Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

#1
Hello everybody,

I am running a discussion with a newbie customer SQA regarding the link between FMEA, flow chart and control plan.

As per my knowledge, all the phases I identify in my flow chart shall be reported with the same number (or name) in my FMEA. In my control plan I should report only those phases where I have established a visual or a measureement check or whater cheks which might effect the quality of my product.

For example, if I have an internal Handling phase (#20) related to material movement from warehouse to machine and I have no checks on the material when arrive to press then I have nothibg to mention in the control plan, but ovviosly yes in the flow chart and FMEA.

Am I right?

Thanks in advacne and sorry for the stupid question.
 

outdoorsNW

Involved In Discussions
#2
Can you give more details about what the customer is asking for?

I am guessing the customer is concerned there is not a line in the control plan for something that is in the flowchart and FMEA. I have two thoughts. 1) You may actually have a weak control from verifying the part number, job number, outputting a computer generated delivery location, or similar for the material. 2) If you do not have any controls, which may be reasonable if there are good controls in other places, you may need a line with "none" or similar to indicate there is not an unintentional omission.
 

Jim Wynne

Super Moderator
#3
Hello everybody,

I am running a discussion with a newbie customer SQA regarding the link between FMEA, flow chart and control plan.

As per my knowledge, all the phases I identify in my flow chart shall be reported with the same number (or name) in my FMEA. In my control plan I should report only those phases where I have established a visual or a measureement check or whater cheks which might effect the quality of my product.

For example, if I have an internal Handling phase (#20) related to material movement from warehouse to machine and I have no checks on the material when arrive to press then I have nothibg to mention in the control plan, but ovviosly yes in the flow chart and FMEA.

Am I right?

Thanks in advacne and sorry for the stupid question.
It's not at all a stupid question, but it sounds like your customer might be asking one. You are correct. A big part of the APQP process is narrowing down, using experience and evidence, what needs to be controlled, and the extent or type of controls to use. This means that while in general the flow diagram and PFMEA should match 1:1, that's not necessarily the case with the control plan. The control plan should display what needs to be controlled, and not be cluttered up with a bunch of N/A entries.

Be aware (if you aren't already) that common sense often goes out the window when dealing with customer quality people. Despite best efforts in explaining why you do things, you might wind up having to do extra, nonsensical work in order to move forward.
 
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#5
Thanks a lot for your feedback. Appreciated.
At the end I convinced the guy and avoid stupid NC. Anyhow Yesterday we did internal sysmet audit using external IATF auditor and I made the same question. He agreed with our statement but he also said that, ufortunately, the result of the discussion might be completly differnt because is linked with the auditor mindset.
Regards.
 
#7
Hello
Please i want to perform FMEA process , i started with making the organigram to see the components for which the process is being analyzed and to select the risks that can appear from this components
So my question is when i solve like that is not about FMEA design ?? or is already correct
 

Jim Wynne

Super Moderator
#8
Hello
Please i want to perform FMEA process , i started with making the organigram to see the components for which the process is being analyzed and to select the risks that can appear from this components
So my question is when i solve like that is not about FMEA design ?? or is already correct
I'm not sure what an organigram is, but it seems more like a DFMEA than a PFMEA. The latter is intended to deal with the risks of a manufacturing process rather than individual components. Please explain in more detail.
 
#9
I'm not sure what an organigram is, but it seems more like a DFMEA than a PFMEA. The latter is intended to deal with the risks of a manufacturing process rather than individual components. Please explain in more detail.
Thank you so much mr jim for your quick answer
The thing that i have special process ( macrography inspection) so FMEA analysis will let discovering the risks that can appear and effect the part inspected , so i want to solve with the compements for example ( tanks / heater / thermometer ... because the malfuction of this component will effect the parts ) this is why i want to perfom PFMEA but in DFMEA way , i don't know if it could be or not . the important think is to avoid risks on this macro-process
 

Jim Wynne

Super Moderator
#10
Thank you so much mr jim for your quick answer
The thing that i have special process ( macrography inspection) so FMEA analysis will let discovering the risks that can appear and effect the part inspected , so i want to solve with the compements for example ( tanks / heater / thermometer ... because the malfuction of this component will effect the parts ) this is why i want to perfom PFMEA but in DFMEA way , i don't know if it could be or not . the important think is to avoid risks on this macro-process
I'm not sure that I understand. "Macrography" is visual (naked eye) inspection. Are you concerned about the manufacturing process (in which PFMEA would be appropriate) or something related to the inspection itself?
 

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