EE - Forum Styles
  • Not Answered

Who owns the BOM (Bill of Materials) in an FDA audit?

One of the more frequent discussions that comes up during the preliminary studies in support of MES implementations is - Who owns the BOM?  Time after time it depends on who you ask.  The ERP guys always claim the its own in ERP since thats where all the ordering takes place and that manufacturing needs to align with ERP.  Manufacturing thinks its under by the automation system since its built into the recipes.  QA trumps all of them since they own all the documents and its in the batch records.  They would claim that if the FDA showed up they would show them the batch records.

In reality they are all correct and information regarding the BOM is stored in all three systems - Question is which one is the System of Record?