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FSSC 22000 2.5.1 - Management of Services and Materials Acquired

#fssc22000 #versio5.1

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kassiardc

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Posted 15 February 2021 - 03:12 PM

a) In addition to clause 7.1.6 of ISO 22000: 2018, the organization must ensure that where laboratory analysis services are used for the verification and / or validation of food safety, these must be performed by a competent laboratory (including internal and external) laboratories, as applicable) that has the ability to produce accurate and repeatable test results using validated test methods and best practices (for example, successful participation in proficiency testing programs, approved regulatory programs or accreditation to international standards such as ISO 17025).

 

 

Requirement 2.5.1 that talks about MANAGEMENT OF SERVICES AND ACQUIRED MATERIALS has undergone some modifications with the new version 5.1 of FSSC 22000. In our last audit in version 5.0, our microbiology analyzes were carried out in the company's own internal laboratory and annually a complete external analysis was carried out in a laboratory accredited to ISO 17025, now the standard requires that even internal analyzes must be carried out in the laboratory. Accredited to ISO 17025 or have a proficiency test. A proficiency testing program in food analysis is expensive and time-consuming. Would you have another suggestion that can meet the standard in this requirement so that the microbiological analyzes performed in the company's internal laboratory are accepted by FSSC22000?


olenazh

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Posted 16 February 2021 - 02:24 PM

It says "as applicable" - so, you may say that proficiency testing programs and accreditations are not applicable to your company as they're over your budget. 



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Charles.C

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Posted 17 February 2021 - 05:17 AM

It says "as applicable" - so, you may say that proficiency testing programs and accreditations are not applicable to your company as they're over your budget. 

 

Hi Olena,

 

This appears to me as not the intended interpretation of the text, ie I agree with the OP's statement (except surplus bracket[?]).

 

Or was it a suggestion for a "last resort when ...." ? :smile:

 

However, I disagree with the OP's comment that proficiency testing is necessarily expensive/time consuming. It depends on how much one has to do, eg if you send 1-2 samples which were analysed by internal lab and compare results to those from an external lab. to demonstrate acceptable agreement.


Kind Regards,

 

Charles.C


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Evans X.

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Posted 19 February 2021 - 12:26 PM

Greetings kassiardc,

 

As stated above you do have to prove your competence to perform the analyses in your internal lab. However (and i state this as a Quality Manager in an ISO 17025 accredited lab) you don't want to get involved with the process of accrediting your methods or performance tests. They are time and budget consuming.

 

So the easy and acceptable way would be for you to have a schedule of proving your continuous competence by testing samples for each parameter you want to test in your internal lab against an external accredited lab.

A small trick there is to make sure that the accredited lab is actually accredited for the specific parameters you want to be testing (eg it could be accredited for E. coli in water and not in food). This way you will have more trust in your methods and also it could put an auditor "in his place" if he went as far as asking the external lab's scope of accreditation to cross-check it.

Since microbiological test methods are pretty stable through the years (as compared to chemical), you could perform a light annual schedule to validate your methods through a rotation. eg If you have 6 total parameters you could do them all once in 2021 to set up a basis and then rotate them like 3 in 2022 and the other 3 in 2023 and stick to this unless some mind-blowing change takes place!!!

 

Have in mind that you only need to prove that your method is working or even simpler that you get the same result as the external lab in each specific parameter. The method itself that you and the external lab use is kind of irrelevant. You only need to show the same end results.

 

Hope it helps,

Kind regards.


Edited by Evans X., 19 February 2021 - 12:36 PM.


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kassiardc

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Posted 19 February 2021 - 12:42 PM

 

Greetings kassiardc,

 

As stated above you do have to prove your competence to perform the analyses in your internal lab. However (and i state this as a Quality Manager in an ISO 17025 accredited lab) you don't want to get involved with the process of accrediting your methods or performance tests. They are time and budget consuming.

 

So the easy and acceptable way would be for you to have a schedule of proving your continuous competence by testing samples for each parameter you want to test in your internal lab against an external accredited lab.

A small trick there is to make sure that the accredited lab is actually accredited for the specific parameters you want to be testing (eg it could be accredited for E. coli in water and not in food). This way you will have more trust in your methods and also it could put an auditor "in his place" if he went as far as asking the external lab's scope of accreditation to cross-check it.

Since microbiological test methods are pretty stable through the years (as compared to chemical), you could perform a light annual schedule to validate your methods through a rotation. eg If you have 6 total parameters you could do them all once in 2021 to set up a basis and then rotate them like 3 in 2022 and the other 3 in 2023 and stick to this unless some mind-blowing change takes place!!!

 

Have in mind that you only need to prove that your method is working or even simpler that you get the same result as the external lab in each specific parameter. The method itself that you and the external lab use is kind of irrelevant. You only need to show the same end results.

 

Hope it helps,

Kind regards.

 

 

Dear Evans X.  :happydance:
 
I believe that you have understood the meaning of my publication, it is not really the company's focus to accredit its internal laboratory to ISO 17025, but rather to validate the analyzes that are carried out internally so that they are approved in the FSSC 22000 audit.
 
I spoke with a consultant who advised me to consider the laboratory's internal analyzes as monitoring analyzes and establish a schedule with a defined frequency to validate these analyzes in a laboratory accredited by ISO 17025.
 
This looks a lot like your answer. 
 
We hope that this will be accepted by the standard, as it is the most viable alternative today for our company.   :spoton:





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