Hello everyone!

I work for a Heat Treating facility and we are working on ISO 9001-2000.

I'm trying to weed out some of our old procedures and need some help.
We have some operator intructions that we use for training. They desciebe the general way that we perfrom start-up and shut-down of our furnaces. We can deviate from them at times and this is allowed depending on the situation.

My question is: Are these considered procedures or are they more like guidelines. If they are guidelines, then how do we control them?

Thanks!

Mike W:bonk:

I'm not sure how to answer the first part in your situation, but

You control them just you like control any other process/document that you do want the operator/employee follow/perform.

What you call it does not change the need for control.
-----
Although I'm far from an expert, I would not change what you call the setup procedure just for ISO (unless you are changing the name of similar processes).

Also even though you are describing the "guidelines" for the setup, you are still providing the procedure or setup instructions. Deviation from a "base-line" is acceptable as long as you state it within the document.

Does that make sense?

(I've been working to hard on updating procedures today. Ouch my brain hurts).

Procedures describe:

"What" the activity is-
"Who" performs the activity-
"When" the activity is takes place-

Work instructions describe:

"How" the activity is performed.
---------------------------------------------------------------

Sounds to me like you are talking instructions, and they need to be controlled through your current document control system.

Do you have a D/C system?

Al...:bigwave:

Originally posted by dbzman
Hello everyone!

My question is: Are these considered procedures or are they more like guidelines. ............
Thanks!

Mike W:bonk:

Doesn't matter, Mike ! Call 'em whatever you want, (Work Instructions, Process Instructions, Procedures, yadda, yadda). Focus your energy on making a usable document. Please don't get caught up in the semantics game!!!

If you using any document thats describes how you meet an objective, it needs to be controlled, period. How much flexibilty you give yourself within the realm of that document is completely up to you. It is required that documents are controlled (4.2.3) but most importantly, it is easy to do & makes a lot of sense. You'll see the value in it. Hope this helps & have a day---

noboxwine,

I don't consider specific definitions for documents as semantics. the definitions come from ISO-8402. We all need to know the differences between the levels of documentation, it gives us a type of roadmap as to the structure of the written word as it applies to the standard.

That aside, I whole heartedly agree that if a document defines an aspect of the system it needs to be controlled in some manner. That is defined, with help from ISO, by the company, in a manner that is effective and useful.

Al...:bigwave:

Al: We must have hit the submit button at the same time as my remarks were in general, not a response to your post. I agree with you that the moral of the story is control it and make it useful. ISO-8402, now ISO 9000, it's a little confusing, but does give the newcomers a decent roadmap.
:eek:

Mike

if i read between the lines correctly, you want to keep the idea and flexability of a guideline, rather than the 'stiffness' of a procedure.

certainly allowed. perhaps define up front that certain parts of the guideline are meant to be interpreted depending on the actual situation the employee faces at the time of use. state that the employee is allowed to use his/her experience and judgement to execute particular steps.

a nice to have: some kind of feedback to others, to get info on what to do and what not to do in a given situation.

Nobo,

I'm with ya!

Al...;)

Unless your standard requires a documented procedure, even a local custom will do as long as everyone can recite the sequence and specifics.

When you hit the 'documented' requirement, anything, just about, will do. Flow chart. Text document. Pictures. Combination of one or more. A procedure is just a way of doing something. How you 'describe' it (format, media, etc.) is not defined anywhere I am aware of.

Ask one thing: Does this achieve the results I seek? Does this give adequate information to someone who has to perform the job?

Marc, could you then give us what you consider as a process and what is a procedure. From what is posted in this thread the two almost seem to be one in the same. Comments please.

Seems like there is a gray line between a procedure and other documents that could be called notices.

If I had a document that gave "Guidelines" for the employee to use what would happen if they deviated from the "Guideline"?

How would an auditor look at this?

Also, how do you control postings in the plant?

Thanks!

:bonk:

Originally posted by dbulak
Marc, could you then give us what you consider as a process and what is a procedure. From what is posted in this thread the two almost seem to be one in the same. Comments please.
How about looking at the ISO definitions:

process
set of interrelated or interacting activities which transforms inputs into outputs

procedure
specified way to carry out an activity or a process

Seems like there is a gray line between a procedure and other documents that could be called notices.

If I had a document that gave "Guidelines" for the employee to use what would happen if they deviated from the "Guideline"?

How would an auditor look at this?

Also, how do you control postings in the plant?


Mike,

Can you give me an example of what you would use a "guideline" for?

As for posting in the plant....I just sign and date. I only post things of very general nature. For example, we have different shipping quantity tolerances for different customers. Some need exact quantity, some will accept 5% over, some will accept +-5%. So I posted the requirements on a single, lamanated sheet with the requirements, my name and the date I issued.

Hope this can help a bit.

CarolX

Hi guys,

Guidelines, very interesting. If you have a process, say one that involves using heat and time to make a reaction occur. Let's also say that the allowable variation in the materials used is such that you need different time and temperatures based on the material variation, product size, ambient conditions, etc. And just to make it interesting let's say the result is an appearance, not functional, requirement that operators can visually detemine and each product is unique. You might give the operators 'guidelines' that are a starting point (this temperature for this amount of time) but they might need to adjust up or down based on the conditions. What do you think?

Rick

I'd use a very basic flow and show that the success of the process is based upon the training and skill required of the operators (i.e. design engineers). If needed you could use statements such as "refer to sample" or "refer to heat/time diagram" or something along those lines.
We do not have anything that states how a designer designs a die or a fixture, but we do refer to design standards and lessons learned.

Hi guys,

Guidelines, very interesting. If you have a process, say one that involves using heat and time to make a reaction occur. Let's also say that the allowable variation in the materials used is such that you need different time and temperatures based on the material variation, product size, ambient conditions, etc. And just to make it interesting let's say the result is an appearance, not functional, requirement that operators can visually detemine and each product is unique. You might give the operators 'guidelines' that are a starting point (this temperature for this amount of time) but they might need to adjust up or down based on the conditions. What do you think?

Rick

You could be describing anything from a making a coffee cup to a pizza, but it doesn't matter. Either your training or your WI can do kinda what Stew said. Set up nominal parameters (pepperoni deep dish 350 degrees for 20 minutes, pepperoni thin crust 325 degrees 15 minutes) and then say the operator can make adjustments up or down in time and/or temperature as required based on his/her knowledge and experience in order to make that particular batch of pizzas come out looking like they should. ISO is not telling you how to cook pizza -- well, at least they shouldn't be.

As a slight side note....

Where you produce a guidline that can be varied by the operator so long as the end result is OK, I would suggest you create a standard which defines what OK is. Particularly important with a visual determination of acceptability.

For the pizza to come out looking like it should I would suggest visual aids of what good looks like.

With such a standard in place you may well find you can dispense totally with the work instruction, in some instances.

Remember the old time song:
Tomato, Tomatto, Potato, Pottato.

Process and procedure tend to get rather mixed up these days and who or what is to blame for that? :rolleyes:

I guess I take the very simplistic stance when defining Process and Procedure.

Process is what we do. ;)

Procedure is how we do it. :p

The allowance for situational or contextual variation can easily be written into the procedure.
I've been totaly thrown out of sync a few times when I was a neophite auditor when coming across this very situation.
Wallace

Process is what we do. ;)

Procedure is how we do it. :p

Wallace

Wallace,

Nice. Short, sweet and to the point. Well done!

CarolX

Lemme steer this discussion in a slightly different direction for a moment. Hypothetical situation:

Let's say you're training an employee to perform process "X". There is no formal WI for this process. The employee takes notes as you train him/her to help remind themselves of what is to be done. Eventually the employee is deemed "trained" to do this process and such is duly recorded in training records.

Months later, an auditor is strolling by as the employee, who maybe doesn't do this process often, pulls out his/her notes and begins to perform the process using the notes as a guide. Does the auditor have any right to complain that these notes are uncontrolled WI's?

Lemme steer this discussion in a slightly different direction for a moment. Hypothetical situation:

Let's say you're training an employee to perform process "X". There is no formal WI for this process. The employee takes notes as you train him/her to help remind themselves of what is to be done. Eventually the employee is deemed "trained" to do this process and such is duly recorded in training records.

