Control of Computer Generated (Electronic) Forms - TS 16949 Control Requirements

[dmhillsburg]

Does the TS standard require revision control of all forms used in the quality system- even those computer generated? In the old ISO 9001 1194- we had all forms used on a master list by department and then each form had to have a revision and authorizing initials on it. Is this still necessary in the TS standard? Thanks!

 

[Marc]

I think there are some threads on this, but I tried a search and didn't find one searching titles. Let me take a closer look.

 

[Marc]

I didn't find a specific thread, but essentially computer generated forms must be 'controlled' at least as far as content goes. Typically if you're using 'store bought' software control isn't an issue because the format and content is fixed. But if, for example, you have a database you wrote in Access and you can change the form, you have to control it. There are different ways to control those forms.

Give us some info about your system (such as are you able to change the form? Is it something like an acces database?) and we can better help with more specifics.

 

[The Taz!]

I believe that the actual control can be accomplished with limited access and authority specified in the Procedure or Work Instruction. Limited control, even in Access, can be set by your system administrator and even in the access program. Authorized personnel have all rights, users have limited Read Only rights. This does not prevent printing of the documents.

If you are networked, you can specify that the latest rev is available in controlled subdirectories or folders on the network. Now it is up to your change control system to maintain it that way.

JMHO

 

[Caster]

Keep it simple

Does the TS standard require revision control of all forms used in the quality system- even those computer generated?

I think "control" is a good idea even if ISO/TS did not require it. I've seen too many costly mistakes from the use of stale information.

But it can be real simple for computer forms.

In an access database, just add a version control table that lists all changes, dates, approvals and ensure the current version number prints on all forms.

In Excel add a worksheet that also lists all changes, dates, approvals and again print the current rev on all forms. If anyone knows how to put a link to a rev number cell in several worksheet footers, I'd love to know how.

Purchased software just needs a reference to the current version in your master list.

Another thing we've done is to put some "weasel words" in the doc control procedure to the effect that the format of a form is unimportant, but it must contain as a minimum the fields shown in the current version. This way even a handwritten form can be used in a pinch. Some auditors scratch their heads for a bit over this one, but it has survived many audits, and more important it's so simple that people actually use it rather than find clever ways to get around it.

Good luck!

 

[TownDawg]

Private Sub Workbook_BeforeSave(ByVal SaveAsUI As Boolean, Cancel As Boolean)
ActiveSheet.PageSetup.RightFooter = "Last Saved " & Date
End Sub

Private Sub Workbook_BeforePrint(Cancel As Boolean)
ActiveSheet.PageSetup.LeftFooter = ThisWorkbook.FullName
End Sub

 

[TownDawg]

By the way.. on the subj of control.. I tend to think like Taz does.. control the ability to change.. to make inputs.. rather than focus on trying to have all sorts of extraordinary controls on the outputs.

 

[DocConPolice]

Electronic Document Control

We had issues trying to store and control electronic versions of documents. We created a website within our intranet and it only shows the latest PDF of the document and if you have a template that you want everyone to use then post the word document of the template for them to download. We have one administrator that governs the approval process and the format of every document, me. I review content and make sure that everything is correct and then insert the PDF into our website. Now people and view the latest and greatest but cannot modify it unless they are the author or the department that it pertains to and then I send them the next revision of the document to modify changes to. Word has a great option of using markups so you can track who does what to the document and review it before you create a PDF of the document.

That is my two sence on electronic document control. I recently had my process and work area audited for ISO 9001:2000 compliance and I passed with flying colors.

 

[CarolX]

Adobe also has a form feature that can allow for forms to filled out electronically, without changing the form.

Adobe can be a pretty powerful tool if you know all it's features.

 

[IEGeek - 2006]

I was going to suggest the Adobe features as well. I have created some pretty great stuff (I am a little modest) with Adobe Designer and it is spectacular. The only rub was that everyone had to have the latest version of Adobe Reader to use all the fill in stuff. Now that everyone is up to par, we are enjoying our access control and the masses seem pleased.

Well worth the cost of Adobe Professional