Many FDA-regulated manufacturers falsely assume that by outsourcing duties to suppliers, these third parties take on the responsibility of maintaining regulatory compliance. This is a fundamental misunderstanding of the expectations in 21 CFR Part 820 for medical device companies and the FDA’s Q10 Pharmaceutical Quality System guidance for the pharmaceutical industry. Although a viable supplier business model demands high-quality products and services, the regulatory burden ultimately rests on the company receiving its products or services. Monitoring and managing quality is critical when outsourcing anything that could impact the product. This includes both the typical outsourced services like component suppliers and contract manufacturers, as well as consulting services, more generally. One of the first steps in developing a robust supplier management program is to determine the risk of your suppliers. Determining the risk often involves an educated guess based on product concepts, design inputs, and expected attributes.

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