Laboratory Audit Nonconformance - Maintenance of Standards

Hi all,

during my recent audit, the auditors found out a NC for my lab.

the NC stated that "we did not do intermediate check of its standard or statistic control for maintenance of standards."

our lab did inter-lab comparison program but according to the auditors, it was not sufficient.

Can someone please give me some pointers on how to clear this NC?

many thanks

Is the NC against a requirement of a standard you follow or of your own procedures, or simply something the auditor is trying to impose on you?

Hi there,

It is the auditor trying to impose on us.

neoth said:

Hi all,

during my recent audit, the auditors found out a NC for my lab.

the NC stated that "we did not do intermediate check of its standard or statistic control for maintenance of standards."

our lab did inter-lab comparison program but according to the auditors, it was not sufficient.

Can someone please give me some pointers on how to clear this NC?

many thanks

Click to expand...

Give more info behind this NC - was this an ISO/IEC 17025 audit and what was the clause against which this NC was issued ?

Ajit Basrur said:

Give more info behind this NC - was this an ISO/IEC 17025 audit and what was the clause against which this NC was issued ?

Click to expand...

Hi Sir,

yes this was an ISO 17025 audit and against clause 5.9.

thank you

This is probably due to an ILAC requirement from ILAC P9 which covers proficiency testing. The relevant section is:

4.2 The minimum PT activity according to a laboratory’s or inspection body’s (where relevant) scope is:
• evidence of satisfactory participation prior to gaining accreditation where PT is available and appropriate;
• further and ongoing activity that is appropriate to the scope of accreditation and consistent with the PT participation plan.
Note: Accreditation bodies should support the use of appropriate PT programmes which meet the essential requirements of ISO/IEC 17043 [1], where applicable

The note directs the assessor to have you use an accredited proficiency tester (ISO 17043 accredited) "where applicable". Some interpret that to mean "when available" and the onus is on you to either use an accredited PT provider or show that there is not one available for your test discipline.

I don't think that your inter-lab comparison was adequate in their eyes, you need to find an accredited PT provider.

Hi there,

i already did the ILCP with other labs and acheive satisfactory results.

our reference standard were also send out for yearly calibration.

so i am not really sure what the auditor is looking for here.

below is the exact stament give by the auditor.

"Although a quality control program was mentioned in the Technical Manual , in practice, apart from participating in a few ILCs, the lab did not do intermediate check of its standard or statistic control on for the maintanence of standards"

please help

thanks

More information, good!

The auditor mentioned a reference in your Technical Manual about a quality control program. What do you claim to do in that quality control program?

As for his reference to intermediate checks / statistical control, it is very good practice to have some internal method of checking your standards between calibration events to assure that they are still valid to use as a standard. Depending on what you have for standards that could include comparing one instrument against another of your standards and charting the result to verify that the test result is within defined limits. I would recommend this for high use and high risk items in any lab. Per 17025 section 5.9.1 "The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results". Auditors like to see graphs of this data, with limits shown, so that they can quickly see trends in the measurements.

You haven't mentioned what type of lab you have there - what standards are you using?

Hi Sir,

I am running a temperature calibration lab.

i have thermocouples and pt100 probe as my reference.

thanks.

So from what I can see that your auditor is requesting, they would like to see some kind of crosscheck program in your lab. A simple method is to do a regular crosscheck of your thermocouples against your RTD probe. It can be monthly, quarterly, whatever makes sense based on the risk involved if one goes out of tolerance. You will need to keep a record of these crosschecks, and have a rule decided on what acceptable results are.

A simple test is to do a simple check in an ice bath / ice point reference. This verifies that the thermocouples are operational (and a check on if the RTD might have been compromised) and if their offsets might have drifted.

Keep the process simple, you just need to have a program to checks your standards that works for you.