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FMEA Process Step or Current Control

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Shane61

#1
We have a situation where we are working on a FMEA for the completion of a documentation work pack, in the process map there is a clear process step where the company Review and approve the documentation pack before sending to the customer. The requirement is "work pack approved by all parties in the allocated time frame" the question we are asking ourselves in this situation is this an FMEA requirement/function or is it a current control, would welcome comments on this as we have a difference of opinion in the team
 
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yodon

Staff member
Super Moderator
#3
I'm a little confused on your terminology. Here's what I consider the building blocks of the FMEA (all the rating / ranking stuff aside):

Failure: what could go wrong
Cause: what were the conditions / situations that could cause the failure
Control: how do we minimize / eliminate each cause

We typically treat the controls as "requirements" in that they drive some action and are verified for effectiveness.

It sounds like your work pack approval step is a control. Presumably those approving do some kind of check for completeness, accuracy, etc. of the work pack. I guess I'm not sure what an FMEA requirement / function would be.
 
S

Shane61

#4
Hi
Thanks for the reply, in answer to your question,
Process Step - Review and Approve work pack
Requirement - Work pack approved by all parties in allocated time frame
Failure Mode - Missing/incorrect information not identified by reviewer in work pack
Effects - Re-work of work pack, Work pack was not approved by Customer
Causes - Untrained/inexperienced engineer. Procedural Failure, deviation/ MOC information not transferred to work pack procedures and drawings.

The reason we have so much discussion is, it looks like it could be a control, however the debate is that review & approve should be considered a separate operation on the flow diagram and FMEA when it is a separate step, and because in this instance the review and approval takes place and the next step doesn't take place until the product (work pack) has been reviewed and approved it is a process step
Personally as long as it has been considered within the FMEA I think we are getting a little hung up on this point.
 
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