Incomplete Process Sheets Closure - DHR - Doc Control

Q

QA-RA Jones

#1
All:

I recently started a position with a manufacturing company of medical devices. They have process sheets/routers/work instructions in place for every job that runs through the shop. When I arrived in this position there were several of these routers sitting in a box that were missing signatures for applicable steps (even though they say that the step was definitely completed), dates for the work completed, changes in quantities throughout that were not explained or associated to NCMRs, etc. At this point, some of these routers are 1-4 yrs old and have never been closed out due to these documentation gaps.

How can I move to close these out? Can I create a Letter to File to close the routers without the applicable information?

Any thoughts on this would be appreciated! Thank you!
 
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yodon

Staff member
Super Moderator
#2
Sounds like a clear case for initiating a CAPA. You have a systemic process issue and you need to both make the corrections and eliminate the root cause(s). Let the CAPA drive how you close out the routers. There should be some defensible rationale behind whatever you do and without the CAPA, you'd just be making (what might appear to be) arbitrary decisions.
 
Q

QA-RA Jones

#3
I completely agree with you on the issuance of a CAPA. This portion is complete and we have already identified solutions to making sure this does not happen in the future (root cause eliminated). My only issue at this point is specifically related to how we can close out the past documents that have gaps associated with them.

Things we know about these process sheets:
We know the final quantity delivered. (inspections are complete for the final quantity)
We know that no complaints have been received on the related products produced through the incomplete routers.

Correctively for the routers with gaps:
Could we close these documents out through just identifying a statement in the CAPA resolution that we know what was delivered and when and that we also know no complaints have been received on the quality of the product, therefor the routers will be closed?
 

yodon

Staff member
Super Moderator
#4
I think you're on the right track. I would probably suggest that the rationale for closure (corrections) include some indication that there's no impact to safety or efficacy of the product. The 'no complaints' may not be the strongest argument but can be supporting.

These are tough and companies get in tough positions trying to dig out. What you're doing sounds like it will put you in a defensible position.
 
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