Hello everybody,

I have serious problem with our PFMEAs.
Our PFMEAs are process related documents. For example process Incoming inspection or process Final test...
Most of our customers require PFMEA to be made for their product only (for example: start with Incoming inspection and finishing with Shipping)
We cannot generate PFMEA for every single devise - they are hundreds!
Please advice is there any written rule? How to convince customers to accept PFMEAs made in such way?

Second question: Is there any written rule describing how Process flow and Control plan to be linked to the PFMEA? I need comprehensive guide (different from AIAG FMEA book)

Hello everybody,

I have serious problem with our PFMEAs.
Our PFMEAs are process related documents. For example process Incoming inspection or process Final test...
Most of our customers require PFMEA to be made for their product only (for example: start with Incoming inspection and finishing with Shipping)
We cannot generate PFMEA for every single devise - they are hundreds!
Please advice is there any written rule? How to convince customers to accept PFMEAs made in such way?

If your customers are automotive, the general expectation is that PFMEAs will be based on individual products, because that's the way the APQP process is supposed to work. There are usually allowances made for "family" products--products for which your process is essentially the same. The soon-to-be obsolete 3rd Edition PPAP manual says, "Asingle Design or Process FMEA may be applied to a process manufacturing a family of similar parts or materials."

Second question: Is there any written rule describing how Process flow and Control plan to be linked to the PFMEA? I need comprehensive guide (different from AIAG FMEA book)

I don't know of a comprehensive guide, but I'm not sure one is necessary, either, insofar as the PFD-PFMEA-PCP progression is concerned. You start with the flow diagram, review each step or operation using the PFMEA process, and output from the PFMEA becomes the control plan. There should be one-to-one linkage by process or operation between the three documents, although not all of the operations or steps shown on the PFD and PFMEA will necessarily reach the control plan.

Let’s try a simple example:

You have a production process for machining a metal part from raw stock that flows like this:
1 - Receiving
2 - Machining
3- Shipping
Of course, you have a process flow diagram that shows these steps.

In the PFMEA, number them the same way and list the process, potential failure mode, etc. across the page:
1-1 Receiving, incorrect components
1-2 Receiving, damaged components
1-3 etc.
2-1 Machining, incorrect setup
2-2 Machining, part incorrectly machined
2-3 etc.
3-1 Shipping, damaged parts
3-2 Shipping, corroded parts
3.3 etc.

In the Control Plan list them the same way with the Process Name, Control Method, etc. across the page:
1-1 Receiving, Incoming Inspection for Kind, Count and Condition Procedure
1-2 Receving, Incoming Inspection for Kind, Count and Condition Procedure
1-3 etc.
2-1 Machining, Machining Setup Instruction for part number XYZ.
2-2 Machining, Test and Inspection Instruction for part number XYZ.
2-3 etc.
3-1 Shipping, Packaging and Protecting for Shipment Procedure
3-2 Shipping, Oil coating of metal parts for shipment Procedure
3-3 etc.

Even if you machine 57 different parts you could use the same Control Plan for each, assuming that you have a specific Setup, Test and Inspection Procedure that is readily available for each part.

If any of these parts have "special characteristics", don't for get to identify them with the proper symbol(s) in the PFMEA, Control Plan AND the individual Test/Inspection Instructions or Checksheets.

There should be one-to-one linkage by process or operation between the three documents, although not all of the operations or steps shown on the PFD and PFMEA will necessarily reach the control plan.

That's the problem: One of our customers insist that except all detection controls which have to be present in the Control Plan all prevention controls also have to be put the Control Plan. This is not relevant because how could you add in the Control Plan some prevention activity such "Regular operator training" - it is nonsense...
That's why I need comprehensive guide about how to link all these documents and to quote it at the customer...

That's the problem: One of our customers insist that except all detection controls which have to be present in the CP all prevention controls also have to be put the CP. This is not relevant because how could you add in the CP some prevention activity such "Regular operator training" - it is nonsense...
That's why I need comprehensive guide about how to link all these documents and to quote it at the customer...
Brutas, see above. Covering a steel part with oil as a corrosion protection in shipping is a preventive control. Would you want to ship from Bulgaria to Canada, across the Atlantic, without such a control?
-Icy

That's the problem: One of our customers insist that except all detection controls which have to be present in the CP all prevention controls also have to be put the CP. This is not relevant because how could you add in the CP some prevention activity such "Regular operator training" - it is nonsense...

If you have a comprehensive understanding of what you're doing and why you're doing it, you should be able to discuss the issue with a customer and explain why you do things the way you do. At that point, if the customer still isn't buying it, you have to either give up and do it their way or escalate the issue to higher management level.

That's why I need comprehensive guide about how to link all these documents and to quote it at the customer...

You're not going to find any sort of publication lists all of the possible permutations. Furthermore, if you talk good sense with your customer and he still doesn't get it, approaching him with a book (especially one that lacks any sort of normative authority) isn't going to help. If a supplier comes to me with a better way of doing something, I listen. But if I listen and don't agree that the method is valid, reading a book about it probably won't help.

OK,
Then please recommend some FMEA software (download trial version) which LINKS PF PFMEA and CP.
I want to see how the links are organized and thus what correlation is most appropriate.

OK,
Then please recommend some FMEA software (download trial version) which LINKS PF PFMEA and CP.
I want to see how the links are organized and thus what correlation is most appropriate.
Follow this link for the best integrated software I've run across (there are threads here which discuss PFMEA software - try a search to read some of those. Also, scroll down and check out the related threads listed towards the bottom of this page.). There is a link for a demo but I've not checked the demo version. Perhaps if Rich Harpster sees this he will contact you with further info.

