The FDA in 21 CFR 820.50 requires companies to control all their suppliers, including suppliers of materials, services, consultants and contractors, if they can have an impact on product quality or quality system. Clause 7.4.1 of ISO 13485 provides that equipment manufacturers have a procedure that contains the following requirements: the supplier agreement or a corresponding procedure or work instruction must clearly state which suppliers must have SAQ agreements and which suppliers should be considered for these agreements. The procedure should also indicate the content of the SQ agreements and specify who is responsible for the development, approval and modification of these agreements. At least quality and related services (usually companies or manufacturing companies) should approve these agreements. The number of admissions should be maintained at a high enough level that agreements are flexible enough to remain up to date, as required by experience and events. While your procedure should define the areas that should be covered by an SAQ agreement with a supplier, the SAQ agreements should always be developed jointly between you and the supplier. None of the parties should take anything for granted. These agreements are a working tool that helps you and the supplier understand your roles and responsibilities and promote good communication between the two of you. The manufacturer should agree with the supplier on individual responsibilities and performance. Although you, the manufacturer, are ultimately responsible for the medical device, the supplier also has certain obligations. To help medical device manufacturers, there were two fairly recent guidelines, one in 2008 from the Global Harmonization Task Force (GHTF) and the other in 2010 by the Body Operations Group (NBOG). Both guides are available for free on the Internet.
See Figure 1 for the names, general information and addresses of the websites of these guides. The GHTF document has been referenced numerous times by the FDA since its release and is now recognized as the “current” practice of supplier controls. This means that the FDA is looking for device manufacturers to follow these instructions, unless they can prove that they have sufficient control over their suppliers without complying with this document. Using MQ to get an overview of supplier processes is essential to minimize risk. It also allows real-time information exchange, but only if vendors interact with your process. I recommend that a supplier quality contract be put in place at the beginning of the development process. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you start educating your suppliers and working productively with them at this point, avoid surprises later in the development cycle – if it may be too late to change a key component or supplier.