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Question on NC due to migration testing


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JoeChew

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Posted 01 December 2021 - 05:36 AM

Good day everyone, I have a question that would like to get some clarification/information/guide on which I'm having a hard time trying to piece together with my limited knowledge. 

 

We have just recently completed out FSSC22000 audit and I was given a NC on the migration testing. The NC details goes as below from the auditor
 

Finding details: 

Lack of product conformity test to confirm hazard levels meeting identified acceptable levels

 

Requirement: ISO22000:2018 Clause 8.8.1 - Verification - The verification activities shall confirm that C) The hazard levels are within identified acceptable levels

 

Objective evidence:

Since the last migration test conducted by external lab on 5th Oct 2018, there was no such migration test conducted (considering also the newly published EU2020/1245)

 

As my major customers are in EU, so I'm following the EU10/2011. 

 

I have tried to justify with the auditor on this but my justification was not accepted because I read the:

"Transitional Arrangements" which writes Plastic materials and articles complying with Regulation EU No10/2011 as applicable before 23 Sept 2020, and which were first placed on the market before 21 March 2021, may continue to be placed on the market until 23 Sept 2022 and remain on the market until all stock has been sold

 

In his defence, he told me 

Standard doesn't specify the frequency of test. 
It shall be based on: 
a-Legal requirements, or 
b-Customer requirements, or
c-Risk due to complaint, rejection, or
d-Change in product, formula, legislation
 

Q1. So my question is did I misinterpret the "transitional arrangements" 

 

Currently I also updated my "Master schedule of verification & validation" to include in description "send product for migration test" frequency of the testing I put 3 years but then it contradicts with his reply where "standard doesn't specify the frequency of test"

 

Q2. How should I put the into the Master schedule for this migration test which is more appropriately correct as I've read a lot of the EU documentation and has not found anything mentioning the legal frequency of testing. I know it warrants a re-test of the migration if you change the product material composition, change the supplier, change in the regulation..etc...

 

Thank you for the assistance and much appreciated. 

 



Fahrani

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Posted 07 December 2021 - 03:40 PM

Hello Joe,

 

Thank you for starting this topic, I also work in the packaging manufacturer and we do migrating test as a local/ customer's country legal requirements. In my case we don't set the frequency based on the how long the products continue to be placed after the last update of the regulation. But we stated in our Standard document to do migration test if there is any condition below:

 

a-Legal requirements, or 
b-Customer requirements, or
c-Risk due to complaint, rejection, or
d-Change in product, formula, legislation

(it is same to your auditor request)

 

so to set the frequency to 3 years is not answering the clause. You should still do retest of migration test if there is any changes of formulation, regulation or any customer requests. I hope it answers your question..






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