Can a Form Template be altered in a 13485 document control system?

[allisonr]

I have found several posts, but none addressed alterations needed for use of the form. Let me explain, please.

If a form is drafted, given a form number, and released through the D&D system, can it be altered? Here is a simple example to divine the need.

A form is created for HR for New Employees. On the form, one area has seventeen lines in a table to indicate what software the employee will need for their duties. Seventeen lines were picked because they never thought anybody would need that made. The form has been used for years and has been okay. A new employee is hired in a new role, and that employee needs eighteen different software.

Here is the question. Can the form be altered to insert an extra line for the eighteenth software?

Or would the form need to be revised, sent for approval, and up-rev'ed to the next version?

The next version of the question will be can a new column be added to the table? Keep in mind, these changes are needed to accommodate the intended use of the form.

I would appreciate suggestions.

Thank you to the community

 

[Tidge]

My personal rules:

Forms never get altered 'on the fly', because they are supposed to be used to record specific information in a consistent way. Forms have a simple set of rules: i.e. "complete the form".

Templates can be altered, as long as the alterations do not violate the instructions in the governing work instructions for generating content to be included in the finished effort. The work instruction mandates what information needs to be present, the template offers a skeleton to hang the meat on.

 

[allisonr]

You were better at helping me verbalize the difference, and with this, I've written the procedure.

Thank you.

 

[Randy]

Is it your form?

Change it as needed, record the change & reason according to your procedure/process to do so, move on and worry about more important stuff like lunch or the lack of intelligent life in government

 

[I_Moy]

Completed forms become records, as a general rule I put in my docs and records SOP that a form cannot be edited to remove sections when creating a record, sections should be marked N/A if not applicable but that additional info may be added to records. I will usually hand enter and sign and date any info that does not have a specific line or box hardcoded in the form, so in your scenario above I would just enter the extra data manually but not change the form. You should then go and uprev your form so its suitable for your needs.
When creating a form with tables to be filled in I will usually add a line into the form that says "add lines as needed", you are then allowed to add as many lines as you like.

 

[FRA 2 FDA]

I allow additional rows to be added where needed or unused ones to be deleted because this doesn't change the information the form is asking for. Adding a column, however, I would not allow without revving the form because this is asking for additional information. If there is additional info that needs to be added in the meantime, I agree with I_Moy's statement above. Just write it in. Then rev the form to add the column if it's something that will be relevant again.