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The 7 Major Components of IATF 16949

 

IATF 16949:2016 defines the quality management system requirements for the design and development, production and, when relevant, the assembly, installation and services of automotive-related products including products with embedded software. The focus of this automotive standard 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.
The standard is divided into ten sections – the first three are introductory, with the remaining seven containing the requirements for the Quality Management System. Below is a brief summary of Sections 4-10:

Section 4: Context of the Organization

The organization determines its context in terms of the QMS, including interested parties and their needs and expectations. It also defines the requirements for determining the scope of the QMS, as well as general QMS requirements.

Section 5: Leadership

Top management is required to demonstrate leadership and commitment to the QMS, along with defining corporate responsibility and the quality policy. The top management must also assign process owners along with other roles and responsibilities.

Section 6: Planning

The planning section defines requirements for addressing risks and opportunities and the requirements for risk analysis. This clause also includes requirements for preventive actions, contingency plans, and quality objectives and plans to achieve them.

Section 7: Support

This section covers requirements for supporting processes and resources. It defines requirements for people, infrastructure, work environment, monitoring and measuring resources, organizational knowledge, auditor competence, awareness, communication, and documented information.

Section 8: Operation

The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. IATF 16949 allows for requirements in clause 8.3, regarding design and development of products, to be excluded if they are not applicable to the company.

Section 9: Performance Evaluation

This section includes requirements for monitoring the effectiveness of the QMS – assessing customer satisfaction, internal audits, monitoring and measurement of manufacturing processes, and management review.

Section 10: Improvement

The last section focuses on continual improvement of the QMS, including requirements for nonconformities and corrective actions, problem solving, and error-proofing processes.


These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.

IATF 16949 is a standard that benefits businesses large and small. The experts at simpleQuE can help your business achieve this standard, ensuring your business cost savings and efficiencies.

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The Time Is Now – Preparing for a Successful IATF 16949 Transition

Automotive industry manufacture line with different metal parts

The transition to IATF 16949 has been a rough one according to industry experts.  More than 68,000 organizations certified to ISO/TS 16949:2009 (and 6,382 companies in the US) will need to undergo a transition audit to IATF 16949:2016. As of April 2017, 181 upgrade audits had been completed, resulting in an average of 5.3 nonconformities and approximately one major nonconformity (.73) per audit.

The top five nonconformities overall are “total productive maintenance” (48 nonconformities), “control plan” (38), “contingency plans” (37), “control of production service provision” (26), and “internal auditor competency” (23). Based on automotive industry datathe top-five major nonconformance clauses are customer-specific requirements (7 nonconformities), internal auditor competency (7), quality management system (QMS) audit (7), TPM (6), and management review inputs (6).

For companies that have yet to transition to IATF 16949, you do not want to wait any longer. The deadline for suppliers to transition to the new standard is your next scheduled annual audit.  All audits as of October 2017 have to be to the new IATF standard.   And note that the IATF will not be granting waivers for organizations that can’t meet the transition plan timing.

According to Russ Hopkins, head of supplier technical assistance for Ford Motor Company, “Globally, over 1,200 audits need to take place each week, which averages out to about one per week per auditor,” he said. “This is doable with the proper planning.  It’s doable as long as people do not wait until the last minute.”

This process can seem daunting to suppliers, but Hopkins notes there are several steps to a successful IATF 16949 transition:

  • Confirm dates for the transition audit with your certification body. Upgrade has to occur at your next scheduled audit.
  • Develop a work plan back from the date of the transition audit
  • Review the requirements and provide feedback regarding any concerns (suppliers contact AIAG, certification bodies contact their oversight offices, and OEM through their IATF representative)
  • Allow enough time after the transition audit to address any non-conformances. All findings must be closed in 60 days.

For those with an existing ISO/TS 16949 certificate with one or more nonconformities of the audit to IATF 16949 which are not either 100% resolved or closed within the required timeframe, the transition audit will be considered “failed” and the IATF database will be updated accordingly.  The certification decision shall be negative which means the ISO/TS 16949:2009 certificate is withdrawn and the client has to start over with an initial certification audit. (International Automotive Task Force)

For more information on transitioning to IATF 16949 visit our website.


Silberline

Silberline was founded in 1945 by aluminum industry pioneer Ernest Scheller.  His vision was to create a business that would provide the highest quality products and customized service with unyielding integrity.  Today Silberline continues that vision as a global manufacturer and supplier of high quality special effect and performance pigments that enhance the visual appeal of coatings, paints, inks, plastics and textiles. Still a family owned business, Silberline has over 700 employees world-wide with manufacturing, technical and research centers in Europe, Asia and North America.  Their products are utilized in a variety of markets including automotive, graphic arts and printing inks, plastics, and industrial coatings.

In 2015 Silberline began the search for a consulting firm that could assist them not only with transitioning to ISO 9001:2015 (along with ISO 14001:2015 for 1 site) , but also a company that understood the complexities of international, multisite and corporate certifications. SimpleQuE fit that criteria and assigned 4 consultants and a project manager to work with the quality teams at the headquarters in Tamaqua, PA and 3 other manufacturing sites in PA, IN and Scotland to prepare them for the transition. By September 2017 they had addressed the gaps in their quality systems, implemented new quality management software and were ready for their surveillance audits with BSI Group.  As a result, all 4 sites passed and received their ISO 9001:2015 certifications! In addition, the Scotland site also transitioned to ISO 14001:2015.  Congratulations to the entire Silberline team!

