IvyKing
Chemical
- Mar 22, 2013
- 5
Hey guys,
Have a question
Our team in Production Process Engineering is trying to come up with a method that would route the tools and equipment used in our fillers.
Our team does not want to serialize every single part.
So here is the path
After filling the parts get disassembled, and they get routed to COP ( Cleaning out of place ) area - so they get cleaned. Once they get cleaned , they go to the parts room and they get put on shelves.
Once on shelves they will sit there for unknown time before next filling time. The parts to be assembled go to sanitation area and get sanitized before use. So it's clear path, they get cleaned and before use they get sanitized.
Now then,
QA asks us how do we know which part has been sitting in parts room for how long and how do we know if they have been cleaned properly.
Our Engineering department puts the case as the parts are getting logged once they leave the line, they get to COP area and once they leave the COP area and get rolled to Sanitization area , get sanitized and go to the filling line. All of which is getting recorded in Chain of custody form and log book at the parts room and at the line. So we do have a good idea how the lifeline of this procedure is taking course. The QA suggest that the parts must be traceable. As long as we have a practical method of proving that parts sitting there for 2 weeks or 6 months are cleaned and before use they get sanitized; we are good. But it seems that they want to serialize all the parts.Operations does not want to go that route. Simply because they are larger parts and they are smaller parts, we cant serilaize one part and not the other because they are small! Too many logbooks and too many problems. We must be problem solvers, so whatever we propose gets shut down. Besides, all these parts are stainless steel and they are cleaned properly and get verified by a second personnel. To me there is no clean hold time. Once they are cleaned, they are cleaned before sanitation. There is obviously sanitization hold time of two hours. If it expires, then we sanitize again. So I don't know from practical stand point how else we can convince people that
1- Maybe we can bag them and tag them before they leave the parts room to go to sanitization.
2- Each part gets cleaned again and sanitized before use
3- Parts room gets modified to ensure that parts are cleaned and segregated.
What other possibilities are out there?
Thanks in advance
Have a question
Our team in Production Process Engineering is trying to come up with a method that would route the tools and equipment used in our fillers.
Our team does not want to serialize every single part.
So here is the path
After filling the parts get disassembled, and they get routed to COP ( Cleaning out of place ) area - so they get cleaned. Once they get cleaned , they go to the parts room and they get put on shelves.
Once on shelves they will sit there for unknown time before next filling time. The parts to be assembled go to sanitation area and get sanitized before use. So it's clear path, they get cleaned and before use they get sanitized.
Now then,
QA asks us how do we know which part has been sitting in parts room for how long and how do we know if they have been cleaned properly.
Our Engineering department puts the case as the parts are getting logged once they leave the line, they get to COP area and once they leave the COP area and get rolled to Sanitization area , get sanitized and go to the filling line. All of which is getting recorded in Chain of custody form and log book at the parts room and at the line. So we do have a good idea how the lifeline of this procedure is taking course. The QA suggest that the parts must be traceable. As long as we have a practical method of proving that parts sitting there for 2 weeks or 6 months are cleaned and before use they get sanitized; we are good. But it seems that they want to serialize all the parts.Operations does not want to go that route. Simply because they are larger parts and they are smaller parts, we cant serilaize one part and not the other because they are small! Too many logbooks and too many problems. We must be problem solvers, so whatever we propose gets shut down. Besides, all these parts are stainless steel and they are cleaned properly and get verified by a second personnel. To me there is no clean hold time. Once they are cleaned, they are cleaned before sanitation. There is obviously sanitization hold time of two hours. If it expires, then we sanitize again. So I don't know from practical stand point how else we can convince people that
1- Maybe we can bag them and tag them before they leave the parts room to go to sanitization.
2- Each part gets cleaned again and sanitized before use
3- Parts room gets modified to ensure that parts are cleaned and segregated.
What other possibilities are out there?
Thanks in advance