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Some Related Topic Tags (Not all threads are Tagged)
work instructions (wi), definitions, procedures (general), processes (general), differences (general)
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  Post Number #9  
Old 13th July 2007, 10:23 AM
Gary E MacLean's Avatar
Gary E MacLean

 
 
Total Posts: 86
Re: How do you decide what is a process, procedure or work instruction?

I know I am a bit late but since I have just read all the other posts and I haven't yet seen what I might consider the best answer I have to throw my two cents in - for whatever it is worth.

Define yourself a six tier system. Yes, six, not four;

LEVEL ONE: Quality Manual (Top Management's committment to follow ISO)
LEVEL TWO: Administrative Procedures (document your selected processes)
LEVEL THREE: Work Instructions (document sub-processes directly related to your processes, or level twos.
LEVEL FOUR:Job Instructions (A very important level. These belong to your organization. They explain expressly how you set this part up, how you package this one, how to run this piece of equipment and so on. They are site-specific. You need them but lets not mix them up with the system related documents. You should never have to change these simply because the standard gets updated. You will only revise them if your operation changes. These really don't even have to be audited - just their existence.
LEVEL FIVE: Blank forms and reference documents (Things like any blank forms that will become a record, SPC ConstantS table, rockwell conversion chart, viscosity table, things that you may want to issue from your own machine but things that are full of unchangeable fact.
LEVEL SIX: Records. (These are simply evidence that somethng has happened.

And yes, the Quality Manual is nearly a re-hash of the standard unless of course you plan on doing something that is not in the standard or you plan on not doing somethIng the standard requires you to do. If you are going to acknowledge the standard and agree with it why not just say so in your top level, committment document. Typically there is very little direction or instruction within the qualty manual anyway; it is usually policy.

There is no set list of processes. In fact the recommended list varies from registrar to registrar (who incidentally truly have nothing to do with what you call your processes anyway - it really is none of their business how you satisfy the standard as long as you make it work) Just look at what you do and name your prmary processes.

There are PROCESS recommendations galore but I would highly recommend resisting calling anything having to do with anything not defined within the standards; costing, profit margins, accounting, personnel benefits, market analysis, bench marking, safety, payment and so on, a process. There are no published criteria within ISO9001:2000 for any of these so there is nothing for you to stake a claim on and nothing for your registrar to reference when they decide to write a NC. They will be auditing these or any other activities that are not defined within the standard to their best judgement and desires, not healthy for you and not healthy for any audit program.

OK, more perhaps somewhat useable advice for you. We seem to all have a good supply of that.

Good Luck
Thank You to Gary E MacLean for your informative Post and/or Attachment!

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  Post Number #10  
Old 13th July 2007, 11:50 AM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,156
Re: How do you decide what is a process, procedure or work instruction?

Quote:
In Reply to Parent Post by Gary E MacLean View Post

Define yourself a six tier system. Yes, six, not four;

LEVEL ONE: Quality Manual (Top Management's committment to follow ISO)
The commitment you refer to is generally captured in the quality policy; the QM should be more than that.
Quote:
In Reply to Parent Post by Gary E MacLean View Post

LEVEL TWO: Administrative Procedures (document your selected processes)
No issues here; this is pretty much standard.
Quote:
In Reply to Parent Post by Gary E MacLean View Post

LEVEL THREE: Work Instructions (document sub-processes directly related to your processes, or level twos.

LEVEL FOUR:Job Instructions (A very important level. These belong to your organization. They explain expressly how you set this part up, how you package this one, how to run this piece of equipment and so on. They are site-specific. You need them but lets not mix them up with the system related documents. You should never have to change these simply because the standard gets updated. You will only revise them if your operation changes. These really don't even have to be audited - just their existence.
Why two tiers here? What's the difference between three and four? They don't have to be audited?? How to you do part/process audits if you don't verify that the work instructions are being followed? I'd like to learn more about your rationale for the bifurcation.

Quote:
In Reply to Parent Post by Gary E MacLean View Post

LEVEL FIVE: Blank forms and reference documents (Things like any blank forms that will become a record, SPC ConstantS table, rockwell conversion chart, viscosity table, things that you may want to issue from your own machine but things that are full of unchangeable fact.
I understand the need to control forms (usually tier 4 in a 4-tier system), but I don't see a need for controlling "unchangeable fact." If it's immutable, why does it need to be controlled?

Quote:
In Reply to Parent Post by Gary E MacLean View Post

LEVEL SIX: Records. (These are simply evidence that somethng has happened.
Again, no issues; pretty much standard.

Quote:
In Reply to Parent Post by Gary E MacLean View Post

And yes, the Quality Manual is nearly a re-hash of the standard unless of course you plan on doing something that is not in the standard or you plan on not doing somethIng the standard requires you to do. If you are going to acknowledge the standard and agree with it why not just say so in your top level, committment document. Typically there is very little direction or instruction within the qualty manual anyway; it is usually policy.
Quality manuals that are "nearly a re-hash of the standard" are mostly worthless beyond the requirement to have a quality manual; why have a potentially significant document that serves no useful purpose? Most quality manuals are useless because they came into being as a result of desire to fulfill what's seen as a bothersome requirement. If the goal is simply compliance with the standard, a rehash QM will certainly fill the bill, but shouldn't we be aiming a little higher than that?

Quote:
In Reply to Parent Post by Gary E MacLean View Post

There is no set list of processes. In fact the recommended list varies from registrar to registrar (who incidentally truly have nothing to do with what you call your processes anyway - it really is none of their business how you satisfy the standard as long as you make it work) Just look at what you do and name your prmary processes.
This isn't about giving things names, like newborn children or puppies; the object should be to identify significant processes, optimize them and document the proven methods. Again, it's about making things work as well as possible, not worrying about what might be audited or what name you give to something.

Quote:
In Reply to Parent Post by Gary E MacLean View Post

There are PROCESS recommendations galore but I would highly recommend resisting calling anything having to do with anything not defined within the standards; costing, profit margins, accounting, personnel benefits, market analysis, bench marking, safety, payment and so on, a process. There are no published criteria within ISO9001:2000 for any of these so there is nothing for you to stake a claim on and nothing for your registrar to reference when they decide to write a NC. They will be auditing these or any other activities that are not defined within the standard to their best judgement and desires, not healthy for you and not healthy for any audit program.
What you call a process doesn't change the fact that it is a process, and if a process is perceived as being worthy of control and documentation, it should be controlled and documented. If you do it well (and that's the primary objective, I hope) then you don't have to worry about auditors. The primary function of auditors (internal or external) is to confirm the auditee's contention that the system is working as designed, not to play "gotcha!". If an auditor (internal or external) is clearly on a search-and-destroy mission, then someone needs to step in and take control, and not allow auditors with fanciful imaginations to make stuff up.

As we discussed in another thread, the standard mandates the existence of certain processes and documents, and beyond that whatever is necessary for the functioning of the system. The idea of a tightly-structured hierarchical document system is a bit old hat, and cleaving to the idea that it's necessary has a tendency to stifle creativity. The best quality systems I've seen are the ones where someone has set out to build an efficacious system, one in which the satisfaction of ISO requirements is a secondary consideration. We all know that it's eminently possible to cookie-cutter your way to registration, but if you set out with banality and needless rigor aforethought, you'll wind up with a system that's banal and needlessly rigorous.
Thank You to Jim Wynne for your informative Post and/or Attachment!
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  Post Number #11  
Old 13th July 2007, 05:22 PM
Helmut Jilling

 
 
Total Posts: 4,362
Re: How do you decide what is a process, procedure or work instruction?

Quote:
In Reply to Parent Post by António Vieira View Post

... For other subjects that are ...still organization activities, I use to right specifications or procedures, but don't consider them as processes.


If it is something you do, it is probably a process, subprocess, or activity... whatever you want to call it.

Gary, wasn't it your comment I applauded in the other thread, that, "if you do it, it's probably a process!" Brilliant and simple.

And if you do it, but you don't define it as a process or part of a process, then it falls off the radar screen and you don't improve it...

You don't "decide" whether something is a process. The processes in your organization are already there. They are designed in. Your job is to find them all, like Easter eggs.

For example, if you buy stuff, you have a purchasing process. You can call it something else, or you can bury it inside another process and call it a subprocess. But, the point is, it is there in your organization. It is your job to identify it is there, and define how you want to manage it. But, you don't decide whether it is there.

If my car uses oil, but I don't define it in my system, the car's need for oil does not go away. It is hard coded into the system. If I fail to identify it, I probably won't manage it, and I will damage my system.
Thank You to Helmut Jilling for your informative Post and/or Attachment!
  Post Number #12  
Old 13th July 2007, 05:53 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,459
Let Me Help You Re: How do you decide what is a Process, a Procedure or Work Instruction?

So, 'P', I have a different approach for you to consider..........BTW - welcome to a 'fellow' Michigander!

A process can defined as value added activities which transform input(s) into output(s). To ensure this happens (output, that is) the process has to be controlled. This can be accomplished by either 'procedures' or, for very specific activities which require control, you could apply a 'work instruction'.

I have found that the analogy of baking a cake is good for explaining this:-

The process transforms the ingredients into cake. The actual measuring of ingredients, mixing, beating etc as described in the receipe can be considered the 'procedure'. In some cases, there may be a need, depending on the competency of the cook, to have a work instruction which amplifies the activities at some point in the procedure. This might be the process for setting up, zeroing out and using the weigh scales (yes, I'm English, we do things by weight - cups are for drinking from)

You should try my cake sometime...........

P.S I ate the records..........
  Post Number #13  
Old 14th July 2007, 05:33 AM
Peter Fraser's Avatar
Peter Fraser

 
 
Total Posts: 456
Re: How do you decide what is a process, procedure or work instruction?

