A supplier agreement focuses more on liability and logistics issues, including the following: Remember that the two agreements serve very different purposes; Having an agreement doesn`t mean you don`t need the other. While it`s important to provide long-term care and maintain the current configuration of a component critical to the design of your medical device, the process may need to become a little more complex. Typical components that can be subject to controls are those that come exclusively from practice or are essential to the performance or safety of your medical device. A supplier quality agreement or supply contract may be required. Additional FDA controls: In addition to design controls, you should also describe the labeling, production, process, and packaging controls that your device must follow. Just like with design controls, you need to clarify in your agreement the steps your contract manufacturer must take to comply with the regulations. Tool and tool property: All designs are probably yours, so make sure the agreement says so. Specifying the ownership of the tool and tool ensures that the contractor returns what belongs to you when the job is completed. This section should also specify who will bear the cost if a part breaks during manufacturing. However, the FDA sets out many requirements in its quality system regulation that a quality agreement must cover. Even if the FDA doesn`t explicitly require a quality agreement, creating one can still help them meet other requirements. Quality Management Requirements: Define whether the supplier should apply a quality management system (QMS). You must provide details on how to manage the appropriate processes within the QMS and assign responsibility for the tasks to be performed by members of your organization.
For example, you need someone to take care of updating a supplier relationship movement within the QMS. Plus, it`s a good idea to invite them to your quality management platform if you`re already using one. Quality agreements can vary from company to company, but each agreement must cover several critical areas depending on logistics and FDA requirements: Quality assurance (QA) agreements for suppliers can play a critical role in helping companies not only prove to regulators that they are properly controlling their suppliers, but also to show that they are informed and aware of what their suppliers are doing. Manufacturers of all types of medical devices are responsible for the product they manufacture and sell. However, more and more companies are outsourcing all or part of their production or other processes. Regulators and certification authorities therefore expect companies that sell the product to have sufficient knowledge and control over their suppliers to ensure that the products are safe and meet the claims made to them. This article explains why supplier agreements are desirable and sometimes even necessary, which suppliers should have quality agreements with suppliers and what should be included in these agreements. Acme Monaco is a manufacturer of custom guide wires and medical yarn molds. The company also manufactures springs, orthodontic fittings, stamped parts and non-sterile medical assemblies. All parts are manufactured to customer specifications and sold to original equipment manufacturers (OEMs) and distributors without the products being sold directly to end users such as doctors or hospitals, says lucas Karabin, executive vice president. Companies often have written agreements with their major suppliers, but these are often supply agreements that focus on financial and legal agreements between the two. It is preferable to separate quality or quality assurance (QA) agreements from agreements with suppliers, although they are usually incorporated by reference into the main supply contract.
Supplier and quality agreements should be kept at least somewhat separate, as supplier agreements often require legal review and approval from a business manager and can last for many years of the relationship between the manufacturer and the supplier. On the other hand, quality agreements, such as annexes such as annual prices and quantities, must be flexible, based on day-to-day operations and easily modifiable if necessary without legal control. See Figure 2 for key points of supplier agreements and quality assurance. Workplace: The agreement should dictate where the supplier will perform the work, and multiple locations should be named if there is more than one construction site. Many companies also require notification in case the supplier relocates its operations. A quality agreement focuses solely on the FDA`s current Good Manufacturing Practices (GMPCs), which describe the following: Quality agreements and supplier agreements are essential to the marketing and maintenance of a medical device. In this context, the two define different requirements in the relationship between the manufacturer and the supplier. Learn how Greenlight Guru can help you achieve your goals, stay organized, and build a strong relationship with your suppliers. Nomenclature and cost negotiations: It is best to determine material costs, shipping and delivery windows, etc. before you start.
Formulate everything in your supplier agreement to ensure that there are no unpleasant surprises when production starts. A quality agreement ensures that you and your material supplier or contracted manufacturer are on the same page by laying the foundation for quality and communication standards. It plays a crucial role in avoiding fines, which can amount to tens of millions of dollars for some medical device companies, and in providing the best possible product. In the future, Karabin says Acme Monaco will work with detailed supplier agreements where nothing is left to chance. “We will have clear agreements with customers for design control and corrective action,” he says. Work closely with your subcontractor or supplier to ensure that the agreement is satisfactory. Several drafts on round-trip communication are likely. What types of changes the supplier can make without contacting you: In the case of a material supplier, these types of changes may involve the replacement of materials or dimensions of the material supplied. For a contract manufacturer, changes may result in adhesives or storage conditions. Your supplier agreement or any related procedure or work instruction must clearly indicate which suppliers must have quality assurance agreements and which ones must be taken into account for these agreements. The procedure should also determine the content of quality assurance agreements and who is responsible for creating, approving and amending such agreements. At a minimum, quality and related services (usually operations or manufacturing) should approve these agreements.
The number of approvers should be kept as low as possible so that agreements can remain flexible enough to be kept up to date according to experience and events. Although your process should define the areas that should be covered by a quality assurance agreement with a supplier, quality assurance agreements should always be developed jointly between you and the supplier. Neither side should take anything for granted. These agreements are a working tool to help you and the supplier understand your roles and responsibilities and promote good communication between the two of you. The manufacturer must agree with the supplier on individual responsibilities and services. While you, the manufacturer, are ultimately responsible for the medical device, the supplier also has certain obligations. Chances are you`re not making your own medical device – custom medical device manufacturing is growing at a compound annual growth rate of around 11%. Even if you make the device yourself, you probably use a material supplier. What are some of the aspects that a supplier agreement can clarify? “These may include: How do you define the relationship? What does the agreement cover? What are the concerns it can help address? Will the obligations set out in the contract be fulfilled? Scott enumerates.
This 90-minute training will help you understand fda QSR requirements, good business practices, and the role of a supplier quality agreement. This webinar will help you create an effective and FDA-compliant supplier management system. Effective supplier management can help prevent problems and reduce their impact if they occur. With the increased focus on supplier management, you can expect strong coverage of this area during an FDA inspection. The FDA`s Quality System Regulation (QSR) explains how a device manufacturer should manage its suppliers. This ranges from supplier evaluation to selection and control methods. A common approach uses a supplier quality agreement. Terms and Conditions: Use this section to determine working hours and any termination clauses and to determine who should be contacted regarding anything outside of CAPA and the quality issues described in the quality agreement.
The success of your medical device is based on a successful partnership with your subcontractors. But how can you achieve this? “According to the FDA, a device manufacturer is responsible for the quality of every component of their device, and at a time when each device contains many critical components, this can be a major challenge. Partnering with your supplier can be difficult if something goes wrong. Agreements with suppliers play an important role here. Clearly defined supplier agreements are one way to make sure things are going well from the FDA`s perspective,” Scott says. .