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.

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ASA AFRA Annual Conference 2018

The Aging Workforce and Transfer of Knowledge

At this year’s ASA/AFRA Conference, Mr. Boyd Parsons, GM Excellence of Air Canada Maintenance shared some tips on how ACM has addressed the labor shortage in the industry and efforts to attract and engage millennials.  Employee training is held to improve skills and satisfy regulatory and ISO/AS/ASA standards’ transfer of knowledge requirements. Organizations must take into account their aging workforce’s “tribal knowledge” and technological advances to effectively tailor their training programs. Companies could boost their training programs with increased industry awareness to high school students, college coop programs, apprenticeships, and internships in addition to on-the-job training knowledge transfer. A community of experience and evidence-based information sharing should prove to be effective to integrate a multi-generational workforce with advanced technology and traditional learning techniques.

Photo credits: Mr. Boyd Parsons, GM Excellence, Air Canada Maintenance

Lauren Manufacturing Achieves Quality and Environmental Management System Certifications

Congratulations!  Lauren Manufacturing (New Philadelphia, Ohio), a Lauren International company, received ISO 9001:2015 and ISO 14001:2015 (environmental) certifications from Eagle Certification Group.  Since 1965 the company has grown from a seal and gasket manufacturer to a sophisticated business supply partner for leading OEMs, engineers and builders and to industries around the globe including automotive, agriculture, window and door, HVAC, renewable energy, lighting and more.  With facilities in Ohio and Michigan, total quality management is the foundation of their entire organization. To ensure quality materials are used for every customer application, they mix and test their own materials on site. They also design and build process equipment in-house to ensure products are manufactured to exact specifications.  Lauren’s adherence to lean manufacturing principles prevents defects and maximizes value for their customers from product design to delivery.

In addition, the company is committed to environmental management requirements and complies with regulations by local, state and federal agencies.  With EMS risks and opportunities identified, Lauren’s leadership planned objectives to address them. Each objective has a responsible person or team assigned with action item plans for achieving the EMS intended results.  These objectives and targets were communicated across the organization and are monitored and evaluated for status/progress updates to ensure continual improvement of the EMS and enhance environmental performance.

To assist with the transition to the new ISO 14001 and ISO 9001 standards, simpleQuE consultants began working with Lauren in early 2017, providing a gap analysis and support in preparation for their external audit in November 2017.  Originally, the company which is currently ISO/TS 16949 (automotive) certified, had thought they would also transition to the new IATF 16949 standard.  However, due to the complexities and numerous requirements of the new standard, it was determined that Lauren Manufacturing could meet their automotive customer’s requirements with MAQMSR and CQI-19 audits and compliance.  SimpleQuE consultants continue to work with Lauren to meet those objectives and to ensure that their reputation is built upon trust, service, innovation and quality.

Transition Time

The deadline for transition to ISO 9001:2015, ISO 14001:2015, AS9100:2016 and IATF 16949:2016 is fast approaching. Have you completed the transition process? If not, take a look at our blog post “The Countdown Begins” to learn how to get started before it’s too late.

Note that 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 nonconformance issues.

 

IATF Transition Update from IAOB

Cherie Reiche of the International Automotive Oversight Board (IAOB) shared the following IATF 16949 transition update at several registrar conferences.  As of April 30th 2017:

  • 68,332 sites are IATF 16949 or IATF 16949 certified worldwide
  • 181 audits were completed to IATF 16949 (0.3% upgraded)
    • To date the total NCs issued = 975 (avg 5.4 findings per audit)
      • Major NCs = 133 (16% of the findings are major)
      • Minor NCs = 842

A summary of the highest incidence of NCs (major/minor) by section is represented in the chart below.  It’s interesting to note that Customer Specific Requirements and Quality Management System Audit had the largest number of major NCs, while most minor NCs were written on Contingency and Control Plans.

