How do you address this requirement in your Quality Manual??

"4.1 General requirements
The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),"

Quality/Control Plan can be use to address the clause stated.


:bigwave:

Since you are asking how to do that in the quality manual, I would expand that on how to show the interaction of the processes, as required by 4.2.2.

One of the easiest ways to do this is to show a flow of your business, identifying your core processes in the flow. Along side (or below) that you could identify the support processes.

Perform a search of process mapping, and you will get a bunch of ideas. Although process mapping is not required, it is an easy, valid and useful way of achieving the requires for both 4.1 a) and 4.2.2 c).

Quality/Control Plan can be use to address the clause stated.

Depending on what your plan is made of it might not meet the requirements. I don't think I've seen a quality plan, or control plan that includes all of the processes (such as sales, engineering or purchasing). I don't think they would include QMS processes such as Management Review and Internal Auditing.

How do you address this requirement in your Quality Manual??

"4.1 General requirements
The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),"



Willy,

A Process Matrix and System (process) Map.

Simple, and very clear to all stake holders.

Stijloor.

Can you pint me to any specific examples?
Thanks

Can you point me to any specific examples?
Thanks

Willy,

I sent you a PM.

Stijloor.

Don't spin your wheels too much worrying over this or anything else in 4.1....It is all easily accomplished by doing everything from 4.2-8.5.3. If you look, every element in 4.1 is further defined as you go through performing all the other requirments. So you don't "do" 4.1 as a seperate clause because it (4.1) can only be met when everything else is done.

How do you address this requirement in your Quality Manual??

"4.1 General requirements
The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),"



Infact I was also confused over the same clause and was about to post it when I see it already on the list. But my question is a bit different from that of W.Grunfeld.

What does it mean by 'their application throughout the organization"

Does it imply that each of the QMS processes like customer satisfaction or CA/PA or purchasing etc. is necessarily applicable to EACH of the departments in that organization ? or it simply indicates 'where applicable' throughout the org. since there are sections in the organization where most of the QMS processes don't apply. e.g. every dept. is not involved in purchasing or dealing with customers and the like. So how to get going on with its interpretation?

Samsung, use Randy's advice - it applies to your question equally.

Does it imply that each of the QMS processes like customer satisfaction or CA/PA or purchasing etc. is necessarily applicable to EACH of the departments in that organization ? ?
No. (Trying to have every department doing everything? Nope. Nightmare.)
or it simply indicates 'where applicable' throughout the org. since there are sections in the organization where most of the QMS processes don't apply. e.g. every dept. is not involved in purchasing or dealing with customers and the like. So how to get going on with its interpretation?

If you must have an interpretation, use this one (which I've underlined).

Don't make it overly complicated!

That's what 'where applicable' means - simply means as and where it applies in your particular organisation.

Depending on what your plan is made of it might not meet the requirements. I don't think I've seen a quality plan, or control plan that includes all of the processes (such as sales, engineering or purchasing). I don't think they would include QMS processes such as Management Review and Internal Auditing.


There are cases like ours, from the raw materials, sales, product development, production, Quality Assurance, and delivery. We just don't get into too much details on the Quality Processes, all the details and intelinks can be found in the respective manuals.:)

Samsung, use Randy's advice - it applies to your question equally.


No. (Trying to have every department doing everything? Nope. Nightmare.)


If you must have an interpretation, use this one (which I've underlined).

Don't make it overly complicated!

That's what 'where applicable' means - simply means as and where it applies in your particular organisation.

Thanks Jane for your reasonable reply which does convince me and infact, it has to be like that - applying wherever the process fits reasonably well to add value to the whole system.

Thanks & regards,

I reference the ISO standard in our Policy manual and also have a link to a "master" flow which goes thorugh the process from beginging to end...a one page overview. the policy manual covers how to identify what procedures /instructions are in the sytem. (for instance... mine are in a "procedures" or a "work instruction" catagory. I have seen others ID them by a certain numbering process).

Randy,
That's exactly the way I thought and did for the last 20 years!
At my old age, here comes an auditor and writes me up on the Quality Manual I wrote for a client saying that I didn't identify all processes and the interrelationship between them, as required by 4.1! In spite that the manual has at least half a page on each and every 4.2-8.5.3 clause and 8 are linked to stand alone documented procedures (this for a company with 12 employees and a single product)
For this reason I posted my questions, thinking perhaps I missed something all these years...

