Quality in medical device manufacturing
Medical devices have the potential to greatly impact patients’ lives, which is a truth the medical device manufacturing industry keeps in mind at all times.
Quality control is a large part of all manufacturing industries, but it is of the utmost importance for medical professionals. Because of this, there are several different measures in place to proactively and reactively ensure products meet specifications and are safe and effective for the end user.
One of the most essential parts of medical device manufacturing is the cleanroom. These rooms are enclosed areas that have stringent cleanliness standards and low particulate counts. Products produced in these spaces are safe for surgeries.
These rooms also are where assembly and manufacturing take place. At our operation, our production manager is present in the cleanroom during production. They are constantly reviewing and improving processes to mitigate risk and improve quality. They provide immediate feedback to the production teams to ensure the training they received is effective.
There are other industry-wide practices that ensure medical devices are clean, safe and effective. One of these is called CAPA, which stands for Corrective Action and Preventative Action.
When a CAPA is initiated, it’s because there’s been a situation or indicator that has been brought to the team’s attention that requires further action. Leading and lagging indicators help to identify potential risks. In this instance, a cross-functional team approach is used to discuss possible root causes and how to address them.
Our team uses situations like this to improve processes quickly and efficiently. In fact, we have systems in place to ensure that CAPAs aren’t open for more than nine months. This enables us to prioritize high risk issues quickly as the team works on a resolution.
Once we identify a root cause, the team brainstorms actions to permanently correct the issue. Then we monitor actions for an extended period of time to ensure the problem that was identified was actually corrected.
In the medical device industry, the focus is placed on the patient. Because of that, it’s easy to know when something isn’t performing to the standards health care providers expect. When that happens, the end user files a customer complaint.
We measure these complaints by utilizing a complaint percentage. This is the number of complaints on devices over the number of products shipped. The typical industry average is between 3-5%. Our customer complaint percentage for 2019 is 0.014% and is 0.035% since the company formed. This can be attributed to a team-oriented effort on complaint reduction. All decision-makers are under one roof, which allows us to make decisions and adjustments quickly and effectively.
Our industry is highly influential and has an impact on many lives. Medical devices encompass everything from bandages to the tools used during cardiovascular surgery. Since they’re so widely used, it’s important to keep them highly regulated, clean and effective.
For many industries, quality might seem like a buzzword, but it’s our main focus in the medical device industry. After all, in the end, high-quality devices can help patients live happier and healthier lives.