Forms review

#1
Hello,

In our company's quality system when forms are reviewed the new revision is registered into the active forms and also the new form.
We have also kept the old forms revisions just for archive but we do not have a document with changes from one revision to another. We have this for procedures, workinstructions (each procedure has a special table with the changes and revisions and what changed from one revision to another). It seems to me excessive to have ths also for the forms but my customer is not very understanding and I am afraid they might consider it a non conformity.
Is it a non conformity? How is in the quality systems you are working with?
 
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John Broomfield

Staff member
Super Moderator
#2
Forms are your system’s data collection devices. These data may be analyzed to become information upon which decisions are based. Naturally you want to make sure the required data are collected.

So, you do need to control forms needed for your system to work effectively. They are not exempt from doc control and should have been controlled with their first issue.

And they can be reviewed and approved for use without anyone signing them. You could use (in the same position - bottom right, for example) a discrete letter or number to indicate their status. A letter could be draft, meaning comments are required but do not use which is replaced by a number when issued for use and improvement

Your process owners could be made responsible for ensuring only the correct versions of forms are available for use.
 

Castaway99

Involved In Discussions
#3
Auditor would be within his rights to write a Non Conformity. This is being done in one of my client company. Though they chose to have one sheet per record to capture the changes ( i wasnt told about it , it happened after the certifcation audit sometime during the survellance audits I guess and I am sure it was the certifying body auditor who suggested that to the company). It was the biggest file in the company, it really stood out this 'Master file of Formats' . :D But how many formats undergo change once approved. I guess not many if they were intially made after applying adequate thought. So one sheet on a computer that captures all the changes of all documents that have undergone changes would suffice I guess.
 
Last edited:

Tagin

Trusted Information Resource
#4
We have also kept the old forms revisions just for archive but we do not have a document with changes from one revision to another....I am afraid they might consider it a non conformity.
Is it a non conformity?
A non-conformity against what standard or what agreement?
 

Jim Wynne

Staff member
Admin
#5
So, you do need to control forms needed for your system to work effectively. They are not exempt from doc control and should have been controlled with their first issue.
In many, if not most, instances it's not necessary to control forms. What needs control is the information that's captured. There should be a documented procedure or work instruction that specifies the information to be recorded, and also specifies that any convenient format may be used to do it. A form can be provided without the form itself being controlled.
 

John Broomfield

Staff member
Super Moderator
#6
Indeed, the data to be collected could be specified by the procedure or it’s instruction as is often the case with forms accessed for data entry via a computer device.

Or the procedure itself could specify the form to be used to collect the required data.

In the latter case the form would need to be controlled just like its procedure/instruction.
 
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