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Supplier Quality Agreements Are Not Just a Handshake Anymore

FDA is not only focusing on U.S. manufacturers and suppliers, but also overseas suppliers. With more inspectors on board, the agency plans to perform overseas inspections on a timely basis. In the recent past, this has not been FDA’s strength. With the advent of our so-called global economy, the issues with foreign suppliers have escalated in geometric proportions that, in many cases, are not well defined. Again, the best way to make sure that you and your critical suppliers show equilibration between risk, cost, quality and regulatory compliance is to develop, issue and co-sign a reasonable and equitable quality agreement to establish process and product deliverables, co-responsibilities and, of course, defined liability. Suppliers must be aligned with your manufacturing and design controls operations as if all concerned were part of the same quality management system (QMS) living under the same roof.

The design and implementation of your company’s QMS is a strategic decision based on the regulatory, quality and monetary needs of your company, the size of your organizational structure, the processes employed and the medical devices provided to your customers. If your company does not perform certain processes (e.g. design and development, sterilization, manufacturing of components, production of raw materials, etc.), i.e. chooses to outsource critical processes related to the design and/or manufacture of medical devices, these suppliers, servicers and supplied processes must be controlled within your quality management system. Your company has the responsibility to make this happen, and FDA does not. Component and raw material manufacturers do not have a regulatory obligation to adhere to the current Good Manufacturing Practices. You will have to define the extent of this type of control in the SQA.

Risk Management

When developing and writing an SQA, your company should identify high-risk component and service suppliers through a documented risk management process, such as the use of design and process failure mode effects analysis. Other more efficient methods can also be used, such as component category risk grid methodologies that prioritize remediation efforts based upon the degree of customization and effect on function and safety.

Not all supplier categories require a full-blown quality agreement in place to enable a relationship to carry on. Commonly, high risk suppliers (custom components, unique or critical services such as calibration checks, clean-room monitoring, sterilization and contract manufacturers) should have a written agreement in place to assure that ongoing mitigation and improvement are always part of decision-making. Your company should develop a quality plan with an accurate timeline to address high- and moderate-risk components and services with an approach on how to address low-risk suppliers in the long term. You should identify any additional interim incoming supply quality controls needed until corrective action is complete. At the end of the day, your quality and purchasing process owners must balance risk, cost and quality while maintaining regulatory compliance. Sometimes this becomes quite a challenge because, as I indicated previously, this part of the QS Regulation is affected by monetary considerations that your company and the supplier impose upon yourselves. FDA has no jurisdiction or interest when it comes to cost considerations.

What Quality Systems Areas Should be Part of this SQA

Once completed, the SQA should establish clear definitions of supplier and customer responsibilities. Depending upon the risks involved with the product or services your company is procuring, these important topics should be covered by this agreement:

  • Ownership of product specifications, such as the documentation presented in the Design History File and the Device Master Records.
  • Inspection plans for releasing product coming from the supplier to the customer and receiving product by the customer.


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