Definition Executive Responsibility - Legal Definition

H

HPLC_Help

#1
If, theoretically, I have a boss who is always trying to work an angle and parse words so as to NOT comply with GMP requirements, and (again theoretically) that boss is questioning the meaning of "Management with executive responsibility" in the phrase "Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization" [CFR 820.20(a)] to avoid taking any ownership of the quality system, and if - theoretically speaking - that boss is president and owner of the business ...

where might one find a legal definition of the term "executive responsibility" to support the argument that it does, in fact, mean this (theoretical) boss.

Or am I wrong, and it does actually mean someone with no managerial duties who cannot execute policy because nobody reports to that person?

Any help is welcome!
H_H
 
Elsmar Forum Sponsor
H

HPLC_Help

#2
Re: Meaning of "Executive Responsibility"

Found a reference pretty quickly in the FDA inspector's guide:

Management with executive responsibility (has the authority to establish and make changes to the company quality policy) ... (emphasis mine).

H_H
 
H

HPLC_Help

#4
Re: Meaning of "Executive Responsibility"

In fact he did! I sort of tricked him into it ... theoretically.

H_H
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: Meaning of "Executive Responsibility"

I once worked for such a theoretical boss. My lesson from that experience: in a situation like this, instead of looking for the legal definition of "Management with executive responsibility", one should look for the meaning of "start looking for your next job"... theoretically, of course...
 
K

Kymmie

#10
I have to say that besides all of the help that this forum has been for me as far as a place to learn what I need to learn and to guide me along....

it is also so relieving to see that so many other quality managers go through the same hassels and headaches that I do!

(Although everyone else in the office looks at me funny when I start laughing in response to a post like I did to this one)

I'm glad I'm not alone in this crazy boat.

Thanks everyone :thanx:
 
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