Who should quality representative report to?

michF

Registered
#1
I am the manager of quality/regulatory and the appointed Quality Representative, and report to the CEO/Owner currently. My company is adding a COO, and is suggesting that I report to the COO. Is there a conflict of interest in this reporting structure? And should the COO then be the quality representative?
 
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Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#2
For the FDA they expect the management representative to report to the person within the organization that can demonstrate the authority to receive and accept and approve the FDA inspection letter and demonstrate the authority to host said audit by commanding senior leadership to the audit opening and closing meetings. The audit result is addressed to this person. They wrote this description in their audit memo.

"Edward Panek is the management representative who reports to the CEO JOHN DOE. JOHN DOE demonstrated his authority by accepting the audit notification and commanding the required attendees to the meeting."

By doing this they prevent any "We didn't have the right people in the meeting" Defense to a warning letter.

I suggest the same for 13485 as it demonstrates senior management engagement in the process however how involved is the COO with QARA in general? Does he have the same training and education as you would? Do you trust him to answer audit questions at a high level about processes?
 
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michF

Registered
#3
For the FDA they expect the management representative to report to the person within the organization that can demonstrate the authority to receive and accept and approve the FDA inspection letter and demonstrate the authority to host said audit by commanding senior leadership to the audit opening and closing meetings. The audit result is addressed to this person. They wrote this description in their audit memo.

"Edward Panek is the management representative who reports to the CEO JOHN DOE. JOHN DOE demonstrated his authority by accepting the audit notification and commanding the required attendees to the meeting."

By doing this they prevent any "We didn't have the right people in the meeting" Defense to a warning letter.

I suggest the same for 13485 as it demonstrates senior management engagement in the process however how involved is the COO with QARA in general? Does he have the same training and education as you would? Do you trust him to answer audit questions at a high level about processes?
My job description and responsibilities include all of the things defined by ISO 13485 as those of the management representative. I am identified as the management representative in our quality manual. I host the audits, and answer the questions, calling in area experts as needed. The COO role is new and being defined, but won't include responsibility for the QMS. If it does, then I'm redundant, and it's not what I signed up for.
 

Ron Rompen

Trusted Information Resource
#5
as a quality manager/quality representative, i have always reported directly to the senior management member on-site. general manager/plant manager, CEO, whatever name they have.
 
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