ISO 17025:2017 Clause 7.7 Ensuring the validity of results - Threshold

fahimk

Involved In Discussions
#1
Dear Standardization Folks,

I am a bit confused about the documentation requirements for the ISO 17025:2017 Clause 7.7 Ensuring the validity of results.

What are the threshold requirements? Will it suffice if only following three files are furnished: Proficiency Testing Plan, Analysis of Proficiency Testing Results and Quality Assurance Plan?

Or, is it mandatory to demonstrate record of each of the 10 stated activities, i.e. a.) use of reference materials .... to k.) testing of blind sample(s)?

Thanks and looking forward.....
 
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dwperron

Trusted Information Resource
#2
Dear Standardization Folks,

I am a bit confused about the documentation requirements for the ISO 17025:2017 Clause 7.7 Ensuring the validity of results.

What are the threshold requirements? Will it suffice if only following three files are furnished: Proficiency Testing Plan, Analysis of Proficiency Testing Results and Quality Assurance Plan?

Or, is it mandatory to demonstrate record of each of the 10 stated activities, i.e. a.) use of reference materials .... to k.) testing of blind sample(s)?

Thanks and looking forward.....

The Clause 7.7.1 is an internal verification by the lab that it is checking their calibration / test results against at least one of the suggested methods.

Threshold requirements is you have to determine when your results are valid and when they are questionable. The Threshold requirements are the pass/fail boundaries that you set for these checks. You will need to be able to explain and defend your choice of limits.

7.7.2 is a different matter. That covers comparisons between your lab and other labs. This is the Proficiency testing requirement, one of the things that a lab shall (must) perform in addition to the "ensuring validity of results" efforts.
 

Benjamin Weber

Trusted Information Resource
#3
Dear Standardization Folks,

I am a bit confused about the documentation requirements for the ISO 17025:2017 Clause 7.7 Ensuring the validity of results.

What are the threshold requirements? Will it suffice if only following three files are furnished: Proficiency Testing Plan, Analysis of Proficiency Testing Results and Quality Assurance Plan?

Or, is it mandatory to demonstrate record of each of the 10 stated activities, i.e. a.) use of reference materials .... to k.) testing of blind sample(s)?

Thanks and looking forward.....
In my understanding and experience you are not required to have records for all the listed activities. The standard says "This monitoring shall be planned and reviewed and shall include, where appropriate, but not be limited to (...)". Not all activities are applicable for all types of testing or calibration laboratories.

You should evaluate which of the activities are applicable and practicable for your lab. If there are no reference materials available for your tests or calibrations, you can skip this. Maybe your accreditation body can help you, if you are unsure about applicability of single items if the list?
 

Gus

Involved In Discussions
#4
seem like you got answered right already, for both the question you didn't know you had and the one you asked, hehe

only thing i can add is that in my case being part of a "test" lab instead of a calibration lab, i am lucky to have the threshold requirements stated in the actual test method standard all i have to add there is the uncertainty and decision rule, IDK if any standardized calibration methods actually have threshold requirements but demonstrating that should be quite easy if they do, this is something i got audited on last time and i had no issues

still, i failed to find the word "threshold" in the 17025:2017 standard... am i missing something?

in regards to your other question, for 7.7.1 you can do as many as you find appropriate for your methods and you can even do more than what is listed in the standard if you find that it supports the validity of your results.
 

Tallinec

Starting to get Involved
#5
Or, is it mandatory to demonstrate record of each of the 10 stated activities, i.e. a.) use of reference materials .... to k.) testing of blind sample(s)?
You should give in writting reason/reasons why your lab does not use each of 10 options given in the standard. And give in writting reason/reasons why your lab in using, for example, exactly option j)intralaboratory comparisons. Your lab can explain, for example, that option k.) is not suitable because participation in testing of blind sample(s) is very expensive for you lab. And option a.) may be not suitable for a lab because suppliers give too long terms of delivery of reference materials. Some suppliers can not make sure, that delivered reference materials will be accompanied with certificates in English or other language which you lab prefer.
 

dwperron

Trusted Information Resource
#6
You should give in writting reason/reasons why your lab does not use each of 10 options given in the standard. And give in writting reason/reasons why your lab in using, for example, exactly option j)intralaboratory comparisons. Your lab can explain, for example, that option k.) is not suitable because participation in testing of blind sample(s) is very expensive for you lab. And option a.) may be not suitable for a lab because suppliers give too long terms of delivery of reference materials. Some suppliers can not make sure, that delivered reference materials will be accompanied with certificates in English or other language which you lab prefer.

You are making a lot of unnecessary work here.
17025 7.7.1 does not require that you use all 11 methods. The intent is "Here are 11 methods recommended to monitor the validity of your results, use the ones that are appropriate to your case, and use something else if these do not work for you."
What they want to see here is that you present evidence of the method(s) you use to monitor the validity of your results, in a way that is appropriate for your organization.
 

Tallinec

Starting to get Involved
#7
You are making a lot of unnecessary work here.
17025 7.7.1 does not require that you use all 11 methods. The intent is "Here are 11 methods recommended to monitor the validity of your results, use the ones that are appropriate to your case, and use something else if these do not work for you."
What they want to see here is that you present evidence of the method(s) you use to monitor the validity of your results, in a way that is appropriate for your organization.
Let we play a "game": you are a representative of an auduted lab, I am an auditor. My request is "Please, give me an evidence, that your lab reviewed all 11 options given in the standard".
 

dwperron

Trusted Information Resource
#8
Let we play a "game": you are a representative of an auduted lab, I am an auditor. My request is "Please, give me an evidence, that your lab reviewed all 11 options given in the standard".
An auditor would not ask that question.
They would ask what method(s) you used to monitor the validity of your results.
You would show them your method(s) and the data you derived.
If you chose a method that was not on the list they would ask you for the reasons for your choice.

It is obvious that nobody would use all 11 methods in their laboratory for every discipline they perform, so no auditor would expect that.
 

Tallinec

Starting to get Involved
#9
An auditor would not ask that question.

It is obvious that nobody would use all 11 methods in their laboratory for every discipline they perform, so no auditor would expect that.
It depends how people understand «where appropriate». It seems, that you understand it as “at lab’s choice”. I understand it as «where lab is capable to use».

My lab is involved in “metals testing” and we are potentially (!) capable to use 10 options from 11 for each method. Regarding one option (e.) of 11
I can not tell “yes” or “no” because I have no understanding what is precisely meant under “intermediate checks on measuring equipment”. And I have no understanding how results of these “intermediate checks” can be used for monitoring the validity of testing results.

Let me guess, that each 17025 accredited lab is capable to use at least 80% of all options. I think, that matter is in „lack of understanding“ of some options (my case), lazyness or lack of time of quality managers, inanity of lab’s managers and lack of financial resources.
 

dwperron

Trusted Information Resource
#10
Since you have a question regarding the interpretation of 17025 I suggest that you reach out to your accreditation board and ask them for their interpretation. That way you know what the assessor will be looking for.
 
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