XYZ Co, Inc.

Number: WI-12345-003
Product Development Process
Revision: B
XYZ Co, Inc. – Design History File Index
Project
Name
DHF Component Required? Format* Location**

Kick-off Mtg Minutes Required N/A (e.g. Word doc, email…) (On-line or physical location)
Product Requirements Required N/A
Business Analysis Required N/A
Regulatory Plan Required N/A
Feasibility Model Required N/A
Phase Review Checklist Required N/A
Design History File Required N/A
Design Reviews Required N/A
Development Plan Required N/A
Design Specifications Required N/A
Hazard Analysis Required N/A
IP Review Required N/A
V & V Test Plan Required N/A
Quality Requirements Required N/A
Manufacturing Plan Required N/A
Mktg. & Sales Plan Required N/A
V & V Test Results Required N/A
Field Testing Required N/A
Production Design Required N/A
Users Manual Required N/A
Work Instruction Revision Required N/A
Pilot Production Run Required N/A
Regulatory Testing Required N/A
Post-Project Review Required N/A

*Format: What am I looking for – paper copy, electronic file, etc?

**Location: Physically, where do I go to find it?