A Test Lab Using ISO 17025 - Question About Nonconforming Work

D

D_Wood

#1
Hello everyone,
It's been quite awhile since I posted here. I am curious as to how many out there may be using ISO 17025 in a Testing Lab and NOT a calibration lab? I operate a product safety test lab within our manufacturing company. I maintain a QMS applicable to our test lab only. The company does not have a formal QMS.

I have a question with regards to Control of Nonconforming Work (Clause 4.9). I am interested in your interpretations as to how this is different than your CAPA process (Corrective Action and Preventive Action).

The way I interpret the standard is that I utilize one process to identify noncorming activities / actions and if they are meet a certain criteria, I then have to apply my process for corrective action (CAPA) (ref. clause 4.9.2).

1) My concerns are as follow. If a "suspected" nonformity has been identified, at a minimum, I am required to perform an assessment - correct? Docuemnted, correct?

2) If during my assessment, it is determined that an action has occurred that is noncompliant with our internal policy or procedure, must I automatically move to the next step and issue a Corrective Action?

3) Can I have a nonconformity and not be required to issue a Corrective Action? For example: a technician forgets to follow a step in a procedure that he was trained on. His action was identifed as non-compliant. However, is it acceptable to offer a verbal "reminder" and let it go at that?

Thank you.
-Woody-
 
Elsmar Forum Sponsor
#2
Re: A Test Lab Using ISO 17025 - Question About Noncorming Work

Woody:

In a testing environment, non-conforming work can be any situation that wasn't planned to happen during testing. It is better aligned to the 'non-conforming product' requirement of ISO 9001, as an example. All testing situations that don't conform do need to be documented and 'dispositioned.

For example, if a test stops due to a product failure, you would record the circumstances and then get instruction as to what should be done next - fix and continue the test, replace and retest etc. etc. It may not lead, in each circumstance, to a Corrective Action. At the end of the testing phase, the Lessons Learned from the testing may become part of a revised set of test criteria, design guidelines, input to FMEA etc
 
D

D_Wood

#3
Re: A Test Lab Using ISO 17025 - Question About Noncorming Work

Hi Andy,

Thank you for the reply. I agree with what you said for the most part.

I have been told by an agency that has certified our test lab and accepts our test data that the failing of a test is not necessarily a "nonconformity". For example, if a test is performed in accordance with written instructions and the sample fails to meet the pass critera, this is perfectly normal and not a nonconformity. However, if the wrong test equipment was used during the test, or its calibration expired for example, this would not be in accordance with procedures and would be a nonconformity.


Presently, I have a form that is required to be completed when a nonconformity has been identified. This form captures the description of the observation, the evidence observed, and the results of the preliminary assessment. From this record, a CAPA may be generated or remedial action assigned, depending on the assessment.

What I want to be able to do is have the option to close the issue after the preliminary assessment for those incidents that are no big deal. In some cases I don't feel a CAPA is necessary. I am looking for an acceptable way to rationalize NOT issuing a CAPA. How do I determine the issue would not "recur" or that there is no "doubt with compliance to lab operations with our own policies"?

-Woody-
 
#4
Re: A Test Lab Using ISO 17025 - Question About Noncorming Work

That's fair Woody and I see where you are coming from, with respect to the equipment etc, rather than the actual testing.

I'm not sure you can set any particular criteria, other than each case being evaluated on its merits. Let's examine the calibration issue. An item of test equipment may, indeed, be shown to be past its recall date, but it may be perfectly serviceable, when submitted for calibration. So the impact of this apparent 'out of cal.' condition is zero.

I'm not sure you could build in something which allows for 'get out of jail free' cards to be issued once a non-conformity is found. They should all go through an evaluation, with the appropriate technical staff (possibly the lab client too) to see the severity of the issue, before any CAPA is issued. It will be from the recorded evaluation 'facts (if you like) that will justify if a CAPA was necessary.
 
S

Southern Girl

#5
You need to make sure that your "get out of jail free" conditions are thoroughly documented, i.e., what constitutes this, how many times will it be allowed for an individual, machine, situation, etc. This way there is no sense of trying to sweep something under the rug or showing favoritism to one individual or group.

Remember, any of these system standards is all about documenting what you do and then auditing to whatever you use to generate evidence of that action.

Keep it simple! ;)
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
Hello everyone,


1) My concerns are as follow. If a "suspected" nonformity has been identified, at a minimum, I am required to perform an assessment - correct? Docuemnted, correct?

2) If during my assessment, it is determined that an action has occurred that is noncompliant with our internal policy or procedure, must I automatically move to the next step and issue a Corrective Action?

3) Can I have a nonconformity and not be required to issue a Corrective Action? For example: a technician forgets to follow a step in a procedure that he was trained on. His action was identifed as non-compliant. However, is it acceptable to offer a verbal "reminder" and let it go at that?

