Beer Camp by Adela Crandell

“I’m taking the bus,” George said.

“But why?  You can drive to Cincinnati in a day.”

“It’s Beer Camp.  A bus seems like the right mode of transportation.  Besides Oldenberg Brewery is in Kentucky, not Ohio.”

That’s right.  GMP Institute is just over the river from the Oldenberg Brewery.  Or at least it was several years ago. GMP Institue is sold and  Jim Wulfeck, the founder, moved on to other things.   The Oldenberg Brewery was sold  to the Silver Creek Brewing Corporation.

I attended the GMP Institute for a “Train the Trainer” seminar in Cincinnati.  That’s where I learned the catch-phrase, “GMP is a Lifestyle.”  Many of our case studies were based on issues Oldenberg actually had, or pretended to have:  Sanitation, storage of materials, procuring quality materials, maintaining batch consistency, preventing contamination.  Other quality attributes brewers must consider are familiar to those of us who work in the FDA regulated industry:  Additives, flavor standards, clarity, quality control, and consistent manufacturing processes.

So many things go into controlling beer quality.  The mineral content of brewing water will make a difference in the taste and quality of the beer.  Enzyme content, starch and protein content are controlled by the type of malt added to the formulation.  Hops, although a minor ingredient, are not only important to flavor and aroma, but they ply an important role in preventing bacterial growth and precipitation of the proteins. (You can find out more in the Brewer’s Handbook.  That’s what I did.)

As an added perk, attendees at the Train the Trainer seminar got a chance to taste several of Oldenberg’s 200 plus micro-brewed beers.

I picked up a flyer for the Oldenberg’s Brewery’s Beer Camp.   Hmmm, this might make a good birthday present for a certain at-home beer brewer.  That was one of my most genius moment.

Beer Camp came with the expert classes where “campers” learn how to tweak  their own recipes, and make new beer buddies.  Each camper got assigned a group:  Pilsner, Lager, Stout, etc.  The group members exchange brewing/consuming war stories, make up their own songs, and compete with other groups.  The second of the three-day camp session ends with a pub crawl on both sides of the river and across state lines.  Campers are on a bus, of course.  What better way to demonstrate what the campers learn?

George’s complimentary Oldenberg Beer Camp T-shirt, is still a conversation starter. Still, it is showing some signs of wear.   I wonder if he’ll notice if I relegate it to the rag box.

This month’s ASQ 1212 section meeting is at The Onion Pub and Brewery.  We’ll get a tour of the micro-brewery and bottling facility where our host will demonstrate what goes into maintaining their high quality beers.  All that is followed by a dinner that is sure to please.

The Onion Pub is one of George’s and my favorite places to eat.  Our visits always bring back memories of Beer Camp.  Maybe I can talk the Master Brewer at The Onion Pub into starting their very own Onion Pub Brewery Beer Camp.  I could ride my bike there.  Better send someone to pick me up afterwards.  Afterall, I have my Mug Card, and I’m saving points for a new t-shirt for George.

See you there!

 

 

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Minutes of February ISO Support Group Meeting

Map of members of ISO

Map of members of ISO (Photo credit: Wikipedia)

Only three members attended the meeting on a very stormy night, February 7, 2013 at the Adinas in Vernon Hills. In attendance were Dave Spengler, Regina Fullen, and Dave Taylor.

We read ISO 19011:2011 Guideline for Auditing Management Systems. We reviewed selections from Additional guidance for auditors for planning and conducting audits”. We almost finished but will wrap up in March.

We will be looking for a new standard or guideline for our next adventure. Interested  in a particular standard review? Email me at the address below with your suggestions.

In the Round Robin:

  • Now that Dave Spengler looking at a particular date next year to retire, he reported his job is more fun!  He is working on a program to pass on his knowledge of braising and hi-tech soldering before he retires.
  • Regina reported she is participating in a surveillance audit next week.

The next two meetings will be will be held on March 7 and April 4, 2013.

