Quality Organization - Does it matter where it reports to?

J

JackieT

#1
I have had an interesting question posed to me and am looking for other's opinions! Organization facts:
  • Division of a larger company (of unrelated/unregulated divisions)
  • 13485 certified supplier to US/OUS med device companies
  • Division President with Business Development heads, global head of R&D, Global controller, and a COO directly reporting
  • COO has 4 General Manager's of 4 different (WW) manufacturing plants directly reporting
  • Each GM has theor own staff directly reporting comprising of a head of quality, head of engineering, head of manufacturing, controller, etc....
  • Each plant head of quality reports dotted line to the Global head of Quality
Here is the question - Should the Global head of quality report to the COO or to the Division President on the org chart. Pro's/Con's?

Thanks for your opinions. I know what I think, but I'd like to get other's points of view!
 
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J

Jason PCSwitches

#2
[FONT=&quot]Sounds like something that should be discussed at management review!?!?!

[/FONT][FONT=&quot]Nothing wrong with it but I don't see why you would report to a COO, if you are alluding to Chief Operations Officer. Not to stereotype but they are not "usually" primarily concerned with QMS issues.[/FONT]
 

jasonb067

Quite Involved in Discussions
#3
COO

This will hopefully avoid confusion in methodologies, goals, etc. in the operations side of the business.

If a COO and Global Quality person had two differing opinions the direction to the operations organization will be clouded regardless of what the Division President would say.

I can see the argument that this person should be reporting to the Division President to ensure Quality is in all aspects (R&D...) but from a functional standpoint I do not think that it works very well in general.

I have seen cases where either one of the two set ups have worked well. It just seems that from memory, considering Quality a part of the Operations organization seems to have been the best in most practices I have seen.
 

jkuil

Quite Involved in Discussions
#4
I depends on how you have organised your corporation and each company included.
If each site is considered an independent entity, with their own management and their own (certified) quality management system, the site managment including QA must have all required information to manage their site. In order to manage the quality of the compagnies, corporate headquarters will (and must by the FDA's opinion) have means of control in place. I prefer to have linking pins between similar functions, i.e. COO with site managers, global QA with site QA. They will speak each others language and understand each others objectives.
Global and site management reviews are good means by which the efficacy of the control is evaluated.
 

somashekar

Staff member
Super Moderator
#5
I have had an interesting question posed to me and am looking for other's opinions! Organization facts:
  • Division of a larger company (of unrelated/unregulated divisions)
  • 13485 certified supplier to US/OUS med device companies
  • Division President with Business Development heads, global head of R&D, Global controller, and a COO directly reporting
  • COO has 4 General Manager's of 4 different (WW) manufacturing plants directly reporting
  • Each GM has theor own staff directly reporting comprising of a head of quality, head of engineering, head of manufacturing, controller, etc....
  • Each plant head of quality reports dotted line to the Global head of Quality
Here is the question - Should the Global head of quality report to the COO or to the Division President on the org chart. Pro's/Con's?

Thanks for your opinions. I know what I think, but I'd like to get other's points of view!
To the Division president.
Global head of quality must be in the peer line with the COO, and others who directly report to the Division president.
 

John Broomfield

Staff member
Super Moderator
#6
I have had an interesting question posed to me and am looking for other's opinions! Organization facts:
  • Division of a larger company (of unrelated/unregulated divisions)
  • 13485 certified supplier to US/OUS med device companies
  • Division President with Business Development heads, global head of R&D, Global controller, and a COO directly reporting
  • COO has 4 General Manager's of 4 different (WW) manufacturing plants directly reporting
  • Each GM has theor own staff directly reporting comprising of a head of quality, head of engineering, head of manufacturing, controller, etc....
  • Each plant head of quality reports dotted line to the Global head of Quality
Here is the question - Should the Global head of quality report to the COO or to the Division President on the org chart. Pro's/Con's?

Thanks for your opinions. I know what I think, but I'd like to get other's points of view!
Jackie,

Message to everyone in current organization could be:

  • Quality is operational not strategic
  • Quality is a line function (doing part of the job of other professionals in engineering, manufacturing etc...)
  • President is not interested in Quality
Quality management should help the President focus on the organization's system for helping employees to determine and fulfill requirements (including statutory and regulatory requirements). In other words Quality (or System Management) ideally is a staff function.

John
 
J

JackieT

#7
Thanks to all, extremely good points for both sides - and differing views which is EXACTLY what I was looking for. :thanx:
 
J

JackieT

#9
Actually, I think it should report to the Division President and not the COO. Each Site has its own Quality head for specific operational issues - and they work with the team and GM there. If the position is intended to be strategic and drive policy, it should not be aligned operationally.
 
J

Jason PCSwitches

#10
If each site has a GM, why wouldn't they report to the GM? I would guess that the GM is responsible for the organization overall and probably is the one that reports to the next level.
 
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