Management Representative - 2 Person Device Company

L

Laura Halper

#1
Hello everyone,
I have a client who wants me to fill the role of Management Representative (MR) at their 2-person device company. I know that ISO 13485 registrars have stated that the MR must be an employee of the company and not an external consultant. But my client is not interested in ISO certification.

I have not been able to find where the FDA has made a definitive statement one way or the other. Has anyone out there ever used an external party as MR and then been audited by the FDA? If so, what was the FDA's position?

Thanks for any guidance you can offer,
Laura
 
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yodon

Staff member
Super Moderator
#2
I've seen this work without issue from the FDA. It was demonstrated and discussed that the MR had the required authority and responsibility and that was fine.

Like you said, some Registrars won't accept this (and some will) - makes me wonder if this is FDA auditor dependent. Hopefully others will weigh in with experiences.
 
L

Laura Halper

#3
:thanks:

Thanks, Don, I appreciate hearing about your experience with this. Has anyone else out there had an FDA audit with an external Management Representative?
 
G

gar4guv

#4
i have seen this tried with companies saying that their consultant was the management rep. the problem was usually that the consultant had no official title, or direct reports, or employee required training, etc...

any auditor can just look at the regs and argue that the rep has to be a "member of management".

that being said, small manufacturers are given a lot more leeway to bend the rules. however i have never seen an inspection report that lists a consultant as the management rep.

PART 820 -- QUALITY SYSTEM REGULATION
Subpart B--Quality System Requirements
Sec. 820.20 Management responsibility

(3)Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:
(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
(ii) Reporting on the performance of the quality system to management with executive responsibility for review.
 
Last edited by a moderator:
D

DrM2u

#5
I do not have direct experience with FDA audits, but ...

ISO 9001 requires that the MR is a member of the management and probably FDA might require something along those lines also (I am not familiar with the requirement). However, nowhere in the ISO 9001 standard is specified or implied that the MR has to be an employee of the company in order to be a member of the management. Therefore the MR can be a contractor hired by the company to be a part of management and to perform the MR duties. A contractual agreement between you and your client should suffice to demonstrate/evidence that you are contracted by the company. The contract/agreement should identify the duties, responsibilities and authorities that are assigned to you, and they should match at least what is required for the MR.

I suggest that you use this approach and reasoning to support your position. If the auditor does not understand or accept it, then:
- take the contract and place it inside a copy of the requirements
- roll the two documents into a tight roll
- smack the auditor upside his/her head with the above roll until some sense gets transferred to their brain :bonk:
- verify effectiveness by explaining the reasoning again
- repeat steps as needed

And that's my :2cents:.
 
N

NoyJDC

#6
i think you will be treated as supplier, as far as purchasing or outsourced process is concerned, you provide technical expertise on ISO 9001 to the organization - your client. as MR you’ll be reporting on the performance of the management system. isn’t it a conflict of interest reporting the performance of purchasing or outsourced process?
 
D

DrM2u

#7
i think you will be treated as supplier, as far as purchasing or outsourced process is concerned, you provide technical expertise on ISO 9001 to the organization - your client. as MR you’ll be reporting on the performance of the management system. isn’t it a conflict of interest reporting the performance of purchasing or outsourced process?
How is contracting someone for a mangement position and MR duties different from contracting an engineer for an engineering project? The only difference between a 'contractor' and an 'employee' is that one has a documented agreement that specifies the scope of the agreement, duties, responsibilities, authorities, compensation, etc. An employee is trading his time and skills for money and/or satisfaction and the employer is trying to get the most for their money. There is no contract, it is all 'at will'. Both contracts and employment can be terminated at any time as long as the termination follows the conditions outlined in the contract or regulations. What happens when a contract is fulfilled? It is terminated. What happens when a company does not have work for someone? Employment is 'terminated'.

What I am trying to get at is that both employees and contractors are suppliers of knowledge and skills to the organization as long as there is a need for them. Therefore the contracted MR is not much different than a direct employee MR and I don't see any conflicts of interest. It is just a trade of skills for money.
 

somashekar

Staff member
Admin
#8
Hello everyone,
I have a client who wants me to fill the role of Management Representative (MR) at their 2-person device company. I know that ISO 13485 registrars have stated that the MR must be an employee of the company and not an external consultant. But my client is not interested in ISO certification.

I have not been able to find where the FDA has made a definitive statement one way or the other. Has anyone out there ever used an external party as MR and then been audited by the FDA? If so, what was the FDA's position?

Thanks for any guidance you can offer,
Laura
It should make perfect sense looking at the size of the organization. Perhaps an offer letter stating your authorities and responsibilities should fit well to the requirement. Why not the company have a talk with the FDA inspection authority in your state for a clarity on this ...
 

Ajit Basrur

Staff member
Admin
#9
:thanks:

Thanks, Don, I appreciate hearing about your experience with this. Has anyone else out there had an FDA audit with an external Management Representative?
If you refer section 820.20, it clearly states -

Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:

(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and

(ii) Reporting on the performance of the quality system to management with executive responsibility for review.
 
G

Groo3

#10
It should make perfect sense looking at the size of the organization. Perhaps an offer letter stating your authorities and responsibilities should fit well to the requirement. Why not the company have a talk with the FDA inspection authority in your state for a clarity on this ...
:agree1: makes sense to me...

The problem may be in the semantics... The term "contracted employee" may be a more appropriate way to describe the position than "external consultant". A talk with the FDA inspection authority sounds like a good way to clear the air on the terminology.:2cents:
 
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