AS91XX: 2016 Certification Body Auditor Non-Conformances

SimpleQuE President, Jim Lee, recently attended the joint meetings of the SAE G-14 including Americas Aerospace Quality Standards Committee (AAQSC) and Americas Aerospace Quality Group (AAQG) in New Orleans.  The summit provides access to the committees that create the aerospace standards and guidelines with the high level players in the industry including Space and Defense.

Of interest to many companies are Certification Body audits and the areas where most non-conformances are written.  The Traditional NC chart on the left shows the typical audit non-conformances certification body auditors are finding with the AS9100, AS110 and AS9120 audits to the new standards. These are the top 10 majors and minor findings by clause.  The right side displays the high risk and concern areas that NASA, DCMA, FAA, and the Original Equipment Manufacturers (i.e. Boeing, GE, Rolls Royce, Northrup, Raytheon) see as supplier problem areas.

The Risk Area chart shows that the certification body auditors are writing fewer findings against these problem areas affecting the major customers.  However, all of these concern areas have new requirements in the new AS standards.  Jim Lee advises, “It should be noted that certification bodies are training their AS auditors to focus on these industry identified risk areas.  It is not yet clear whether the AS suppliers were well prepared for these new requirements, or the certification body auditors were not auditing as deeply or effectively against these new requirements.  Be prepared for greater focus and scrutiny on future AS audits in these areas.”

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SimpleQuE Associate Spotlight – Megan Genet

We are thrilled to highlight one of our newest team members, Megan Genet, a Project Manager here at simpleQuE. Read on to get to know more about Megan’s background, interests, and favorite things about working at simpleQuE.

What is your position and what do you do for simpleQuE?
My career at SimpleQuE is Project Manager. My main focus is to monitor and manage our many consulting projects.

How long have you worked for simpleQuE?
I have been working at simpleQuE for five months.

What do you like most about working for simpleQuE?
The team! We are all very supportive of each other and we often come together to share ideas. Each one of us brings something special to the company.  

What is your favorite QMS standard and why?
I’ve studied the ISO/TS and now IATF over the past six years. I really respect the standard and I know the hard work and determination a client must put into having a automotive certificate.

What attracted you to simpleQuE?
The thought of helping companies start their quality systems and providing them the confidence to get it done made me feel like I could make a difference.

What is your favorite part of the day?
I love the morning. All is still quiet and I love to sip my coffee and prepare for my day.

What was your first job?
At 16 I started at a local outdoor lighting manufacturer. They really took me under their wing and through the 13 years I was there I was able to experience every aspect of a manufacturing business. I held many different roles which I believe gave me a good stepping stone into a career in quality.

What is your hometown?
I was born and raised in Norton, Ohio and now I raise my family in the same town.

What is your favorite sports team?
I always root for the home team! Go Cavs, Indians and Browns.

If you could have any superpower what would it be and why?
I would have to say teleportation because I would have the ability to do what I want, when I want. If I want the best pasta I can go to Italy, if it’s Winter in Ohio I can pop over to a beach in the Bahamas, I’m bored on a Saturday I can shoot down to Disney World.

Thinking back over your career, what is the professional accomplishment you are most proud of achieving and why?
Achieving my lead ISO 9001:2015 certification was the highlight of my career. The years I spent in quality and all the studying of the standard lead me to that accomplishment.

Client satisfaction is pinnacle to your background. What are your client-focused approaches to simpleQuE?
In the world of technology, I still believe person to person conversation is key to customer service. I like to pick up the phone and speak to people. By doing so you grow a great working relationships with your customers.
 
Explain how simpleQuE is different from their competition.
Our name says it all “simple”. SimpleQuE strives for simplicity, efficiency and sustained value when approaching a client’s system.

How would other people describe you in three words?
Helpful, determined, and funny.

Supplier Quality Audits – Do You Really Know Your Supplier?

Binders with papers are waiting to be processed by bookkeepers back in blur. Accounting planning budget, audit, insurance and business concept.

Supplier quality audits – a way to examine and really know your suppliers.  Many factors contribute to making a company successful, from both internal and external perspectives. While you can certainly ensure the success of your internal operations, your external operations – such as your suppliers, external providers, and outsourced processes – can sometimes be a riskier situation.

