What to audit against clause 6.4 of ISO 9001:2000

E

energy

#11
Re: just MHO

Originally posted by CarolX
OK---I feel the need to jump in on this...
So why can't we stick to the issue at hand. The requirements are for an enviroment to assure product conformity.
CarolX
CarolX,

Oh, how I agree with the rest of your post. But, the issue at hand is the interpetation of 6.4 of ISO 9001:2000. Once more..If an Auditor observes an employee wearing a respirator while he is painting product, I think (I don't know yet, but our consultant days it does) the Auditor can ask to see the Written Respirator Procedure and ask to see evidence that the painter has had his medical clearance to wear one. That includes the selection of the proper cartridges, etc.. I don't like it. Just look at the guidelines and you will see "Safety Rules and Guidance". I do not see any way around it. Of course, it's to be tailored to your specific industry. If heat is not an issue, so be it. For in-house calibration, under the old standard, heat and vibration was an issue. Nice to see you again!:eek: :ko: :smokin:
 
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gpainter

Quite Involved in Discussions
#12
The 94 standard was basically related to housekeeping. 2000 standard goes farther by saying "needed to achieve product requirements". Some areas to look at:
temperature- is anything temperature senitive
humidity- moisture levels
light- does it have an effect
pests- if in product
contamination- if in product
A few of our customers call out that their product must be produced at this temperature and humidity. I lot of this area will hit heavy in storage depending on your business.
 
M

M Greenaway

#13
I'm with carol on this one, the clause is specifically to do with product conformity, not other health and safety issues.

Energy, isnt ISO9004:2000 guidelines for performance improvement, or excellence or something like that. i.e. things you can do to go beyond the requirements of ISO9001:2000.

As such the requirements of ISO9004 cannot be audited against, and cannot prevent you from getting ISO9001:2000 approval.

Which brings me back to what is this clause all about (i.e. ignoring ISO9004 ramblings) ?
 
A

Alf Gulford

#14
Outside auditors can go pretty far afield sometimes. I had one from a registrar go off into health and safety issues, saying that one requirement of ISO 9001(1994) was that a company adhere to all applicable laws. That's the way he led into areas that aren't even alluded to in 9001.

He's gone now (although he actually did us some good) and I've always wondered how far he would have taken that. Would we have gotten a minor non-conformance if a company vehicle registration was overdue?

Alf
 
M

M Greenaway

#15
I think the important word in the last post is APPLICABLE.

i.e. applicable to quality would be laws on prduct liability, sale of goods, etc (or your national equivalents). Not rasing NC's if you are parked on double yellow lines.
 

SteelMaiden

Super Moderator
Super Moderator
#16
According to our registrar, they will be considering all the things that energy talked about....BUT they are not really interested in auditing the safety system as such, just know that it exists. If it appears that our work areas are arranged and sized appropriately for the work being done, personnel appear to be using the proper PPE and working in a safe manner, general housekeeping and upkeep are appropriate, they are not looking for a reason to write us up on safety violations.

I think that all of us would agree that it is easier to do a good job in a non-violent, non-confrontational workplace. If I walked into a facility where employees were allowed to carry their 12 ga. and threaten people with it, I think I'd be questioning management's commitment.:biglaugh: :bonk:

If you have a reasonably clean (as appropriate) well maintained facility, without obvious safety violations going on all over and the workers seem to be working together, I can't imagine that you'd see much in the line of nonconformance.
 

CarolX

Super Moderator
Super Moderator
#17
way toooooo scary!!!

Energy,

Once more..If an Auditor observes an employee wearing a respirator while he is painting product, I think (I don't know yet, but our consultant days it does) the Auditor can ask to see the Written Respirator Procedure and ask to see evidence that the painter has had his medical clearance to wear one. That includes the selection of the proper cartridges, etc.. I don't like it.
I don't like it either!

I've been around, just waaaaaaayyyyyyy tooooo busy to post much....but thanks for noticing!

CarolX
 
M

M Greenaway

#18
If that is really the intent of the clause then i cant see what it is doing in this standard.

Also its amazing how ISO9001:2000 can sum up the whole world of occupational health and safety in one meaningless sentence.
 
J

JodiB

#19
I agree

I agree with just about everything here, with respect to the inclusions for the clause. I do take exception to the degree of intrusion of health and safety issues as described by energy (sorry!).

If you look at the cross reference of 1994 with 2000, you will find that this is not the old "preservation of product", but rather "process control". And yes, if you need a special air filter to cleanse the air because what you are making is sensitive to such things, etc. then that is managing the environment. Temp control, etc. as mentioned by gpainter are all equally applicable.

But it goes beyond the creature comforts for the product itself, and extends to the creature comfort aspects of the employees who produce the product.

I don't know about you, but I certainly could not maintain my concentration or accuracy for very long if I was required to work in sub-zero or supra-100 extremes for long periods. The product would suffer, whether I was in design, or in assembly. Not to mention slippery hands, or (heaven forbid) sweat dripping onto the silk fabric while I tried to sew it.

We have policies in place to manage the environment that our offshore employees work in, down to the number of hours they are allowed to work without break. This is because the potential for error increases when you exceed boundaries.

What if the culture in my office made someone keep problems to themselves because they were afraid to report it? The "I'm not getting involved" syndrome". Can you tell me that the quality of the product will not suffer?

So don't limit yourself to just the physical aspects required by the product for production integrity. Take it further.

You aren't required to do anything other than consider the factors and then manage what you determine are "needed". If you have a 14001 in place then this would be similar to identifying your aspects then putting them through a significance test.
 
#20
Out of Scope

Quote:
___________________
Originally posted by Alf
“I had one from a registrar go off into health and safety issues, saying that one requirement of ISO 9001(1994) was that a company adhere to all applicable laws.”
__________________
ISO 9001:1994 4.9 c) states: “compliance with reference standards/codes,…”

This is where your auditor got this. It could be (and often was/is) easily expanded to include all kinds of safety stuff.


Quote:
___________________
Originally posted by energy
“…the Auditor can ask to see the Written Respirator Procedure and ask to see evidence that the painter has had his medical clearance to wear one…”
_________________

Anytime an auditor ask questions such as this, I recommend responding asking the auditor to show you where the “shall” is. In case, it would require the auditor to pull out the standard that says a quality management system requires painters in this situation had to have medical clearance. Just saying “OSHA requires it” is not good enough. The auditor would not allow you to say something without evidence, they can’t either!

Another sneaky option is to include in you quality manual a definitions page where you define what is meant by “work environment”. Registrars routinely rubberstamp the QM without fully reading it. If the QM has been accepted by the registrar with the definition, then there is nothing the auditor can say, or do. You can eliminate a lot of problems by limiting the definitions of a lot of things.
 
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