Is it a requirement to monitor environmental conditions in a metrology lab or quality control test environment where dimensional measurements are performed? (seems like a dumb question to me but would like your responses).

well, it depends on what's going on in there.......

Typically, lab conditions are monitored because those conditions are the 'standard' at which the results are 'true'. For comparison purposes, with say your customer, those standard conditions will help to ensure any detected variation isn't due to thermal effects (for example).

So, if you want to assure your results, then yes, you need to have control over the environmental conditions in the lab. Of course there are many other reasons for controlling these parameters, and I'm certain our fellow Covers will oblige........:agree1:

Andy

Some depends on the standard(s) involved. If you are discussing ISO 9001 then the answer is fuzzy.....in that if it affects quality then yes.....and dimensional equipment is in fact affected by temp, RH, and sometimes other concerns.....your measurement uncertainty from your (hopefully) accredited calibration provider (for your standards), and your own follow-up uncertainty studies will tell you how much effect the influences have.

If you are running the metrology/test lab as a lab, (1) you should use ANS/ISO/IEC 17025, whether you seek accreditation or not; and (2) that standard REQUIRES monitoring and control of applicable environmental conditions (and the standard lists several examples).

Hope this helps.

Hershal

If the question is does ISO 9001:2000 require you to monitor temp and humidity then the answer is no. It requires that you follow your process and written requirements and all applicable regulatory requirements.
Is it best practice? Yes it is in my opinion.
I think metrology requirements and good practice are one of the most misunderstood and important areas of quality control.
I always try to get folks to think in terms of the magnitude of measurement and criticality of the result when deciding what is adequate. Of course in many situations other compliance standards make this less of an objective choice and move it into a more controlled approach.
Most unnerving to me are companies that because they outsource calibration and metrology services they are convinced have no responsibility for the process the vendor uses and have no need for any internal supplemental and verification process. The example that comes to mind is dropped or damaged tools, transfer standards etc.
I look forward to seeing other folks opinions.
Regards,
Mary

I believe that the temperature needs to be controlled. The humidity control is so that tools don't rust. This is what I have been told over the years and it seems to work for this lab. We record both temperature and humidity.

Have a great day.

If the question is does ISO 9001:2000 require you to monitor temp and humidity then the answer is no. It requires that you follow your process and written requirements and all applicable regulatory requirements.


Err............6.4 Work Environment.........."the organization shall determine the work environment needed to achieve conformity to product requirements.....":notme:

The monitoring would be based on the specific application parameter that you are following.
On calibration for example if you only calibrat to an accuracy of +/- .1 inch with a 6 inch max length impact of temperature would not be noticable (thermal expansion being the driver)
If you are traing to calibrate precision instruments then you would not only need to monitor but in some cases control it as the correction factors used may not work to cover the devitation from the accepted standard starting point.
For lab testing if you are performing moisture determination and the materials are hydroscopic then this could be an impact to the readings you obtain.

Look at the potential influance the temp and humidity can cause and incorporate accordingly.

Andy N.

Are you implying that the requirements listed in 6.4 require all organizations to monitor and/or mesaure temperature and humidity?

You quoted clause 6.4 but I do not understand the intened application.

Thank you,

Dirk

Most of the standards that I have seen state something like “ Assurances shall be made so that the environmental conditions do not unduly influence the calibration being made”; or something to that effect.

So for evidence that the calibration was not significantly affected by temperature/ humidity, generally these parameters are monitored and recorded.

If the calibrations that you are performing can be significantly influenced by environmental factors, you would do good to control those factors, and be able to provide evidence of the control.

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

Hello Andy:

Awesome posting. Thank you for the info. I agree with your comments.

Regards,

Dirk

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

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

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

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

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

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.

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.

Thanks Wes,

Doesn't get much clearer than that.

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.

While the text was unchanged, I'm surprised that the old revision of ISO 17025 was cited.

Hi CalRich,

Sorry for using the 1999 version. I have not worked for a testing and calibration laboratory for 6 years, so I no longer have the current revisions of the documents.

Wes R.

Ding!

Wes, you should be written up for not having the latest version of ISO/IEC 17025...........How could you, man??:lmao:

Andy

Hi CalRich,

Sorry for using the 1999 version. I have not worked for a testing and calibration laboratory for 6 years, so I no longer have the current revisions of the documents.

Wes R.

Wes,
No worries. You seemed like such a well-informed up-to-date kinda guy.;) But I promise you, the 2005 revision is amazing.

Is it a requirement to monitor environmental conditions in a metrology lab or quality control test environment where dimensional measurements are performed? (seems like a dumb question to me but would like your responses).

Yes it is a requirement to monitor environmental conditions in Metrology Lab, and to relative Standards when testing product reliabilty Go to http://www.a2la.org/ for ISO17025 info.

I actually have another question: Any automotive experts on TS16949 out there.

I understand that Toyota has set up there warehouse for ESD, temp and humidity control. Is this a requirement for automotive to set up the warehouse with a ESD bench when packaging component reels.

Do you really need an ESD set-up when labelin your component reels. You don't actually touch components as they are protected in the reel right!

So is it just another " GOOD Practice" or are you really eliminating the possiblity of ESD damage through the reel?

appreciate your thoughts! I do think humidity and temp control is a should be around components based on storage temp requirements called out on specs.

CG

I suspect that this practice ( static bench) is for when the reels are removed from the static bags to verify components ( cover lost labels on bag and such) or remove some off components the reel in the storage area to cover repair work.
The reel itself does not ensure protection from static but is the holder of the components.

I would refer to ANSI/ESD S20.20-1999 for further info on ESD and do a Goggle search on ESD pratices. The web is full of info.

qm

thanks I will do a search. but if any one knows why Toyota US would have a ESD set-up for labeling reels in there warehouse I would appreciate it.

I'm trying to find out if it is a automotive requirement for suppliers?

thanks
Cindy, in California

I actually have another question: Any automotive experts on TS16949 out there.

I understand that Toyota has set up there warehouse for ESD, temp and humidity control. Is this a requirement for automotive to set up the warehouse with a ESD bench when packaging component reels.

Do you really need an ESD set-up when labelin your component reels. You don't actually touch components as they are protected in the reel right!

So is it just another " GOOD Practice" or are you really eliminating the possiblity of ESD damage through the reel?

appreciate your thoughts! I do think humidity and temp control is a should be around components based on storage temp requirements called out on specs.

CG
ESD requirements are not specific to automotive requirements - Toyota may be doing lot sampling on components, they may be checking the ESDA packaging material, etc. T/H may be monitored when opening moisture sensitive packaged components, and baking them before sealing and restock. Also other material may be subject to degradation or corrosion, i.e., batteries, contacts. It all depends upon what material they are processing. Good Practices are supposed to be efficient - if they are not required it's not efficient.