Can a sticker be a controlled document?

L

little__cee

#1
Sticker?

Can a sticker be a controlled document?

More specific information: this is a sticker that our company designed and is printed by a different company. It is a sticker that is placed on a box when it is "ok to ship".

I am updating the Controlled Documents Log that I inherited and am trying to figure out what should be on it, what should not, and am adding a column to designate what level the document is (1, 2, or 3).

If a sticker CAN be a controlled document, I'd have to go with level 3 since it would essentially be considered a form. If not, I'm removing all stickers from the Log, which would make me a very happy camper :D today.

Thanks for your help.
 
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Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#2
little__cee said:
Can a sticker be a controlled document?

More specific information: this is a sticker that our company designed and is printed by a different company. It is a sticker that is placed on a box when it is "ok to ship".

I am updating the Controlled Documents Log that I inherited and am trying to figure out what should be on it, what should not, and am adding a column to designate what level the document is (1, 2, or 3).

If a sticker CAN be a controlled document, I'd have to go with level 3 since it would essentially be considered a form. If not, I'm removing all stickers from the Log, which would make me a very happy camper :D today.

Thanks for your help.
little_cee:

IMO it is a form that should be controlled like any other form. I'm assuming you reference it in the procedure that addresses the release of product. It or lack of it indicates the product status.
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#3
What I'm thinking is that it doesn't matter whether it is a sticker, tag, sign, etc. - what I would consider is "Is it revisable?"

If this is a simple sticker that just says "OK to Ship", I'd say no. But - if it is a sticker that contains customer info or serializing - blank fields to fill in let's say - and at some point you might need to add another field, in which case you would change your design with your supplier, pull all the old ones and begin using the new, you may want to control it as a form.
 
L

little__cee

#4
Thank you

Yes we do use it as a form. We have blanks on the sticker for Customer, Employee Number, etc and that gets placed on the box as an identifier.

Thank you for your help.
 

RoxaneB

Super Moderator
Super Moderator
#5
Cari Spears said:
What I'm thinking is that it doesn't matter whether it is a sticker, tag, sign, etc. - what I would consider is "Is it revisable?"

If this is a simple sticker that just says "OK to Ship", I'd say no. But - if it is a sticker that contains customer info or serializing - blank fields to fill in let's say - and at some point you might need to add another field, in which case you would change your design with your supplier, pull all the old ones and begin using the new, you may want to control it as a form.
I'm with Cari on this one! I've had stickers and stamps used within the process before that said stuff like "Controlled Document". I do not control what that stamps says...however, my Document Control procedure does state "The usage of the 'Controlled Document' stamp in a non-black ink overrides the electronic header of Uncontrolled Document."...or something to that effect.

And if the stamp/sticker is a "template" showing fields where information must be entered after the stamp/sticker is applied, then I would treat it as a form.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#6
There is another aspect to this particular sticker. Who is authorized to apply the sticker? Correct me if I am wrong but it appears to be used as a means to identify the status of the product like an inspection stamp.
 

Mike S.

Moved On
Trusted Information Resource
#7
Even if it is used as a form, who/what requires that it be controlled? IMO forms do not need to be controlled unless they also serve as a WI. If your procedure/WI says "a red APPROVED tag that includes the customer name and employee number shall be placed on the container" I would say the tag does not need to be controlled. If the WI says "fill out the required blanks on the tag" then the tag is acting as part of the WI, telling youwhat must be added, so I would control it. Some folks like to control every form no matter what, and this is okay if it works for them, but IMO it is not an ISO 9001 requirement (shall).
 
G

Groo3

#8
First off... as I see you only have a few posts and are recently registered, Welcome.

The answer to your question can be either yes or no depending on what information goes on the sticker, or how it is used. As it appears that you only use the sticker when material is "OK to ship", then - with that assumption, I would be inclined to say 'yes' it is a quality document. The closest I could come to a requirement would be section 7.5.3 of 9001-2000. However, you may also wish to consult with your registrar to get their interpretation.

As for where I work, we use stickers throughout our facility and the way we control them is via procedures and training. We do not put all of these stickers on our various departmental quality records logs, just the ones which indicate a primary status change = OK to Package, NCM (Non-conforming Material), Hold for Testing, Final Product Labels and the like. When material is packaged, our understanding is that it is (by definition) OK to ship - unless another sticker (such as NCM) is placed on the package.

Hope that helps?

PS: Not sure what you mean by the level of the document 1, 2, 3 ? are those designations for your document pyramid? Not all companies use the 3 tier system... some have 4, 5,etc. As for my company, we have 6 levels to our pyramid = (1) Policies, (2) Objectives, (3) Quality Manual, (4) System Procedures, (5) Departmental Procedures and work instructions, (6) Forms, records, flowcharts, exhibits, etc... all of which are controlled at some level or another.
 

CarolX

Super Moderator
Super Moderator
#9
Ok, here's my take...

I am assuming, the sticker is used as a means to identify status and identification of the material.

It is not a record.

And let me ask...do YOU need to control the sticker.

I use calibration stickers to identify the calibration status of my gages. Do I control the sticker...no. Do I control the record with the calibration results...yes.

IMHO...you don't need to add it to your doc control system.

CarolX
 
L

little__cee

#10
More information

Thank you for all of your input.

I am new to the forum, new to my company, new to being a Management Rep...all the way around I am a newbie so thanks for your patience.

Okay, the sticker. We do have a work instruction that references the sticker (commonly called the OK to Ship sticker). The work instruction was written in a "when, who, where" format that tells me anyone authorized by their supervisor can fill it out, stick it on the box, and do so for completed fabrication jobs that are ready to be shipped to the customer.

Background: I guess the consultants :mad: were concerned that our employees would just see a box laying around and not know what to do with it? Anyways, this sticker was created SO that when the sticker was applied that was the sign to all who saw it that this box is OK to Ship!

Sorry for any excess sarcasm. I'm just trying to figure this all out!


As for the document levels, our document control procedure states:
DEFINITIONS:
Level I Documents include the Quality Manual and Procedures.
Level II documents shall include, work instructions and prints and product drawings). Whenever the words “excluding prints and product drawings” appears in the text of this procedure, the reader should refer to procedure (Print Control) for clarification.
Level III documents will include forms, flow charts and records.

So that's what I'm trying to work with. I think I may create a separate post inviting suggestions for what brand of beer I should drink this evening, since this has given me a royal headache today. Again, thanks for all of your help.
 
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