Randy,
That's exactly the way I thought and did for the last 20 years!
At my old age, here comes an auditor and writes me up on the Quality Manual I wrote for a client saying that I didn't identify all processes and the interrelationship between them, as required by 4.1! In spite that the manual has at least half a page on each and every 4.2-8.5.3 clause and 8 are linked to stand alone documented procedures (this for a company with 12 employees and a single product)
For this reason I posted my questions, thinking perhaps I missed something all these years...
I think you are dead on. They should of insisted on challenging / appealing the write up. I became so sick of one auditor saying one thing...me changing things...another telling me something different... finally I did what i should of done in the beginning and just did what was right for my company and not to please the auditor. I do challenge them quite a bit but dont have a problem admitting when they "got me". I see how difficult that could be as a consultant. At least it is written up so when the next guy comes and says that it is incorrect they can show the corrective actions already passed. Crazy.

Randy,
That's exactly the way I thought and did for the last 20 years!
At my old age, here comes an auditor and writes me up on the Quality Manual I wrote for a client saying that I didn't identify all processes and the interrelationship between them, as required by 4.1! In spite that the manual has at least half a page on each and every 4.2-8.5.3 clause and 8 are linked to stand alone documented procedures (this for a company with 12 employees and a single product)
For this reason I posted my questions, thinking perhaps I missed something all these years...
Out of curiosity, how did you explain interactions?

I think you are dead on. They should of insisted on challenging / appealing the write up. I became so sick of one auditor saying one thing...me changing things...another telling me something different... finally I did what i should of done in the beginning and just did what was right for my company and not to please the auditor. I do challenge them quite a bit but dont have a problem admitting when they "got me". I see how difficult that could be as a consultant. At least it is written up so when the next guy comes and says that it is incorrect they can show the corrective actions already passed. Crazy.


Yeah, I can't explain that without getting into competence and slamming others in the business. The requirement is as plain as the nose on your face....identify the processes needed for the quality management system... QMS processes, not organization, business, finance or all the other stuff!

You might have been hammered on that one. Did the auditor issue a Major or Serious level NC? If he/she didn't then they are wrong because anything against 4.1 will be serious and systemic.

Out of curiosity, how did you explain interactions?
I made a table with all processes in the first column, the owner in the next and 'participating functions" in the third. In addition, in each procedure I have a table of responsibilities and authorities listing who does what for the process in question

Out of curiosity, how did you explain interactions?


I made a table with all processes in the first column, the owner in the next and 'participating functions" in the third. In addition, in each procedure I have a table of responsibilities and authorities listing who does what for the process in question


Of course, it's very easy to get confused without seeing a sample of such table, but... your description suggests that the table describes how functions participate in processes, not how processes interact with each other... :confused:

Is there any chance you could post a sample here? Please?

How do you address this requirement in your Quality Manual??


"4.1 General requirements
The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),"



In the Quality Manual? By establishing and documenting quality management system.

But to address the requirements, the established and documented QMS should be implemented and maintained and continually improve its effectiveness.

Yarik,
I have no problem posting a sample but I am afraid it's quite superfluous since there's nothing more nor less than those 3 columns.
Right "the table describes how functions participate in processes, not how processes interact with each other"
I admit I have no fancy graphics showing arrows between shapes representing functions..I just have a documented procedure for each process defining the inputs, the outputs, what needs to be done , how and by whom and what needs to recorded in what forms....
As I mentioned, this was good enough until I came across this particular CB auditor...

I have no problem posting a sample but I am afraid it's quite superfluous since there's nothing more nor less than those 3 columns.


"Superfluous" does not necessarily mean "useless", does it? ;)


Right "the table describes how functions participate in processes, not how processes interact with each other"
I admit I have no fancy graphics showing arrows between shapes representing functions..I just have a documented procedure for each process defining the inputs, the outputs, what needs to be done , how and by whom and what needs to recorded in what forms....
As I mentioned, this was good enough until I came across this particular CB auditor...


I'm very new to this area, and here is one of my main problems: I'm still having a hard time trying to find good samples of descriptions of interactions between processes (as opposed to just sequences). Textual or pictorial - does not matter. The vast majority of samples I've seen so far show only sequences...

If your processes interact strictly in sequential manner, then (I think) it should not be a big deal for you to illustrate that graphically and probably satisfy your current CB. But if your processes actually are more complex than links of some conveyor (which I believe is the case in the company I work for)... well, if you happen to be in the same boat I woud be very interested to take a look at your table, even in its current form.

If there are any reasons why you can't post it, please just ignore my request. I'm just trying to explain why I am so curious about it. :)