We have yet another entry from an EG-GILERO expert in our ongoing series. This time we’re hearing from Wade Stauffer, Plant Manager at our manufacturing facility located in Asheboro, NC. This plant is one of our FDA Registered facilities with Class 7 & 8 Cleanrooms where we have injection molding and highly specialized assembly and finishing services. For this blog, we’ll hear from Wade on how his approach to the manufacturing and assembly of medical and drug delivery devices has driven a tremendous amount of change over the past two years at EG-GILERO.
Quality mindset and patient safety should be the #1 focus in healthcare.
Combining quality and operational excellence with an emphasis on patient safety has been a pivotal focus of my career, and the reason why I was chosen to take on my current role as Plant Manager. It’s a belief that senior leadership of EG-GILERO and I have in common, as we all know it is not enough to only pay attention to the bottom-line. Quality assurance must of course consider the cost side of the business, but patient safety should be seen as the final outcome when manufacturing medical and drug delivery devices.
Six Sigma can work in regulated industries.
Our methodology incorporates the fundamentals of Six Sigma, which isn’t easily applied in highly regulated industries. Mainly because most people trained in Six Sigma don’t have a regulatory background, and aren’t equipped to address queries from regulatory departments when changes are proposed in the process.
Regulatory groups aren’t typically well versed in manufacturing processes that have variable outputs, so we partner with our internal and external regulatory teams to help them better understand why the process variation needed to happen. Then we assist with creating any justification necessary to defend the change, whether it was due to the evolution of the manufacturing equipment used, or how the manufacturing process itself caused variance in each product run. This approach can greatly reduce the amount of work it typically takes regulatory to gain approval on a change, and allows our sampling to be based on true process rather than on standards.
We’re implementing a new way of thinking and working.
It’s important that we implement this problem-solving methodology into the culture completely, so it stays in place even after the initial proponents of it have moved on. The goal is for it to become a way of thinking and working, but first we must define our infrastructure needs, encourage growth in our quality system, and identify the right leaders to carry it out. If these are in place, any plant will run much smoother, and allow your P&L to actually deliver what was forecasted, while creating a high-quality product for customers.
Our thanks go to Wade for contributing to EG-GILERO says…A different perspective, and how his unique approach to the manufacturing and assembly of medical device and drug delivery devices is forging new paths in our industry. We welcome all comments and questions, and be sure to follow our blog or check out our Twitter feed to stay up to speed on what we have coming up next.