I am not a QA engineer and do not deal with the Calibration Standards and their requirements with any great frequency or understanding. It seems that there is a great deal of very good information on Calibration Standards shared by this forum and I look forward the forums thought on my concerns.

I support a legacy Navy nuclear program (20+ years of production) that specifically requires all level of calibration/test/measurement (Calibration, Maintenance, Procedures, Records, Analysis, Non-Conformance Reporting, Calibration Sources, Adequacy of Standards, Intervals, Labeling, Recall, Handling/Storage, Environmental Controls, etc.) to the requirements of ANSI/NCSL Z540.

I am in turn required to flow these requirements down to all levels of sub-tier supplier/support for this program.

I'm trying to understand what the realistic expected impact is to my program and sub-tier support as a result of ANSI Z540 not being renewed.

Personally at our facility we conduct a great deal of our own calibration as well as the test/measurement that goes with the production of our deliverables. We have a well developed set of requirements that currently support Z540 and I expect will continue to state that we are in compliance to Z540.

I'm more concerned about what the dropping of Z540 will mean for the smaller sub-tiers in our supply chain. In many cases these suppliers do no internal calibration.

Does the dropping of Z540 mean that there will be a movement by calibration suppliers to eliminate their compliance to Z540 from their calibration certifications?

If so, do "we" believe that this movement will be fairly fast moving (is there a great benefit for no longer maintaining compliance to Z540) for the calibration suppliers?

For my program's benefit, if I need to be concerned about the elimination of Z540 as an industry standard, I need to begin our "push-back" to the Navy as soon and as forceful as possible to expect and concession.

Appreciate any insight this forum might bring to my questions.

Actually, ANSI/NCSL Z540-1-1994 has been retired and supersceded by ANSI/NCSL Z540.3-2006, which is more aligned with ANS/ISO/IEC 17025.

So there is no need to remove Z540 from your requirements, simply require the newest version, which is the Z540.3 and you have the same requirements in place with the most up-to-date standards listed.

Hope this helps. feel free to keep putting up questions on this, as the new revision likely is getting others nervous also.

Hershal -

Thanks VERY much for the reply.

My "Problem" is that the Navy will be very reluctant to change a requirement that they have so deeply imbedded in their flowdown and fo so long.

So realistically will we be able to continue to work with a Z540.1 requirement - will the independent calibration houses continue to provide our sub-tiers certs indicating that they comply to Z540.1?

They should be able to and likely will.....I still see certs claiming compliance to the long dead and buried MIL-STD-45662A.....

Hershal -

Your forum tag identifies yourself as an auditor.

If an "unknowing" person such as myself were going to try and do a quick/easy assessment of a calibration system and it's compliance to the ANSI Z540-1 requirements, can you identify a couple of specific elements to evaluate that might be particular to Z540.1 and what the objective evidence for compliance to the Z540.1 system would be?

Are there any specifics to Z540.1 that a practicing system might tend to overlook or ommit?

May this will help some which is a comparsion between z540-1 and 17025
from Nist.

RandyM,

The link to the document below is a good document, but is a bit dated.....

Still, to give an example of what to look for, the general requirements between ANS/ISO/IEC 17025:2005 (the 1999 version is retired and no longer used for assessment) and both the Z540-1 and Z540.3 center on a few differences. The technical key is the 4:1 ration. In the Z540-1 that is considered a TAR (Test Accuracy Ratio), and in the Z540.3 it is a TUR (Test Uncertainty Ratio). There are differences, but either way, that is the basic key.

The evidence hinges on the uncertainties for the lab. Even the accuracy ratio requires some knowledge of uncertainties, but the TUR rests completely on uncertainty. For that, take the delivered uncertainty (what the lab's customer gets) and compare it to the uncertainty of the lab's standards (remember it is a collective uncertainty, that is, all the standards are added).....if the lab's standard are less than 25% of the delivered uncertainty then you have a 4:1 (or better) ratio.....but there is also a trap, if their standards reference 4:1, then you must have 25% of the RATED ACCURACY of that instrument for the reading as the default uncertainty.

There are also some record keeping kinds of things are different from 17025 and between the two versions of Z540.

If full compliance is required, then can be some pretty significant differences between theZ540-1 and Z540.3, primarily because the Z540.3 is aligned with 17025, and Z540-1 is not.

Hope this helps.

Randy:

As you mentioned that this is a legacy nuclear program, bear in mind that you may still be required to meet ANSI Z540, irregardless of what its been replaced by.

Mark

Thanks Marshal -

And your right Mark, I do have to comply with the Z540-1 no matter what happens in the "rest of the world" as long as that is my directed flowdown.

That's the real issue I'm trying to get a handle on. If I "require" that everyone doing business with us in support of this program comply to the Z540-1, how long will it be before I begin to expect compliance issues - either knowingly or unknowingly?

How long will it be before calibration houses begin to remove the Z540-1 from their certs (knowingly) and how long will it be before a suppliers cal system evolves away from meeting all the Z540-1 requirements or the supplier begins getting certs from outside labs that don't have the Z540-1 compliance stated and the supplier does not identify it as being in violation of our program's flowdown (unknowingly.)

Randy,

If it is a contract requirement then you should not have any issue. Organizations who accept a contract containing this requirement must comply even if the specification has been superseded. Z540-1 can still be purchased from document suppliers.

The problem I frequently run into with these old legacy programs and even older flowdown requirements (our drawings still require compliance to "MIL-I- " NDT Specs in many cases) is that as the requirement becomes less of an "industry standard" it eventually is "lost" and frequently the supplier/sub-tier does not even realize that he no longer can show compliance.

Randy

Organizations understand that many MIL-I specifications have been cancled. The replacement method or standard is stated on the notice of cancellation for that Military Specifications/Standards. If your “old legacy program” has this type of requirements, it is up to the suppler to notify you of what they intend to supply and what test methods will be used by them.

Once your organization and supply agree on what is acceptable you will find little problems in the “old legacy programs”.

On the contrary, our flowdown requirements indicate that the supplier can not use the identified superseding specifications. Changes can only be made by revising the drawing requirements.

Randy,

Remember that your supplier has the right to offer you what he can supply or will supply if you agree to it. If you will not agree to the use of superseding requirements or methods then your supplier has one of two options:

1. Accept order and test to the as stated requirements; or
2. No bid.

Your organization at some point may have to supply the very specifications you list on the PO or drawing to your supplier once document supply houses no longer carry them. You may even be forced to revise the drawing requirements or issue wavers.

Randy:

You're stuck with the requirements you've got. I would imagine that most calibration labs will continue on with Z540 for the time being, but make sure this is clearly called out in your PO (I know - this is a requirement already), and be prepared to provide them with a copy of the standard if they don't already have one.

I'm all too familiar with MIL-I specifications for NDT, so I understand your pain.

I've been involved in upgrading a few Z540 programs to 17025; while I've never tried this in reverse, I can't think of where 17025 wouldn't be in compliance with Z540....?? I don't think this will be too bad if you work through (collaboratively) with your suppliers.

Mark

Thanks to all for your collective insight - I'll plan on "crossing my fingers" and press on until one of my suppliers indictes they can't/won't comply to the Z540.1 flowdown then go off and do battle with the Navy.

Randy:

I've been involved in upgrading a few Z540 programs to 17025; while I've never tried this in reverse, I can't think of where 17025 wouldn't be in compliance with Z540....?? I don't think this will be too bad if you work through (collaboratively) with your suppliers.

Mark

In reality, there are several clauses in the Z540.1 that were not covered in ISO 17025. The accrediting bodies recognized this, and actually had specific checklists made up to augment the differences between Z540.1 and 17025.

One specific area I am talking about is in the uncertainty vs. tolerance. Z540 required in section 10.2 (b) that "The laboratory shall ensure that calibration uncertainties are sufficiently small so that the adequacy of the measurement is not affected. Well defined and documented measurement assurance techniques or uncertainty analysis may be used to verify the adequacy of a measurement process. If such techniques or analyses are not used, then the collective uncertainty of the measurement standards shall not exceed 25% of the acceptable tolerance...."

This was the basis for what many on this board mistakenly were referring to as the 4:1 TAR rule, (when in actuality, it is the 4:1 TUR rule.) This is actually a major item that is not in 17025, but not the only one.

ISO 17025 accreditation does not equal compliance to ANSI Z540.1. First, I would recommend that you find a copy of the old standard. Secondly, if you do a search on Z540 checklist, you will find several documents in the forum that adequately list the requirements.

I would also urge you to use caution when accepting self declaration as a basis for approval of a calibration laboratory. Self declaration is not a method to prove competency. The only methods to prove competency are third party accreditation, or an audit using experts in the area of calibration you are auditing. In 18 years, I have seen many labs that state compliance to Z540.1 even though it is a document that they do not even have, and/or have no true understanding of.