WRWP Makes the Calculated Jump to ISO 9001:2015

WRWP, LLC (Western Reserve Wire Products) has been designing, building and distributing wire harnesses since 1987.  Through the years they have evaluated and implemented more efficient means of production with state of the art equipment and manufacturing plants in China to reduce time and costs for their customers, while maintaining a high standard of quality.

The engineers at WRWP often work with their customers’ engineers in the design phase of new products to produce the best possible fit and function for the wire harness that will be needed, thus reducing unnecessary changes down the road.  And with that approach, in 2015 WRWP searched for a consulting firm that was the best fit and function to review their quality management system and develop a customized implementation plan to achieve ISO 9001:2008.  They selected simpleQuE, and with consulting and training support, achieved their certification.

Due to that success, when it was time to transition to ISO 9001:2015, they again turned to the experts at simpleQuE who utilized a Fast Track approach and developed an action plan while utilizing a detailed gap checklist to identify where WRWP was already compliant and where gaps existed.  Over the next several months with the guidance of simpleQuE consultants, their quality team worked hard to close the gaps while maintaining their quality system and improving internal processes. That preparation resulted in zero findings and certification to the new standard by Smithers Quality Assessments.  Congratulations to the team at WRWP!

Sign Up For Our Newsletter

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.

 

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.

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 IATF 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.

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.

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

The Countdown Begins

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.

Pilgrim Harp is AS9120:2016 and ISO 9001:2015 Certified!

Pilgrim Harp 1

Pilgrim Harp, located in Avon, Ohio, provides the global and domestic sourcing of components and assemblies, handling every aspect of the sourcing process from beginning to end and ensuring the highest quality levels at all times.  Pilgrim Harp and its manufacturing partners all maintain TS, ISO and/or AS certifications.

As a manufacturing outsourcing company for the healthcare/medical, heavy industrial and aerospace industries Pilgrim Harp is a source for a wide range of products.  For aerospace, their aircraft interior products include: airplane seat legs, seat spreaders, seat backs, seat frames, seat arms, seat arm assemblies, seat tray tables, seat tracks and more.  For this customer base, Pilgrim Harp leadership recognized the need for AS9120B certification – which pertains to Quality Management System (QMS) requirements for Aviation, Space and Defense distributors. This standard includes ISO 9001:2015 QMS requirements.

SimpleQuE consultants, Jen Briese and Jim Lee began working with Pilgrim Harp in 2016 to assess where there were gaps between their current system and the new requirements.  They then worked out a customized action plan and timetable to make implementation simple and sustainable.  End result – certification was achieved in June 2017 with no findings from Eagle Certification Group!  Congratulations to the team at Pilgrim Harp!