Relative Humidity + ISO 9001:2000 Audit of Maintenance Department

[Ajit Basrur]

I agreed with everything you agreed with until you threw in "operator comfort".
I don't believe that is a requirement under ISO 9001:2000. It may be nice to have, but that is not a focus of 6.4; product quality is the criteria.

Sorry, I disagree with you.

What will happen if the operator is working in discomfort .............:mg:

.............. the product quality might get affected

The requirements for temp and Relative Humidity are very clearly specified in ISO 14644 for the cleanrooms.

 

[AndyN]

Sorry, I disagree with you.

What will happen if the operator is working in discomfort .............:mg:

.............. the product quality might get affected

The requirements for temp and Relative Humidity are very clearly specified in ISO 14644 for the cleanrooms.

Did the auditor verify this first (or at any time during the audit)??

What has ISO 14644 got to do with ISO 9001:2000? You are introducing criteria which were not stated in the OP, please be careful.....

 

[Ajit Basrur]

Did the auditor verify this first (or at any time during the audit)??

What has ISO 14644 got to do with ISO 9001:2000? You are introducing criteria which were not stated in the OP, please be careful.....

Sorry Andy. I was just trying to stress the importance of "Operator Protection" so as not to contaminate the product.

 

[AndyN]

Qualityalways:
No apology necessary!

I wanted to ensure that anyone reading this post and trying to avoid similar issues isn't confused over the requirements for controlling infrastructure from ISO 9001:2000, the auditor's approach to this situation and what's required in this particular industry (paper/printing). This will help to minimize the hearsay and 'legends' that have sprung up around implementation...............
Thanks - for the ref. to ISO 14644, though.............

 

[Ajit Basrur]

Hi AndyN

 

[harry]

I wanted to ensure that anyone reading this post and trying to avoid similar issues isn't confused over the requirements for controlling infrastructure from ISO 9001:2000, the auditor's approach to this situation and what's required in this particular industry (paper/printing)......

Me too, Andy!

If we take a good look at the original post, the OP made an observation:

LAter on auditor asked him about building maintenance and he explained what he does. Then auditor asked why he is maintain Relative humidity at one place 50 and one place 75?

and ask a question:

My question is, auditor can ask such type of fundamental engineering questions or not?

Based on these two sentences, I thought we had too little information to make a judgement about the audit or the auditor. Of course, I re-read your reply in post #2 where you qualified by saying: I'm guessing ...................
My apologies - I miss out this part while reading.

The message that I am trying to convey is that we must not guess/conjecture where we aren't sure. Instead we should ask the OP for more info or state our assumptions. Isn't this a good practice for conducting audits also?

By the way, you mentioned in post #17 that:

The auditor should have determined, first, what the effect on product quality the humidity has

For the benefit of non auditors like myself, could you elaborate this further? Also, can't the auditor start the audit from the middle of the trail (upon noticing the difference in humidity maintained at different places) and then moved forward or backward?

Thanks in advance.

 

[AndyN]

Also, can't the auditor start the audit from the middle of the trail (upon noticing the difference in humidity maintained at different places) and then moved forward or backward?

Harry:
If any auditor is to be effective in performing their assignment, there has to be a basic understanding/comprehension of the process and the required controls. I believe that there may be some confusion between an audit strategy (as you've described) which might mean starting at either end of the process - and audit tactics; finding some details which might (in the auditor's mind be a 'clue') then asking questions around that.

A process based audit requires that the auditor study the process, inputs, outputs, controls etc (and more) then follows the 'natural path' of the process, verifying that the controls etc are in place and effective (from the results, measurements etc.) This is an effective audit strategy.

Starting an audit 'in the middle', identifying something and then asking 'why', such as described in the OP is a very poor audit tactic, IMHO.

 

[harry]

Got your point Andy. In other words, you advocate a more 'structured' approach similar to that used in TS. Am I right?

 

[AndyN]

I believe that's what the IATF were attempting to correct with 3rd party auditors, when performing audit to the TS requirements, Harry.
Of course it should be done this way or very similarly by all external auditors, regardless of the audit criteria.......

 

[armaan]

Harry:
A process based audit requires that the auditor study the process, inputs, outputs, controls etc (and more) then follows the 'natural path' of the process, verifying that the controls etc are in place and effective (from the results, measurements etc.) This is an effective audit strategy.
.

In this case auditor starts their audit from end activities like shipping receiving and maintenance and finally check Quality manual........Are they really doing process audit

Input ----->Output

Thanks,