Work Instruction vs. Reference Only document - Computer software use instructions

BradM

Staff member
Admin
#21
Re: Work Instruction vs. Reference Only document

The point almost all document management systems make is any document not in general circulation, which has no approvals stamped or signed on it should not be used in a process. A document going through the authoring and approval process is NOT in general circulation and does not have such approvals on it; so, ipso facto, it is not usable in the same way a copy of a document which was previously approved, but may now be obsolete, might find its way into the hands of someone performing a process who could mistakenly accept it as a current document. Stamping such an in-process document "uncontrolled" is absolutely unnecessary and may needlessly confuse folks who might think it could be used as a reference when it may contain one or more errors which have not been caught in the approval process, creating havoc for folks who believe "uncontrolled" and "reference" are synonyms.

I find it easy to believe some folks with an "uncontrolled" stamp in their hands (regardless of who they work for) might be eager to stamp it on everything in sight, but that does not make it correct usage as promulgated by most document management experts.
Agreed, Wes. Nice post. Stamps are a tool to communicate a status of sorts to individuals; a signal to let them know something they otherwise would not have know without the stamp. If you have documents in process or whatever, employees should be trained well enough to know what they are should they see it. All controlled documents in our case have form numbers and revisions. Anything people see without that is uncontrolled, reference only, etc.

I have always found better luck in training/supporting a simple (but effective) system and developing understanding of why control is important.
 
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W

Watchwait

#22
Re: Work Instruction vs. Reference Only document

Wow! What a great discourse! Exactly the type of idea/thought exchanges I so appreciate on the Cove.

As it happens, we too have an "ongoing" dialogue about something we call "Desktop Instructions". They fall into the exact description/operational category previously described. This was something I have on the back burner, but now you guys have all made me feel guilty to the point of having to actually go after this issue.

BTW...how big of an issue has this been in the past? I'm fully aware of the *potential* of the issue, but speaking from past actual experience, has anyone been called out by ISO or FDA auditors on this issue?
 
#23
Re: Work Instruction vs. Reference Only document

Actually, the standard clears it all up for us. 4.2.1 tells us what documents must be controlled, and what doesn't. For local documents, look at 4.2.1d) “documents need by the organization to ensure the effective planning, operation and control of its processes.”

Simply put, if any document is necessary to get the job done, it has to be controlled. A “for reference only” document tells me that we can remove that document and there will be no detrimental effect on the process. If removing the document adversely affects the process, then it must be controlled.
 
M

Mustang

#24
Re: Work Instruction vs. Reference Only document

Actually, the standard clears it all up for us. 4.2.1 tells us what documents must be controlled, and what doesn't. For local documents, look at 4.2.1d) “documents need by the organization to ensure the effective planning, operation and control of its processes.”

Simply put, if any document is necessary to get the job done, it has to be controlled. A “for reference only” document tells me that we can remove that document and there will be no detrimental effect on the process. If removing the document adversely affects the process, then it must be controlled.
That's a good, simple way to think of it, DB! I'll try to remember that the next time someone asks about the difference. :thanx:

Something to remember: If a process/task/etc. is fairly stable, once it's created, controlling it shouldn't be too difficult, as changes won't be very frequent.

And to avoid confusion when a "controlled" document is going around for review, we package the new copy (marked "proposed") the existing copy (marked "current") and the Change Notice (what we use for sign-offs). This seems to keep people from getting confused.
 

Caster

An Early Cover
Trusted Information Resource
#25
Re: Work Instruction vs. Reference Only document

BTW...how big of an issue has this been in the past? I'm fully aware of the *potential* of the issue, but speaking from past actual experience, has anyone been called out by ISO or FDA auditors on this issue?
My 2 cents. Forget the auditors, they are the last reason to do anything.

There have been and will always be costly errors from people following an incorrect method.

That's what it's all about. That's why the requirement for "control" got into ISO in the first place.

I'm always amazed at the effort people put into "gaming" the ISO system (desk procedures, uncontrolled stamps, etc). It shows me they have lost touch with (or never understood) the intent behind "control".

And yes, we got a finding for uncontrolled documents. A copy of a work instruction at a machine was stamped uncontrolled (I don't even know where they got that stamp from - perhaps someone got it at Staples on their own time).

The hard copy was three revs old, and the current version was on the intranet at the computer at the work area. The hard copy was on the desk, just beside the keyboard. Our system states the computer version is the master. Despite all this someone had printed a copy and thought they had made it all OK by stamping it uncontrolled. Our procedure makes no mention of "stamping things uncontrolled".

A bit of a surreal experience to live through.
 

Helmut Jilling

Auditor / Consultant
#26
Re: Work Instruction vs. Reference Only document

...I'm always amazed at the effort people put into "gaming" the ISO system (desk procedures, uncontrolled stamps, etc). It shows me they have lost touch with (or never understood) the intent behind "control".

....

Bravo! :applause: (...and that's coming from an auditor, even...!)
 
W

Watchwait

#27
Re: Work Instruction vs. Reference Only document

Caster - great reply! Though - I don't know as I'd go so far as to say "forget about the auditors..." A bit too bold for my FDA-driven world..:)
 
A

amariepsu

#28
Re: Work Instruction vs. Reference Only document

How do you ensure your 'reference only' documents aren't out of date?
 
N

naghee

#30
Re: Work Instruction vs. Reference Only document

The biggest value I see is:

  1. SOP documents should describe the best practices and methods we know about a particular process.
  2. Requiring people to follow those SOPs is simply so we standardize around those best practices.
  3. Controlling the information (documents) is needed to ensure everyone is using the same information.
This combines and satisfies ISO and Lean into a simple concept. I think we ought to add these three sentences to our Doc Control Procedure, under "Purpose" - they would finally explain the intent.
I totally agree with you...
this tells the user why we need these documents afterall
 
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