Anyone has the ability to review the FDA database of 483’s, warning letters and FDA statements. Upon reviewing that information, there are essentially eight areas where companies are facing challenges in regards to supplier oversight:
- Confusion between internal and external suppliers – There has always been confusion in determining whether a company’s other site(s) or sister companies are to be treated as an outside supplier. According to the FDA, “the requirements apply to all product and service received outside the finished manufacturer, whether payment occurs or not. Thus, a manufacturer must comply with these provisions when it receives a product or services from its ‘sister facility’ or some other corporate or financial affiliate.”
- Not establishing adequate supplier criteria – Your company must define what requirements need to be met by the supplier, and then determine if your supplier can meet those needs.
- No identified monitoring over time – What has been identified for follow-up evaluations? This can include an updated ISO certificate, having the supplier complete another questionnaire, or on-site audits. Identify what frequency these need to be completed.
- Poor supplier records – Your supplier file should include some combination of contracts, quality agreements, or supplier criteria. Also, it is advised to keep your Approved Supplier List (ASL) current, follow through on any supplier corrective actions, and maintain current revisions of any drawings.
- No traceability or linkages across products – A component needs to be traceable throughout the production process.
- Relying too much on the supplier questionnaire/survey – It is advised to use the questionnaire to gather basic information about the supplier, not to rely on this as the primary evaluation tool.
- Relying strictly on certificates – Using a Certificate of Analysis/Conformance without having an independent verification of the data provided.
- Not taking control of suppliers – Your company must have some level of control and/or evaluation of your suppliers.