Toyota Opportunity Exchange – Turning Relationships into Opportunities

Every year we look forward to the Toyota Opportunity Exchange where the automotive giant brings together Tier I suppliers and diverse business owners for a day of networking, education, and professional development. We’re excited to be heading to the Motor City, an apropos destination for the 28th year of this event.

With nearly 2,000 attendees each year, including over 300 Toyota suppliers exhibiting at the event’s trade show, the Opportunity Exchange is one of the largest events of its kind in the United States and acts as a standard for supplier development within the automotive as well as outside industries. It is also a key event for simpleQuE for making new contacts that have led to business opportunities and company growth. We also gain important insights on how to consistently provide a solid, quality service as a minority owned business.

Prior to the conference, we like to prepare and get inspired for a busy day of networking by reading some of the Diverse Supplier Stories that are shared on the event website.  These stories illustrate how the TOE has provided companies a platform to network and build meaningful connections that have generated millions of dollars in diverse supplier contracts.

Follow the event on social media using #ToyotaSD.

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IATF 16949:2016 Transition Q & A from IAOB

Welding robots movement in a car factory

Cherie Reiche, program manager for International Automotive Oversight Bureau (IAOB) recently presented at Eagle Certification Group’s June Boot Camp to discuss progress of the IATF 16949 transition and the unique intent behind some of the new requirements.   While no FAQs or SIs have yet been published for IATF 16949:2016, Cherie shared some of the common questions that IAOB and IATF members have received for interpretation and clarification from Certification Body automotive auditors.

Must both ISO 9001:2015 and IATF 16949:2016 be used when conducting audits?
Answer:  Yes, as it states in the IATF 16949 Foreword – Automotive QMS Standard, IATF 16949 is not a stand-alone standard, it must be used in conjunction with ISO 9001:2015.

Will the IATF be granting waivers for those organizations who cannot meet the transition plan timing?
Answer:  No, there are no plans to approve/grant waivers.  If the organization does not complete their transition audit in a timely manner (including allowing time for Non Conformance management and CB certification decision), then the organization will lose their certification.  ISO/TS 16949 certificates are not valid past their expiry or September 14, 2018.

Is IATF 16949, Section 4.4.1.2 related to product safety during manufacturing or final customer product safety concerns?
Answer:  4.4.1.2 was created to address final customer safety concerns (braking systems, airbags, fuel systems, etc.).  If the product (or process) is a safety item on the final product, then the organization has to identify the statutory and regulatory product safety requirements that must be met, along with items a) through m) in 4.4.1.2.  This is one of IATF 16949’s required documented processes, so inputs/outputs, metrics, etc. are required.

Can an organization demonstrate competence only through degrees and certifications for their employees?
Answer:  No, there are multiple ways for an organization to identify training needs and achieving the necessary competence for their personnel.  It is up to the organization to define (and document) training needs, including awareness, and competency requirements for all personnel performing activities that impact conformity to product and process requirements.

What about competency for internal auditors and second party auditors?  Do they all have to take an IATF-sanctioned lead auditor training course?
Answer:  No.  Organizations are responsible for ensuring key personnel, including their auditors, are properly trained and competent.  The IATF supports the use of IATF-recognized training providers; however, the IATF does NOT mandate the use of a lead auditor training course for all auditors in the organization.  Organizations are still allowed to have key personnel trained and certified as lead auditors, and then use those key personnel to train-the-trainer to disseminate the information throughout the organization.

If an organization is not design responsible for the software used in their product, does 8.3.2.3 (embedded software) apply?
Answer:  Section 8.3.2.3 refers to internally developed embedded software, not “functional test” software to see if a widget works (or not) during production.  For those organizations that are design responsible for the software used in their product, they must use a software development assessment methodology to assess their own software development process.  Annex B contains suggested Software Process Assessments such as CMMI or SPICE.

What is the goal of 8.4.2.3?  Do all organizations supplying automotive product have to be IATF 16949 certified?
Answer:  The ultimate objective is to have IATF 16949 certification; however, the IATF recognizes that for various reasons, that is not feasible for all organizations.  At a minimum, the expectation is for organizations to be certified to ISO 9001:2015, unless otherwise authorized by the organization’s customers.  Items a) through e) are a cadence which is applicable to the entire automotive supply base.

How are 8.3.2.3 and 8.4.2.3.1 different?
Answer:  8.3.2.3 refers to the organization itself and their internally developed embedded software. 8.4.2.3.1 refers to the organization’s suppliers of automotive product related software.  The organization needs to ensure that their suppliers of automotive product related software implement and maintain a process for software quality assurance for their products.

