Quality Department Structure in a Small Medical Device Company

[terry31575]

I am at a small device start-up. We are working towards being ISO 13485 and 21 CFR 820 compliant.

I am the quality manager and I have one document control person working for me. I am in the process of hiring a QC person as move into manufacturing. I do not have a specific QA person.

Does anyone see a problem with the Quality Manager acting as QA and being the direct supervisor of QC? I can see how this would be a conflict of interest but we are also small company and can only hire so many employees. Is there a guidance or regulation around this?

Thanks
Terry

 

[John Broomfield]

Re: Quality Department Structure

Terry,

I see no problem with the Quality Manager ensuring the QMS delivers confidence that the requirements will be fulfilled.

This is the essence of QA.

Whether the regulators agree may be another matter!

John

 

[DannyK]

I am at a small device start-up. We are working towards being ISO 13485 and 21 CFR 820 compliant.

I am the quality manager and I have one document control person working for me. I am in the process of hiring a QC person as move into manufacturing. I do not have a specific QA person.

Does anyone see a problem with the Quality Manager acting as QA and being the direct supervisor of QC? I can see how this would be a conflict of interest but we are also small company and can only hire so many employees. Is there a guidance or regulation around this?

Thanks
Terry

There should be no problems whatsoever.

 

[mihzago]

I'm not sure if I understand what the problem would be, where is the conflict of interest?
I would think that it is advisable for QA Manager to be a supervisor of a QC function. Unless, as a QA manager you are somehow directly involved in production.

 

[Jordan Thornes]

We've never had a problem with auditors or inspectors with this type of arrangement. It's far less of a conflict of interest than QC reporting into operations or production. Neither ISO 13485 or 21 CFR Part 820 regulates the reporting structure in the company. It's more that certain arrangements (such as QA reporting to operations) may invite additional scrutiny from an auditor due to being more likely to lead to nonconformities.

I understand your concern is that you are signing the release of a product based on the manufacturing and QC test results. Since the QC operator reports to you, you may take is easier on "one of your own"