Organizational Chart - Manufacturing Manager report to Director of Quality

Achemd

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#1
As a Director of Quality and Regulatory affairs, would it be "wrong" to have the Manufacturing Manager report up through my position? It is either that or report straight to the VP of Technology. Will the FDA frown on Mfg reporting in thru QA?
 

Gert Sorensen

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#2
As a Director of Quality and Regulatory affairs, would it be "wrong" to have the Manufacturing Manager report up through my position? It is either that or report straight to the VP of Technology. Will the FDA frown on Mfg reporting in thru QA?
I know that FDA does not object to QA reporting through Manufacturing, so I guess that as long as it is described it is OK. But, the usual interpretation under ISO is that QA is to be an independent function and should report directly to management. ISO does not want Quality and Production to be intertwined so as to make sure that Quality is not biased or subject to pressure.
 

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