FMEA/DCP Structure and Quantity - Similar Parts and Processes

#1
Hey,

My boss wants to create a DCP/FMEA for each part we manufacture. That would be over 150 parts, all of which run through the same machines following almost identical process.

Should we create 150 documents which are practically identical or one high level document which follows the broad strokes and has caveats for unique steps?

I'm worried about when a change may come to the process causing a requirement for sweeping updates to all 150 documents.
 
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Jane_S

Starting to get Involved
#2
I think you have answered your own question here. If the parts essentially are not different from one another (in terms of use/safety/general production process steps etc.) one document should suffice. You can also consider splitting the devices into several 'families' of devices.
 
#3
I think you have answered your own question here. If the parts essentially are not different from one another (in terms of use/safety/general production process steps etc.) one document should suffice. You can also consider splitting the devices into several 'families' of devices.
Moving away from automated identical process. Say you have 3 manual assembly lines that handle 70 products. Each line is configured differently to handle a grouping of products with similar processes. Each product though still has slightly different components and assembly operations.

Does each product need its own FMEA/DCP?

I have the same worry as above, managing each document during a sweeping change to the assembly lines. Also, many of the product operations, such as screwing in components, would have identical failure modes.
 

Ninja

Looking for Reality
Trusted Information Resource
#4
Note that "Suffice" and "Should" and "My Boss Wants" are three very different things.

I agree with Jane S. on the "Suffice" part.
Your common sense can guide you on the "Should" part.
And "save as" can help you with the "My Boss Wants" part if you can't talk your way around it.

If "Suffice" and "should" are already met...explain that, as well as the added expense of managing the document copies for similar products...but at the end of the day...the word "Boss" is there for a reason...don't lose sight of it.
 

GRP

Involved In Discussions
#5
Moving away from automated identical process. Say you have 3 manual assembly lines that handle 70 products. Each line is configured differently to handle a grouping of products with similar processes. Each product though still has slightly different components and assembly operations.

Does each product need its own FMEA/DCP?

I have the same worry as above, managing each document during a sweeping change to the assembly lines. Also, many of the product operations, such as screwing in components, would have identical failure modes.
If you are in the automotive industry and you want to align with SAE J1739, then:

A process family FMEA is a PFMEA covering a series of operations that produce multiple products or part numbers. Processes producing many similar products do not need unique FMEA’s for each product. The family PFMEA is dictated by the manufacturing process that is used to make the product, not by the product’s functional requirements or application. When the manufacturing process is the same as other parts in the family then a family PFMEA is appropriate.

In this way you can justify having, say, 3 family PFMEAs for each 70 product assembly line. Make sure you maintain an updated reference to the drawings, and make sure you do not compromise on the pfmea outputs. I would definitely raise the issue to the boss with an argument backed up by standards and regulations.

A further note on this line: The family PFMEA is dictated by the manufacturing process that is used to make the product, not by the product’s functional requirements or application

I would tread with caution the statement that the intended application of the product is beyond the scope of the PFMEA. As I have argued in this thread PFMEA severity score different applications, the application of the product IS important for the effects and severity table.
 
#6
Thanks, this discussion so far has been very helpful.

I was recently at a conference where I was able to discuss this topic with some other QE's. They all agreed that a family PFMEA was the right choice although they added that to capture the unique aspects of certain products, you may still need smaller product PFMEAs. The content of these product PFMEA would only cover unique attributes such as special steps, materials or quality incidents among other things. For all generic steps on the product PFMEA, the line would state the step and reference the family PFMEA for scoring and actions.

This makes sense to me if we are trying to capture all potential risk. That being said. Including the generic steps that reference the family PFMEA would require that all documents potentially need updating when a big change roles through. Without the steps on the product PFMEA, a user trying to understand the logical progression will have difficulty.

The line, The family PFMEA is dictated by the manufacturing process that is used to make the product, not by the product’s functional requirements or application, sounds like it's trying to address this potential overlap. If you don't factor in the application of the products then it reduces the number of unique factors across the products.

What are the thoughts on this approach? Is best practice only to perform the family PFMEA? Or does a breakdown between family and product PFMEA make sense? Is there another option?
 

GRP

Involved In Discussions
#7
Thanks, this discussion so far has been very helpful.

I was recently at a conference where I was able to discuss this topic with some other QE's. They all agreed that a family PFMEA was the right choice although they added that to capture the unique aspects of certain products, you may still need smaller product PFMEAs. The content of these product PFMEA would only cover unique attributes such as special steps, materials or quality incidents among other things. For all generic steps on the product PFMEA, the line would state the step and reference the family PFMEA for scoring and actions.

This makes sense to me if we are trying to capture all potential risk. That being said. Including the generic steps that reference the family PFMEA would require that all documents potentially need updating when a big change roles through. Without the steps on the product PFMEA, a user trying to understand the logical progression will have difficulty.

The line, The family PFMEA is dictated by the manufacturing process that is used to make the product, not by the product’s functional requirements or application, sounds like it's trying to address this potential overlap. If you don't factor in the application of the products then it reduces the number of unique factors across the products.

What are the thoughts on this approach? Is best practice only to perform the family PFMEA? Or does a breakdown between family and product PFMEA make sense? Is there another option?
I can't backup this up with standards, but I would stick to the family PFMEA and make a handful of product PFMEA with the differences. I would not try to "fill the gaps" with generic content. If for any reason your organization decides to go with "filling the gaps", and supposing you use MS Excel, just unleash the power of Visual Basic.

As for people struggling to make sense of the progression, they can find their way with the flowchart.

Besides, I can imagine there are some out there who would root for not being too straightforward with documentation in times of audit :notangel:
 

northbranch

Starting to get Involved
#8
If I remember correctly, my old company used family PFMEA's for processes, such as stamping, wash, weld, etc... The part PFMEA would then reference the process PFMEA and then with only what was specific with that part (wash temp, hardness info, etc).
 
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