ISO 17025 - Requirement to Monitor Environment

[greif]

Looking to get our first 17025 audit around December. Right now I have auto temp and RH logging only in one area, the other areas have thermohygrometers.

With the auto log I print a graph of the history once a month for a record.
Do I need more than this to keep the auditor happy?

 

[AndyN]

Looking to get our first 17025 audit around December. Right now I have auto temp and RH logging only in one area, the other areas have thermohygrometers.

With the auto log I print a graph of the history once a month for a record.
Do I need more than this to keep the auditor happy?

Who knows? Predicting auditor "happiness" is like the lottery. However, you should offer that which shows you have control over the environmental conditions. If they are not happy, tell them to pack sand.

 

[greif]

Well! Auditors aside, does this group think my combos of thermohygrometers and one logging location shows I have control of the environment?

What do you other folks do?

(our measurements are all dimensional or photometric).

 

[AndyN]

Well! Auditors aside, does this group think my combos of thermohygrometers and one logging location shows I have control of the environment?

What do you other folks do?

(our measurements are all dimensional or photometric).

How big is the lab? What influences on a stable reading are present (doors, windows etc?) Have you done any monitoring across the lab to determine any gradient etc?

 

[greif]

We do measurements in various parts of the building. Typical office conditions.

We have one instrument in a temp/rh controlled clean room for which we specify the max measuring conditions to be 65-70 F, 35-50% RH.

In the office areas we specify the max conditions as;
66-76 F, 5-70% RH.

Temperature range potential changes are included in our uncertainties.

The overall building is 3 floors around 15000 SF total. Individual rooms are typ. 15 x 25 ft.

We report the temp and rh at time of measurement.

 

[AndyN]

Sounds good to me. I understand that Lab Accreditation auditors can sometimes "whip out" an experience and use that to ask the "what if" question, but who knows?

 

[dwperron]

First, the only areas that will be audited are the ones where 17025 accredited calibration or testing takes place.

In those areas you will need to document (they will ask for the document) the environmental conditions required to be suitable for laboratory activities. That will include temperature and humidity, but can include anything that can influence your results, such as vibration, dust, or electrical supply quality.

The lab shall "monitor, control, and record environmental conditions". You need to be able to produce records that show that the conditions are within the controls you have established (and what happens if they drift out of control), this will be true for all areas where 17025 activities are conducted.

You can probably get away with thermohygrometers and showing that you are recording the data on your records, but be prepared to prove that those areas have been kept in control. That's why most labs have recorders in each area, so they can produce the history.

 

[greif]

We have procedures written that state "Do Not Measure" if outside the state temp. and %RH range. Would that be considered adequate control?

 

[dwperron]

Typically there is also something about who has authority to stop and resume work.

Unless you have alarms set on your monitoring devices they might ask how you know that conditions didn't change after hours, possibly affecting equipment that would need time to stabilize.

 

[ScottBP]

We have temperature/RH dataloggers in most of our lab rooms, and we do accredited calibrations in most of those rooms. My question is:

1. Do the dataloggers (or their probes) necessarily need to be accredited themselves?
2. Is a single point calibration at ambient conditions sufficient, or do we need to calibrate them for linearity at three points?
3. Do we necessarily need to report the datalogger/probe on calibration certificates?

From time to time we have assessors cite us for all three. Our argument against number 1 is that we are only monitoring the lab conditions for compliance to our quality system. Our argument against number 2 is that we have so many probes (49 at last count) spread across several locations that it's logistically difficult taking a unit out of service and shipping it off for calibration, so instead they're calibrated in place against a calibrated master probe. Our argument against number 3 is that the item being calibrated does not have any parameter traceable to the probe in that room that would matter (e.g. a 2% panel volt meter).

So what say ye?