How are Electronic Editable Documents Controlled

[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

 

[Marc]

If *anyone* can edit them they are not controlled.

The "best" cheap method (my opinion) is to make the current revisions into "read only" .pdf files and only make those available to the employees. Only the person or people responsible for specific document(s) should have access to editable documents.

There are *many* ways to control documents. The key is to remember the key word in the requirement: Document *Control*

 

[Andy501]

Thanks Mark, it makes perfect sense really. Because they can be accessed by the relevant managers using them and they input data then print and file is it acceptable to remove the control status or do they have to have a control number as they are part of our processes and procedures?

Please forgive my ignorance.

Regards

Andy

 

[Marc]

Well, if they are inputting data are you referring to forms?

The problem is that every company can define how they want to handle document control and control of forms. Some have a central function that does this. Most are "distributed" systems which allow, for example, departments (the department manager, for example) to make new documents and forms, to approve them and issue them, to revise them, etc.

Think about the intent of document control. The intent is to have documents and forms that are current available to the people who use them. Thus, you have to ensure that not just "anybody" can edit them. A document control system in a company has to have a mechanism to ensure this, but there are very many ways to do it.

There is no requirement for a "control number" or anything like that, but it is required that you can identify revisions and have a history of revisions. Again, different companies have different ways to do this. The most common way is for a document or form to have a revision "level" on it such as "Release", or "Revision a", or "Revision 1", or something like that. Some companies just use the date the revised document was released for use. It doesn't have to be a complex system. But you do have to have some way to identify the "version". If you don't, how would one know whether or not they were using an obsolete document which had been changed 4 or 5 times over the last couple of years (or months or what ever time frame)?

Another aspect to consider is the change mechanism has to have a way for employees who use a document or form are notified of changes, not to mention whether the employees have to be trained on the new revision. You don't want to change a document and not ensure those who have to use the document are notified that it has been revised.

 

[Andy501]

Thanks Marc,

I appreciate the feedback, I was indeed talking about forms. I need to do some further research and influence and educate people within the business reference our procedures. I think we are making things extremely difficult for ourselves. I have found this evident in previous audit reports prior to my arrival with constant non conformances raised against document control and control of records.
Thanks again

Andy

 

[Pancho]

If *anyone* can edit them they are not controlled.

The "best" cheap method (my opinion) is to make the current revisions into "read only" .pdf files and only make those available to the employees. Only the person or people responsible for specific document(s) should have access to editable documents.

There are *many* ways to control documents. The key is to remember the key word in the requirement: Document *Control*

Actually, QMS documents can be controlled even if *anyone* can edit them. If edits are saved, attributed, time-stamped, identifiable, reversible, and doc owner is alerted of them, then control can be achieved even when anyone can edit. All this is easily done in a wiki.

In fact, given those conditions, it is probably better to allow anyone to make the edits. Doing so empowers employees and they take ownership of the documents. And continuous improvement takes off: With contributions from all, a ratchet mechanism develops where very few "bad" edits are ever made, and the many good edits capture tacit knowledge in the organization.

 

[Marc]

Thanks Marc,

I appreciate the feedback, I was indeed talking about forms. <snip>

Forms are a different breed of document. Some forms need a revision level on them and others don't. It depends upon the type of form it is and its purpose, amongst other things. The important thing is that a person can not change the form its self. You can use pdf files which allow for data input but will not allow the person to change the form its self. There is also the potential of using a database which is more common.

That said, as soon as someone inputs data on a form it becomes a record.

What is the Difference between a Form and a Record

Document vs. Record

Actually, QMS documents can be controlled even if *anyone* can edit them. <snip>

Yes, that is true. But I doubt you would want the guy sweeping the floor making changes to the engineering department's documents, as an example. I have nothing against wikis for documents but it's not as simple as you make it sound.

As to wikis and forms, I can not comment because I have no idea how that would work.

 

[Wes Bucey]

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

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.​