Links between Process Flow, Process FMEA and Control Plan

[shallowmike]

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

 

[Jim Wynne]

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.

 

[Bill Ryan - 2007]

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.

 

[shallowmike]

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

 

[Icy Mountain]

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.

 

[kemble]

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

thanks a lot.

 

[Jim Wynne]

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.

 

[raju8177]

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.

 

[raju8177]

Required help.....

 

[Jim Wynne]

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.