We’ve heard of the recent Food and Drug Administration (FDA) decisions to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area.

Although there are 26 references to the role of executive management within the Quality System Regulation (QSR) 21 Code of Federal Regulations (CFR) 820, these warning letters address two basic requirements of quality systems: quality and system.

The following are excerpts from the two warning letters:

“Failure of management with executive responsibility to adequately ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). For example, the Quality Policy has not been established by any member of executive management….”

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