indian_99_2008
5th April 2008, 04:52 AM
Hi, let me first just say thank you for creating such a nice and useful website, it is really helpful.
My question is on "validation of production equipment, tools". clause requires "validation shall include first article inspection" does this mean we have do first article every time we are using a tool/equipement? In my case, we are NJ based electronics & electro-mechanical assembly house, so typical example can be a crimp tool for crimping operations in various cable assemblies (used almost every single day). do we have to do first article of each and every cable assembly to validate? same way we use hand-soldering irons for soldering operations...which are used every single day on multiple assembly jobs for multiple customers. do we have to "validate" them everyday by creating first article for every single assembly?
What does "prior to use" word exactly mean? Does it mean prior to each use?mean every single day? or i can interpret like prior to starting a particular job instead of building a complete assembly as a first article we can take a representative sample of where we are going to use tool/equipment? for example, in crimp tool case, we take a piece of wire and crimp it and inspect it to match specifications, can this be considered as a validation? same way for soldering iron, can we validate lets say every 3 months by making a general sample of soldering and inspection per IPC standards?
Any help would be greatly appreciated. If examples are there, even better.
thanks
My question is on "validation of production equipment, tools". clause requires "validation shall include first article inspection" does this mean we have do first article every time we are using a tool/equipement? In my case, we are NJ based electronics & electro-mechanical assembly house, so typical example can be a crimp tool for crimping operations in various cable assemblies (used almost every single day). do we have to do first article of each and every cable assembly to validate? same way we use hand-soldering irons for soldering operations...which are used every single day on multiple assembly jobs for multiple customers. do we have to "validate" them everyday by creating first article for every single assembly?
What does "prior to use" word exactly mean? Does it mean prior to each use?mean every single day? or i can interpret like prior to starting a particular job instead of building a complete assembly as a first article we can take a representative sample of where we are going to use tool/equipment? for example, in crimp tool case, we take a piece of wire and crimp it and inspect it to match specifications, can this be considered as a validation? same way for soldering iron, can we validate lets say every 3 months by making a general sample of soldering and inspection per IPC standards?
Any help would be greatly appreciated. If examples are there, even better.
thanks
