The end of the 20th century was marked by a drastic increase in the incidence of foodborne illnesses, large-scale outbreaks and the emergence of new foodborne pathogens and chemical hazards. An alarming number of food safety incidents and crises, widely reported by the media, also fueled the feeling of insecurity among consumers. A combination of different factors is believed to have contributed to this trend, among which:

● The industrialization of agricultural production, mass production and increase in the number of food service establishments;

● The liberalization of trade and the growing number of imported foodstuffs;

● Tourism, urbanization with subsequent changes in lifestyle, food consumption pattern and food preparation practices. Additionally, the increased availability of and accessibility to information and its rapid communication through mass and social media further amplified the feeling of insecurity.

The consumer perception and the trend of requiring better quality, fresher food and more ethical food production practices has also weighed in the decision-making process. These developments have been the impetus for major changes in the management of food safety and the development of new procedures and principles for decision-making, changes in systems and requirements for food production and processing, and for the strengthening of the infrastructure for food safety management (Table 1.1).

Hence, the 21st century sets the beginning of a new era in food safety. Reviewing the history of food safety from prehistoric times, we can divide it in three major eras:

● A time where consumers were directly managing the safety of products by consuming a food and judging the safety by its impact on their health; ● A period where governments were managing food safety by testing products and removing contaminated or non-compliant products from the market; in general, food was considered safe unless people became ill or tests would indicate

 ● The present era where food businesses have become responsible for providing evidence that they have taken necessary measures to prevent contamination of foods. This means that foods are considered safe when there are proofs that the safeguard measures have been taken and the hygienic conditions of production, processing, transport and distribution or preparation have been observed.

Key Guiding Principles that Gained Prominence in the 1990s for the Management of Food Safety :

1. Integrated approach, i.e. consideration of the risks and control measures along the entire food chain, from

primary production up to the point of consumption.

2. Shared responsibility, which is the recognition that all sectors, including consumers, have a responsibility in ensuring food safety.

3. Multi-disciplinary approach, which comes from the understanding that ensuring food safety requires different types of scientific and operational expertise.

4. Evidence-based and risk-based decision-making to ensure objectivity and the most efficient use of resources in food safety management. This principle is important to assure stakeholders or trading partners that measures are based on scientific and technical evidence, and are effective and commensurate to the degree of risk. The principle also facilitates the implementation of the WTO/SPS article on equivalence as it allows countries to deviate from the requirements of importing countries, if they can demonstrate the equivalence of measures on a scientific basis.

5. Transparency, uncertainty and precautionary principles. Transparency is an obvious consequence of the abovementioned principles on the evidence-based decision-making process. However, it gains particular importance when there is uncertainty in data or when data are lacking. The value of transparency is that, in absence of full scientific information or variation in the degree of risk, the uncertainty and variability are declared, and evidence of the adequacy of protective measures is provided. Transparency also increases trust in stakeholders and trading partners. The precautionary principle states that if a product, an action or a policy has a suspected risk of causing harm to the public or to the environment, protective action should be supported before there is complete scientific proof of a risk.

6. Structured approach: i.e. while risk managers and risk assessors should maintain an active interaction, there should be a functional separation between risk assessment and risk management to ensure objective and unbiased decision-making, balancing scientific consideration with societal values and economic interests, as well as considering the risk perception of consumers.

7. Harmonization of food standards which is a goal as well as a consequence of the WTO/SPS Agreement.

8. Continuous improvement. As in any quality management system, a Plan, Check, Act and Do/Review process should be applied to food safety management. Such activities will continuously improve the safety of foods by reducing risks to a level that is as low as technically/reasonably achievable.

THE CONCEPT OF FOOD SAFETY AND ITS DEFINITION

Today, the subject of food safety has become a discipline in its own right and a formal definition was elaborated by the Codex Alimentarius Commission1 (CAC) in 1997.

