Definition of a controlled document --> is a form a controlled document

M

MareikeBausch

#1
Hi everyone,
we are currently implementing a QMS according to ISO 9001.
I am working on a list of all the controlled documents.
Now my Questions:
1. What exactly is the definition of a controlled document?
2. Is an empty form, that provides a template for someting, a controlled document?
So for example: the non-conformance report that needs to be filled out?
or: the Audit Report that is filled out after an Audit.

I hope someone can help me with this.
Cheers!
Mareike
 
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John Broomfield

Staff member
Super Moderator
#2
Hi everyone,
we are currently implementing a QMS according to ISO 9001.
I am working on a list of all the controlled documents.
Now my Questions:
1. What exactly is the definition of a controlled document?
2. Is an empty form, that provides a template for someting, a controlled document?
So for example: the non-conformance report that needs to be filled out?
or: the Audit Report that is filled out after an Audit.

I hope someone can help me with this.
Cheers!
Mareike
Mareike,

Your blank forms are documents controlled to help ensure they collect the required data or records.

You may control blank forms by making sure that only approved forms are available for use as in electronic forms on screens linked to a database. Or you may uniquely identify a hardcopy form with its revision status so users can verify they are using the correct version of the blank form.

The data collected are then controlled as records so they are retrievable by authorized persons; otherwise known as filing and archiving. The form is designed so each record includes a unique identifier such as NCR 2015-001.

So, look for two controls: one for the control of blank forms (per 4.2.3) and the second for the control of data collected (per 4.2.4).

Watch out for the 2015 version of ISO 9001 where data become documented information. We all knew that information used to be meaningful data but ISO seems to be dropping the distinction between data and information.

John
 

somashekar

Staff member
Super Moderator
#3
1. What exactly is the definition of a controlled document?
When a document is approved for use, and it is the current and duly identified document...
2. Is an empty form, that provides a template for something, a controlled document?
If you decide to control it as above it is a controlled document.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
Forms are most often controlled, but could be uncontrolled. For example, if your procedure says "...record data - you may use a form such as Form XX or similar" the form would not necessarily need to be controlled.
 

Ninja

Looking for Reality
Trusted Information Resource
#5
As your company decides whether or not to control the form, the most pertinent consideration may well be the question:

"If someone wrote it on a blank napkin or the back of their latex glove instead...would it have a significant effect on anything?"
 
#6
What's this nonsense about forms not being controlled? Seriously? You mean it's OK to allow anyone to write anything they want on any medium? I don't think so...
 
P

PaulJSmith

#7
What's this nonsense about forms not being controlled? Seriously? You mean it's OK to allow anyone to write anything they want on any medium? I don't think so...
Interestingly, ISO 9001 does not prohibit this, even going so far as to note that "The documentation can be in any form or type of medium."

Is it acceptable to use a latex glove as a form? If it's allowed for in their procedures, then yes it is.

Is it a good idea? I believe it is not.
 

Ninja

Looking for Reality
Trusted Information Resource
#8
I wonder if much of it comes down to an individual's mental image when the word "form" is used.

- To some, it may bring to mind a worksheet of critical data
- to others, it may be a simple tool to organize one's thoughts
- to yet others, it may be a useless piece of paper that someone else made up.

Some in my company use a template or "form" to collect viscosity data. It is later transferred to the mandatory "official" recording location.
Some bring the "official" record with them and record it directly.
Some write the result on the back of their glove and then transfer it to the proper location (thus the reference to latex)...45 years and never an issue.
I couldn't care less how the data gets from the viscometer to the official record. I care only that it is accurately recorded where it belongs before the words "I'm finished" are used.

The "Official" recording location is controlled.
The viscometer is calibrated.
There exists a template for recording from the viscometer that is optional...some call it a "form"...others call it useless and don't use it.
Darned if I'm gonna waste calories controlling what I call a template and others call a form.
Darned if I'm gonna waste calories correcting people for calling it a form.

Hopefully that explains a bit more of why my post above targeted "What is important" rather than control of forms...
 
#9
Interestingly, ISO 9001 does not prohibit this, even going so far as to note that "The documentation can be in any form or type of medium."

Is it acceptable to use a latex glove as a form? If it's allowed for in their procedures, then yes it is.

Is it a good idea? I believe it is not.
You're missing the point, I think, Paul. It's NOT the medium used - you are correct - it's the control of forms. It's managements' way of doing things, not writing some bizarre methods down and then saying "have at it".

Even if it's "allowed in their procedures", it's NOT going to be effective, now, is it? This point is often overlooked - what's effective. Using "say what you do, do what you say" as a justification (following procedures) isn't (and hasn't been) appropriate since 2000.
 

John Broomfield

Staff member
Super Moderator
#10
Ninja,

In my experience:

We must use forms sparingly and when we do they must be well-designed to avoid time wasting.

Forms are data collection devices (part of a procedure which may or may not be documented)

Collect the wrong data and we waste time.

Collect incomplete sets of data and we waste time.

Data analysis results in meaningful data, more commonly called information.

We make decisions using information which we'd like to be reliable.

Therefore forms that collect data are controlled.

John

BTW, templates are more like formatting devices than data collection devices.
 
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