In 2017, the FDA cited 3,515 observations for 21 CFR 820 and sent 138 warning letter citations for 21 CFR 820.50. That means that somewhere during the process of designing, manufacturing, or packaging a medical device, these organizations failed to follow FDA regulatory guidelines for purchasing controls.
Usually, the failure to comply falls on you, the quality manager. As a quality manager, it’s critical to understand, prepare, and execute the processes and guidelines necessary to adhere to 21 CFR 820.50 standards. When you take a proactive approach to purchase controls, you can easily prevent any potential 21 CFR 820.50 challenges.
7 Steps to Comply with 21 CFR 820.50
To comply with 21 CFR 820.50, you need more than a quality checklist or a few best practices for creating medical devices. From research and development to production, you must employ excellent manufacturing practices.
Here are the seven steps we recommend using to meet 21 CFR 820.50 standards.
1. Document Supplier Evaluation
As a device manufacturer, you must evaluate every supplier you may potentially use. You want to be confident that any supplier, contractor, or quality management consultant you work with follow regulations and best practices.
These evaluations can be interviews, questionnaires, or even site visits, but each supplier evaluation should include:
- The items that you are ordering
- The firm’s type
- The financial relationship you will enter with any potential supplier
You will use these evaluations to assess any potential partners and determine which one can best satisfy the FDA requirements. You also want to document and save the results of each assessment, even if the firm was not selected.
If you do not adequately assess potential partners and document that assessment (if it isn't documented, it didn't happen), the FDA will issue a warning letter detailing your organization's failure to do so.
2. Create Contractual Agreements Regarding Supplier Expectations
Before entering a partnership with a supplier, contractor, or quality management consultant, you want them to sign a detailed contractual agreement. These contracts should outline the responsibilities of your company as well as the supplier, such as:
- The items that you expect to receive
- The expected timeline for supplying the items
- An agreement that outlines the quality management process for items
- Any quality control (QC) steps that must take place
You should also set the expectation within your contract that suppliers update you with any changes to their process or product. Otherwise, there’s a risk of a faulty item. In the case that there is an issue with the medical device, you’ll be protected, as the responsibility of communicating that change was clearly on the supplier.
By adding as much detail as possible and being specific about these expectations, you can minimize the risk of any potential miscommunications or noncompliance issues.
3. Define the Type/Extent of Control & Records
To ensure that you comply with 21 CFR 820.50 standards, the FDA recommends that you define the type and extent of the records you keep of any supplier, contractor, or quality management consultant. You also want to clarify what details and information your team must keep about hospitals or centers that purchase medical devices.
By keeping consistently detailed records, you can easily organize and maintain information about former partners or customers. As a best practice, you should avoid using paper records or documents, as they can be easily damaged or lost. A document control system will support the management of these files, ensuring that they are in compliance with regulations and quality management systems for documentation.
4. Keep Lists of Both Qualified and Disqualified Suppliers
You want to keep track of any qualified and disqualified suppliers that you work with or evaluate. These lists and records can inform future evaluations, and act as a Rolodex of trustworthy suppliers, contractors, or quality management consultants. You also want to keep track of these suppliers, in case you receive a citation from the FDA or there’s a recall on your medical device.
5. Establish and Maintain Purchasing Data
As a device manufacturer, it is your responsibility to contact customers in the case of a product recall or issue. That’s why it’s critical to establish and maintain your purchasing data. This way, you can easily contact affected hospitals or organizations as quickly as possible.
6. Ensure That Staff Are Informed
To ensure compliance, every member of your staff needs to be trained adequately in your quality management processes. You want every team member to understand the systems and tools you're using to ensure compliance, such as a Quality Management System.
When your entire team is properly trained, there are fewer barriers to complying with 21 CFR 820.50. The entire team fully understands the part they play and know what can happen if they don’t follow your guidelines.
7. Ensure That Suppliers Notify Manufacturers About Changes Before Implementation
You need to ensure that any suppliers notify you about product changes before implementation. This way, you can remain abreast of any potential complications that may impact the success of your deployment, inflate costs, or affect ease-of-use for your customers.
Go Beyond Medical Device Compliance
When your team has a clear process, it’s easy to ensure 21 CFR 820.50 compliance. However, it’s even easier when your team becomes quality-driven, rather than compliance-driven. When your team has the tools, processes, and a culture that prioritizes quality, you can enhance your medical devices, get products to market quickly, easily avoid regulatory issues, and, most importantly, improve the lives of the end users.
To learn more about how to work with your team to improve medical device quality, check out our free Improve Medical Device Quality eBook. In this eBook which you can access instantly, you'll learn seven things you can do now to improve quality in medical device product development.