Control of Forms - Do forms need to be controlled?

[Hanr3]

Re: Do forms really need to be controlled?

Another question.

How do you controll reports from other computer programs, say Oracle? How do you maintain version levels for a computer program and the reports it will generate?

 

[bobdoering]

Re: Do forms really need to be controlled?

Since we have records stored in Excel files and those are controlled, how do you put a copy of that record/form in your QMS Master Document list? As in, do you put in a unfilled out form with the ISO controls and refer to the file location?

The excel spreadsheet would only likely be considered a form if you print out a blank, take it somewhere to hand fill out the blank, then use the blank to fill out the file record. A blank form can be given a document number, revision and owner, etc., which can be printed out in the footer, for example. You can save a copy of the empty spreadsheet, or a printed copy (not as effective) as the controlled document. A link to the blank file location is OK.

But, the completed spreadsheet with data in it is a record. Your procedure needs to identify how you will identify, store, protect (from accidental deletion, etc.), retrieve the data, as well as its retention time (painful). Most folks have a separate list of records because of the retention issue.

 

[bobdoering]

Re: Do forms really need to be controlled?

Another question.

How do you control reports from other computer programs, say Oracle? How do you maintain version levels for a computer program and the reports it will generate?

If it is a formatted report. If you print out a certification, purchase order, etc. from a database, the blank report should be controlled. You can print out a blank report, and either save the scan or the hard copy - whichever your system accommodates best.

 

[Hanr3]

Re: Do forms really need to be controlled?

Let me mull that over and run it through a couple of our computer records to work out any quirks. Thanks!

 

[tmoreau]

Re: Do forms really need to be controlled?

Do this test: give the people blank sheets of paper instead of the form. Are they equally as effective? Then do not waste your time on the form. Do they have to go back and grab information they missed? Then use the form, control the form.

This suggests another possible solution to make the 'blank paper' work; post a work instruction in the dock area listin itms that need to be recorded.

Interestingly, this helps to illustrate how forms serve as work instrctions, and how a controlled form could serve as a work instruction even when the data is recorded elsewhere (blank paper, another user created form, etc). Which is my original point, and the purpose behind the clause in my doc control procedure:

3.5.6 Controlled forms are provided as a guideline, to be consistent with procedures, and to ensure all required information is documented.

·Records may be kept on controlled forms or an equivalent, provided that all information is present and legible.

 

[bobdoering]

Re: Do forms really need to be controlled?

Interestingly, this helps to illustrate how forms serve as work instructions, and how a controlled form could serve as a work instruction even when the data is recorded elsewhere

If you can add enough information on a form to make its use self-explanatory, it is clearly a lot handier than having a separate work instruction on how to use the form! Highly recommended!

 

[Hanr3]

Re: Do forms really need to be controlled?

and if that infromation is retained, it becomes a record.

That simple form is a Work Instruction, Form, and Record. Plus a group of those records could lead to monitoring and measuring data, which will lead to Management Review of Quailty Objectives, and Continual Improvements, Preventive Actions, or Corrective Actions.

That simple form carries alot of weight if used correctly.

 

[JaneB]

Re: Do forms really need to be controlled?

If you can add enough information on a form to make its use self-explanatory, it is clearly a lot handier than having a separate work instruction on how to use the form! Highly recommended!

Agree! Forms that require a lot of explanation (instructions/procedures) are usually not well designed. There's a lot of bad designs around (alas). It's worth studying what makes a form useful and usable - well designed.

and if that infromation is retained, it becomes a record.

That simple form is a Work Instruction, Form, and Record. Plus a group of those records could lead to monitoring and measuring data, which will lead to Management Review of Quailty Objectives, and Continual Improvements, Preventive Actions, or Corrective Actions.

That simple form carries alot of weight if used correctly.

Yes indeedy!

 

[JaneB]

Re: Do forms really need to be controlled?

There is no requirement to make a form. There is no requirement to be efficient or effective. There is no requirement to stay in business. So, just because there is no requirement does not necessarily make it a good idea not to do it.

Bob, I took that as an affectionate reference to the following Deming saying (as well as a reminder that we don't only do things 'because ISO says so' and of course not do certain things 'because ISO doesn't say we have to'. Correct?

"It is not necessary to change. Survival is not mandatory.”

 

[bobdoering]

Re: Do forms really need to be controlled?

I am not one to quote Demming often, but I suppose that sure came close!