Integrating a Contract Manufacturer's documentation into our Quality System

[snoopy2017]

Hi everyone,

My company recently brought the manufacturing process in house from the contract manufacturer. In our DMR, I have noticed that there is a lot of documentation from the contract manufacturer including their quality plan and DHR templates. What I don't know is how the contract manufacturer's documentation was integrated into our quality system in the first place. I am not aware of any formal change request to bring in the other guy's DMR documentation. Now that we have the process in house, we would like to have our own DMR documentation in lieu of the contractor's. I need to remove their documentation from their system but I don't see any change request that brought in their documents in the first place.

Can somebody shed light on this?

 

[John Broomfield]

Hi everyone,

My company recently brought the manufacturing process in house from the contract manufacturer. In our DMR, I have noticed that there is a lot of documentation from the contract manufacturer including their quality plan and DHR templates. What I don't know is how the contract manufacturer's documentation was integrated into our quality system in the first place. I am not aware of any formal change request to bring in the other guy's DMR documentation. Now that we have the process in house, we would like to have our own DMR documentation in lieu of the contractor's. I need to remove their documentation from their system but I don't see any change request that brought in their documents in the first place.

Can somebody shed light on this?

Focus first on connecting the processes and to remove any duplication of effort.

...obtain top management support for this.

Then update or document the procedures necessary for effective control of the changed and new processes.

...do this with the relevant process owners.

Have the process owners engage process team members in their review and mark-up of the documented procedures - encourage them to make the document bleed so it is accurate (aka not a work of fiction).

Have the supervisors (may be the process owners) provide training and verify the competence of their process teams.

Review their plans for verifying effectiveness of new and changed processes and update your internal audit schedule.

John

 

[yodon]

It's not uncommon for the CM to own / house the DMR and relevant documents. So your question about how those items were integrated in your quality system is likely that none of it was!

Hopefully you were able to get all the documents the CM was using (sometimes those contain proprietary processes and they're not willing to release them). If you have everything, then the process Mr. Broomfield described will certainly get you to where you need to be.

 

[SpinDr99]

If there wasn't an original change request, write one. This will show changes are planned and in the form of documented information. Often in cases like this, it's easier to start from Step 1 rather than to implement fixes. It'll save you a lot of hair.

That will allow you the freedom to look at all the information available, decide what you need and what you don't, re-create some if not most of your forms to give you exactly what you need/want. Just re-invent the processes. MUCH easier.