Organizational Independence of the Quality Division

[sagai]

Hi!
Do we know any regulatory requirement that set organizational requirement for the Quality Department?
Is it okay in case the Quality Department under the Manufacturing Director?
Thank you in advance
Szabolcs

 

[Ajit Basrur]

Quality Unit has to remain independent. There are multiple instances where this is expressed by the FDA.

 

[ScottK]

As long as the authority is defined well you can do almost anything you want with regard to titles.
"Manufacturing Director" to one company might be a position strictly resonsible for running the manufacturing floor of one site, but to another it might be a position responsible for all the operations of an entire site.

Ultimately one person is in charge of a company and all facets of the company report up to this person. You can't get away from that. So as as auditor or inspector you have to make sure the quality function has the authority to designate the status of the product no matter what the job titles are.

To make a judgement on what you are asking we'd really need to see an org chart and job descriptions.

 

[sagai]

Thank you, actually I am looking for those instances
I have this one only:

Personnel performing quality system functions should:

• have sufficient, well-defined responsibilities and authority;
• be afforded the organizational freedom to identify and evaluate quality problems;
• be able to formulate, obtain, and recommend possible solutions for quality system problems; and,
• verify implementation of solutions to quality problems.

http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122400.htm

Actually regardless authorization appropriateness of the QM department, if it is subject to parents Division's budget, it could cause the lack of independence.

With other words, what non conformity against ISO9001/ISO13485/21CFR820 would you submit having such example in an internal audit.

I am still looking for regulatory source to reference or any suggestion.

Regards

 

[ScottK]

Thank you, actually I am looking for those instances
I have this one only:
http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122400.htm

Actually regardless authorization appropriateness of the QM department, if it is subject to parents Division's budget, it could cause the lack of independence.

With other words, what non conformity against ISO9001/ISO13485/21CFR820 would you submit having such example in an internal audit.

I am still looking for regulatory source to reference or any suggestion.

Regards

ISO 13485 5.5.1 says top management shall establish the interrelations of all personnel that manage, perform, verify work afecting quality and shall assure the independance and authority neccessary to perform their work

Still - We really can't answer your question without seeing the org chart and job descriptions of the applicable people on the org chart.
Depending on how that's set up there may not be a nonconformity at all.

 

[Ajit Basrur]

In most organizations (incl my current one), all my Quality Manager from different plants reports to me (as a Global Quality function) functionally and administratively to the Plant GM. I, in turn, report to VP _ Quality who reports to the President.

Thus the reporting of the Quality Unit is totally independent.

 

[ScottK]

In most organizations (incl my current one), all my Quality Manager from different plants reports to me (as a Global Quality function) functionally and administratively to the Plant GM. I, in turn, report to VP _ Quality who reports to the President.

Thus the reporting of the Quality Unit is totally independent.

I have the same type of setup.
Site QA Managers > Me > General Manager of the division

But at other cGMP companies I've worked at there was no "corporate" QA person and the site QA Managers reported to the Site Plant Managers.
Which is when you need to demonstrate clear responsibilities and authorities, usually via org chart and job descriptions.

 

[Ajit Basrur]

You are right Scott

 

[sagai]

I can not show on public forum the internal orgchart of the No 1/2 MD manufacturer's division with job description, but I like these initiatives and I do try to benefit from them, thank you.
Regards
Sz.

 

[BAnneS]

Has anyone implemented (or considered implementing) a structure in which Quality Engineers report into engineering and not into Quality? It seems that you could structure it that way, increase the surveillance/auditing of these areas and then have a Regulatory/Quality Systems-only focus in the Quality/Regulatory groups. Has anyone ever tried this?

Would love to hear any insight or experiences.