According to the CAC, “food safety is the assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.” This definition embodies several important notions:

1. The notion of harm, which separates safety aspects of food from other quality aspects that make food unfit for human consumption without necessarily presenting a danger to health. The aspects of food which make it unfit for human consumption, even though it is safe, are referred to by the CAC as food suitability.

2. The concept of assurance, i.e. food safety and its management should be based on measures that are in place to provide assurance that food is safe. In other words, food safety depends on the conditions in which food is produced and prepared, and not on  the results of the end-product testing, which for many contaminants cannot be a reliable method for food safety assurance. The conditions for ensuring both safety and suitability are referred by the CAC as “food hygiene.”

3. Preparation and/or use of a food product should be considered in product design. A food product is considered safe if it is prepared and/or used according to its intended use. Subsequently, the intended use should be considered by the manufacturer in the design of the product as well as in their information conveyed to the consumer. The consumer must also follow on-pack instructions as provided by the manufacturer.

ELEMENTS OF FOOD SAFETY MANAGEMENT

The modern approach to food safety management recognizes the need for cooperation of different sectors and a role and a responsibility for each sector. Figure 1.1 illustrates the functions of the different sectors as described below.

Government

Public health and food control authorities have the leading role in managing food safety and have the responsibility of overseeing the safety of the food supply, from primary production up to the point of consumption. With this responsibility, they have to do the following:

● Foresee all infrastructures and public health services that are necessary for a good food safety management, such as public health laboratories, water supply and sanitation, etc.;

● Promulgate laws and regulations, which give priority to public health but which can also meet other societal and environmental factors;

● Enforce legislation through the provision of advice to trade and the commercial sector, inspection and monitoring of food supply, and, where necessary, prosecuting offenders;

● Provide education to caregivers, consumers, travelers, health professionals and the public at large.

Today, decisions on measures required to manage risks are taken in the context of the risk analysis process. There are different types of models for describing the risk analysis process. Figure 1.2 depicts the process of risk analysis according to Codex Alimentarius. The process includes: risk assessment, risk management and risk communication.

FIGURE 1.1 General overview of the organization of food safety management in society.

FIGURE 1.2 Risk analysis process.


The first step is referred to as preliminary activities. As part of this, governmental risk managers will commission a preliminary risk profile for a given hazard or hazard/food. Based on the outcome of this and in the light of existing data, they will decide if a risk assessment is required, or if it is possible to evaluate the various control options. Should risk managers find that a risk assessment is justified, bearing in mind the resource and time investment, they may decide to commission a qualitative or a quantitative risk assessment. In this case, they are responsible for elaborating a risk assessment policy in consultation with risk assessors and other interested parties. A risk assessment policy is a guidance to risk assessors,
outlining information such as:

● The purpose and scope of the risk assessment, e.g. sector of the food chain, types of food and products to consider;
● Target populations or subpopulations; ● Key scientific judgments, particularly when there is a high  degree of uncertainty in existing data or in data gaps;
● The type and sources of data to be considered;
● How the data should be presented, in particular the types of assumptions and uncertainties.


The process of risk assessment and risk management follows an iterative interaction between risk assessors and risk managers, during which these need to foster mutual understanding and refine the risk assessment so that it responds as closely as possible to the questions posed by risk managers. When deciding on the appropriate control measures, risk managers need to take into consideration a number of other factors, sometimes also referred to as “other legitimate factors.” These factors vary according to the nature of the hazard under consideration and can include costs, feasibility, benefits, other risks (e.g. environmental or nutritional), consumer preferences and societal values such as animal welfare. At
times, a risk assessment may be required to advise on the efficiency of the control measures, to develop an understanding of the public health outcome according to different levels of contamination, to have an estimation of the risk of various foods/hazards combination, etc. In managing a risk, depending on the nature and degree of the risk and on other factors mentioned above, risk managers have different options at hand. These range from taking a regulatory action, such as those listed below, to taking no action.
● Compliance with certain standards (e.g. setting a norm for a chemical hazard or a food safety objective or microbiological criteria for a microbiological hazard);


