11 replies to this topic

[Thanhtien]

Hi evryone 

 

My company has an internal Laboratory, the laboratory got the ISO 17025 ( on validation), Can I use the testing resut of the internal laboratory for the verification? ( For theo CCP ) 

 

Thank you 

[Charles.C]

Hi evryone 

 

My company has an internal Laboratory, the laboratory got the ISO 17025 ( on validation), Can I use the testing resut of the internal laboratory for the verification? ( For theo CCP ) 

 

Thank you 

 

It my depend on what specific results and who/what you are specifically using the results for.

[Thanhtien]

Hi Mr Charles C

 

The verification for Swab test ( The scop of labratory include all Microbiologic that We test for verify ) 

 

Can I use that testing result ? 

 

Tthank 

[Charles.C]

Hi Mr Charles C

 

The verification for Swab test ( The scop of labratory include all Microbiologic that We test for verify ) 

 

Can I use that testing result ? 

 

Tthank 

 

It depends on the Specifics.

[Thanhtien]

Hi Mr Charles C

 

But, My company have a non- conformity. The auditor don't accept the testing result from internal laboratory ( But my laboraytory got ISO 17025 ), The auditor require that result from external laboratory   

 

I want to know that is right/ wrong ? 

 

Thank 

[Charles.C]

Hi Mr Charles C

 

But, My company have a non- conformity. The auditor don't accept the testing result from internal laboratory ( But my laboraytory got ISO 17025 ), The auditor require that result from external laboratory   

 

I want to know that is right/ wrong ? 

 

Thank 

 

Hi Thanhtien,

 

What specific results ?

 

What specific reason does the auditor give for not accepting the results ?

[Thanhtien]

The Auditor explain that internal laboratory, Not third party and not competent laboratory 

 

Thank 

[Charles.C]

The Auditor explain that internal laboratory, Not third party and not competent laboratory 

 

Thank 

 

Hi Thanhtien,

 

Does the auditor refer to a specific clause in the Standard ?

 

It sounds like the auditor may have had some specific "practical" objection to the laboratory results. If so, they should have detailed their objection(s).

[Thanhtien]

Hi 

 

The auditor show me that non-compliance with 8.5.3 of ISO 22000. But I don't know excactly 

[Charles.C]

Hi 

 

The auditor show me that non-compliance with 8.5.3 of ISO 22000. But I don't know excactly 

 

Thks.

 

Is the audit for iso22000 or fssc22000 ? It can matter.

 

Offhand, I cannot see any direct requirement for laboratory accreditation in clause mentioned or the iso22000 standard.

 

The auditor may have had some objection to the methodology/implementation being used by yr laboratory for achieving validation. If so, IMO, the specific objection should have been stated. (And someone should have asked).

 

Difficult to make more specific comments without details of the validation involved.

[liberator]

You state that your lab is certified to ISO 17025 - which means compliant to that standard. Is the test method you're wanting to use under the scope of the ISO standard? If it is then there should be absolutely no reason why you cannot use your inhouse testing to validate your results. You would have to be conducting performance testing (inter labs) to maintain your ISO certification and that validates that your testing is correct.

 

You could always test the samples and send to an external lab to validate your test methods and results  (but that's why you do interlabs.) Unless there is a clause in the standard (I don't know if there is or is not) that states you can't validate a result inhouse in a certified laboratory I'd be challenging the auditor. Now if your lab or test method is not certified, then I would question using your lab for validation as well unless you had data proving your test procedure and results aligns with an external certified laboratory.

[Charles.C]

You state that your lab is certified to ISO 17025 - which means compliant to that standard. Is the test method you're wanting to use under the scope of the ISO standard? If it is then there should be absolutely no reason why you cannot use your inhouse testing to validate your results. You would have to be conducting performance testing (inter labs) to maintain your ISO certification and that validates that your testing is correct.

 

You could always test the samples and send to an external lab to validate your test methods and results  (but that's why you do interlabs.) Unless there is a clause in the standard (I don't know if there is or is not) that states you can't validate a result inhouse in a certified laboratory I'd be challenging the auditor. Now if your lab or test method is not certified, then I would question using your lab for validation as well unless you had data proving your test procedure and results aligns with an external certified laboratory.

 

Hi liberator,

 

I agree yr first paragraph ("is" > "if").

 

The NC Clause mentioned/iso22000 Standard contains no mention of the word "laboratory". Or iso17025. This Standard also has no "Normative References" but It does have (Section 3) a typically iso-mysterious reference/link to "terminological databases" which i avoided pursuing further.

FSSC22000 may have/imply further requirements.

 

The immediate problem afai can tell is that the auditor apparently gave no indication as to the reason for the NC. Dereliction of duty ?.