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Audit finding - Components being transferred inter-plant

g021283

Starting to get Involved
#1
Hi All, I recently completed a course to become an internal auditor to ISO 13485. I also took part in my first audit for the medical device company I work for (I’m in training).

During this audit I found components being transferred inter plant ( from one global site to another) but the SAP transactions weren’t completed to show the movement. The components were in plant B but Sap shows them in plant A. I believe this is a traceability concern but I’m having difficulties linking it back to the standard. Any suggestions of a clause that would suit this situation appropriately?

Thanks
 
Elsmar Forum Sponsor
#2
Was this on any plan, according to the process planning requirement (Product Realization)? If not, was there a change to the plan authorized and implemented?
 

Golfman25

Trusted Information Resource
#3
I think more investigation is in order. When you say the SAP transactions where not completed, is it a timing issue (i.e.; scheduled to be completed) or not done at all (are they required to be done). I know for us it can be a week before some transactions hit the computer system. Are these transactions how you establish traceability?
 

somashekar

Staff member
Super Moderator
#4
Hi All, I recently completed a course to become an internal auditor to ISO 13485. I also took part in my first audit for the medical device company I work for (I’m in training).

During this audit I found components being transferred inter plant ( from one global site to another) but the SAP transactions weren’t completed to show the movement. The components were in plant B but Sap shows them in plant A. I believe this is a traceability concern but I’m having difficulties linking it back to the standard. Any suggestions of a clause that would suit this situation appropriately?

Thanks
Hi.. A SAP entry is not more a trace-ability concern as much as its manufacturing lot number or a run number at the source of manufacturing. Coming to the inter plant transfer issue, there could be many more reasons other than the QMS (or those processes not covered by the QMS) which I am telling from my experience point of view. Perhaps ...
1. The SAP is not set for inter plant transfers
2. The company does not want the inter plant transfer on record
3. There is another system out of SAP to track inter plant transfer which you may have not unearthed.
I hope you can investigate out of your audit scope.
Thanks and good luck.....
 
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