Definition Procedure vs. Guidelines (Like local work instructions) - Definition of

CarolX

Super Moderator
Super Moderator
#21
Mike S. said:
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
 
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I

Isolytica

#22
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.
 

SteelMaiden

Super Moderator
Super Moderator
#23
CarolX said:
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.
 
M

M Greenaway

#24
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.
 
E

energy

#25
Stirring the pot right back

Mike S. said:
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:
 
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Mike S.

Happy to be Alive
Trusted Information Resource
#26
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?
 

howste

Thaumaturge
Super Moderator
#27
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.
 
M

M Greenaway

#28
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.
 
E

energy

#29
maybe Anal?

Mike S. said:
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:
 
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CarolX

Super Moderator
Super Moderator
#30
Mike S. said:
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?
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
 
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