Photo taken at Silberline Global Headquarters – Tamaqua, PA

Front Row: Sheila Setcavage (Quality System Manager), Jennifer Mikovich (Site Manager, Hometown), Lisa Scheller (Chairman), Jan Moos (VP Innovation/New Product Development), Herb Whildin (Manager, Pilot Plant/Process Improvement/Technical Support)

Back Row: Blake Russell (simpleQuE Consultant), Tom Schwarz (Global CFO), Gary Karnish (CEO), Chris Gross (Interim VP Operations), David Stanko (VP Technical Service/Quality Functions)


12 Years At The Toyota Opportunity Exchange

For the last 12 years simpleQuE has attended the Toyota Opportunity Exchange (TOE) to network with Tier I suppliers like Dana Incorporated. Dana has 100+ facilities and 29,000 employees in 34 countries making it one of the world’s most influential automotive suppliers. Through the TOE, a relationship was developed with Dana and in 2013 simpleQuE won the opportunity to perform ISO/TS 16949:2009 internal audits for the Dana site in Auburn Hills, MI. That opportunity has expanded to now include internal audits and/or IATF 16949:2016 transition consulting at five more Dana facilities in PA, IN, TN and KY. SimpleQuE consultants worked with the dedicated Quality team at Dana – Gordonsville, TN which recently successfully transitioned to IATF 16949. The first of our clients to do so!

Providing a forum for suppliers and minority business enterprises to connect is just one of the many ways that Toyota ensures its supplier base continues to reflect the diversity of its customers, partners and team members.



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.


Who Says Quality Isn’t Fun?

VEGA Americas‘ management takes a creative and fun approach to preparing for an ISO audit of their Quality Management System.  They are a global manufacturer of level and pressure instrumentation for the process industry.  VEGA’s COO John Kronenberger plays the character ISONO, who isn’t sure what to do in some audit situations like this one where simpleQuE Consultant, Don Milinkovich plays the role of auditor while Quality Manager, Gretchen Lisi, looks on.  They give suggestions on their intranet on how to be an ISOPRO – a great way to communicate internally and create awareness* among their employees.  Way to go team VEGA!

*ISO9001:2015 Clause 7.3 Awareness
The organization shall ensure that persons doing work under the organization’s control are aware of:   a) the quality policy;   b) relevant quality objectives;  c) their contribution to the effectiveness of the QMS, including the benefits of improved performance;  d) the implications of not conforming with the QMS requirements.


What You Need To Know About ISO 45001

Worldwide over 6300 people die each day from work-related accidents or diseases – nearly 2.3million every year.  ISO is developing a new standard, ISO 45001, Occupational health and safety management systems – Requirements, to provide a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world. ISO 45001 is targeted to be published in the first quarter of 2018 and will replace OHSAS 18001. Current users of OHSAS 18001 will need to update their systems according to the requirements of the new international health and safety standard within a three year transition period that will commence after ISO 45001 is published.

 


Recognizing our Nation’s Manufacturers

Industrial robot with conveyor in manufacture factory,Smart factory industry 4.0 concept.

During National Manufacturing Month, simpleQuE recognizes the important role that manufacturers have in our economy and everyday lives.  We work with a wide range of manufacturing clients who produce components and parts of every kind for a variety of industries. Those products include:  tires, wheels, brake systems, fitness equipment, electronics, motors, batteries, lighting, assemblies, harnesses, springs, air compressors, acoustical insulation, specialty chemicals, coatings, firearms and ammunition, gears, powertrains, meters and pumps, steel and other metals, gauges and valves, compressors, electrical connectors, machines and tooling, rubber molded and extruded parts, plastic molded parts, steel, metal stampings, printing ink, and clay products. (Just to name a few.)

Many are Tier I and Tier II suppliers to the automotive and aerospace industries, and as with all of our clients, they take pride in the design, development and manufacture of their products and recognize the importance of establishing and maintaining a quality management system to provide the highest level of customer satisfaction.

Industries/Market Sectors Served

  • Automotive/Truck/Commercial Vehicles
  • Aerospace, aircraft parts, space, defense
  • Chemical
  • Steel
  • Construction
  • Consumer Products
  • Electronics/Electrical, including semiconductor
  • General Manufacturing (machining, molding, stamping, assembly)
  • Medical
  • Mining
  • Oil and Gas
  • Telecommunications
  • Train/Locomotive

Questions for Auditing Utilizing a Process Approach

Whether facing a surveillance audit from a certification body or preparing for an internal 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)?

8)  Are these methods effective? – refer to outputs

9)  Are the resources adequate? Which are they?

10) Are records available and appropriately maintained?

11) What are the inputs to this process?

12) Are these inputs documented and reviewed by competent persons?

13) Is a description of the processes available and documented?

14) Are these descriptions controlled? – Verify the effectiveness of the organization’s

documented information control procedure.

15) Who are the “customers” (internal and external) of the processes?

What are the requirements of these customers?

17) What are the characteristics of the intended results of the process?

18) What are the characteristics of the unintended results of the process?

19) Are correction and corrective action applied as appropriate?

20) What are the criteria for monitoring, measurement and analysis?

21) How are these criteria incorporated into the planning of the processes?

22) Are the business performance issues taken into proper account?

23) What methods are used for data gathering?

24) What records are kept and how these are maintained?

25) What are the communication channels?

26) How is external and internal information about the process provided?

What are the outputs of the process? – Identify outputs.

28) Do these outputs provide evidence of effective implementation of the process?

29) How is process performance monitored?

30) Are appropriate controls defined?

31) What measurements are applied?

32) How is the gathered information analyzed?

33) How are the results of the analysis taken into account?

34) How is feedback obtained?

35) What data is collected?

36) 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 quality internal auditing possible.

Links to Sample Manufacturing Process Audit Checklists:

IATF 16949 Checklist

AS9100 Checklist

ISO 9001 Checklist