Hello,

I've ready a few other posts on similar topics, but I'm hoping to get a little more feedback on combining two functions. We are a small company (15 people), and we're ISO certified. We are about to inherit a business area from our parent company, and so we're contemplating a re-org. Currently, the Quality function also is responsible for Reg Affairs and some Product Development. The Production function is responsible for all manufacturing of our products as well as the majority of Product Development. We won't be hiring any new people with this re-org, so we've got to "make do" with what we have. We could keep it the way it is, or I'm thinking that we could have Production and Quality report into the same person, who would report directly to the General Manager (who's the highest management on site). Keeping R&D and Production together is somewhat more efficient, but it's a signficant burden to the manager. Putting Quality and Production together would relieve that burden, and may also provide some other synergies. Quality would still be responsible for the system, not just production quality. Either way, two (or more) functions will need to be combined. I'd love to hear how other small companies handle this, how others have seen it done at their suppliers, clients, etc. Thanks in advance!

If you use org charts (and there is no "requirement" to have them) you can, and should create them so as to make the most sense to your company and its customers. Just make sure that regardless of other activities, you show that your MR reports to top management in his/her capacity as MR.

We do utilize org charts, and it has been helpful to try to explain how our small company works (which can be harder to explain sometimes than big organizations). I can see where it is key to show how MR reports in. Thanks for your help!

:2cents:As a rule, on an org chart, the MR /QA/Quality department is normally shown to be NOT directly repsonsible to production. I cannot see that there would be a problem with anyone, suitably qualified, to perform the function of MR provided that the person performing the MR function is aware that he/she has to change hats and be objective in his/her position as MR and not influenced by his/her other function of production.

Another :2cents:
Consider who's doing internal auditing. My registrar is keen to see independence to ensure the auditor isn't auditing their own work. Another aspect to watch when combining roles.

Another :2cents:
Consider who's doing internal auditing. My registrar is keen to see independence to ensure the auditor isn't auditing their own work. Another aspect to watch when combining roles.

This is a challenge for us already in our current configuration. I perform internal audits, and I have one other trained individual who helps me, but since we're all involved in different parts, it can be difficult to not audit an area for which you are responsible. For example, I am the Quality Manager, but I'm also responsible for product development for one line of products. Additionally, I just revised our whole development process. I don't feel comfortable auditing development, as I am intimately involved. So, my other auditor audits this part. No matter how were structured, I will be the internal auditor, as I am the Quality department.

My guess is that if we change our organizational reporting structure, and I am responsible for both Quality and Production, I will remain the MR. Does anyone see an issue with this?

Just in case you don't have dedicated auditors, you can show independence from an area (although, that is not a requirement in ISO 9001) through your audit schedules/assignments.

One of the challenges of a small company is that it seems everyone wears all of the hats at one time or another. I have seen org charts that have the owner on one line and everyone else underneath in a single line. Such org charts are useless. The important thing is that responsibilities are defined and communicated (they do not have to be documented). You can do this in any manner that works for your company.

Regardless of how you do it, you have to ensure that your method eliminates unwanted variation from your processes.

You can combine the Quality Control function with production. Production employees can perform tests to provide evidence that the product meets specs and make decisions to reject non-conforming products.

You should not combine QA with production. In many regulated (GMP) industries it is required to have an independent QA function to release final products. For that purpose they verify the test data provided.

Still, however, a single employee can perform both production an QA tasks when:

They do not qualify/release any product that they have (partly) manufactured/controlled themselves
The report to an independent manager for the production and the QA activities

This is not an ideal situation. Consider the case, where a person performing the QA task reports to the production manager, who definitely needs to release products in order to meet the yield/sales requirements. An independent QA manager (manager representative) is minimally required to solve that dilema.

From a Pharmaceutical / Med Devices background, Quality unit has to be seperate and can not be merged with Production.

Which industry are you in ?

I am, amongst other in the GMP business. As I put in my response, QA and production need to be seprated inits in this business. Your org chart should show this, that was the original question.
However in very small businesses employees are easily transferred from one unit to the other or have to perform multiple tasks. For product release it should be assured that the final responsibility (i.e. the manager who makes the final decision) is independent from production. The employee performing the final inspection should preferably also be independent, but as a minimum report for the QA activities to the QA manager and not the Production manager.

I am, amongst other in the GMP business. As I put in my response, QA and production need to be seprated inits in this business. Your org chart should show this, that was the original question.
However in very small businesses employees are easily transferred from one unit to the other or have to perform multiple tasks. For product release it should be assured that the final responsibility (i.e. the manager who makes the final decision) is independent from production. The employee performing the final inspection should preferably also be independent, but as a minimum report for the QA activities to the QA manager and not the Production manager.

Hi Jan,

My apologies - I wanted to refer this question to the OP :)

Hi Jan,

My apologies - I wanted to refer this question to the OP :)

Hi there,

I'm the Original Poster (if that's what OP refers to - I'm not always clear on acronyms). My company makes both IVD and research products. Our business model is likely to change in 2010 and we will move away from making IVD products but will remain ISO certified (probably 9001, we're currently 13485). We are a very small company (15 people), and we wear many hats. As part of our changing business model, we're looking to see if we will also need to reorganize, and if so, how will we do that. Right now one person is responsible for Production and some R&D, and another person is responsible for Quality (all aspects), Regulatory Affairs, and some R&D. We were considering changing that, but based on the feedback I've received from my original question, I think we're going to stay the way we are today.

Thanks to everyone for their input! It is much appreciated! :thanx: