SEC 820.50 PURCHASING CONTROLS

Some of the key requirements in purchasing controls are always have procedures to evaluate and select potential suppliers, contractors and consultants. Sponsor are advised to have an ‘Approved Supplier List’ where the detail of each sponsor evaluation. How and when it is being evaluated. What is the outcome of each evaluation? Qualified auditor should physically go to the site to audit thoroughly the whole site and should also re-audit per schedule. Update the Approved Supplier List regularly. Should any supplier disqualified, inform all purchasing department of the sponsor’s status.

Another key issue is that sponsor must sign a quality agreement with the supplier so that part/parts must be made accordingly to sponsor specification.

Sponsor must have a supplier evaluation form to ‘evaluate’ each supplier. Example of items in the form are: Name, Contact Information, Supplier Quality Certification like ISO 13485, Job/Part Description, Initiation Date, on-time delivery, evaluation results etc.

The following are the exact working I copy from FDA website (1).

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.
(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.

1.     –CFR-Code of Federal Regulation Title 21 part 820 Quality System Regulation,  www.fda.gov, page last updated 06/01/2013.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.