How to Ensure Supplier Quality in Medical Devices

Sparta Systems

Outsourcing is on the rise, with more manufacturers using third parties than ever before. This helps boost the bottom line, but it also introduces certain risks.

Supplier quality management systems can help manufacturers ensure high-quality processes across an increasingly complex supply chain. These systems help address supplier selection and evaluation, nonconformances, risk and product deviations.

It’s up to the manufacturer to maintain quality procedures as it is the one that will be held accountable by the FDA and the consumer if there is an issue with the product. Manufacturers must not only find partners that can provide the materials and components necessary for production; they must also find partners who are trustworthy and pose as little risk as possible to the final product.

Here’s why managing risk, quality, safety, and compliance begins with an effective supplier quality management system.

The Rise of Outsourcing

Medical device companies are becoming more global, sourcing more and more in raw materials and components from countries all over the world. The need to manage the complex supply chain is a crucial component to a company’s business strategy. A major challenge is not the lack of supply, delivery, inventory or critical supply data, but rather the visibility of critical information to perform proactive tasks or to make impactful decisions.

Companies use multiple suppliers that are “out-of-the-four walls” of their own IT environment, so it is imperative to provide near real-time access to a common system so there is no delay when using data to make both minor and major product decisions.

Managing Supply Chain Risk

With many suppliers both in the U.S. and abroad working under different regulatory bodies or requirements, having access to the same set of real-time data can be very challenging. In many cases, recalls are caused by supplier-related issues.  

Considering the cost and resources it takes to remediate, replace, repair and recall a product, it is critical that proactive measures of supplier quality metrics are in place to mitigate as much risk as possible.

Learn How to Improve Supplier Quality

Ultimately, manufacturers will have to keep accurate records of every aspect of its relationships with suppliers, including transactions and communications. It must also implement best practices. These include a comprehensive selection and evaluation process, supplier audits, supplier scorecards and supplier risk files.