21 CFR 820 - 820.50 purchasing controls

Original text

Expert opinion

Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

(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.

Purchasing controls demand for ALL received products or services conformance to specifications. Thus, for any service or product received, which in the context of the QSR has an impact on the product, specifications must be established prior receiving the service or product. These specifications must be created based on written procedures which assure at least that suppliers, contractors and consultants (together suppliers) are evaluated based on pre-set quality and other requirements.

Therefore, suppliers need to be formally, i.e. documented, evaluated and selected based on pre-defined requirements. Requirements, especially when it comes to services, might be tricky to create and document.

The type and extend, or rigour, of control per product, service and/or supplier should reflect the documented evaluation of the selected product, service and/or supplier. This, in fact, leads to a risk-based evaluation and a control strategy of the purchased product, service or supplier.

The supplier evaluation reports should be stored and updated in cases of change.

(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.

Manufacturers of medical devices should have documented records on the requirements per product, service and/or supplier.

These documents, refered to as purchasing documents, should include in addition and if applicable, written agreements of notification in cases of changes. The suppliers potentially changing a parameter on the delivered service or good might affect the quality of the manufactured medical device. These quality impacting changes need to be assessed beforehand by the manufacturer and approved in accordance with the document controls stated in 21 CFR 820.40

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