6. Drawing up functional specifications

The functional specification is a summary document whose aim is to express and prioritize the company's requirements for its production tool in terms of the results to be achieved. It is used to evaluate the solutions proposed by the design team or suppliers, in order to arrive at a well-founded choice. The functional specifications must be validated by the members of the qualification committee before moving on to the search for solutions.

Whatever the extent of the resources allocated to the design, production and operation of a tool, it will always present risks. The company's needs with regard to the tool must therefore be expressed not only in terms of quantitative production performance, but also in terms of quality and risk control for the company.