TOP LEVEL PRODUCT DEVELOPMENT DOCUMENTS

The top-level documentation should provide a three stage, recorded viewpoint of the product:

• The Product Requirements List is composed of ALL product claims: technical, User, market, financial, production, support, regulatory, life expectancy/mortality, review and legal. In other words everything you should know about the product and 'need to prove' is contained in the product requirements. This document may also list the project framework and project objectives.
  
  
• Implementation of the product's claims includes all design, development, verification tests, and production, service and support documents that are used to develop and manufacture a product that upholds the Product Requirements claims.
  
  
• Testing the implemented product to the Product Requirements' claims is accomplished by an objective; measurable process described by very specific test documents. These documents must outline a process for the validation of EACH and EVERY product claim made in the product requirements; i.e. prove that all the claims are true.

All the documents should be maintained and controlled within a repository (not just somebody's head!), which is available to all authorized groups. Following the FDA's (Food and Drug Administration) Quality System Requirements (based on "best Industry practices") two repositories are sufficient and highly recommended:

The Design History File (DHF) contains the complete design and development history of the product. Everything you want to know about how and with what it was designed, how and who made pertinent decisions, and how and who implemented the design and tested the product is contained in this repository. This repository is held, maintained and controlled by the owner/developer of the product.

The Product Master Record (PMR) contains the complete manufacturing, testing, support, maintenance and production-compliance information and instructions for the product. Everything you need to know about producing, supporting and maintaining the product is contained in this repository. This repository is held and maintained by the manufacturer of the product and controlled by both the owner and manufacturer.

Now we'll discuss the 'groups' and 'guidelines', which will oblige you to prepare specific documentation, and then we'll show how appropriate documentation will actually add strength and direction to your product development project.