Food Safety Management System (FSMS) is a carefully structured approach geared towards identifying, preventing, and mitigating food-borne hazards, in order to ensure food is safe for consumption. Food safety management is undoubtedly a good business.
Many groups have defined risk and risk characterization. For example, the World Health Organization’s (WHO’s) International Program on Chemical Safety defines risk as “the probability of an adverse effect in an organism, system, or (sub)population caused under specified circumstances by exposure to an agent” (IPCS, 2004).
Others have expanded this definition to include the fact that this probability can be expressed quantitatively or qualitatively and that risk characterization includes a discussion
of the significant scientific uncertainties in this information.
Furthermore, the committee agreed upon the following working definition for a risk-based
approach: “a systematic means by which to facilitate decision making to reduce public health risk in light of limited resources and additional factors that may be considered.”
The committee identified the following as key attributes of a risk-based food safety system: (1) is proactive based on a strategic management plan; (2) is data driven; (3) is grounded in the principles of risk analysis; (4) employs analytical methods to rank risks based on public health impact; (5) incorporates deliberation with key food safety stakeholders; (6) considers factors such as consumer perception, public acceptance, market impacts, and environmental impacts in decision
making when appropriate; (7) employs analytical methods to prioritize the
allocation of limited resources to manage risk most effectively; (8) employs
measures to evaluate the efficacy of the risk management program on a
continuous basis; and (9) performs all of these functions in a systematic and
transparent manner with the involvement of stakeholders.
A Conceptual Approach to Risk-Based Food Safety Management
The risk-based system envisioned by the committee will entail analysis and prioritization at several distinct levels:
• the formulation of a strategic plan that identifies outcomes/goals of the risk-based system,
• broad-based risk ranking to identify the most important risks based exclusively on public health considerations,
• the identification of additional data/information needs upon which prioritization of resources may be based,
• the choice of intervention strategies and allocation of regulatory resources, and
• the evaluation of outcomes
Attributes of a Risk-Based Food Safety System
- A risk-based system is proactive and based on a strategic management plan. Notwithstanding the need to respond to unforeseeable crises, risk activities should be planned in advance, an exercise that should include various stakeholders and be based on the knowledge gained from past experience with a vision of predicting food contamination problems. Managing a crisis in the short term and implementing a
well-developed strategic plan for managing food safety in the long term are equally important; attention to unanticipated outbreaks should not detract from implementation of the strategic plan.
- A risk-based system is data driven. Although expert opinion is a valuable asset when there are uncertainties or data must be interpreted, a risk-based system should be grounded in science.That is, the collection, analysis, and interpretation of quality data, as well as data management, are essential tasks for the implementation of a risk-based system.
- A risk-based system is grounded in the principles of risk analysis. A risk-based system should be grounded in risk analysis, with risk assessment, risk communication, and risk management as the essential basis for establishing a sound public health protection capability. If implemented appropriately, the system ideally provides a transparent,
data-driven means by which to determine the extent of public health protection achieved as a result of different risk management actions, and therefore it provides a decision-making tool. This concept has worldwide support and has been applied for several decades by regulatory and public health agencies.
- A risk-based system employs analytical methods to rank risks based on public health impact. A risk-based system systematically ranks risks even if those risks differ in complexity and uncertainty. The development of analytical methods (models) that can assign numerical values to the various risks based on public health impact is the foundation of this activity.
- A risk-based system employs analytical methods to prioritize the allocation of limited resources to manage risk most effectively. The evaluation of intervention strategies is an essential element of risk management. Risk managers must consider multiple characteristics or attributes of different risks and integrate these data for the purpose of
prioritizing and making effective use of resources. In this manner, decisions
are made by considering the food system as a whole, that is, with a systems-based approach. Important decision analysis tools that may be used in this process are feasibility, cost-effectiveness, and cost–benefit analyses. A major element of this activity is a clear statement of regulatory philosophy and the use of a road map showing how decisions will be made regarding the mix of private responsibility, government incentives, and government regulation that will be used to manage different risks.
