Congratulations to the entire Barrett team!

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Congratulations to the entire Barrett team for achieving ISO 9001:2015 certification from global registrar NQA!

Headquartered in Murfreesboro, Tennessee, Barrett Firearms Manufacturing is a world leader in large-caliber rifle design and manufacturing. It was founded in 1982 by Ronnie Barrett, who invented the first shoulder-fired .50 caliber rifle. Continue reading “Congratulations to the entire Barrett team!”

A “simple” Way to Transition to ISO 9001:2015

SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified, so we know what it takes to transition to the new standard. Utilize our expert consultants or gap checklist to guide you through the process.

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The simpleQuE consulting approach applies to companies getting certified for the first time, adding a new standard, or upgrading an existing certification.  For a customized quote and information, call 740-305-0868 or contact us by email.

You’ll Be Surprised At These ISO Certified Organizations

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For some businesses, ISO certification is a legal or contractual requirement. Other organizations choose to become ISO certified to add credibility, or to demonstrate their product or service meets the expectations of their customers. It’s common to see ISO certified businesses in the manufacturing or healthcare sectors, but here are six organizations you’ll be surprised to learn are ISO-certified!

Africam Safari – Mexico
In 2004, Africam Safari became the first ever animal park to gain ISO 9001 certification for the quality of its guided tours. As part of the process, the park compiled a company history and used it to optimize the way the park was run. They’ve since reported optimal use of resources, including time, money and supplies, improved performance, and greater transparency.

City of Dayton, Ohio, Department of Finance
It’s unusual for a government agency to achieve ISO certification, but the City of Dayton’s Department of Finance was awarded ISO 9001 compliance status in 2012. The coveted certification verifies that the department has detailed policies in place, that employees are well-trained in policies and procedures, and that there is an ongoing and successful effort to improve customer service. The Department of Finance worked for several years to achieve certification.

ATG – AllStar Travel Group
ATG is a travel agency that boasts of being “one of a kind” and “best of the best,” and it has the ISO certification to prove it. When ATG was certified in 2009, it became the only ISO-certified travel management company in the United States. For the agency, achieving certification sets them apart from competitors, and tells customers that every policy, procedure, product and service used is done in the most efficient and cost-effective way possible.

Corbus, LLC
Headquartered in Dayton, Ohio, Corbus is a service company offering sourcing and procurement, business process management and information technology services. The company has earned ISO certification for Information Technology (IT) and Supply Chain (SCM). Certification assures Corbus continues to execute consistent and repeatable processes, produce excellent management control and reporting, shows continuous improvement, and hires employees that know what to do and how to get projects done.

Easter Seals Crossroads—Crossroads Industrial Services
Easter Seals Crossroads boasts one of the nation’s most comprehensive rehabilitation programs, with programs and services designed to meet the needs of children and adults with disabilities. Crossroads Industrial Services, a division of Easter Seals Crossroads, is an ISO certified contract manufacturing and assembly solutions company that’s part of AbilityOne, a federal program that creates employment opportunities for people with disabilities. In 2006, Crossroads Industrial Services was awarded ISO 9001:2000 certification, recognizing its commitment to improving performance to exceed customer expectations for quality, cost and delivery.

Four Season Environmental
Four Seasons Environmental, with headquarters in Monroe, Ohio, offers environmental consulting services that help clients save money, increase efficiency and maximize energy savings—in turn, maximizing productivity and return on investment. As of 2009, 11 Four Seasons Environmental sites operate under the umbrella of the ISO registration, including the EPA Environmental Science Laboratory, USDA sites in Athens, Georgia, and Ft. Pierce, Florida, and an IRS site in Covington, Kentucky.

Some of these organizations utilized simpleQuE’s consulting, training and/or auditing services to achieve and maintain their certification.  Other unique organizations who are ISO certified include 1-800-FLOWERS.COM, Inc., the Grand Canyon Railway, Ball Memorial Hospital in Muncie, Indiana, and Death Valley Lodging Company in California.  Every day more and more organizations are joining the ranks as they realize the importance and value of being ISO certified.

