Requirement to Identify Changes to record in ISO 13485 : 2016

A1S2H3I4T5H

Starting to get Involved
#1
Hey Guys,

Can u please help in figuring out what "Changes to record" means and how to incorporate in our system ?? (ISO 13485:2016, 4.2.5)

Thanks.
 
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yodon

Staff member
Super Moderator
#2
You're referring to this paragraph, I presume:

Records shall remain legible, readily identifiable and retrievable. Changes to a record shall remain identifiable.

There are a variety of ways a record can be changed so you have to have a strategy on how this is managed. Consider, for example, a lot production record (maybe a traveler). As it is goes through the process, someone may make an entry and someone downstream may need to correct that entry. How will you be able to identify who made the original entry, what the original entry was (legible), and who made the change?

If you are dealing with electronic records (refer to Part 11), you will need to ensure that there's an audit trail with the above information for each change. (This actually applies to all entries, not just changes). So if your traveler above is an electronic record and all entries are done electronically, as well as the downstream change, the system has to enable capture of the audit trail with the identifying information.

Hope that makes sense. If you have specific questions / scenarios, it might help to share them to help us give better responses.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Changes to a record shall remain identifiable.
In my understanding this comes down to the following:
1. The change must not remove/obscure the original information.
2. The person making the change must be identified in connection with the specific change.
3. The date that the specific change is made must be captured in connection with it.
4. Unless the authority to make that specific change is obvious, it needs to be documented somewhere that is reasonably easy to track (eg a change control record).

As Marcelo suggested, in paper form the trivial way of doing so is striking through the original information, adding the new one, signing-off and dating the change in close proximity. The downsides of this practice are that sometimes the individual can't be readily identified from the signature (or initials, as some orgs require), and the authority trail is sometimes not that obvious (or well documented).

For electronic records see yodon's comments. The 4 principles I listed above apply just the same.
 

rlangeZMC

Starting to get Involved
#5
I also have the same issue but my example will be a completed COA.

We have updated a test value, it was initially typed as N/A but now, for whatever reason, they want to go back and do the test and add it to the COA. I'm sure we don't want to cross anything out and make it look bad and I'm sure the customer doesn't want a COA that looks like that. Would we be allowed to put an * next to the added data and put the * in the footer stating that the data was added on MM/DD/YYYY? We would save the new COA with the lot number and date of update in the title so it was obvious. Ex: 123456 04132018. The previous COA would be obsoleted and marked as such, 123456 - obsoleted 04132018 then placed in an obsolete folder within the original folder. If you right-click over the document, it shows you who updated it. Does that cover: legible, readily identifiable and retrievable? :thanx:

Thoughts? :bigwave:

We already have a good way of controlling documents but I have so many thoughts about controlling records. It's a whole other game.
 
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