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)

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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.

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!

Quality Management Dos and Don’ts – Don’t be guilty of being in the red

Business Man. Business man put idea on board. Business man use pen for create business planning. Business accessory background. Business strategy. Business working. Business people concept. Business man over sunny. Business plan background

1. Meet Customer Requirements

Surprisingly there are companies that want ISO 9001 certification just to satisfy one customer requirement. The customer states that it will only do business with vendors that are certified as ISO 9001 – so to get (or keep) the business they need that certification. The problem with these companies is that they’re looking for a short-term payoff and an end to the journey with a certificate. They see nothing but that one benefit — we need a certificate for this customer — and ignore the long-term benefits a robust quality management system will provide, like:

  • Less firefighting;
  • Fewer repeat problems when you perform better root cause analysis and systemic corrective actions;
  • Increased performance because you’re monitoring trends against goals;
  • More efficient and effective business processes;
  • Less scrap, rework, rejects, warranty; and
  • Increase customer satisfaction leading to more business opportunities.

Some organizations don’t embrace the concept of quality linked with the business systems and tied into the strategic direction of the company, to drive continual improvement and continued customer satisfaction. In other words, they haven’t bought into the program or the true intent of the standard.  Focusing only on that one benefit — your immediate gain — without putting the customer in front will end up costing you much more in the long run.

2. Increase Revenue and Business from New Customers

Once you earn your ISO 9001 certification, you can advertise your quality certification and respond to Requests for Quotes (RFQ) from companies that make ISO 9001 certification a “must-have”.  ISO 9001 certification can open up new markets you were virtually unable to do business with before your certification.

Yet, companies are not advertising their ISO certification enough, costing them potential business. Transition or implementation of a new standard is the perfect time to share that the company has achieved this important recognition with your potential customers, current customers, and stakeholders. Consider a link to a copy of your ISO certificate right on your website.

3. Improve Company and Product Quality

quality management system standard is all about quality so, of course, one result of adopting a QMS should be an improved level of quality for the entire organization — every process, and every product. Organizations should use the ISO series of standards to develop a QMS that is integrated into the way they do business, and assist in achieving their strategic business objectives – adding value.

Unfortunately, some organizations may have missed the mark and created a bureaucratic set of procedures and records that don’t reflect the reality of the way the organization actually works and simply add unnecessary costs, without adding value. When the business system is the same as the quality system processes, the value of ISO and certification become more logical and value-added for the business.

4. Describe, Understand, and Communicate Your Company Processes

The ISO 9001 QMS standard requires that you identify and describe your processes using business metrics, the purpose of which is to better manage and control your business processes. Quality objectives or your business process goals form the center of your system. Metrics are used to understand and communicate your system’s performance and trends relative to your quality objectives. The level of monitoring, measurement and improvement of each process will depend on the organization’s context, strategic intent and determined risks and opportunities.

Companies may identify too many processes. So it is important to understand the differences between a process, a procedure and an activity. We recommend less than 10 core processes, and fewer is commonly better.  Looking at your business from a 50,000 foot view to understand the high level business processes needed to deliver the products or services you provide your customers are the core processes ISO wants you to define.  Everything from sales, to new product development, to production planning, to production or providing a service, and finally delivery are the processes to identify for your business.  A flow diagram is most commonly used with the linkages and interactions between each.  Each of these core processes needs to have at least one objective that is measured to evaluate the effectiveness and efficiency of that process. Problems can also occur when companies don’t have set metrics on which to evaluate processes and manage the control of their business processes.

The International Organization for Standardization (ISO) has created a useful whitepaper to explain the Process ApproachContact simpleQuE to see how our consultants can assist your company with these problems or other areas of concern.

 

 

 

IATF Transition Update from IAOB

Cherie Reiche of the International Automotive Oversight Board (IAOB) shared the following IATF 16949 transition update at several registrar conferences.  As of April 30th 2017:

  • 68,332 sites are ISO/TS 16949 or IATF 16949 certified worldwide
  • 181 audits were completed to IATF 16949 (0.3% upgraded)
    • To date the total NCs issued = 975 (avg 5.4 findings per audit)
      • Major NCs = 133 (16% of the findings are major)
      • Minor NCs = 842

A summary of the highest incidence of NCs (major/minor) by section is represented in the chart below.  It’s interesting to note that Customer Specific Requirements and Quality Management System Audit had the largest number of major NCs, while most minor NCs were written on Contingency and Control Plans.

2017-08-15-2

The Benefits of Working with a Management System Consultancy

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Ultimately companies hire a management consultancy firm like simpleQuE to save both time and money. Working with experienced professionals can help businesses achieve their objectives quickly and avoid costly mistakes along the way. And thanks to their specialized knowledge, quality and environmental management consultants can help innovate, improve and enhance organizations at every level.

Businesses of all sizes seeking to outperform their competitors and stay at the top of their industry are increasingly choosing to work with QMS and EMS consultants. When selecting a consultancy, they’re looking for someone who can provide tangible results and a clear return on investment. The best consultant-client relationships are based on clarity and transparency, where both parties have set clear roles and expectations and put in place a system to effectively measure results.

Management consultants help organizations improve their business by analyzing their systems and processes and developing plans to help them improve. Whether it’s preparing for first time certification, upgrading to a new standard, simplifying cumbersome quality systems and documentation, or defining processes and process mapping, simpleQuE can help.

Each management consultancy offers different specializations and simpleQuE’s consultants are proven experts in their respective fields. We bring experience from all sides of the table—third party auditor, business owner, management representative, implementer, facilitator, project manager, etc.—in areas including general manufacturing and service, automotive, aerospace, environmental and safety.

After performing a gap analysis, we offer customized solutions for each client we work with. Our strength is in evaluating and understanding your business and culture to find the solutions that will be most efficient and sustainable over time. We’re known as the consultant that simplifies ISO implementation and maintenance.  And simpleQuE is even ISO 9001:2015 certified – proof that we practice what we preach.

No company is exactly the same, and every company’s needs for certification are unique as well. At simpleQuE, we tailor our approach closely to your specific needs and deliver exactly the consulting, auditing and training services your company requires. Our approach eliminates confusion and ensures your company is investing only in the work that is required for certification. Contact us to see how we can add value to your business!