Taking Quality To The Next Level

Quality Assurance has always been second to none at Empirical Testing Corp.  ISO/IEC 17025:2005 accredited by The American Association for Laboratory Accreditation (A2LA) since 2002, ETC has been continually developing our scope of accreditation while instituting lean practices.  Now Empirical Testing Corp. is furthering our commitment to our customer's success by creating a department whose sole focus will be quality assurance.

Catherine Lehman has been a test engineer with Empirical Testing Corp. for more than seven years.  While also acting as the Deputy Quality Manager, since 2008, she has played an integral party in the creation and maintenance of various quality control systems.  "Quality has always been at the top of ETC's priority list.  Our quality system is forever evolving and it was concluded that the next logical step was to create a separate department whose entire focus would be on quality." states Ms. Lehman.  Her new position as Quality Manager will shift Ms. Lehman's concentration from job ownership on the lab floor to an exclusive responsibility toward quality.  The addition of this new position will ultimately allow for greater efficiency throughout a job's life cycle.  "ETC understands the link between quality and efficiency as well as the strict deadlines our customers are up against." notes Lehman, "For our customers, this change will mean faster turnaround while eliminating possible opportunities for errors." 

Ms. Lehman's new duties will encompass all aspects of a successful quality assurance system including the performance of laboratory observations in order to proactively uncover ways to improve overall quality and efficiency, weekly 5S audits for lean systems maintenance and quality audits several times a month.  "The ultimate goal of these tasks is to focus on preventative actions; however, if an opportunity is identified, we direct our attention to solving the ultimate root cause and determining sustainable corrective actions." explains Lehman.  "For this reason ETC goes an additional step by further evaluating all corrective and preventative actions put into place in order to establish their effectiveness.  We feel it is important to work toward a solution that makes sense and has purpose rather than just finding a quick fix." 

ETC recognizes that the long term solution to improving quality is the sustainability of the processes we put into place; because of this, management has proactively adopted a stance toward open communication between team members.  Daily "stand-up" meetings to review the day's activities have proven beneficial in promoting an open dialogue while ensuring all employees feel comfortable voicing their ideas and suggestions for ways to improve upon processes and procedures.  Aristotle quoted, "Quality is not an act, it is a habit"; at Empirical Testing Corp. quality is a habit that we cultivate.

Visit our website at www.empiricaltesting.com/quality to view our A2LA ISO/IEC 17025:2005 Scope of Accreditation and experience our commitment to quality or feel free to contact us directly at (719) 264-9937.

Start-up, SpineFrontier, Benefits from ETC's Outstanding Customer Service

With the goal of developing innovative medical devices for spine surgery, SpineFrontier Chief Innovations Officer, Chris Chang, began shopping for a test lab to ensure that the devices will meet FDA standards. After meetings at several facilities, Chang realized that given SpineFrontier’s focus on only developing distinctly innovative devices conceived by spine surgeons, his organization needed more than a process-driven testing house that takes specs from its client, tests its device, and then mails a report. So, based on the recommendations of industry colleagues, he contacted ETC President and CEO, Dawn Lissy.

“Interacting with Dawn was a big solidifying factor for me,” says Chang. SpineFrontier had a vision and an end goal, but, Chang says, We didn’t know what kinds of fixtures were needed and we weren’t sure what testing was available to achieve high quality and objective results. Dawn walked SpineFrontier through all of it “from Instron machines to test set ups and now we are up to speed with the best in the business.”

That type of support was key in Chang’s decision to work with ETC. “Partnership is the main quality startups are looking for,” says Chang. Since then, SpineFrontier has valued ETC’s input when developing protocols, while keeping abreast of FDA regulatory and ASTM standard changes, and during SpineFrontier team meetings when making important decisions. “Our relationship with ETC is deep in trust and mutual respect so much so that it is a competitive advantage,” Chang adds.

ETC Adds Value that Permits Growth

The benefits of working with ETC have allowed SpineFrontier to quickly grow beyond a single–device company.

“Like SpineFrontier, ETC is agile and nimble and adjusts well to the fickle nature of a startup,” says Chang. “ETC is willing to grow with us, not just get us through the phase. ETC is acquiring more equipment to handle more of our projects and continues to keep running a quality system.”

“We wouldn’t be as efficient at meeting our goals for FDA submissions without Empirical Testing Corp. (ETC),” adds SpineFrontier Innovations Manager, Todd Saunders. “ETC helps us to establish what testing we’ll do. And, ETC allows us to get the most value out of our dollars spent. We make informed decisions quickly and ETC helps us to do so.”

Partnering throughout the Product Development Cycle

The ETC business model is based on a foundation of outstanding customer service, bio–medical knowledge, and the highest quality testing. Each one is delivered through a stream of continuous communications throughout the product development cycle.

According to Saunders, ETC contributions include sharing insights into how one might develop test protocols during the concept phase, how to ensure that a device meets performance goals during the development phase, and, all the while, ETC keeps SpineFrontier abreast of FDA regulatory changes and the latest ASTM standards. Then, adds Saunders, “we are asked what we want to do with the information.”

When SpineFrontier was preparing to go into production, ETC assisted SpineFrontier with design verification and validation of processes to ensure that all of SpineFrontier’s products were of the highest quality.

“Dawn and ETC have helped us to grow our knowledge,” says Saunders. “By going through the process and testing requirements, we have developed a protocol and an understanding of what processes need to run. Now we see how the feedback from Dawn, and FDA regulations, lead to successful 510k submissions. As a result of ETC’s partnership, we are becoming more and more efficient at getting a device from concept to FDA clearance quickly.”