I have no affiliation with HarpCo other than using their product.

http://harpcosystems.com/

I once used a software that automatically generated, linked and updated both FMEA and Control Plan. This was in 1998, and was used exclusively for all the products at that company. It was called "Impact". I thought it was rather laborious at first, but after using it a few times was OK. This was a Tier 1 to GM, Ford, Chrysler, Mercedes, Freightliner, etc. I left there in 1999 and they were still using it.
Maybe some others here have used it and have further input.
However, I perfer jus plain old excel for the company I am with now.

Hi, I to have an issue with a control plan but from an internal auditor view point. In the reaction column is it a requirement to complete this for a particular process that historically never goes wrong. I argue that any process can fail even if procedures are followed. I am getting beaten up by our quality department who say there is no need to fill this section in. The process in question is cleaning component parts.

Can anyone help why I look for my tin helmet. Shallow Mike

Hi, I to have an issue with a control plan but from an internal auditor view point. In the reaction column is it a requirement to complete this for a particular process that historically never goes wrong. I argue that any process can fail even if procedures are followed. I am getting beaten up by our quality department who say there is no need to fill this section in. The process in question is cleaning component parts.

Can anyone help why I look for my tin helmet. Shallow Mike

The methods for dealing with nonconforming product should be uniform--identify, segregate, evaluate and disposition. You should have a written procedure that covers this, thus you can just reference that procedure in the "Reaction Plan" column. That column is not a good place for going into a lot of specific detail. If nothing ever goes wrong with the operation in question, why is it on the control plan at all? If it must be controlled somehow, then there is opportunity for failure.

Hi, I to have an issue with a control plan but from an internal auditor view point. In the reaction column is it a requirement to complete this for a particular process that historically never goes wrong. I argue that any process can fail even if procedures are followed. I am getting beaten up by our quality department who say there is no need to fill this section in. The process in question is cleaning component parts.

Can anyone help why I look for my tin helmet. Shallow Mike
In short - with all automotive customers I've dealt with anyway - Yes it is a requirement to fill in the Reaction Plan if there are any Process or Product characteristics listed for that operational step. The column is in place to show a customer what you do when the "process that historically never goes wrong" does go wrong and produces a nonconformance.

Thanks Guys,

My thoughts entirely, my argument was as a pfmea was produced with that part of the process in and its associated risks then a reaction plan must be included. My company is in transition period with old school ideas and dont understand that N/C's will result in that TS journey.Your comments have tipped the balance in my favour. Cheers

The methods for dealing with nonconforming product should be uniform--identify, segregate, evaluate and disposition. You should have a written procedure that covers this, thus you can just reference that procedure in the "Reaction Plan" column. That column is not a good place for going into a lot of specific detail. If nothing ever goes wrong with the operation in question, why is it on the control plan at all? If it must be controlled somehow, then there is opportunity for failure.
My Control Plans all have:

Verification of Purchased Product as the first Process Name
Specific Product is listed under Product
Warehouse Team under Process
Per the Purchasing, Verification of Purchased Product Procedure under Product/Process Specifications/Tolerance, Evaluation Measurement Technique, and Control Method.
Reject, complete Supplier Corrective Action Request under Reaction Plan.

The details for each part are listed in our online specifications by part number so the Verification procedure says something like "inspect per part XYZ specs". No reason to list them all in the Control Plan.

SOMETHING can always go wrong in any process. The Control Plan should list all the processes in the flow and reference your standard non-conforming procedure as the reaction at the very least.

Could someone post a diagram to explain the relationship among PFD/PFMEA/CP,especially the linkage between PFMEA and CP.

thanks a lot.

Could someone post a diagram to explain the relationship among PFD/PFMEA/CP,especially the linkage between PFMEA and CP.

thanks a lot.

I don't have a diagram, and don't think it's necessary. The PFD shows the process operations in order of execution; those operations are transferred (in the same order) to the PFMEA form, and when the PFMEA is complete, the same operations are transferred to the PCP form and the relevant process and product controls are entered. In some cases it might not be necessary to transfer all of the operations shown on the PFD and PFMEA forms to the control plan form. It may be determined during the PFMEA process that certain operations don't require special controls due to the low risks involved.

Hello everybody,

I have serious problem with our PFMEAs.
Our PFMEAs are process related documents. For example process Incoming inspection or process Final test...
Most of our customers require PFMEA to be made for their product only (for example: start with Incoming inspection and finishing with Shipping)
We cannot generate PFMEA for every single devise - they are hundreds!
Please advice is there any written rule? How to convince customers to accept PFMEAs made in such way?

Second question: Is there any written rule describing how Process flow and Control plan to be linked to the PFMEA? I need comprehensive guide (different from AIAG FMEA book)



Hello Everybody, Good evening,


Here I want to add one query. Which we are having major issue & misunderstanding during preparing a Process Flow.

What would be the " Incoming Source of Varition" in each process?

We are having lots of confusion. As per one of my team met it should be the varition which occured in previous process Characteristics. But we are thinking of the Previouss process Product characteristics which was not meeting the specification.

Can I get a valuable results.

Required help.....

Hello Everybody, Good evening,


Here I want to add one query. Which we are having major issue & misunderstanding during preparing a Process Flow.

What would be the " Incoming Source of Varition" in each process?

We are having lots of confusion. As per one of my team met it should be the varition which occured in previous process Characteristics. But we are thinking of the Previouss process Product characteristics which was not meeting the specification.

Can I get a valuable results.

I don't know why you want to get into that level of detail in a process flow diagram. That's what the PFMEA is for. The PFD should be as simple as possible--all you need to do is show the process operations in order of execution. Once you have that, and the PFMEA process begins, you can consider sources of variation and the risks associated with them.