Betty is the founder and president of Be Quality Associates, LLC, a consulting firm that helps medical technology companies implement and improve their quality systems to improve their businesses and comply with legislation. Other services include training, audits, vendor management and software validation validation for medical devices. Conversely, a delivery contract explains how the supplier promises to provide all goods or services reported over a period of time and at what cost. It also includes the buyer`s obligations as to when and how the goods are purchased. The delivery agreement helps to facilitate the management of companies working together, eliminates ambiguities and establishes the framework for ordering and delivering goods and services. Distributors should have SAQ agreements because they are directly linked to the customer and the extent of their responsibilities can have an impact on both quality and regulatory. For example, when action on the ground is required, it is important that a trader is cooperative and has the necessary information. In addition, devices that require installation and/or service and are often the responsibility of a distributor can seriously affect the safety and operation of a device. Outsourced processes are again part of the manufacturing process that you do not directly control as a manufacturer. There are often processes that you can`t just check have been done properly. SAQ agreements are one way to keep control of outsourced processes in addition to validating processes that you can use.
As requested in the above guidelines, the risk should be taken into account when deciding on the nature of supplier control. High-risk outsourced processes and high-risk outsourced processes, such as contract sterilization, design and development, are examples of processes that are generally considered key or critical and therefore expect quality agreements. 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. Below is a list of things to include in an SAQ agreement with a supplier, as they apply to the specific task of the supplier. Your supplier contract or any work procedures or instructions associated with it should clearly specify 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.