Q: I recently attended one of your training sessions on Supplier Quality Management. You recommended we qualify and categorize our vendors by various criteria, including risk. Could you help me further define and differentiate the various levels of suppliers, such as Qualified, Approved, and Preferred? And what are FDA’s expectations?
A: Here are the definitions I usually use — but your company should define these terms according to its own specific needs and procedures:
Qualified Suppliers: Vendors you have qualified for providing services to you, but you haven’t used them yet.
Approved Suppliers: Vendors who been have been qualified, reviewed and approved by your QA professionals, with Purchasing also involved in the approval process.
Preferred Suppliers: Approved vendors you have used previously and prefer to use them again for an additional or new service.
FDA would consider a Qualified Supplier to be approvable if the vendor meets all of your quality requirements. But from a business point of view, there are other factors your company may want to consider, such as:
– How long has the vendor been in business?
– Is it financially stable?
– Can it deliver on time?
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]You should always include QA, Purchasing, and Management in the decision to add a vendor to your list of Approved Suppliers.[/pullquote]
You should always include QA, Purchasing, and Management in the decision to add a vendor to your list of Approved Suppliers.
I also have seen a Preferred Supplier defined as a specific vendor the design team wants to use, based on the product’s design and the designers’ work with the vendor during the design process. I believe, however, it’s important that — before you even consider involving a vendor in the design process — you make sure it’s on your company’s list of Approved Suppliers.
Answered by Jan Olson, EduQuest VP of Regulatory and Quality Services (22 years as an FDA investigator and office director) and lead instructor of EduQuest’s 1.5-training class on Managing and Auditing Supplier Quality.