Please review my Process Flow / PFMEA / Control Plan

fraktion

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#1
Hello all.

I wonder if some of the wiser guru's here could give my PFMEA a once over? It would be greatly appreciated. I've never had any formal training in them and have kind of picked it up as i've gone along. I've had to do 15 different ones for a suite of products lately, i'd just like to know i'm on the right track.

The attached has been updated recently as a result of an 8D on some pre-production parts. One dimension was out. Please could you have a look and tell me if it would survive a product readyness review or whether i'd be laughed out of the building!

I'm coming from a plastic injection moulding background.

Thanks for you time :)

Young Fraktion.

Edit: Just had to remove the process flow for size issues.
 

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Jim Wynne

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#2
Hello all.

I wonder if some of the wiser guru's here could give my PFMEA a once over? It would be greatly appreciated. I've never had any formal training in them and have kind of picked it up as i've gone along. I've had to do 15 different ones for a suite of products lately, i'd just like to know i'm on the right track.

The attached has been updated recently as a result of an 8D on some pre-production parts. One dimension was out. Please could you have a look and tell me if it would survive a product readyness review or whether i'd be laughed out of the building!

I'm coming from a plastic injection moulding background.

Thanks for you time :)

Young Fraktion.

Edit: Just had to remove the process flow for size issues.
It would be a good thing to see the process flow diagram, if you could reduce the file size somehow. What's the file format and size? There are some issues with your PFMEA and control plan, but they start with the PFD.
 
D

DrM2u

#3
I took a look at the PFMEA and I'd say that it looks OK for a first shot at it. One thing that stuck out at first was that 'operator failure' was a frequent cause of failure. Also the process controls seem a little weak, often focused on training, instead of instructions for the operators, product inspections, process and tooling/gauges verification and monitoring, etc.

Here is one suggestion I have and that I used myself: create a PFMEA for each major process step. Most of them are general and generic process steps, like receiving, shipping, material handling, etc. The only PFMEA that would change with product family or be product specific would be the one for the molding process. I am attaching for your reference a sample PFMEA and Control Plan for the Receiving process.

I hope this helps. Keep up the good work, you are on the right track as long as you want to improve and be better at what you do!
 

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fraktion

Involved In Discussions
#6
DrM2u. Whilst it's in my head, the product doesn't require any gauges. There are no key/special characteristics on the drawing. All process controls would lay at the hands of an operator, apart from the first off being measured to drawing and sample inspection at the end via a quality engineer.

There are instructions on our job cards as well as hourly checks via a supervisor. Should these additional checks be added in? thank you for your help :)
 

qusys

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#7
DrM2u. Whilst it's in my head, the product doesn't require any gauges. There are no key/special characteristics on the drawing. All process controls would lay at the hands of an operator, apart from the first off being measured to drawing and sample inspection at the end via a quality engineer.

There are instructions on our job cards as well as hourly checks via a supervisor. Should these additional checks be added in? thank you for your help :)
Hi,
I think you should use the last updated form for process FMEA . You can check in the last edition of FMEA Blue Book.
In the Control plan, reaction mechanism should be link or referred. Special characteristics should be indicated too.:bigwave:
 
D

DrM2u

#8
fraktion, to answer to your last question, I have attached the tool I used for process development for the Moulding part of the process flow. :read: I hope that the PFMEA and Control Plan part of it will shine some light regarding the use of gauges, who, when, where, etc. There are some additional tools in there that might help as well. Feel free to use the information as you wish. Best of luck! :agree1:
 

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M

Malito

#10
Hello Folks,
I'm looking for some advice regarding a question I have for the linkage of the PFD - FMEA - CP. I was reading the thread, but didn't find somethig related so I preffer to ask.

I have a linked my Process Flow Diagram with the PFMEA and CP activity by activity , except by one operation; this operation it's a movement of raw material from the receiving area to my warehouse. Reason for not including it is that I do not see any risk that is worth to write in the PFMEA for this movement of material, neither do I perform any inspection for this movement, nevertheless my customer is aking me to link all documents to match 100% .

Question: am I doing wrong not including the movement listed in Flow process diagram int o PFMEA and CP? what is your opinion? it would be better to erase the movement from the PFD or must I include something to control and observe for this movement in my CO and PFMEA?

Many thanks in advance for your opinion.


Saludos a Todos !
 
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