We will review a new standard or guideline. Email me with your suggestions. The meetings will be held at Adinas on Route 45, just SE of Dover Straits. Phone (847-918-9060)

As always, a luscious 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
2-24/2013

 

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February 21, Main Program: Global Product Safety and Quality – New FDA Initiatives and Tools By Director of Office of Regional Operations, Office of Regulatory Affairs FDA, Chicago District Director Scott MacIntire (7:30-8:30 PM )

Gain an inside view: this presentation will focus on new FDA strategic plans, initiatives, and tools to meet today’s global challenges and rapidly changing environment providing insight into the significance of these changes to different stakeholders. No matter your company’s area of expertise, help your company thrive. Everyone in your organization with a role in Regulatory Affairs, Research and Development, and Strategic Planning deserves to take part in this event. Whether you are a professional who works in pharmaceutical, biologics, devices, diagnostics, or food industries, this presentation is for you!

We live in a nation that increasingly relies on other countries to produce the food, drugs, cosmetics, and devices we use in our daily lives.  Nearly two-thirds of the fruits and vegetables–and 80% of seafood–eaten domestically come from outside the U.S.  Half of all medical devices used in this country are imported, while 80 percent of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere. FDA-regulated products account for about 10% of all imports into the U.S., arriving from more than 300,000 facilities in 150 different countries. Learn how FDA is poised to meet the challenges presented by a rapidly changing environment and a global marketplace through new FDA initiatives and tools. Rather than just intercepting harmful products, FDA is pushing to anticipate and prevent the arrival of harmful products before they reach our borders.

Changing Paradigm – from a reactive system to a preventive one. The  global outlook outlined in FDA’s new strategic plan, “Pathway to Global Product Safety and Quality” described the FDA paradigm shift to overcome the challenges of globalization today and in the future. This presentation – Global Product Safety and Quality: New FDA Initiatives and Tools is an update that outlines the FDA’s plan for meeting the unique, and complex, demands of globalization. Stay current, be proactive, reduce risk, improve your compliance programs, and improve your competitive edge. If you had the opportunity to talk with the Director of Office of Regional Operations, what would you want to ask? What would you want to know? Facing a FDA challenge? Get the FDA perspective. Gain real-world advice from an FDA expert with a wealth of experience and expertise to help you gain the inspiration and strategies to help you to make decisions with greater clarity and better outcomes – to make the right choices now and in the future.

Scott MacIntireMr. MacIntire currently serves as the director of the U.S. Food and Drug Administration’s Chicago District Office. The office is responsible for conducting investigations on over 6,000 registered firms and annually screening 500,000 import shipments in the state of Illinois. Firms include food, medical devices, imports, drug firms, biologic firms, and veterinary medicine. He recently supervised a large portion of the 2012 Office of Regulatory Affairs reorganization while serving as the Acting Director of the Office of Regional Operations, and has served many years as the chair of the Center for Veterinary Medicine field committee. Mr. MacIntire has worked for FDA for 22 years, and previously worked for the Virginia Department of Health and the Virginia Department of Agriculture. He graduated from East Tennessee State University with a Bachelor’s Degree in Environmental Health in 1982.

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Excerpts from: Pathway to Global Product Safety and Quality, Executive Summary by Dr. Margaret Hamburg, Commissioner of Food and Drugs. For decades, FDA has been a recognized world leader in product safety standards. But as the agency looks to the future, it can no longer rely on the historical tools, activities and strategies to regulate products…In order to cope with the magnitude of the fundamental shifts on the horizon, the agency is committed to substantially and fundamentally revising its approach to global product safety and quality. Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders…To achieve this transformation, FDA is

developing an international operating model that relies on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships.

The Strategic Plan’s new approach rests on four core building blocks:

1) FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2) With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.

3) FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.

4) FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

The New global outlook outlined in FDA’s new strategy, “Pathway to Global Product Safety and Quality”: The essence of this strategy marries creative international coalitions with cutting-edge investigative tools to continue to provide the consistently high level of safety and quality assurance the public expects—and deserves. FDA will continue to partner with other federal agencies, the states, and nations across the world. It will also look to Congress to modernize its antiquated authorities so that FDA’s legal tools keep pace with globalization. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf

Excerpts from: The Speech, Remarks at GMP by the Sea by Carolyn Becker, J.D., Senior Regulatory Counsel, Office of the Commissioner Food and Drugs.  “A new strategy is needed to cope with the magnitude of the fundamental global shifts on the horizon and ensure the safety and quality of FDA-regulated products imported into the U.S. Our current tools and approaches will not be sufficient to provide the needed assurance of safety and quality as globalization continues to increase in the future. FDA must substantially and fundamentally revise its approach…What is envisioned for the future is a public health safety net for consumers around the world that is created, supported, and maintained by global alliances of regulators…The Pathway strategy will enable us to take these efforts to the next level…This is a long-term strategy. As you may be aware, Commissioner Hamburg recently created a directorate focused on grappling with the truly global nature of today’s world so that FDA can move from being a regulator of domestic products to one overseeing a worldwide enterprise. The new Office of Global Regulatory Operations and Policy will be led by a Deputy Commissioner who will provide broad direction and support to FDA’s Office of Regulatory Affairs and Office of International Programs. The mandate of this new office is to make FDA’s response to globalization challenges and import safety a top priority in years to come, and to ensure that FDA fully integrates its domestic and international programs to best promote and protect the health of the public. This Office will also be responsible for implementing the Pathway strategy. As initial steps, the Office will establish a framework and approach for broader data sharing and use of third parties. It will also work rapidly to partner with foreign counterparts to create global coalitions of regulators”. Remarks at GMP by the Sea by Carolyn Becker, J.D., Senior Regulatory Counsel, Office of the Commissioner Food and Drug Administration, August 8, 2011  http://www.fda.gov/NewsEvents/Speeches/ucm267671.htm

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The American Society for Quality (www.asq.org), is a not-for- profit organization, and the world’s largest organization dedicated to quality. ASQ is a global community of people dedicated to quality who share the ideas and tools to make our world work better. With millions of individuals and organizational members of the community in 150 countries, ASQ has the reputation and reach to bring together the diverse quality champions who are transforming the world’s corporations, organizations, and communities to meet tomorrow’s critical challenges. ASQ is headquartered in Milwaukee, Wisconsin, and organized into local sections and sector-specific divisions.  Our ASQ Northeastern Illinois 1212 is a section dedicated to the promotion and advancement of quality tools, principles, and practices in the workplace and community and has over 800 individual members (plus corporate members: ASQ Enterprise and Site members). It is one of the top rated sections in the society and it meets on a regular basis to help their members become leaders of quality – to share ideas, experiences, and knowledge. Our members are dedicated Quality Professionals who are constantly working on self-improvement knowledge that can be applied in the workplace. Our Section provides them with a diverse network committed to assist them with their individual and organizational learning and is a primary source for their individual and organizational excellence. American Society for Quality, Northeastern Illinois 1212’s meetings are always free and members and non-members are always welcome Join us on Thursday February 21st, 2013 at the Arboretum Club, 401 W. Half Day Rd., Buffalo Grove IL.  asq1212reservations@yahoo.com

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Thursday February 21 Pre-Meeting Clinic: How Many Samples Do I Need? – Justification for Sample Sizes By Dr. Taylor (5:30 – 6:00 PM)

The proper sample size is an important issue in Statistics.  It depends on the statistical property (average, standard deviation, RSD, proportions, rate), the size of effect considered important, and the amount of variation in the data.  The impact of sample size is very different for Confidence Intervals versus Hypothesis Testing.  Learn how to find the information required to decide the proper sample size and what to do when the number of samples available is different from the calculated sample size.

wayneDr. Taylor is a leading expert in the application of Statistics in the pharmaceutical, medical device and diagnostics industries.  Dr. Wayne Taylor is the founder and chairman of Taylor Enterprises, Inc. where he is responsible for developing the VarTran®, Change-Point Analyzer, Sampling Plan Analyzer and Distribution Analyzer software packages as well as providing consulting and training to the FDA regulated industries in Statistics.  He authored the books Optimization and Variation Reduction in Quality and Guide to Acceptance Sampling.  He is a leading expert in acceptance sampling, process validation, trending and CAPA problem solving. Dr. Taylor has a Ph.D.  in Statistics and is an Accredited Professional Statistician. He is a fellow of the American Society for Quality, a fellow at the Royal Statistical Society, and a member of the American Statistical Association. Dr. Taylor received his Ph.D. in Statistics from Purdue University He is a Fellow of the American Society for Quality, recognized as one of 100 Notable People in the Medical Device Industry by MD&DI Magazine and received the Distinguished Science Alumni Award from Purdue University.

 

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January, 2013 Minutes of ISO Support Group Meeting

Four members attended the meeting on January 3, 2013 at the Adinas in Vernon Hills. In attendance were Dave Spengler, Ron Bateman, Regina Fullen, and Dave Taylor.

We Met at Adinas, in Vernon Hills.

