Is it acceptable to mix components from two different lots into an assembly?

QE1993

Involved In Discussions
#1
I've searched the forums and have not found a direct answer to this question: Does anyone have any thoughts?

My gut is telling me it is acceptable as long as we've analyzed the risk of doing so and as long as there is no customer requirement not allowing this.

Our company has always had one lot of components per top assembly lot; however, we are running into issues now that we are doing more complex assemblies. We have requires ourselves to go through the nuisance of splitting top level assemblies into two WO"s, just so we can have one lot of components going to one top level WO, rather than just having both lots of components going to the same WO. Splitting WO is adding a lot of documentation work that I don't believe is needed.

These are minor components (not heat treated, so mixing heat lots is not a worry). I believe that as long as we can trace it back to the two different lots (i.e. record both lot numbers), it is acceptable per the standard. Am i wrong?
 
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shimonv

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#2
Hi there,
I agree with your gut feeling :)
There is no regulatory or standard requirements that dictates otherwise, not that I'm oware off.

Process wise, there seems to be no restriction to go forward with this.
I suggest you review your process validations, in-process controls, and final procedure to see if there is something you can do to assure that quality is not compromised.

Good luck,
Shimon
 
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