Control of Electronic Forms and Documents Embedded in Software

[JRKH]

Hello all,

I need to know how others handle forms etc. that are embedded in software.

Our shop control software generates stock pick lists, and shop travelers, plus loads of reports. None of these "documents" will have the usual control signatures.

I am sure there is some simple verbage I can put in my Doc control procedure for this but it seems to be eluding me.

Any Ideas?

James

 

[Marc]

They will be referenced within your documentation where you explain what document types exist and what they are. This is rarely a significant issue in a company your size. I will bet you will find that your MRP (or MRP like) software will have control features necessary for what they are used for.

There is a concept here I will bring out. Controlled documents do not all need signatures for approval and such. Most do not need approval signatures per se. There are other methods. Don't take the signatures thing too far. Make sure there is a very good reason before you have people signing things.

Thoughts from others?

 

[SteelMaiden]

I take your same approach Marc. Forms are controlled here when they are created on a computer and filled out by hand. Approval is documented when someone sends me a revised file to place in the system I save their e-mail in a special folder called e-approval making sure that the document name is the subject (we use an intranet system, forms are saved by me in .pdf so if someone needs a clean one at 3a.m., all they need to do is hit the link to open it, then hit print)

As far as forms in software....let's use the example of corrective actions being done using some software package. I do not use form numbers, approvals, or anything else. The quality manual states that the controlled records reside in the computer system and all paper copies are used only for reference and are not controlled. It is obvious in this case that if you are using software that resides on a server, all employees will be using the same version, the computer system is secure and has the appropriate security, and records are backed up per the policy/procedures documented within the quality system. Also, if the "record" is filled out within the computer, anything you print becomes a report, not a form.

There are a lot of ways to approach the requirements, be inventive and try to find the least labor intensive method that makes sense to your organization.

 

[m-rome1]

I would agree to the posts above.

When QS9000 started all of our forms had signatures. It became very time consuming if there was ever a change in a document. Now our whole system is NT based with no signatures. The computer has the original controlled document, while any hardcopy can be treated as an uncontrolled or reference document. Document permissions are setup within the computer to make sure only the authorised people can make changes to the document.

I believe that most companies are doing it this way now. One possible suggestion if you are not comfortable with not having any reference details on the forms is to export the form to Word or Excel (or else print the form) and manually give it a form number. Treat this form as the controlled document and the computer system form that is used as the reference document. However I would tend to agree with the comments from the last post.

 

[Marc]

Originally posted by SteelMaiden

.....if the "record" is filled out within the computer, anything you print becomes a report, not a form.

This is an important concept for everyone to understand. And the 'record' is in the database, though many companies do printouts and identify them as quality (or other) records. :thedeal:

 

[Michel Saad]

Change control?

Interesting subject.

We are in the process of transfering a lot of forms to electronic. I understand and agree with the previous post when it comes to the use of the form, what I am questionning is how do you manage the changes to the forms if no one approves them? Couldn't you wind up with a lot of garbage on a form if its anybody's wish list that changes it?

Intersersted on how others do it.

 

[Marc]

You need my Implementation files... (Unabashed plug ). Review and approval can be evidenced by the fact that the file resides where it is. If it's in the 'publish' directory (or whatever you want to call it), directory permissions allow you to restrict who can put a file there. Ergo, if a file is there the person who reviewed and approved it did so (if your system describes your system in this way). Many companies have departmental protected directories, maybe a 'quality' directory, etc. This is shown in the example document control flow chart in the one of the Implementation files.

If your document control procedure tells how this is done you don't need signatures and such. Since it's electronic, any update precludes someone using the wrong version (with the notable exception in situations where printouts are part of the system).

See https://Elsmar.com/Imp/ for some thoughts. :thedeal:

 

[Michel Saad]

Good try Marc.

You are still talking about the mecanics of changing the form on the system and access control. My question pertains more to the management of the content of the form. If I am the only person authorised to change the CAR form, should I be allowed to get rid of 3 steps (from an 8D) without anyone else approving the change? Of course not ! Then if no one approves the form itself, how do you show that changes were warranted? Through a document change control form (or ECN system) maybe? Thats what seems to be proposed in your chart.

I am simply looking for best praticises.

 

[SteelMaiden]

The person who has access to change any forms should be someone that the company trusts to do the right thing. i.e. I am the only approver necessary for publishing new or revised forms. Anybody in the facility can ask for changes, after I check with the area supervisor or manager to see if it is OK, I approve it and publish.

As long as you state WHO, it doesn't matter if it is the janitor, as long as they meet the expectations and don't do stupid things, what does it matter? I myself am not about to jeapordize my job by sabotaging forms. I guess I just can't imagine working in an environment where you can't find a one or two folks that can't be trusted to do their job without fearing they'll change things on a whim or deliberately mess up? Am I missing your point, I have a feeling I must be?

 

[Michel Saad]

Thanks for the response.

No it is not for deliberately messing up a form. It is more the lack of understanding all the effects that the change might cause. We have a lot of systems and a lot of people. For some things it is straight foward. I use the form, I change it. There are some forms that affect the entire organization (part creation in the production sofware, ECN form, etc...). It is not easy for a single person to know the impacts on everyone else.

I guess that some need no approval and others need a change control form.

Regards,