ISO/TS 16949:2016 – Shifting into High Gear

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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. 

3 simpleQuE Ways To Transition to ISO 9001:2015

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SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified.  The transition is simple when utilizing our expert consultants or gap checklist to guide you through the process. 

  1. FastTrack your way to success – with our expedited approach to implement the 2015 changes based on lessons we have learned with numerous clients and through historical changes to various standards.    Through the FastTrack program your team will develop and complete a clear roadmap in four months (1 day/month for 4 months) and be ready to upgrade your certification in 5 months.  (The FastTrack model can be customized and accelerated with your implementation team to meet your timelines.)  Click here for more information.
  2. Customized on-site consulting and training – We offer unique quality consulting insights that result in customized solutions. We are known as the consultant that simplifies ISO implementation, transition, training and maintenance, by integrating simple solutions that fit in your company’s culture.  We perform a thorough gap analysis to identify what needs to be implemented or changed.  With our expertise, we help identify where you’re already in compliance and target only those areas that need work. Part of our job with the gap assessment is to educate you on how you already comply with your current systems. The result of the gap analysis is a thorough action plan of each task that needs to be accomplished.  The action plan is laid out against your timing and resources to successfully achieve your upgrade to ISO 9001:2015.
  3. Utilize our ISO 9001:2015 Gap Audit Checklist – Companies that have mature Quality Management Systems and experienced Quality Managers will find this a useful tool to identify the differences between the 2015 standard versus 2008.  The checklist can be shared with your certification body as evidence of internal audits to the new ISO 9001:2015 requirements. The purchase of this gap checklist comes with a free half hour of phone or email consulting.  Purchase checklist.

For more information or to obtain a quote for implementation consulting services or training, please call 740-305-0868 or contact us by email.

How Does ISO 9001 Affect the Bottom Line?

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ISO standards impact businesses, governments and societies worldwide in a powerful and positive manner by providing practical tools for sustainable development.  This sustainability is incorporated economically, environmentally and socially, but many business owners want to know how these standards will affect their bottom line.  Continue reading “How Does ISO 9001 Affect the Bottom Line?”

4 Aspects of a Better Business With ISO 9001

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Successful business leaders know that a good quality management system results in overall efficiency and improvement for the organization.  However, when there is a lack of consistent processes, inefficiency is inevitable.  Without uniformity, audit trails or accountability, it is difficult to identify and fix the gaps in the system, which can result in loss of time and money and not meeting performance objectives. Continue reading “4 Aspects of a Better Business With ISO 9001”

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.

Congratulations G-NAC!

Photo from left: Cannan Christ - Management Rep., Jim Lee – SimpleQuE President, Toshikazu Mitsugi - G-NAC President
Photo from left: Cannan Christ – Management Rep., Jim Lee – SimpleQuE President, Toshikazu Mitsugi – G-NAC President

Congratulations! G-TEKT North America Corp. (G-NAC) achieved its ISO 9001:2015 certification! G-NAC enlisted the services of simpleQuE consultants, Don Milinkovich and Jim Lee to provide Quality System Implementation Support to prepare their office in Dublin, OH for certification, which they received through BSI.

G-NAC provides design and R&D services to automotive OEMS; and sales, new model design services and production equipment for the factories that manufacture automotive vehicle frame, transmission and engine components. What’s next for G-NAC? Over the next two years they’ll be working on ISO/TS 16949 implementation for their new plant with ISO 14001 to follow after that.

G-TEKT has an environmental philosophy that places the highest priority on the conservation of the global and local environments. “As a member of the society responsible for passing on the green Earth to the next generation, it shall strive to both engage in environmentally considerate business activities and help conserve the global environment under the slogan, ‘The Earth is our shared resource’.”

G-TEKT sets a great example for responsible stewardship!