Dear Sir,
After Risk Assessment if it is identified that, the URS is not available of any existing equipment/system. From the Risk Mitigation Approach, will it be logical to recommend that the URS is to be prepared for the existing equipment that is being commercially used from long days back ?Otherwise how it would be rectified ?
Thanks
Since URS have a quality approach, yes, even if the equipment is already contructed and in operation, it is logical to reconstruct or prepare URS. This will allow you to verify if the system that is already in place is able to meet or comply with all URS needed to mitigate risk to product quality.
In addition to prepare URS, you should also verify if the current qualified state of the equipment demonstrates compliance with this “new” URS. For every URS not met, there should be a control to mitigate the risk associated to that URS.
For example: let’s say this is a labeling machine. After preparing URS one of these URS is that the equipment must have an automated inspection system to identify non-labeled product, and reject it.
But the current equipment does not have this system. This is a risk that needs to be reduced. You can either add this system and qualify it, or you can place procedural controls to manually inspect and detect defective product. The management of this risk was possible thanks to URS being prepared even if the equipment is already in operation.
URS compliance is the basis for equipment qualification; it is always a risk to not have them if the equipment is subject to validation/qualification activities.
I hope this is helpful.
Dear sir,
Cordially thanks for the excellent feedback.
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