How to meet the requirements of Environmental Conditions in a Laboratory

[TheGoldenBlazer]

We are a test laboratory looking to be ISO 17025 in various mechanical tests (let's just say Rockwell hardness testing and tensile testing for the purposes of the post).

My question is about section 5.3.2, we have a calibrated measurement of temperature and humidity (it is not currently recorded along with the test, but that is an "easy" change to make), the last part of the requirement which states
"tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations" (There's the shall for you shall Nazis )

The lab is temperature and humidity controlled, within reason. The fact of the matter is any minor temperature and humidity change is not going to have any reasonable affect on the testing. Do I need to post some type of sign out in the lab saying, "If the environmental conditions jeopardize the results of the tests, discontinue testing," or can I just put in the quality manual that the tests are performed in a controlled environment and due to the nature of the testing no notable difference would occur if there were a large change in environmental conditions...unless the lab would still be operational at 140 F .

 

[Ajit Basrur]

Re: How to meet the requirements of Environmental conditions in a laboratory ?

Hi,

From Guidance Document -

E-Clause 5.3.2—Parameters that affect the test shall be monitored appropriately. The best way to evaluate the environment is to check the recorders. The laboratory should have records that indicate that they have checked all environmental conditions that may affect their data. Check that all environmental conditions that affect the validity of data are recorded appropriately. The laboratory should have a plan that indicates what actions will be taken when environmental conditions are outside the acceptable range. Some of the conditions that must be monitored are listed in ISO/IEC 17025, but others may be found in test/calibration methods or are known by the technical personnel of the laboratory.

 

[somashekar]

Re: How to meet the requirements of Environmental conditions in a laboratory ?

The lab is temperature and humidity controlled, within reason.

Can you explain this within reason.
Are you able to maintain the temp and humidity within your set limits which are acceptable to your measurement conditions, under any external environmental conditions...
If your controls fail, do you have some alerting system that will enable you to stop tests and attend to getting the work environment back to required conditions.

 

[TheGoldenBlazer]

Re: How to meet the requirements of Environmental conditions in a laboratory ?

By within reason I mean the lab is in a controlled environment to the extent it needs to be. Tensile and hardness properties do not vary enough with temperature and humidity that any flucuation in temperature or humidity would have a meaningful impact on the test with steel. Certainly the uncertainity associated with the test procedure is much higher than any effect temperature and humidity would have.

 

[somashekar]

Re: How to meet the requirements of Environmental conditions in a laboratory ?

By within reason I mean the lab is in a controlled environment to the extent it needs to be.

Agree with you, but can you call it controlled or monitored ?
Perhaps Temperature is in your control. So you can say within what limits your measurements are good. The band can be large to the extent required as you claim.
How about humidity. Does your test instrument supplier recommend any conditions on humidity?
I guess you need to determine from the instrument user manual or guidelines the required environmental conditions for its optimum operation. You could then decide if you must control it or be good with just monitoring. A lot depends on which part of the world you are and what peaks and low in temperature / humidity you face against how much you can control / monitor to your measurement requirements.

"tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations"

About this, your system must be able to address it as said above and be able to demonstrate it, and no signage or statement can replace or show proof you have it addressed within your system.

 

[Hershal]

Based on the tests described, I suspect you are using a UTI (Universal Test Machine) capable of both tension and compression. The calibration of them can be accomplished over a broad environmental range, and they can be used the same way. This is especially true if they are calibrated using load cells under ASTM E 4.

However, you may want to shoot for an environment that is more consistent with an office. You define the environment. For example, you may decide 23 +/-5 C and 30-80%RH. The cal lab then needs to complete calibration within that range, even if their own rules allow a broader range.

Hope this helps.

 

[TheGoldenBlazer]

Thank guys! I think I figured out what I need.

 

[somashekar]

Thank guys! I think I figured out what I need.

That's good and please come back with how you did successfully.

 

[TheGoldenBlazer]

I'm doing a study to see how the temperature and humidity vary over the course of the week, then I will set the extremes of what is measured as the boundaries of what is allowable and add to our procedures that if the temperature/humidity is outside that range the testing should be stopped, also I'm going to check the manuals for the machines today and see if they have any specified temperature/humidity requirements. Sound good?

 

[somashekar]

I'm doing a study to see how the temperature and humidity vary over the course of the week, then I will set the extremes of what is measured as the boundaries of what is allowable and add to our procedures that if the temperature/humidity is outside that range the testing should be stopped, also I'm going to check the manuals for the machines today and see if they have any specified temperature/humidity requirements. Sound good?

The seasonal peaks and average of temperature and humidity must already be available for your location. Study that over the years and see where you are and check what controls you have installed. A week is too small to represent your all season conditions.