Internal transfer of work from one line to another?

FloridaST

Involved In Discussions
#1
Good morning everybody, I have a quick question regarding the best way to handle transferring a medical product (board assembly, not a finished device), from one SMT line to another SMT line. We are a contract manufacturer and we need to move a pcb assembly from SMT line 1 to line 2 in order to free up manufacturing resources. Both lines have had IQ OQ PQ performed and both lines are currently in use.

Would performing only a FAI be sufficient to validate that the line change is able to produce products that meet requirements?

Wanted other opinions before I make a decision. Thanks!
 
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Jen Kirley

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#2
Good day FloridaST, I am sorry for the delay in this response.

Unless your customer states otherwise, I would say yes, but with a note that the FAI should have multiple parts and also include a functional test if you do that.
 

John Predmore

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#3
IMO your customer is the one to answer that question. They have a stake in the consequences if something unpredicted happens. One extra measure they might ask, or you might offer, is enhanced traceability by serial number or other method, even segregation of PCBs that deviate from the normal process flow until the quality data for the entire lot can be examined, rather than a first article piece or a small sample .
 
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