Elements of an Approved Arrangement

As the manufacturer, you are responsible for conducting the product recall, under the guidance and direction of FSANZ (Food Standards Australia New Zealand) and the regulatory authority. For exported products, you may wish to consult with your importing country and customer to ensure a correct and accurate product recall is achieved.

There are two types of food recalls as classified by FSANZ, consumer recalls and trade recalls. A trade recall is conducted when the food has not been available for direct purchase by the public, such as food sold to wholesalers and caterers. A consumer recall is conducted when the food has been available for retail sale such as your local supermarket. Companies may also consider conducting a product withdrawal, which is separate to a food recall. A product withdrawal is the action taken to remove food products from the supply chain and stores where there is no public health and safety issue.

Your documented traceability procedure must describe how you identify the goods you receive and how they remain traceable throughout manufacturing, storage and distribution. Your procedure should include how the products are identified, what unique code is used for traceability, how you decipher this code, how does this code relate to your production records, what details are included in your production records, how your raw materials (including packaging and any re-work) are traced (referred to as a ‘product traceability matrix’) and the traceability of your distribution network through to your customer or/and stores, both domestic and export. If you use an electronic or a batch coding system to control and manage the traceability of your goods, your documentation must clearly describe how this is managed at all stages.

Your records must ensure they reflect the date of preparation of dairy products in each lot, as well as the lot or batch number. The description of the product, including ingredients and quantity must also be recorded.

You must ensure that all your production records are accurately completed to ensure traceability from receival of farm milk or raw material at your establishment, through to manufacturing, storage and distribution. Your finished product must be able to be traced back to the raw materials used to produce the batch, including any packaging materials used.

If your process involves re-work product being blended back into a batch of product, it must be traceable to its original batch. All your ingredients must be traceable in both non-reworked and reworked product.

During your internal audits, your inventory controls and traceability system should be tested to ensure it is maintained and you have a record of this. Alternatively, you may choose to undertake a “mock recall” exercise instead. The mock recall plays a pivotal role in assessing your current recall and traceability system by using a realistic mock scenario to test the accuracy and functionality of your traceability and recall system. Any corrective actions from the mock recall exercise or internal audit should  be documented and available for review.

Your documented recall procedure should include who is responsible for determining a product recall, details of a recall team(where applicable), training and qualifications of the recall team or responsible person, the different categories and steps involved and the risk assessment or determination process for a product recall. You must identify the key stakeholders you would notify of a product recall, who is responsible for ensuring an accurate recall process takes place, verification step for accuracy and details of a mock practice recall exercise and how often these would take place.

Export registered manufacturing establishments have a legal responsibility to provide information to the department should a recall be conducted for any product. The department is responsible for advising the importing country authorities when exported Australian food poses a food safety risk, including trade recalls (from wholesalers or distribution centres). 

Where and importing country authority advises the Australian Government of an Australian product that has a potential food safety concern, a trace-back and investigation is required. The importing country authorities will determine if a recall is required in that country based on their investigation. Where a recall is required as a manufacturer (and/or exporter), it is ultimately your responsibility to ensure all products are removed from the overseas market. Your overseas customers will play a pivotal role in ensuring you achieve this goal. 

All affected product, whether still in your possession or at your buyers or which has been distributed, must be put on hold. You must notify your buyers, including those in another country or a domestic buyer that may intend to sell or export the product, that they must remove any products for sale and place all affected product on hold.

All product on hold must be segregated from non-affected product and the status of the product and how much has been traced must be recorded.

Some areas for you to consider when documenting your traceability and recall systems are listed below;

• Do your labels meet the relevant regulations and ensure product details correctly identify the product for traceability purposes?
• Do your records clearly define the product?  Is it uniquely identified?
• Are all inputs (ingredients, packaging, etc) clearly recorded and identified?
• Can you effectively trace back to your suppliers for all inputs?
• Do your production records include quantities produced?
• Do you use any codes when identifying your product, (Best Before, Date of manufacture, etc)? Are all relevant personnel aware of these codes and their meaning? (for example; Julian code)
• Are all Work-in-progress (WIP), reworked products or partly used ingredients clearly identified?
• Consider whether your supplier of raw materials has an effective traceability system in place, so that should a product recall occur from your supplier, your raw materials will be traced accurately back to your establishment.
• Do you conduct a mock traceability exercise on your product to ensure your traceability system is effective and can be performed accurately, within the required time frames, in the event of an actual recall?

Your Approved Arrangement must provide measures for the identification, traceability and integrity of your dairy products to ensure that they can be fully recalled if necessary.

FSANZ Food Industry Recall protocol is a important document which can assist industry to conduct food recalls accurately, efficiently and effectively.

The holder of the Approved Arrangement must retain records relating to this procedure for at least 3 years.