The Nor’easter
News from the Northeastern Illinois Section
American Society for Quality
www.asq1212.org
__Sailing into the Future ______
FEBRUARY 2008 Volume 38, Number 2
February 21st Section Meeting: Difficult Decisions
By Marlyn Hyde, Section 1212 Program Chair
Do you struggle with tough decisions? Making the right decision means focusing on the process, not just the results, and the consequences of that choice - to keep problems from becoming catastrophic nightmares. These are difficult decisions, which may mean standing up to others in your organization and in your company. In the long run, both you as an individual, and your company will grow, mature, and be better off. Learn the tools and proven, real-world advice from an FDA expert with a wealth of inspectional experience and expertise to help you make decisions with greater clarity and better outcomes. Understand value-based decision-making is more than a delicate balancing act between competing forces. Learn to identify the source of difficulty, gain the strategies, resources, and courage to make the right choices personally and professionally that will improve quality processes in areas that have long needed improvement. Whether you are from the service, manufacturing or pharmaceutical industries, this presentation will enable you to have the tools necessary for decision analysis, and to be able to turn unexpected outcomes into positive ones.
This evening’s program will be followed by an Ask the expert’s session. The question and answer format following tonight’s program will allow participants to get the information that they need about corporate compliance, the Food and Drug Administration (FDA) Inspectional process, how to prepare for a successful FDA inspection, and how to interact with the FDA investigator. If you had the opportunity to talk with the FDA Investigator of the Year, what would you want to ask? What would you want to know? Facing a FDA challenge? Get the FDA perspective. Bring all your FDA Inspection problems to February’s ASQ meeting and get the advice and answers you need.
Lorelei Jarrell has worked for the U.S. Food and Drug Administration Chicago District for 30+ years. She has done virtually every type of inspection in all commodity areas. For the last twelve years, she has been Chicago District’s pre-approval manager, specializing in medical device and pharmaceuticals. She currently wears three hats - Acting Special Assistant to the District Director, Acting Compliance Officer, and Pre-Approval Manager. Lorelei has been instrumental in several precedent-setting cases and has won several FDA awards. She is most proud of being thevery first FDA Investigator of the Year.
.JOIN US FOR OUR NEXT SECTION MEETING!
Don’t miss this presentation at our next section meeting, Thursday, February 21st, 2008 at the Arboretum Club, 401 W. Half Day Rd (Rt. 22 E. of Rt. 83), at Buffalo Grove Road (across from the large Dominiks store), in Buffalo Grove, IL.
Pre-meeting presentation: 5:30 Networking: 6:00 – 6:30 P.M. Dinner: 6:30P.M. Business Meeting: 7:30 P.M.
The meals are $20. If planning to have dinner, you must reserve in advance; please send e-mail to at least 5 days in advance.
Football’s over, time for that career improvement you’ve been putting off.
Our CMQ class with Marlyn Hyde kicked off successfully on January 26th. Our remaining spring classes are shown below. Any suggestions would be appreciated.
Class / Duration / Coordinator / Contact / Start date / ASQ Test Registration / ExamCQE / 30 Hrs / Bill Antti / / 3/22/08 / 4/4/08 / 6/7/08
Green Belt Certification / 30 Hrs / David Spengler / / 3/22/08 / 4/6/08 / 6/2/08
Quality Auditing / Two Days / Bettina Karlove / / April TBD / 4/6/08 / 6/2/08
SPC / Two Days / Dave Ingram / / Not Scheduled / NA / NA
Statistics Workshop / Four days / Dave Ingram / / Not Scheduled / NA / NA
Almost any quality related subject can be arranged for in-house training. Contact Dave Taylor for details.
Quality Quote
"In the end, it is important to remember that we cannot become what we need to be by remaining what we are."
~ Max De Pree Submitted by: Willie Carter
Inside This IssueFebruary Section Meeting & Pre-Meeting Clinic / 1 & 2 / SLC Contact Information / 3
Guest Article / 5 / Mark Your Calendars / 2
January Section Meeting & Pre-Meeting Clinic Reviews / 3 / Call for Articles / 6
Education / 1 & 2 / Quality Quotes / 1,3,5
ISO Group Minutes / 6 / ASQ 1208 Section Meeting Invitation / 6
Placement News / 4 / Plan to Advertise in the Nor’easter / 7
February 21st Pre-Meeting Clinic: Successful Supply Chain/Supplier Quality Management: Best Practices
By Marlyn Hyde, Section 1212 Program Chair
"For the want of a nail, the shoe was lost; for the want of a shoe the horse was lost; and for the want of a horse the rider was lost, being overtaken and slain by the enemy, all for the want of care about a horseshoe nail.” Benjamin Franklin
With the impact of new standards and their derivatives, as well as the intranets and extranets making supply chains progressively more transparent, there is a revolution happening in supply chain politics. Learn how to make improvements and build efficiencies into the processes throughout the supply chain; identify and reduce cost components; build a supplier relationship/management program that creates open communication and a universal acceptance of change. Learn how to make the most of your customer-supplier partnerships to substantially improve customer satisfaction levels and the entire quality process from receiving inspection thru product shipment. Correctly managing the quality performance level of your supplier base will keep your quality systems and processes lean and profitable, significantly increasing the quality of your product and process, as well as your market position and bottom line.
