Identify affected products and assess the risk

Checklist

Identify affected products – name, model, serial numbers, batch numbers, production dates, manufacturer, expected lifespan of the product.
Stop sale, manufacture, import, and advertising of the product.
Identify the number of affected products supplied to consumers and those in the supply chain.
Identify the defect and hazard – write a clear description.
Submit a mandatory report within 2 days of becoming aware of death, serious injury or illness - review details of all known injuries or incidents.
Conduct risk assessments to understand the risk, failure rate and urgency of the recall.
Identify the cause of the defect and the stage of supply where the fault occurred.
Fix the root cause – decide the steps to take and assess whether your fix is effective – keep good records of the steps taken.

See the complete supplier checklist

Identify the affected product

Find out as much as you can about the affected product, including:

the product name, make, model and any distinguishing features including manufacturing dates, serial or batch numbers, product codes, barcodes
if the defect is caused by a part in your product – find out if the part is in other products you supplied
how many are with consumers and/or are still in the supply chain
the product’s lifespan, retail price and how often consumers use it.

Identify why the product is being recalled

Identify

the reasons why the product is unsafe (the defect or dangerous characteristic)
the potential harm to consumers (don’t underplay it), and
how and when it may occur.

You may be recalling the product because:

the product may cause injury because of a design or manufacturing issue.
use or foreseeable misuse of the product may cause injury, or
the product does not meet a mandatory safety standard or is banned for safety reasons under the Australian Consumer Law or other Australian law.

‘Use’ refers to using consumer products for their primary, normal or intended purpose.

‘Foreseeable misuse’ refers to using consumer products or product-related services in a way not intended, or in a wrong or improper way, but where the use is predictable or not far-fetched or fanciful in the circumstances.

For example:

children commonly swallow finger paint – this is recognised in the maximum level of lead (Pb) and other hazardous elements allowed in children’s finger paint.

children may mistake liquid laundry packets for lollies and try to eat them.
Young children often throw or drop their toys. Suppliers need to make sure that toys for children under 36 months of age don’t release small parts when they break.

The hazard explains how the recalled product may cause harm.

Example – children’s toy containing button batteries

Defect: The button battery compartment is not adequately secured, and the button batteries are accessible.

Hazards: If young children gain access to the button batteries and ingest them, they are likely to suffer severe internal burn injuries, which can result in serious illness or death. Button batteries are also a choking hazard to young children.

Risk is the chance, whether it be high or low, that someone will be hurt using the product.

Example – children’s high chair

Children can suffer a range of injuries in high chairs. One hazard is falling from the chair. Children are typically exposed to this hazard when trying to stand up in the chair or climb in or out of the chair. The risk of the child falling is reduced if the chair is sturdy, has a five-point restraint harness and the child is secured in it.

Assess the risk

Build regular quality assurance and testing into your business processes. This will help you identify and address risks early for a more effective recall.

Once you decide that you need to start recall action, you should have a clear strategy for assessing and addressing the risk posed by the affected product.

Risk is the chance, whether it be high or low, that someone will be hurt when using the product.

When carrying out a risk assessment:

use evidence of the defect and/or harm when making decisions about your recall
appoint a responsible person or small team to assess the risk – they should understand how to use the risk assessment method in your recall plan, be knowledgeable about the product and its hazards, and know to seek expert advice if needed
consider if you need expert advice when assessing the risk and likelihood of occurrence – this could be from within your business or an outside consultant
document your risk assessments.

When doing a risk assessment, identify the:

defect or why it is dangerous– there may be multiple
hazard and how it occurs – through use or foreseeable misuse of the consumer product
intended user and whether they will be able to recognise the hazard
other users of the product, if any – this could include any bystanders
injury severity – how serious the injuries are to the user (injuries that could be fatal or need long-term hospitalisation are a higher risk than those that would only need basic first aid)
defect rate – of the products supplied, how many are likely to be defective (more products sold and/or a higher defect rate can increase the risk).
failure rate – of the defective products supplied, how many are likely to cause injury.

Use the information from your risk assessment to decide the risk associated with the product. The higher the risk, the more urgent your recall. The outcome of your risk assessment will influence your recall strategy including how often you need to advertise your recall.

Risks may change throughout the life of a recall. Some products may become more dangerous over time, increasing the risk to consumers. It is important to review those risks, and adjust your recall strategy as needed, especially if incidents keep occurring.

See Reassess the risk to find out when you will need to reassess the risk and what actions you need to take if the risk level is higher.

Consider our priorities

Suppliers should consult our product safety priorities when assessing risk. The factors we consider are if:

there is a high risk to public safety due to the severity or number of injuries that may result from the product (such as an unsafe product likely to cause death or significant harm, or being widely available to consumers)
users are unable to perceive or safeguard against the risk of the product, such as where it is difficult to detect the safety risk or identify a link between the product and possibility of injury
the product is targeted at vulnerable users, such as children
users of the product potentially expose other people to the risk of death or injury
the product is subject to a safety standard, compulsory recall, ban or safety warning under the Australian Consumer Law.

Conduct a root cause analysis

Understand the products and parts used in your supply chain and know whether you, or your suppliers, are using defective parts in your products.

Conducting a root cause analysis can reduce or eliminate the risk of the defect occurring again and the need for future recalls.

If the fault is in the design of the product, the manufacturer is best placed to address this issue.

Identify what triggered the recall action

what occurred, when and where
keep it factual and identify any gaps in the information
test the product, if needed.

Identify the factors that led to the defect occurring

Consider making a decision tree or mapping out the events that led to the defect.

Identify the root cause

Why did the defect happen? Some of the reasons may include:

reduced costs due to financial pressure
new suppliers or manufacturers
outdated processes or quality management systems
outdated information about safety standards
lack of or inadequate staff training
infrequent independent testing.

Identify ways to prevent the issue from occurring again
Decide if these are effective.

Identify the actions needed to correct the issue
Check to make sure that these are effective.

Keep records of your findings and decisions

Keep detailed records of your findings

Search online for tools to help you with conducting a root cause analysis. Example search terms include a “Fishbone diagram” or a “5 Whys analysis”.

Tell us if the risk level changes or other products may be impacted

If you discover that other products share the defect or your analysis changes the risk level, you need to let us know.

Check whether the same faulty parts, poor design elements or manufacturing issues are in other product lines.

Advise us if you find that the unsafe product you have sourced may share its defect with other products. This includes products supplied by others. Email: recalls@accc.gov.au

Reassess the risk after completing a root cause analysis. After this process you should know more about the defect and hazard, which may change the original risk level.

Tell us if the risk level is higher or lower than your initial risk assessment and update your recall and communication strategy. Keep the risk level in your recall communication up to date and consistent across all your communications.

Tools

These tools may assist to assess the risk including what information you need to gather and questions to consider.