The ISO Preproduction Planning Procedure outlines the steps, planning, and reviews needed to manage the orderly transfer of a new or modified product upon completion of its design phase into full-scale production in conformance with ISO 9001:2015.
This procedure applies to all departments and individuals involved with the development and release of a new or modified product prior to full-scale production. (8 pages, 1614 words)
The Design and Development Manager is responsible for overseeing the release of the product design, including completing all forms and documentation as identified in this procedure.
Design Engineers are responsible for ensuring that product specifications have been adequately addressed in the product design.
The Quality Assurance is responsible for ensuring that all product quality specifications have been or can be met.
The Manufacturing Manager is responsible for producing the product to specifications in a timely and cost efficient manner by providing input and feedback before the product is released to Production.
The Preproduction Planning Team consists of Engineering, the Manufacturing Manager, the Quality Assurance Manager, and other departments directly affected by or having a significant effect on preproduction planning.
Achieved quality – Quality assured through procedures for orderly transfer of the design information to the production department, where manufacturing is controlled.
First article inspection (FAI) – Inspection/analysis of the first item manufactured in a production run to verify correct setup and process alignment.
Intrinsic quality – Inherent quality designed into a product and associated manufacturing processes.
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