If anyone has this type of procedure,l I would love to see how you addressed the issue. It is new to me and I have already written & implemented over 200 Procedures & work instructions, this one is a wee bit out of my area of expertise.:truce:

If anyone has this type of procedure,l I would love to see how you addressed the issue. It is new to me and I have already written & implemented over 200 Procedures & work instructions, this one is a wee bit out of my area of expertise.:truce:

Hello Riverbend.

Yes, this topic has been covered (is that a pun?) and many people have (I'm sure) posted their approach to document controls, including electronic version.
Please feel free to do a search. At the bottom of each thread there are also listed related threads. See what you come up with and feel free to return to this thread if your needs aren't met. We're here to assist!

Welcome! As Andy said, there are some related threads at the bottom of the page, there are also documents available through links at the top of the page (post attachments list, more free files). But most of all, instead of relying on what someone else has done, why not start with where you are? How do you control data? Since you ask about "documented and electronic" I am making the assumption that you are talking about things like production data (characteristic measurements etc)? I am sure that you already have some sort of policy for computer back-ups, and also some method of filing paper/hard copy/handwritten information?

Just explain what it is you do already, who is responsible, how often you do it (back-ups), how long you keep it.

If anyone has this type of procedure,l I would love to see how you addressed the issue. It is new to me and I have already written & implemented over 200 Procedures & work instructions, this one is a wee bit out of my area of expertise.:truce:
I think you are in the right church with your question, but perhaps you sat in the wrong pew and can't hear the sermon. In my opinion, you need a good overview of exactly what is possible with "electronic document management" before you can write procedures on actually doing it. The topics listed below this thread may change from time to time as folks add new terms in their posts. Using different permutation of search terms using the advanced search utility here in the Cove can help you get that overview.

Some time back, I wrote a post on this general topic which included this excerpt Here is a copy of a post I wrote several years ago - most of it is pertinent today.

here's a copy of something I wrote on the ASQ Forum on 9-3-2004:
Quote:
I know lots about "electronic document management" (EDM) software.

I need a lot more information about the scope of your operation to make a meaningful suggestion.

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?"-Wes Bucey, Quality Manager

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.

Somewhere else, I wrote
Quote:
Why not take the entire QMS system paperless? Is your company a public company? Will you ultimately want to include Sarbannes in your thinking?

It appears the toughest part is that you want to go back and include all your legacy data (FAI) as well.

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.

-Wes Bucey, Quality Manager ___