2017-08-15-2

News Regarding Revision of the ASA-100 Standard

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Aviation Suppliers Association (ASA) promotes safety, regulatory compliance and ethical business practices among aviation parts suppliers throughout the aviation community. Jim Lee is a presenter and attending the ASA Annual Conference and shares news about important changes to the standard.

The ASA-100 standard is going through a revision that will require all accredited companies to add to their quality manuals.  The standard and checklist will be released October 1, 2017 and all audits afterJanuary 1, 2018 must be completed to the new 4.1 version.

  • One of the changes requires that quality manuals or specific procedures contain requirements for drop shipments direct from a supplier to a customer, bypassing the distributor who sold the part.
  • Another change follows ISO and requires that suspect and non-conforming material be addressed in a procedure. Material is to be segregated. If non-conforming material is shipped, the customer must be notified timely.
  • All changes to the quality manual must be submitted to ASA by 1/1/2018.

Over 300 companies have received accreditation to the ASA-100 Quality System Standard and FAA Advisory Circular 00-56 since 1996.

5 Steps To Manage Your Environmental Impact And Boost Growth

hand holding signs of different green sources of energy in hexahedron shape a 'reduce reuse recycle' sign in the centre. Blurred green background. Concept of clean environment.

Twenty years ago small businesses focused on one thing: how to make profits. Today, environmental impact is turning out to be just as important as meeting the bottom line. Here’s how to manage it for growth:

  • Incorporate planning – the very first place to start with addressing environmental impact and risks is to include them in strategic planning at every level. Because ISO 14001 is the cornerstone of environmental standards for a business, planning is essential. If the matter isn’t addressed to begin with from the top down, one of two things occur: 1) no one internally treats the matter as a priority, and 2) responses that do occur end up being ad hoc and disparate, which often incurs more costs than expected.
  • Anticipate that not everyone will be happy at first – getting environmentally focused is still a politically-charged approach. Education is probably the best response, even though it may require a bit more effort. At the end of the day, however, socially-conscious businesses sometimes have to stake out a claim. Choose wisely and then stay the course.
  • Embrace leadership – businesses that really break out and become the major players using ISO 14001 as their environmental management system are not necessarily the biggest in their industry. Smart businesses are out ahead looking for these leadership opportunities to craft their own path and market niche before anyone else.
  • Use size to an advantage – Being a small business comes with a lot of advantages in terms of flexibility and speed for adjusting to changes. Rather than a big bureaucracy involved in shutting down an assembly line, small business can test the waters far more rapidly and frequently with new ideas in environmental impact and that’s a huge competitive advantage when used effectively.
  • Don’t throw out the baby with the bath water – Every new change should have a thorough cost-benefit analysis. There are plenty of existing quality management procedures that align with ISO 14001, including ISO 9001 and IATF 16949.

SimpleQuE offers customized consulting solutions for all sizes of Aerospace, Automotive, Laboratory, Manufacturing and Service organizations. When it comes to environmental impact and responsibility, ISO 14001 certification makes good business sense for businesses small and large, across all industries.

Risky Business vs Risk-Intelligent Business

Rolling the dice concept for business risk, chance, good luck or gambling

Digitalization, globalization, competition and the speed of technological advances has changed the nature of business.  ISO 9001:2015 has been in effect for a full year and it places a heavy emphasis on using “risk-based thinking” for managing quality-related processes. Risk has always been implicit in ISO 9001.  But the latest revision asks organizations to make a cultural shift—rather than focusing on isolated problem solving and resolution, they’ll focus on prevention and performance improvement.

The International Organization for Standardisation (ISO) explains it this way:

“Risk based thinking ensures these risks are identified, considered and controlled throughout the design and use of the quality management system”.

Under the new guidelines, risk management serves as the cornerstone of quality management system design. As organizations determine the processes needed for a quality management system, they’re also asked to determine the associated risks and opportunities and to plan and implement appropriate actions to address them.

In the context of ISO, the concept of “risk” relates to the uncertainty in achieving the main objectives of International Standards—namely, to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services, and to enhance customer satisfaction. Risk is the possibility of events or activities preventing an organization from achieving its strategic and operational goals.

