OK, here are the points I would make. I assume by NRC auditor you mean Nuclear Regulatory Commision. I worked on the DOE side of nuclear, but we followed most of the same source rules. By the way, I wrote the chapter on Control of Electronic Records in the new edition of the "Nuclear Auditing Handbook" from ASQ. So I have researched by DOE and NRC requirements for electronic records. There is a lot more such as backup copies, safeguarding the software, making sure only approved trained and qualified persons use the software, etc.
1. I don't work for the maker of GAGEpack, so do not know what it would take to modify the GAGEpack software. I see they are a COVE Forum sponsor, so someone here may have a connection to them
2. You need to decide what is "THE RECORD" when it comes to your certificates. If "THE RECORD" is indeed the electronic software called GAGEpack, then so be it. That software needs to be controlled as an electronic record. So, no, you would not be taking screen shots with an NRC auditor "breathing down your neck" You would say - sir or madam, this is the official record for that gage, here it is. Be that a file of pdf shots, or the software itself.
3. If you choose to take screenshots, make pdf's etc from the GAGEpack software, then that needs to follow some sort of quality controlled procedure as to how those copies are to be made, and if the copies then become "THE RECORD", then that needs a formal process and designation. Seems easier for traceability to leave the GAGEpack as the official record. And you would need an electronic filing system for access to those pdf's.
4. I would still think if you can "print a cert" from that software, you can print that to the "PDF printer". Again, you need to control that copy, and keep track of what is "THE RECORD". If you are talking about having a "convenient file" of PDF's of the records, then it needs to be labeled and controlled in that manner.
LATE EDIT:
5. The software is made by PQ systems (Jim Wynne let me know this). So I would like to add, especially in the context of Nuclear: I would presume that someone at your facility did an initial acceptance test of the software to ensure it met NRC electronic records and gage calibration requirements. If so (I hope that is so) I would be very careful about making or requesting any changes to that software.
1. I don't work for the maker of GAGEpack, so do not know what it would take to modify the GAGEpack software. I see they are a COVE Forum sponsor, so someone here may have a connection to them
2. You need to decide what is "THE RECORD" when it comes to your certificates. If "THE RECORD" is indeed the electronic software called GAGEpack, then so be it. That software needs to be controlled as an electronic record. So, no, you would not be taking screen shots with an NRC auditor "breathing down your neck" You would say - sir or madam, this is the official record for that gage, here it is. Be that a file of pdf shots, or the software itself.
3. If you choose to take screenshots, make pdf's etc from the GAGEpack software, then that needs to follow some sort of quality controlled procedure as to how those copies are to be made, and if the copies then become "THE RECORD", then that needs a formal process and designation. Seems easier for traceability to leave the GAGEpack as the official record. And you would need an electronic filing system for access to those pdf's.
4. I would still think if you can "print a cert" from that software, you can print that to the "PDF printer". Again, you need to control that copy, and keep track of what is "THE RECORD". If you are talking about having a "convenient file" of PDF's of the records, then it needs to be labeled and controlled in that manner.
LATE EDIT:
5. The software is made by PQ systems (Jim Wynne let me know this). So I would like to add, especially in the context of Nuclear: I would presume that someone at your facility did an initial acceptance test of the software to ensure it met NRC electronic records and gage calibration requirements. If so (I hope that is so) I would be very careful about making or requesting any changes to that software.
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