Marion Menze, PE, CQA, CQE, employed by Siemens Building Technologies, will present the responsibilities of an SQE at SBT regarding participating in supplier selection to approving, monitoring, evaluating, and improving a supplier’s quality performance. Find out what the details are and how to improve the quality of your suppliers.
PPlanning Ahead - Mark Your Calendars:
Ø Regular Monthly Meeting Schedule (see back panel for highlights)
Page 1 of 8
ISO Support groupDate: 1st Thurs. each month
Location: The New China Buffet. 1161 S Milwaukee Ave.
Time: 6:00 pm / Leadership Committee Meeting
Date: 2nd Thurs. each month
Location: Dover Straits, 890 E Rt 45,
Mundelein. (847) 949-1550
Time: 6:00 pm / Section Meeting
Date: 3rd Thurs. each month
Location: Arboretum Club 401 W. Half Day Rd (Rt. 22 E. of Rt. 83), Buffalo Grove
Pre-meeting clinic: 5:30 pm Networking: 6:00 – 6:30 pm Dinner: 6:30 pm Presentation: 7:15 – 8:00 pm –
Education Program Opportunities. By David Taylor, Education Chair.
Classes are scheduled for the winter/spring.
As always, your input is welcomed! If you have any ideas or want to serve on the team email Dave Taylor at
Look for training information in this newsletter.
ON-SITE COURSES OFFERRED ALL YEAR
One accomplishment of note, all the CMQ (Manager) students passed the certification exam on the last session. Congratulations to Marlyn Hyde (The trainer) and all the students!
We are now planning our classes for the spring (see page 1). Any suggestions would be appreciated.
There is NO quality-related subject we cannot provide for your training needs.
If your company has specific training requirements or you want information about any of our courses, please contact Dave Taylor at .
FREE TRAINING! - Because of the high cost of meeting space, we are constantly looking for opportunities to present classes in the training rooms of our members’ companies. If you think your company could make space available for our one or two day workshops, or on Saturdays for the Certification classes, call me at the number below. We offer the incentive of one FREE enrollment for your company in each class hosted.
January Section Meeting Review Pictures: By Karen Perkins / January Section Meeting Review:/ Newly Elected SLC Members Section 1212
These candidates were unanimously elected for these positions.
Chair Elect - Sandra Storli -
Secretary - David Norby -
Treasurer - Joseph Lierman -
Current SLC contact information:
Chair/ Placement Peter Larson
Cell: 847 877 6956
Chair Elect Jim Hopkins
Home 815-675-6741
Secretary Madrene Bradford
Cell 224 381 8123
Treasurer Joe Lierman
Cell: 224-610-0269
Certification/
Re-certification Merle Goddard
847-938-8252
Education Dave Taylor
Home 847 816 1638
Newsletter Frances Blosser
Cell: 248-892-4680
Programs Marlyn Hyde
Home: 847-816-4933
Awards Winners from January’s 1212 Section Meeting.
Come – Invite friends. Invite co-workers. Invite managers. Invite strangers. Learn. Enjoy.
Congratulations to our award winners!
Founder’s Award: Dave Spengler – Historian
Distinguished Service Awards:
Marlyn Hyde – Programming Frances Blosser – Newsletter
Peter Larson – Section Chair
Dave Taylor – Education/ISO Chair
Exceptional Service Award: Donna Nash – Awards Chair
From Peter Larson,
To all,
I just wanted to say "Thank you" for your contributions at this evenings Business Meeting. In retrospect of this evenings meeting, things went well. I owe this to the members of the SLC board. They are an extraordinary group of people that I have the privilege of working with in 1212.
Peter
Quality Quote
"It is not enough to manage results. The way in which those results are achieved (the process) is also important. If we are achieving the results, we need to know why. If we are not achieving the results, we need to know why. In both cases, to a great degree, the answer lies in the process."
~ Gary A. Rummler & Alan P. Brache. Submitted by: Willie Carter
Placement News. By Peter Larson, Placement Chair
As a service to our members, we offer this space to list any openings that benefit our membership. How it works: To list openings in your organization simply e-mail a brief position description before the third Wednesday of the month. Include job requirements, company, location, and compensation, as appropriate. To further inquire about any available positions, please e-mail Peter Larson your resume or inquiry any time. Contact: Peter Larson, Placement Chair. E-mail: . ASQ Section 1212 provides advertising access to its newsletter as a service, but has no control over the operating policies or practices of those who provide the advertised services.
