ISO Preproduction Planning Procedure

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)

ISO Preproduction Planning Responsibilities

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.

ISO Preproduction Planning Definitions

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.

ISO Preproduction Planning Activities

• Design Completion
• Design Transfer and Documentation
• Production Plan
• Plan Roll-Out

ISO Preproduction Planning References

• ISO 9001:2015, “Quality Management System Requirements”, International Organization for Standardization (ISO), Sep., 2015.
• Quality Procedures
  • QP0600 RISKS AND OPPORTUNITIES MANAGEMENT
  • QP0700 INFRASTRUCTURE CONTROL
  • QP1000 DOCUMENTED INFORMATION CONTROL
  • QP1070 COMPETENCE AND AWARENESS
  • QP1100 DESIGN AND DEVELOPMENT
  • QP1110 DESIGN CHANGE
  • QP1140 MANUFACTURING CONTROL
  • QP1170 MONITORING-MEASURING RESOURCES CONTROL
  • QP1180 MONITORING-MEASUREMENT

ISO Preproduction Planning Forms

• Product Design Release Form