See the 21CFR 820.20(b)(1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
What does this mean? The QS regulation also requires that each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the GMP requirements.
Now if you look at the discussion of the regulation, Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation, Federal Register: October 7, 1996 (Volume 61, Number 195), Page 52601-52662, specifically discussion #47, However, FDA has retained the broad requirement that the necessary independence and authority be provided as appropriate to every function affecting
quality. FDA emphasizes that it is crucial to the success of the quality system for the manufacturer to ensure that responsibility, authority, and organizational freedom (or independence) is provided to those who initiate action to prevent nonconformities, identify and document quality problems, initiate, recommend, provide, and verify solutions to quality problems, and direct or control further processing, delivery, or installation of nonconforming product. Organizational freedom or independence does not necessarily require a stand-alone group, but responsibility, authority, and independence should be sufficient to attain the assigned quality objectives with the desired efficiency.
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Claudia Jackson
Milwaukee WI
United States
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