The Importance of TraceabilityBatch Management at the Distribution Level

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Natural Health Products Directorate

Health Canada publishes Good Manufacturing Practices (GMP) Guidance Document

This means that there are particular regulations for all players in the supply chain for Natural Health Products that must be followed

For Operations the Directorate is as follows:

Every manufacturer, packager, labeller, importer and distributor shall establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of the natural health product that has been made available for sale

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Why Batch Management?

In Order for Manufacturers to adhere to the stiff regulations laid out in the Directorate, all Raw Materials that are used in the production of a Natural Health Product must be identifiable by a unique batch number (lot code).

Each production run of both raw materials and finished product must also be assigned a unique batch number.

The Directorate also states that a manufacturer must:

Prepare and follow batch records for each batch of product. These records must be an accurate representation of the master production document and include documentation that each significant step in the manufacturing process was completed.

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Why track batch numbers?

The US Bioterrorism Act and a 2005 European Union directive, state that traceability is required by law.

Companies must precisely track all finished goods from their component parts all the way to the kitchen table.

The primary reason for this traceability is to protect consumers.By accurately and quickly identifying potentially suspect product and

where it has been shipped, the manufacturers then have the ability to pull the product back much quicker and more efficiently.

If there is reasonable grounds to believe that a batch of a natural health products made available for sale may result in injury to the health of a purchaser or consumer, the product will be recalled.

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What is a Recall?

When a product is deemed a risk to the consumer, the Health Ministry RECALLS the product, demanding that all saleable units in the marketplace be returned to the point of origin.

Only the production runs that are affected are taken out of the marketplace. Once the raw material that is the issue is identified, the manufacturers

can then determine which batches of the finished product are affected.Only affected batches are recalled.The Health Ministry requires a sample of the product be forwarded for

testing to determine the severity of the riskSamples are taken from the original production run as all companies must

keep samples of all items produced, in a storage facility for this purpose.Recalled items are placed under quarantine until disposition is decided –

destruction of the risk product.

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The importance of Batch Picking at the Distribution Centers

In order to adhere to Health Canada regulations, we pick our products based on the batch codes provided upon receipt of the product.

Expiry dates are respected to ensure our clients do not suffer the losses caused by out dated product.

Our computer system tracks all of the batches from the time the products land on our dock until it has left the building by either a transfer to another facility or to a consumer.

Each and every transaction of a batch numbered item is recorded in our system to enable our clients to recall a product if required.

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What are reasons for a product recall?

The Health Minister will recall a product, or request a voluntary recall if the product is deemed a risk to the consumer.

The severity of the recall is based on the possible effects to the consumer.

Some reasons for a recall are:Undeclared milk products (or other allergens)Accidental exposure to allergens during production (Such as nuts)Foreign objects foundUnacceptable levels of minerals, micro-organisms or metalsPresence of harmful bacteria such as Salmonella or ListeriaPackage Tampering

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The Importance of Accurate Picking of Orders

When a product arrives in the building, it is entered into the system with the assigned batch number and expiry date.

SAP allocates the items to customer orders based on a First Expiry, First Out (FEFO) method, meaning the product the will expire first are the ones that leave the building first in orders.

In the event of a product recall, we can extrapolate from SAP all the names and addresses of customers and consumers who were shipped the item.

We can provide this list to Health Canada and to the manufacturer to ensure safe and complete product recall.

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BUT…

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Incorrect batch picking

If, for some reason, you pick item A and the batch number DOES NOT match the order, but you put it in the order anyway, thinking that Inventory Management will fix it, what happens?Item A has 5 different Batch numbers in our warehouse3 of these batch numbers have tested high for a micro biotic that may be

harmful to young children and people with suppressed immune systems. Client recalls the three batch numbers, but leaves the remaining two in

place for customers to order in the upcoming daysWe provide a list of all the addresses the three batch numbers shipped to.We isolate the three bad batches and place them under quarantine so no

other consumer will receive them.

WHEW!! We did it!

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BUT…

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The dangers….

Someone picked the wrong batch on three different orders and did not report it to the Inventory Manager

SAP thinks that one of the two good batches were sold to these three customers

The customer is unaware of the recall and ingests the productThe customer becomes seriously illThe manufacturer cannot account for several missing units of the

product from our warehouse (According to SAP we should have 100 in stock but we have only 97)

Unless the consumers who received the at risk product is aware of the recall and comes forward, the manufacturer must justify the balance missing to Health Canada

We have a responsibility to our client to ensure accurate and timely response to a product recall

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What Can You Do?

When receiving, ensure that all batches are recorded correctly and entered accurately into SAP Quantity of each batch is just as important so ensure your counts are correct.

Review Receiving documents to confirm if stock is QA. If QA ensure Quarantine tape is applied across skid and receiving document is signed off

confirming that this was applied.

Ensure that EVERY PICK matches the SAP requested batch number Match the batch number on the item to the batch number on the RF Gun/Carousel Screen Always scan the batch number when picking if possible If the batches do not match, short pick the item, and see your immediate supervisor – a short

pick form must be filled out and the order will be reissued with a new batch and location to complete the order

DO NOT pick items of a different batch without the approval of your immediate supervisor Only pick batches that are requested on the RF Gun/Carousel screen

DO NOT pick if skid/product is labelled with Quarantine tape or Block Stock Sticker When Packing, spot check batches against the invoices to ensure accuracy When putting items away, DO NOT mix batches in the same bin.

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Summary

Picking by batch number is a federally regulated system and is mandatory by law.

Manufacturers and Distributors are all equally responsible for accurate record keeping of all items that enter and leave the building.

We are the last stop before the product enters the marketplace and into the hands of the consumer

Inaccurate tracking of batch numbers can result in issues with Health Canada, as well as illness in our client’s customers.

Many inventory variances are caused by miss picked batch codes. It is your responsibility to ensure the batch codes are recorded

correctly from the bay door to the customer.