Quality Management at Enthermics

Posted by Lauren Burke on

Enthermics prioritizes quality first. In order to achieve the best quality, specific rules and guidelines are set in place and maintained by everyone in the company. This job commitment takes a lot of “problem solving, data analysis, and cross-functional project coordination skills” to maintain quality across every unit, explains Nicole Polley, our Quality Assurance Manager. Nicole has provided Enthermics with her skills for 3 years. She has a Bachelor's degree in Materials Science & Engineering from the University of Illinois Urbana-Champaign along with a Masters in Materials Engineering from the University of Dayton. Recently, Nicole describes her biggest accomplishment within the company as “upgrading our Quality Management System to meet the ISO 13485:2016 standard requirements and to be more effective and efficient with storing our medical device records.”  This accomplishment involves the above skills and time commitment from team members, which leads to success.

On a day-to-day basis, you can observe Nicole working closely with “Engineering, Manufacturing Engineering, and Production to define, evaluate and implement changes that will improve our products and processes.” She explains, “Enthermics has a strong team environment and relies on each other to accomplish goals.”  Enthermics lives up to the famous phrase; “Teamwork makes the dream work.” In order to meet goals, employees possess a mutual understanding. Nicole discusses how “all employees are aware that everyone impacts quality and that delivering products of the highest quality is a central part of our company values.”

Employees can agree quality impacts both the company and the end user, so Nicole “implemented a focus on a timely and effective corrective action process to ensure that when quality issues occur, Enthermics can determine the root cause of the issue and implement a solution to resolve the problem.” Catching quality issues before the units leave the facility gives Production and Manufacturing Engineers the opportunity to avoid future mistakes. The Enthermics team goes through the required steps in order to maintain common goals and core values of producing high quality blanket and fluid warming devices.

Like other products on the market, Enthermics’ units are required to go through a series of multiple inspections that analyze different aspects of the production process. Developing a thorough quality process is imperative, especially when assessing medical equipment. Enthermics’ fluid and blanket warming cabinets go through multiple checkpoints to record any inconsistencies that may arise. Nicole explains how “all units go through a final inspection by a trained Quality Assurance technician that consists of electrical safety testing, thermal performance testing, and visual inspection for cosmetic defects and labeling.”

Nicole emphasizes, "The organization’s overall commitment to quality is extremely important,” which allows Enthermics to achieve a sophisticated approach to patient warming using quality blanket and fluid warming cabinets.

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