Section 4.1 of ISO9001:2000 states (amongst other things) that an organisation shall identify the processes needed for the quality management system.

Are these processes different to product realisation processes ?

Pardon me - just read the note at the bottom of this section.

Very sorry - it is Friday !!

If a moderator wishes to delete this thread please do so.

The 00 standard gives one the model in Q9000-2000, not the same as manufacturing processes (eg. extrusion,forming,etc.). We are interpreting it as the 94 elements are our sub-processes as the conversion charts show. Our QMS processes are our systems for providing customer satisifaction. Q9000-2000 gives the answer.

But the note at the bottom says

"Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realisation and measurement."

Originally posted by M Greenaway
Section 4.1 of ISO9001:2000 states (amongst other things) that an organisation shall identify the processes needed for the quality management system.

Are these processes different to product realisation processes ?

Martin,

I had the same question not long ago. See thread:

http://Elsmar.com/Forums/showthread.php?s=&threadid=4172&perpage=10&pagenumber=2

As you mentioned, the note in the standard says:

"Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realisation and measurement."

It includes product realization processes. Does this mean from receipt of a customer order to the shipping of the product?

Best Regards,
Hank Fowler
:confused:

Notes are not auditable unless you add it to your system. And this note supports what I had said. Clauses 5,6,7,8 IMO

Here's how I handled it. I used the model provided by 9000 that shows all of the clauses of the standard in the circle, with customer requirements going in and satisfaction coming out. You know the one.

Anyway, from this model I hooked little text boxes from each clause. And within the text boxes I named the Processes we have that belonged there. For product realization's box I identified the product realization processes (we only broke them down into three threads- so far). In the center of the circle I put a box with the supporting processes for the QMS as a whole : doc control, control of records, IT security.

This is how I will represent the identification of our processes.

Then if you click on the name of a process it opens up a process chart for that process, and shows the inputs and outputs with other processes. The interaction.

How can you possibly leave out product realization?

Lucinda!!!!!!!!!!!!!!

Outstanding methodology:cool:

Excellent method, Lucinda. I did something similar, using the model provided in the Standard, but simply replaced the boxes that represent the clauses with boxes representing the company's Key Business Processes. There are more than 5, but if you arrange it right, it is clear and shows the interaction of the processes.

These can then of course be hyperlinked to the process maps that support them (if the company is set up to do this, as most are).

This approach doesn't show the link to the clauses, but I found that this particular company didn't need or care about this, except at the beginning (to give them assurance that all of the clauses were covered). To show the relationship, we created an overlay that shows where the clauses interact with the processes. After they had that comfort level, they were happy to have the model show their own company's processes and nothing else.

Fun stuff, eh?

Julie

Originally posted by gpainter
Notes are not auditable unless you add it to your system. And this note supports what I had said. Clauses 5,6,7,8 IMOg,

Can you expand on "notes are not auditable". My thoughts were that the notes assist both auditors and companies in determining what is required that doesn't appear in the normal text. As you also said "unless you add it to your system", I've attached another thread where I inquired about using a note from the standard in my Quality Plan. I didn't put it there to be audited. I put it there so that anybody can see that we will not have a full blown 7.2.2 'Review of requirements related to the product" for two of our three Business Units (all under the same roof). I resisted the idea of coming up with three individual Quality Plans. I also believe that I uploaded our Quality Plan for reference in the FTP Files. Please look at this link and let us know what you think.
http://Elsmar.com/Forums/showthread.php?s=&threadid=2645&highlight=7.2.2


:ko: :smokin:

Originally posted by Lucinda
Here's how I handled it. I used the model provided by 9000 that shows all of the clauses of the standard in the circle, with customer requirements going in and satisfaction coming out. You know the one.

Anyway, from this model I hooked little text boxes from each clause. And within the text boxes I named the Processes we have that belonged there. For product realization's box I identified the product realization processes (we only broke them down into three threads- so far). In the center of the circle I put a box with the supporting processes for the QMS as a whole : doc control, control of records, IT security.

This is how I will represent the identification of our processes.Sure would like to see a gif or pdf or something to see what it looks like.

It's not glamorous, but here it is. We'll add more processes as we think of them. We are definitely not moving very quickly. As I mentioned before, you click on the process name (ex.Commercial) and it takes you there. Each process has a cover sheet with links to the process's flowchart, all of the procedures for the process, and to the other processes.

