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Development Project Initialization and Design Review

Quick Overview This Standard Operating Procedure (SOP) describes the Design Review requirements associated with a specific design project and is intended to ensure that a design satisfies the requirements for the intended use of a product and meets the needs of the user. This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP.

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567 views

Development Project Initialization and Design Review

Quick Overview This Standard Operating Procedure (SOP) describes the Design Review requirements associated with a specific design project and is intended to ensure that a design satisfies the requirements for the intended use of a product and meets the needs of the user. This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP.

Uploaded by

qmdocs
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PDF, TXT or read online on Scribd
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Quality Management

Documents & Templates

Development Project Initialization and Design Review


Proceed with Development Project which will be under Design Control Delay project pending Reject project (compile documentation and forward to QA for archiving; no DHF number is assigned)

If project is approved, this document becomes part of the DHF. The DRC approves the acceptance of each feasibility aspect when it is moved into formal Design Control as outlined in Attachment 2 (Part 2).
7.2 Design Review (general)

A formal Design Review is a mandatory requirement following each phase of the design and development process as specified in the Design Control SOP and Development Plan. Additional reviews may be held if needed and should be described in the specific Design and Development Plan. Unplanned reviews may be held at the if needed, requested by the PL / HE and should have the same degree of formality, control, and documentation as planned reviews. The Design Review is intended to: Provide assessment of design results (assess progress) Provide designers with feedback on existing or emerging problems Provide confirmation that the project is ready to move on to the next stage of development.
7.3 Design Review Elements

The Design Review should focus on ensuring that design requirements are met and that the requirements of each design phase are completed in accordance with written procedures and the specific Design and Development Plan for the project. The critical elements of the Design Review are:
7.4

Design evaluation Risk Analysis review Resolution of concerns and Implementation of Corrective Actions
Design Review Approval

The Members of the DRC are specified in the Design and Development Plan for the specific project. The PL / HE circulates draft copies of applicable documentation of the specific design development phase or activity which was conducted under Design Control to the members of the DRC and schedules a DRC meeting. The DRC verifies that all of the design phase or activity requirements have been completed and that any incomplete, ambiguous, and/or conflicting issues are resolved.

Document Type SOP

Document ID XX_WWW_ZZZ_YYYY

Version 1.0

Status Approved

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Copyright by QMdocs 2010 Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited by law. Neither the document nor the information contained therein may be reproduced or disclosed without written consent of QMdocs.

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