posted 11 June 2000 09:08 AM               

From: "Charley Scalies" [email protected]

> Bob Bartschenfeld asks:
> Our company is working on developing training manuals for workstations
> (i.e.: extrusion). These manuals are to be provided for each employee's use
> during training. We would like to be able to keep this as general as
> possible (no revision controls) yet we need to be able to reference
> controlled procedures.
>
> How have you folks addressed this issue of using training manuals that are
> not controlled without losing track of the specific procedural requirements.
>
> For example, we would like to ensure that all extrusion operators follow a
> prescribed procedure for cleaning out the extruder, but if this procedure is
> in the training manual and a change is made, not all operators will get the
> change. The other issue is that we want the manual and instructions to be
> easy for the trainee to carry around with them, so they use it.
>
> We are trying to get our system as paperless as possible (other than the
> training manuals). Even the training manuals have the potential to be
> paperless. Each operator has a computer at their workstation.
>
> Are there any suggestions on how to deal with this control issue?

Sounds to me like your training manuals are really to be used to a large degree as work instructions or workmanship standards, in which case they need to be controlled.

That does not mean, however, that every trainee needs to personally have one. You might have centralized, easy to reach paper copies - that reduces the number of pieces of paper that need to be controlled, or, as you indicated, they could be published and accessed electronically. Either way, it's important to remember that controlling information is more than knowing who has what information, but, more importantly, ensuring they know which is the correct information to use. So if you go paperless, be sure you have a system whereby the operators are informed or otherwise made aware that a requirement has changed.

Document control requirements can be summed up in 2 words. "Right There" They have to be Right AND Right There (i.e. readily available) If you do that, you have a system that works. If you don't, you don't.

You may have noticed that the new draft standard mandates fewer documented procedures. That, IMHO, is really a recognition that not all requirements are procedural in nature and that training plays a large part in what and how people are supposed to perform tasks. That should not be construed to mean that those requirements need not be documented. If it's important enough to do, then its important enough to document - and therefore control. For example, you might decide that machine operators have a demonstrated ability to safely and properly operate the particular machine and know, for example, how to make a raw bar of steel look like the finished print. (I couldn't imagine otherwise). That qualification requirement needs to be documented and controlled. The final call is always yours.

You need to find the most effective and cost efficient method that works for you.

posted 11 June 2000 09:22 AM               

From: [email protected]

> How have you folks addressed this issue of using training manuals that are
> not controlled without losing track of the specific procedural requirements.
>
> For example, we would like to ensure that all extrusion operators follow a
> prescribed procedure for cleaning out the extruder, but if this procedure is
> in the training manual and a change is made, not all operators will get the
> change. The other issue is that we want the manual and instructions to be
> easy for the trainee to carry around with them, so they use it.

I had a similar situation and here's what worked for me:

Regardless of the work procedure's revision level, the current procedure for (say) "cleaning out the extruder" is pretty much always going to be called, "The Current Procedure for Cleaning Out The Extruder." It might be Rev. 1 dated June 5, 2000 one day, and Rev. 2 dated June 6, 2000 the next day, but everyone should know what you're talking about when you just say "the current procedure for..."

SAVE THIS FOR YOUR OWN BOOK:

Next, guarantee yourself at least one weekly migraine headache by using actual work procedures integrally with the training documentation (In other words, a separate, identical set, one for "floor use" and one for "training use"). That way, any rapidly made QMS procedural documentation correction made in a hurry right before (say) a Registrar's surveillance audit will surprise everyone at how rapidly and efficiently it can be accomplished, and everyone will be a hero right up until the Registrar's auditor finds that the procedure in the training documentation is lagging behind, usually by at least one "Revision Level" and sometimes, more than one Revision Level in cases where that particular training session hasn't been conducted in some extended period of time.

Or, if you dislike migraines as much as I do, use "the current procedure for..." in all of your training documentation, and ensure access to "the current procedure for..." during training (paper, paperless, etc.).

(Hint: It probably wouldn't be a bad idea to define and document the words you're going to use to describe "this procedure" or "that procedure," not for everyone's use, but for those who handle the QMS documentation, because it's an almost certainty that if you don't "control" those words, you'll end up with one reference that says "Extruder Cleaning" and another that says "Cleaning the Extruder" and another that says... and so on. And you want to keep the whole choir on the "same page" so to speak ;o)

David Kozenko