Controlled Documents....or not? One and two-page "how-to" instructions

#1
I have a large quantity of one and two-page "how-to" instructions. Most of these are "how-to" press the right buttons in our computer system to do things like set up a customer in the database, assign a part number to a given accounting group, generate a work order, etc. These instructions are used, maybe once, to train someone on given screen. After that, they go back on the shelf and are never used again because if you do them wrong you don't get a result.

Is there a way for me to use these without them rising to the level of "auditable"? I have nightmares about an auditor raising 100's of findings because Betty pushes F2-insert (because it's a great shortcut) rather than entering the 5 keystrokes listed in paragraphs 5.3.2 through 5.3.6. These things are not testing or measurement instructions for "special characteristics" and I'd rather not spend the time and effort required to maintain each one with the training, control and auditing required for a "controlled document".
-Icy
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Technically they are work instructions or training materials and must be controlled if only 'locally', by one person on their computer (assuming backup somewhere, of course). I hate to hear you say "They may only be used once for training" because training materials should be controlled in some way. If the training materials are of such little importance, why do you have them at all? Why not just OJT?

My question is, if "Betty pushes F2-insert (because it's a great shortcut) rather than entering the 5 keystrokes listed in paragraphs 5.3.2 through 5.3.6", why does the work instruction / training material cite 5 steps when one will do?
 

RoxaneB

Super Moderator
Super Moderator
#3
Marc beat me to it.

To often when developing management systems, we forget to develop it for the users and instead do what we think the auditors want and/or what we believe the standard wants.

If F2 is used - but the 5-keystroke is also an option - list both if necessary/preferred. This information, while not used for measuring, has been documented for a reason...odds are it was to standardize the process so that fewer errors were made.

Combining On-the-Job training with a documented standardize process can be a very effective way to communicate how a process is to be done.
 

SteelMaiden

Super Moderator
Super Moderator
#4
I agree, these are instructions for performing work...you should control them either as training or work instructions, and if there are two ways (F2 vs. mutiple keystrokes) why not go ahead and put both in? We have lots of folks that don't like shortcuts, for whatever reason, so I know that it happens. Good luck.
 
F

fuzzy

#5
Depends on the output...

Icy,

I'm rusty on TS even though I passed the Lead Auditor course back in 2005, but it seems to me that the output of these one-pagers is what drives the need to control or not. I was with you until "generate a work order", as that made me think work order for product (?) which sounds like a product realization process. If these one / two -pagers lead to QMS associated processes then I would hold that they should be controlled. Do any of them also tie to competencies identified within a training matrix for key positions which also impact the QMS? These are the angles I would explore in deciding to control or not...hope this is helpful.:)
 

apestate

Quite Involved in Discussions
#6
Or

Why not loosen the control. The desired outcome is an accepted and correct data entry.

Include a clause that says the work instruction is one way of accomplishing the result.

I do agree that it sounds like a work instruction, but you could probably control them easily. Are they titled? Are they document numbered already?

Who would audit a bunch of simple data entry work instructions?
 

Jim Wynne

Staff member
Admin
#7
Icy Mountain said:
I have a large quantity of one and two-page "how-to" instructions. Most of these are "how-to" press the right buttons in our computer system to do things like set up a customer in the database, assign a part number to a given accounting group, generate a work order, etc. These instructions are used, maybe once, to train someone on given screen. After that, they go back on the shelf and are never used again because if you do them wrong you don't get a result.

Is there a way for me to use these without them rising to the level of "auditable"? I have nightmares about an auditor raising 100's of findings because Betty pushes F2-insert (because it's a great shortcut) rather than entering the 5 keystrokes listed in paragraphs 5.3.2 through 5.3.6. These things are not testing or measurement instructions for "special characteristics" and I'd rather not spend the time and effort required to maintain each one with the training, control and auditing required for a "controlled document".
-Icy
The reason to control work instructions is to establish standard methods of doing work that have been proven to be efficacious. If standardized methods aren't necessary--if there are multiple methods that all accomplish the same objectives--then controlled instructions probably aren't necessary.
 