We read ISO 19011:2011 Guideline for Auditing Management Systems. We reviewed selections from Appendix A “guidance and illustrative examples of discipline-specific knowledge and skills of auditors”. Next month we will begin reviewing appendix “B Additional guidance for auditors for planning and conducting audits”.

In the Round Robin:

Dave Spengler is planning on retiring next year. He is working on a program to pass on his knowledge of braising and hi-tech soldering by that time.

Ron Bateman had a very good customer service story of a company who sold and delivered a treadmill he had purchased for his wife. It seems the unit was too large to carry into his basement where he was intending on using it. So the delivery crew dismantled the treadmill and reassembled it in the basement. He then discovered it wasn’t the model he had ordered but an upgrade costing more. The company assured him that it was their mistake and he could keep the upgraded model at no additional cost. The company’s name is Proform. They are in Utah.

The next two meetings will be will be held on February and March 7 3, 2013.

We will review appendix “B of 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, we enjoyed a satisfying, succulent meal for $5.00 (free for members searching for a position), the balance 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
1/13/2013

 

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Milwaukee Section Announcement

Milwaukee Section

2013 Education Seminar
February 23, March 2, March 8, March 9, 2013

 

SQ Milwaukee has provided high value education and training to the community for over 30 years. With returning favorites and new additions, the Spring 2013 Education Seminar is sure to have something for you.

Our goal is to provide this annual seminar to ASQ members and non-members alike to continue and maintain their education in quality systems and process improvement. We focus locally on Milwaukee and the surrounding area, and do everything at a price that is less than half of comparable opportunities!

We are still fleshing out the details of the courses and instructors. Below is our planned line-up.

Subject to enrollment demand. Details subject to change, please visit this website later for the latest information.

More information and how to register can be found on the links to the left.

Sat, Feb 23
Sat, Mar 2
Fri, Mar 8
Sat, Mar 9
Quality Systems

Supplier Quality
& Use of PPAP

Statistical Methods

Data Analysis

Problem Solving & Prevention

A3 Problem Solving

Visual Management

🙂
Team Leadership
Skills

 

Dates and Times February 23, March 2, March 8, March 9, 2013
8:30am to 4:30pm each day
Location MRA in Waukesha, WI
N19 W24400 Riverwood Drive
Waukesha, WI 53188
Credits 0.7 RUs or CEUs per day
Price 1-day : $275
2-days: $400
3-days: $500
4-days: $600Price includes refreshments, lunch, and class materials.10% discount given for groups of three or more participants from the same organization.

Prices are valid if registered before 2/11/13.

Price is for each unique individual and may not be shared.

Contact Info
for Questions
asq-register-questions@jholder.org
414-371-5837
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Outstanding Contributions Award Given in December, 2012

DSC00649Walter I. Holms Founder’s Award went to Adela Crandell– This award is presented for outstanding contributions to the section’s advancement.  This constitutes advancement well above the maintenance of the section’s status.  Recipient must be a member of ASQ NEI Section 1212.  Adela is recognized for the ASQ 1212 website revamping.

 

 

 

 

2012-12-13_19-25-10_644Quality Oriented Company of the Year Award went to Scott Forge Company– Presented to any size organization that has demonstrated a sincere and continuing interest in the quality profession as well as increasing industry, individual and public awareness of quality.  The organization can be nominated by any member of the ASQ NEI Section 1212. We recognize Scott Forge for their ongoing support of the section and for their recent donation of a notebook computer to Section 1212.  This computer brings our meeting capability up to date.

To find out more about how to earn awards, or promote someone for an award, please visit out Awards page.

Congratulations Adela and Scott Forge Company!

January 17 th Council on Competitiveness: 2013 Global Manufacturing Competitiveness Index 7:30-8:30 P.M.

 

Jack McDougle is flying in from Washington DC to give you a first-hand look at their 2013 Manufacturing study. The Council on Competitiveness, in collaboration with Deloitte, just released the 2013 Global Manufacturing Competitiveness Index. The Index, gathering data from more than 500 CEOs and senior manufacturing executives around the world, is part of the Council’s multi-year effort to better respond to the trends creating a hyper-competitive global manufacturing environment. This presentationwill use the results from the Index to look at the highly complex forces driving the future of manufacturing and many of the structural changes reshaping the global economy.

