Making correct and practical best use of design qualification
Poor definition of operationalization of design qualification. John Lees definition of design qualification: Do your homework before you buy a piece of equipment, before you go into contruction. Show that the design fulfills conforms with the user requirements.
John Lees practical recommendation: perform and make a design review (a pre-design, an informal design qualification). Make the final and formal design qualification just before deliverance. You have to do design qualifcation, but be carefull when you actually do it. Otherwise, deviations, corrections and updates of the protocol will have to be done