In-depth analysis tagged Compliance — covering PLM history, vendor strategy, and the technical decisions reshaping engineering software.
2 articles
Supply chain traceability is the ability to answer two questions about any part in any shipped unit: where did it come from, and where else did that lot go? It is product genealogy extended upstream past your receiving dock, and it is built from PLM, MES and supplier data that most companies keep in three unconnected places.
Quality engineers and PLM administrators can close the gap between design revisions and compliance records by systematically connecting document control, CAPA workflows, and audit trails inside PLM.
An approved vendor list (AVL), or approved manufacturer list, is the controlled record in PLM of which suppliers and manufacturer part numbers are qualified to supply each internal part at each revision. It is the part-level foundation of supply chain traceability and the trigger point for supplier change notification.
Any document whose content, revision history, and approval status are formally managed so that only the current approved version is used in production or submitted in regulatory filings.
A structured quality process for identifying the root cause of a defect or nonconformance, implementing a correction, and taking steps to prevent recurrence across the product line.
A computer-generated mark that legally binds an individual to an electronic record, subject to authentication and audit trail requirements under regulations such as FDA 21 CFR Part 11.
Lot traceability is the ability to identify every unit manufactured from a specific batch (lot) of raw material or purchased components, and conversely to identify the lot behind any component in a unit. It is captured at the point of manufacture, typically in MES, by recording lot consumption as each unit passes each operation.