Controlled Document Location

#1
Hi All,

Looking for some advice on how to control documents correctly per ISO9001:2015. I'm currently updating the form of my companies work instructions. In the past, we have added a print date and expiration date to the document, and had all copies electronically. However, there was a lack of computer knowledge with the floor workers, so I'd like to have a printed copy available for daily use.

I'm leaning towards putting a file path at the bottom, and saying something like "This document is controlled at location. Verify that the document is current before use. If questions, contact the quality department."

In doing this, I'm concerned about a potential audit. I know having documents printed at all leads to potential NCs. I'm going to have a master list with locations of all documents to be obsoleted and recalled when a new revision is created. However, I don't want to add a statement like that in, and then in an audit have an operator not check for the correct version.

Am I making this too difficult? Do I need any of this? Or can I control it purely with a master list and have only quality responsible for the correct versions on the floor (and if that's the case, do I just put controlled in the footer)? Furthermore, do I need to mark documents as controlled at all, or can I just have my doc control procedure lay all of that out?

Thanks in advance!
 
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#2
ISO 13485 Medical Device environment here

I have almost all of my controlled documents available only electronically. All controlled documents live on one controlled drive on our network. All employees are trained to this network drive. I have a few work instruction manuals where the owner of the manual refuses to give up her hard copies. Auditors are always finding incorrect revisions and the owner refusing to give up hard copies is responsible for completing any CAPAs related to these nonconformances. All employees have computer access at or near their work stations.

I do have several "wall postings" controlled and hard copies are assigned to certain locations on the plant floor. These are noted within my Document Masterlist.

My way may not be the best way to handle documents but no audit issues have been raised as of yet.
 

JimS

Registered
#3
ISO 9001:2015, not medical.
All of our controlled docs are available electronically from a controlled SharePoint library. There are a few workstations that don't have computer access, however, so our SOP defines a process whereby the manager can request a hard copy, noting where it is to be used. Doc Control prints it, stamps it as a controlled copy, then initials and dates it, noting the location where it "belongs". And since a good color copier can easily replicate all that, we also use a non-circular hole punch to punch a hole in it. Something odd available at hobby stores but someone would have to go through a lot of trouble to duplicate. If someone does that, you've got bigger problems!

If a new revision is released, the manager submits another request. I prepare it but don't hand it over until he hands me the old revision, which is destroyed. This process is working well for us.
 

hogheavenfarm

Quite Involved in Discussions
#4
Ours are in electronic form also, however to minimize disruptions when auditors show up, I have made up a notebook of our controlled documents and so keep one book current with all.
This is helpful when I need to quickly access a particular form for a possible revision or update, and we dont have to waste alot of time showing auditors how to access the system. Keeping one book is not really much of an added burden and has been more of a help than a hindrance. As part of our internal audits, this book is checked for being up to date and accurately reflecting the electronic information.
 
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