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If the QY-10 is required as part of the Purchase Order (PO), prior to First Piece Inspection (FPI) a Process Flow Chart/Control Plan (FC/CP) is to be developed using GDLS Work Sheet and instructions. This document is to be attached to the FPI request form. The request for FPI will not be processed without this document being completed in it’s entirety in accordance with instructions. (PQA 3000 Page 24-26)
The purpose of FC/CP is to provide a logical pictorial representation of the manufacturing process flow and process control points. The Supplier develops and updates FC/CP as needed if changes occur. This document can be used as an aid for work station development, identifying process control points, defining the methods being used at these control points, and must include all Key Product Characteristics such as KPC/QARs/QAPs and all out sourcing identification.
A walk through of the manufacturing process to include a review of the FC/CP and work instructions should be anticipated as a means to validate process requirements. The FC/CP will be used as part of the Process/Product Validation at FPI and on future GDLS audits.
Summary