Linking: Process Flow - 'Common' Process FMEAs - Control Plan

B

brutas

#1
Hello,

As we know first is Process flow then a PFMEA should be made and at the end comes Control plan.

The problem in our company is that we do not make single product related PFMEAs but PFMEAs for a group of products. Next to this we have separate PFMEAs for common processes like: "Reception and incoming inspection", "Storage", "Packaging and shipping", "Outgoing inspection"...

Process flows of most of our products include these processes.

At the same time we make separate PF and CP for every product. Some of our customers require PF, PFMEA and CP to be made for their product only. They want PFMEA to cover the entire flow - from "Reception and incoming inspection" to "Packaging and shipping"...

Could you advise how the link PF-PFMEA-CP is organized at your company. How do you proceed in case of huge variety of products? Do you make one and the same PFMEA for group of devices?
 
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P

preetham - 2007

#2
Hi brutas
I can give my openion in this manner.
First i want to ask you that, are you doing any manufacturing or machining activities in your organisation?
 
P

preetham - 2007

#3
Hi brutos ,to my knowledge
If your process flow is same for all your products.then you can do PFMEA & control plan for individual process .
If any customer need PF,PFMEA,control plan for a perticular part you can submit the process flow strightaway and for PFMEA & control plan you can give refference of the other components for which you have made the PFME & control plan earlier (that component must have the same specifications & requirement)
is my openion is ok guys?:cfingers:
 
Q

quality.shesha

#4
preetham said:
Hi brutos ,to my knowledge
If your process flow is same for all your products.then you can do PFMEA & control plan for individual process .
If any customer need PF,PFMEA,control plan for a perticular part you can submit the process flow strightaway and for PFMEA & control plan you can give refference of the other components for which you have made the PFME & control plan earlier (that component must have the same specifications & requirement)
is my openion is ok guys?:cfingers:
Hi Preetham,

lemme me put this way,

i feel
it is not necessray that the component must have the same specifications & requirement to do a group of FMEA together.

shesha
 
Q

quality.shesha

#5
brutas said:
Hello,

As we know first is Process flow then a PFMEA should be made and at the end comes Control plan.

The problem in our company is that we do not make single product related PFMEAs but PFMEAs for a group of products. Next to this we have separate PFMEAs for common processes like: "Reception and incoming inspection", "Storage", "Packaging and shipping", "Outgoing inspection"...

Process flows of most of our products include these processes.

At the same time we make separate PF and CP for every product. Some of our customers require PF, PFMEA and CP to be made for their product only. They want PFMEA to cover the entire flow - from "Reception and incoming inspection" to "Packaging and shipping"...

Could you advise how the link PF-PFMEA-CP is organized at your company. How do you proceed in case of huge variety of products? Do you make one and the same PFMEA for group of devices?
Hi Brutas,

In our company too we had the same situation
ours was a manufacturing industry
we were supplying to OEM's
What we had made is, we made groupings for the products for the same customer and we used to make one PF-PFMEA-CP for 10-12products which had a similar process
I beilieve this should be fine.

Shesha
 

Jim Wynne

Staff member
Admin
#6
brutas said:
Hello,

As we know first is Process flow then a PFMEA should be made and at the end comes Control plan.

The problem in our company is that we do not make single product related PFMEAs but PFMEAs for a group of products. Next to this we have separate PFMEAs for common processes like: "Reception and incoming inspection", "Storage", "Packaging and shipping", "Outgoing inspection"...

Process flows of most of our products include these processes.

At the same time we make separate PF and CP for every product. Some of our customers require PF, PFMEA and CP to be made for their product only. They want PFMEA to cover the entire flow - from "Reception and incoming inspection" to "Packaging and shipping"...

Could you advise how the link PF-PFMEA-CP is organized at your company. How do you proceed in case of huge variety of products? Do you make one and the same PFMEA for group of devices?
The AIAG requirements allow for "family" PFDs, FMEAs and control plans for parts which have common processing. "Processing" includes everything from receiving raw materials to shipping finished product. If there are significant differences in processing for different parts, those differences should be reflected in the documentation. This is especially true when it comes to special charactreristics. If processing is substantially similar enough to allow for "family" documentation, there's no reason that the PFD, PFMEA and PCP shouldn't line up. If they don't line up, you don't have a "family."
 

Miner

Forum Moderator
Staff member
Admin
#7
There needs to be another test to confirm that all products belong in the same family.

This test is: Do each of the products in the family experience the same type and rate of nonconformances both internally and externally? If you have a product that experiences a unique nonconformance or a significantly different rate of failure, you need to investigate further before grouping them into that family.

Regarding the handling of the common processes, I recommend numbering the PFMEAs and then referring to them in the appropriate section of the part/family PFMEA. For example, create a section called Receiving then state "See PFMEA # xxxxx, Receiving".
 
D

DeLaina Green

#8
Grandfathering (Control plans for all processes or not)

I am pretty new to the cove but have to say you guys have helped me tremendously with my TS implementation.....but could not help the fact that I failed my stage 1 audit. My auditor was Peter Theobald, NQA (08-05) and I failed due to I only met the shalls and did not grasp the whole philosophy thing of what the standard is trying to accomplish and reading between the lines; blah blah blah. I have tried to approach it differently but still have my doubts of what I am really trying to accomplish. I noticed several people in this thread have passed their stage 1 with some nonconformances identified but I was told that the stage 1 was pass or fail; you either have it or not. :confused:

We have several different products that we manufacture (heavy truck industry) and we group our FMEA and Control Plans in families. My question for everyone is, we are a very old company and have several product lines that have been around for a long time. We have control plans for most of our product familes but are lacking a few on the older lines. I know the standard TS says control plans for (7.5.1.1)........but is anyone aware of any exceptions made for older companies. I was given advice that we would be okay as long as I could show processes as stable and final product okay. It would be almost impossible to get control plans for all of my processes considering some of them we only manufacture about 50 pieces a year. What value could it add to our already overworked staff to design control plans for these processes? :bigwave:
 
B

brutas

#9
preetham said:
Hi brutas
I can give my openion in this manner.
First i want to ask you that, are you doing any manufacturing or machining activities in your organisation?
Yes, we have manufacturing. We use different types of machines.
 
B

brutas

#10
Jim Wynne said:
The AIAG requirements allow for "family" PFDs, FMEAs and control plans for parts which have common processing.
Jim,
Could you specify where this is written? Which of the AIAG books?
 
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