Months later, an auditor is strolling by as the employee, who maybe doesn't do this process often, pulls out his/her notes and begins to perform the process using the notes as a guide. Does the auditor have any right to complain that these notes are uncontrolled WI's?

Mike,

I would say absolutely not. These are not company issued WI's, therefore, cannot be controlled. Many people will do this, taking notes during the initial training, as a memeory jogger. Done it myself before!

But having said that.....perhaps this employee has pointed a weakness in the system. Perhaps this process needs some formal WIs? Just thinking out loud.

CarolX

Agree with CarolIX about the deficiency in training. ie, if the employee is trained why do they need crib notes? If the person needs them to do the job, in your example, then they should be approved.

but to answer your question; they are unapproved instructions, rather than uncontrolled. The approval could be your signature and date on the notes, or even the employees signature and date on the notes (from when they were written).

If this is the only instance of the notes and there were no other 'sightings' of notes, I would ask the employee what they were used for and file it in memory for the rest of the audit, then walk away. Unless it was on a 'critical' or 'safety' step.

Auditors should be looking for trends and important findings.

Mike,

But having said that.....perhaps this employee has pointed a weakness in the system. Perhaps this process needs some formal WIs? Just thinking out loud.

CarolX

Good point, I actually use this as an example when people ask me what they need to create work instructions for. I tell them if they are training people for some job (let's say an entry level position that is filled often because people come in, learn and then move up the ladder) quite often, or if it is an important task that is done infrequently and they have to pull out the notes every time to do it right, then the task is perfect for a work instruction. IMHO, it is not the tasks I do everyday that needs to be documented, I've been trained well, and continual repetition keeps my competencies sharp; it is the things that need to be done a few times a year that I forget.

I think others have made the point, but my opinion would be that the use of personal notes indicates that further training is required, or possibly a need for formal instructions to be created.

Lemme steer this discussion in a slightly different direction for a moment. Hypothetical situation:

Months later, an auditor is strolling by as the employee, who maybe doesn't do this process often, pulls out his/her notes and begins to perform the process using the notes as a guide. Does the auditor have any right to complain that these notes are uncontrolled WI's?

No External Auditor just "strolls by". He/she is tailed every second that he/she is there. Also, the employees know he/she is there, that day. If an employee did as you hypothesized, they are in some need for counselling. If they weren't told, ultimately it's the Registrar Contact person who failed to do their job. If knowing all this and the employee still did it, then ISO Awareness Training is sorely lacking. There is no valid excuse. Sheer stupidity.

Now if it is an Internal Auditor, then you tell them---then tell on them through the use of a CAR, or my method, "What are you stupid? How many times do I have to tell you that if you need notes to do a job, write a procedure. Yes, YOU write it. If not, trash them or look at them in the dark with a flashlight." Finally, this type of "just strolling by" scenario demonstrates how paranoid we are. If its worrying about your own employees (auditors) seeing this, it's double paranoia. Just stirring. :bonk: :confused:

Paranoia? You used that term before directed at me. Hmmm....

Anyway, the question could be asked several ways -- I did it by a hypothetical scenerio -- no special meaning to it. But I got to wondering about personal notes. I was trained to do a fairly simple process a day ago -- clicking thru a web site to post something on a network. Not hard, but I will not do it often. So I jotted down a note go to www.xxx.com, click on option 3, click on option 5, click on post new doc, enter info, click submit. That type thing. Just wondering if ISO might consider that note I wrote myself a bad thing. Paranoid?

4.2.3 states that documents required by the QMS shall be controlled. Think about when the QMS requires a document. 4.2.1d says:
The quality management system documentation shall include... documents needed by the organization to ensure the effective planning, operation and control of its processes...

So, if the document is necessary to ensure control of the process, then the document must be controlled. If the employee lost the notes and could still get good results, then it's not necessary to have a document (and they don't need to have the notes at the workstation). If they can't get good results without the notes, then a controlled document is necessary.

Well if we wanted to argue the toss with an auditor we could say that the document is controlled.

It is unique, you know who wrote/authorised it, and there are no other copies.

Now if the employee had copied his notes to everyone else you might have a problem.

Lets look again at what 'controlled' means.

Reviewed and approved by appropriate authority - who is to say the employee is not appropriate authority, they are the user after all.

