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.

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.

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.

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.

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.

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.

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).

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.

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

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.

Thank you for all of your input.
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.
I prefer a light or amber beer... depending on where you are, you may also find a good micro brew? As for regular, off the shelf stuff... I recommend Amstel Light, Coors or a Heiny... The heavy beers just make the headache worse for me...

Well, welcome to the Cove Cee, and if you ask me, I would suggest you skip the beer and go straight to Old Grandad. Just kidding.
Bring your headaches to the Cove and you will be surprised how quickly they can disappear. We have some great people with a lot of experience and knowledge to share.
Dave

Beer = good.

Whiskey=bad :ko: and it makes me go blind, I swear.


I am fortunate to have access to the Canadian brewed Labatt Blue Light, which is my favorite beer. In a pinch I settle for the regular strength Labatt Blue Light. Always in a glass bottle or poured from a glass bottle into my personalized frosted mug.

But I digress.

Thank you for all of your input.
. . .
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.
. . .
suggestions for what brand of beer I should drink this evening
. . . Based on your description over several posts, it appears to me this sticker is NOT a record, NOT a controllable document of any kind. (I agree with Carol who wrote):
"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'm going to go out on a limb and guess that the sticker (label is more accurate description) is NOT the only record that a fabrication job has been completed.

Many organizations have "travelers" (documents and records which travel with the workpiece from department to department) which contain the actual record the job has passed a certain stage in production.

It appears to me there is no more control to the sticker once it is put on the box than control over a rubber stamp or a smiley face which may also be affixed to the box.

The record and documents which need to be managed and controlled in this scenario appear to be the notation somewhere that the fabrication has been completed and is ready to ship on some sort of schedule (maybe this is on the traveler which returns to administration once final production, inspection, and packaging are complete.) and the work instruction (or instructions) which tells personnel how to handle the product between the time it is finished, inspected, and packed and the time it is shipped.

When you get through this successfully, we'll all toast your success. I prefer a "growler" of beer from my local brew pub where I go (too) frequently to watch the beer making process. The wheat ale was particularly good this month.

I would have to agree that the sticker is not controlled. We use stickers throughtout our manufacturing process but all information relating to the product is recorded on the job traveler and is our record of conformance to internal and customer requirements. The stickers that we use are more of a visual aid for operators, supervisors and material handlers as they clearly identify inspection status.

Welcome to the Cove l'l_cee :bigwave:

We also use an "OK to Ship" tag. It is a light green color and is only used to help our shipping department get the correct shipper on the correct product. The operator responsible for packing is the main person putting the tag on the container. We also use an "OK to Ship to Vendor" tag which is white in color. These tags are helpful, once again, so that our shipping dept. can tell quickly what state the product is in. NEITHER tag is "controlled". It is only used as an internal aid. If we decide to change the look of the tag, we do so and don't put the "new & improved" tags out until the older style is used up. Our "controlled" document is the routing sheet, which has the signed and dated operations signed off.

Bill

I am confused here. If a tag is referenced in a controlled document as part of a procedure or process should there not be some control over the tag? Would it not be like the controlled, obsolete, reference only stamps that many registrars insist must be controlled so they do not get misused? In this case isn't the tag being used to help control the process? My thoughts are that the tag should be controlled somehow at least as to its application so that it can perform its function.
As far as it being on the masterlist of documents and records I think that it could be debated either way(I believe it should be on the list for the purpose of identifying responsibility and location of issue). But for its use should it not have some controls to prevent unintended or malicious use?
I could be way off but I think it would be a jump to say it does not need control. Am I nuts?

Mark :confused:

I look at it simply Mark. 4.2.3 states: "Documents required by the quality management system shall be controlled..." The question is what documents are required by the QMS? The answer is the documents listed in 4.2.1. So, basically, that means that any document you use to perform tasks/processes within the QMS must be controlled. A sticker is a document (it gives you information related to the QMS task), and therefore needs to be controlled.

What kind of sticker? What is its purpose?

Hershal

What kind of sticker? What is its purpose?

Hershal
The sticker mentioned in post #1 of this thread.

Mark

I'm amazed we are still growling over this bone after a year.
I still "stick" [pun intended] with my answer in post #14.
You may "control" the shape and color of this sticker in the same way you control the shape and wording of a blank inspection record form.

The essence of "Control" is gone the second this sticker is stuck on the box. I know of companies which "control" the brand, width, color, and company name printing with logo of tape used to seal the box, but that doesn't make the tape a controlled document, just another advertising gimmick, perhaps with an added touch of security against unauthorized opening and resealing (not usually a real danger in business to business transactions.)

Apparently the horse is not dead yet. Maybe we could put a controlled sticker on it that indicates it is dead. :bonk:

When I am talking about control on this sticker I am talking about controling distribution and application. If this is not done then the sticker really has no point does it? I mean if anyone can put it on anything then it may as well be a smiley face stamp and all the employees should get one.

:topic: Why don't we have a beating the dead horse Smile?

Mark

When I am talking about control on this sticker I am talking about controling distribution and application. If this is not done then the sticker really has no point does it? I mean if anyone can put it on anything then it may as well be a smiley face stamp and all the employees should get one.

:topic: Why don't we have a beating the dead horse Smile?

Mark
I guess this is the closest to it:horse: but it is obviously very much alive or perhaps it is in the throes of death.

When I am talking about control on this sticker I am talking about controling distribution and application. If this is not done then the sticker really has no point does it? I mean if anyone can put it on anything then it may as well be a smiley face stamp and all the employees should get one.

:topic: Why don't we have a beating the dead horse Smile?

MarkNow you are talking about adherence to a work instruction. Putting the sticker on does not make it a controlled document any more than the work instruction telling how to seal a carton with printed tape makes the tape a controlled document. (darn! I tried to put the "paint me a picture" smiley here and I got some bollixed thing instead.)

You might just as well say the entire carton to which the sticker is affixed becomes a controlled document.:truce: