We recently had an external consultant tell us we needed to have FMEAs for our inspection and test processes as well as incoming materials and shipping. The standard and its companion the semi conductor commodity supplement, indicates that they must be quote "considered" in FMEAs and Control plans. I did not translated the word considered to mean a whole separate FMEA. My understanding of the TS is that one is needed for Design and one for MFG.
My question is at what decides how many FMEAs you need to have? Do most companies typically have an FMEA for every process that affects quality or do they have just a few FMEAs that integrates the processes?
:argue:

We recently had an external consultant tell us we needed to have FMEAs for our inspection and test processes as well as incoming materials and shipping. The standard and its companion the semi conductor commodity supplement, indicates that they must be quote "considered" in FMEAs and Control plans. I did not translated the word considered to mean a whole separate FMEA. My understanding of the TS is that one is needed for Design and one for MFG.
My question is at what decides how many FMEAs you need to have? Do most companies typically have an FMEA for every process that affects quality or do they have just a few FMEAs that integrates the processes?
:argue:

There is no requirement for separate documents. If your consultant thinks that there is, he/she needs to be corrected. My own view is that inspection and test should be considered integral operations in what ISO refers to as the "product realization" process, and thus should be included in a single comprehensive PFMEA whenever possible.

My question is at what decides how many FMEAs you need to have? Do most companies typically have an FMEA for every process that affects quality or do they have just a few FMEAs that integrates the processes?
:argue:

Hi QualityBoi,
I believed the question here should not be how many FMEAs a company would need to have and it also does not matter so much as to whether it should be integrated into one FMEA or should it be separated into multiple FMEAs.
The key question here is if you decide to adopt FMEA, then you should most probably want to assess through the risks associated with each and every processes so as to mitigate or eliminate such risks that could affect the company's quality and bottomline. All in all, it is the improvement actions that are generated from the risk assessment that matters and not how many FMEAs are generated. :biglaugh:
thks.
jeffrey.

I am new to this site and would like to know if anyone has examples of Shipping, Receiving and Incoming Inspection FMEAs that they could please share with me? We are an automotive Tier 1 supplier and are having to create these FMEAs. Is there any Logistic FMEA training available?
Thanks.

FJ - welcome:

as ever, your best place to start is with a search of the various forums - you will find plenty of examples.

We recently had an external consultant tell us we needed to have FMEAs for our inspection and test processes as well as incoming materials and shipping. The standard and its companion the semi conductor commodity supplement, indicates that they must be quote "considered" in FMEAs and Control plans. I did not translated the word considered to mean a whole separate FMEA. My understanding of the TS is that one is needed for Design and one for MFG.
My question is at what decides how many FMEAs you need to have? Do most companies typically have an FMEA for every process that affects quality or do they have just a few FMEAs that integrates the processes?
:argue:

Typically, the Process FMEA is developed from the Process Flow Chart and should contain all aspects of processing from receipt of supplied products (raw materials etc.) to the shippiing of finished product. That way you will be able to have one PFMEA and have considered the things you mentioned.

If you decide to change consultants, I'm available to help:notme:

Typically, the Process FMEA is developed from the Process Flow Chart and should contain all aspects of processing from receipt of supplied products (raw materials etc.) to the shippiing of finished product. That way you will be able to have one PFMEA and have considered the things you mentioned.


Yes--one PFMEA for each product, or family of products.