Is it common practice to have a Compliance manager and a Quality manager employed in the same factory?

My thinking is that the left hand is not knowing what the right hand is knowing.

Thoughts please.

Thanks in advance

Is it common practice to have a Compliance manager and a Quality manager employed in the same factory?

My thinking is that the left hand is not knowing what the right hand is knowing.

Thoughts please.

Thanks in advance

Perhaps I am displaying my ignorance, but the term Compliance Manager seems a bit more open than Quality Manager. What is he/she managing compliance to? this could be quality, or environmental/regulatory etc.

James

Is it common practice to have a Compliance manager and a Quality manager employed in the same factory? My thinking is that the left hand is not knowing what the right hand is knowing. Thoughts please. Thanks in advance

It depends on what the role is of each. Compliance might be focused on regulatory requirements or external standards (ISO 9001/quality, 14001/environmental, 18001/OHS, cGMP, etc.) and quality manager focused on performance improvement. They require somewhat different thinking processes. Might also depend on size of the organization as well as industry.

Is it common practice to have a Compliance manager and a Quality manager employed in the same factory?
Thoughts please. Not in my experience. Product regulatory compliance is one of the facets of Quality Management. It would be as unusual as having a quality manager and a customer satisfaction manager...Not unheard of, but not common in my experience.

Obviously there are other regulatory issues at hand such as Environmental, Occupational Health & Safety, Accounting Reporting, etc...

Usually the position of Compliance Manager exists in Pharmaceutical organisations but havent really heard in medical devices.

In my organsiation, we have a Compliance Manager responsible for audits - both Internal and external. They are also responsible for other responsibilities like Regualtory, Participate in Review Boards like Material review Board, Validation review Borad etc,

The Quality manager is basically responsible for QC functions.

Tomjess - In my organisation, the right hand is knowing what the left is doing but they come together to give a BIG :applause:

Sidney is correct...What type of compliance are you referring to

Standards

Food & Drug

Occupational Safety

Environmental

Ms Leather and her whip?

My :2cents:

Usually there is a Compliance Manager that is mostly involved in FAA requirements. At least in my experience. I have seen that there is both the QA Manager and RA Manager.

I can't speak to too many other industries, but in the ones that I've been around (pharmaceuticals and plumbing products) the evironmental and safety compliance is handled by a EH & S manager, usually reporting to HR, and the product quality is handled by a QA Manager. Regulatory compliance in the pharmaceutical industry is generally handled by a RA manager; in the plumbing industry it was handled by the engineers.

At my old company I was the ISO Coordinator and we had a Quality Manager. An old fashion quality control type organization.

I can't speak to too many other industries, but in the ones that I've been around (pharmaceuticals and plumbing products) the evironmental and safety compliance is handled by a EH & S manager, usually reporting to HR, and the product quality is handled by a QA Manager. Regulatory compliance in the pharmaceutical industry is generally handled by a RA manager; in the plumbing industry it was handled by the engineers.

Ditto as far as the EH&S manager being a separate entity from the QA Manager. Reporting has differed though...
Currently the EH&S Manager reports to me.
At another job (much larger, more plants) the EH&S Manager was my (Corp. QA Manager) equal and we reported to the same guy.
Another job that was very small and I held both positions.

We have both - Our compliance Manager deals with mostly Safety compliance issues, DOT Regulations etc. However, in the beginning there was a "struggle" of what you mentioned. Answer: I cross trained the the Complaince Manager to be an internal auditor - He has learned alot more about process compliance and quality and I have learned alot more about Safety compliance - it has worked out very very well.:)

I think this is something seen in FDA regulated companies...not sure why. I was once Director of Quality and Compliance for a medical devices company. I've been in several different industries and not seen that title anywhere but in FDA regulated businesses.

But I have to admit that when i was Director of Quality AND Compliance, there were days when the left side of my brain wasn't sure what the right side was doing. Time for a conference call! :biglaugh:

Is it common practice to have a Compliance manager and a Quality manager employed in the same factory?

My thinking is that the left hand is not knowing what the right hand is knowing.

Thoughts please.

Thanks in advance

Here at Fluor Hanford the Vice President position is "Regulatory Compliance" and the QA Director reports to this VP. Environmental, Nuclear Safety, Assessments, and Corrective Action Management report to the Regulatory Compliance VP. Safety and Health has its own VP, so does not fall under Regulatory Compliance.

My own opinion over the years is that the phrase "Regulatory Compliance" has rather stifled continual improvement for QA in our company. Yes, we need to ensure we stay within Regulations, but for some it has turned in to all you have to do is stay within Regulations and you are "okay".

Most of our continual improvement efforts are over in Safety and Health (especially with the OSHA Voluntary Protection Program efforts) rather than with QA.

Slightly :topic: .

One of my professional interests is in "Organizational Development". I have seen way too many organizational charts with "unexplainable" positions and departments, over the years. In more than one occasion, when probing senior management to explain those oddly appointed jobs, departments and functions, I reached a conclusion that, a decision had been reached to side-track individuals (instead of demoting or firing them). Many times the decision was made to minimize the damage such individuals could inflict in case they had any authority or power. Other times, it was just to offer a chance for some people to remain gainfully employed for another couple years until they retire. The curse of the "special projects" manager....:tg:

The point is organizational development is a dysfunctional process (in many cases) and many organizations that stray away from their core processes develop totally dysfunction organizational structures along the way. And, the only constant in life, CHANGE, is too painful for many companies to endure. But organizations in the private sector that fail to constantly adapt are doomed. Employees that have excessive resistance to change are a big burden to their employers.