Controlling Expandable Forms in Paper-Based Document Control System

#1
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?
 
Elsmar Forum Sponsor

Cari Spears

Super Moderator
Staff member
Super Moderator
#3
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.
 
#4
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

Looking for Reality
Trusted Information Resource
#5
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

Staff member
Admin
#6
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

Trusted Information Resource
#7
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.
 
#8
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. :)
 
#9
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!!!!!
 
Thread starter Similar threads Forum Replies Date
R Controlling Quick Reaction Checklists Document Control Systems, Procedures, Forms and Templates 1
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
qualprod Controlling documents in two different Applications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M AS9100d Controlling External Provided Processes (purchasing 8.4) - The customer want us to use supplier X AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
qualprod Minor non-conformance for not controlling local regulation laws? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
Q Controlling Multi-Tab Microsoft Excel Forms Excel .xls Spreadsheet Templates and Tools 5
C Controlling Software Versions that are part of a medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
A ISO 13485 - Controlling Production and Service Provision - Product Catalogues ISO 13485:2016 - Medical Device Quality Management Systems 3
M Difficulties Controlling Foreign Suppliers Supplier Quality Assurance and other Supplier Issues 8
R OHSAS 18001:2007 Section 3 - Controlling Work Place Risks Occupational Health & Safety Management Standards 3
T Controlling an Excel Spreadsheet (Database) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2008 4.2.3(f) - Controlling Documents of External Origin Quality Manager and Management Related Issues 9
M Controlling Flow Charts that are hung in workplace. Quality Manager and Management Related Issues 6
N Controlling Records query that may cause some serious trouble for me ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Controlling Manual - Control of 10 Printed Manuals throughout our 9 Branches Document Control Systems, Procedures, Forms and Templates 8
Fender1 Controlling Documents and Records in a Custom Weld/Fabrication Company Document Control Systems, Procedures, Forms and Templates 10
C Tool Monitoring - Controlling a Process with Better Tool Monitoring Manufacturing and Related Processes 4
C Controlling QMS - We are expanding globally and want to keep our QMS Confidential Quality Manager and Management Related Issues 20
C Controlling Documents: Beyond the standard, how do we truly define what to control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Referencing and Controlling Labels & Stickers used internally throughout Production Document Control Systems, Procedures, Forms and Templates 1
Q Controlling Prints in Shop - Audit Finding Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Controlling "Stamps" used throughout our processing Records and Data - Quality, Legal and Other Evidence 16
T Requirements - Controlling and Maintaining Sheet Metal Templates for Production Use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Controlling Solidworks model, CAD & Gerber files Document Control Systems, Procedures, Forms and Templates 3
M Defining and Controlling External Documents (Documents of External Origin) Quality Tools, Improvement and Analysis 5
M Controlling Temperature and Time - Do I need to calibrate the thermostat? IATF 16949 - Automotive Quality Systems Standard 4
S Controlling Documentation - Which procedures to control Document Control Systems, Procedures, Forms and Templates 12
C HACCP in Egg Production - Controlling hazards at the farm level Food Safety - ISO 22000, HACCP (21 CFR 120) 7
M Controlling Data Labels on Graphs - Number of Decimal Places Reported - Minitab Using Minitab Software 7
I Controlling Minitab by vba (visual basic) or vb Using Minitab Software 6
T Procedure for "Controlling Nonconformity" for a software company Document Control Systems, Procedures, Forms and Templates 2
R Controlling and monitoring of measuring devices - AS9100 General Measurement Device and Calibration Topics 3
D Establishing and controlling process capability - Meaning of Phrases Capability, Accuracy and Stability - Processes, Machines, etc. 2
E Controlling CNC Machine Programs - Your recommendations appreciated Manufacturing and Related Processes 12
T Controlling filled out "forms" (eg Operator job specific work instructions) Document Control Systems, Procedures, Forms and Templates 3
B Controlling Reference Material Document Control Systems, Procedures, Forms and Templates 1
J Controlling Temperature and Humidity in the CMM Room and does anyone use Artifacts? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
R Procedure for Controlling Transmitted Technical Data - ITAR compliance Document Control Systems, Procedures, Forms and Templates 18
S Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 8
Raffy Controlling Handler, Tester, Computer and other Equipment Manuals. Document Control Systems, Procedures, Forms and Templates 2
H Controlling Continuously Changing Forms IATF 16949 - Automotive Quality Systems Standard 12
W Controlling Revisions of External Documents - Documents of External Origin Document Control Systems, Procedures, Forms and Templates 10
A Controlling Humidity in a Textile Testing Laboratory General Measurement Device and Calibration Topics 10
M Polyurethane Foam Testing and Controlling the Foaming Process Manufacturing and Related Processes 6
G Controlling a male 6% Luer with permanent collar according to EN1707? General Measurement Device and Calibration Topics 5
C Controlling External Customer Documents (Documents of External Origin) Document Control Systems, Procedures, Forms and Templates 5
L "Document Controlling" Queries run to obtain information reported to customer Document Control Systems, Procedures, Forms and Templates 7
A Still Confused About "Controlling Suppliers Records" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Controlling the records of suppliers - AS9100 Rev B Clause 4.2.4 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Controlling external processes - Alternatives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom