I recently sent our temp/humidity monitor out for calibration and it just came back as the humidity out of tolerance. We are QS-9000 certified, I now have to issue and Material Review Request Action, I'm not sure as to what exactly to say on this MRR, any suggestions on how to word this review? Our Lab that does the calibration is evironmentally controlled and has never had the environment out of tolerance could I use that as an answer? :thanks: :thanks:

How can you say the environment has never been out of tolerance if the monitoring device was out of calibration? If the gage was only out by, say, 2%, and you were always 3% or more away from the limits you'd be okay, but can you say that?

How much does humidity affect your operation?

Well it was a lot out of tolerance, 10% humidity out. I say the lab has never been out because we calibrate the temp/humidity monitor yearly and in 5 years that I"ve been the Lab tech I've never had to adjust the temperature or humidity in the lab. Our plant is here in kansas where the humidity does get extreme in the summer and non-existant in the winter. So environmental controls are very important in our lab testing.

I guess to give some more background on this situation, we are a manufacturing plant of nearly 300 people, we make for GM, Honda, various automotive makers. The lab does calibration, and testing. So I guess I'm more or less asking that since the humidity monitor was found several %'s out of tolerance, but our lab is always kept at the same temp/ humidity and isnt' adjusted on any basis how can i answer that our testing and calibration's are good?

Pancho,

A few questions......

Was this one of the round chart types devices or a digital?
Did you specify the RH to be calibrated at multiple points or rely on the cal lab?

The round chart types tend to be more consistent than the digitals, with the possible exception of dataloggers. That does not assure that they won't go out.

Typically, cal labs run RH at one point. The exception - generally - is if the client requests multiple points. That costs more, but depending on the situation may be worthwhile. Also, if using the digitals or dataloggers, have the RH charted, not just pass/fail, so you can make any corrections in CALCULATION, not in the unit itself.

Hope that helps.

Hershal

The bottom line is whether the OOT on your T/H Recorder caused you to erroneously exceed environmental calibrating limits for units calibrated. OR... The other bottom line (regarding dimensional calibrations) is whether the OOT could have caused a deviation in your standard and/or unit being calibrated.

You need to look at the OOT data on the T/H Recorder and compare with the above limits and correction factors.

I interpret that the temperature was IN-TOLERANCE. That potentially makes things less complicated.

If the Humidity was OOT on the T/H Recorder, take the OOT readings, compared with what the recorder displayed, and calculate as needed to determine what the environment actually was at (%RH). Use that corrected value to determine if your lab was in or out of environmental limits. If you were within limits after calculating in the OOT, my opinion is you don't have an issue.

If after applying the OOT offset your environment was outside its limits, review calibrations performed during the time(s) it was outside limits. Verify whether or not any instruments calibrated during those excursions (or the measurement standards used to calibrate them) were operating outside their allowable environmental conditions; or whether they must have correction factors applied.

If indeed you find any above conditions to have occured, re-calibrate those instruments. If you have significant changes in AS-RECEIVED readings compared with AS LEFT readings on them when cal'd during errant environmental conditions, send the owning dept notice of the deviations. The owning department then needs to compare measurements and determine if any customer product could have conceivably been impacted. That part is the Material Review.

Whether any end material needs to be reviewed is a factor of the above details (determining if the OOT on the T/H Recorder caused any errant readings on any calibrations; then using departments determing if the errant readings on the test instruments were enough to cause product impact).

Well the problem that I'm seeing here is that first of all we are not A2LA, our lab is only compliant to 17025, 10012-1, ANSI. We have all of our standards needed calibrated out of house with a lab who is compliant. Our customers have never asked for temp or humidity readings yet at all, much less asked for various points in humidity, we are not that type of lab, I just calibrate gages used for production against standards. However we do have in our lab set up and temp and humidity optimum levels. Basically our temp/ rh monitor was digital that I simply looked up when I calibrated the gages and saw that the reading were within our own spec limits.

The issue isn't necessarily ISO Guide 17025. QS-9000 requires you to evaluate the potentials for having produced out of specification product when a calibrated gauge is found to be out of calibration.

The outline provided by Jerry on what to do is IMHO excellent. It is also a major undertaking to do correctly, but it is required by your QS registration.

When I ran a mechanical testing lab for a steel mill, I made certain that calibration intervals were short enough that we could go back to verify test results without major problems, so we could accomplish the activity, quarantine any material necessary and hopefully not have to contact customers. I had to do some checks to verify results after out of calibration incidents, but didn't have to contact customers or quarantine material.

Pancho,

Jerry offered some good ideas. It is a lot of work, but just going forward without checking may well be much more work.

Just for a bit of info.....if your lab is compliant to ISO/IEC Standard 17025, then you may well be able to approach A2LA (they are one of several accrediting bodies), NVLAP, IAS, or L-A-B about accreditation under the Standard.

Hope this helps.

Hershal