simpleQuE Spotlight – Karen Spencer

Allow us to introduce one of our accomplished consultants, Karen Spencer. She has been with simpleQuE for nearly 2 years and continues to be an asset to the company. Read on to discover Karen’s interests, achievements, and goals.

What is your position and what do you do for simpleQuE?
I am a consultant, auditor and trainer for simpleQuE, as well as a lead auditor in ISO 9001, AS9100, ISO 14001 and OHSAS 18001. I am also an ASQ Certified Quality Auditor.

What attracted you to simpleQuE.
My husband has worked with them for many years. After going through the intense interview process I decided that I wanted to pursue a career with them. I like that they are on Facebook and LinkedIn.

What is your favorite part of the day?
I am a morning person. I love that first cup of coffee in the morning and take that time to review my plan for the day.

What was your first job?
My very first job was when I was sixteen and worked at a factory doing inspection after school.  

Have you met someone famous or interesting to you?
I love art so when I had the opportunity to meet Peter Max I jumped at the opportunity.

Where did you go to college?
I graduated with honors from Cardinal Stritch University in Milwaukee, WI

Where is your hometown?
Belvidere Il

What is one thing you’d love to do or have?
I am living life to the fullest and enjoying visiting many places with my job and on vacation. My husband and I work hard and we pick places to travel and plan for it. We just did a cruise to Alaska this year and it was truly a beautiful place. Everyone should see a glacier.

What is your hidden talent?
I love to rehab houses. I like to take an ugly house and make it beautiful. My husband and I have flipped about 8 houses. We bought our existing house to flip but we fell in love with it and we are still here.

What is your favorite sports team?
Chicago Bulls and of course the Cubbies

Client satisfaction is pinnacle to your background. What are your client-focused approaches to simpleQuE?
When I am teaching a class I adjust my approach to the weakest person in the class. We may have to work on a workshop longer than expected but when I am done the students know what they are doing. When I am auditing or consulting I take the approach that everything will not work for everyone. I adjust to what the client needs to have in pace to be successful. I also want to make sure that it is value added for the client.

What advice would you give to a new college graduate entering the technology industry?
Try to be an intern at a company that you want to work at. Give it your all and don’t give up. It will be a tough road but you can do it.

Explain how simpleQuE is different from their competition.
SimpleQuE is amazing and they want all of the employees/consultants to succeed. They had an symposium for all of the team. It was really nice to meet the team face to face.

How would other people describe you in three words?
Helpful, kind, and considerate.

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Coming Soon: Core Tools – an International Collaboration – By Kim Roan

On the heels of the revision of ISO/TS 16949 to IATF 16949, the AIAG (USA) and VDA-QMC (Germany) are collaborating to improve the automotive Core Tools.  These Core Tools are the building blocks of an effective quality management system and include Advanced Product Quality Planning & Control Plan (APQP), Production Part Approval Process (PPAP), Failure Mode and Effects Analysis (FMEA), Measurement System Analysis (MSA), and Statistical Process Control (SPC). Their starting point, aimed at improving risk assessment automotive industry wide, is the FMEA manual.

The Automotive Industry Action Group (AIAG) was established in 1982 and the German Industry Automotive Assn. (VDA-QMC) in 1997.  Each organization serves as the IATF oversite office in their respective country. Both organizations serve the automotive industry by standardizing publications for the industry and by providing automotive industry training.

Currently suppliers to both North American and German OEMs are required to use different FMEA rating tables for severity, occurrence, and detection.  This has created confusion and related frustration for both suppliers and OEMs. The primary goal of the current collaboration is to revise the rating tables to provide a common rating scale for risk accepted by all German and North American OEMs.  The secondary goal is to update the manual in areas that need revision to support risk analysis and harmonize the documents overall. This is a great opportunity to combine the strengths from each FMEA manual with improved risk assessment tools that will support the advancing technology of the automotive industry.

The targeted release of the revised FMEA manual is December 2018 followed by OEM release of their customer specific requirements to support the changes.  AIAG and VDA-QMC plan further collaboration to continue harmonization and update of all automotive core tools manuals. These tools have proved so useful that they have also been adopted by the aerospace and defense manufacturing sectors. SimpleQuE has been preparing for the changes and developing the training needed for companies to implement the updated FMEA requirements.  Let our automotive experts partner with you as you roll out your FMEA upgrades to meet automotive customer demand and take your FMEA risk analysis to a higher level.

About the author:  Kim Roan has completed her undergrad in Mechanical Engineering and her Master’s in Psychology with an emphasis in Organizational Leadership.  Kim is a simpleQuE consultant with over 20 years automotive industry experience with 11 years working for a German automotive supplier in the USA and experience supplying OEMs in North America, Germany and Asia across the years of her career.

Congratulations to Dana Incorporated!

With sites in 33 countries on six continents, Dana Incorporated is positioned to serve customers worldwide. In 2016, Dana was named to Forbes’ List of America’s 100 Most Trustworthy Companies.  That kind of trust and quality has earned Dana an impressive list of automotive customers including Ford, FCA, Renault-Nissan, GM and Toyota. That’s why IATF 16949 quality management system certification is so important to automotive suppliers like Dana and required by the OEMs.  SimpleQuE has consulted with multiple Dana sites in the U.S. to prepare them to successfully transition from the old standard to the new and we’re very proud of their success. Congratulations to Dana, Inc. and their Quality Teams who have an important role in making our vehicles reliable and safe!

Dana, Inc – Gordonsville, TN
From left:  simpleQuE Operations Manager, Barb Dodson and Dana Quality Team – Will Lanham, Jose Arras, Guy Buckner, Debbie Oldham, Shannon White, John Billingsley

Dana, Inc – Louisville, KY
From left:  Jason Van Over, Quality Manager; Natalie Sheflyand, simpleQuE Consultant;  Tim McDevitt, Plant Manager

Dana, Inc – Dry Ridge, KY
From left:  Todd Perry, Production Manager; Greg White, Quality Manager; Natalie Sheflyand, simpleQuE Consultant; Carol Locke, QE – Audit Lead; Sara Meyer, QE; Mike Hirsch, Plant Manager; Frankie Wuebbling, Quality Team Leader

IATF 16949 Certification – The Automotive Quality Standard

Industrial automotive machine tool equipment close up, abstract industry manufacturing metalwork background, blue toned

IATF 16949 is the global standard recognized by the automotive industry. IATF 16949 defines the quality management system requirements (QMS) for the design and development, production assembly, installation and services of automotive-related products including products with embedded software. The focus of this standard and IATF16949 certification is the development of a QMS that provides for continual improvement, emphasizing defect prevention and the reduction of waste in the supply chain. Combined with applicable Customer Specific Requirements, IATF 16949 is also fully aligned with the structure and requirements of ISO 9001:2015 which was designed to assure effective quality management systems for manufacturing and service industries around the world.

The Characteristics of IATF 16949 Certification

Developed by the International Automotive Task Force, IATF 16949 has a variety of automotive industry-specific features, including:

  • Defect prevention
  • Reduction of variation and waste in the supply chain
  • Customer focus and satisfaction
  • Identification of risks and problems in the production process
  • Management of resources
  • Product realization
  • Responsibility of management
  • Measurement, analysis and improvement

There are over 68,000 suppliers worldwide which currently have ISO/TS 16949 or IATF16949:2016 certification.  The standard can be used by any supplier, large or small who manufacture customer-specified production parts, service parts, and/or accessory parts.

 

How do you cross the finish line to become IATF Certified?

If you’re searching for an IATF 16949:2016 consultant, our team at simpleQuE is well positioned to support your IATF 16949 and MAQMSR consulting (Minimum Automotive Quality Management System Requirements), certification, maintenance, training and internal auditing needs. Our consultants are qualified, certified, competent and are experts on the automotive standards, customer specific requirements, and AIAG or VDA core tools. In addition, many are current or former 3rd party auditors who bring valuable insight because of the knowledge gained from auditing for certification bodies.

SimpleQuE also offers a full line-up of IATF 16949 training courses which includes AIAG and VDA Core Tools, Root Cause Analysis and Problem Solving, Requirements and Implementation.  With IATF also putting a major focus on internal auditor competency, it is essential to have IATF 16949 Internal Auditor Training. Our IATF 16949 auditor training utilizes the process audit approach. Contact us to learn more about the customized services offered to match your certification and training needs.

Questions for Auditing Utilizing a Process Approach

Whether facing a surveillance audit from a certification body or preparing for an internal quality audit – knowing what you face and being prepared puts you a step ahead.  Review this checklist which covers the majority of the QMS requirements.

  1. Who or what are the:
    • Processes
    • Process Owner
    • Personnel Interviewed
    • Documentation Reviewed
    • Records Sighted
  2. What are the resources needed for the process?
  3. Are these resources appropriate?
  4. Are authorities and responsibilities for required resources defined, documented and known throughout the organization?
  5. Are these persons competent?
  6. Are competency criteria defined? What are these criteria? How is competency evaluated, approved and monitored, and by which method(s)?
  7. Are these methods effective? – refer to outputs
  8. Are the resources adequate? Which are they?
  9. Are records available and appropriately maintained?
  10. What are the inputs to this process?
  11. Are these inputs documented and reviewed by competent persons?
  12. Is a description of the processes available and documented?
  13. Are these descriptions controlled? – Verify the effectiveness of the organization’s documented information control procedure.
  14. Who are the “customers” (internal and external) of the processes? What are the requirements of these customers?
  15. What are the characteristics of the intended results of the process?
  16. What are the characteristics of the unintended results of the process?
  17. Are correction and corrective action applied as appropriate?
  18. What are the criteria for monitoring, measurement and analysis?
  19. How are these criteria incorporated into the planning of the processes?
  20. Are the business performance issues taken into proper account?
  21. What methods are used for data gathering?
  22. What records are kept and how these are maintained?
  23. What are the communication channels?
  24. How is external and internal information about the process provided? What are the outputs of the process? – Identify outputs.
  25. Do these outputs provide evidence of effective implementation of the process?
  26. How is process performance monitored?
  27. Are appropriate controls defined?
  28. What measurements are applied?
  29. How is the gathered information analyzed?
  30. How are the results of the analysis taken into account?  
  31. How is feedback obtained?
  32. What data is collected?
  33. Is the issue of improvement of the processes properly addressed? How? What are the results?

 

Source:  Eagle Certification Group – 2017 Annual Bootcamp/Conference

SimpleQuE offers free sample manufacturing process audit checklists for AS9100, ISO 9001 and IATF 16949 which can be used as an example to examine a company’s key manufacturing process and prepare your company for the highest internal quality auditing possible.

Links to Checklists:

IATF 16949 Sample Manufacturing Process Audit Checklist – FREE

AS9100 Sample Manufacturing Process Audit Checklist – FREE

ISO 9001 Sample Manufacturing Process Audit Checklist – FREE

Congratulations to Meteor, FireCraft Safety, American Micro, and Pentair

Congratulations from our team at simpleQuE to the companies that have worked so hard to earn their certifications!  It was a long road, but worth all the meetings, training, internal audits, updating of procedures and documents, and conversations about quality and risk.  We’re proud to have played a part in their successful transition/implementation to these quality standards.

FireCraft Safety Products – ISO 9001:2015

Photo from left – Toni Gill, CFO; Tom Lochner, President; Tom McCoy, Director of Sales; and Don Milinkovich, simpleQuE Consultant

Meteor Sealing Systems LLC – IATF 16949:2016

Photo from left – Thorsten Conrad, Vice President – Meteor Sealing Systems LLC;  Masahiko Ito, Managing Director – Toyoda Gosei Meteor GmbH; Deanne Sparr, Vice President – SimpleQuE; Ryan Ayers, Quality Manager – Meteor Sealing Systems LLC

American Micro – AS9100:2016 and IATF 16949:2016

Photo from left –  Matt Gilbert, QE;  Evan Smartnik, QE;  Sheila Floyd, Purchasing Supervisor;  Michael Shelton, Process Engineer; Ryan Siebe, Production Manager;  Rob Berger, Production Supervisor;  John Woods, Engineering Manager;  Kevin Neal, Quality Manager;  Harold Williams, Production Supervisor;  Greg Stamper, Production Supervisor;  Rita Gragg, SQE

Pentair – ISO 9001:2015

Photo from left – Peggy Jones, Quality Manager; Gregg Swint;  Dave Christine;  Matt DeHart;  Kayla Smith; Ed Henricksen

The Advantages of Outsourcing Internal Quality Audits

Business concept. Business people discussing the charts and graphs showing the results of their successful teamwork.

If your organization is certified to ISO 9001 or a standard that is aligned with it, like AS9100 or IATF 16949, and you perform internal quality audits, then you should know this:

This means that Certification Bodies are scrutinizing internal auditors and their competency, especially when it involves IATF.  That’s why many companies are choosing to outsource their internal audits to a 2nd party like simpleQuE whose auditors are qualified, certified, competent and are experts on the standards and customer specific requirements. In addition, many are current or former 3rd party auditors and bring valuable insight because of that knowledge gained from auditing for certification bodies.

Here are more reasons to outsource internal audits from our very own team of auditors (who have seen it all):

Why audits should not be done internally:

  • Without proper training and experience, internal auditors don’t fulfil the competency requirements
  • Lack of time to perform the audits and write reports
  • Reports with limited or no findings or objective evidence
  • No demonstration of the process approach or risk based thinking
  • Timeliness of management in responding to findings/report
  • Internal turnover resulting in too much variation in reporting/focus and overall quality of audits

Advantages to outsourcing internal audits

  • Fresh set of eyes from outside the organization that are objective and unbiased
  • Reduces company’s investment in continual training on changing requirements
  • Professional and timely reports
  • More cost and time effective, freeing up internal resources
  • Management gives greater attention to an outside expert, especially when there are sensitive issues that an inside auditor may be hesitant to address
  • Better internal response and acceptance of findings and opportunities for improvement
  • More content, findings, comments, opportunities for improvement and observations for added value
  • Our auditors have:
    • In depth knowledge of the standard’s requirements,
    • Experience in the field and can share best practices,
    • An understanding of the process approach and risk based thinking
    • The ability to provide consulting while auditing
    • Compliance to ISO 19011 on auditing management systems

All solid reasons for turning your audits over to the experts.  Contact us at 740-305-0868 or [email protected] for more information about internal quality auditing.

IATF 16949 Transition Strategy and Requirements Update


The International Automotive Task Force just released Revision 5 of the IATF 16949 Transition Strategy and Requirements. This revision of the Transition Strategy document incorporates a new FAQ no. 20 that clarifies questions for those situations where a previously certified IATF 16949 organization has to start over with an initial certification audit to IATF 16949.

Download the IATF 16949 Transition Strategy and Requirements document

12 Years At The Toyota Opportunity Exchange

For the last 12 years simpleQuE has attended the Toyota Opportunity Exchange (TOE) to network with Tier I suppliers like Dana Incorporated. Dana has 100+ facilities and 29,000 employees in 34 countries making it one of the world’s most influential automotive suppliers. Through the TOE, a relationship was developed with Dana and in 2013 simpleQuE won the opportunity to perform IATF 16949:2009 internal audits for the Dana site in Auburn Hills, MI. That opportunity has expanded to now include internal audits and/or IATF 16949:2016 transition consulting at five more Dana facilities in PA, IN, TN and KY. SimpleQuE consultants worked with the dedicated Quality team at Dana – Gordonsville, TN which recently successfully transitioned to IATF 16949. The first of our clients to do so!

Providing a forum for suppliers and minority business enterprises to connect is just one of the many ways that Toyota ensures its supplier base continues to reflect the diversity of its customers, partners and team members.