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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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

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.

Quality + Certification = Success!

SimpleQuE congratulates the following companies on their successful certification and commitment to quality.

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SimpleQuE (an ISO 9001:2015 certified company) assists organizations with implementation, improvement or transition of these standards by providing customized consulting, training and internal auditing services and solutions. Contact us for more information.

August Training – Sign Up Now

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This course is designed to meet the specific needs of your company in fulfilling the requirements for competent, knowledgeable, and well trained internal auditors and includes hands-on development of key processes, audit planning, and hands-on auditing exercises. The course was developed by a former president of a registrar, former owner of an accreditation body, certified auditors, and portions of this training have been used by multiple registrars for training their auditors to the process approach. Continue reading “August Training – Sign Up Now”

The Value of Outsourcing Internal Audits

Several possible outcomes of performing an audit

Guest post by Larry Vance

As a professional auditor and consultant, I have had the opportunity to visit hundreds of different companies that have a certified Quality Management System and have opted to have their staff and employees perform the required internal audits. I have encountered internal auditors that have the proper training, knowledge, and experience and that want to complete the audits to the best of their ability and for the betterment of the company they work for. Unfortunately, I have also experienced internal auditors that, based upon their audit reports and my interviews, are only going through the motions and do not do any more than provide some evidence that they did an audit. They and their companies are really missing out on the true reason that all of the Quality Management System standards require a certified company to do internal audits. Continue reading “The Value of Outsourcing Internal Audits”