ISO 9001:2000 Clause 4.1e Monitor, Measurement of Processes, etc.

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
4.1e Monitor, Measure... Processes

Comments anyone?
**************************
"Leon Poels" wrote in message news:[email protected]
> Hi,
>
> I'm updating our quality system to the new standard now.
>
> In chapter 4.1e of ISO 9001-2000 it is stated that we have to "monitor,
> measure and analyse" -skip- "the processes needed for the quality management
> system and their application throughout the organization".
>
> My question now is: which processes are meant here? I can hardly imagine any
> processes needed for the QM *system* in our company; I can imagine, though,
> our production processes, but that's not what is stated here.
>
> Does anybody know for quite sure?
>
> Thanks,
>
> Leon

From: "Brian O"
Newsgroups: misc.industry.quality
Subject: Re: ISO 9001-2000 Which processes are these?
Lines: 44
Date: Sat, 13 Jan 2001 21:39:24 GMT

Leon,

I'm glad I'm not the only one who thinks that line is little vague. When I first skimmed through the standard, I thought it was odd.

After looking at 4.1 for a while, I finally saw the Note at the bottom which says that it does include "processes for management activities", which presumably includes internal audits and management reviews, and implies that they were mainly talking about production processes. This raises the question of how one "measures" an internal audit or management review.

But it seems really strange to call a production process a process "needed for the quality management system".

Brian O
 
Elsmar Forum Sponsor
D

David Mullins

#2
My advice would be to not get hung up on anything the standard contains in clauses 4.1 or 4.2.1 as these are all encompassing statements which have detailed requirements spread throughout the standard.

In the case of monitoring, measuring, etc, a good place to start is 8.2, which is curiously titled 'monitoring and measurement'!!!!


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O

Oscar

#3
I took an ISO 9001 transition course in August from a gentleman that sat on the commitee that rewrote the standard (TAG-76 or whatever). He explained that the processes referred to are QMS processes and not production processes. His suggestion was to prepare a flow chart of all processes in your unique QMS and then define criteria, methods, how you will measure and monitor each of the identified processes.

I don't know if this helps but I am interested in what others have to say on this subject.
 
D

David Mullins

#4
A former employer had a massive amalgamation of businesses after I left, with each former company being certified/registered. Certification to 9002 was then also amalgamated by the thrid party auditor. Consequently the system/s were left to decay, with the former employers staff still using the documents written several years ago.

This would appear to be just fine under 9001:2000!

An auditor asks three questions (let's pretend):
1. What do you do?
2. where does it tell you to do it like that?
3. Show me the proof/evidence/records.

An auditee can now respond (provided we are talking about following the "SIX" procedures rule):
1. None of your business.
2. Nowhere.
3. Don't require any.

QUESTION:

So what will you include in 5.6.2 where it requires management review to include process performance and product conformity?

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[This message has been edited by David Mullins (edited 15 January 2001).]
 
D

David Mullins

#5
Let me take the subject of records one step further. We need to have a procedure for doc control, right? (ISO SIMON SAYS)

BUT, 9001:2000 doesn't require us to keep records of document control.

The only records required, and I've verified these against the final standard, are detailed at http://www.iso.ch - Dead Link - was /9000e/2000rev_7e.htm

Implications - a simple example:
5.3 requires that the quality policy is reviewed, but it doesn't require us to keep any records of these reviews. Hmmm.

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G

gutieg

#6
See the introduction of ISO 9004: 2000, point 0.2 Process approach. This paragraph defines and explains the concept and provide a graphical description of the model of a process-based quality management system.
What are those processes ? The sequence of inter-related tasks, responsibilities and actions needed for the organization to run with compliance to the requirements of the customers. The standard provide guidelines and "shalls" that need to be addressed.

G.G.
 
A

Alf Gulford

#7
I'm still pretty vague on the finer points of 9000:2000, particularly in the area of what documentation is required, but I always go back to the FDA philosophy: "If it isn't documented, it wasn't done." I have to believe that any ISO registrar will adopt the same viewpoint when looking for evidence of document control, management reviews or anything else.
 
R

Ron Byrge

#8
If you do anything related to the QMS, from a Registrar's point of view, it'll need to be documented. If it isn't recorded, dated and approved...it didn't happen, and you aren't complying with 4.2.3, a thru g. If you think you are complying, then prove it to me by showing me records. *smile*


------------------
Ron Byrge
Operations Manager
CwC Registrar, Inc.
http://cwcregistrar.com
 
D

David Mullins

#9
Yes - QMS - Records - Yes.

Ron, people may translate your post to mean you are advocating the hard line on documenting everything about everything.

The reality of your post is an endorsement of the 6 procedures approach, is it not?

"If you do anything related to the QMS"

Ah, but what is in the 2000 concept of a QMS? Easy:
Write two procedure, one for auditing and one for corrective action (Control of nonconformity and preventive action are generally covered in this procedure anyway).
Now write a third procedure about how you will control the first two procedures. Now put the 3 procedures in a pot with a policy and some objectives. Stir, simmer for 1 month, then serve to the nearest auditor. Now put it all on the shelf, until you need it next time, and get back to business.

2 minute QMS c/- ISO Simon Says!



------------------
 
R

Ron Byrge

#10
What I mean is that if you change anything in the system, or the documentation that describes the system (procedures, work instructions, flow diagrams...whatever), you need to review and approve the changes, and retain records of those changes. You need to ensure the changes don't compromise the integrity of the system, and the only way to do this is to review the records you've made of the changes.
As for documenting everything about everything, that's not necessarily needed. But, if you discover a problem in a process that has historically been stable, then the records you've made will be indispensible in troubleshooting the process, hence, those records are required by inference in the new revision of the standard.
Does it spell out for you exactly what records are needed?? Yes and no...you need to use your head when determining what is and isn't needed, and not try to cut corners just because the standard doesn't specifically tell you what records are needed...make the system work FOR you and not against you.
 
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