In order to continue operating an efficient quality management system, it is vital that your relationship with your suppliers and external providers is strong and reliable. And in order to maintain that relationship, it is just as important to sometimes perform a supply chain audit to determine what is working and what areas need improvement. Especially when risks or problems drive the need for supplier audits of their quality systems.  

A supplier audit from simpleQuE can go above and beyond other auditing processes, and certainly beyond ISO and good manufacturing practices. When it comes to your relationship with suppliers, our audits can provide a number of services:

  • Problematic supplier assessments
  • Sourcing evaluations
  • Ongoing supply chain strategy assessments and audits
  • Corporate quality audits
  • Assistance in the monitoring and closeout of corrective actions
  • Improving your company’s measures of effectiveness
  • Training

Our supplier quality audits and corrective actions will drive supplier development, and allow you to resolve both supplier quality and internal issues more effectively. 

With supplier quality experts from Fortune 100 companies, simpleQuE has the auditing expertise and certified resources to offer true value to your business. Whether you need help with problematic supplier assessments, sourcing evaluations, ongoing supply chain strategy assessments and audits, automotive 2nd party audits (including MAQMSR – Minimum Automotive Quality Management System Requirements), or corporate quality audits – simpleQuE can deliver.  Contact us to discuss a customized strategy.

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

ISO 14001 Certification – Much More Than a Green Standard

When the ISO 14001 standard was initiated, it served as a guide for gauging and monitoring the activities of a company and its impact on the environment. ISO 14001 certification is now widely utilized by thousands of organizations around the globe to illustrate to the public and its constituents that it is environmentally responsible. As a result, more and more companies are able to monitor and correct any processes and systems that could be negatively affecting the environment, making the organization more eco-friendly.

ISO 14001 certification has numerous benefits for an organization in addition to helping the environment.  Some of these could include:

  • Reducing waste and carbon footprint
  • Cutting costs by conserving energy and input materials as well as decreasing incidents that can cause an organization to sustain liability expenses.
  • Promotes a positive image and credibility to the public by pledging to customers an organization’s commitment to caring for the environment and preventing pollution
  • Utilizing accurate data and information on the improvements to be made within an organization will decrease the chances these changes will be unsuccessful and require additional testing, resulting in more time and expense
  • Fosters a positive attitude with employees who are motivated to work in an organization that demonstrates environmental responsibility.

Implementing an ISO 14001 environmental management system provides an organization the framework for monitoring its effects on the environment and how to improve and increase the positive impact. This commitment demonstrates the responsibility of an organization’s environmental effect, which in turn builds greater customer trust, employee confidence and potentially new business opportunities.  Establishing and upholding the environmental aspects of a company’s processes is the first step towards making helpful changes within an organization, its environment and around the globe, creating positive affects for years to come.

If your organization is looking to reduce its impact on the environment, contact us to find out how your company can obtain ISO 14001 certification through simpleQuE’s range of ISO 14001 training and consulting services.

Rolling Out ISO 19011:2018 – Guidelines for Auditing Management Systems

Administrator business man financial inspector and secretary making report calculating or checking balance. Internal Revenue Service inspector checking document. Audit concept.

ISO 19011:2018 was released in July, and the new revisions have truly transformed the contents of the standard. The changes, including most significantly a new risk-based auditing approach, recognize the importance of managing risk in any management system, as well as the marketplace.

ISO 19011 provides guidelines for auditing management systems, enabling effective auditing across multiple systems at the same time. The document offers guidance regarding:

  • The principles of auditing
  • Managing an audit program
  • Conducting management system audits
  • Guidance on evaluating the competence of those involved in the audit process, including the managers, auditors and audit teams

It can be used by any organization that needs to conduct internal or external audits of management systems, including 2nd party and supplier audits.

The new standard revision puts an increased focus on risk – a Principle of Auditing has been added into Clause 4, and a series of new sub-clauses emphasizes the standard’s new risk-based approach principle, including calls for consideration of risk and opportunities when performing an audit and managing the audit program.  

Auditors are now advised to employ a Risk Based Approach, an audit approach that considers risks and opportunities. This risk-based approach, according to the new language, should “substantively influence the planning, conducting and reporting of audits in order to ensure that audits are focused on matters that are significant for the auditee and for achieving the audit program objectives.”