● Labeling;
● Testing and/or certification of foods;
● A specific processing of foods to inactivate pathogens;
● Application of a code;
● Recalling a product in case of an incident

Alternatively, they may decide to manage the risk by providing education to consumers or requiring the training of food handlers in food service establishments. It can also happen that they decide not to take any action (e.g. if the risk is low or negligible). In any event, the food safety authorities have the responsibility to communicate and explain their decision to the stakeholders. To identify possible food safety problems and to review the implementation of the risk management decisions and to evaluate the need for any revision in decisions or implementation, the collection of various types of data need be considered. Examples are:

● Inspection reports and evaluation of implementation of risk management decisions by the food industry;

● Monitoring of chemical contaminants;

● Surveillance of foodborne diseases (data from different types of surveillance methods need to be considered);

● Consumer complaints;

● Trade rejections;

● Public recalls, withdrawals and/or incidents; and

● Applied research based on defined indicators (knowledge, gaps).

Other types of information may also be required for planning improvement or preventive actions. Examples are trends in incidents and alerts, be they occurring in a country or outside the national boundaries, adequacy of resources, as well as various changes in the society such as changes in climate, demography, international trade and travel, or emergence of new pathogenic agents.

Industry

The food industry is responsible for ensuring that the food that it puts on the marketplace or that is served in food service establishments is safe, fit for human consumption and meets regulatory   requirements of the country where it is marketed. They have to consider the regulatory norms for hazards as food safety standards and ensure that their products are not violating these limits. To meet these responsibilities, the food industry is required to have an integrated food safety assurance system. A model for this system consists in combining three sets of measures according to the three lines of defense (Figure 1.1).

The first line of defense is the implementation of codes of good practices. These are a set of general principles and measures which have been identified through past experience as necessary to ensure the safety and wholesomeness of the foods produced; with some adaptation, they are generally applicable to all categories of foods and products and/or establishments regardless of location, specific conditions and type of business. Depending on the sector, they are referred to as Codes of Good Agriculture Practice, Codes of Animal Husbandry, Codes of Good Manufacturing Practice, Codes of Good Transport or Storage Practice, etc. Very often, such codes are voluntary, but at times they are legally established

by regulatory authorities. However, where they do not exist or are not stringent enough, the industry may also develop such codes. The Codex Alimentarius Commission has developed a large number of codes of practice. The recommended International Code of Practice –General Principles of Food Hygiene is one of the “horizontal” codes that has wide application in the food industry. For given categories of products, there are also product-specific codes where guidance is provided for the handling of that particular group of products. The second line of defense is the application of the HACCP system. During this process, hazards specific to a food and/or process are proactively identified and control measures

specific to the hazards in question are determined. Concerning steps that are considered critical for ensuring the safety of the food product, monitoring parameters characterizing the control measures and critical limits for the monitoring parameters are established and the steps are monitored to ensure that the critical limits are respected at all times. Additionally, any regulatory requirements (such as codes of practices or national standards, food safety objectives, sampling plans, etc.) or customer requirements, e.g. specifications, performance criteria for intermediary processes, need to be considered during product/ process design and respected during operations. Needless to say that during the development of an HACCP plan, measures identified for controlling the hazards and the parameters as well as limits to be respected need to be validated, short of which the HACCP study will become a simple paper exercise. HACCP also has other elements such as corrective actions in case the process is going out of control, and, as explained below, verification and documentation.

A strategy that has been used by some governments to assist small or less developed businesses in applying the HACCP system is to develop HACCP-based codes of practice for specific categories of food products. Such an approach is important for small or less developed businesses as these often lack expertise in food safety, and unless they are assisted by a trade organization, they may not be in a position to carry out an HACCP study by themselves. A HACCP-based code of practice for a specific sector combines both the general principles of food hygiene and the considerations and requirements specific to a given food sector.

