FMEA 3rd edition - FMEA is required only for high risk operations?

[Andrews]

FMEA 2nd edition - under the "Development of process FMEA" it has been stated that a process FMEA should begin with a flowchart/resk assessment of the general process and in addition Appendix C says FMEA is required only for high risk operation but this statement has been removed from the third edition FMEA. Therefore are we required to look at the existing FMEA and conduct FMEA for medium and low risk operations.

[M Greenaway]

I thought FMEA was conducted on the product design and then on the process design, didnt think it went down to seperate FMEA's for seperate operations, unless by operations we mean processes.

Also how would one determine the risk without conducting an FMEA in the first place ??

Yours

MG

Confused

[Andrews]

I meant processes in the above query? My question was whether FMEA has to be done for all processes required for the product or only the high risk processes like palting , heat treatment that have no. of failures?

[Obi-Wan]

Having spoken with one of the contributors to SAE J1739 (the parent to Third edition), the "high risk" reference was removed because it was so subjective. The intent is that there is an FMEA for each process/operation. For those that are very generic (receiving operations or packaging might be an examples) "generic" FMEAs can be referenced, reviewed for the new product and revised as required as a time/effort saver.

OBI,

Were close but I differ in that a FMEA is a living document of the entire process to provide a part/product to the customer.

The FMEA starts with ordering and receiving raw material, processing, and final shipment of that product. I see no need for seperate FMEA's for each individual step in the process. I guess that would be to me just more of a document control aspect.

[brutas]

In Reply to Parent Post by Andrews

FMEA 2nd edition - under the "Development of process FMEA" it has been stated that a process FMEA should begin with a flowchart/resk assessment of the general process and in addition Appendix C says FMEA is required only for high risk operation but this statement has been removed from the third edition FMEA. Therefore are we required to look at the existing FMEA and conduct FMEA for medium and low risk operations.

I don't know for which second edition the question is about (and the posting is too old), but there is a JEDEC publication Potential Failure Mode and Effects
Analysis (FMEA):
http://www.jedec.org/download/search/jep131a.pdf

In the previous revision (JEP131, February 1998) flowchart/risk assessment of the process steps was recommended and FMEA was required only for high risk operations.
In the new revision this requirement was removed and I think this is right decision - risk assessment cannot be made before to make the FMEA.

What is your oppinion? One of our suppliers and one of our customers continues to make risk assessments of the process steps before FMEA form to be filled in. And only the operations with "Higher risks" are included in the FMEA...

[Jim Wynne]

In Reply to Parent Post by brutas

I don't know for which second edition the question is about (and the posting is too old), but there is a JEDEC publication Potential Failure Mode and Effects
Analysis (FMEA):
http://www.jedec.org/download/search/jep131a.pdf

In the previous revision (JEP131, February 1998) flowchart/risk assessment of the process steps was recommended and FMEA was required only for high risk operations.
In the new revision this requirement was removed and I think this is right decision - risk assessment cannot be made before to make the FMEA.

What is your oppinion? One of our suppliers and one of our customers continues to make risk assessments of the process steps before FMEA form to be filled in. And only the operations with "Higher risks" are included in the FMEA...

Don't confuse the process with the output. FMEA is not a document, it's a process, and the document is the output of the process. So when "risk assessments" such as those you refer to are being done, that is FMEA, and the ensuing decision involves only which aspects get documented.

[brutas]

In Reply to Parent Post by Jim Wynne

Don't confuse the process with the output. FMEA is not a document, it's a process, and the document is the output of the process. So when "risk assessments" such as those you refer to are being done, that is FMEA, and the ensuing decision involves only which aspects get documented.

My question is:
Why this risk assessment was removed in the JEDEC FMEA publication last edition? Is it because it was realized that is not relevant and makes non sense?

And I am sure that our supplier and our customer do NOT use the FMEA process for this risk assessment. They just make (like the previous Jedec version recommends) list of all process steps and for every step they mark "low" "medium" and "high risk" (I don't know how they decide for this) and only the items marked with "high risk" are considered further in the FMEA process...