If you are a food business, you will need to have a documented Product Recall Procedure. Perhaps you already have one, but you may want to review it to see that you have considered all the aspects that will need to be managed in a product recall incident.
We have created a Product Recall Guide to make it easier for you. The Guide is divided into 2 Parts.
In Part 1 we provide cover the first three steps of the Product Recall Process.
in Part 2 we cover the balance of the Product Recall Process.
Be sure to read our eBooks on Incident Management (eBook #12) and Traceability (eBook #10) as well before you begin working on documenting your Product Recall Procedure.
Why do I need a Recall Procedure?
The following legislation requires a documented Recall Procedure
- The R638, (Regulations Governing General Hygiene Requirements for Food Premises, the Transport of Food and Regulatory Matters) says under Clause 10 (18) “…. A traceability system is maintained according to the best available method and a recall procedure is in place and any incident requiring recall activation is reported to the local inspector and the National Directorate: Food Control”
- Consumer Protection Act: The “Consumer Product Safety Recall Guidelines – What a supplier is required to do when conducting a product safety recall” were published to provide guidance to suppliers on how to conduct a product safety recall, which includes planning for and responding to an incident.
When can a recall be initiated?
- Suppliers. A voluntary recall can be initiated by suppliers when they become aware of a food safety safety or serious product quality issue. The National Consumer Commission must be notified by the company in writing within 2 days.
- National Consumer Commission or other Regulators: Recalls can also be negotiated by the National Consumer Commission or other Regulators when they identify a safety issue or following enforcement or compliance action
- National Consumer Commission: A compulsory recall may be ordered by the National Consumer Commission and they will monitor compliance with all such notices issued by it.
What are the objectives of a Product Recall?
- Stop the distribution and sale of the affected product as soon as possible,
- Inform the relevant authorities of the problem
- Remove the affected product from the marketplace effectively and efficiently
- Prevent further distribution of unsafe products
What steps do I need to take in the event of a Product Recall?
According to the National Consumer Commission, the supplier has the following responsibilities, in a recall situation:
- Conduct a comprehensive risk analysis of the safety hazard
- Stop distribution of the identified product batch
- Cease production or modify manufacturing processes that have been identified for the recall
- Remove unsafe product from the marketplace
- Notify relevant regulators, prepare and submit a recall strategy to the regulators
- Notify the Commission in writing of the recall, preferably prior to the recall commencing. If not possible, the notification must be sent within 2 days. This must be submitted on the prescribed Recall Notification Form
- Notify the public
- Notify international product recipients
- Notify others in the domestic supply chain
- Facilitate the return of recalled products from consumers
- Store and dispose of recalled product safely
- Have a written recall strategy/plan
- Maintain records and establish procedures that will facilitate a recall
- Provide progress reports on the conduct of the recall to the Commission and relevant regulators
Process overview - Product Recall
Let’s go into each step in a little more detail
1. Receive Customer Complaint
2. Recall team assembled
The Food Safety Manager decides to assemble the Recall Team so that the team can decide whether a recall is necessary.
The team must have access to all the relevant information available regarding the batch, in order to effectively determine the risk.
The required information could include:
– Brand name
– Product name
– Product description
– Product image
– Batch code/s involved
– Quantity of product involved
– Distribution details (where the affected batch/es have been sold to)
– Whether the product has been sold to consumers
– The nature of the hazard
– Results of any investigations/tests
3. Conduct Risk Assessment
Your team will conduct a risk assessment to determine the category of recall that may need to be initiated based on the risk of the hazard to the consumer.
Codex Alimentarius has set some guidelines to utilize for conducting a risk assessment:
- Hazard Identification – this is the step that involves identifying the hazard that is capable of causing adverse health effects and which may be present in the identified food
- Hazard Characterisation – this is the qualitative or quantitative evaluation of the nature of the health effect of the hazard
- Exposure Assessment – this is the qualitative or quantitative evaluation of the likely intake of the identified hazard
- Risk Characterisation – this is the integration of the hazard identification, hazard characterization and exposure assessment into an estimate of the risk
The gathered information is utilized when using a Risk Matrix and/or decision tree method.
A risk matrix would determine the risk of the hazard, taking into consideration the likelihood of the hazard being in the batch and the significance on the consumer, should they utilize it.
1–3 = Class 3 (low risk)
4–5 = Class 2 (moderate risk)
6–7 = Class 1 (serious risk)
This matrix would determine the category/class of the risk:
- CLASS 1 (Serious Risk): This is a serious risk health hazard situation, in which the consequences of use or exposure to the product are life threatening or involve a serious adverse health consequence. This requires rapid action. e.g presence of glass shards found in product from shattered bulbs
- CLASS 2 (Moderate Risk): Involves a potential health hazard where the probability of serious adverse health consequence is remote. This requires some action. eg presence of small amounts of food-grade cleaning chemicals left in the production line
- CLASS 3 (Low Risk): Where there is a situation in which the use of, or exposure to the product is not likely to cause adverse health consequences.This situation is not generally requiring action for products in the market. eg label is skew
As with the risk matrix, the decision tree to be utilized would need to be determined prior of any potential recall and recorded in your company Product Recall Procedure.
We have covered the first three steps of the Product Recall Process in Part 1 of our Product Recall Guide. We will be covering steps 4 to 8 in Part 2 of our Product Recall Guide. Be sure to look for it here on our website.