A Declaration of Independence

Quality personnel must have top management’s backing to keep defective medical devices from reaching the market. Richard Nass, Director of Content, Medical Devices Media Group, UBM Canon

In 2004, the FDA sent a warning letter to the Satalec Action Group regarding the company’s failure to give quality-assurance employees the “independence and authority” to do their work as required by federal regulations. The letter cited 21 CFR 820.20(b)(1) and noted, for example, that Satalec’s QA personnel were not given responsibility “for inspection/testing of materials, components, in-process units, or finished devices.” 

In 2007, a plant manager for Rockwell Medical overruled the facility’s QA manager and released a product that did not meet Rockwell’s own quality standards. The result of this encounter comes out in the Establishment Report (EIR), where the FDA stated, "Employees who manage, perform, and assess the work affecting quality have not been assigned the appropriate authority and responsibility to accomplish their work."

These two examples clearly show that the FDA will hold medical device manufacturers responsible for following regulations related to quality assurance and regulatory compliance. The key to that mandate is the need for QA personnel to possess the “independence and authority” that will enable them to monitor the manufacturing process and, if needed, stop products from going out the door.

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