ISO 1705:2017 Checks for Calculations & Data Transfers

[DMS8]

I am in the process of updating my SOP to the new standards for 17025:2017 and I am curious how others are handling 7.11.6 regarding checks for calculations and data transfers. In the ANAB training that I have attended, it has been stated that the transfer of images from an SD card to a computer would fall under this standard. The AR 3125 states that this would not apply if the data is not subject to human error, so I am thinking that importing the image through Adobe Bridge may qualify for this. How are other laboratories addressing this stadard?

[anwilson]

We have the following in our SOP which I think would address your question: "After upload, a visual confirmation should be performed to ensure all images from the photo session have been saved in DIMS."

Basically, when I upload images I will close out and then open the case again to ensure that all photos uploaded correctly before I reformat the memory card.

[NRivera]

We have similar wording to visually verify that the images copied over correctly and the files were not corrupted in the process.

[josher89]

The spirit of this clause is that all data, when transferred from one media to another, be verified for accuracy. This typically means if you crank out a scene sketch and then convert it to a CAD at a later date, one should verify that the measurements are the same.

In my not-so humble opinion, assessors have taken this so far over the top to include digital images being transferred from card to computer (or CD). I can't think of any situation in which, as long as you select all of the images, they won't all be transferred properly without there being some sort of error when it doesn't occur.

Unfortunately, when we were going through our original assessment, we had to confirm that the number of images we have on a CD (the one that's in our case file) matches with the number that we write on the label of the CD--this is checked off on our AR/TR form. Completely ridiculous and a waste of time but whatever, we're doing it.

I second anwilson; make a very generic statement in your SOP about confirmation of image transfer and leave it alone.

We had a phone call with the ANAB accreditation manager (or one of them) and asked the question about excel formulas and whether or not they needed to be verified. The answer was no, especially given that Excel is an off-the-shelf software system that has previously been validated.

So, some choose to take this clause too far (both assessors and quality managers). I recommend not adding unnecessary layers to the cake.

[DMS8]

Thank you for the replies. I am definitely a spirit of the requirement person, but have a habit of overthinking how to meet the requirement and making things more complicated.

[ER]

While not exactly on-topic, I get nervous any time I hear about agencies storing data on CD's.

Under ideal conditions, the average lifespan of a burned CD-R should be 20+ years. But that's an average.

CD-R's are pretty unreliable once you start burning them for thousands of cases and storing them for decades. What are the chances that at least one of those CD-R's that was burned 10 years ago is now unreadable? Pretty high when compared to other storage options.