Who owns the PFMEA - The Customer or the Producer?

G

gyravena

#1
Just out of curiosity, say that you work for a contract manufacturing and one of your customer (medical) is requesting for a PFMEA. Is there anything preventing you from saying no or is it just appeasement? And who owns the PFMEA, the customer or the producer?
 
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Jim Wynne

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#2
Just out of curiosity, say that you work for a contract manufacturing and one of your customer (medical) is requesting for a PFMEA. Is there anything preventing you from saying no or is it just appeasement? And who owns the PFMEA, the customer or the producer?
IT all depends on the contract. If your customer refers to special requirements in its purchase orders, such as a supplier quality manual, and those requirements include PFMEAs, then you're obliged to comply. On the other hand, if there is no such documented requirement, your company would be within its rights to revisit pricing in light of new requirements. Whether or not this would be advisable depends on individual circumstances.

As far as who "owns" a PFMEA is concerned, the organization that executes and documents the process "owns" it, again unless there are contractual stipulations to the contrary. No different from any other processes. I'm not sure what difference it makes, though. Why does this concern you?
 
G

gyravena

#3
IT all depends on the contract. If your customer refers to special requirements in its purchase orders, such as a supplier quality manual, and those requirements include PFMEAs, then you're obliged to comply. On the other hand, if there is no such documented requirement, your company would be within its rights to revisit pricing in light of new requirements. Whether or not this would be advisable depends on individual circumstances.

As far as who "owns" a PFMEA is concerned, the organization that executes and documents the process "owns" it, again unless there are contractual stipulations to the contrary. No different from any other processes. I'm not sure what difference it makes, though. Why does this concern you?
Thanks for the reply

There is nothing stating anything about PFMEA for my company, it is new to us.

It concerns me because I was appointed to do them. I was just wondering if there was anything about the property right of the PFMEA, so I know whether or not I can send them to customers (if requested) or if I have the final say in the procedures for the processes
 
J

JaxQC

#4
dFMEA – Design FMEA – Customer (Engineering)
pFMEA – Process FMEA – Producer (Production)

In some cases it is prudent to say “the pFMEA is available for Customer, on-site review” if you don’t want them to have it. Also may refer to other internal documents to avoid listing proprietary info (under control method) or retract info if you’re worried about it.

You may have final say over the procedures but understand if they question your RPN rankings (2 for visual detection) or lack of control methods (lack of equipment verification). A proper FMEA will either highlight gaps that could be better addressed or show how you’ve covered all the bases.

Have a separate document defining your justifications and methods for determining your RPN values. ie… How are you consistent and others within the company in creating the documents?
 
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