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.”

Sign Up For Our Newsletter

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.

Soar Above the Competition with AS9100, AS9110 and AS9120

Serving aerospace and defense manufacturers, suppliers and distributers since 2005, simpleQuE offers customized AS9100, AS9110 and AS9120, or ASA-100 (FAA AC00-56) consulting, internal auditing and training services.

Our lead AS9100 series consultants are International Aerospace Quality Group (IAQG) certified lead auditors with aerospace experience and know what it takes to help clients achieve their goal of establishing, implementing, maintaining, and improving their Quality Management System. As 3rd party auditors for registrars they have first-hand knowledge of what is required to pass an AS9100 certification assessment.

Using this knowledge and experience along with the required tools and techniques, all of our clients have had successful AS9100 certification audits on their first registration assessments and have attributed that mostly to our consulting and training.  That’s a major accomplishment and many of these companies continue to use simpleQue for their internal audits and continuous improvement needs, freeing up limited resources and benefiting from the other advantages to outsourcing these services.

If you are already AS9100, AS9110 or AS9120 certified but are struggling to maintain and improve your Quality Management System, or just need to update the knowledge and skills of your quality team, simpleQuE can help. We offer several courses including AS9100 Internal Auditor Training that have proven to be very beneficial to our customers.  Executive Overview, Requirements, Risk Management, and Problem Solving/Root Cause Analysis are some of the AS9100 Training Courses available that can be customized and held on site. We believe in experiential learning where you go beyond lecture and incorporate exercises to apply the learning, and use actual workplace examples from your company; thus allowing students to better learn, retain and apply their knowledge.

Visit simpleQuE’s website to see the many services we offer for your AS9100, AS9110 and AS9120 needs. Contact us for a customized path that will put you far above the competition.

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.

A Look at the AS9100D Transition Data

With the transition to AS9100:2016 well under way, what can we interpret about the data from the International Aerospace Quality Group (IAQG)? Overall, aerospace and defense organizations are transitioning to plan, and exhibiting preparedness with the new requirements.

Some organizations still struggle with Process Identification, but Production Controls and Purchasing make up the highest nonconformities. Here are the top 9 by clause:

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.

The Countdown Begins

Hour glass on calendar concept for time slipping away for important appointment date, schedule and deadline

By Jim Lee, President of simpleQuE

With the deadline for ISO 9001:2015, ISO 14001:2015, AS9100:2016 and IATF 16949:2016 approaching on September 14, 2018, companies have been slow to transition.  The statistics are sobering, although not unexpected.  The new ISO standards have been in effect for 2 years but only 6-20% have made the leap. (The number varies among registrars and the ANAB.) The final draft for the AS 9100 series followed a year later, but with the same deadline, and only 3% have upgraded.  Even fewer IATF companies have transitioned – and all have only 1 year left to get the upgrade completed.

What should you be doing if you’re one of these companies that has pushed out the inevitable?

  • Know that your next scheduled annual audits are the dates when you must transition to the new standards. If your next audit is a recertification and upgrade, you will need to perform the audit at least 2 months prior to your certificate expiring to give you enough time to address any potential nonconformances.
  • Review the new standard and do a gap analysis to see where there are differences in your quality (and/or environmental) management system and the changes to the standard. Generic basic checklists are available from your certification body, or detailed gap checklists with tips and explanations can be purchased from simpleQuE.  Learn more about simpleQuE’s Gap Checklist for: ISO 9001:2015, ISO 14001:2015, or IATF 16949:2016.  Note that IAQG offers a free AS9100D Gap Assessment Workbook.
  • Establish an action plan that will have you ready for your audits. Assign responsibilities and due dates to ensure you’re ready on time.
  • Train your internal auditors and perform a full system audit to make sure your system is on track and in compliance. You must have evidence of a full internal audit and subsequent management review prior to upgrading with your certification body.  If you can’t get your audits done in time you’ll need to outsource them.  (SimpleQuE can conduct an internal audit to the new standard after the implementation effort to prepare you for the external audit.)
  • Don’t expect to wing it and do nothing in preparation for these changed standards, or you will fail your next audit and lose your certification. Worst case if you aren’t ready in time, you may have to let your certification lapse and then become recertified at a later time when you’re ready.  No one wants to hear that, but it is a reality for some who haven’t started.
  • If you still aren’t sure how to proceed, work with a consulting firm (like simpleQuE) with certified experts who can provide consulting, training and customized plan to guide you through the transition.