1. The Importance of Traceability
Batch Management at the
Distribution Level
2. 2
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
3. 3
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.
4. 4
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.
5. 5
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 risk
Samples 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.
6. 6
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.
7. 7
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 found
Unacceptable levels of minerals, micro-organisms or metals
Presence of harmful bacteria such as Salmonella or Listeria
Package Tampering
8. 8
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.
10. 10
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 warehouse
3 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 days
We 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!
12. 12
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 product
The customer becomes seriously ill
The 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
13. 13
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.
14. 14
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.
