Supplier Quality Agreement
You also need to be sure that your agreement determines exactly what comes with the materials they deliver, in what degree of purity, to what extent and within what delivery time. The first step is to understand the unique differences in each document and then recognize how together they form a foundation for all aspects of a business relationship with a supplier. What kind of process validation do you need? Do you need in-process information or just a certificate of analysis for the final product they provide? It is important that you tell what should be included in the certificate of analysis to prove the identity, quality and purity of the product. I recommend launching a supplier quality agreement from the beginning of development. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you educate your suppliers at an early stage and work productively with them at this stage, surprises will be avoided later in the development cycle – if it`s too late to change a key component or supplier. It is important that you define all the terms used in the supplier`s quality agreements to avoid further confusion. This includes a clearly defined perimeter that ensures that both parties are aware of what is contained. Your supplier contract or a procedure or work instruction should clearly state which suppliers must have QA agreements and which ones should be considered for these agreements. The procedure should also indicate the content of the SAQ`s agreements and who is responsible for developing, approving and amending these agreements. At a least, quality services and related divisions (usually operations or manufacturing) should approve these agreements. The number of rights holders should be kept to a minimum so that agreements can be kept flexible enough to be kept up to date, as required by experiences and events. Although your procedure is supposed to describe the areas that should be covered by an SAQ agreement with a supplier, QS 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, end up being responsible for the medical device, the supplier also has certain obligations. In order to achieve these benefits while minimizing risk, many companies are turning to supplier quality agreements to ensure compliance with internal and regulatory standards. Conversely, a delivery contract describes how the supplier promises to deliver all the goods or services indicated over a specified period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased. The supply agreement facilitates the management of cooperation between companies, removes ambiguities and provides the framework for how goods and services are ordered and delivered. Your order supplier or manufacturer is your partner, so you want to let them know in advance what it takes to succeed and win your future business. The FDA in 21 CFR 820.50 requires companies to control all of their suppliers, including suppliers of materials, services, consultants, and subcontractors, whether they may impact product quality or the quality system.
. . .