This shift in thinking does not replace the standard’s process-oriented approach, but enhances it. While the process is still a critical part of ISO 9001:2015, processes must now be implemented with an acute awareness of risk.

Organizations are asked to identify, analyze and prioritize all potential risks as they undergo building or adapting their existing quality management implementations for updated certification.

Risks can be defined by two parameters—the severity, or seriousness, of the harm, and the probability that the harm will occur. Risks can be assessed based on the likelihood they will occur, the likelihood they can be detected, and potential impact should they occur. From there, risks are evaluated based on their importance (what is acceptable, what is unacceptable?) and actions are planned to address the risks, whether that’s avoiding or eliminating the risk or mitigating it.

Once plans are implemented, it’s essential for organizations to check the effectiveness of their actions and continually learn from experience.

What’s the best way to document risk-based thinking and demonstrate the approach during audits?. Evaluate how you evaluate risks today with the processes you have. Understand how you decide when risks are acceptable or unacceptable.  ISO wants to see that you record identified risks when action is required, and the action steps to be taken. 

Putting into place the Plan-Do-Check-Act (PDCA) methodology can be a great way to define, implement and control corrective actions and improvements. Companies should Plan what to do and how to do it, Do what was planned, Check that things happened according to plan, and Act on how to improve the next time around.

Companies have two years to make the transition to ISO 9001:2015, as certifications for the 2008 edition will expire after September 2018.

SimpleQuE was one of the first consulting companies to be ISO 9001:2015 certified and we’re ready to assist organizations with transition or implementation.  Please visit our website for more information about our services.

IATF 16949:2016 Will Be Out By Year-End

Gearbox cross-section, automotive transmission with sprocket and bearing mechanism for commercial trucks, SUV, cargo, and construction vehicles, selective focus ** Note: Shallow depth of field

The new IATF 16949 standard is due out in December 2016, per the IATF (International Automotive Task Force) http://www.iatfglobaloversight.org. The first draft is completed and they are obtaining additional input, while also planning to complete some pilot gap assessments worldwide to refine the new TS standard and associated Rules by July of this year. This will give IATF time to finalize and publish the new standard by year-end.

What are the changes we can expect to see to address some of the automotive OEM issues?

  • New requirements for safety-related parts and processes (i.e. airbags, tires, brakes, inspection/testing, etc.)
  • Enhanced product traceability requirements to support new laws and changes to regulations
  • Requirements for products with embedded software (i.e. engine control modules, emission control software, change control, etc.)
  • Warranty management process including addressing NTF (no trouble found) and use of automotive industry guidance (AIAG CQI-14)
  • Clarification of sub-tier supplier management and development requirements (based on risks, it may be necessary to manage sub-suppliers, not just direct suppliers. Also, clause 7.4.1.2 from the beginning of TS has always had FAQS and/or Sanctioned Interpretations to allow deviations from this TS clause)
  • Addition of corporate responsibility requirements (i.e. ethics, risk management and so much more is published in various ISO documents and guidelines on social responsibility – ISO 26000 as an example,  or social accountability – SA8000 commonly used outside the US)

We don’t know the extent of these requirements, but just know these new concepts are being added to the TS standard.

The timeline to upgrade to the new IATF 16949:2016 will be September 14, 2018, less than 21 months after publication of the standard.  Certification bodies will require some time to train their auditors and get approved to issue certificates to IATF 16949:2016, so the transition time will be tight.

 

Want to learn more? Click here to view the certification transition plan.

So what exactly is “ISO?”

Group of Business People Working Together in Office
Have you ever heard the old business saying “You can’t manage what you can’t measure?” ISO standards are the answer to the problem of measurement.

The International Organization for Standardization, based in Geneva, Switzerland, publishes over 19,500 international standards that cover everything from quality management to sustainability to codes used to convey international currency types. Continue reading “So what exactly is “ISO?””