Risk Assessment – An Essential Element of Recall Management – 22/01/10

When faced with a potential product recall from the marketplace, taking that final decision can prove very difficult. On one hand it is company policy to put the safety of the consumers as your first priority, but on the other hand, such a recall campaign will have significant impacts on the company's brands and finances. It is therefore critical to make the correct decision. Utilising a systematic approach, such as a risk assessment of the situation, can provide the much needed assistance in making that decision. The decision on whether to recall or withdraw a product or not can then be based on the identification of a hazard and the associated level of risk to the safety of consumers or users.

This article touches on the risk assessment process that is discussed in more detail in RQA's new "Practical Product Recall Management" training course as well as being covered in the Online CrisisPlan Toolkit (www.crisisplantoolkit.com).

The risk assessment methodology considers both the severity of a potential injury / illness to the consumer, as well as the likelihood of it occurring. We take risks everyday of our lives - crossing the road, cutting food with a sharp knife, ironing clothes with a hot iron and many more. However, in carrying out these activities we appreciate what the associated hazards are, and know that if we conduct the task with prudence, the level of risk is acceptable to us.

When considering the seriousness of a hazard it is also important to consider the type of consumer that will come into contact with the product, as the level of severity can alter significantly between different user groups. These groups may include vulnerable consumers, such as children and the elderly. If we take one of the earlier examples, cutting food with a sharp knife; it is easy to appreciate that the risk would be much greater if this was being performed by a child, as opposed to a competent adult. In addition, the way in which the product might reasonably be used must be considered, which would include foreseeable mis-use of the product, over-use of the product, and use of the product by a non-intended user. All of these considerations can have an impact on your risk assessment, and so should be included. The recommended approach would be to conduct a separate risk assessment for each of these variations.

Having determined the level of severity, and the likelihood of it occurring we can use a standard risk assessment matrix, like the one shown below, to give us our overall risk classification. This gives an indication of the risk to the consumer taking into account both the severity and the probability of the hazard. Now that we have this classification, it becomes easier for us to determine the correct course of action.

In order to make this matrix more usable for your own business, it is necessary to define the types of injuries that could result from your own products, under each of the severity levels.

In order that this risk assessment approach provides meaningful information to the Recall Team, it is essential that the persons (not an individual) conducting the assessment have the appropriate level of experience and expertise with the affected product, and the way it is used.

So, how do we apply this methodology to a potential product recall situation? Well, in the exactly the same way. Firstly, assess the severity of the injury or illness that the defective product could cause - do you consider it to be very serious, serious, moderate or slight? Again, having examples of injuries against each of these classifications, relevant for your own product, make it easier to determine the level of severity. Then, consider how likely this defect will cause the injury. This can include two elements depending on the product and the nature of the defect. For example a defective power supply, that may fail (1st element of probability) and when it fails how likely is it to cause electric shock (2nd element of probability). The same approach can be adopted for all types of products including food. If the defect was pieces of glass in loaves of bread, the first element would consider the likelihood of the glass being present, and then the second would consider how likely this glass would cause injury. As before, we then combine both the severity and the probability to provide us with an overall risk classification. This provides us with a more structured approach from which we can make our decision on the action to be taken in terms of recalling the product from the marketplace, or not.

Note: These are provided as an example only and should be modified for your specific business and purpose

The risk assessment should be continually reviewed and updated throughout the incident, especially when new information becomes available. This may include the results of laboratory analysis, which may affect the severity, the probability, or both. Also, again at the end of the incident when the team are deciding if they have done all they possibly can and are looking to close the case. The risk assessment can be used to determine the residual risk to confirm that this is now at an acceptable level.