Electronic (Online Database) Calibration Records

RSEGRIGGY

Involved In Discussions
#1
In the past, we have received hard copies of gauge calibration/verification results from our outside suppliers. Most of them are moving to a system that provides an online database with company specific log-in and do not provide hard copies. It is a bit of a motivator, as we have been wanting to go paperless internally for a while. It's just been easier to take the packet of certs and file them in a drawer by year than have someone scan each cert individually.

As we're working on becoming ISO 9001:2015 certified, we want to provide that record of calibration when being audited. We already have a (in-house generated) gauge database in Access.

There appear to be some options here for records:
A) Have a field in the database that identifies which supplier calibrated the gauge and a link to their website/database.
B) Download each cert/record as a PDF and save locally
C) Print each cert and file it in the cabinet as we have been (I can't imagine this being the best option)
D) Something else?

We're not medical, aerospace, or FDA. There are over 1700 items that get some form of calibration or verification. We do get a summary of which gauges needed adjustment or were non-repairable. Is this enough to show all items are in calibration? Do you need a locally stored (electronic or physical) copy of a calibration certificate? Looking for options and trying to learn from others experience. This can't be the first time this has come up....

Thanks
Rick
 
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howste

Thaumaturge
Super Moderator
#2
Re: Electronic Calibration Records

I personally prefer option B. I like to maintain close control of records like this. ISO 9001 (7.1.5.1) says "The organization shall retain appropriate documented information..." so you are responsible to keep the record unless you decide to outsource the record retention. If you decide the calibration supplier should keep the records then you would need to communicate (per 8.4.3) the requirements for them to maintain the records for you, probably in the purchase order.
 

Ninja

Looking for Reality
Trusted Information Resource
#3
FWIW,

I would not be comfortable having my necessary documentation stored "somewhere" by "someone". I would get the pdf and store it myself.

At the end of the day...what is the risk you are willing to bear?
Are you willing to have "someone" decide only to keep the last 30dys records (without telling you) and delete your old records?
I would not be comfortable with that...so I would get the pdfs and save them myself.
 

RSEGRIGGY

Involved In Discussions
#4
I do think downloading is the way to go. It just seems a tedious effort if you have many gauges done at once.

Which leads me to a follow up question/line of thought:

Once you download your cert files as a PDF, how to you organize them? My current thought is to create a folder by year, then save each cert as a PDF by serial number. Any other strategies you've thought of/seen work? Anything you would warn against?
 

dwperron

Trusted Information Resource
#5
The place where I am currently working has a simple system that works rather well.

You open a folder for each instrument by it's control / asset / serial number. Whatever method works for you. Then you load all your documents for that unit into the folder, date stamping the file name. This allows you to place all info for each unit in a single location - calibration certs, repair orders, invoices, emails, notes, etc. Then you name the file with something descriptive, like:

20170428-CERT
20170321-RMA
20170427-OOT Impact review
20161211-Repair work order

It works well to have everything in one spot... but that means you will be scanning all paper documents as well. Depending on your internal document retention program it might make sense to get all of your paper records scanned as well, especially if only 2 or 3 years of records are required. Also, you are best saving everything as a PDF to assure that the records are not modified.
 
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