ISO 9001:2015 Calibration Records - List vs. Software

[drobbins329]

I would like some community support on this.

I perform all the calibrations of the metrology equipment at my facility. We are transitioning into ISO 9001:2015. The document control individual is getting a little out of hand.

How should I interpret the record keeping portion of my calibrations?
My equipment list, calibration detail, and record of performance is maintained in one file. It is backed up on a secure server. How does calibration specific software work into ISO? I feel there is a misunderstanding regarding the difference between records, documents, and lists.

Also, I am continuously revising and improving my records, and how I interact with them. Always forward of course. I have taken it from a pad and paper setup to a fully digital software driven record.

Please help.

 

[howste]

Re: ISO 9001:2015 Calibration records, list vs software

I'm trying to make sense of what you're asking. It sounds like you and someone with document control authority are having a dispute.

How should I interpret the record keeping portion of my calibrations?

The standard requires evidence of fitness for use for measuring equipment. This should include records of calibration results and, for equipment that is found out of tolerance, records of evaluation of any affected product.

These records can be maintained in any way your organization determines to be effective, but must meet the requirements of clause 7.5 and any documented procedure that your company has.

How does calibration specific software work into ISO? I feel there is a misunderstanding regarding the difference between records, documents, and lists.

There are no specific requirements for calibration software. From another thread, I understand you're using an Excel spreadsheet for this. This spreadsheet has attributes of both a form (specifies what should be recorded) and a record (history of calibration results).

I'm guessing that the primary concern you have may be version/change control. It gets updated every time a new calibration occurs (new records). It also gets updated when you change the code in the spreadsheet to automate it.

Changing the code or the columns in the spreadsheet would be like changing a paper form (document). You need to ensure that you have "review and approval for suitability and adequacy" (7.5.2c) to ensure that it still functions as intended. You also need to address "control of changes (e.g., version control)" (7.5.3.2c). I would suggest that whenever you make changes to the structure of the spreadsheet or the coding that you change the revision (Rev A or Rev 1 or Rev 3/30/2017). This can be identified in the file name and/or at the top of the spreadsheet. If you keep copies of previous versions of the file make sure that they are identified as obsolete.

Adding records to the spreadsheet would not require version control. Each record (row in the spreadsheet) has a date, so you can see what was added and when.

I hope I understood your question. If not, please let me know.

 

[drobbins329]

Re: ISO 9001:2015 Calibration records, list vs software

That actually answered it quite well. Thank you.

The concern is that as I develop this system further, I have to explain to an individual who doesn't understand the content or the file it is kept in, how and why a revision is being made. I imagine that the actual code that makes it work together is of no concern. Just that it works, and is recorded. Correct?

Would a new rev be needed each time I update the code for my dialog? or just when new/different data (columns) are added? Also, would it suffice to control what records are maintained, not necessarily how they are presented?

ie: gage number, dates, locations, usage etc.

Specify what is being recorded, not in what order the columns are in, or what color they are?

 

[howste]

Re: ISO 9001:2015 Calibration records, list vs software

I imagine that the actual code that makes it work together is of no concern. Just that it works, and is recorded. Correct?

Yes.

Would a new rev be needed each time I update the code for my dialog? or just when new/different data (columns) are added? Also, would it suffice to control what records are maintained, not necessarily how they are presented?

ie: gage number, dates, locations, usage etc.

Specify what is being recorded, not in what order the columns are in, or what color they are?

To me it would be easier to just change the revision any time you make code changes or make it look different. Revision numbers are free.

 

[drobbins329]

Re: ISO 9001:2015 Calibration records, list vs software

Our document control person has a nasty habit of using revs in the discription of the documents. So any revs, result in a hundred other revs of any documents referencing the first.

 

[howste]

Re: ISO 9001:2015 Calibration records, list vs software

Our document control person has a nasty habit of using revs in the discription of the documents. So any revs, result in a hundred other revs of any documents referencing the first.

That's an incredibly poor practice IMO. I (almost) never refer to revisions of referenced documents. The only benefit to doing it is job security for the document control person because it adds a LOT of unnecessary work.

 

[drobbins329]

Re: ISO 9001:2015 Calibration records, list vs software

That's an incredibly poor practice IMO. I (almost) never refer to revisions of referenced documents. The only benefit to doing it is job security for the document control person because it adds a LOT of unnecessary work.

agreed.