Is Temperature & Humidity monitoring in a Metrology / Test Laboratory required?

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O

Old Quality Gal

#12
Dirk:
My post was in response to 'Old Quality Gal's' post. I was drawing attention to the issue that (apparently) ISO 9001 doesn't require monitoring or control of environmental conditions like temp/humidity, and was attempting to identify that there is a requirement (and not in the 7.6 requirements) to consider such items, including the conditions in a lab - since that's where product conformity work is often performed.;) Actually, it would extend to even more conditions if it affected product requiements (vibration, etc.)

(I also don't agree that ISO (simply)requires us to follow processes and written requirements......but that's another matter):rolleyes:

I should have added section 4.1 (c), since temp/humidity are (in many cases) required to be controlled and by specifying these values, that would be applicable..........

Hope that clears things up for you.......:yes:
Andy
My statement stands that it is not required. Environment can be considered and dismissed if one chooses to so and I agree it includes lighting, vibration and housekeeping (one I think is very important and overlooked).
I want to clarify what I meant by saying you need to follow your own procedures and process. I mean if you have said this is how you intend on doing it in a documented process based on the minimum requirements of the standard and your people are trained and doing what your process describes repeatably that should satisfy most auditors. It isn't the registrars job to push you into a particular path of compliance and best practice or even to pass judgement of your choice of methods. The auditor should be looking at indicators such as customer complaints, audit results and findings, nonconformance reports, lapses in record keeping or continuity of process execution etc as part of determining whether your process is adequate enough to meet the minimum requirements of the standard. Observations may abound and they might keep picking away at it each visit but they can' t dismiss your process out of hand.
Now is it prudent to just do the minimum? I think you need to always strive for continual improvement and be prepared to show how you are trying to get there.
Remember the old Tom Peters example of a mediocre companies slogan. I think it was "International Widget! We are no worse than anyone else!"
I just have an issue with auditors bullying companies into accepting their interpretation of a standard. I see it happen too much for my taste.
Regards,
Mary
 
#13
My statement stands that it is not required. Environment can be considered and dismissed if one chooses to so and I agree it includes lighting, vibration and housekeeping (one I think is very important and overlooked).
I want to clarify what I meant by saying you need to follow your own procedures and process. I mean if you have said this is how you intend on doing it in a documented process based on the minimum requirements of the standard and your people are trained and doing what your process describes repeatably that should satisfy most auditors.
Mary:
Thanks for the explanation. I wanted to add some caution, that it's not simply a matter of 'doing what's written'. As has been posted here and other places, the fact is that there's a lot of malicious compliance going on, and just because "ISO-didn't-say-so", people do not put in place effective systems.
I noted you agreed in your original post to the control of temp/humidity etc., due to being 'best practice'. I'd go so far as to say that it's necessary and that to truely have control over a lab and its results, the environmental effects must be estimated (ala the auto industry MSA studies).

But there are those who stand by the 'it's not a requirement', rather than taking time out to open minds to why these things exist, instead of looking to ISO 9000 all the time for minimal requirements. That's malicious compliance in my book........

Andy
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#14
REASON FOR THE MOVE:

I realize this might be a little controversial, and I recognize that the orgnization that owns the lab is ISO 9001 registered.....

However, the lab is clearly and openly characterized as a laboratory in use (although likely internally) for calibration and/or testing, hence, responses that are more in line with laboratory considerations may be offered in the Laboratory board.

Hershal
 
#15
Recording said parameters can be a good idea for at least one more reason (unless I missed it in the previous posts): More often than not manufacturers require temp and humidity parameters within quite narrow tolerances if they are to guarantee proper operation of the quipment they supply.

/Claes
 
O

Old Quality Gal

#16
Mary:
I noted you agreed in your original post to the control of temp/humidity etc., due to being 'best practice'. I'd go so far as to say that it's necessary and that to truely have control over a lab and its results, the environmental effects must be estimated (ala the auto industry MSA studies).

But there are those who stand by the 'it's not a requirement', rather than taking time out to open minds to why these things exist, instead of looking to ISO 9000 all the time for minimal requirements. That's malicious compliance in my book........

Andy
Andy,
Well said and I totally agree with you. Really taking the time to make a correct decision about the best way to store, maintain, calibrate and use each tool is critical to having any sort of accurate product test and assessment program.
I see some people do a great job at creating what one of my clients calls a "profile for care and proper use" of each tool and fixture. I see others that are just clueless and worse have no desire to understand the impact of bad tool selection and maintenance.
I wish I could say it was just the little guys but I have seen large organizations that just skate by these requirements.
Letting a tool stabilize for a period of time when moving it to a metrology lab and recording temperature and humidity are all good practice.
I think of compliance as a sliding scale. If 0 was noncompliance and 10 was aggressive continual improvement many folks start at a 2 or 3 and I keep trying to nudge them to the higher end of the scale over time.I have found if we try to get them to start at an 8 they are just overwhelmed by the changes they need to make. They key seems to me to be keeping them thinking and analyzing and moving once you overcome the initial inertia.
I tend to think of what you describe as post compliance complacency and it can totally dilute the long term value that begins with simple initial compliance.
Regards,
Mary
 
D

drikwah

#17
Thanks to everyone for your replies. I have always understood that you should at least monitor your environment where measurements are taking place. Someone told me that such things as ANSI Z-540-1, Mil-S-45662A, the same I know, ISO-10012-1 replaced by ISO 10012-2003 or something, and 17025 are just guidelines and not requirements. ISO 10012-1 for example states that your TUR should be 3:1. ANSI Z540-1 states the TUR should be 4:1. It depends what you are doing and for whom but unless you monitor the environmental conditions, perform uncertainty analysis, correlation studies etc. How can you know what your TUR is? Some companies use type B uncertainty budgets but you must still ensure that the equipment is operating in an environment that is specified by the equipment manufacturer to meet the equipment specifications so I would think you would need to monitor the environment and record the data. ANSI Z540-1 also states something to the effect that the TUR must be a minimum of 4:1 unless you are using statistical methods of analysis. I'm sure that doesn't excuse the minimum of 4:1. What if your statistical analysis shows an uncertainty of 1:1. There are other exceptions as well and you are not required to be 3:1 or 4:1 but you are required to know your estimated measurement uncertainty I think. Thus you must monitor the environment.
 

Wesley Richardson

Wes R
Trusted Information Resource
#18
From ISO/IEC 17025-1999:

5.3.2 The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned. Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations.

The testing or calibration laboratory needs to first determine if temperature or humidity can affect the results of the tests and/or calibrations. If the answer is yes, then "The laboratory shall monitor, control and record environmental conditions..."

Note that the same applies for any other environmental condition that could affect the test or calibrations.

Wes R.
 

CalRich

Involved In Discussions
#20
From ISO/IEC 17025-1999:

5.3.2 The laboratory shall monitor,...
While the text was unchanged, I'm surprised that the old revision of ISO 17025 was cited.

Since no one else mentioned this, I will. Typically, when controlling temperature for dimensional calibration, the norm is 20°C (68°F) (per ANSI B89.6.2 Temperature and Humidity Environment for Dimensional Measurement). In several standards that describe dimensional calibration methods, this same temperature is reiterated as a requirement for accuracy. No tolerance is ever stated... you just have to control as close as possible.
 
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