This Risk Based Approach joins Integrity, Fair Presentation, Due Professional Care, Confidentiality, Independence and Evidence Based Approach as ISO 19011’s expectations.  Your certification body will want to see your knowledge of the new standard, implementation plans and timing for your company to adopt this new approach to your internal audits.

Other revisions to the standard include:  

  • Additional guidance on managing an audit program
  • Expanded guidance on conducting an audit
  • An expansion of the generic competence requirements for auditors
  • Adjusted terminology to reflect the process and not the object
  • Removal of the annex providing competence requirements for auditing specific management system disciplines
  • An expansion of Annex A to provide guidance on auditing new concepts such as organizational context, leadership and commitment, virtual audits, compliance and supply chain.  

SimpleQuE’s auditors have extensive training and experience and follow ISO 19011’s guidelines for conducting audits, can you say the same for your auditors?  Contact us for more information about training your internal auditors or outsourcing your audits.

SimpleQuE Attends Toyota’s 2018 Power of Exchange

Diversity drives Toyota which is why simpleQuE’s VP, Deanne Sparr, is at Toyota’s 2018 Power of Exchange – a unique supplier diversity and development conference for diverse businesses. This is a targeted networking event to gain and share knowledge and build relationships with current Toyota 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.

Over the years, 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 10 more Dana facilities in OH, PA, IN, TN and KY. Seven of the eleven sites have already successfully transitioned to IATF 16949!

At simpleQuE we like to challenge what looks to be impossible and make quality excellence “simple.”

Associate Spotlight – Kimberly Roan

We are excited to introduce one of our newest team members, Kimberly Roan, a simpleQuE consultant.  Kimberly brings not only years of experience, but a great curiosity and drive to find the best solutions for our customers.  Here’s more on Kimberly:

What is your position and what do you do for simpleQuE?
I am a consultant for simpleQuE and I consult with clients, perform internal audits, and teach on site training on automotive QMS topics.

What do you like most about working for simpleQuE?
This is an opportunity to make a difference.  Every day I get to help clients identify issues and improve processes.  Sustained process improvements lead to greater customer satisfaction and improved effectiveness and efficiency in the organizations we work for.

What is your favorite QMS standard and why?
My favorite QMS standard is ISO 9001:2015.  This standard builds the foundation of an effective QMS and is the cornerstone for a series of important industry QMS standards.

What attracted you to simpleQuE?
Top managers who understand QMS development and believe in simple, sustainable, and value added quality management solutions.

What expertise do you bring to simpleQuE’s clients?
I spent 17 years in automotive and was always involved in auditing both first and second party and spent many years participating in 3rd party audits and acting as the management rep. If I could draw you a picture, I would show you a pyramid that includes a 17 year work experience – base, and approximately 8 year formal education – middle, and a 3 year certified auditor – crown. The large sections of the pyramid underpin everything I knew to make me an effective auditor. With this balanced experience I can provide clients with answers from a company management perspective, an internal auditor perspective and a third party auditor perspective. Every day I use the whole pyramid but the biggest part of it will always be my work experience.

What was your first job?
My first automotive job was part time administrative assistant for an engineering team at Saturn.  My first job ever was doing office work for a neighbor in direct sales at the age of 12 to 13.

Have met…
John Glenn, in an elevator at a Marriott hotel.  We talked about Harley Davidsons and how he wouldn’t get one now because he promised his wife he was done with high risk activities.

Where did you go to college?
Baker College of Flint for my Mechanical Engineering degree and The Chicago School of Professional Psychology for a Masters in Psychology with an emphasis in organizational leadership.

What is your hometown?
Cadillac, MI

Would love…
To visit the hometowns of my great grandparents in Germany.

My hidden talent is…
Slow racing my VT1100

What is your favorite sports team?
Let’s go Red Wings!!!

What advice would you give to a new college graduate entering the technology industry?
Learn something new every day and do something good with what you learn as often as you can.

Explain how simpleQuE is different from their competition.

SimpleQuE is different because they focus on simple solutions to meeting complex QMS requirements.  The company supports a value added approach to meeting requirements.

Where do you see simpleQuE the next five years?
SimpleQuE will grow to become the leading QMS consulting firm and they will continue to support the success of their clients.

How would other people describe you in three words?
Independent, tenacious, and helpful.