Quote:
In Reply to Parent Post by hjilling View Post

You don't "decide" whether something is a process. The processes in your organization are already there. They are designed in. Your job is to find them all, like Easter eggs.
Very well put! All I would add is: "... designed in - or in some cases just happened to evolve, without being recognised"?!

I am not sure if the APQC's Process Classification framework has been mentioned elsewhere, but it is the most comprehensive and understandable reference I have come across.

See http://www.apqc.org/portal/apqc/site...pcf/index.html
  Post Number #14  
Old 14th July 2007, 02:57 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,631
Re: How do you decide what is a Process, a Procedure or Work Instruction?

Quote:
In Reply to Parent Post by AndyN View Post

I have found that the analogy of baking a cake is good for explaining this:-

The process transforms the ingredients into cake. The actual measuring of ingredients, mixing, beating etc as described in the receipe can be considered the 'procedure'. In some cases, there may be a need, depending on the competency of the cook, to have a work instruction which amplifies the activities at some point in the procedure. This might be the process for setting up, zeroing out and using the weigh scales
Interesting analogy. I believe that one of the greatest challenges one has to face when implementing process-approach based QMS's is the distinction between activities and processes. My interpretation is that when the standard states "processes", they are referring to macro-processes, such as sales, design, warehousing, new product introduction, etc... Under these macro-processes, we have sub-processes and activities. For example, answering a phone call or creating an email are activities, which also have input, criteria and output. But we don't treat activities such as processes that require monitoring, objectives, etc. So, coming back to Andy's analogy, if baking a cake is a process, where is the requirement for continual improvement? How can you improve it? The recipe is a winner, so is the baking method well proven (validated). So, how would the "Andy's cake baking process" be improved upon?

As usual there is "guidance" from the TC176, such as in the following hyperlinked documents Identification of processes ; Understanding the process approach ; Determination of the “where appropriate” processes and N544 - Guidance on the Concept and Use of the Process Approach for management systems
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #15  
Old 14th July 2007, 03:44 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,459
Thank You! Re: How do you decide what is a Process, a Procedure or Work Instruction?

Quote:
In Reply to Parent Post by Sidney Vianna View Post

Interesting analogy. I believe that one of the greatest challenges one has to face when implementing process-approach based QMS's is the distinction between activities and processes. My interpretation is that when the standard states "processes", they are referring to macro-processes, such as sales, design, warehousing, new product introduction, etc... Under these macro-processes, we have sub-processes and activities. For example, answering a phone call or creating an email are activities, which also have input, criteria and output. But we don't treat activities such as processes that require monitoring, objectives, etc. So, coming back to Andy's analogy, if baking a cake is a process, where is the requirement for continual improvement? How can you improve it? The recipe is a winner, so is the baking method well proven (validated). So, how would the "Andy's cake baking process" be improved upon?

As usual there is "guidance" from the TC176, such as in the following hyperlinked documents Identification of processes ; Understanding the process approach ; Determination of the “where appropriate” processes and N544 - Guidance on the Concept and Use of the Process Approach for management systems
Thanks, Mr. Vianna

In my specific analogy, I've actually put in place some improvements. The cake in point is a traditional English Christmas cake (no, it's better than fruit cake.) I have implemented a number of improvements using lean techniques, like not storing the flour for months before, thus making sure it's fresh, buying the other ingredients etc on a 'just in time' basis. It's a cake which does best in the freezer for a month or so, so that helps with the timing of when to make it, the marzipan coating is a seasonally available product, but needs to be bought at a time when the stores have it fresh, since it becomes harder with age. I've also been trying different friuts from different stores - Whole Foods etc. to see if the taste improves.

I won't mention the whiskey which is added after cooking and before freezing..............
Thanks to AndyN for your informative Post and/or Attachment!
  Post Number #16  
Old 15th July 2007, 02:31 AM
harry

 
 
Total Posts: 6,286
Re: How do you decide what is a Process, a Procedure or Work Instruction?

Quote:
In Reply to Parent Post by AndyN View Post

.....I have found that the analogy of baking a cake is good for explaining this:-

The process transforms the ingredients into cake. The actual measuring of ingredients, mixing, beating etc as described in the receipe can be considered the 'procedure'. In some cases, there may be a need, depending on the competency of the cook, to have a work instruction which amplifies the activities at some point in the procedure. This might be the process for setting up, zeroing out and using the weigh scales (yes, I'm English, we do things by weight - cups are for drinking from)

You should try my cake sometime...........

P.S I ate the records..........
I like your cake making analogy. It's easier to understand than Greg's coffee making example. Commercial cake & pastry houses do tweak and experiment with recipes (R&D) to come out with new flavors & others - continuous improvement. By the way, the best fruit cake I ever tasted is from 'Collin Street Bakery' (not advertising for them but just miss it) and the ones over here are far off in terms of taste.
Thanks to harry for your informative Post and/or Attachment!
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