Document Control - Applying Suitable Identification to Obsolete Documents

mmnelson553

Registered
4.2.4 (h) states "prevent the unintended use of obsolete documents and apply suitable identification to them."

I'm curious to what extent do you need to "apply suitable identification to them". I have our controlled docs on our server as word documents. When a newer revision is created, the obsolete document gets moved to a locked folder labeled "Archived Documents", is that considered suitable identification? Do I need to rename the file to have the word "Obsolete" added to it, or add a watermark in the document that says "obsolete"? That seems like the best way to meet the standard but also seems like a lot of work to go through all of our old documents.

I'm curious how others interpret that and what experience/suggestions you may have to meet this.
 

John Broomfield

Leader
Super Moderator
Obsolete docs are usually turned into records that are filed and archived.

As such they no longer are stored or controlled as documents which are subject to review and updating.
 

John Predmore

Trusted Information Resource
There may be a valid need to access obsolete documents, to research what specification or work instructions were in place at a particular time in the past, in the course of a product quality or other problem-solving investigation, for example.

I notice 4.2.4 (h) uses the word AND. That means both limiting access and conspicuous labeling of an obsolete document. It is good you have a restricted access folder. You had the idea of renaming files, and that could work to both prevent inadvertent access and prominently label the digital file. There is an old MS-DOS command to rename any number of files in a folder matching a wildcard filespec. I suggest this as a way to minimize the work to open and edit hundreds of old obsolete files.

From an MS-DOS Command window, in the folder of interest, type
RENAME *.docx *.docx.OBSOLETE
will name all MS Word files ending in docx to add the suffix of OBSOLETE. This command works on any number of files from one to infinity in a single folder. You will see a warning popup message that you are changing the file type to one the operating system does not recognize. By changing the "file type", the file will no longer simply open in MS Word. A user would have to rename a file to remove the extra suffix before the file opens in MS Word . You can rename a single file within the File Manager window, without using a Command window, so this measure is not a security measure but only adds an extra step to restrict unintentional access. Older MS Word files use the file ending .doc and macro-enable files use .docm, so you might have to repeat the MS-DOS command with alternate file endings to rename all variations.
 

Swimming In The Soup

Involved In Discussions
I had a similar situation just recently. We had an SOP that was a duplicate procedure of 2 other SOPs. I asked my team to do a revision to the SOP to replace the sections with references to the other 2 SOPs that address the process. Then we obsoleted it. If the auditor asks for the SOP there is a clear trail on what happened with it.

Just a side note - Using word docs kind of defeats the controlled part of the document. It can be modified when it is accessed. You may want to convert to PDF with the exception of forms that are designed to be edited.
 

Tidge

Trusted Information Resource
I am familiar with two controls, the first is IMO sufficient, the second is "above and beyond" the first.

1) The documents are maintained with a lifecycle in the repository; it is obvious which state the life-cycle they are in. For example, a simple life-cycle is (under review) -> (released) -> (obsolete) . Access to obsolete documents is generally restricted. In PDM systems obsolete documents are removed from product structures.

2) The OBSOLETE documents get watermarked by a "librarian" as such, as a life-cycle activity.
 

Tagin

Trusted Information Resource
4.2.4 (h) states "prevent the unintended use of obsolete documents and apply suitable identification to them."

I'm curious to what extent do you need to "apply suitable identification to them". I have our controlled docs on our server as word documents. When a newer revision is created, the obsolete document gets moved to a locked folder labeled "Archived Documents", is that considered suitable identification? Do I need to rename the file to have the word "Obsolete" added to it, or add a watermark in the document that says "obsolete"? That seems like the best way to meet the standard but also seems like a lot of work to go through all of our old documents.

I'm curious how others interpret that and what experience/suggestions you may have to meet this.

In our case, our work instructions for assembling product are accessed via links on webpages on a SharePoint server. Older revision work instructions for assembling product will get copied to a new location on the server where the permissions are restricted to allow only engineering and repair personnel (as they need them to repair older product revisions out in the field) to access them when it is replaced by a newer version. This other webpage also has big red header text stating that these are older revisions for repair purposes only.
 

ChrisM

Quite Involved in Discussions
If your procedures state that obsolete and superseded documents are moved to a folder named "Archived documents" (and ideally you also add that they should only be consulted for reference purposes) then you are OK.
Apart from repair/maintenance purposes as outlined above, there are other reasons, such as when conducting an internal quality audit on a recently updated process, you may need to refer back to the now-superseded procedure/instruction/form that was in place at the time of the activity/record being audited
 

Philip B

Quite Involved in Discussions
We watermark ours 'OBSOLETE - DO NOT USE' and place them in a read-only folder. I watermark and archive the old version as part of the procedure for issuing the new one.
 
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