In this post, we consider 7 must-haves for your supplier quality agreements. Cooperation is essential to any successful business partnership, which is why it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization. Processes such as corrective and preventive measures (CAPA) and gap management can lead to dissent, so responsibilities related to investigations and other processes related to the management of quality events should be clearly defined in the agreement. The guidelines also state that quality agreements should be clear with regard to product release. If a separate contract laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly state what data is transmitted and how it is disseminated. It is important that you define all the terms used in your supplier quality agreements to avoid further confusion. This includes a clearly defined scope, which ensures that both parties are clear about what is included. A quality agreement is a comprehensive document that describes both the specific quality parameters of a project and the part responsible for executing those parameters. The degree of detail of a quality agreement will vary depending on the development phase of the project.
Which supplier should have SAQ agreements? It is neither expected nor desirable for all suppliers to have SAQ agreements. However, critical and important suppliers should have all SAQ agreements and all outsourced processes related to the manufacture of your product should be considered for SAQ agreements. See Figure 4 for definitions of critical suppliers. In addition to critical suppliers, major suppliers may be those that come from one hand for a key component or material, even if the component or material does not affect product safety, those with long delivery times, or those that do not have a certified quality management system. Contract manufacturers need saQ agreements because they act on behalf of the manufacturer and perform a large number of transactions that the manufacturer does not directly control. The SAQ agreements are how the manufacturer can have maximum control over the manufacturer without interfering with the actual operation of the contract manufacturer. A quality agreement should include at least the following sections: To assist 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 of the Group of Health Organizations (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. While there may be unexpected hiccups in the order manufacturing process, these should not be a surprise. Set milestones and make paths for regular communication so that all parties can stay informed and stay on track. Make sure you and your supplier have a “no surprises” approach to doing business. In summary, the SAQ agreements are not only the expected control method for high-risk suppliers, but can also ensure clarity and fluidity of procedures for both the manufacturer and the supplier.