Frequently, the question is raised about the difference between the code approach to food safety assurance versus the HACCP system, and their respective benefits. Originally, a code approach was viewed as a general and prescriptive system of management of food safety in a business. Subsequently, HACCP was recommended by public health authorities to promote a preventive approach based on the analysis of hazards in foods or processes, before these lead to an incident. When applying the HACCP system, hazards specific to a particular food product, process and to the conditions in which the food is prepared are identified and control measures specific to the hazard in question are devised. In this way, as opposed to codes that are general guidance, through the HACCP system control measures are targeted to hazards specific to the product (raw material or conditions of production).

However, with experience, it became evident that both approaches have their respective values, and that HACCP would be more efficient if some basic hygienic conditions and preventive measures were in place. Today, these are referred to as prerequisites in food safety assurance systems of the food industry, and it is recognized that it is by combining both approaches that the optimum conditions of food safety management are attained. Very often, the documentation required as part of HACCP has given the HACCP system the negative image of being burdened by paperwork. However, records and documentation are essential as support material for communication between members of the HACCP team and/or with time, for the maintenance of the plan, i.e. for the HACCP team to be able toconsider the need for any change in the plan and thus ensure that the system remains valid and up to date. Also, records are required to provide evidence to customers and/or inspectors of the adequacy of measures.

The third and last line of defense is verification activities. These are also part of the HACCP application, but to delineate between measures implemented for prevention and those required for verifying that preventive measures are effective and performing correctly, these are presented separately.

As for the governmental evaluation process, verification activities include all tests and other data collected to verify that preventive measures achieve the objectives set. Verification should not be mistaken for validation, which is a process to ensure that control measures are effective to achieve the objectives desired. The validation process is usually implemented during the product and process design stages, or when a change has been made in product design or during its manufacturing. If verification data indicate that a product is not meeting a set standard, even though the plan has been implemented, the validation of control measures may need to be questioned.

In principle, where codes of good practice and the HACCP system are optimally implemented, a high degree of safety can be assured. Nevertheless, verification measures are important to detect any dysfunction in the system. They also provide evidence of compliance with the food safety standard and should not be stopped on the grounds that data on contamination are negative, as data are needed for proving the performance of the food safety assurance system at all times. Examples of verification measures are:

● Raw material and end-product testing;

● Environmental monitoring;

● Calibration and other maintenance checks;

● Release of products;

● Audits;

● Consumer complaints handling.

Should verification data indicate non-compliance, the adequacy of the implementation of the HACCP system and the prerequisites must be examined in the first place. In absence of any failure in  implementation, the validation of the elements of the HACCP study can then be questioned.

At times, in spite of all measures, it can happen that a raw material used in a product is contaminated or a product that is contaminated is marketed. Through a traceability system, i.e. information on the source of raw materials or on the customers who have received the product, a contaminated product can be traced and recalled. Regulatory authorities in some countries require that the traceability system of an establishment ensure that information on the source of a raw material or destination of a final product be available for one step up or one step down. With the globalization of the food supply and the passing of food ingredients through various traders, it is sometimes difficult to ensure precise or valid information on the condition of the production of raw materials. Where information on traceability is lacking, the investigation of outbreaks and the identification of the implicated food become more difficult as observed in an outbreak of Salmonella Saintpaul the United States in 2008 (CDC 2008). Originally, the outbreak was attributed to tomatoes until it was discovered that the main vehicle was jalapeño and serrano peppers. The outbreak lasted from April to August and some reported 1442 persons fell ill. The weaker the traceability, the larger the scale of the outbreak or product loss. This was demonstrated in the dioxin incident in Ireland where a full product recall was conducted for pork meat, whereas for beef meat it was possible to limit the recall to the contaminated product because after the BSE crisis, a traceability system was established for beef products (Casey et al. 2010). Similarly, in the food manufacturing industry, the finer the traceability, e.g. indicating the date and time the product was produced, the smaller the quantity of product wasted in case of recall. Finally, the entire food safety assurance system should be supported by a well performing crisis management system to protect consumers from exposure to contaminated products.

