kisxena
Starting to get Involved
Didn't really know how to word the title but here is my delima.
First of all, my company is still trying to grasp GMP and most don't have the years of experience in GMPs. Also, there addage is, "if it's not in our documents, then we don't do it" Technically they are right but if the QSR's dictate it then we are in the wrong regardless.
Okay, here is my issue: Per 21 CFR 820.40 - Document Control: (b) Approved changes shall be communicated to the appropriate personnel in a timely manner.
We have devices that are staged to manufacturing for debugging/rework/testing. At the time they are staged (ie: 2004) the traveler was a rev A. The device had been sitting on the rework shelf for the past 2½ yrs until yesterday. The process traveler had since been updated to a rev C. I performed a Final Inspection and noted that the document was out-dated and to use the most current form, even if to reference the old form for data and then complete any sections in the rev C form that was not in the rev A form. The supervisor refused and said that it wasn't in any procedure and that some verbal conversation happened between my boss and her boss and they wouldn't have to do that.
The QSR of course is at best, MINIMAL requirements. Does manufacturing have a leg to stand on?
Please respond is you have the correct definite answer. Assumptions will not work in this case.
Thanks in advance.
First of all, my company is still trying to grasp GMP and most don't have the years of experience in GMPs. Also, there addage is, "if it's not in our documents, then we don't do it" Technically they are right but if the QSR's dictate it then we are in the wrong regardless.
Okay, here is my issue: Per 21 CFR 820.40 - Document Control: (b) Approved changes shall be communicated to the appropriate personnel in a timely manner.
We have devices that are staged to manufacturing for debugging/rework/testing. At the time they are staged (ie: 2004) the traveler was a rev A. The device had been sitting on the rework shelf for the past 2½ yrs until yesterday. The process traveler had since been updated to a rev C. I performed a Final Inspection and noted that the document was out-dated and to use the most current form, even if to reference the old form for data and then complete any sections in the rev C form that was not in the rev A form. The supervisor refused and said that it wasn't in any procedure and that some verbal conversation happened between my boss and her boss and they wouldn't have to do that.
The QSR of course is at best, MINIMAL requirements. Does manufacturing have a leg to stand on?
Please respond is you have the correct definite answer. Assumptions will not work in this case.
Thanks in advance.
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