imecoli
Registered
Looking for insight on URS creation for a manufacturing site. I'm working with a vendor overseas and generating some URS. His approach is you create the URS, which appears to be a wish list for some equipment functionality, not so much a requirement. Once completed you send the URS off to several equipment manufactures and see if the equipment matches what the needs are. Next you complete a Design Qualification (DQ) once you get the responses. Also, if the URS requirements aren't met you just add a note to the URS and attach it. this is a mystery to me also since the "R" is for requirement
Historically, my approach has been you either already know the equipment and its capabilities so you generate your URS based on that, or you get a manual or possibly the cutsheet and use that to identify if the needs are met . these may also be confirmed during IOQ , or if the vendor provides the IOQ paperwork you would have a supplemental IOQ capturing your requirements.
He also mentioned having several different brands and models of the same equipment. My response to this was it would require additional SOPs and potentially increase user error since the procedures would all be different.
Historically, my approach has been you either already know the equipment and its capabilities so you generate your URS based on that, or you get a manual or possibly the cutsheet and use that to identify if the needs are met . these may also be confirmed during IOQ , or if the vendor provides the IOQ paperwork you would have a supplemental IOQ capturing your requirements.
He also mentioned having several different brands and models of the same equipment. My response to this was it would require additional SOPs and potentially increase user error since the procedures would all be different.
the process should already be defined and you should have the necessary equipment in house to move forward.