Caster

An Early Cover
Trusted Information Resource
#8
Help files - but still need control

Icy Mountain said:
I have a large quantity of one and two-page "how-to" instructions. Most of these are "how-to" press the right buttons in our computer system to do things like set up a customer in the database, assign a part number to a given accounting group, generate a work order, etc. These instructions are used, maybe once, to train someone on given screen. After that, they go back on the shelf and are never used again because if you do them wrong you don't get a result.
Icy Mountain said:

Is there a way for me to use these without them rising to the level of "auditable"? I have nightmares about an auditor raising 100's of findings because Betty pushes F2-insert (because it's a great shortcut) rather than entering the 5 keystrokes listed in paragraphs 5.3.2 through 5.3.6. These things are not testing or measurement instructions for "special characteristics" and I'd rather not spend the time and effort required to maintain each one with the training, control and auditing required for a "controlled document".
-Icy


These sound like software manuals and/or help files to me....can you make them disappear into on line help files?

They still need "control", but I seem to have a less rigorous vision of control than your definition

"with the training, control and auditing required for a "controlled document"

If its current, and available, as far as I care it has been "controlled".

As an example, Marcs FAQs for the Cove are controlled as much as they need to be <IMHO>. My audit would easily accept these FAQs, so I see no downside to having anything exposed to auditing.

Is your control system cumbersome? Can it be simplified and still remain effective? Some random thoughts.
 
#9
Thanks for the tips

I hate to ask and run but I've been on the production floor for a couple of days.

Anyway, we are talking about a couple of hundred instructions for operating our "Enterprise Management" system. Most of them are very simple, so that if you enter a work order a couple of times, you are never going to look at the work instruction again. The mistakes that could impact the company are not failing follow these instructions properly (most of them give you no result if you don't do them correctly) but rather, say, entering a work order and mistyping the part number or quantity, since the BOM, routing and other things that impact the system are done automatically. It's not so much that the control system is cumbersome, it's the prospect of putting a number and revision level on each of these documents and running them all through our ECO system to release them. As far as generating a finding for someone not following an instruction to the letter, woo boy, that's what TS auditors live for!!!

These documents are already numbered, titled and dated. After reading your comments, I believe I have the answer. We shall create a folder on our server titled "General Work Instructions" (i.e. work instructions that do not impact product realization or the QMS in general, we already have all of those in a Procedures Manual folder). All of these documents will be available for everyone, controlled in that everyone will always be using the same instruction and we'll top the folder with a one page instruction for recording name and date on the cover page if any changes are made (i.e. noting the shift-F2 shortcut).

Then, I gird my loins, and get ready to fire up on the first auditor that has to go to this level to generate a finding. See my rant on "why my rulers are not in the calibration system".
 

Wes Bucey

Quite Involved in Discussions
#10
I generally agree that "some" external auditors can be a big PIA.

That said, let me be slightly humorous by adopting a politician's pose:
"It all depends on what you mean by control."

In my lexicon, control merely means a special attention to managing a document for
  • version (only current version available - see "configuration management")
  • access (who is entitled to view the document?)
Whether or not folks actually refer to and adhere to the controlled document has absolutely nothing to do with whether it is adequately controlled. The point being it is the document that is controlled, not the employee.

The whole concept of document management and control is primarily a filing function. The reality of life is that document management can be likened to a children's coloring book - some kids will color within the lines, some won't. Whether they do or don't has nothing to do with the creation, publication, and sale of the coloring book.

Some folks buy coloring books that are inconsistent with the fine motor skills of the child (pre schoolers don't have the same fine motor skills as eighth graders.) Similarly, organizations have documents which are not compatible with the skills and abilities of the employees. If Deming's Red Beads teaches anything, it is NOT the employee's fault when the instructions cannot be followed to the letter to achieve the desired result.

My suggestion:
Time to review the documents for compatibility to the business purpose of the organization and the willingness or ability of the employees to adhere to the instructions in the documents. When there is doubt as to what is at fault, my instinct is to look first at the documents and the process before blaming the employees or some nameless, faceless TS auditor who hasn't even seen anything, yet.
 
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