Validation of Method(s) in Testing Laboratories

E

ebrachhausen

#1
Could use the good wisdom of those cove people with practical experience in testing laboratories. Lots of questions, please feel free to reply to any.
1. Explain the difference between ILC and PT for a stand-alone testing lab that does analyses where there is not always general agreement on a standard method (marijuana testing). Must the lab use both to meet 5.4.5.2, or can it do comparisons internally among different sets of equipment or lab personnel?

2. If the lab outsources all of their equipment calibration to a 17025-accredited lab or to the equipment OEM, do they meet the 17025 requirement for calibration?

3. What is the expectation if a lab does ring comparisons, and finds they are an outlier? Must they have a procedure to diagnose their deviation from the crowd?
 
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blueicecube2

Involved In Discussions
#2
Hi There,

In my opinion :

2. If the lab outsources all of their equipment calibration to a 17025-accredited lab or to the equipment OEM, do they meet the 17025 requirement for calibration?

- the equipment must be sent to an accredited lab to ensure traceability requirement is met. OEMs dont always have accredited labs. 17025 emphasizes on traceability. Unless you can't find a lab that can perform an accredited cal. If so, you need to proof the chain of traceability is unbroken to the accreditation body.

Hope this helps
 
E

ebrachhausen

#3
Hi, thanks for the reply, and appreciate your comment about the OEMs. That makes complete sense.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
Could use the good wisdom of those cove people with practical experience in testing laboratories. Lots of questions, please feel free to reply to any.
1. Explain the difference between ILC and PT for a stand-alone testing lab that does analyses where there is not always general agreement on a standard method (marijuana testing). Must the lab use both to meet 5.4.5.2, or can it do comparisons internally among different sets of equipment or lab personnel?

2. If the lab outsources all of their equipment calibration to a 17025-accredited lab or to the equipment OEM, do they meet the 17025 requirement for calibration?

3. What is the expectation if a lab does ring comparisons, and finds they are an outlier? Must they have a procedure to diagnose their deviation from the crowd?
Realize my answers are based on ISO/IEC 17025.

Method validation under Clause 5.4 does not give specific guidelines for a validation plan. That being said, if the method is non-standard it needs to be validated. That generally requires a plan. The plan typically requires what is to be tested, how, what the expected results are, and management approval of the plan. That needs to be followed up with a report tying the results to the expectation, and management by-off, plus a statement that it is adequate for the intended purpose. That can be done by email.

For calibration, short answer is yes.

For PT/ILC, There may be formal PTs available for specific chemical analysis or for food applications. I would look there first. While your produce does not strictly fit that, the applicability will be more general. If you have an outlier, then you need to initiate a corrective action, so it is documented.

It seems you either are accredited or about to seek accreditation. If accredited, good, keep your AB in the loop. If about to seek and if you are in US, there are six ABs that you can and should talk to before deciding on one. If outside the US, go to www.ilac.org and see which AB is in or closest to your country.

Hope this helps.
 
E

ebrachhausen

#5
Thanks for taking the time to reply. Appreciate your insights. In the context of this MJ testing lab, what is the difference between a "laboratory-developed method" and a "non-standard method"? This lab has developed its own methods, but they are based on sound science and commercially available test equipment with its own embedded sensors and software. Does the term "standard" method imply it has been adopted by some recognized authority, or is there some other meaning in this context? Thanks for any help you can give.
 
T

t.PoN

#6
Thanks for taking the time to reply. Appreciate your insights. In the context of this MJ testing lab, what is the difference between a "laboratory-developed method" and a "non-standard method"? This lab has developed its own methods, but they are based on sound science and commercially available test equipment with its own embedded sensors and software. Does the term "standard" method imply it has been adopted by some recognized authority, or is there some other meaning in this context? Thanks for any help you can give.
the lab developed method is one type of the non standard method.
Non standard methods include methods adopted from journal publication, or method taken from another laboratories. these methods include validation. but usually validated using one lab. the astm and iso standard usually validate their methods by including 50 labs.

if the test method is published and accepted, then its a standard method. which mean you don't need to perform any validation.

if the test method require validation before use, for example - changing the scope of iso test method. or changing the test items in astm- then its a non standard method.
 
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E

ebrachhausen

#7
Thanks again for the help. One phrase caught my eye. When we say the test method is "published and accepted," it raises the questions of published by whom, and accepted by whom? Who would we be looking to as the ultimate authority to say a certain method is legitimate?

By the way, if anyone can help, it would be really educational to see documented examples of PT, ILC, and Estimation of Uncertainty applied in the case of a real lab. Would anyone have non-competitive data or real-life examples to share?

Thanks again all.
 
T

t.PoN

#8
An easy answer will be Regional and National standard organisation such as ASTM, BS, DIN....etc.

but sometimes you'll find others like the WHO "World Health", the AOAC, Military, and IEEE....etc

i guess "Reputable" organisation is the answer which is up to debate.
but you'll have to agree with customer on test method so its kinda a solution.
its not an easy answer, even journal publication can be standard method if they have inter-lab comparison and all other validation elements.

but if you want to be in safe side, the provider of test method is considered as a supplier and you have to check their competency, and you can use Journal Ranking and Expert survey to judge if they are good enough to be called standard

Examples:
For iLC, i don't have one sorry :(
PT example:
http://fapas.com/pdfpub/reportEXAMPLE.pdf

check program:
http://afpc.net/AFPC Rock Check Program Results.htm

Uncertainty M3003 and Example is attached.

is there a certain test you are interested in?
 

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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#9
Thanks again for the help. One phrase caught my eye. When we say the test method is "published and accepted," it raises the questions of published by whom, and accepted by whom? Who would we be looking to as the ultimate authority to say a certain method is legitimate?

By the way, if anyone can help, it would be really educational to see documented examples of PT, ILC, and Estimation of Uncertainty applied in the case of a real lab. Would anyone have non-competitive data or real-life examples to share?

Thanks again all.
I can mention examples of published an accepted, but realize not all such methods are Government or similar.

For example, A standard published by ASTM, UL, CSA, or similar are published and accepted. Industry can also develop an publish a standard, such as grading rules for lumber. You may also have a harmonized standard such as ISO/IEC/EN/UL/CSA/ASNZS 60950-1.

In the US (can't speak for other countries on this one), the applicable CFR (Code of Federal Regulations) also counts as an accepted and published standard, besides being US Law. An example is COGSA (Carriage of goods At Sea Act) under 46 USC.

If the lab-developed method is taking a published and accepted method and simply amplifying it for lab use as a procedure, such as "turn this knob" for example, then it may well be considered validated, though of course must reference right back to the method. If based on the available methods, but is truly lab-developed, then it does require validation.

Hope this helps.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#10
For uncertainty, if you have not yet gotten formal training, then get training. You can likely get a distance learning option from either Workplace Training or Quametec. There may be other in-person venues near you also. For example, if in the western half of the US, there is usually uncertainty training at Measurement Science conference in SoCal. www.msc-conf.com

The thing I usually tell labs is put down everything that may affect a measurement, even what seems silly like whether you had coffee that morning (it actually does affect some people).

Separate the influences into ones like coffee that you likely will never worry about, the ones that can be easily quantified like equipment calibration uncertainty and environmental influences, and the ones that will take work.

Then you have to work on the Type A influences, which are the test results. The type B are things like calibration uncertainty, environment, and other systemic type influences.

The final calculation is a root-sum-square (RSS).

Training should walk you through the steps to build an uncertainty budget.

Hope this helps.
 
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