Thank you.
-Woody-
Woody, in truth Clauses 4.9, 4.11, and 4.12 are related and inter-dependent.

If you find non-conforming WORK then the investigation must at the least be root cause analysis, and must be documented.

If the failure is because of the product, then address it only in the report and move on.

If test results are affected, then a corrective action must be generated.

So, if the technician forgets a step and cathes it or it is caught, prior to test results that go the customer are affected, then give the warning and move on. But if the test results get out the door then the investigation per Clause 4.9 must also consider the potential for recalling the work.

Hope this helps.
 
L

lucasso

#7
Does anyone feel that there is a difference between terms nonconformity and nonconforming work ?

There is a definition of nonconformity in ISO 9000. Too bad there ins't one for nonconforming work. And in ISO 17025 these both terms are used. I know there are people and institutions who explain nonconforming work in a different way than nonconformity in ISO 9000. From which i make a conclusion that these two must be different things. I am sure there will be people who say that nonconformity and nonconforming work is the same thing. I just wonder which approach gets more votes :)
 
Last edited by a moderator:

Jim Wynne

Staff member
Admin
#8
Does anyone feel that there is a difference between terms nonconformity and nonconforming work ?
"Nonconformity" is failure to fulfill a requirement. If conforming work is a requirement, nonconforming work is a nonconformity.

As an example: there is a documented procedure for performing some task or process. The performance of the task isn't done in accordance with the documented requirements, but the product conforms to requirements. Failure to do the thing in accordance with the documented procedure (the process requirements) is an example of "nonconforming work" (as differentiated from nonconforming product) and should be considered a nonconformity.
 
L

lucasso

#9
Thank you, Jim, for your response.
Yet it is not clear if these two terms mean absolutely the same thing or not.

Every nonconforming work is a nonconformity. But is every nonconformity a nonconforming work?

As it is explained by some our AB people: nonconforming work has to do with a result of a measurement/calibration (the issued protocol).

Let me give you a couple of examples:
A work instructions states that a measurement equipment for outside measurements must be used with an attachable umbrellain case it rains. An operator drives 100miles to a customer's site and then realises he has forgotten the umbrella. He knows that the rain would make the measurement results unreliable. But he is lucky, there is no rain. He takes measurements and drives back to office.
So, the requirements of the procedure were not fulfilled (the equipment was not assembled in a way it has to be for outside measurements) = nonconformity, correct or not?
But every specialist of the field would agree that the umbrella is important only during the rain, so since it was clear, the result of the measurements is reliable, there is no need to withhold of test report etc. = conforming work (conforming result), correct or not?

Another example:
There are bunch of statutory requirements for internal documents layout (font type, size, color, page size, numbering of pictures within a document etc.) Let's say there is a written procedure which does not follow the requirements (font type and size is wrong etc). But for the operator who uses the document does not make any difference if it is written in arial or times new roman font. He can produce (and it's been confirmed by management, external auditors etc) a reliable product.
So, in this situation we have what? A nonconformity? A nonconforming work? Both? None?

Thank you for your thoughts.
 

Jim Wynne

Staff member
Admin
#10
Thank you, Jim, for your response.
Yet it is not clear if these two terms mean absolutely the same thing or not.

Every nonconforming work is a nonconformity. But is every nonconformity a nonconforming work?

As it is explained by some our AB people: nonconforming work has to do with a result of a measurement/calibration (the issued protocol).

Let me give you a couple of examples:
A work instructions states that a measurement equipment for outside measurements must be used with an attachable umbrellain case it rains. An operator drives 100miles to a customer's site and then realises he has forgotten the umbrella. He knows that the rain would make the measurement results unreliable. But he is lucky, there is no rain. He takes measurements and drives back to office.
So, the requirements of the procedure were not fulfilled (the equipment was not assembled in a way it has to be for outside measurements) = nonconformity, correct or not?
But every specialist of the field would agree that the umbrella is important only during the rain, so since it was clear, the result of the measurements is reliable, there is no need to withhold of test report etc. = conforming work (conforming result), correct or not?

Another example:
There are bunch of statutory requirements for internal documents layout (font type, size, color, page size, numbering of pictures within a document etc.) Let's say there is a written procedure which does not follow the requirements (font type and size is wrong etc). But for the operator who uses the document does not make any difference if it is written in arial or times new roman font. He can produce (and it's been confirmed by management, external auditors etc) a reliable product.
So, in this situation we have what? A nonconformity? A nonconforming work? Both? None?

Thank you for your thoughts.
In both cases there are documented requirements that weren't fulfilled, and non-fullfillment of a requirement is the definition of nonconformity. The fact that nothing bad happened as a result is mostly irrelevant to the question at hand. In the first case the requirement should be changed to allow for operator discretion in use of the umbrella. In the second case there are statutory requirements, so the statutory requirements must be met.

There's a description for this sort of thing that I learned a long time ago: The operation was a success, but the patient died.
 
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