SimpleQuE will be sharing more information from IAOB and other Eagle Boot Camp sessions in future posts and on social media.  Follow us on Facebook, LinkedIn and Twitter for the latest quality and certification news.

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.

ISO/TS 16949 Certifications Across the Globe

 

ISO/TS 16949 is being adopted across the world and setting in place the quality management requirements for the design, development, production, installation, and service of automotive-related products. Take a look below at the world leaders in ISO/TS16949 certification.
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News Update from the International Automotive Task Force (IATF)

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In October 2016 IATF 16949:2016 will be published by IATF and it will replace the current ISO/TS 16949, defining the requirements of a quality management system for organizations in the automotive industry. It will be aligned with ISO 9001:2015 and its structure and requirements. IATF 16949:2016 will be implemented as a supplement to, and in conjunction with, ISO 9001:2015.  www.iatfglobaloversight.org

IATF has also released a new transition strategy document for automotive suppliers and certification bodies to help with the transition.  It includes information about timing and transition audit requirements. After October 1, 2017 no audits (initial, surveillance, recertification or transfer) will be conducted to ISO/TS 16949:2009. IATF Transition Strategy ISO/TS 16949 › IATF 16949

It is also important to note that IATF/IAOB will recognize TS certified companies that have upgraded to ISO 9001:2015 prior to IATF 16949 and allow reduced audit days when the company does eventually upgrade to the new IATF 16949 standard.  Companies should coordinate with their registrar to determine the optimal audit approach and cost benefit.  (Separate audits may be not be cost effective, but it will depend on each company’s situation.)

SimpleQuE consultants and instructors are ready to assist companies now with implementation, transitioning and training for ISO 9001:2015 and TS 16949:2009.  Consulting and training for IATF 16949 will be available after its release in October.  Contact simpleQuE

Planes, Change and Automobiles

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Tight Transition Timelines

Important updates regarding the Aerospace and Automotive industries were shared with SimpleQuE representatives attending the Smithers Quality Assessment’s annual conference on July 14th.  Speakers from the International Automotive Oversight Bureau (IAOB) and International Aerospace Quality Group (IAQG) provided insight into the upcoming changes to the ISO/TS 16949 and AS9100 standards.  All are targeted for release in the last 4 months of this year, with certification bodies ready to audit to the new standards in the first quarter of 2017 for AS and possibly later for TS.  Transition timelines are going to be exceedingly tight.  Here are a few key takeaways:

ISO/TS 16949:2016

  • The IAOB recommends TS certified companies upgrade to ISO 9001:2015 now, prior to upgrading to TS. The benefit will be less audit days when upgrading to 16949:2016
  • The IATF is still working on how it can have more time beyond the September 15, 2018 expiration, before ISO/TS 16949:2009 expires and the 16949:2016 standard has to be implemented.
  • The IAOB was very careful not to say the new TS standard is based around ISO 9001:2015, but said it does follow the 10 clauses from Annex SL. They were also careful not to call the new standard ISO/TS 16949:2016.
  • There are only 4,353 active TS certificates in the US, down from a high of almost 6,000 prior to the recession.
  • OEM’s are raising the bar with the new TS standard and performance is key for the automotive supply chain.  (See our previous post – Shifting into High Gear for what we learned about the Rome, Italy meeting with TS stakeholders earlier this year.  Many things are still changing from that meeting, so expect differences with the final release.)

AS9100:2016

  • AS is accelerating requirements to upgrade. After June 15, 2017 no certification body can perform audits to the current AS standards.  After 6/15/17 all scheduled surveillance and recertification audits must be to the new 2016 standard.
  • This prevents companies from waiting until the last minute to upgrade because there are a limited number of AS certification body auditors and it would not be possible to get everyone upgraded near the deadline.
  • There is concern regarding the extremely tight timelines. Companies have a shorter amount of time to retrain internal auditors, conduct audits, do a new management review, and get upgraded at the next scheduled audit after 6/15/17.  Watch for simpleQuE’s aerospace training on the new standard.
  • Here are two scenarios of the new timing requirements communicated by SQA:
    • If your last registrar audit was June 1, 2016 then you could delay upgrading to your June 2018 annual audit.
    • If your last registrar audit was June 21, 2016 then you must upgrade during your June 2017 annual audit, and have no choice to delay until 2018.

Keep up with simpleQuE’s blog posts and training courses for the latest information affecting the quality world.

ISO/TS 16949:2016 – Shifting into High Gear

close up of hand on manual gear shift knob

SimpleQuE representatives were recently invited to attend the Eagle Certification Group auditor training, which included the latest information on anticipated changes to ISO/TS 16949:2016, and they are significant!  In May, Eagle participated in 4 days of meetings in Italy with all the stakeholders to provide feedback on the final draft TS standard to be released Q4 of this year.  Get ready because the changes will greatly impact automotive suppliers and the industry!

