ABSTRACT

The fundamental step in in-process QA is the preparation of a formal written manufacturing procedure. This document describes each operation required in the process from procurement of raw materials through final shipping. It also normally defines the paperwork that must accompany the part through the process, lists the signatures that are required on this paperwork to certify that each operation has been followed as specified, and describes the procedure that must be followed if a process change is considered. The signed paperwork that follows the part through the process is kept on file as traceability for that part and as a record that the part was processed by the designated fixed process.