Document Storage/Archival Procedure

S

sniderdi

#1
My question is, is there any specific requirements when storing documents that are being archived by ISO Standards. Where I came from we had strict storage processes and at my current job they store their documents in their on-site warehouse. I need to write a procedure for this and want to make sure I am within the proper guidelines.
 
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Jim Wynne

Staff member
Admin
#2
My question is, is there any specific requirements when storing documents that are being archived by ISO Standards. Where I came from we had strict storage processes and at my current job they store their documents in their on-site warehouse. I need to write a procedure for this and want to make sure I am within the proper guidelines.
What types of documents? There is no general requirement for methods. Let common sense prevail. If there are documents that you (a) need to keep and (b) need ready access to, keep them such that the can be readily accessed. In all of this there isn't necessarily a need to have documented requirements.
 
S

sniderdi

#3
They are controlled documents, such as SOPs, Forms. This was an audit observation that we have no procedure for storage and archival of our documents. I know when I was pharmaceutical, we had very specific requirements on where our documents were stored.
 

Mark Meer

Trusted Information Resource
#4
They are controlled documents, such as SOPs, Forms. This was an audit observation that we have no procedure for storage and archival of our documents. I know when I was pharmaceutical, we had very specific requirements on where our documents were stored.
Unless you have some very specific requirements (as you did previously), I'd caution against developing procedures that artificially limit you (unless you have good reason).

In our operations, we intentionally keep our documentation control requirements quite general. Documents must be stored in a manner so as to preserve integrity, legibility, identification/retreivability, and security when applicable. That's it. This allows us a lot of flexibility, which is important to us because there are a lot of storage options available, and we'd like to always be able to choose those that work best for us depending on the nature of the documents being stored.
 

qualprod

Trusted Information Resource
#5
It depends on the needs, type of business.
You may have a business where records or documents are very important and the devices where information are stored, are sofisticated (e.g. servers, virtual services,etc.)
Some people take the bakups off-site for more security.
It may be necessary to establish a special procedure for the backups.

But again, it depends of the business, or you may be a business, 5 people,
nothing special, records may be stored in a USB memory.

Hope this helps
 

RoxaneB

Super Moderator
Super Moderator
#6
I'd suggest speaking with the process owners or subject matter experts. They may be aware of specific legislation regarding the retention of records including storage, archiving, access, protection, disposal, etc.

It may not be a situation where one solution applies to all and best to have the discussion ahead of time to mitigate future risks.
 

dwperron

Trusted Information Resource
#7
Since you do not state whether or not you are working to any specific standard(s), I'll use ISO 9001 as a generic example.

It sets up some common sense requirements for document retention:
* it is available and suitable for use, where and when it is needed
* it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
You must address the following:
* distribution, access, retrieval and use
* storage and preservation, including preservation of legibility
* control of changes (e.g. version control)
* retention and disposition
* shall be protected from unintended alterations.

As you can see, they don't get specific as to how you accomplish document control. Just that you are cognizant of the risks and have addressed them to meet your organization's requirements.
 
S

sniderdi

#8
Thank you and yes, those are the standards I need as a guideline. I have almost all of those addressed, so I am on the right track and understood what I was reading. I just want to do this right the first time.
 

Alyana

Starting to get Involved
#10
Hi,

In the organization that I worked in, we stored documents according to the shelf life of the product plus 1 year. Let say the shelf life is 5 years that means we stored for 6 years altogether. This is not in accordance with any standard (I haven't seen anywhere stating the retention duration, however the auditor could accept this kind of way.
 
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