Controlling Expandable Forms in Paper-Based Document Control System

[thompford]

Greetings!!!

I was recently hired to lead QA for a company that has a very basic paper-based Quality Management System. Many of the forms have fields that are far too small to capture what is required in them and they are required to be filled out by hand. For example, there may only be a few inches of space to allow for a full root cause analysis and definitely not enough space to write it out. The result is always to write "see attached" and attach a fully typed investigation.

I would like to get away from that by changing the forms to "fillable" (typeable) forms that have locked down content, but have expanding fields. While it would not change the content of the form template, it would change the structure format. For example, Section II may originally be at the bottom of pg. 1. However, Section I was filled out with much greater detail and Section II ended up on pg. 3. My controlled version may only be two pages long, but it could be 10 pages once completed.

My question is... how do I control a form that can expand as such?

 

[RW451]

Why not use a database or spreadsheet forms? Expandable and email-able.

 

[Cari Spears]

Welcome to the cove!

Are you putting the page number in a footer manually when you create the document, instead of using the insert "page XX of XX"?

The number of pages a form ends up being once completed is not something that you need to "control". Almost all of my forms are typeable and end up being any number of pages once completed.

 

[thompford]

Thank you both for such quick responses. Greatly appreciated!

RW451 - I would have loved putting together something in Access to basically recreate other eQMSs that I've used. We have no intentions of purchasing an eQMS any time soon, so that would have been my first choice. However, my company does not have Access and I would get a lot of pushback regarding validation. We manufacture OTCs so we have to be 21 CFR Part 11 compliant.

Cari - Our company has a few forms that they can type into or write into. However, the format is completely unchangeable from the hardcopy that resides in the master folder of forms. The content (headers, titles, descriptions, etc.) is all the same between the static and expandable form. It just gets moved around a bit when the fields expand. The concern that has been expressed to me is that an expandable form may no longer resemble that hardcopy original. There are rev numbers in the footer. I feel like this should not be a concern. Do you think that should even be a concern?

 

[Ninja]

FWIW, Adobe can work for you.
The fields wont expand...but you can set the font to downsize to fit in the existing layout (as long as you're reasonably close on space...if you write a novel, the font will get pretty small.

 

[Jim Wynne]

The concern that has been expressed to me is that an expandable form may no longer resemble that hardcopy original. There are rev numbers in the footer. I feel like this should not be a concern. Do you think that should even be a concern?

The filled-out form will no longer resemble the template no matter what you do. Your feeling that this shouldn't be a concern is well-founded. A container that's designed to expand to fit whatever is put in it is still just a container. It's the contents that count.

 

[qualprod]

Greetings!!!

I was recently hired to lead QA for a company that has a very basic paper-based Quality Management System. Many of the forms have fields that are far too small to capture what is required in them and they are required to be filled out by hand. For example, there may only be a few inches of space to allow for a full root cause analysis and definitely not enough space to write it out. The result is always to write "see attached" and attach a fully typed investigation.

I would like to get away from that by changing the forms to "fillable" (typeable) forms that have locked down content, but have expanding fields. While it would not change the content of the form template, it would change the structure format. For example, Section II may originally be at the bottom of pg. 1. However, Section I was filled out with much greater detail and Section II ended up on pg. 3. My controlled version may only be two pages long, but it could be 10 pages once completed.

My question is... how do I control a form that can expand as such?

Just be sure to have numbered this document with its revision,
e.g. PR-MG-001 Rev 3, and additionally to show the page number in each page.
e.g. 1 of 10, 2 of 10, 3 of 10, that way, the document is controlled.

 

[thompford]

FWIW, Adobe can work for you.
The fields wont expand...but you can set the font to downsize to fit in the existing layout (as long as you're reasonably close on space...if you write a novel, the font will get pretty small.

LOL - We had a few forms like that at my last job. The different font sizes in every field wreaked havoc on my OCD.

 

[thompford]

Just be sure to have numbered this document with its revision,
e.g. PR-MG-001 Rev 3, and additionally to show the page number in each page.
e.g. 1 of 10, 2 of 10, 3 of 10, that way, the document is controlled.

Thank you, qualprod! That piggybacks off of Cari's response. So long as the control number, rev number, and page X of Y are in the footer of every page I feel like this should be acceptable.

Thank you!!!!!

 

[thompford]

The filled-out form will no longer resemble the template no matter what you do. Your feeling that this shouldn't be a concern is well-founded. A container that's designed to expand to fit whatever is put in it is still just a container. It's the contents that count.

Perfect analogy, Jim! Thank you!