“With Propel we implemented over ten years of QMS innovation in six months”
Advanced Sterilization Products (ASP) is a medical device company based in Irvine, California. Founded in 1986, ASP is a patient-centric global leader in developing best-in-class innovative sterilization and infection prevention products for the health care industry.
ASP was acquired from Johnson & Johnson in April 2019 by Fortive. The acquisition meant that ASP could no longer use their legacy quality management systems and would need to deploy their own technology solution within one year. This switch would be critical to their success, since “most mergers and acquisitions fail because of poor handling of change management,” according to researchers Kansal and Chandani.
IT Director Brent Lewis noted that when ASP evaluated their full inventory of applications to replace, they identified over 177 different applications that were being used for product lifecycle management, quality management systems and customer satisfaction. Faced with this large challenge, the team used it as an opportunity to create a more integrated solution for quality assurance while leaving behind the legacy systems they had inherited. That's what led them to Propel.
Change is an opportunity for improvement
As Lewis and his team worked to build out a new technology solution, they quickly decided, if possible, to consolidate the more than 177 applications. Their legacy solutions contained multiple systems for risk management, quality assurance, document management, corrective action and preventative action, leading to a lot of redundancy. “Through this transition, we found that over 6 enterprise-level applications could be replaced with a single solution,” Lewis stated.
Though all of their existing systems were “best in class” for the functions they served, the team wanted to distill that functionality into a single solution. Bringing everything together under a single information system wouldn’t just simplify things for ASP’s teams, it would also improve process control, document control and decision making along the entire supply chain.
“We had solutions that were fine-crafted for their specific function, such as specific PLM or training systems,” explained Lewis.
“What we didn’t have was a solution that did them all. We desired a system that did everything we needed from our previous solutions — plus met the high demand for our global business needs for compliance and top quality.”
Integration can simplify the compliance process
As a medical device company, ASP must comply with FDA regulatory requirements in order to protect the safety of their customers and patients. Because of this, it was important that the new solution allowed them to communicate events directly from their systems to the FDA’s web portal. With customer safety involved, customer feedback and complaints needed to be investigated, documented, and reported within the timeframe required by the FDA. Lewis expounded, “We needed a solution that allowed us to end-to-end take that data from our customers, evaluate it swiftly, and get it reported accurately without it being double-keyed from a secondary system.”
Out of the box solutions aren’t always sufficient
It was clear that an “out of the box” solution wouldn’t work for the type of integration the ASP team needed. In the process of assessing their options, Lewis and his team found that most systems offering a great QMS offered little (if any) in the way of PLM. Another issue was that a number of their available options weren’t very adaptable. Implementing those systems would mean they needed to alter their processes to fit the system. Not only was this undesirable, it was also impractical given their time constraints.
In the video below, Lewis discusses the challenges ASP faced. He also details their quest for an efficient solution that would work with their limited time frame.
The search for an elegant and practical solution led Lewis’s team to Propel, a highly configurable quality control solution with a user interface that people actually wanted to use. A key factor in their decision was that Propel could be configured to meet their needs without any customization. Team members could move quickly because they had the tools they needed and didn’t need to adapt any of their quality processes to work with the new system.
ASP opted to use Propel and were able to consolidate all 6 of the QMS applications they’d used under J&J into a single solution that fully integrated PLM and QMS into a single easy-to-deploy solution. “With Propel, we implemented over ten years of QMS innovation in six months,” Lewis noted. That short turnaround time allowed them to build and implement a new technology stack within their one-year action plan.
Learn more about how ASP quickly launched their integrated QMS solution by downloading the case study.