Controlled Forms - To what extent do forms need to be controlled?

F

Fire Girl

#1
Hello

This may seem like a bit of a silly question. But to what extent do forms need to be controlled. In the past, any form that dealt with information controlled by the system I have controlled. But do I need to control every form we use? I feel that we don't, but is my registrar going to agree with me.

Any thoughts would be most appreciated.

Fire Girl
 
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CarolX

Super Moderator
Super Moderator
#2
Fire Girl,

I have many forms that I use that are not addressed in my documents, therfore, I do not control them.

For example - we need to detail some parts for an out of tolerance condition. I will create a data sheet strictly for that use. I do not assign a form number or a rev number to it. And it looks neater to the Engineer that needs to review the information, instead of using a tablet paper.

Hope this helps,
CarolX
 
A

Al Dyer

#3
Originally posted by Fire Girl:
Hello

This may seem like a bit of a silly question. But to what extent do forms need to be controlled. In the past, any form that dealt with information controlled by the system I have controlled. But do I need to control every form we use? I feel that we don't, but is my registrar going to agree with me.

Any thoughts would be most appreciated.

Fire Girl

Fire Girl, Welcome!

Very few questions are silly, and yours is not.

Just my opinion, but:

We have our Level I (policy manual) and Level II (procedures) controlled. This means that we keep a list of who has those documents and submit new revisions to the document holders as required. (internally)

If we decide to not control the document we include a footer on the document that notes "Uncontrolled Copy".

Our position is that all documents sent outside of the company are not controlled and noted as such.

When we get into other documents the word "control" becomes somewhat moot. With a work instrucion we have the usual approval system and update them as needed. They are not controlled documents as they do not have a footer that says "controlled"

They are documents that are "registered" through our our document contol process and updated when applicable.

Maybe we should all talk about the difference between a controlled document and a registered document????????

I realize this post may sound ambiguous but I believe there is a difference between "controlling" a document and using a "registered" document.

Do we control the time card? no
Do we control an approved supplier list? Depends to whom it is issued.
Do we control SPC records? No, we store them per 4.16.

etc..

Waiting for further responses, document control is very important but can get out of hand very easily!

ASD...
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Originally posted by CarolX:
Fire Girl,

I have many forms that I use that are not addressed in my documents, therfore, I do not control them.

For example - we need to detail some parts for an out of tolerance condition. I will create a data sheet strictly for that use. I do not assign a form number or a rev number to it. And it looks neater to the Engineer that needs to review the information, instead of using a tablet paper.
What you fail to realize is that the form is your form and it is technically controlled by you.
 
E

energy

#5
This is just an opinion: If the mis-use of the "document" can have a detrimental effect on the system, I control it. Also, if the audit trail leads leads to having to provide the document as evidence of compliance to a specific procedure, it should be controlled.
That way there is no need to put out a fire, girl.
 
Q

QADCPCSS

#6
In my experience the forms you control will have a procedure related to them. The question I thinkyou should ask is do I need a procedure or does a procedure exist for this process? If you have a controlled procedure the form should also be controlled.
 
H

HFowler

#7
Originally posted by energy
This is just an opinion: If the mis-use of the "document" can have a detrimental effect on the system, I control it. Also, if the audit trail leads to having to provide the document as evidence of compliance to a specific procedure, it should be controlled.
That way there is no need to put out a fire, girl.
I realize that this is an old topic, but as I was trying to decide which, if any forms should be controlled, energy's response above "nailed it" for me. THANKS ENERGY for such clear advice on this subject

Best Regards,
Hank
:)
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
You might also want to take a read through the section on 'Quality Records' following http://Elsmar.com/Imp/sld185.htm

Records start out as forms. Typically if it's important enough to be a record, the form should be controlled. It is for this reason that I would first look to what records are important to you and from that you should have a list of forms you shold have under control. You probably have forms which do not end up as a quality record. Look closely before you decide to control a form.

I think this parallels energy's 'litmus test'.
 
G

Greg Mack

#9
Just to add a little something extra -

If I tried to worry about controlling every form in the business (I did try once) - it ended being an 'uncontrollable' mess!:rolleyes:

When you deal with Sales - the only corrective action for them sometimes is to 'create a new form'. :p

So with that - I have taken the path that every document that is a critical part of our system, directly referenced in our procedures is controlled.

If an employee develops a form for their personal use to assist them and nobody else, then it is 'controlled' through their log on script.

I have not had a problem with this since taking this option and our Registrar is happy. And no - for those of you thinking - it is not out of control now. The employees know the deal with forms but at least minor personal ones are off my 'to do' list!:smokin:

So in other words - control what you need - but don't over-control.
 

gpainter

Quite Involved in Discussions
#10
This can be a hot bed. Any form that becomes a record is controlled. Any form that is important to fill out is controlled. All other forms are marked uncontrolled. Any form that is controlled requires documented training
 
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