Medios y control

According to ISO 31000 standard (2009), risk assessment is a “science-based” part of risk management in which scientific information and other elements include, for example, social, cultural and ethical issues, are combined and weighed in choosing the convenient risk management options.

Specifically, those perform risk assessments have to be informed about:  The context and objectives of the organization,

 The extent and type of risks that are tolerable, and how unacceptable risks are to be treated,  How risk assessment integrates into organizational processes,

 Methods and techniques to be used for risk assessment, and their contribution to the risk management process,

 Accountability, responsibility and authority for performing risk assessment,  Resources available to carry out risk assessment,

 How the risk assessment will be reported and reviewed.

Risk assessment is totally the process of risk identification, analysis and evaluation. Risk assessments can be performed at various levels such as at organizational or departmental levels, for projects, individual activities, as well as, distinct risks. Various tools and methodologies may be helpful in particular contexts. Risk assessment declares a figuring out of risks, the reasons, outcomes and probabilities which would contribute to decisions by providing inputs about:

 Whether an activity should be undertaken;  How to maximize opportunities;

44  Choosing between options with different risks;  Prioritizing risk treatment options;

 The most appropriate selection of risk treatment strategies that will bring adverse risks to a tolerable level.

As the risks may include a broad range of causes and consequences, then, a multidisciplinary approach may be needed for risk assessment. In the food safety domain, risk assessment might have a marginally separate definition and procedure structure, but, the overall principal of the logic and outcome is similar to risk assessment techniques introduced by ISO 31000 standards. Codex explained four analytical steps in risk assessment (see Figure 2:13), which would be particularly addressed in the next section. The way of implementing these steps might be to some extent different for chemical or microbiological hazards.

2.4.2.1 Risk assessment in the food industry

Hazards that are a focus of food safety control deals with risks on customer safety, animal health, economy and the general public. This risk depends mainly on the degree of injury and the likelihood of occurrence (Lammerding & Fazil, 2000). An evaluation of this risk is important to support the decision-making with respect to administration and regulation. Risk assessment is the scientific foundation for every further steps of risk analysis, i.e. risk management and risk communication (Codex Alimentarius Commission (1999).

CAC and EU characterize hazard analysis as the general term that joins secondary tasks of risk assessment, risk management and risk communications. Risk assessment is further grouped into hazard identification, exposure assessment, hazard characterization and risk characterization. This scheme has turned into an integral section of the EU food hygiene legislation and was introduced by World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (Scott, 2007) which obliges that all protective measure must be risk based. It should be mentioned that in the field of business administration (ISO 31000 standards) and quality management risk management is viewed as the more general term, which comprises of risk identification, risk assessment and risk control.

The outcome of the risk assessment is used as an input in risk management, i.e. to select, recommend, or develop an appropriate control measures (prevention or intervention). For the risk management objective the outcome of the risk assessment needs to be transferred into legislation, regulation, or operation procedure in concepts like HACCP, GHP, GAP, etc. This transferring the outcome from risk assessment to risk management is quite a challenging task in practice.

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methods may be used to assess different kinds of food safety problems (Table 2:6). Methods vary according to the class of hazard (i.e. chemical, biological or physical hazard), the food safety scenario (e.g. concerning known hazards, emerging hazards, new technologies such as biotechnology, complex hazard pathways such as for antimicrobial resistance) and the time and resources available.

Table 2:6: Characteristics of biological and chemical hazards that impact on risk assessment method selection (ISO31000 ISO, 2009)

Biological Hazard Chemical Hazard

Hazards can occur at many point along the food supply chain

Hazards usually occur in the raw materials and ingredients, or certain processing steps (e.g. packaging migrants)

The concentration of hazards change at different points along the food supply chain

The level of hazards present in a food after occurrences often does not change significantly

Health risks are usually results from a single portion of food

Health risks may be acute but are generally chronic

Individuals have wide variability in health response to different levels of hazards

Types of toxic effects are generally similar from person to person

In biological and microbiological hazards, the hazards can occur and transmit in different nodes of supply chain, from supplier to consumer. Thus, it is required to move forward along the various stages of food chain to evaluate the estimation of risk. Although the accuracy of estimated risks is often limited by uncertain dose-response data, the most advantage of such risk assessments lies in their ability to model the relative influences of distinctive food control measures on risk estimates.

In chemical hazards, by contrast, “safety evaluation” is a standard risk assessment methodology. In this method, maximum exposure levels (a dose level that is certain to pose no considerable risk to the consumer) are recognized to meet a “notional zero risk” consequence. However, this method does not support precise estimates of risk versus dose and cannot model the impact of various interventions in terms of risk reduction.