Medical device, equipment and supplies manufacturers have an obligation to ensure that their suppliers, contractors, and consultants meet quality standards and deliver reliably. To do this, medical manufacturers must have purchasing controls in place that comply with FDA standards. In this blog, we will cover the expectations the FDA outlines in 21 CFR 820.50 – Purchasing Controls and how to meet these conditions through Enterprise Resource Planning (ERP).
What are Purchasing Controls?
Purchasing controls are a set of processes that ensure that you only purchase from suppliers, contractors, and consultants who meet your specific requirements and quality standards. Medical manufacturers are held responsible for their products’ quality issues, even when the cause of an issue is subpar work from their suppliers.
FDA Supplier Management Quality System Regulations (QSR) in CFR 21 Part 820.50, in Subpart E – Purchasing Controls
The FDA has outlined its Quality System Regulations (QSR) for medical device manufacturers. There are a few different pieces to Subpart E of CFR 21 Part 820.50, so we will analyze them one at a time.
The beginning of the Subpart reads, “Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.” It is important to note that suppliers, contractors, and consultants for both products and services must comply with the requirements. Don’t forget to include service suppliers in your purchasing control system.
The Purchasing Controls continue in Part A:
(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
This section is all about evaluation. Medical manufacturers must set preestablished requirements and then evaluate a potential supplier, contractor, or consultant on their ability to meet those standards. Some suppliers will be offering items which are essential to the success of your final product, while other components may be less significant. Accordingly, Section 2 describes that you can vary your purchasing controls depending on the product, service, or hired support you are working with.
During the entire process, documentation and maintaining accurate records is critical. An ERP makes it simple to keep track of every aspect of supplier management. Under each supplier, contractor, or consultant, you can see all of their evaluation documentation, whether they are an approved supplier for specific products or services (see our blog on Approved Supplier Lists for more information), order records, and the results of any audits or quality assessments you conduct. With this information at your fingertips, you never need to worry about inspections from the FDA, at least when it comes to purchasing controls. If you want an ERP to simplify your supplier management system, talk to an expert like Datix. Our business-first approach means that we take to time to understand your needs so we can recommend the best possible ERP solution.
Finally, the Purchasing Controls end with Part B:
(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with § 820.40.
Once again, the Purchasing Controls are highlighting the importance of accurate data and consistency. Suppliers, contractors, and consultants must keep their products or services the same or notify you if they change something. If a supplier does change their product/service, you may need to reevaluate them all over again, especially if they contribute a critical component to your final product.
You are also expected to keep perfect order records for each of your suppliers, which is a seamless process with an ERP. As we already mentioned, an ERP tracks order history for each of your suppliers, contractors, and consultants. Without the right system, keeping track of purchasing data can be a nightmare. It can take countless hours to retroactively find information that fell through the cracks. Work with a one-stop shop to gain the best ERP solution for your business. Our experts have 25 years’ experience providing tailored solutions that can include everything from ERP, CRM, integration, hosting, disaster recovery, and more.
FDA requirements can be intimidating, but their expectations emphasize the importance of documentation, tracking, and record keeping. The right ERP can support medical manufacturers with managing all of the important data that they need to maintain compliance and support their businesses.
Read our 10 Tips for Implementing a New ERP
Datix is the ERP consultant of choice for medical manufacturers. Our consultants understand the medical device, equipment and supply industries and dedicate themselves to analyzing each of our clients so that we can develop the best software solutions to maximize their investments to the fullest.