This is just what I call the QMS Process Overview.

Excellent! Thank you!

Is this in a flow charting program or powerpoint?

I appreciate you sharing that Lucinda. It's a great visual representation of what needs to happen.
:agree:

Originally posted by Marc
Is this in a flow charting program or powerpoint?I use Visio.

Here is the Commercial Process chart to further illustrate what I've been trying to describe. Each of the sectioned off areas refers to the procedure that describes this part of the process. I've done this for each of our processes. By clicking on the procedure title you are taken to the procedure. There are also links to the other processes that are referenced.

Everything is still Draft at this point, so everybody feel free to make useful comments, criticisms, and suggestions!

The attached flow diagram is how I represented the identification of our business processes. The references in red are links to actual procedures (i.e. CPP-106 or QMP-115). The shapes with the shadows have links to other detailed flow diagrams. Inside each shape is the ISO 9001:2000 clause number (all clauses with guidance text are represented). When I showed this to most employees the “Uncle Fester light bulb” went off over their heads with a comment of …”so that’s how this stuff all fits together.”

Very Nice, Phish!:bigwave:

I don't like the continuous improvement area being labeled "Quality System Process" though. That implies that it lives outside of the rest of the business processes, when actually it is ingrained with the business processes. I have been extremely unsuccessful in trying to get my boss to understand this. To his mind, Quality is a stand alone "thing". He sees Quality as consisting of internal audits and inspections, not as simply the way that we do conduct our business. When I showed him your flowchart he pointed to the Quality System Process and said that "there it is, separate " like he likes it. Arrggh.:frust:

Lucinda - I only put the quality related "things" in a single spot so everyone of my "Sea Lawyers" could find them. I got to thinking about what you said ... see if this helps.
It's like a car in a race. The drivers area has all of the controls for making the car do what you want it to do. It also is the central point of data collection in the system so that decisions can be made on what to do under various circumstances (i.e. do you apply the brakes or turn the wheel and accelerate when the bonehead in front of you stops). Of course this doesn't mean that the car can function without any of the other components (the engine in the front, the drive train in the back, the brakes, etc.). All the components operating TOGETHER make the car perform its task. The drivers area is a practical convenience factor. Be sure to note in the flow diagram where the CPI triangles are used to note constant data output from the processes (like the sensors on a car) and are collected, analyzed and changes are made by the driver (i.e. the quality system process area). Your boss has to realize that for this example EVERYBODY in the company is acting together to make the car operate effectively like in a race (i.e. the mechanics, the gas guy/girl, the tire guys/girls, the body guys/girls, etc.). The Management Rep as the driver does not win the race alone.
Hope I didn't get carried away.
Also tell your boss that if the quality stuff was truely separate ... it would be on a differrent piece of paper ... not ingrained within the overall process like the chart shows. The Sea Laywers always see what they want to see no matter how hard you try.
But having said all of that ... thanks for the comments. I'll see if there is another method to display the "quality stuff".

MrPhish: Nice! Very nice! Thanks for sharing! Your idea and Lucinda's are VERY good ideas!

Originally posted by Lucinda
It's not glamorous, but here it is. We'll add more processes as we think of them. We are definitely not moving very quickly. As I mentioned before, you click on the process name (ex.Commercial) and it takes you there. Each process has a cover sheet with links to the process's flowchart, all of the procedures for the process, and to the other processes.

This is just what I call the QMS Process Overview.And another Visio :bigwave: fan (I knew I couldn't be by myself) creates an easy to read, conforming and useful document. Fantastic. May your system include more of the same. Thanks for sharing.

Gee, Lucinda sure does have a lot of great forms and diagrams! They are giving me inspiration to refine my documents...

Mickeyman,
It's the air mixture in my tank....gives me aaaalllll kinds of ideas!:)

Plus of course I am a flagrant plagiarizer and make positive use of every piece of inspiration I can find! :vfunny:

This site is the best source of inspiration there is. So many good ideas, so many good cautions and life stories to build on. If you like anything of mine that I post you are absolutely welcome to recycle it.

Thanks! You're a peach...

MrPhish said:

The attached flow diagram is how I represented the identification of our business processes. The references in red are links to actual procedures (i.e. CPP-106 or QMP-115). The shapes with the shadows have links to other detailed flow diagrams. Inside each shape is the ISO 9001:2000 clause number (all clauses with guidance text are represented). When I showed this to most employees the “Uncle Fester light bulb” went off over their heads with a comment of …”so that’s how this stuff all fits together.”
The jpg file MrPhish attached to his post is so good in my opinion that I want to remind people it is in this thread.

Okay, since we're sharing...here's another approach.

Julie

WOW!

Simple is good! nice chart, Julie.

This chart is just meant to show an overview of the Business System. The references below each process (KP001, KP002, etc.) are flow diagrams showing inputs and outputs, responsibilities, etc. for each process. Those flows in turn reference the procedures or work instructions needed to carry out the process.

Julie

Some great examples so far. Here's another one I found that looks pretty good.

In a previous post Lucinda said to MrPhish "I don't like the continuous improvement area being labeled "Quality System Process" though. That implies that it lives outside of the rest of the business processes, when actually it is ingrained with the business processes. "

In looking at the post just now from Mike S. ... it came to me ... the area I have labeled 'Quality System Process" should be the "Management/Control Process" of the entire QMS (i.e. clause 5).

Now, it's not an issue of quality being "displayed" as a separate function, but quality (as Lucinda pointed out) being an integral part of the entire Business Process.

What a brain cramp!

Mike,

I've seen that flow (the MMTC one) elsewhere, I think in the CMTC (California) literature.

I like it because it's comprehensive, but other than the "Main Production Stream", it seems more focused on departments than processes.

One of the things that people ask when they first look at my example is "But where is QA?", and the answer is that Quality Assurance is not a process, but a supporting function.

I find that one of the toughest challenges is to get people to transition their way of thinking from department-centered to process-centered. Seems obvious to me, but tell that to the Engineer who's been conditioned to think that the Sales department is full of idiots who are keeping them from achieving their goals, and vice-versa.

When you start to describe the system in terms of processes, the light starts to come on that they are all part of the same team. Sometimes, anyway.

Julie

juliedrys said:


One of the things that people ask when they first look at my example is "But where is QA?", and the answer is that Quality Assurance is not a process, but a supporting function.


Julie

Fully agree with you. Except one -QA is not a supporting function, it is a Main function of management, which is carried out constantly during all production time.
PDCA ( plus Analysis, Motivation, Communication etc.) are not management processes, they are management functions which interact with production processes.

I think part of the reason it is tough to get people to change thinking "from department-centered to process-centered" is that most companies have been, and remain, broken-up into "departments". Thinking "process" is also more abstract while thinking "departments" is more concrete. Different people have different talents and thought processes and the shift is easier for some types of thinkers than others. Generally speaking, artists and musicians probably adapt to the process approach better than engineers and mathmeticians.

I think on some level everyone believes they are part of one team with a common goal of trying to make customers happy, but many companies, especially smaller ones with many product lines, would have great difficulty actually re-organizing themselves and doing completely away with "departments" to become a totally process-organized outfit. And many don't need to -- many very succesful companies existed before the "formal" focus on "the process approach". For years ISO 9001:1994 was touted as the cat's meow, world class, best quality system -- then when 2000 came out with changes the band moved to a new bandwagon and now it is fashionable for people to bash 1994 -- and many of the bashers were on that bandwagon in the past. Some folks simply follow the crowd.

But we all know the real issue, where the rubber meets the road, regardless of what QMS one has, is what the companies really do when the registrar isn't looking. Gimme a dedicated and honest company with a MIL-I-45208A QMS any day over an unconcerned and sneeky company with a ISO 9001:2000 certificate.

Hey Jim,

I agree that a process map and a procedure have different purposes, audiences, etc., and therefore require different elements.

Questions for discussion:

Should a proess map show just a single input and a single output (or possibly 2 or 3 outputs)? Or are you suggesting that rather than arrows on a traditional flow chart, should there be an input and an output shown at each step?

Also, does this mean that you should not or don't need to show inputs and outputs on a procedure? Don't these micro activities also have inputs and outputs?

Julie

Quote:Jim Wade said:

Of course. I have to set off against my expectations the fact that some registrars are continuing to allow certificates for systems that do not meet good practice standards and, arguably, do not even meet the requirements of the 'standard'. Examples:

For the 1994 version: lack of objectives. Prime 2000 example: admitting linked procedures as adequate process descriptions.

Ho hum.

rgds Jim


This is what I was referring to earlier in the post about "written" objectives. Gotta love that search feature. Can you help ME and anybody else who cares, with this rather harsh statement? I intend to do just that and happen to think there is nothing wrong with it. But, I'm almost always wrong, anyway. What's one more? Is it procedures vs. processes? I envision an overall "Process" Chart, like a Quality Plan. Showing all the major functions of the Company with hyperlinks to ancillary maps or procedures. Why would that be considered to "not even meet the requirements of the 'standard' ? If one wants to see the interaction, just click away. Is it because it's easy to do and we don't want easy? Take it easy on me because I'm fragile!

Seeing all these great presentations still hasn't changed my mind that "linked" procedures are not a satisfactory way of meeting the requirement for showing "interaction" of processes. I moved it here as you requested.:p :ko: :smokin:

Energy

I see nothing wrong with hyperlinking from a process map to relevant procedures. In fact it is an excellent way of transferring from the quality manual to the procedures, if we so choose to construct our QMS in that way.

However merely linking procedures will probably not meet the requirement or intent of describing process sequence and interaction. What you describe sounds more than just linked procedures.

I would also think that any company that constructed its procedures around the 20 clauses of the 1994 standard (which many did - and one in my experience did) would be hard pressed to show linkages between these sets of documents. Also the suggestion is that every clause of the old standard was a process itself. Clearly 'Control of Customer Supplied Product' is not a process, neither is 'Inspection and Test Status', neither is 'Statistical Techniques', neither is 'Product Identification and Traceability', neither is 'Process Control'.

M Greenaway said:

Energy

I see nothing wrong with hyperlinking from a process map to relevant procedures. In fact it is an excellent way of transferring from the quality manual to the procedures, if we so choose to construct our QMS in that way.



I guess I'm really in the dark on this, so I will go back to the beginning of this thread and look at all the presentations/suggestions and see if I can grasp the concept. Then, I'll be back. Thanks. ;) :ko: :smokin:

Jim,

That picture looks like the creature out of the movie "Aliens". If I wasn't confused before, I sure am now.
I will comment on something you said in this thread regarding omitting those "get in the way" ISO clauses that showed up on McPhish's chart. Those are intended, I again assume, to preclude MR. Pinhead Auditor from asking "what's this all about?". A primer, if you will to assure that Mr. Outsider knows why it's there. And, it also shows confidence that McPhish is ready to do battle over that section, if need be. No guessing games. I like it.

Aisle bee bock!!:rolleyes: :ko: :smokin:

What's wrong with the picture? As far as I can see it makes perfect sense.

/Claes

Looks like the mind map of a very confused mind !

Its kind of Plan Do Check Act rolled together with a few select clauses from the standard in no particular shape. I cannot easily identify inputs or outputs (although I see a lot of controls and mechanisms/resources).

Personally dont like it.

All

Here is something I have thrown together, its a little conceptual at the moment so go easy.

Anyway it is an attempt to process map in an IDEF0 style the content of ISO9001:2000. The attached is just the 'design' element of the standard.

My thinking is that this could be a valuable template for those guys who like that sort of thing. Simply replace the ISO9001 generic terms with your own specifics.

Remember it follows the IDEF0 rules of inputs to the left, outputs to the right, controls above, and mechanisms/resources below.

I am thinking of creating a full map, with a hyperlinking type hierachy.

Fire away !!

Jim Wade said:

Thanks, Claes.

Help me out here - WHY does it make sense to you?

----X----


No worries. Well.... Two reasons:

1. I suppose I see it for what it is, and nothing more: A listing of the clauses that come into play when you consider processes. A mindmap used like this is no different from an ordinary list of clauses, except for the important fact that I personally find it a lot easier to see how the items interact.

2. I use mindmaps daily, had already created something similar to your design, and use the same software as you do...;)

/Claes

P.s. Mindmap hint: Use it to create Ishikawa (Fishbone) diagrams. They look a bit different, but the function is exactly the same.

Jim

I have stuck to the generic words of ISO9001:2000, as such a specific item like a 'design specification' does not appear, just the general terms 'purchasing, production, service information' and ' product acceptance criteria' and 'essential characteristics'.

In the real world where perhaps we use this template to model our own systems we may well replace these generic terms with the single 'design specification' term, or even 'product drawings' or 'assembly instructions' etc, etc.

Like this............

Yes Jim

I am thinking that conceptually it could be done - trying to do it might reveal that its impossible, but I intend giving it a go.

Yes Jim

All the main clauses (or sections) of ISO9001:2000, that is:-

Management Responsibility

Resource Management

Product Realisation

Measurement, Analysis and Improvement

I will start with Product Realisation processes, as they fit better in my mind to this mapping style, and I perhaps understand them more. Knitting it all together will be tricky, and this may be my lifetimes work - but I'm sure it will be a classic, much like Steven Hawkings publications :biglaugh:

M.

Beside being uncluttered, it answers Julie's (I think) question about multiple inputs. I had to copy it to Visio to be able to magnify it to read it. That's cuz I be computer illiterate. So you can do other things besides play Rugby.:vfunny: :agree: :smokin:

Claes Gefvenberg said:

What's wrong with the picture? As far as I can see it makes perfect sense.

/Claes

Claes,

Because I'm lazy and do not care to do the research at this time, is this an example of a "Mind Map"? ;) :ko: :smokin:

Multi-talented energy, you should see me on the dance floor !!

Anyway if you double click the image it should load into Visio anyway, cos it was created in Visio.

energy said:

Claes,

Because I'm lazy and do not care to do the research at this time, is this an example of a "Mind Map"? ;) :ko: :smokin:

Hi Energy, :D

Yep, it is.

/Claes

juliedrys said:
I've seen that flow (the MMTC one) elsewhere, I think in the CMTC (California) literature

The diagram came from me, and you are right Julie. It originated with the California MEP. We, too are belong to the MEP network, and we got it from the west coast bunch. I do believe they are the originators.

Now, back to processes and procedures.

Process is an activity. A procedure is the activity "how". It outlines the "steps" of the process. In a good valid process diagram, the inputs and outputs would be listed, as well as the process steps (procedure). Each step could be a sub-process with its own inputs/outputs and procedure.

Methinks we gets all too upset as we try to formalize and articulate what the standard says we are to do. The standard wants us to be intimate with our processes!!! If we KNOW the processes, and have a full understanding of what they are, it really makes no difference how we got there.

In a different thread, we talked about auditing out of theregular auditing box. We need to apply that same thinking to process understanding. How you define, analyze describe the processes is up to the organization. The way I do it might not work for you, and the way you do it might not work for me. As long as yours works for you and mine works for me, then we should not be in contention.

Jim Wade said:

Dear colleagues

The proposed rule is that all interconnecting lines on a process description [or diagram or map] must show the direction of transfer and be annotated in some way to show what is being transferred (the inputs and outputs)...

rgds Jim

Jim,

Don't call me that. That means we are equal. :biglaugh:

Just so you and others know, after viewing this thread and all the inputs, I put the question to our Consultant. He said that the flowcharts I'm using show that we understand the interaction of processes. All we have to do is show inputs and outputs. Well Duh:bonk: He had a look at these months ago and said they were fine. Duh:bonk: Maybe I'm his "Consultant". So, it's back to the Visio Program to add in some "interaction" stuff. At least, I will feel more comfortable presenting them to a Registrar instead of having to do it later. See? Some day, I might even be a "Colleague". I'm also taking a good hard look at Martin's map because it's so clean. I do have some questions, but I'll post them later. Got things to do, people to meet, etc...Thanks, Y'all.
:ko: :smokin:

Jim Wade said:

So it looks like your consultant is on board with 'the rule'.

rgds Jim

Yeah, NOW. Where was he when he blessed similar charts for release? Standing in the station?:vfunny: :ko: :smokin:

He's been paid in full a long time ago. Smart move on his part. WE have really been dragging our feet towards Registration. It has been recently determined that we are not ready for a pre-assessment. I knew it, all along. Now, they know it. It really isn't a one man show. :bonk:

When you get right down to it, the information and idea sharing here in the Cove is much more valuable, for me, than any Consultant's services. Of course, there are consultants here that would do just fine. Too late. :ko: :smokin: