Hi,

I know I may start a firestorm of people who hate "reference only" documents, but let me ask if this case might be ok......

We have Procedures for our Quality System and Work Instructions for our Mfg tasks (Asm, Shipping, Service). My question is regarding SPECIFIC indirect support job tasks, and if they need work instructions.

For example, our customer service rep was leaving, so she created a big list of uncontrolled instructions for her replacement - how to enter orders, how to invoice, etc - basically, how to use our computer software to perform the tasks. The new person ended up using these to learn, but modifying them to fit the way she liked to do the job. I don't think these need to be controlled. Can these remain "Reference Only"? I see them more as job aids than work instructions. Also, since we're a small company, if I start making everyone document work instructions, the author and the trainee will end up being the same person.

Comments?

Thanks in advance for the feedback.

Emily

Hi,

I know I may start a firestorm of people who hate "reference only" documents, but let me ask if this case might be ok......

We have Procedures for our Quality System and Work Instructions for our Mfg tasks (Asm, Shipping, Service). My question is regarding SPECIFIC indirect support job tasks, and if they need work instructions.

For example, our customer service rep was leaving, so she created a big list of uncontrolled instructions for her replacement - how to enter orders, how to invoice, etc - basically, how to use our computer software to perform the tasks. The new person ended up using these to learn, but modifying them to fit the way she liked to do the job. I don't think these need to be controlled. Can these remain "Reference Only"? I see them more as job aids than work instructions. Also, since we're a small company, if I start making everyone document work instructions, the author and the trainee will end up being the same person.

Comments?

Thanks in advance for the feedback.

Emily

Emily,

When you work for a small organization, how important is it that experience is maintained? (Preservation of knowledge). In your example, the instructions should have been developed long before the person left. It's all part of mitigating risk (within reason of course).

As far as documents are concerned, aren't they all "for reference only?";)
Any time you look at a document, aren't we "referring?"

I know, I may be splitting hairs here. :)

In the end, do what makes sense for your organization but keep it simple, practical, and easy to maintain.

I always say about a document: "If you keep it; control it!"

Good Luck.

Stijloor.

If it has to be referenced, it isn't, it's an operational document. Just a hint;)

Having these documents available becomes more important when only one person knows how to do the job - often the case in a small company.

The way to make sure the documents remain available is to control them.

Your control method does not have to be complicated. The hardest part will be thinking of a simple way to handle them.

:topic:Did you ever notice how easy it is to think of a complicated way to do things, and how hard it is to think of a truly simple way?

I see two issues.

Operating instructions describe how a system works when certain inputs are entered. This is pretty much like saying the light will [probably] go on when one flips the switch. Sounds to me like the first operator combined this information with the following information (work instructions) and needlessly muddied the water.
Work instructions describe when and under what conditions a worker should flip the switch. This is pretty much like saying, "Flip the switch to on when you start the shift."
Neither of those instructions goes into a lengthy discourse about the nature of electricity, the type of lamp used, the current and voltage, or even preventive maintenance of cleaning and changing bulbs in the lamp (since the need for that information may be for a different employee function.)

The biggest value of a controlled work instruction which is followed by each and every worker performing the task is that it provides a baseline for determining root causes of nonconformance AND simultaneously provides a baseline for potential improvement of the methods used in the process.

When internal auditors perform an audit, they try to determine if a system or process is being performed according to plan. If not, does the change from the plan result in a nonconformance of output? If there is no nonconformance of output or (especially) if there is an improvement in output as a result of the change from the plan, is this an improvement which should be documented and the plan modified to adopt it as the new plan?

Emily,
in my opinon,if one oprocess operation is not enough simple for the process owner,the WI need to be devopled ,of course the WI need to be controlled,or the concerned person will be guided wrong.

Hi,

I know I may start a firestorm of people who hate "reference only" documents, but let me ask if this case might be ok......

We have Procedures for our Quality System and Work Instructions for our Mfg tasks (Asm, Shipping, Service). My question is regarding SPECIFIC indirect support job tasks, and if they need work instructions.

For example, our customer service rep was leaving, so she created a big list of uncontrolled instructions for her replacement - how to enter orders, how to invoice, etc - basically, how to use our computer software to perform the tasks. The new person ended up using these to learn, but modifying them to fit the way she liked to do the job. I don't think these need to be controlled. Can these remain "Reference Only"? I see them more as job aids than work instructions. Also, since we're a small company, if I start making everyone document work instructions, the author and the trainee will end up being the same person.

Comments?

Thanks in advance for the feedback.

Emily

Hello Emily,

The 'instructions' given by the out going person can also be controlled by stamping it 'UNCONTROLLED' (as is being done on Engg.drawings), and the new incumbent can revise and endorse it by showing 'Rev.- 01'.

Hope this helps

Umang :bigwave:

Hello Emily,

The 'instructions' given by the out going person can also be controlled by stamping it 'UNCONTROLLED' (as is being done on Engg.drawings), and the new incumbent can revise and endorse it by showing 'Rev.- 01'.

Hope this helps

Umang :bigwave:

And we have always been at war with Eurasia. How can something that is marked "uncontrolled" be controlled? I think it's a fairly simple matter. As Wes suggested, the "operational" part of it should be extracted and left uncontrolled, and the instructions relative to running the process should either be controlled or gotten rid of. A decision needs to be made about controlling the process. If the process needs to be controlled, the documentation does too.

Personally, if the job is so that you need pages of instructions, and nobody (one person) could teach you how to do the job, you should probably create either work instructions, or a training document (same thing imho) so you do not lose bits and pieces through the cracks only to wonder at some later date - What Happened?

THANK YOU EVERYONE! I think I knew I had to control them, but I didn't want to overcomplicate things. Everyone gave great feedback and ideas, and my favorite was this quote below:

"Did you ever notice how easy it is to think of a complicated way to do things, and how hard it is to think of a truly simple way?"


That will be my task!

Thanks again

Emily

Ok, I have an idea on how to keep this simple.

I create the templates, and the authors document their instructions within my template. They become the ONLY approver. But, I keep the instructions in a central, controlled location.

Typically, my Work Instructions require 3-4 approvals, but in this case, the author is really the only approver. That keeps the whole process simple.

Hmmm...this just might work!

Hello Emily,

The 'instructions' given by the out going person can also be controlled by stamping it 'UNCONTROLLED' (as is being done on Engg.drawings), and the new incumbent can revise and endorse it by showing 'Rev.- 01'.

Hope this helps

Umang :bigwave:

Perhaps I was not able to put across my point properly. Let me retry. We use three stamps to mark our Drawings/documents, id-est :

1. CONTROLLED - Document currently in vogue.

2. UNCONTROLLED - In the process, may/may not qualify as a controlled document, but is good for reference at this point of time. viz :Engineering Drawing is being 'prepared by'....'checked by'....'approved by'.... different people at different point of time. During this journey it is stamped 'uncontrolled' and becomes a 'controlled' copy only after the final approval. Same applies to a lot of documents, like 'Inspection report' etcetra.

3. OBSOLETE - Not in vogue since superceded, yet retained, since may be revived in the future. Again good for reference only at this point of time.

So the 'Uncontrolled' too needs to be 'Controlled', that is the point I was trying to communicate.

Hope the doubts are cleared.

Umang :D

Perhaps I was not able to put across my point properly. Let me retry. We use three stamps to mark our Drawings/documents, id-est :

1. CONTROLLED - Document currently in vogue.

2. UNCONTROLLED - In the process, may/may not qualify as a controlled document, but is good for reference at this point of time. viz :Engineering Drawing is being 'prepared by'....'checked by'....'approved by'.... different people at different point of time. During this journey it is stamped 'uncontrolled' and becomes a 'controlled' copy only after the final approval. Same applies to a lot of documents, like 'Inspection report' etcetra.

3. OBSOLETE - Not in vogue since superceded, yet retained, since may be revived in the future. Again good for reference only at this point of time.

So the 'Uncontrolled' too needs to be 'Controlled', that is the point I was trying to communicate.

Hope the doubts are cleared.

Umang :DNot for me. The definition of "uncontrolled" is faulty. Documents in the creation/approval phase are as much controlled as ANY controlled document. The point of control is primarily to assure an obsolete or as yet unapproved document is not used to perform any process within the organization, especially one which may then result in nonconforming product or service being created.

Ok, I have an idea on how to keep this simple.

I create the templates, and the authors document their instructions within my template. They become the ONLY approver. But, I keep the instructions in a central, controlled location.

Typically, my Work Instructions require 3-4 approvals, but in this case, the author is really the only approver. That keeps the whole process simple.

Hmmm...this just might work!

Excellent! - Simple, elegant, would work for most most, non-complex, not regulated industries. :applause:

...The biggest value of a controlled work instruction which is followed by each and every worker performing the task is that it provides a baseline for determining root causes of nonconformance AND simultaneously provides a baseline for potential improvement of the methods used in the process.




The biggest value I see is:


SOP documents should describe the best practices and methods we know about a particular process.
Requiring people to follow those SOPs is simply so we standardize around those best practices.
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.

Perhaps I was not able to put across my point properly. Let me retry. We use three stamps to mark our Drawings/documents, id-est :

1. CONTROLLED - Document currently in vogue.

2. UNCONTROLLED - In the process, may/may not qualify as a controlled document, but is good for reference at this point of time. viz :Engineering Drawing is being 'prepared by'....'checked by'....'approved by'.... different people at different point of time. During this journey it is stamped 'uncontrolled' and becomes a 'controlled' copy only after the final approval. Same applies to a lot of documents, like 'Inspection report' etcetra.

3. OBSOLETE - Not in vogue since superceded, yet retained, since may be revived in the future. Again good for reference only at this point of time.

So the 'Uncontrolled' too needs to be 'Controlled', that is the point I was trying to communicate.

Hope the doubts are cleared.

Umang :D

Not for me. The definition of "uncontrolled" is faulty. Documents in the creation/approval phase are as much controlled as ANY controlled document. The point of control is primarily to assure an obsolete or as yet unapproved document is not used to perform any process within the organization, especially one which may then result in nonconforming product or service being created.

You have re-iterated what I have already stated. May be, you perhaps missed the punch line in my post.

Umang :cool:

You have re-iterated what I have already stated. May be, you perhaps missed the punch line in my post.

Umang :cool:

I don't think he missed anything; you're saying that something that is controlled is stamped "uncontrolled." It's self-contradictory and makes no sense.

I don't think he missed anything; you're saying that something that is controlled is stamped "uncontrolled." It's self-contradictory and makes no sense.Precisely! The stamp is the clinker in the grate.

I don't think he missed anything; you're saying that something that is controlled is stamped "uncontrolled." It's self-contradictory and makes no sense.

["Documents in the creation/approval phase are as much controlled as ANY controlled document." - Wes Bucey]

During the creation/approval phase, these documents can not be stamped as "CONTROLLED". That is why they are being marked as "UNCONTROLLED", yet they are needed to be controlled at par with a controlled document!! I and Wes have said the same thing, to the best of my understanding, and also to the understanding of some of my customers based in USA (TS certified).

You are welcome to hold your opinion, as you deem fit, that is your prerogative.

Umang

["Documents in the creation/approval phase are as much controlled as ANY controlled document." - Wes Bucey]

During the creation/approval phase, these documents can not be stamped as "CONTROLLED". That is why they are being marked as "UNCONTROLLED", yet they are needed to be controlled at par with a controlled document!! I and Wes have said the same thing, to the best of my understanding, and also to the understanding of some of my customers based in USA (TS certified).

You are welcome to hold your opinion, as you deem fit, that is your prerogative.

UmangThe 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.

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.

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?

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.

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.

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.

...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...!)

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..:)