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Process to use Special Characteristics as FMEA Inputs

R

riversince83

#1
Special Characteristic would be got from Customer, Regulation, and similar part FMEA. When we start to use FMEA, the special characteristic as above will be a base as well as an input to FMEA. The FMEA will also identify some new special characteristic by severity and occurrence. My question is that the input special characteristic will definitely to be defined as a high severity one that will link to our internal criteria (like severity : 9 -10) and be the same way to marked SC or CC? Should we use another symbol to identify it?

If the special characteristic from customer is been solved by Actions of FMEA, should it still to be put in the control plan?:thanx:

the process is as attachment.
 

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qusys

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#2
Re: Process to use Special Characteristic as a input of FMEA

With regards to your second question , you shall insert the controls you put in place ( derived from P-FMEA for the specific potential failures you have identified) in your control plan. P-FMEA outputs feed the control plan. It could be unproper to say that actions of P-FMEA solve the identified risks: they shall be translated into controls used in control plan. For a right approach, you shall start from the process flow ( from incoming to shipping through production ) and identify/evaluate the potential failures. So, thake into consideration all the process flow, not partially including only production.

For the first question , consider that special characteristics can also be identified by the organization itself. In my opinion , it is unproper to say that special characteristic have a high severity, this shall be said for the the potential failure.
As to the identification with marks of the special characteristics, you shall confrom to the customer requirements for this clause (7.2.1.1). So, check this with your customer.
I think that at the end you will sign off a PPAP and in these documentation you can report all .
Hope this helps:bigwave:
 
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E

erichau

#3
Re: Process to use Special Characteristics as a FMEA Inputs

Please try to understand the definition of the special charateristic,
on the TS technical specification, it states that product characteristic or manufacturing process parameter which can affect safty compliance with regulations,fit,function,performance or subsequent processing product.
So when you develop the PFMEA, you may find some way to prevent it from happening frequently,but you can never change its importance, they still affect regulation,fit,function,performance or subsequent processing product. So the SC should be remained.
 
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