As-Found FAILED calibration

[Vader22]

Asking for our Environmental Manager. Does ISO 14001 have a requirement to assess the risk of a failed AS-FOUND calibration result similar to IATF 16949 7.1.5.2.1, The organization shall ensure that calibration/verification activities and records shall include the following details: c) an assessment of risk of the intended use of the product caused by the out-of specification condition?

 

[mattador78]

What is the calibrated instrument measuring and how does it affect your envoromental controls? For example we discharge waste water which has to stay within a certain bandwidth, our meters have to be controled and calibrated with a record stored for our enviromental controls which are then compared and contrasted with the water board and the weekly reports they send us. Our Ph meters therefore have a direct impact on our enviroment system. My paint test meters and gloss meter, thickness gauges etc have no impact on the enviromental audits so they have no reference in the 14001 audits or management system.

 

[Mike S.]

No, but common sense would dictate you do this.

 

[Vader22]

I 100% agree with the common sense, but he received an External ISO 14001 Audit nonconformance for this. I was thinking along the lines that an auditor can't give a finding against common sense, only violating the requirements of the standard. Does ISO 14001 require this?

 

[Jim Wynne]

I 100% agree with the common sense, but he received an External ISO 14001 Audit nonconformance for this. I was thinking along the lines that an auditor can't give a finding against common sense, only violating the requirements of the standard. Does ISO 14001 require this?

You should post the entire text of the auditor's NC statement so we can give you the best advice.

 

[Vader22]

Standard (as applicable) / Requirement (# and description):
9.1.1 Monitoring, measurement, analysis and evaluation : General. The organization shall ensure that calibrated or verified monitoring and measurement equipment is used and maintained, as appropriate. The organization shall retain appropriate documented information as evidence of the monitoring, measurement, analysis and evaluation results.

Nonconformity Description (basis of Root Cause Analysis and Corrective Action):
Measurement equipment is not always effectively controlled.

Objective Evidence Observed (Basis of Correction):
Calibration records indicated as found failures for several pH meters (MU1000 for 6/23/22 & 2/11/22 &4/18/22, MU1001 for 1/30/22 & 2/11/22 & 4/18/22 & 6/22/22) without evidence of investigation/assessment as to impact on environmental systems.

 

[Jim Wynne]

It appears to be a legitimate NC. You calibrate pH meters, and some were found to be out of calibration, and no record was created (or seen by the auditor) of what was done, if anything, to evaluate the impact of the out-of-calibration devices. While 14001 might not be as explicit as 16949, I don't know why this NC would be questioned. As an aside, kudos to the auditor for providing a textbook NC statement.

 

[Mike S.]

Do they operate under any other standard?

 

[Vader22]

Like I said before, I agree with the common sense of assessing the risk, I just don't see the requirement in the standard. If this is indeed a requirement of ISO 14001, then shouldn't it meet the requirements of being explicit? Stated clearly and in detail, leaving no room for confusion or doubt.

 

[Jim Wynne]

Like I said before, I agree with the common sense of assessing the risk, I just don't see the requirement in the standard. If this is indeed a requirement of ISO 14001, then shouldn't it meet the requirements of being explicit? Stated clearly and in detail, leaving no room for confusion or doubt.

The organization shall retain appropriate documented information as evidence of the monitoring, measurement, analysis and evaluation results.
So you don't think that providing a documented trail of actions in this situation is appropriate? Good luck arguing that with the auditor. If you expect that ISO standards will always be unambiguous, you're dreaming.