Do you have a Program for Evaluating your Suppliers?

According to the Code of Federal Regulations (CFR) section 21 CFR 820.50 Purchasing Controls each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements.  Each manufacturer shall establish and maintain data that clearly describes or references the specified requirements, including quality requirements, for purchased or otherwise received products and services.

A company recently received the following observation:

….. Requirements that must be met by suppliers and contractors have not been adequately established.

Specifically, your procedure SOP…, “Supplier Selection and Management Instructions”, does not ensure that suppliers used by your firm are adequately controlled and evaluated. For example,

a.         Your firm does not ensure that all suppliers have a documented evaluation as defined by your procedure, prior to purchase and use in your manufacturing process. For example, your supplier used in your …, does not have a documented evaluation.

b.         Your Supplier procedure does not have a system for the removal of outdated, inactive or noncomplying suppliers.

c.         Supplier audits for last year were not completed for 6 out of 10 supplier files reviewed.

d.         Three (3) out of 10 supplier files reviewed did not have all documentation maintained as required by your procedure.

e.         Your firm’s procedures require that each supplier is evaluated and provided a tier number between … and … Your approved supplier list shows that … suppliers out of  … do not have an assigned tier.

For additional information about purchasing controls, refer to FDA presentation: Purchasing Controls.  You can also refer to FDA’s Dashboards for Firm/Supplier Evaluation Resources.  Here you can find information on a supplier’s inspections, compliance actions, recalls and import alerts.

To view more observations pertaining to purchasing and supplier evaluation, refer to the following GMP Trends® Issues:  1127, 1126, 1124, and 1121.

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