Measuring instruments not requiring calibration

[qualitymanagerTT]

This shouldn't be the case. The company we out source external calibration to isn't ISO 17025 Certified, but the reference equipment they use most certainly is, and they can prove it. Our auditor has never had an issue with this.

I'd be wary of "our auditor never had an issue" with anything calibration-related.

The vast majority of auditors (and company personnel) I've dealt with don't understand calibration. Some believe in devices which claim to perform "self-calibration" - see note 2 here: JCGM 200:2008 - English - 2. Measurement

 

[mattador78]

We dispose of waste water and are monitored by the UK Enviroment Agency the water board and 14001. We use calibrated and serviced probes to control our effluent system. However for what we call "walking around" testing we just use normal non oustside calibrated ph probes for validation and verification. We internally calibrate these against a series of base solutions which do have calibration certificates. This has provided us with no NC on audits for the last 10 years minimum. As you can see we have a balance between what is and isnt against a known standard.

 

[WEAVER]

Thank you so much guys. I think the next step would be to determine if ISO17025 is still required for our calibration service providers for instruments outside our QMS. This is required for all our outside calibration agencies but since the instruments to be calibrated will not affect our product characteristics, i don't know if it would be worth the trouble finding ISO17025 certified calibration agencies for these specialized instruments. Maybe we can acquire standard solutions so these verification can be done in-house but for the instruments that involve gas concentration. illuminance and sound level I still need to look for other ways of validation.

WEAVER,

What standard are your internal auditors referencing? Or is this requirement mandated by your organizations processes?

Our internal rule for external calibration service provider requires ISO17025 certification.

 

[WEAVER]

Would using instruments to measure wastewater parameters which are not calibrated affect your product? If not, then you can exclude them from the QMS.

However, if there are requirements (legal, corporate, customer, or otherwise) that measurement of wastewater parameters must conform to metrological (or even measurement) traceability requirements, then you need to comply. Requirements do exist outside of the QMS, and there can be severe penalties if you fail to meet those requirements.

This is just a wider perspective of what Bev D said: “what is the best thing to do or the right thing to do?”

I already checked with our environmental requirements and the answer was that the measurements were done by government agencies and all our measurements are for internal control--but the official measurement data will come from the third party/government) agency.

 

[Bev D]

Thank you so much guys. I think the next step would be to determine if ISO17025 is still required for our calibration service providers for instruments outside our QMS. This is required for all our outside calibration agencies but since the instruments to be calibrated will not affect our product characteristics, i don't know if it would be worth the trouble finding ISO17025 certified calibration agencies for these specialized instruments. Maybe we can acquire standard solutions so these verification can be done in-house but for the instruments that involve gas concentration. illuminance and sound level I still need to look for other ways of validation.

Our internal rule for external calibration service provider requires ISO17025 certification.

Simple: change your overly restrictive procedure and calibrate/validate the instruments that matter to reduce the risk. How much money will a nonconforming result cost in legal fees, fines, stop manufacturing orders, etc.? I’ll bet it’s far more than a calibration. This should not be a matter of “our internal requirements have handcuffed our hands to our ankles and there is nothing I can do….”

 

[Ed Panek]

Of more importance to calibration is testing to make sure they work in production as you want to use them. A risk analysis of them in use will help you but actually use them in their end point of use and compare that data. For example, a calibrated thermometer has an accuracy of +/- 0.1'C from the 20'C-30'C ranges. On a test bench, it works perfectly. It seems to work ok, right? Another engineer later puts the exhaust vent for an oven near this thermometer so its ambient temperature is 35'C-45'C and you start having NC output as the thermometer doesn't hold spec at that range.

If you can demonstrate the risk of anything is controlled as is with evidence its hard to push for extra. However basic calibration should be done imo to avoid questions and concerns.

 

[qualitymanagerTT]

I already checked with our environmental requirements and the answer was that the measurements were done by government agencies and all our measurements are for internal control--but the official measurement data will come from the third party/government) agency.

Well, what happens when your internal control measurements say you are within the requirements, but the government measurements say you are outside of the allowed limits?

 

[dwperron]

Well, what happens when your internal control measurements say you are within the requirements, but the government measurements say you are outside of the allowed limits?

No measurement is perfect, there is always uncertainty involved and it must be taken into account.
If you get into a pissing contest with the government, the government wins. Check with them to see how they make their measurements and then get your process to comply and get results within the window of acceptable uncertainty. Then improve your process further to get better results than what the government is looking for.