3 replies to this topic

[devezajohnpatrick]

Hello everyone,

 

I would like you ask help you guys regarding the closing of our recent FSSC 22000 findings. See below the findings.

 

1. Failure to update OPRP/HACCP plan. Where the OPRP plan uses EU regulation 10/2011 as reference of limits.

 

2. Lapses on execution of Internal Audit programme. Some clauses that are found on the Audit Plan is not included on Audit checklist.

 

 

 

 

Thanks in advance

[YongYM]

Dear devezajohnpatrick:

 

These are my opinions:

 

1. Failure to update OPRP/HACCP plan. Where the OPRP plan uses EU regulation 10/2011 as reference of limits.

à Maybe you are using the inappropriate regulation as reference when setting the critical limits. You may need to refer to your own country’s food regulations or applicable Codex standards and update the OPRP/HACCP Plan Summary accordingly.

 

 

2. Lapses on execution of Internal Audit programme. Some clauses that are found on the Audit Plan are not included in Audit checklist.

à You may need to standardize the clauses listed in the Audit Plan with the clauses listed in the Audit checklist. Quickly revise the Audit checklist and give training / briefing to your internal auditors.

 

 

Regards,

Yong

[devezajohnpatrick]

Dear devezajohnpatrick:

 

These are my opinions:

 

1. Failure to update OPRP/HACCP plan. Where the OPRP plan uses EU regulation 10/2011 as reference of limits.

à Maybe you are using the inappropriate regulation as reference when setting the critical limits. You may need to refer to your own country’s food regulations or applicable Codex standards and update the OPRP/HACCP Plan Summary accordingly.

 

 

2. Lapses on execution of Internal Audit programme. Some clauses that are found on the Audit Plan are not included in Audit checklist.

à You may need to standardize the clauses listed in the Audit Plan with the clauses listed in the Audit checklist. Quickly revise the Audit checklist and give training / briefing to your internal auditors.

 

 

Regards,

Yong

 

Thank you for your timely response Mr. Yong.

 

For Item #1. Its so happen that there were no published local regulations applicable for our product. As the standard suggest, in the absence of local regulation you may refer to internationally recognised/accepted  regulation.

 

See below the statement of findings.

 

The process of updating the preliminary information following the establishment of OPRP and/or the HACCP Plan was not adequately demonstrated:

1. Update on the Regulation (EU) 2016/ 1416 amendment to EU No 10/2011 was recognized by the Plant on October 2016, namely “Addition of migration limit for Aluminum (1mg/ kg food) and Zinc Migration was reduced to 5 mg/kg”.. However such update was not captured in the Raw Material Description for PE Film (Direct Product Contact) particularly on the chemical characteristic relevant for food safety, (Appendix 2, Version 3, Eff. Date: Feb. 16, 2015).

Note: 3^rd party analysis related to the above showed passing results.

 

1. End Product Description, Appendix 3, Version 2, Eff. Date: Nov. 3, 2014, showed the applicable regulation for raw materials such as Adhesive (21 CFR 175.105), and Resin (21 CFR 177.1520). However specific requirement related to the above, was not clearly identified.

 

 

All the best,

Mr. Deveza

[Charles.C]

Thank you for your timely response Mr. Yong.

 

For Item #1. Its so happen that there were no published local regulations applicable for our product. As the standard suggest, in the absence of local regulation you may refer to internationally recognised/accepted  regulation.

 

See below the statement of findings.

 

The process of updating the preliminary information following the establishment of OPRP and/or the HACCP Plan was not adequately demonstrated:

1. Update on the Regulation (EU) 2016/ 1416 amendment to EU No 10/2011 was recognized by the Plant on October 2016, namely “Addition of migration limit for Aluminum (1mg/ kg food) and Zinc Migration was reduced to 5 mg/kg”.. However such update was not captured in the Raw Material Description for PE Film (Direct Product Contact) particularly on the chemical characteristic relevant for food safety, (Appendix 2, Version 3, Eff. Date: Feb. 16, 2015).

Note: 3^rd party analysis related to the above showed passing results.

 

1. End Product Description, Appendix 3, Version 2, Eff. Date: Nov. 3, 2014, showed the applicable regulation for raw materials such as Adhesive (21 CFR 175.105), and Resin (21 CFR 177.1520). However specific requirement related to the above, was not clearly identified.

 

 

All the best,

Mr. Deveza

 

hi Mr Devesa,

 

afaik, fssc do not care what source is used to support yr chosen CCP/oprp methodology of distinction. afaik no regulatory procedures exist anywhere.

 

This looks more like a criticism of the product specification or a PRP related program. The former could relate to Yong's comment but if non-existent the choice would then first shift to intended location of usage. Is this the EC ? If only local the choice is presumably up-to-you (IMEX many countries simply refer to some particular international system of limits).

 

Which specific  clause of the fssc standard(s) was referenced ?

 

Why not simply update the specification (if that is the problem) ?

 

Sorry if i have not fully understood the difficulty.