Reach out to Annette Baltzer Larsen for more information.
By Alan Friis and Annette Baltzer
Professionally grounded and thorough risk assessments ensure a high level of hygiene, which forms the basis for safe food production.
According to legislation, food-producing companies must carry out risk assessments of food safety in their production. Food legislation is based on the companies' own checks where risk assessments form an important element. Equipment manufacturers are also required by the Machinery Directive to conduct risk assessments of their equipment so that it meets the customers' (the food producers') requirements.
Therefore, risk assessment is a central tool in work with food and product safety—both for food and for other products that impact human health and well-being. In practice, risk assessment is used in various contexts when examining, for example, all aspects of a food’s safety for the consumer.
The same basic tool is always used for risk assessment. The process comprises:
Finally, it is evaluated whether the risk in the given context is sufficiently low to be accepted. If the risk is not acceptable, it is necessary either to reduce it further or introduce actions to manage it in practice so that product safety is not jeopardised.
This article focuses on the two most central risk assessments:
There are a number of other situations where risk assessment is used, including:
In principle, risks relate either to consumer safety or to product integrity.
Consumer safety concerns adequately avoiding the presence of pathogenic microorganisms and allergens.
Product integrity concerns avoiding the presence of foreign bodies or other factors which ultimately damage the producer’s reputation and brand.
The risk of the presence of microorganisms and allergens depends on the raw material, the product, the production equipment and the cleaning process, including how often and how long cleaning is performed.
An installed plant essentially has an accepted residual risk. Therefore, the aim is to be able to control the process and stay on the correct side of the limits. The residual risk may change over time—a poorly designed or inadequately cleaned plant can accumulate material that increases the risk of remaining microorganisms and allergens.
Acceptance criteria depend on consumer groups and the consumer’s use of the product.
For a food producer, the risk assessment of the two identified risk elements could look as follows:
The critical hotspots are identified and delineated. If the critical element is a CCP (Critical Control Point), there are often other measures which ensure that the identified element poses a lesser risk, provided, for example, that a maintenance plan or other controls are followed.
The two identified risk elements in this example are:
The analysis must be based on available scientific documentation and also be independent, objective, and transparent.
A risk analysis of the above-identified risk elements could be:
Risk evaluation is a comprehensive assessment of how serious the particular risk is and how often it may occur.
A risk evaluation of the above-identified issues could be:
Risk assessment of process equipment and production lines before installation and commissioning, along with the requirement for a cleaning guideline, are among the prerequisites for CE marking to be performed.
CE marking of all machines is mandatory. CE marking always addresses operator safety and electrical safety. For machines intended for food, pharmaceutical, and cosmetic production, CE marking also requires assurance of adequate cleanability and use of materials that do not react with products.
The risk assessment for the equipment manufacturer is based on the specification requirements from the producing company.
A risk assessment of a plate heat exchanger at an equipment manufacturer, for the risk elements identified in the section 'Risk assessment at a food producer”' could look as follows:
The critical hotspots for the given equipment are identified. The equipment manufacturer’s customer has required:
The risk analysis must be based on available scientific documentation and must be independent, objective, and transparent. A risk analysis of the two identified problems could be:
Risk evaluation is a comprehensive assessment of how serious the particular risk is and how often it may occur.
A risk evaluation of the above-identified problems could be:
The two risk assessments each address what is important for the food and equipment manufacturer. At the same time, they highlight why it is essential for the parties to communicate and align expectations.
The equipment manufacturer needs input to the risk assessment from the food producing company regarding the criteria for when a residual risk on a machine is acceptable. This can only be evaluated based on the food producer’s criteria for when a given product is safe.
On the other hand, the food manufacturer needs to know that satisfactory process solutions are available, and that, for instance, it is possible to carry out the required measurements and corrective actions at a CCP.
The key message is: establish ongoing dialogue about risk assessment and share the necessary knowledge between the parties. In this way, you will achieve the best process plants and thus the best opportunities for producing safe foods that also meet the food company’s quality requirements such as shelf life.
Reach out to Annette Baltzer Larsen for more information.