- A risk-based system considers other factors, such as consumer perception, cost, controllability, public acceptance, environmental effects, and market impacts, in decision making when appropriate. Risk mitigation strategies and public policy decision making are influenced by factors other than public health risk. These considerations
should be formally communicated to stakeholders.
- A risk-based system employs measures to evaluate the efficacy of the risk management program on a continuous basis. An essential step in a risk-based system is evaluation of the efficacy of the system itself with respect to public health and other factors selected by decision makers. Evaluation of programs, always a daunting process, requires the
identification of indicators by which to link interventions to public health
outcomes. To collect and integrate food safety data so that attribution models can be built is a critical first step in this process.
- A risk-based system performs all of these functions in a systematic and transparent manner with the involvement of stakeholders.
- Risk managers should develop a process for implementing a two-way communication approach whereby stakeholders have an opportunity to engage in the risk-based decision-making process.This approach should include input and access to discussions regarding the basis for decision making, as well as information about the uncertainties and variability of the underlying data. Likewise, a risk-based approach requires disclosure of all sources of information, comprehensive analysis, and transparency
regarding the considerations taken into account in the decision-making process. In addition, independent peer review is fundamental to all scientific undertakings and critical for risk-based decision-making processes.
cycle of risk prioritization and regulatory (intervention
HOW TO ADOPT A RISK-BASED DECISION-MAKING APPROACH TO FOOD SAFETY MANAGEMENT
Step 1: Strategic Planning
1. Identify public health objectives related to food safety in consultation2
2. Establish a risk management plan (general and specific strategic
plans for meeting public health objectives and for considering and
choosing policy interventions to achieve those objectives).
3. Establish metrics with which to measure performance in consultation
Step 2: Public Health Risk Ranking (Ranking of Hazards)
1. Develop or select tools (models, measures, or other) for public health risk ranking in consultation with stakeholders.
2. Rank risks based on public health outcomes.
3. Report results to stakeholders and solicit feedback.
Step 3: Targeted Information Gathering on Risks and Consideration of Other Factors That May Influence Decision Making
1. Identify and consider additional criteria upon which risk-based decision making will be based (e.g., public acceptance, cost, controllability, environmental effects, market impacts) in consultation with stakeholders.
2. Conduct targeted information gathering. For each high-priority and/or uncertain risk, determine the need for collection of additional information and implement accordingly:
a. additional data collection (research, surveillance, survey, baseline
b. risk assessment (qualitative, quantitative, semiquantitative).
3. Based on that additional information, identify priority risks for which intervention analysis is needed.
Step 4: Analysis and Selection of Intervention(s)
1. Identify an appropriate level of protection for each high-priority risk, based on available data and in consultation with stakeholders.
2. Identify intervention options in consultation with stakeholders.
3. Identify the types of technical analysis, including but not limited to risk assessment, needed to evaluate the options; identify performance measures and the initial design of databases.
4. Gather the information necessary to conduct the technical analysis.
5. Choose intervention strategies for implementation using multicriteria
6. Report results to stakeholders, solicit feedback, and modify intervention
strategies if needed.
Step 5: Design of an Intervention Plan
1. For a successful food safety management system, you have to develop a plan for implementing the selected interventions in consultation with stakeholders.
2. Allocate resources and implement interventions.
Step 6: Monitoring and Review
1. Collect and analyze data on evaluation measures selected during
2. Interpret data and evaluate whether the interventions result in the desired intermediate outcomes.
3. Determine whether public health objectives are being met by using performance metrics developed in Step 1 (broad strategic planning).
4. Communicate the results to stakeholders for a near perfect food safety management practice
5. Review and refine the entire process in an iterative manner as necessary to accomplish both intermediate outcomes and public health objectives so as to achieve continuous improvement over time.
In conclusion, Food safety management is should be integrated to all sectors of the economy. Strategic planning, conducted at several different levels, is an essential
element of a successful food safety management systems or program.
The highest level of strategic planning involves the identification of long-term and broadly stated goals for protecting public health from the threats associated with food contaminants, sometimes referred to as public health objectives
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