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22nd May 2007, 03:07 PM
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How long do you maintain (retain) calibration records?
Hi all
We've come into a situation with our calibration records. We used to record calibrations on sheets of paper and file them into folders by gage IDs. This was done for about a decade. A couple years ago, we started using a gage control database that stores all of the information. Up until this point, the retention was "life of gage" for these records... and this hasn't been a problem. Now we need the room taken up by these file cabinets full of calibration records. The idea of scanning all of the records and putting them into the database is daunting, and I don't think we've got the time for what it's worth. (We've got ~10,000 unique gage ID's in our company).
So now we're thinking of disposing of many (or most) of them. The question is, how many years back should we maintain them? I know, the answer is, "depends on what it is". For our master gages, we will maintain all records. However, for calipers and micrometers, does it matter what the gage read 5 years ago? What's the norm out there?
Cheers
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22nd May 2007, 03:19 PM
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Re: how long do you maintain calibration records?
Just some questions to consider:
What's the life of your product?
Does it impact safety or health?
if you make a product that is going to be consumed in, say, 3 years then why keep the records any longer than that + a safety factor?
there may be some futher info in the threads you can find at the bottom of the page if you scroll down.
-----------------------------------
FWIW: Our Notified Body for CE marking requires us to keep records for 10 years.
We just made that a rule of thumb across the business.
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22nd May 2007, 03:22 PM
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Re: how long do you maintain calibration records?
Not sure how efficient this might be vs. cost/volume of records, but perhaps they can be transferred to microfilm? This is how older records were stored in a previous life...just a thought.
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22nd May 2007, 03:39 PM
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Re: how long do you maintain calibration records?
What kind of industry are you in, and what kind of regulatory requirements do you have in place?
Generally your regulatory agencies have guidelines. Outside of that, your specific industry usually has rules of thumb they follow. Pending any of that, ask your customer.
I would keep the calibration records for the period of time that a product issue could come back to you. I would say seven to ten years, but that' s shooting from the hip.
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22nd May 2007, 06:51 PM
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Re: How long do you maintain (retain) calibration records?
Good answers!
Calrich, there's also the question of establishing that the calibration management system is on control of the equipment and it's use. So, while keeping the stuff for 10 years may seem enough, that might represent only a (relatively) small number of calibrations. You will want to build a history to allow you to manage recall/recal. more (cost) effectively. Using these records to detect trends might take more or less 'events' from more or less recrds being saved. If you've been doing this (and you have, haven't you????) then you can keep your records for less time (customer/regulatory advice notwithstanding).
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23rd May 2007, 03:40 AM
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Re: How long do you maintain (retain) calibration records?
Not until the failure of the gage/equipment, we keep those records.
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23rd May 2007, 07:04 AM
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Re: how long do you maintain calibration records?
Thanks for your ideas, guys.
Quote:
In Reply to Parent Post by BradM
What kind of industry are you in, and what kind of regulatory requirements do you have in place?
Generally your regulatory agencies have guidelines. Outside of that, your specific industry usually has rules of thumb they follow. Pending any of that, ask your customer.
I would keep the calibration records for the period of time that a product issue could come back to you. I would say seven to ten years, but that' s shooting from the hip.
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We manufacture fabricated metals product. True, I hadn't thought of requirements on retention by regulatory agencies Unfortunately, product could come back after many, many years. Fortunately, (maybe?), there's not direct traceability of any particular gage to any particular piece after so long. So even if a product does come back, there's no way to link a product problem with a gage problem.
Quote:
In Reply to Parent Post by AndyN
Good answers!
You will want to build a history to allow you to manage recall/recal. more (cost) effectively. Using these records to detect trends might take more or less 'events' from more or less recrds being saved.
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Very true. With our new computer system, this is easy. And the space for records is a non-issue. But all of the old records... sheesh.. a nightmare.
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23rd May 2007, 08:29 AM
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Re: How long do you maintain (retain) calibration records?
Life of the measuring instrument. That way you have a history.
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Thanks to gpainter for your informative Post and/or Attachment!
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