IATF 16949

lpatch83

Starting to get Involved
Good morning,
I am the Quality Systems Coordinator for an extrusion site. We produce what would be considered a raw material that is sold to other manufacturing sites. These sites use this material for injection molding and producing automotive parts. We currently hold ISO 9001:2015. My location took over the sales and trading side from another location. We are now being asked to create documents for IATF 16949 for only 3 of our processes. Those are sales, warehouse, and outsourced warehouses (we have two warehouses that receive and ship material that is imported). I was asked to complete a PFMEA for Warehouse. In my understanding PFMEA's are used to highlight potential risk in a process that involves the production of a product and are then used to improve that process when a non-conformance occurs as it should be part of the corrective action process to review and update pfmea and control plans. I have never been asked to create a PFMEA for just warehouse processes. I have also never seen a standard only applied to certain processes. I was previously at a dual site that was ISO 9001 and ISO 13485. The whole site was treated as ISO 13485. If anyone has any knowledge of this I greatly appreciate it as I have 0 support in dealing with this.
 

Golfman25

Trusted Information Resource
While typically used for a production process, PFMEA can be used for your warehouse. Just go thru and figure out all the places you can "mess up." For example, one area I have seen as a problem in my customer's bigger warehouses is loosing parts. They are in there somewhere, but not where they are supposed to be. You may want to get the AIAG books to use as a reference as that is what your customers are likely using.
 

lpatch83

Starting to get Involved
While typically used for a production process, PFMEA can be used for your warehouse. Just go thru and figure out all the places you can "mess up." For example, one area I have seen as a problem in my customer's bigger warehouses is loosing parts. They are in there somewhere, but not where they are supposed to be. You may want to get the AIAG books to use as a reference as that is what your customers are likely using.
Thank you Golfman25
I apologize if I was unclear about where this is originating. This is originating from our parent company not a customer. We do not hold an IATF certification the main corporation has an IATF certification and we have just been added to their scope. I have no issue completing one my issue is, is this the right tool. Yes I can hammer a nail with a sledgehammer but is that the proper tool.
 

Golfman25

Trusted Information Resource
Thank you Golfman25
I apologize if I was unclear about where this is originating. This is originating from our parent company not a customer. We do not hold an IATF certification the main corporation has an IATF certification and we have just been added to their scope. I have no issue completing one my issue is, is this the right tool. Yes I can hammer a nail with a sledgehammer but is that the proper tool.
The problem is IATF says it's the right tool. :) Your parent company is just trying to cover itself for their next audit.
 

lpatch83

Starting to get Involved
The problem is IATF says it's the right tool. :) Your parent company is just trying to cover itself for their next audit.
If the scope is not our manufacturing process only our sales department and shipping and receiving then the design and development cllauses couldnt be applied. We have excluded the design and development from our ISO 9001:2015 scope as we do not design or engineer any product then is it still required and what section states that?
 

lpatch83

Starting to get Involved
I recommend reading IATF 16949 8.5.1 You can't just have a PFMEA and be compliant. It requires alot more than a PFMEA.
That wasn't the concern. I may not being very clear on this. We are a subdivision of a global company. We are just being added under the Global companies IATF scope. My location is not IATF certified nor do we want to, we dont manufacturer or store automotive parts. Since we handle the trading division those processes are in that scope. I realize that to be compliant takes more than a PFMEA. My issue was I have not seen a PFMEA done for nothing more than receiving and shipping. Which is what I was asked to do. Every PFMEA I have been apart of those items were included in a manufacturing process we were never asked to have a stand alone PFMEA for warehouse.
 

Golfman25

Trusted Information Resource
If the scope is not our manufacturing process only our sales department and shipping and receiving then the design and development cllauses couldnt be applied. We have excluded the design and development from our ISO 9001:2015 scope as we do not design or engineer any product then is it still required and what section states that?
Your parent company is driving the bus on this. They feel you need it for some reason. That's all I got.
 

Miner

Forum Moderator
Leader
Admin
Good morning,
I am the Quality Systems Coordinator for an extrusion site. We produce what would be considered a raw material that is sold to other manufacturing sites. These sites use this material for injection molding and producing automotive parts. We currently hold ISO 9001:2015. My location took over the sales and trading side from another location. We are now being asked to create documents for IATF 16949 for only 3 of our processes. Those are sales, warehouse, and outsourced warehouses (we have two warehouses that receive and ship material that is imported). I was asked to complete a PFMEA for Warehouse. In my understanding PFMEA's are used to highlight potential risk in a process that involves the production of a product and are then used to improve that process when a non-conformance occurs as it should be part of the corrective action process to review and update pfmea and control plans. I have never been asked to create a PFMEA for just warehouse processes. I have also never seen a standard only applied to certain processes. I was previously at a dual site that was ISO 9001 and ISO 13485. The whole site was treated as ISO 13485. If anyone has any knowledge of this I greatly appreciate it as I have 0 support in dealing with this.
This is unusual for them to not include your extrusion process in their request. I would recommend contacting them to ensure they understand the full scope of your operation. You said that you have two warehouses that just receive and ship. Maybe that is their perception of your entire operation, and they don't realize that you extrude as well.
 
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