Here at our facility, we are seeking QS9000 certification. There was an issue that came about involving work instructions hung up at workstations (not actual controled work instructions, sort of a "memo" or statement). We have a work instruction defining material handling (i.e. where to place when through, etc). My question is this: There is a work instruction (a controlled doc), but there is a "homemade" statement placed on some paper and attached to the work area. Would our registrar/auditor have a problem with non-controlled statements like these hung up around the shop? Please advise on this situation.

Thanks,
Joe, the hated QA/QC man! http://www.qs9000.com/ubb/smile.gif

They'll have a problem with it if it 'tells employees how to do something' which relates to 'the quality' of the product. Generally 'personal' notes and such aren't a problem, but be ready for questions such as "...why does the employee need to keep notes? Is training not adequate?"

I would have something specifically written to define the conditions under which an 'uncontrolled' document can be posted.

If they are 'memos' from 'somebody', does your system address these types of documents? Often 'memos' or 'statements' are in response to a problem. Should they be 'Quality Alerts' or something of that nature.

Joe,

Lassitude is correct. You will have issues. Your registrar will ask you if these "reminders" are used in the day-to-day (to control quality of product or service), in which you would reply yes.

Many times I will find that new associates and sales folks tend to create these little cheat sheets. Registrars know this, so they often look for them. Do a careful sweep of the facility to detect the areas where these may be found.

Regards,

Kevin

We had to go so far as to make "notes" and "sticky tabs" illegal except in a rare instance in our system, due to those issues stated. Some people took liberties, and this created confusion for the operators.

I believe the standard requires a form of authorization system for instructions. If anyone can post temporary instructions, imagine what the org chart would look like.

Keep your Operator instructions simple and meaningful. At many of our work stations, a couple of sheets were all that was needed, so our document controller would laminate them. This also helps to keep them clean.

you can set up a local control procedure where the facilitator in the area controls them, by date and signature authority, laminated is an awesome idea...if its noted from an industry source, it should indicate that as well.

I agree with the last comment, and i think its an essential part of a QMS.

If your QM System is a real one, not a ghost system, it will be changing nearly daily. HoD's can generally see the point of a documented Work Instructions, but they hate the idea and all the bureacracy associated with having to do print-outs, sign them, get them approved by the QM copied and circulated etc.

I beleive quite strongly that if you want to keep the HoD's on board you have to give them a simple tool. For this reason i always base the Work Instructions around departments ie i allow Purchase Dept to have WI's just for themselves. I then base everything in a Intranet and arrange that if anybody prints one out they are automatically printed with the words 'Uncontrolled Copy' (Possible in Word).

I then allow one person from each dept to have change rights so that they can update their own WI's (usually the HoD'S secretary).
As you can imagine this can be done directly during the Dept weekly meeting for example if a PC is close by connected to the network. No paperwork at all.

This of course does not solve the problem where personnel do not have access to PC's, and it also has other disadvantages, but the biggest single advantage is that it helps the system to 'live'.

Sadly to satisfy auditors we have to arrange that the QM printsout all changed WI's and checks that any changes conform to the ISO 9000 Standard

Lastly in a recent company we have created a mask called 'Tips and Hints' which is for items that do not influence the quality of the product. ie How to claim expenses?, What to do if you have an accident in a company car?, how to use the phone system etc etc. And we state in the handbook that these are uncontrolled documents (To avoid problemns if they are hung on walls etc).

Batman,

I hear you loud and clear on the "sticky pad" issue. Tough to clear a system of these once folks find it so convenient to scratch and stick friendly little reminders.

Barb,

I have done similarly with giving limited authority to department managers in the control of content and distribution of these reminders(the initial and date thing). But sadly, this is abused or not followed through on, so it no longer exists as an option.

I also received a passing comment from a Registrar who asked if these notes and memos exist somewhere on a Master List of Documentation.

Is there a perfect solution to the problem? Not that I know of. But some solutions are better than others, so I opt to deter against memos, post-its, and cheat sheets and work towards better written documentation. Guess what? It still ain't perfect!

Regards,

Kevin

I have not had a problem with well defined local control of 'certain types' of documents. I do agree where the folks are not disciplined it could lead to serious problems.

Thanks you guys. I'm having to fight the battle of Normady to get our quality system running smoothly (if you know what I mean!). I somewhat made the same judgements on this matter, but a Shift Forman and I didn't see eye to eye on this subject. After explaining things over and over to him, he finally "got it"! Thanks for all of your help!

------------------
Joe W. Guy,
QS9000 Administrator

Hello,

I am looking for standard plastic injection setup sheet templates. I am trying to help our Molding Manager develop a standard setup sheet for his production tooling. ANy ideas where I could find these ?

Thanks !

Hello,

I am looking for standard plastic injection setup sheet templates. I am trying to help our Molding Manager develop a standard setup sheet for his production tooling. ANy ideas where I could find these ?

Thanks !

New thread started here
http://elsmar.com/Forums/showthread.php?p=185103#post185103

I was thinking about a situation in our plant, and after a quick search here I see that this discussion was happening about the same thing almost 10 years ago! (Some things never change.)
Andy's comments here seem to follow what's going on here:

... i always base the Work Instructions around departments ie i allow Purchase Dept to have WI's just for themselves. I then base everything in a Intranet and arrange that if anybody prints one out they are automatically printed with the words 'Uncontrolled Copy' (Possible in Word).

I then allow one person from each dept to have change rights so that they can update their own WI's (usually the HoD'S secretary).
As you can imagine this can be done directly during the Dept weekly meeting for example if a PC is close by connected to the network. No paperwork at all.

This of course does not solve the problem where personnel do not have access to PC's


Generally here, all controlled copies are on the intranet, and the documents have "Uncontrolled if Printed" in the background. But within most (if not all )production departments, these documents are posted up on boards and you can see the uncontrolled message. If they are uncontrolled, then why are they up there?!?

Doesn't this seem like a "no-no"? Nobody's questioned it... yet.

I was thinking about a situation in our plant, and after a quick search here I see that this discussion was happening about the same thing almost 10 years ago! (Some things never change.)
Andy's comments here seem to follow what's going on here:




Generally here, all controlled copies are on the intranet, and the documents have "Uncontrolled if Printed" in the background. But within most (if not all )production departments, these documents are posted up on boards and you can see the uncontrolled message. If they are uncontrolled, then why are they up there?!?

Doesn't this seem like a "no-no"? Nobody's questioned it... yet.

What does your Document Control Procedure say?

Stijloor.

What does your Document Control Procedure say?

Stijloor.

Yes, yes. I guess mostly I was venting or hoping just to get support for my thoughts. It's amazing that it's not been questioned before.


Our Doc Control procedure says how documents are controlled and how changes are controlled... but there is something explicit missing saying something like "don't hang up information pertinent to product quality that is not the latest revision". I think there are just a lot of people at our company that don't know what it means to have a controlled document.

Thanks.. have a great weekend everyone.

Let me put on my W. Edwards Deming cloak for a moment.

Ultimately, the reason operators and others put up "homemade" work instructions is to fill a void left by the managers who have not provided clear, adequate instructions which the workers have agreed are clear and adequate for them without having to add little post-it notes or "liner notes" to clear up ambiguous and muddy instructions provided by management.

The solution, therefore is NOT punishment nor "clean sweeps" before an audit. The solution is staring the managers in the face, but most managers go on in their arrogant, Red Bead mode, unwilling to evaluate the instructions with a view to revising them so they WILL be clear and adequate for the workers to use without homemade additions or clarifications.

Here is the solution!
Change the instructions!

Ultimately, the reason operators and others put up "homemade" work instructions is to fill a void left by the managers who have not provided clear, adequate instructions which the workers have agreed are clear and adequate for them without having to add little post-it notes or "liner notes" to clear up ambiguous and muddy instructions provided by management.

Ah.. but the problem we have here is not that these are homemade cheat sheets or whatever we wish to call them. They are just obsolete versions of the official documents. My question was that if they are "uncontrolled if printed", how can they be posted at all?

Overall, I've seen the problem here was created because QA people have "helped" with the documents of production departments, but now they've stopped. So the department supervisors think it's QA's job and QA thinks it's the department's job to keep up with their own work instructions.

To make things worse, QA made a lot of the work instructions into pseudo-flow charts which leave one with more questions than answers in many cases. I'm just waiting for it all to blow up.

Ah.. but the problem we have here is not that these are homemade cheat sheets or whatever we wish to call them. They are just obsolete versions of the official documents. My question was that if they are "uncontrolled if printed", how can they be posted at all?

