A simple electronic (software) document control question

rvanelli

Involved In Discussions
#1
Say a company decides to use a computer system such as Agile to control, approve and maintain records of all approvals of their quality manual, procedures and work instructions.

Then they locate these documents into a local drive and link that document to a webpage for electronic usage by all that need access to this document. No printed copies of documents are allowed.


If the local drive is available to all is the document still controlled? The local drive also has the obsolete folder with obsolete documents inside for all to see.
 
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Jim Wynne

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#2
Re: A simple document control question

Here's 4.2.3(g) from ISO 9001:2008:

A documented procedure shall be established to define the controls needed
...
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.


So, you would need to demonstrate that the document identification is "suitable," and you would need to demonstrate how you prevent unintended use. You should be able to apply permissions to a folder that would prevent it from being opened by unauthorized people. "Suitable identification" could then be the presence of obsolete documents only in a folder with controlled access.
 

Wes Bucey

Prophet of Profit
#3
Re: A simple document control question

Here's 4.2.3(g) from ISO 9001:2008:

A documented procedure shall be established to define the controls needed
...
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.


So, you would need to demonstrate that the document identification is "suitable," and you would need to demonstrate how you prevent unintended use. You should be able to apply permissions to a folder that would prevent it from being opened by unauthorized people. "Suitable identification" could then be the presence of obsolete documents only in a folder with controlled access.
I agree with Jim. The primary factor in control of documents is essentially Configuration Management (Keep obsolete documents from general view or circulation so they aren't used by mistake.)

As described in your original post, you are not "controlling" documents, merely "sharing" them. There are off-the-shelf software solutions to include control of documents.

Given your concept, why limit the system to just your "quality manual, procedures and work instructions"? In fact, many organizations use software solutions to control ALL their documents. I wrote about this years ago and most recently this March:
Original Question:
In Reply to Parent Post by Andy501


Hello Everyone,

I have a question I'm hoping one of you can provide assistance with. I am relatively new to QMS and need to get my head round this issue.

We generate alot of documents electronically which are printed for reference purposes and submission of reports. My question is firstly, can editable electric documents have controlled status and secondly what is the best management system to ensure everyone who has access to the docs don't mess around with them?

Thank you in advance.

Regards

Andy
Wes's response:

I have written about electronic document management a number of times in the past nine years. Most recently just last month. Here's a "brief" summary:
(pay particular attention to comments in bold red font):
Document management (both manual and electronic) has been a particular specialty of mine for for 40+ years. I try to keep abreast, but I can practically guarantee that any brand name recommendation I might give today might be obsoleted by a competitor's new development tomorrow, so I never publish a brand name recommendation.

I do, however, provide a set of guidelines which might help folks looking to adopt an electronic system. I first wrote this ten years ago. One small addition a year or so ago has made it [almost] current for today's use:
Quote:
Make sure you know and understand the difference between "document sharing" and "document management."

Here's a brief summary to start you off:

Document Management Software

Background:
An organization wants to improve efficiency of document management by ?grafting? a program over current legacy files and all newly-created files which will provide the following minimum benefits:

a) Ease of Search & Retrieval (on different fields/characteristics)


b) Ensure only the most recent revision is available on standard Search menu

c) Automate the procedure of notifying pertinent parties a document is ready for redlining

d) Maintain an audit trail for the status of documents (released or waiting for checking/approval [and by whom])

e) Allow ?full preview? of documents without opening native programs ? i.e. AutoCAD documents can be viewed without latest revision of AutoCAD being resident on user?s computer.

f) Permit ?group printing? of documents, regardless of native file format.

g) Maintain up to 30 security levels on any document, determining whether user has authority to create, modify, redline, view, print, copy, etc.

How do they work?
The primary feature of Document Control Software is a relational database which manipulates very small files called ?metatags?, which relate to certain attributes of documents. Basic attributes are file name, revision level, author, topic, key words, type of file format, etc. which are used for field headings in the database.

By querying the database, a user retrieves a ?menu? of documents which meet the search criteria. Self-contained viewing software permits a user to view and print documents, regardless of the native file format. The views can be scrolled, zoomed, and cropped (i.e. user can print an enlarged detail of a document.)

Users who have redline authority can markup documents without invoking the native file program (the redlines are saved as ?overlays? in separate files without changing the original document.)

Users who have checking/approval/redline authority can be automatically notified via email when a document is ready for their review. The program will track when and whether the review is completed and maintain an audit trail for ?real time? status reports on any or all documents in the review process.


By keying on the attribute ?Revision level?, the program can ensure only the most recent, authorized revision is available to most users, reserving authority to view ?superseded? documents to special categories of users.

