SOP04: Product Design, Development, and Risk Management
Project Identification
Each project gets a 2-letter abbreviation at the time of the Input Design Review. This abbreviation is used to identify project-specific design history documents.
Project Planning, Deliverables, and Design Reviews
Project design and development activities follow a series of planned phases. Prior to the completion of each phase, a formal design review is held to review the project status and reach a cross-functional design decision regarding the acceptability of proceeding to the next phase.
Design Review Checklist (SOP04-F5) indicates the deliverables required for each phase.
Project phase flow chart for consumer products:
Design Review Logistics
Design review meetings are organized and chaired by the project leader.
All attendees sign the Design Review Attendance Record (SOP04-F1).
The deliverables listed on the Design Review Checklist (SOP04-F5), including a review of action items from the prior design review, are discussed at the meeting.
Upon completion of the meeting, the Project Leader completes the Design Review Approval Record (SOP04-F4) as agreed at the meeting and obtains approval as required.
Design History Files
A design history file (DHF) is maintained for each project containing the deliverables associated with each project phase. After completion of each design review, the project leader forwards all DHF deliverables to Quality for verification and archiving.
Design Changes
Design change control begins during the input phase with the release of the product specification and continues through the product life cycle.
Design changes cannot be implemented with justification, review, and approval of the associated document per SOP03.