s presence throughout the world, focusing on membership growth, business growth, and developing and implementing strategic and operating plans.  Fowler has more than 30 years of experience in the pharmaceutical industry. He has served in senior line management positions and as president and COO in both for profit and nonprofit organizations where he has focused on growth, global operations, and international expansion.

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December 13th Pre-Clinic and Quality Celebration: ASQ – the Global View (5:30 – 6:00 PM)

Come celebrate quality on a global scale! In addition to presenting presents and door prizes, our speaker will present ASQ Global Quality.

John Fowler

John T. Fowler is managing director of ASQ Global with a vision and passion for Quality. He is expanding ASQ’s presence throughout the world, focusing on membership growth, business growth, and developing/implementing strategic and operating plans.  ASQ Global Quality advances ASQ’s mission to be the Global Voice of Quality. It supports quality on a global level. Its focus is building Quality enthusiasts from around the world.

Over the past decade, ASQ Global has expanded its presence in key markets, supporting members in more than 150 countries and operating offices in China, India, and Mexico. ASQ Global provides local access to professional development, certification, knowledge and information services, as well as to a membership community.  ASQ’s enthusiasm, interaction, and exchange of ideas is incredible. It represents varying ability and knowledge – as industry leaders, worldwide, to experience a higher level of inspiration and collaboration

Said John Fowler about this program, “I am pleased to join ASQ as it builds on the foundation that has been set up globally by the very committed member leaders and staff,” he continued, “I am honored to work with ASQ Global to make a positive impact on the lives of people worldwide.”

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Highlighting People in Quality: Rainier Andres, by Adela Crandell Durkee

“Last year, we sent sheets to Cuba.  My wife’s grandmother had surgery, and the hospital had no sheets.”  Rainier Andres  (Ray) is an American citizen who came to these United States with his mother.  He has no brothers or sisters and his father is still in Cuba.   Ray reminds me of a documentary I saw last Fourth of July:  “Citizen U.S.A.:  A 50 State Road Trip,” by Alexandra Pelosi.  These new citizens brought tears to my eyes.

httpv://www.youtube.com/watch?v=iCjsw9zwAgg

Ray was a teenager when he came to America, he was too naïve, or perhaps too filled with machismo to understand the dangers.   Ray considered the trip a chance for high adventure.    Two and a half days, in a hand-made raft, Ray and his mother journeyed from Havana to Miami.  After living in Miami for a month, they moved to New Jersey to live with an aunt.  Ray never liked the cold weather in New Jersey, so as soon as he could, he moved back to the year-round warmth.

“Cuba used to be a rich country:  sugar cane, tobacco, coffee.  Now it’s like the Dawn of the Dead.  The refineries are all dead, all the machinery is old, and the buildings are old.  Everything is dead.  It is really sad.”  Ray’s visit to Cuba in 2005 left a lasting impression.

I met Ray in Orlando.  Right away, I recognized him as a positive, helpful fellow.   Continue reading

ISO Meeting Minutes for Nov, 1212

Minutes of November ISO Support Group Meeting

Six members attended the meeting on November 1, 2012 at the Adinas in Vernon Hills. In attendance were Dave Spengler, Bill Sherman, Jan Agostinelli, Regina Fullen, Alice Chang, and Dave Taylor.

We Met at Adinas, in Vernon Hills. We had a discussion and the consensus was we would continue to meet there in the foreseeable future.

We read ISO 19011:2011 Guideline for auditing Management Systems, and finished the main body of the guidelines.. We then rated the sections of the standard as to how effective it would be in providing a good audit. The ratings are recorded by Dave Spengler and are shown elsewhere in this newsletter. Next month we will continue to review the annexes to the guidelines.

In the Round Robin:

Bill Sherman has been certified to Level one FDA auditor. Congratulations!

Dave Spengler is currently working on compliance to brazing standards. He is also revising the BOM requirements for Special Processes.

Regina has successfully passed the Certified Manager of Quality exam. Also Congratulations!

We will review the annexes to the guidelines of ISO 19011:2011 Guideline for auditing Management Systems. The meetings will be held at Adinas on Route 45, just SE of Dover Straits. Phone (847-918-9060)

As always, a pleasantly 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
11/8/2012

ISO Support Group Minutes by Dave Taylor

Five members attended the meeting on October 4, 2012:  Dave Spengler, Bill Sherman, Jan Agostinelli, Alice Chang, Peter Larson and Dave Taylor.

We Met at Adinas, in Vernon Hills, which proved a good location. They had live music playing, but would not have this going forward.

Continuing our study of ISO 19011 2011 Guideline for auditing Management Systems, we reviewed Section 7 Competence and Evaluation of Auditors, 7.1 General and 7.2 Determining Auditor Competence. We rated the sections of the standard on how effective it would be in providing a good audit. The ratings are recorded by Dave Spengler.

Bill Sherman is doing “road trips” in downstate Illinois. One of the problem he experiences is that some of the locations registered with the FDA are closed, but the FDA records still have them on the roster.

Dave Spengler is exploring future options with his employer as he is nearing retirement. Right now he is doing contract review and is revising the database of active parts.

Dave Taylor reported an audit conducted at an electronics manufacturer in Palatine.

Our next two meetings will be held at 6:00 on Thursday Nov. 1 and Dec. 6 2012. We will continue our study of ISO 19011:2011 Guideline for auditing Management Systems. The November meeting will be held at Adinas on Route 45, just SE of Dover Straits. Phone (847-918-9060)

As always, a pleasurably yummy 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.

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