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.
