My company has recently decided to seperate QA and RA into two seperate departments. We all seem to agree on the scope of the regulatory department with the exception of Internal Auditing. I would approciate any comments from other experiences.
I feel IA falls under QA oversight due to the direct relation with the quality systems, related to process improvement , preventative actions and of course corrections when nonconformances are found. thank you - K

Hello, Karen! Welcome to the discussion board! Just so no one like me gets confused:D, can you clarify the terms QA and RA? By context I am assuming they are Quality assurance and Regulatory assurance, but just want to check. Also IA would be Internal Auditing.

Is there any rationale for having two distinct functions? Just wondering.

Added- I changed the title a bit for better detail. Please let me or another moderator know if it does not suite you, and we'll change it. :)

thank you - you are correct -- I should have spelled out the words - sorry about that -
No rationale was given - except they wanted to promote someone and give them their own department ( regulatory affairs )
Historically the department has been Quality Assurance & Regulatory affairs.
I have defined the scope of the new department to include risk,vigilance and significant change reporting, domestic and internaional product submissions(510k, CE marking,etc.) certificate filings to agencies, input for new product intended uses, and packaging and labeling approvals. Not Internal audits - am I correct ?

Ok, thanks for the clarification. As we have a pretty diverse group here, letters can sometimes represent multiple things.

Now... I am still a little unclear as to "correctness" concern. Why are you feeling there should be rightness/wrongness for your scope of the departments? Are you concerned from the regulatory end of it? In the end, how you structure your organization and define their scope is totally up to you.

Also, you gave the scope of the "new" department. Is that the quality assurance scope or the regulatory affairs scope? It looks like the Regulatory Affairs scope, but I did not want to assume. What are you thinking for the Quality Assurance scope?

I know you indicated you don't know the reason why they split off. I am quite inquisitive why this occurred. I would think if the split was necessary, the scope would manifest itself.

Will there be a third department/area performing the internal auditing for the two units?

Karen, I'm sorry for all the questions/clarification stuff:D. I usually find you get better answers/ feedback when we get as much detail/ background out at the beginning. Too, recall this is a weekend, so answers may be slower than during the week.

Just be patient with us, and we will try to help you on your question.

ok thanks agian. :) This is the first time I have actually ever submitted a posting such as this _ thank you for the guidance. I realize there is not one "correct" way - I was just curious to know what the common approach was for the assignment of the internal auditing function.
The new department would be the regulatory affairs department, with the scope I listed.

Quality assurance will maintain continued responsibility for document control, quality engineering support for manufacturing change control, process change, nonconformance /corrective and preventative actions, product inspection , test and release, quality system procedures, training, company and product performance metrics.

The question was, where is internal auditing typically placed ? I have established and managed all of these quality system functions within one department for over ten years at this company. To me internal auditing is a QA function, however I do relaize it can go either place as long as the correctly trained resource is available. I was just wondering what other companies have done. - thanks

ok thanks agian. :) This is the first time I have actually ever submitted a posting such as this _ thank you for the guidance. I realize there is not one "correct" way - I was just curious to know what the common approach was for the assignment of the internal auditing function.
The new department would be the regulatory affairs department, with the scope I listed.

Quality assurance will maintain continued responsibility for document control, quality engineering support for manufacturing change control, process change, nonconformance /corrective and preventative actions, product inspection , test and release, quality system procedures, training, company and product performance metrics.

The question was, where is internal auditing typically placed ? I have established and managed all of these quality system functions within one department for over ten years at this company. To me internal auditing is a QA function, however I do relaize it can go either place as long as the correctly trained resource is available. I was just wondering what other companies have done. - thanks

Hi Karen,

What I have suggested to my Clients is to have the Finance Department (a Finance Manager) take ownership of the Internal Audit process. Some of the reasons are that Finance is somewhat removed from ISO 9001 and folks in Finance are usually very detail-oriented. Another reason is that as soon as the Quality Department takes ownership, internal auditing becomes another Quality Department reponsibility, and I try to avoid (strongly suggest) that whenever I can.

A great way to get Finance involved.

Has worked for me a few times.....:agree1:

Stijloor.

My company has recently decided to seperate QA and RA into two seperate departments. We all seem to agree on the scope of the regulatory department with the exception of Internal Auditing. I would approciate any comments from other experiences.
I feel IA falls under QA oversight due to the direct relation with the quality systems, related to process improvement , preventative actions and of course corrections when nonconformances are found. thank you - K

Welcome Karen.

Thanks for asking your questions in this new Forum.

The Quality Management System is everyones responsibility, because each of the different process interact somewhere, within the Business Operations. The Internal Audit process does not need the Quality Process to monitor or control for proper operations of management of the system.

It has typically fallen under the Quality Function, but now with the changes from ISO9000(et all) to the most current version of ISO9001:2000 (soon to be 2008), it is focusing on the results or output of processes, and ultimately the satisfaction of the Customer/Clients.

Look at ISO9001:200x as a Business Management System, not the "A" typical Quality Management System.

Regulatory Affairs (RA), is another part of the Business Process, just like Finance is a part. Each of these functions/processes has some impact on the end results.

Each internal audit team should be multi-functional, to include groups from the other functions (eg; Quality, Finance, Human Resources, Engineering and so forth).

Look at the system as a whole.

As for your comment about the Corrective-Preventative Action (CAPA), everyone in the organization should have the freedom to initiate any CAPA's, if something is identified.

This is my opinion.

My company has recently decided to seperate QA and RA into two seperate departments. We all seem to agree on the scope of the regulatory department with the exception of Internal Auditing. I would approciate any comments from other experiences.
I feel IA falls under QA oversight due to the direct relation with the quality systems, related to process improvement , preventative actions and of course corrections when nonconformances are found. thank you - K

IMO you have the right feeling to keep IA under QA. The person conducting Internal Audit must be fully conversant with the system, should also have practical experience in QA. A person from different department (without Q/A exposure) can be easily entrapped into overlooking a nonconformance or rigidly issuing uncalled for NC.

Umang :cool:

thankyou to all who took the time to answer my question - I see I am on the right track - Ill let you know how it all works out.

This is a great resource and I hope I will be able to support others as you all have done for me. - K:thanks:

...thank you also for bringing that enquiry… at least, anyone who will be in the same scenario can somehow have an idea of process approach… ;)

thankyou to all who took the time to answer my question - I see I am on the right track - Ill let you know how it all works out.

This is a great resource and I hope I will be able to support others as you all have done for me. - K:thanks:

You are most welcome. We will wait for your input.

Umang :D

My company has recently decided to seperate QA and RA into two seperate departments. We all seem to agree on the scope of the regulatory department with the exception of Internal Auditing. I would approciate any comments from other experiences.
I feel IA falls under QA oversight due to the direct relation with the quality systems, related to process improvement , preventative actions and of course corrections when nonconformances are found. thank you - K

Hi Karenkaye,

Agree with you - Internal audits can be a part of Quality Assurance. In fact many companies also call this section as QA and Compliance.

I'm a bit late on this thread, but we've recently done the same RA/QA split.

Historically we have treated quality systems as internally focused, i.e. as tools for us to improve our operations. An RA department was created to increase our horsepower devoted to external communications processes, i.e. 510(k)s, regulatory system interactions with customers for whom we are a Contract Manufacturer, product classification strategy, other FDA interface issues, etc.

RA is also a sales tool for us, and the goal is to increase that function as well. It's been part of my prior job portfolio (under the vague title "Research & Development") to work trade shows and participate in customer meetings and conference calls in a technical-sales role. The expectation is that now with the additional job of Regulatory Manager, I'll be more effective in what might be called a regulatory-sales role, in instances where regulatory compliance issues are key to our medical-OEM customers' product design decisions.

As such, internal audits remain with QA, for us.