Yesterday's Traceability - Inadequate For Today's Needs

Over 99% of all food manufacturers failed to meet current Homeland Security and customer traceability requirements. Meanwhile commercial and legal risks, including incarcerations for managers, have increased significantly.

Surprisingly, over 95% of food & beverage manufacturers who claimed compliance failed even basic requirements tests. These companies typically relied on the fairly limited traceability provided by their business / ERP system.

Paper systems did no better. Even in the cases where the correct data was being collected, the sheer number of documents required and the need to cross reference the data, made timely retrieval impossible.

These solutions do allow some level of traceability. However , the traceability paradigm has expanded dramatically from simply knowing what items you sent to whom to knowing the items, logistics path, lot details, manufacturing genealogy, etc. for every product and ingredient anywhere in your supply chain, past or present .

 

Enterprises that meet the current requirements typically have either used :

    1) their standard business / ERP system linked to a traceability utility such as     SupplySync

    2) their standard business / ERP system and a standalone traceability utility such as     SupplySync

    3) a more comprehensive warehouse management solution such as the WCS     (Warehouse Control System) .

 

To find out more, scroll down or click the area of interest :

* 10 Examples of Homeland Security / FDA 306 Failure Points

* Traceability Demo

 

Related Links :

Recall Management

FDA 306 Checklist

Supply Chain VIsibility

 

10 Quick Points About Homeland Security Requirements for Food & Beverage Manufacturers

The following represent an overview taken from the checklist at http://www.operationstech.com/Downloads/FDA%20306%20Bioterrorism%20Checklist.pdf

1) FDA 306 is a security law, not a safety law and requires the collection and filing of significantly more detail. Lack of compliance can result in civil (fines of $100,000) and criminal actions (one year in jail for the person responsible for the operation).

2) You must record the vendor’s "available identifiers" i.e. lot number, manufacturing date, etc for all incoming food and packaging materials that touch food

3) You must record the packaging types, brands, and sizes of incoming and outgoing material

4) You must know the specific transporter firm and contact data for each piece of covered inventory

5) FDA 306 requires identifying transport data as well as inventory data. Since the same vendor's lot delivered at different times has differ logistics, it is , by this standard, different inventory (see Items 2 and 4 above). The end result is a “de facto” need to assign an internal lot number for all incoming material

6) “Standard” back flushing involves calculating the items, lots and quantities used to make a product based upon the amount of product made and its recipe.


Calculating a lot, usually FIFO based, is not sufficient. You must record actual lots used

7) You must record the carrier and exactly which lots, their ingredients, packaging type, etc , sent to each receiving organization

8) You must hold the records for up to 2 years and be able to retrieve any and all data within 24 hours

 

9) Even if a manufacturer never touches or physically controls inventory that still "runs through the company books" the company must maintain the same level of documentation as if the company processed the inventory directly.

Example : Company A buys ingredients that are drop shipped to tolling operation - Company B. Company B uses the ingredients and makes product that it ships directly to Company C. Company A then bills Company C.

Company A is responsible for recording the same information on the inventory receipts, production , and shipment as Company B.

 

10) Food samples (incoming and outgoing) require the same level of traceability as other food

A Quick Traceability Demonstration

TOTAL TRACEABILITY

SupplySync and WCS both provide "total traceability". From any piece of data, all events before and after that point for that inventory item, lot, sub lot, pallet, tank, bulk area etc. can be extracted.

Essentially from any point beginning at the shipper's dock to to any point up to the receiver's dock.

Total Traceability can extend beyond the enterprise itself and as deep into the supply chain as access permits.

 

The following example represents a small part of that traceability.

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Example 1 : Find all the ingredients of a specific lot

First restrict the search to lots via the "Lot" option (1).

Use the drop down box , type or scan the lot number (2).

The ingredient items, lots, etc for this lot are displayed (3).

Any lots that this lot were itself an ingredient of are listed (in this case - none) (4).

traceability  lot ingredients

Example 1 : Find all the ingredients of a specific lot

First restrict the search to lots via the "Lot" option (1).

Use the drop down box , type or scan the lot number (2).

The ingredient items, lots, etc for this lot are displayed (3).

Any lots that this lot were itself an ingredient of are listed (in this case - none) (4).

 

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trace lot ingriedient 1

Example 2 : From the example above, determine ALL the finished goods or intermediate lots that one of the ingredients went into.

Begin by "right clicking" on the lot (1)

Select the Examine option (2)

 

trace lot vendor lot

All the "outputs" or lots this lot was an ingredient of are listed ( in this case , just one) (1)

Since this lot was originally brought in from the outside, its original Vendor Lot, etc is listed (2)

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trace history

Example 3 : From the example above, display the entire history of that ingredient .

Begin by "right clicking on the lot and select the History option (1)

 

trace lot history 2

The history of that lot is displayed.

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