Fundamental to all these systems are the training and education of the staff as well as the management’s commitment. Therefore, fostering a culture of food safety, from training of the staff to motivating them and appreciating their constraints, constitutes one of the most important pillars of food safety management in industry and in governmental functions.

The importance of organization culture cannot be emphasized enough. Reporting any noncompliance or a risk-prone situation at an early stage can contribute to preventing outbreaks before they occur.

On the technical aspects, scientists contribute to food safety management by providing different types of scientific data and their assessment, which is necessary for making decisions. Examples are:


● Toxicological information, mechanisms of contamination of foods with chemicals, or their formation;
● Ecology of microorganisms and epidemiology of foodborne diseases;
● Validated analytical methods;
● Process and technologies to control hazards;
● Consumer perception, beliefs and practices.


In industry, scientists can minimize risks associated with products and processes by designing out risks during product development and defining necessary control measures for managing the operational risks during the production or manufacturing of foods.
Additionally, scientists can further contribute to the management of food safety by creating tools to make information on food safety easily accessible to all stakeholders in society. 

CHALLENGES IN MANAGEMENT OF FOOD SAFETY AND OUTLOOK

Some Major Developments in Food Safety Management in the Last Two to Three Decades

1. Increased general awareness about food safety.

2. Research on pathogens, chemical contaminants and technologies and increased scientific and technical

know-how.

3. Development and emergence of high-performing food technologies and analytical methods.

4. Increased availability of epidemiological and scientific data on foodborne pathogens and chemical

contaminants.

5. Improvement in the procedures for risk assessment and risk management.

6. Strengthening of national legislation (standards, codes of practices) and its enforcement (inspection,

monitoring).

7. Strengthening of the international requirements (Codex Alimentarius, Agreement of the Sanitary and

Phytosanitary Measures of the World Trade Organization, ISO 22000 refers).

8. Increased preventive measures at the primary industry.

9. Improvements in quality assurance, including application of the HACCP system.

10. Strengthening the foodborne disease and food contamination surveillance systems, alerts, traceability and incident management.

11. Increased training of professionals involved in food safety (governments, food industry and food service sector).

12. Recognition of the importance of risk perception and good risk communication.

13. Educational campaigns for consumers and the general public.

14. Improved waste management, protection of the environment and of water and sanitation facilities

Complexity of Food Safety

In food safety, we are facing a mind-boggling number of hazards of biological, chemical, physical and other nature, not to mention the unexpected chemicals that may find their way into the product due to accidental contamination, tampering or sabotage. With developments in science and technologies, increases in our knowledge and analytical capabilities, the list of hazards is becoming longer. Chemical hazards alone group countless chemical agents, e.g. hundreds of different types of pesticides, antibiotics, food additives, environmental contaminants from heavy metals to PCBs and radionuclides, naturally occurring toxins, including a number of mycotoxins, as well as processing and packaging contaminants.

Microbial hazards are also numerous, but their greatest challenge lies in their multifaceted nature. For instance, they vary in their:

● Conditions for growth (pH, water activity, aerobic versus anaerobic conditions);

● Mechanism of pathogenicity and ability to produce toxins with different sensitivity to heat;

● Virulence and in their opportunistic nature, i.e. some pathogens target mainly vulnerable

population groups;

● Dose–response relationship, which also depends on the food matrix and the target person;

● Resistance to various control measures, e.g. heat, acidity, chlorination, etc.;

● Ecology and vehicle of transmission; and

● Health consequences.

Managing this technical and scientific complexity and communicating this complex set of information to decision-makers or other actors in the food chain are not always easy.

A particular difficulty lies in communicating with food handlers/caterers in the food service industry, who have a generally low level of academic background, or with the general public in a convincing manner; yet this knowledge is fundamental to the decision-making process and a prerequisite to good practices. This communication becomes an intricate task when food safety measures are intertwined with economic factors, ingrained cultural habits and beliefs, or simply food preferences. An example is the consumption of raw milk or cheese made with raw milk versus the pasteurization of milk for health protection. In the food industry, even in the most resourceful companies where there is access to technical expertise, the complexity of food safety is an issue in designing food safety control systems, particularly when other conflicting quality criteria have to be met. An example where this technical complexity has led to a mistake in decision-making can be seen in an outbreak of salmonellosis in the United Kingdom in 2006 (Carroll 2009). In this incident, the company in question undermined the consequences of low level of salmonella in chocolate. It assumed that at the level salmonellae were present, it did not present a concern for public health while a number of previous outbreaks provided evidence of the risks. Another example is found in an outbreak of Staphylococcus aureus where it was believed that by reheating milk which was subject to time–temperature, the milk could be rendered safe, while toxins of S. aureus are heat stable. In the area of chemicals, the contamination of soft drinks with benzene shows the global difficulty in keeping track of the scientific and technical know-how and transferring it to a new generation of professionals. In 2006, it was found that some soft drinks, where a combination of sodium benzoate and citric or ascorbic acid was used, contained unacceptable levels of benzene due to the interaction between these ingredients. This interaction and potential formation of benzene was known already in the 1990s, but presumably, with time, this knowledge had faded away from the institutional memory of the scientific and technical organizations. A rigorous implementation of HACCP can prevent many such technical errors; however, it requires that HACCP studies be carried out by a team of competent experts and be duly validated.

This is still not the case in many businesses. Thus, communicating the science of food safety to all stakeholders of the food chain, commensurate to their role and in a responsible manner, will be an important task in the 21st century. This is a huge but important challenge, as this means basically educating the entire world population in food safety since everyone is a potential food handler and some may have a professional life in the food sector. This can be achieved only if food safety is taught systematically in schools, starting from primary schools to academia, be it food science and technology or public health and medicine. Making this science accessible to every individual will promote common understanding. For the food industry personnel, training of the professionals is fundamental; while human error can be forgiven by consumers, ignorance or negligence cannot.

An Introduction to Creating a Food Safety Management System

A Food Safety Management System (FSMS) helps a food business operator avoid potential hazards in food preparation and handling.

 Who needs an FSMS?

All business premises where food and drinks are manufactured, processed, prepared, handled, stored, distributed, sold or served (including mobile or temporary premises such as delivery vehicles) must be registered with the environmental health department of the local authority in the area where the business is located. The business proprietor must submit an application form for registration at least 28 days before they begin trading.

Under the EC Regulations, as part of the registration process, proprietors must produce a written FSMS. The FSMS must be based on Hazard Analysis Critical Control Point (HACCP) principles, which require the proprietor and any staff who prepare, handle, store, distribute and serve food to follow procedures that ensure food is safe to eat. Go to www.food.gov.uk/business-industry/food-hygiene/haccp for further information about HACCP.

Following registration, a local authority environmental health enforcement officer will inspect the business premises and any proposed food preparation, serving and display areas, as well as the storage areas where food supplies are kept. They will continue to inspect the premises and any statutory documentation systems such as an FSMS on a regular basis to ensure adequate systems are in place and are being followed.

It is the responsibility of the business owner to ensure that the FSMS is implemented and maintained, but anyone who works in a food business and whose actions could affect food safety must follow the processes laid out by the FSMS. In most cases, it will be necessary to involve a range of employees in the creation, implementation and monitoring of the FSMS, including managers, cooks, food preparation staff, cleaners and other members of staff. In some cases, it will be useful to form an FSMS or HACCP team to enable staff to contribute to the FSMS. All staff will need to be suitably trained in the use of the FSMS and HACCP principles.

What should an FSMS include?

An FSMS provides a breakdown of a food business’s processes, such as making, preparing, serving or selling food, and identifies potential hazards and suitable control measures. An individual FSMS must be created for each separate activity if the business carries out more than one food-related operation, for example making sandwiches and selling them to customers via a mobile delivery service.

An FSMS is a written document that must be kept up to date and available for inspection by the local authority’s environmental health enforcement officers. As part of the FSMS, a food business operator must create and maintain a monitoring and record-keeping system.

The FSMS should be based on the seven HACCP principles, which provide a system for identifying and preventing potential food safety hazards. The seven HACCP principles are:

Identify hazards. This requires a risk analysis in order to identify any biological, chemical or physical hazards that may cause food to become unsafe.

Identify Critical Control Points (CCPs). These are specific points in business procedures and processes where steps can be taken to remove or reduce any potential hazards to an acceptable level.

Establish limits for CCPs. The limits are the maximum and minimum thresholds at which potential hazards must be controlled at each CCP. Examples include minimum frequency of cleaning, or minimum heating and storage temperatures.

Establish CCP monitoring procedures. Each CCP must be suitably monitored in order to ensure CCP limits are being met and processes are safe and under control.

Establish corrective actions. These are steps that need to be taken if the CCP monitoring procedures reveal that any limits for hazard control are not being met.

Validate and verify the FSMS. This involves putting checks in place to ensure the FSMS is working as intended, for example by checking CCP limits and records, or by microbiological testing of food.

Keep records. All food operators must keep written records, including records of the hazard analysis, FSMS, CCP limits, monitoring of CCPs, handling of corrections and any checking and verification activities.

The format of an FSMS should be appropriate for the individual business and easy to use. Some food business operators use flow charts to map out business processes and printed worksheets to document monitoring and corrective actions. Others use more detailed computer-based systems to record their FSMS. There is no specific format required, although many local authorities do provide their own templates and guidance documents. A food business operator should contact their local authority’s environmental health department for more information about this.

The FSA has also developed a range of schemes and guidance packs for different food sectors to help food business operators across the UK create FSMS plans. Go to www.food.gov.uk/business-industry/food-hygiene/haccp for further information. Schemes include:

The Safer food, better business (SFBB) scheme, which provides various information packs and training materials to help different types of food business operators comply with food safety requirements (www.food.gov.uk/business-industry/sfbb).

How often should the FSMS be reviewed?

Although the regulations do not stipulate any specific schedule, an FSMS must be reviewed regularly, and certainly whenever there is any change in food operations or processes. When a change occurs, relevant hazards and CCPs should be identified, with limits and monitoring procedures established. All relevant staff should be kept up to date with changes to the FSMS.

Who needs to see the FSMS?

The FSMS is a working document designed to help a food business operator maintain food safety, so it should be readily available to all staff that are required to follow its procedures. Buyers and other suppliers in the business supply chain can ask to see the FSMS in order to confirm that systems and processes are safe.

When a food business is inspected by local authority enforcement officers, the enforcement officers will need to be provided with the FSMS, along with records detailing the checks that have been carried out to ensure that the system is working and being followed. In most cases, inspections by enforcement officers will be carried out without prior notice, so it is important that records are continually kept up to date.

Hints and tips

An FSMS/HACCP team should be set up that includes key supervisors and staff in order to create and implement an effective FSMS.

Efficient record keeping is essential to the implementation of an effective FSMS, and HACCP procedures should be documented for the benefit of staff, customers and local authority environmental health enforcement officers.

An individual FSMS must be created for each separate food-related operation, if the business carries out more than one.

The level of documentation should be appropriate to the size of the business; for example, completion of paper-based worksheets may be sufficient for a very small business, while larger firms may require computer-based records.

Establish good practice, such as food hygiene precautions, before applying the HACCP principles.

Creating a flow chart of business processes can be a useful first step when setting up an FSMS.

Validation and verification of processes should be carried out by someone other than the person responsible for monitoring a CCP, and, if necessary, by a qualified external person.

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