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FDA Guidance for QA in Blood Establishments 11 July, 1995, which includes references for the CFR 200's and 600's, has been very helpful. In the guidance document you will find an annual review reference and a statement about defining the roles for review, approval, etc... Pages 6 and 7. The CFR's aren't as specific as the AABB standards because they also address manufacturing of pharmaceuticals, biologics, etc... Many times the audit is to determine if you are compliant with your own SOP's.
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We consider each event an occurrence. In our error management process we need to identify where the process is failing and if someone at an upper level is not reviewing multiple steps, we have a way to at least flag that there is a problem and determine if it is related to a specific employee. This isn't punitive, it is a process improvement action. Employees are counseled individually and the types of errors/events occurring are classified.