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FSMA and traceability - USA


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#1 chilly

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Posted 06 August 2015 - 01:21 PM

It is intended that food manufacturers trace their products from origin of inputs, through the supply chain right-up to the customers, the FDA has defined CTEs and KBE as tracking factors with the goal that manufacturers track and record every unit of product along the entire supply chain or at the very least 1-up and 1-down. What is meant by unit of product because I believe the unit of product varies with the position in the supply chain - could this unit ultimately mean individual consumer or retail packages?


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#2 MWidra

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Posted 06 August 2015 - 02:16 PM

It depends on what you are tracing and why.  If you found contamination in a production run of your product, then it is that production run.  If a raw material supplier tells you that their raw material was contaminated, then you trace that entire batch/lot/shipment of raw material through the production runs it was used in (and account for all of it, no matter if you have some on hand or not).  If a customer finds contamination in a product, then you trace all the raw materials (and packaging) that went into that product into other production runs to see if they were contaminated or if the batch was contaminated during processing.

 

The information from this trace is used to decide what is the root cause of your problem, if a recall is needed, and what should be recalled if it is.

 

So...the ultimate legal answer...it depends.

 

Martha


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#3 Charles.C

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Posted 06 August 2015 - 07:16 PM

It is intended that food manufacturers trace their products from origin of inputs, through the supply chain right-up to the customers, the FDA has defined CTEs and KBE as tracking factors with the goal that manufacturers track and record every unit of product along the entire supply chain or at the very least 1-up and 1-down. What is meant by unit of product because I believe the unit of product varies with the position in the supply chain - could this unit ultimately mean individual consumer or retail packages?

 

CTE = ?

KBE = ?


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Charles.C


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#4 MWidra

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Posted 06 August 2015 - 07:35 PM

CTE = ?

KBE = ?

Critical Tracking Event

 

Key Data Element ( think it should be KDE)

 

Martha


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"Life's like a movie, write your own ending."  The Muppets


#5 Charles.C

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Posted 06 August 2015 - 07:42 PM

Hi Martha,

 

Thanks. It becomes a bit less muddy. :smile:


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#6 expl73xavier

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Posted 06 August 2015 - 11:22 PM

Critical Tracking Event

 

Key Data Element ( think it should be KDE)

 

Martha

si asi es


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#7 Charles.C

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Posted 06 August 2015 - 11:37 PM

Hi exp173,

 

Welcome to the Forum ! :welcome:

 

But please post in English.


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Charles.C


#8 chilly

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Posted 07 August 2015 - 05:21 AM

Thanks Martha for the "decrypting" and your answer - indeed law-makers tend to cover the spirit of a matter but NOT the substance e.g. the concept of "due diligence". I work in Germany and we are exporting to the US and I'm trying to find a quantifiable recall-risk metric. Whereas CTEs are quickly discernible I find the ultimate solution lies in common KDEs through-out the supply chain which can be electronically queried; a paper trail could suffice but lacks the speed. From your answer I suppose we must find at least every Handling Unit i.e. pallet which in turn would mean retail delivery unit.

Anybody know the FDA recommendation on this? Read through a very detailed US National Fisheries Institute paper with GS1-US but residual doubt remains...


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