Here are some of the significant changes we learned are in the TS final draft, which is still subject to change.  But due to this late date, we anticipate many of the revisions are realistically coming, along with some unexpected new requirements.

  • A new layout to 10 clauses to include all of ISO 9001:2015.  Get a copy of this standard and begin compliance to the ISO changes, as they will be in the new TS standard.
  • Harmonization of the Customer Specific Requirements within the TS standard, along with the core tools requirements. 
  • A new requirement for a documented process on Product Safety. It should include the identification of regulatory and customer requirements affecting safety, along with approvals for changes, customer notifications/reaction plans, special approval of control plans and PFMEA’s, specific training, and flow down of product safety requirements down the supplier chain.
  • A new clause on Corporate Responsibility – in light of the problems with the VW emissions scandal and Takata airbags. There needs to be an escalation policy (which includes whistle-blowing) to improve integrity in social and environmental matters.
  • A greater emphasis on process effectiveness and efficiency, with the need for management reviews to include process performance review.  A rule that went into effect this year for certification bodies is that if processes are not performing effectively and efficiently and corrective actions taken by the company are not effective in a subsequent audit, the certification body is to write a major nonconformance.
  • For plant, facility, and equipment design and layouts, a cross functional team is required, along with risk identification and risk mitigation techniques. This includes manufacturing feasibility prior to, and ongoing evaluations after start up, for maintaining process effectiveness and updating of documentation (control plans, job set-ups). This is also a new input to management reviews.
  • A new requirement for customer-specific training as it may relate to customer portals and the communication of information to and from the customer (orders, releases, ASN, PPAP, corrective actions, etc.).
  • A process must exist for determining and ensuring training needs for employees working with the customers during the quote, project development and production phases.  As appropriate, these employees must be trained in APQP, Customer Specific Requirements, FMEA and Control Plans.
  • A new focus and attention on embedded software as part of the design and development process (i.e. engine control modules, emission control systems, etc.).  It also has its own clause outside of design, which requires a process for software quality assurance and the use of Automotive SPICE (Software Process Improvement and Capability Determination). A SPICE assessment or audit is also required prior to PPAP.
  • Supply chain risk for quality and delivery is a new requirement for consideration in supplier selection.  This may include financial stability, volume of automotive business, change management process, business continuity planning, and more.
  • Total Productive Maintenance is a new clause requiring documented maintenance goals that include at least OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure) and MTTR (Mean Time To Repair).  These also are now inputs to Management Reviews.  When objectives are not met, there must be a documented action plan to address corrective actions.
  • Companies need to identify manufacturing processes and error-proofing devices that can be bypassed.  Based on risk and FMEA severity, bypass procedures must be developed, and may require customer approval.  Bypasses must be reviewed daily with focused audits, with daily leadership meetings to reduce or eliminate bypass operations.  Restart verification is required when no longer bypassing.
  • Non-conforming product that is scraped must now be physically rendered unusable prior to disposal.
  • There are new flow-down requirements to suppliers and external providers of products and services, which include cascading down the supply chain for regulatory/statutory requirements and special product and process characteristics. 
  • Gauge calibration clearly includes monitoring and measuring equipment required to ensure effective control of manufacturing processes. 
  • Internal audit requirements are enhanced with clear annual plans for the QMS, manufacturing process, and product audits.  The number of audits and audit days must be specified and planned.  A risk based approach needs to be utilized to prioritize the audit program, based on customer issues, performance trends, and criticality of the processes.  Software development capability audits are also required.
  • A process must exist to ensure internal auditors can demonstrate competence to audit TS, manufacturing processes and products, core tools, relevant Customer Specific Requirements, and more.  There are also trainer requirements that must be met. Approved auditors must be documented and competency monitored through conducting of a minimum number of audits per year (as defined by you).
  • Management review inputs are expanded by ISO 9001:2015 and the new TS standard, and include new topics of warranty performance, maintenance action plans, etc.  Clear action plans must exist when customer requirements are not met.
  • Warranty management is a new clause, requiring a process that also includes warranty part analysis and “no trouble found”.
  • All customer complaints and field failures (including returned parts) must initiate formal problem solving and corrective action.
  • TS will add back the requirement for Preventive Action.
  • A documented process for continual improvement is required.

SimpleQuE offers quality management system consulting, internal auditing and training for Automotive, Aerospace and other industry standards.  Contact us to learn more about transitioning to ISO/TS16949:2016. 

ISO/TS 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 ISO/TS 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 ISO/TS 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 ISO/TS 16949:2016, so the transition time will be tight.

 

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