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
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.