Whether they require materials and electronic components or assembly and molding services, medical device OEMs collaborate with a host of vendors in the course of bringing their products to market. But with a plethora of suppliers from which to choose, how should the manufacturer go about selecting the right one for the right job? To answer this question, Jonathan M. Lewis, principal at Advanced Biomedical Consulting LLC, provides some guidance. Expanding on this theme, Lewis will speak on “Rating and Evaluating Vendors and Suppliers” at MD&M West on Monday, February 10, in Anaheim, CA.
“Supplier performance assessments truly depend on the type of supplier,” Lewis explains. “For example, a compliance consultant clearly relies on different performance metrics than a supplier of such critical components as pacemaker batteries. Regardless, establishing documented performance assessment procedures, forms, and templates for different classes and types of suppliers—in other words, controlled documentation—is critical.” This approach, Lewis adds, is superior to allowing vendor qualification resources to develop supplier evaluations on a per vendor or generic basis.
Developed a few years ago by Advanced Biomedical Consulting is the QUEST approach, a simple and sustainable method for rating and evaluating vendors and suppliers. This approach involves five phases:
- Question phase—what potential vendors need to supply
- Understanding phase—how vendors meet the requirements
- Evaluation phase—determining the best potential vendors
- Site audit phase—on-site and off-site verifications
- Tracking phase—monitoring and requalifying
A focal point of the QUEST approach—one that is often overlooked in supplier assessments—is prequalification by way of documenting formal user requirements prior to researching potential vendors.
“Depending on the type and location of the vendor—in other words, for offsite audits or assessments—the process of qualifying a vendor takes an average of between 50 and 200 hours,” Lewis notes. “Often, outsourcing some aspects of the process to external firms that specialize in vendor qualification can not only save time and money but also help maintain successful vendor relationships.”