7.6.3.1 Requirements for Capability to Perform Tests Correctly - Review of Records

[morteza]

Hi all
ISO/TS in clause 7.6.3.1 states that:
The laboratory shall specify and implement, as a minimum, technical requirements for
capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN,etc.), and
review of the related records
May someone explain me more (if it’s possible, with some examples of such requirements) about:
Specifying technical requirements for capability to perform these services correctly,
Specifying technical requirements for review of the related records
which records are the intent of the second requirement? only test/calibration results records or other records such as lab temperature records?
Thanks

[Jennifer Kirley]

Good day Morteza,

I can see why the clauses you are asking about seem challenging.

TS 16949 adds a note at the end of this section, suggesting accreditation to ISO/IEC 17025 may be used to help demonstrate the internal lab's conformity to 7.6.3.1. This of course does not intend to send you into pursuit of yet another accreditation (a 17025 synonym for certification) to meet the requirements of TS 16949. However, 17025 can provide a good deal of insight into this subject, and this seems like a good opportunity to refer to it.

I have found a set of ISO/IEC 17025 explanations published by one of the accreditation bodies, A2LA, titled A2LA Explanations for the ISO/IEC 17025 Requirements. I did a search in that site for the key word "review" and found Sections 4.10 and 5.9.2 seem particularly useful, saying the records included in Management Review, including audits of both technical and management processes and an overview of the laboratory's effectiveness espcially

A documented plan (which may be part of the QC procedures above) for monitoring the validity of all tests/calibrations on the lab’s Scope.

The first bullet you listed is less ambiguous. 5.4.6.1 describes "capability" as "uncertainty:"

If the uncertainty of the calibration of that equipment is not known, it is impossible to determine if that equipment is capable of operating within the limits established in the test method.

... and it is true that laboratories must be capable, which means able, to assess the condition (measurement or other result of test) in terms that can be trusted to be accurate, which means, certain. That accuracy must be "believable" by its conformity to industry accepted standards such as ASTM - in this case, possibly ASTM E2655 - 08.

I hope this helps!

[morteza]

In Reply to Parent Post by J The first bullet you listed is less ambiguous. 5.4.6.1 describes "capability" as "uncertainty:" ... and it is true that laboratories must be capable, which means able, to assess the condition (measurement or other result of test) in terms that can be trusted to be accurate, which means, certain. That accuracy must be "believable" by its conformity to industry accepted standards such as ASTM - in this case, possibly [URL="http://www.astm.org/Standards/E2655.htm"

ASTM E2655 - 08[/URL].

Hi Jennifer,
I always find your replies as great guidelines for me in better understanding and deployment of ISO/TS in my organization.
Also your referred links are excellent. If it would be possible I would send you more than 1 "thanks"!
In our organization, we thought that the meaning of capability should be competency. According to our Idea the requirement interpretation would be:
Specifying technical requirements for capability (=competency) to perform these services correctly.

Because we could not imagine how by specifying some requirements for uncertainty (according to your answer) we can do tests correctly.

[Jennifer Kirley]

Hello again morteza,

Thank you - you are very kind.

One of the most useful portions of the linked Explanations page can be found in section 4.5.1:

A2LA will only include on a laboratory’s Scope those tests or calibrations that the laboratory has been assessed as being competent and capable to perform, meaning that it has the appropriate equipment, method(s) and trained personnel.

But A2LA muddles the terms by swapping their places in the explanation portion of their document, implying competency is about appropriate equipment, etc. and that capability is referring to personnel readiness to perform the tests. This only adds to the confusion invited by 4.1.4 and 4.1.5, in which A2LA says about personnel:

The term “essential personnel” is one developed by A2LA to allow us to identify specific individuals who have a unique, technical capability within the laboratory.

What is a person supposed to think??

No one should be surprised when professional organizations' carelessness with the English language results in misinterpretation.

[Jim Wynne]

In Reply to Parent Post by morteza

Hi all
ISO/TS in clause 7.6.3.1 states that:
The laboratory shall specify and implement, as a minimum, technical requirements for
capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN,etc.), and
review of the related records
May someone explain me more (if it’s possible, with some examples of such requirements) about:
Specifying technical requirements for capability to perform these services correctly,
Specifying technical requirements for review of the related records
which records are the intent of the second requirement? only test/calibration results records or other records such as lab temperature records?
Thanks

The general expectation is that you will determine the "technical requirements"--which is the infrastructure needed to perform the testing--mainly the types of devices required and a lab area suitable to use of the devices.

"Traceable to the relevant process standard" means (as an example) that you are capable of performing corrosion testing in accordance with ASTM B117. The relevant process standards are those which are specified by customers or internally identified, and in the latter case may originate in your company--they don't necessarily have to be national or international standards in all cases.

"Review of the related records" is anyone's guess, but generally it means that the requirements for use of standards has been researched and confirmed.

[somashekar]

If it would be possible I would send you more than 1 "thanks"!

Hi morteza.
When you wish to do such for any post, look for the Karma button in that post at top right, click on it and say your few words about that response and click on Add to Karma to send it ...

[Peters]

In Reply to Parent Post by Jim Wynne

"Review of the related records" is anyone's guess, but generally it means that the requirements for use of standards has been researched and confirmed.

I have problem with this requirement. My friend got NC from TS auditor during the certification audit (Lack of review of the related records - 7.6.3.1).
I'm not sure how to help him with corrective actions. What is good solution/implementation for this requirement?
1.List of records created in lab?
2.Authentication of the testing / calibration reports?
3. ...?

[Jim Wynne]

In Reply to Parent Post by Peters

I have problem with this requirement. My friend got NC from TS auditor during the certification audit (Lack of review of the related records - 7.6.3.1).
I'm not sure how to help him with corrective actions. What is good solution/implementation for this requirement?
1.List of records created in lab?
2.Authentication of the testing / calibration reports?
3. ...?

Your friend needs to ask the auditor what he expected to see. Because it's such an ambiguous requirement (I don't know how it's possible find an NC against it) anything anyone advises could be wrong.