I. From the ASQ Headquarters:
ASQ's Career Center http://www.asq.org/career/index.html is free to all job seekers and provides access to the best employers and jobs in the quality industry. It is powered by Boxwood Technology, an external vendor, so job seekers must register separately from the regular ASQ member site to apply for a position or post a resume. ASQ also offers an unemployment benefit http://www.asq.org/members/leadership/mbrapp/index.html to those unable to pay membership dues due to being unemployed.
II. Positions Available
Head of Consulting Operations: The Luminous Group LLC (Farmington Hills, Michigan).Primary Responsibilities:
- Oversees non-sales activities of on-going consulting and training practice. Plans and manages client engagements. Manages employees and contractors. Provides consulting and training facilitation on client engagements. Interfaces with clients and assures project objectives are met.
Requirements:
Significant consulting experience. Excellent organizational skills and attention to detail
- Superior interpersonal skills. Process/systems thinker. Expert (depth of knowledge and experience) in practice area, such as: Lean, Six Sigma, TQM, Quality Planning or Change Management. Track record of proven results. Must be available to travel out-of-town approximately 20%-30% of the time. Professional certification (such as ASQ, PE, APICS, PMI) and a Master’s degree are preferred. Conversation proficiency in one or more foreign languages would be a plus.
More information about our firm is available at: www.LuminousGroup.com
Please send response with resume to
2-08 / Lean Specialist
Job Qualification Requirements:
Bachelors of Science Degree and 5-10 years in manufacturing applying lean techniques
Six Sigma Green Belt certification
Cross functional experience and team skill
Excellent interpersonal and communication skills
Presentation and facilitation skills
Travel required
To apply for this position contact: John Garcia, Winergy Drive Systems, 950 Tollgate Rd., Elgin, IL 60123
Fax 847-937-9818 or e-mail:
No phone calls, please
01-08
Second shift Quality Inspector wanted-
Lewis Plastics, a plastic injection molder is seeking a Quality Inspector for second shift.
- First piece, In process, and Final inspections
- Visual and Mechanical inspections
- Ability to read blueprints and use inspection tools
- Ability to use a computer a plus
- ASQ certification a plus
Send resume with salary history to Donna Nash, Quality Manager
01-08 / Regulatory Affairs Specialist III
A Major medical device manufacturer located here in the Chicago area is looking for a Regulatory Affairs Specialist-Level III. Under general supervision of RA Manager, is responsible for developing, implementing, enforcing and maintaining the company’s policies and procedures to ensure regulatory compliance. Performs related duties as required.
Training and Experience:
Ø A Bachelor’s degree in life sciences, quality management, or a related field supplemented by at least three years experience in regulatory affairs in a medical device or pharmaceutical organization.
Knowledge, Abilities and Skills
Ø Thorough knowledge of cGMP and ISO 13485 (or equivalent) as well as industry requirements for Class I and II medical devices. Thorough knowledge of Health Canada and MDD regulations. Demonstrated leadership ability. Ability to communicate effectively, both verbally and in writing. Ability to respond to inquiries pertaining to regulatory compliance. Ability to handle multiple assignments and meet deadlines. Ability to teach and train others. Excellent analytical skills, with demonstrated ability to solve problems and make logical decisions. Good leadership and interpersonal skills.
Contact Information: Kenneth Bruning, FPC of Hinsdale, 630-920-1952,
12-07
Quality Assurance/Regulatory Affairs Manager:
A Major Medical Device company is looking to fill their open position of QA/RA Manager. Under general supervision, is responsible for maintaining at one of the company’s sites a quality system that meets all regulatory requirements worldwide. Through administration of Quality Assurance & Control activities, process improvement initiatives and product design verification activities, assures that products sold by the Division meet all customers’ needs and expectations while supporting all other Divisional objectives.
Training and Experience:
Ø A Bachelor’s degree in a related field from an accredited college or university supplemented by at least eight years work experience in Quality and Regulatory Affairs. Experience in the Medical Device industry including the FDA Quality System, the Medical Device Directive and other international and local regulatory systems including ISO 13485. At least three years of supervisory experience. Or an equivalent combination of training and experience is required.
Please contact: Kenneth Bruning, FPC of Hinsdale, 630-920-1952,
12-07 / Quality Manager
Carematix is a fast growing healthcare technology company in Downtown Chicago. The Carematix wireless patient monitoring system enables regular monitoring of patient's vital signs. For more details visit www.carematix.com
The Quality Manager is directly responsible for the quality system, and manages all aspects of quality conformance at Carematix. The Quality Manager is the Appointed Management Representative.
Requirements: 2-5 years experience with FDA and ISO 13485 regulated organizations as a part of a quality management system - Bachelors degree in applicable field and/or relevant work experience in quality assurance.
Proven ability to manage multiple people and multiple varied concurrent tasks - Excellent communications skills (written and verbal)
Reply by email with your resume/coverpage/requirements to
12-07
A Few Excerpts from the IMDS 2007 Supplier Questionnaire Results