Jack McDougle is a Senior Vice President at the Council on Competitiveness, Council on Competitivenessan alliance of CEOs, university presidents, national laboratory directors and labor leaders, where he leads the U.S. Manufacturing Initiative. Previously, Jack was Senior Vice President for Strategy and Business Development at United Elite Technologies, where he created business strategies for small technology companies. Jack served as Deputy Undersecretary for Economic Affairs at the U.S. Department of Commerce where he oversaw various programs, including efforts to turnaround the 2010 Census. He also served as Deputy Assistant Secretary for Industry Analysis, developing programs to improve the global competitive position of U.S. firms. Jack speaks regularly on economic, competitiveness, manufacturing, regulatory, and trade issues, and has been featured on PBS News Hour and in many print publications. He earned his MBA at Northeastern University and his BA at New England College.

The council on Competitiveness is the only group of corporate CEOs university presidents and labor leaders committed to the future prosperity of all Americans and enhanced U.S competitiveness in the global economy through  high-value economic activity in the United States. It is dedicated to setting an action agenda to drive U.S. economic competitiveness and leadership in global markets and believes the best way to drive prosperity in a global economy is to have the most competitive workforce and business environment go to: http://www.compete.org  The Council helps shape the national debate on competitiveness by concentrating on evaluating economic challenges and opportunities some of the few critical issues including Key U.S. competitiveness issues and Initiatives are: Energy Security, Innovation & Sustainability; Enterprise Resilience; Global Innovation; High Performance Computing (HPC); National Innovation; Regional Innovation; Benchmarking.

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January 17, 2012: Annual Business Meeting 5:00 – 6:30 P.M.

Come one, come all to our annual ASQ Business Meeting, in which our Section Leadership Committee will share with you the goings-on with the section, facilitate nominations, and plans for elections, and share with you how you can build your career by being a part of the world’s largest organization dedicated to Quality!  This year, our leadership will share with you the changes of moving to a new fiscal year model, and wants your participation in the decision-making!  Keeping with tradition, the ASQ Northeastern Illinois Section 1212 always offers free meetings, but, to ensure full participation with the business meeting, the meal for the January business meeting is FREE!

 

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CMQ/OE Certification Course Study, by Kam Gupta

ASQ Northeastern Illinois Section 1212 CMQ/OE Course

The Certified Manager of Quality/Organizational Excellence (CMQ/OE) leads and champions process improvement initiatives, facilitates and leads team efforts to establish and monitor customer/supplier relations, supports strategic planning and deployment initiatives, and helps develop measurement systems to determine organizational improvement, etc. Qualifications: on-the-job experience in one or more of the areas of the Certified Manager of Quality/Organizational Excellence Body of Knowledge. For more requirements go to: http://www.asq.org/certification/manager-of-quality/right-for-you.html

Most of our students pass the exam after taking this course combined with lot of self-study. Our course is more than a refresher course, it offers a mixture of lecture, workshops, and challenge sessions (Individual and group essay challenges as well as group QCI’s CD quizzes) that explore the body of knowledge, and prepare you to succeed. Our Winter CMQ/OE 10 week (50 hour) course could run Wednesdays at one of Baxter’s Conference Centers from 4p.m – 9p.m. The course is $500 for members. You receive 0.5 RU’s per session attended up to a max. of 5 RU’s (the class qualifies for 5 re-certification points).
First class is on a Thursday to adjust for the Holidays

Class 1   (January 3rd) Introduction, Logistics, and Leadership (Thursday)
Class 2   (January 9th) Training and Development (Wednesdays)
Class 3   (January 16th) Strategic Planning and Deployment
Class 4   (January 23rd) Management Elements and Methods (part 1)
Class 5   (January 30th) Management Elements and Methods (part 2)
Class 6   (February 6th) Quality Management Tools (part 1)
Class 7   (February 13th) Quality Management Tools (part 2)
Class 8   (February 20th) Customer Management
Class 9   (February 27th) Supplier Management
Class 10  (To Be Determined) Test Review and Practice Run

Please sign up with Kam Gupta (citkam@gmail.com) 847-612-4244 or Chris Kapetanopoulos , as we would like you to have the QCI Primer in time for  the course and make sure we have enough people committed. You must first get approval from your management, if they are picking up the cost.

Exam is March 2 – Application Deadline is January 11th go to: http://www.asq.org/certification/manager-of-quality/apply.html