Category: Automotive

Coming Soon: Core Tools – an International Collaboration – By Kim Roan

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On the heels of the revision of TS 16949 to IATF 16949 the AIAG (USA) and VDA-QMC (Germany) are collaborating to improve the automotive Core Tools.  These Core Tools are the building blocks of an effective quality management system and include Advanced Product Quality Planning & Control Plan (APQP), Production Part Approval Process (PPAP), Failure Mode and Effects Analysis (FMEA), Measurement System Analysis (MSA), and Statistical Process Control (SPC). Their starting point, aimed at improving risk assessment automotive industry wide, is the FMEA manual.

The Automotive Industry Action Group (AIAG) was established in 1982 and the German Industry Automotive Assn. (VDA-QMC) in 1997.  Each organization serves as the IATF oversite office in their respective country. Both organizations serve the automotive industry by standardizing publications for the industry and by providing automotive industry training.

Currently suppliers to both North American and German OEMs are required to use different FMEA rating tables for severity, occurrence, and detection.  This has created confusion and related frustration for both suppliers and OEMs. The primary goal of the current collaboration is to revise the rating tables to provide a common rating scale for risk accepted by all German and North American OEMs.  The secondary goal is to update the manual in areas that need revision to support risk analysis and harmonize the documents overall. This is a great opportunity to combine the strengths from each FMEA manual with improved risk assessment tools that will support the advancing technology of the automotive industry.

The targeted release of the revised FMEA manual is December 2018 followed by OEM release of their customer specific requirements to support the changes.  AIAG and VDA-QMC plan further collaboration to continue harmonization and update of all automotive core tools manuals. These tools have proved so useful that they have also been adopted by the aerospace and defense manufacturing sectors. SimpleQuE has been preparing for the changes and developing the training needed for companies to implement the updated FMEA requirements.  Let our automotive experts partner with you as you roll out your FMEA upgrades to meet automotive customer demand and take your FMEA risk analysis to a higher level.

About the author:  Kim Roan has completed her undergrad in Mechanical Engineering and her Master’s in Psychology with an emphasis in Organizational Leadership.  Kim is a simpleQuE consultant with over 20 years automotive industry experience with 11 years working for a German automotive supplier in the USA and experience supplying OEMs in North America, Germany and Asia across the years of her career.

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IATF 16949 Certification – The Automotive Quality Standard

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Industrial automotive machine tool equipment close up, abstract industry manufacturing metalwork background, blue toned

IATF 16949 is the global standard recognized by the automotive industry. IATF 16949 defines the quality management system requirements (QMS) for the design and development, production assembly, installation and services of automotive-related products including products with embedded software. The focus of this standard and IATF16949 certification is the development of a QMS that provides for continual improvement, emphasizing defect prevention and the reduction of waste in the supply chain. Combined with applicable Customer Specific Requirements, IATF 16949 is also fully aligned with the structure and requirements of ISO 9001:2015 which was designed to assure effective quality management systems for manufacturing and service industries around the world.

The Characteristics of IATF 16949 Certification

Developed by the International Automotive Task Force, IATF 16949 has a variety of automotive industry-specific features, including:

  • Defect prevention
  • Reduction of variation and waste in the supply chain
  • Customer focus and satisfaction
  • Identification of risks and problems in the production process
  • Management of resources
  • Product realization
  • Responsibility of management
  • Measurement, analysis and improvement

There are over 68,000 suppliers worldwide which currently have ISO/TS 16949 or IATF16949:2016 certification.  The standard can be used by any supplier, large or small who manufacture customer-specified production parts, service parts, and/or accessory parts.

 

How do you cross the finish line to become IATF Certified?

If you’re searching for an IATF 16949:2016 consultant, our team at simpleQuE is well positioned to support your IATF 16949 and MAQMSR consulting (Minimum Automotive Quality Management System Requirements), certification, maintenance, training and internal auditing needs. Our consultants are qualified, certified, competent and are experts on the automotive standards, customer specific requirements, and AIAG or VDA core tools. In addition, many are current or former 3rd party auditors who bring valuable insight because of the knowledge gained from auditing for certification bodies.

SimpleQuE also offers a full line-up of IATF 16949 training courses which includes AIAG and VDA Core Tools, Root Cause Analysis and Problem Solving, Requirements and Implementation.  With IATF also putting a major focus on internal auditor competency, it is essential to have IATF 16949 Internal Auditor Training. Our IATF 16949 auditor training utilizes the process audit approach. Contact us to learn more about the customized services offered to match your certification and training needs.

Not ready for IATF Certification? MAQMSR May Be an Option

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worker with protective mask welding metal. in Industrial automotive part. in car production factory.

For automotive suppliers who are having a difficult time meeting the requirements of the new IATF 16949 quality standard, Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) may be an option you want to consider in conjunction with ISO 9001 certification.  With initial audit results coming in from certification bodies, it is evident that companies are failing to comply and in some cases IATF certification can’t be achieved.

IAOB released the top IATF 16949 findings based on 3,172 audits conducted as of August 2017 – the top 5 non-conformances overall were written against:

  • 5.1.5 Total productive maintenance
  • 5.1.1 Control plan
  • 1.2.3 Contingency plans
  • 5.1 Control of production and service provision
  • 2.3 Internal auditor competency

As an option for suppliers, the Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) was released in September 2017 as a possible intermediate step for a supplier’s Quality Management System (QMS) under the authorization of IATF 16949, Section 8.4.2.3.c and Sanctioned Interpretation, SI #8.

Conformance to MAQMSR helps a lower tiered supplier transition to IATF 16949 by allowing many of the key Automotive Requirements to be met while developing the remainder of the QMS. The ultimate goal of the supplier development process is to achieve 3rd party registration to IATF 16949.  It is important to note that the customer determines the path and steps, so approval must first be obtained before proceeding.  The suggested steps of supplier development referencing 8.4.2.3 are as follows:

  1. Certification to ISO 9001 through 3rd party audits
  2. Certification to ISO 9001 + compliance to MAQMSR through 2nd party audits* (suppliers who did not achieve upgrade transition may consider this)
  3. Certification to ISO 9001 + compliance to IATF 16949 through 2nd party audits*
  4. Then finally certification to IATF 16949 through third party audits

MAQMSR aligns the Automotive QMS Requirements with the corresponding IATF 16949:2016 section(s); however, it is not certifiable or a third party auditable standard, though the guideline may be referenced during a second party audit *(by customer or with a qualified 2nd party like simpleQuE).

SimpleQuE consultants have been assisting companies to understand their options and make the change to drop IATF 16949 and prepare for ISO 9001:2015 certification.  Upon receiving  customer approval to use 2nd party audits to be compliant with MAQMSR, our consultants can provide guidance for that process and perform the audits.  For more information on MAQMSR, contact us.

The Countdown Begins

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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.

IATF 16949:2016 Transition Q & A from IAOB

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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.  IATF 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.