Moving from a Paper based Quality System to an Electronic Quality System

[Ninja]

Consider open architecture software that you can control yourself.

A rapid deployment dbase such as Filemaker Pro leaves you in control of when it is worth upgrading..(and thus validating)...

We moved electronic in Filemaker for less than 1% of what it would have cost for a closed system ERP...and we can customize as we see fit...IF we see fit.

It took longer to scan the documents than to make the pdf's accessible and govern restrictions on each.

(I do not work for Filemaker)

 

[Claes Gefvenberg]

At least there is more to choose from today than when we first decided to go paper free. We had more or less one choice: To build it ourselves.

So we did cobble something together, and I have to say that the end result left something to be desired. I think it is called user friendliness Well, the end users actually could live with it, but the admin side of it was an all hands on nightmare. Time better used to develop the system disappeared into an admin quagmire.

What I am trying to say is that given the choice between putting something together myself again and buying something off the shelf, I would shy away from building it myself. There are pretty decent alternatives on the shelves today.

 

[Sebastian]

We have some procedures driven by forms.
Problem we had, which was caused by establishment of second plant, was flow of these forms between plants. Initially, people signed forms with pen, than scanned and forwarded them by e-mail. So readability was poorer and poorer even file size gone up.
I have decided to buy Adobe Acrobat. There is Livecycle Designer embedded with it, which is particularly designed to make pdf forms.
Now we have pdf forms and every Adobe Reader user can create own signature and sign them free of charge.
Problem is price of Acrobat and getting knowledge how to use it.

 

[mattador78]

I'm a dinosaur, I know.

I use MS Excel for our form 0001 - Master Doc List.

There is an active and an obsolete tab.

In the active tab, each row lists a form/procedure/work instruction and I have columns for Form, Rev., Rev. Date, Doc Title, Reason for Creation/Revision, Date of Review, Reviewer, and Notes.

In the Doc Title column, I link the correct document to my form 0001.

I have someone test the link as part of the document acceptance process (in case I thought I did it and just checked the box).

The Master Doc List obsolete tab is not linked.

Current revisions are on a shared network drive with appropriate network permissions (read only, full access...). Obsolete revisions are moved to a drive that is only accessible by doc control and upper management.

I also keep (*gasp*) three ring binders for the Quality Manual, the Procedures, Work Instructions, and Forms. Each doc has a hard copy in the book with the hard copy of the approval\training form. The fields on the approval\training form are the same as on the Master Document List, to make copy and paste easier.




To access documents, employees go to the Master Doc List and click or they go to the forms folder and go to form 0024 - ASL, because it is easy to get to. It is also cool to see people go to a folder and type "0-0-2-4 enter" and see their form pop up. It has impressed an auditor before.

I don't class that as a dinosaur way of doing it as ive just started something similar myself. I think its a system that works and isn't over complicated. Extremely glad I read somebody else works on a similar principal,

 

[UncleFester]

I'm old school - rather like most of the clients I work with - there's nothing you can't digitise these days and as already suggested, most of the templates are forms you're already using.

I tend to help clients organise their documentation, either on an intranet or within a local folder whereby document controllers have write access.
The folders are simple to organise in a tiered structure: policies, procedures, work instructions, forms and records.

Whether or not there's an intranet, I help the client create a dashboard, usually in PowerPoint that links Policies, Procedures, Work Instructions, Forms and Records in a pictogram format, showing how all processes are interlinked. The PowerPoint is saved as a pdf and a shortcut sent to everyone. So everyone can use the dashboard to understand how their processes are mapped and users can locate documents by navigating the dashboard.

Updates are easily made to the Master PowerPoint which is then saved over the existing pdf. As everyone has a shortcut there's no need to send out updated documents, merely update the change history on the PowerPoint.

Easy to manage and control, just how clients like it.