An important consideration in grafting legacy documents into the new system is choosing fields pertinent to the organization. Many documents, like autocad and word documents have features which provide automatic tags (create date, author, department, etc.) [click on "properties" under File in a Word document to get an idea of already available fields.]

The problem is most users write documents which still show "valued customer" as the author because they have never explored the Properties feature.

An expense to consider is going back into each legacy document and adding the meta tags which allow for sorting and retrieval.

I hope this helps - there are many consultants like me who would come in and give your organization background on choosing the best brand for your organization. Caution is "Are they truly independent or do they have bias toward one brand?"


I didn't add in that post that most software programs have web versions, too. In point of fact, the documents "could" be located either on one server or scattered among hundreds or even thousands of hard drives or servers as long as they were connected or accessible via password over a network, a virtual private network, or the internet.

[<SNIP>

Back to today
Google "electronic document management" to see some other thoughts on this topic. I hesitate to recommend ANY product by brand name, because the competitive nature of the business is that one company can be hopelessly obsolete in a month or two and another can have a great breakthrough in the same period. Regulatory laws change quickly - a user's current and projected situation in that regard are important factors. Current quantity of documents and projected number of authors and changes are a major factor. Collaboration with suppliers and customers is another big factor. __________________
I can add that, back in the mid 90s, my organization spent over $200,000 creating an electronic data and document management program from scratch. It was unique and wonderful for its time, but hopelessly obsolete and simplistic today (everything was written in COBOL.) Today, a sharp shopper can get a pretty good program for less than $500 per seat (a computer and its operator which have author rights.) Many programs, especially web-based ones, have no extra charge for folks who can only read or print documents, not implement any changes. This is very handy for allowing customers and suppliers access to see documents pertinent only to them.

Do you have a time table for your implementation? Will you be adopting a large number of legacy documents into the system? How many new documents would you generate from your people in a week? a month? a year? How many changes (revisions) to existing documents in those same time frames? Do you have a budget range for accomplishing this? How sophisticated (computer-savvy) are your folks? Will they need mild training or intensive training? Are you budgeting the time and expense for that training? Do you envision collaboration with folks in different geographic locations (customers? suppliers? consultants?)

If anything, let me caution you that this decision on software is one which should take some intensive research and analysis. Often, trying to save a few dollars on the initial capital expenditure is penny wise and pound foolish because of the extra time and effort required by users to implement or "work around" bare bones systems compared with feature-rich ones.​
 
#4
A few items from my humble experience as my company?s ?document terrorist?:
1. rvanelli enquires about a simple electronic software system. I love simplicity, but simplicity goes hand in hand with rigidity; you will sooner or later find yourself trapped by system limitations. Flexible systems that can grow with you and your needs are necessarily complex. Document control requirement practice varies depending on whether you are in pharma , aircraft, or ball bearing manufacturing (you indicate that you work under ISO 9001).
2. It is very difficult to evaluate and compare different vendors? document control software. Generally such systems are complex and have a steep learning curve. Still, you really need to check out the market thoroughly before buying.
3. If you already use a document control software, it will be very difficult to change to another software.
4. Automate critical document control functions. Don?t rely on staff always following instructions. Put together your document control system in such a way that the system automatically handles what users are allowed to do and what they are not allowed to do. E.g., you will need to prevent that previous/obsolete documents leak out into the business and eventually are used somewhere in production. A manual system could accomplish this by a good combination of information/training of staff and conspicuous labeling of documents that are obsolete. The idea is that nobody should be able to use an obsolete document without noticing it. The weakness is that this kind of document control assumes that everybody follows instructions, and does so always. From experience we know that this is not very reliable. Much better is to let the document control software prevent access to obsolete documents; basically it should not be technically possible to pull out an obsolete document. This is accomplished by restricting access permissions of obsolete documents (perhaps only one librarian should be able to access these). Also, if possible, consider preventing printing of controlled documents (I know, this is almost impossible, but one can dream?), otherwise sooner or later you will find staff with obsolete document printouts stuck away in drawers, binders and manuals.
5. Prevent the birth of wild (i.e., uncontrolled) documents. Wild documents pop up if staff doesn?t find that the controlled current documents are adequate. Suggested preventative measures: Make it easy and natural to update the controlled documents whenever necessary. Simplify ways for staff to provide feedback and to suggest document updates. Involve staff in writing the documents. Ensure that the documents are written for the users on the floor - too many quality documents consist of abstract language catering mainly to auditors or management.

By the way, Wes? summary is great - thanks for sharing!
 
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