System to ensure the latest copy is available - well there is only one copy, the master.

Paranoia? You used that term before directed at me. Hmmm....

Anyway, the question could be asked several ways -- I did it by a hypothetical scenerio

Well hypothetical usually means it's on someone's mind, so, to me, worrying about an Auditor "strolling by" indicates a child-like fear of the Boogy Man. Sorry bout that. In the 94 version I was prepared to argue away, in the very unlikely event that some egghead reached into his toolbox and produced a note(s) in front of an External Auditor, that the standard allowed keeping uncontrolled documents for "historical" (reference) purposes. I didn't see that in the revised standard. I suppose that they wanted to make this "Low hanging fruit" available for citations. The best way to prevent this is simple. Prevention. If they're going to use crib notes in lieu of written procedures, against the wishes and orders of management, they must know that they will pay a price if they are caught by any type of Auditor, Mgt or even you! :vfunny: :agree:

Anyway, the question could be asked several ways -- I did it by a hypothetical scenerio -- no special meaning to it. But I got to wondering about personal notes. I was trained to do a fairly simple process a day ago -- clicking thru a web site to post something on a network. Not hard, but I will not do it often. So I jotted down a note go to www.xxx.com (http://www.xxx.com), click on option 3, click on option 5, click on post new doc, enter info, click submit. That type thing. Just wondering if ISO might consider that note I wrote myself a bad thing. Paranoid?

Mike,
Taking this as a hypothetical situation....I see it as just keeping some personal notes on how to do the job quickly without having to read all the buttons and stuff. I would assume in this situation (as in most task that we do) the instructions are right in front of you....it's just easier to know to click on option 3, click on option 5, click on post new doc, enter info, click submit.

JMHO
CarolX

Wouldn’t the deciding factor be that the absence of the document (notes) would cause a problem? Does the absence of these notes cause customer dissatisfaction or Non conforming?

Mike W

:bonk:

I would say absolutely not. These are not company issued WI's, therefore, cannot be controlled.



I think the question is not who "owns" the document, but how it is used (similar to calibration). If it is used as part of the process, it must be controlled.



Well if we wanted to argue the toss with an auditor we could say that the document is controlled.
It is unique, you know who wrote/authorised it, and there are no other copies.
Now if the employee had copied his notes to everyone else you might have a problem.
Lets look again at what 'controlled' means.
Reviewed and approved by appropriate authority - who is to say the employee is not appropriate authority, they are the user after all.
System to ensure the latest copy is available - well there is only one copy, the master.



I agree Martin, however, I do not believe that this would pass most organization's document control system. It could result in everyone having their own controlled documents, and the organization not having any control over docs.

Wouldn’t the deciding factor be that the absence of the document (notes) would cause a problem? Does the absence of these notes cause customer dissatisfaction or Non conforming?

Mike W



Mike,

I think you hit the nail on the head. If the absence of the document prevents the task from being carried out correctly, then it should be a controlled document and part of your work instruction system.

CarolX

Okay, thanks to all for helping me deal with my "child-like fear of the Boogy Man". I guess I'm just a big sissy and manly men aren't concerned with such trivial matters. :rolleyes:

Sounds like to be safe some type of control needs to be exercised, and the safest bet is to follow the same doc control procedures as all other docs -- i.e. make it "formal".

But if anyone has any better ideas I'm open. I'd rather not create busywork if I don't need to. Seems crazy to write a formal WI for a process I might only do a few times over the period of a few months.

I'd rather not create busywork if I don't need to. Seems crazy to write a formal WI for a process I might only do a few times over the period of a few months.

Sometimes those are the WIs that are the most valuable. If you do a job every day, do you really need the instructions? If you only do it once in a while, you're more likely to forget the way things should be done.

I see your point, Howste, and mostly agree, but I know that after a short while I'll probably never do this process again -- nor will anyone else.

By the way, Mike I'm curious. What process do you have that requires you to go to www.xxx.com? :eek:

Sounds like to be safe some type of control needs to be exercised, and the safest bet is to follow the same doc control procedures as all other docs -- i.e. make it "formal".