Overall, I've seen the problem here was created because QA people have "helped" with the documents of production departments, but now they've stopped. So the department supervisors think it's QA's job and QA thinks it's the department's job to keep up with their own work instructions.

To make things worse, QA made a lot of the work instructions into pseudo-flow charts which leave one with more questions than answers in many cases. I'm just waiting for it all to blow up.I guess I didn't make MY point clear. Management has dictated (by virtue of the "uncontrolled" imprint) that paper instructions at the workstation are, by definition, "illegal." Management has thus made it impossible for a worker to have legal instructions. Seems to me management has to change something! Perhaps you have a suggestion to resolve the conflict between a need for instructions (see ISO 9001:2000 4.2.3 (d) [Control of Documents] "d) to ensure that relevant versions of applicable documents are available at points of use,") and the concept of control. It would probably make sense to make a clean sweep of old documents when a new revision comes out and to suspend the "uncontrolled if printed" dictum for the officially posted copies (which only an authorized person may post, change, or remove.) How frequently are work instructions revised? If changed for each order, then perhaps they should be part of the order traveler and not be posted at all.

I guess I didn't make MY point clear. Management has dictated (by virtue of the "uncontrolled" imprint) that paper instructions at the workstation are, by definition, "illegal." Management has thus made it impossible for a worker to have legal instructions. Seems to me management has to change something! Perhaps you have a suggestion to resolve the conflict between a need for instructions (see ISO 9001:2000 4.2.3 (d) [Control of Documents] "d) to ensure that relevant versions of applicable documents are available at points of use,") and the concept of control. It would probably make sense to make a clean sweep of old documents when a new revision comes out and to suspend the "uncontrolled if printed" dictum for the officially posted copies (which only an authorized person may post, change, or remove.) How frequently are work instructions revised? If changed for each order, then perhaps they should be part of the order traveler and not be posted at all.

In my experience over the past years, we have date stamped the QMS procedures, work instructions, and forms for that days use only. This requires an operator to monitor his area for any work instructions that are out of date. Also, I use a policy that "that all notices hanging vertically must have an authorizing signature and current date".

Manufacturing routers which dictate the flow of work and provide operational instructions are controlled through release process and reconciled upon completion.

Programming set up books and tools lists are controlled through engineering.

Approved Programs are stored in protected library on the Server with a Gatekeeper. All program changes go into a unproven status until the change is approved though the system.

We monitor factory and office through routine Safety and 5 S audits. Additionally, this is monitored during Internal Audits and the Auditors have some "fun" with looking for unauthorized hanging pieces of paper.:cool:

There have been a couple of embarrassing moments over the years primarily with my inspectors and customer specifications (harboring an old revision printed out from a customer web site), but having taken those to our server and and that seems to have solved the problem though I alway scour the lab on my walk through for "interesting items":)

There is always the challenge of ensuring that management is sending the right message at the right time at the right target.

Just Sharing

I guess I didn't make MY point clear. Management has dictated (by virtue of the "uncontrolled" imprint) that paper instructions at the workstation are, by definition, "illegal." Management has thus made it impossible for a worker to have legal instructions. Seems to me management has to change something! Perhaps you have a suggestion to resolve the conflict between a need for instructions (see ISO 9001:2000 4.2.3 (d) [Control of Documents] "d) to ensure that relevant versions of applicable documents are available at points of use,") and the concept of control. It would probably make sense to make a clean sweep of old documents when a new revision comes out and to suspend the "uncontrolled if printed" dictum for the officially posted copies (which only an authorized person may post, change, or remove.) How frequently are work instructions revised? If changed for each order, then perhaps they should be part of the order traveler and not be posted at all.

I've seen a lot of ways people try to get around actually controlling documents. It usually takes the form of a "printed copies are uncontrolled" watermark, and sometimes a watermarked date of printing and the legend, "valid only on date of printing." Neither is a good idea, imo, although the latter strategy is better than the former. As Wes points out, what management is doing is allowing people to use documents that are not under control.

I think there are only two options: control through use of PC workstations with no printing allowed, or control through distribution of paper copies with an efficacious recall system, so that controlled paper copies are always promptly replaced with new editions. Anything else is just work avoidance, and flies in the face of actual document control.