Process FMEA Scope - Does PFMEA cover Incoming (Receiving) Inspection & Dock Audit?

Hello everyone,
yesterday our new customer had an internal audit in our plant, one of open issues is " PFMEA does not cover overall processes, including <1>materials stock-in, <2>finished goods stock-in and <3>dock audit..." I have never seen a PFMEA involing incoming materials and out-going products. as we just perform incoming mat'l inspection and sampling check our finished goods. are such PFMEAs mandatory? as far as know, P--Process, only covers from the first working station to the last working station of an assembly line, excluding incoming / dock audit inspection. Am I right?
BTW, Our product is motor.
Thx in advance.

Process FMEA's

"Process" goes further than Manufacturing Process.

In ISO TS - item 7.3.1.1 it is stated that FMEA's ( and control plans ) should be developed to prepare for product realisation. And this is a lot more than only the manufacturing process.
On the other hand in item 7.3.3.2 there is a specific question for manufacturing process FMEA.

Hope this clarifies a bit.

Antoine

I have always beleived that the PFMEA should cover the whole process from receipt to dispatch.
Does your control plan and flow chart cover these areas?
If so then the PFMEA must as well.

In the past, we restricted our PFMEA's to processes that we actually controlled. However, after much discussion with our major customers, and THEIR customers (Ford most especially) we have rethough our strategy.

We now include all processes, from raw material in, to finished goods out. We normally have several outsourced processes as well (deburring, heat treating, plating) and we try and identify the MAJOR potential failures in their processes, to show what WE are doing to either prevent or detect those failures.

One other thing that we have added is failures which relate to health and safety, since they impact our ability to meet customer requirements. I have shared a generic PFMEA which we have developed in the past, and would be happy to share it if anyone would like to see.

Helllo all,

thank you for your helps, but I am still confused about the control plan (CP) and PFMEA, yes, we have incoming material CP, production CP, dock audit CP for different stage use, olny Production CP prepared based upon the PFMEA, as to the other 2 types of CPs, we have no FMEA for reference except for the Key Control Characteristics in the engineering drawings. maybe it is a systematic problem in our plant?
I cannot find an FMEA reference manual in English version. Sigh~~~

Dear Mr. Ron Rompen,
could you please attach the past PFMEA of yours for our information? thanks a lot in advance!!

Buffalo

Ask and ye shall receive.

The macro attached to this file is a non-entity....it actually serves no purpose (from a previous PFMEA revision).

If anything needs clarification, don't hesitate to ask.

Flow/FMEA/Control Plan

buffalo_hua said:

Hello everyone,
yesterday our new customer had an internal audit in our plant, one of open issues is " PFMEA does not cover overall processes, including <1>materials stock-in, <2>finished goods stock-in and <3>dock audit..." I have never seen a PFMEA involing incoming materials and out-going products. as we just perform incoming mat'l inspection and sampling check our finished goods. are such PFMEAs mandatory? as far as know, P--Process, only covers from the first working station to the last working station of an assembly line, excluding incoming / dock audit inspection. Am I right?
BTW, Our product is motor.
Thx in advance.

Click to expand...

Hi Buffalo_hua

We just got whacked pretty hard during our TS16949 audit for being "part" focused on our control plan.

They reminded us that first you map your process flow (sorry to say starting at receiving and ending at shipping), then you do FMEA to prioritize risks, then put in place controls in a control plan to mitigate those risks.

The reminded us it was a P for Process not P for Part control plan.

Like most auto suppliers, we just pulled the critical part dimensions off the customers print and called it done. D'oh!

So we have lots of work ahead of us...now that we see it more clearly we were missing many operations that can and have caused problems.

So I guess I agree with your customer. Dock to dock. Good luck.

Thanks for the example PFMEA attached. Could you please send the subsequent control plan generated from this PFMEA as an example to be used for training purposes.

We are in our infancy of using FMEAs and Control Plans.

Thanks!

...include all processes, from raw material in, to finished goods out.

Click to expand...

QS-9000 required this - The requirement is not new.