Impact Label – Making a Lasting Impact

Image of Impact Label Corp

Congratulations to Impact Label Corporation for achieving ISO 9001:2015 certification! Impact Label leaves a lasting impact with their custom labels, panels, overlays and tags for industrial and consumer applications. The company has been a West Michigan product identification provider since 1964. Customer driven and quality focused, Impact Label is continually striving for zero defects by encouraging team members to use scientific problem solving methods and empowering them to stop the production process when necessary in order to build quality the first time, ensuring consistent results.

ISO certification was a way to further ensure their quality objectives were met.  Working with simpleQuE consultant, Karen Spencer, who performed a gap analysis of the quality management system, the Impact Label team worked their way through the action plan to be sure they were ready for their certification audit with DQS, Inc.  Good work and congratulations!

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VEGA Americas – Where Quality and Measurement go Hand in Hand

From left:  Ron Foltz, Manufacturing Manager; Bob Herbst, QC Technician; John Kronenberger, COO; Gretchen Lisi, Quality Manager; and Nickie White, RIG Champion.

VEGA Grieshaber KG is a global manufacturer of process instrumentation. Its product portfolio includes sensors for measurement of level, point level, pressure as well as equipment and software for integration into process control systems.  Its subsidiary, VEGA Americas, focuses on the design, manufacturing and servicing (including Radiation Safety Training) of Nuclear Measurement Systems.  The facility also manufactures, tests and services the full range of VEGA Measurement Systems.

Because quality and measurement go hand in hand, VEGA has been ISO 9001 certified since 1997. When the company needed to transition to the new standard, they utilized the expertise of simpleQuE quality consultant, Don Milinkovich, to conduct a gap analysis.  Following an action plan to close any gaps, VEGA Americas achieved ISO 9001:2015 recertification through Eagle Certification Group.   Congratulations to the VEGA team where they know how to Run, Improve and Grow (and even have a designated champion just for that purpose)!

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!

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.

 

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

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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!

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!

Stelfast Maintains Their Quality Tradition – Achieves ISO 9001:2015 Certification

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Stelfast is a family owned and operated company, which began operations in 1972 as a small and progressive manufacturer of industrial gears and screw machine products. Seeing the need in the market for a reliable and quality oriented fastener company, Stelfast incorporated in 1976 and today is a leading importer; stocking master distributor of fasteners and specialty parts from Asia, Europe, and South America; and manufacturer of truck and specialty fasteners. With a knowledgeable and dedicated team of employees, Stelfast has expanded to include an automotive division and ten regional distribution centers across North America.

As evidence of their commitment to quality, the Stelfast Quality Control Department, based in Strongsville, OH, is responsible for all of their branches to ensure conformance to customer requirements. The ISO-9001 certified facility includes a Quality Lab with measurement and testing equipment specifically used for fastener inspection and testing.

When it was time to upgrade to ISO 9001:2015, Stelfast turned to simpleQuE consultant, Jen Briese to provide certification support and guidance for implementation and improvements of the quality management system. This included a full system internal audit, in preparation for their external surveillance audit. The end result – Stelfast is now ISO 9001:2015 certified!

The quality department is also responsible for maintaining all suppliers certifications, which are kept on file for customers to meet dimensional, material and mechanical properties as required by specifications and customer requirements. Stelfast Quality also performs internal audits to assure compliance to their own strict quality guidelines. PPAPs are generated to meet both AIAG and customer specific requirements. At Stelfast, customer satisfaction is priority one and the Quality Control Department helps to assure that this happens. Stelfast President, Simmi Sakhuja says, “We have a catch phrase around here: ‘GET IT DONE.’ We do everything we can to support our suppliers and satisfy our customers.”

 

Quality + Certification = Success!

SimpleQuE congratulates the following companies on their successful certification and commitment to quality.

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SimpleQuE (an ISO 9001:2015 certified company) assists organizations with implementation, improvement or transition of these standards by providing customized consulting, training and internal auditing services and solutions. Contact us for more information.

Powder Processing & Technology Transitions to ISO 9001:2015

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Powder Processing & Technology, LLC  has maintained ISO 9001 certification since 1998 and just transitioned to the latest version – ISO 9001:2015.  PPT’s professionals have assisted the top materials technology companies around the world for over 30 years. The company performs process development and contract manufacturing on a wide range of powders, and has a fully equipped pilot plant as well as multiple production areas specializing in spray drying, calcining and firing

PPT uses the formulas and processing parameters provided by their customers and/or develops the formulations and processing parameters of the products produced for customers.  Therefore precise process control is necessary to meet high quality standards. For that reason in 2012, PPT brought in simpleQuE to conduct its quarterly internal audits.  Kenneth Bartelt, President, said,  “PPT is a small technology company which places significant weight on its quality management system and which needs to ensure its valuable and limited technical resources are focused on customer requirements and our ability to deliver results.”

“We consider the quality system to be part of the fabric of our management system and simpleQuE has added a critical component to that system,” added Ken.  “I think that simpleQuE has a practical approach to quality management that is effective and efficient.”  In the case of PPT, the commitment to maintaining quality standards is evident and practiced from the highest level of management to their plant workers.

SimpleQuE matched PPT to auditor/consultant, Don Milinkovich, whose 34 years in the chemical manufacturing business made him the right fit.  “Don is an experienced and personable consultant who has delivered meaningful audits and provided relevant expertise. Our audits have been at the right level of detail and have made a significant contribution to the business. The performance from simpleQuE has been such that the registrar’s representative and auditor has been very complimentary of the service they have performed,” stated Ken regarding the benefits of working with an experienced auditor.  Don also worked with the PPT team to prepare them for a smooth transition to the new standard.

These internal audits have reinforced the objectives of PPT to maintain high levels of service and customer satisfaction while utilizing the principles of ISO 9001 to incorporate continual improvement into their business practices.

IATF 16949:2016 Transition Q & A from IAOB

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.