But if anyone has any better ideas I'm open. I'd rather not create busywork if I don't need to. Seems crazy to write a formal WI for a process I might only do a few times over the period of a few months.

Once again I must ask, what is keeping you from maintaining local control? Can we have notes, that we make to remind us of things that we keep under our control. On my monitor is my username and password for the Cove, there is also several key phone numbers I need to keep close at hand. There is also a real quick 2-step process outlining how to log onto an MEP site. Do these have to be in the "master list"? ISO doesn't care, as long as I meet the 4.2.3 requirements. But who says the control can't be strictly local? How "formal"?

Don't tell me -- it's an "adult" site? I'm not even gonna go see what it is. I just typed XXX as a generic address -- guess I should have used XYZ, huh?

I must have missed your "local control" explanation. Please explain.

I must have missed your "local control" explanation. Please explain. First of all, I don't know about anyone else, but I took your xxx.com along the same line as the way "x" is used in mathmatical equations.

As far as my "local control". I ask the question, where does it say we cannot exercise local control of documents? The notes on my monitor, or your notes on xxx.com are good examples. Why can't we, as individuals, have control over making sure the information is correct? Local document control may be at the individual, or possibly department level. In too many cases, we seem to think that we need one "Document Controller" who has sole control over documents.

I've seen several companies that have a company-wide document control system, then allow departments the flexibility to control other documents in the way they would like (but still must meet certain criteria). One example is a person who maintains a schedule in an Excel spreadsheet on their PC. When they print it out for distribution, there is a date/time for revision control. BTW, I don't think that username and password for the Cove falls under the 4.2.3/4.2.1d definition of what needs to be controlled. :vfunny:

I noticed the "funny" website when my adult content filter started sending Cove update notices to the "deleted items" folder... :rolleyes:

Mike S. don't get into over-controlling documents. the main doc control SOP should let you do a signature and date on some items that need to be kept like your original example stated. i have seen others use a 'for reference only' stamp, or a 'desk reference' stamp. what ever works and is easy. just define the usage in a SOP. your original example was a good one, don't let the replies off topic get ya.

Well if we wanted to argue the toss with an auditor we could say that the document is controlled.

It is unique, you know who wrote/authorised it, and there are no other copies.

Now if the employee had copied his notes to everyone else you might have a problem.

Lets look again at what 'controlled' means.

Reviewed and approved by appropriate authority - who is to say the employee is not appropriate authority, they are the user after all.

System to ensure the latest copy is available - well there is only one copy, the master.

I agree with M Greenaway, but it is not so much an arguement with the auditor as long as you believe what you are saying and convince them you are right!:vfunny:


"Sounds like to be safe some type of control needs to be exercised, and the safest bet is to follow the same doc control procedures as all other docs -- i.e. make it "formal".

Mike S. Dont even think about it!:frust: I dont think that creating more work for yourself is productive. Do what is best for the company and then perform Internal Audits to verify effectivity. If you find any nonconformances then follow your corrective action system. If it is such a concern, stick the notes in your desk before your next assessment.:) It doesn't sound like Paranoia, just like someone who wants to get it right...

Paula

I personally dont think you can ever 'control', i.e. formally publish every note that every employee creates to help them in their jobs.

In addition the proliferation of PC's on everyones desk means we now also have numerous spreadsheets and databases, and forms created by everyone that they also personally use to help them in their jobs. Should these also be formally controlled ? If a written document must be, then these also must be as the only difference is the media itself.

Imagine that nightmare scenario.

I think a sensible approach is are people publishing things that look as if they are formally approved/issued - if so clamp down on them. But if there is clearly no confusion between a document seen in use and an official document in the QMS then there is no real problem is there - so long as they are still compliant to the main QMS document ??

But if there is clearly no confusion between a document seen in use and an official document in the QMS then there is no real problem is there - so long as they are still compliant to the main QMS document ??

How simplistic, but how true! Great Point.
Mike,
Our department managers & supervisors are allowed to develop, publish and maintain their WI's. Since operations change on the fly in prototype we have to have this level of control. Our procedure just requires their signature and date. If the operator needs additional notes, we view this as a line up sheet. Similar to the Day Shift - Night Shift turnover. It's not controlled, not distributed except to the immediate audience.
Never had a problem.