High-Risk Management

Key Considerations of High-Risk Management

Products intended to be consumed as Ready to eat (RTE) or Ready to reheat (RTRH) need to be manufactured within facilities that have specialised controls for microbiological safety. The requirements for High-Risk production facilities should reflect Food Industry ‘Best Practice’, as this reduces risk for consumers, and by proxy, for the businesses manufacturing such products.

Ready-to-eat products are relevant for the application of High-Risk practices due to their status. Ready to reheat items are relevant as consumers may not always follow instructions for storage and use, which can result in foodborne illness.

Product Design and Development

Procedures for product design and development must be developed, documented, and implemented to ensure the process yields appropriate outcomes. The product design and development should include structured consideration of HACCP, production trials, specifications, packaging, labelling, and shelf-life consideration for microbiological, chemical, physical, and organoleptic parameters including challenge testing where applicable.

It is important to consider within any Product Design and Development flow process that stages are linked in a logical order of dependency. Each stage of the Product Design and Development process contains a set of prescribed and concurrent activities incorporating industry best practices. The activities during a stage are generally run concurrently rather than one after another. This ensures that they are carried out quickly and effectively. Process stages must be cross-functional to allow all areas of the food business to contribute.

When considering the implementation of Product Design and Development elements for High-Risk processes and products, additional emphasis must be placed on the microbiological status of raw materials. This is because the management of microbiological risks within a High-Risk scenario relies heavily on the assumption of microbiological limits of process inputs. A lack of consideration of raw material microbiological status can result in a significant microbiological non-conformance.

As with any risk-based activity, implemented Product Design and Development protocols need to follow the established steps, including Development, Documentation, Implementation, Monitoring, Corrective Action, Verification, Validation and Skills, and Knowledge.

About Premises and Equipment Design and Construction Standards

The physical facilities and structure of a food establishment must be properly designed, constructed, installed, operated, and maintained to allow the receival, storage, production, and dispatch of safe food. The design and construction of the premises and the items within it have a direct link to the control of the entry of pests and potentially their harbourage and ability to cause contamination of processes or products. The design and construction of premises and equipment are also directly related to the control of cross-contamination by staff and visitor traffic flows, process flows and waste flows.

Many factors are important to premises and equipment design being supportive of food safety including:

• Water supply, sewage, and water waste disposal;
• Garbage and recyclable matter storage;
• Ventilation;
• Lighting;
• Construction of floors, walls, and ceilings in an appropriate manner, and of correct materials;
• Correct installation and allowance for cleaning of fittings and equipment;
• Availability of designated hand-washing facilities;
• Storage areas that are appropriate for the items being stored within them, and in the correct vicinity related to food areas. For example, chemicals are stored away from food ingredients and food packaging;
• Food transport vehicles are constructed and maintained to reduce food contamination risk;
• Provision of designated eating, drinking, and smoking areas.

The internal and external design and layout of food establishments should permit good food hygiene practices, including protection against cross-contamination during and between food production operations. This may include a defined one-way product flow, the segregation between high and low-risk areas, and entry to high-risk areas via specially designated and managed changing facilities.

Sanitary facilities such as toilets should not be adjoined to operational areas within any food business. As a minimum, a double door and airlock between the sanitary facilities and low-risk production areas would be acceptable.

Adequate suitably designed and constructed facilities should be provided for cleaning food utensils and equipment. Such facilities should have an adequate supply of hot and cold potable water where required.

High-Risk ‘Zones’

High-Risk ‘zones’ within a food business usually refer to the areas of the site flow process following a microbiological kill step. High-Risk based controls are implemented until the foodstuff is fully packaged. Items that undergo a final microbiological kill step or microbiological reduction step while contained within their fully sealed packaging may not be classed as High-Risk.

It is generally considered best practice for High-Risk ‘processes’ to be identified as such within HACCP documentation, such as the process flow diagram. High-Risk ‘zones’ should also be clearly defined within site floor plans and layouts.

Where a food business cannot fully meet the expected requirements for design and construction of High-Risk areas and facilities, the business must provide substantial evidence of effective, validated implementation of microbiological controls.

High-Risk is the more stringent standard. High-Risk status items may be used within a High-Care area because they have had a higher level of microbiological intervention, whereas High-Care status items entering a High-Risk area require additional controls to manage the related risks.

High-Risk Transfer Points

The methods and facilities used to transfer items to and from High-Risk areas require thorough risk assessment to confirm they control microbiological risk. Common methods include:

• Travelling heat treatment equipment, such as an oven or fryer, that is loaded in the Lower Risk area and unloaded in the High-Risk area;
• Heat treatment through a double door system fitted with an airlock, loaded in the Lower Risk area and unloaded in the High-Risk area;
• Transfer of heat-treated materials through piping from the Lower Risk area to the High-Risk area;
• Tipping heat-treated foodstuffs from the Lower Risk area to the High-Risk area over a defined control barrier;
• Transfer of fully packaged, appropriately heat-treated items into the High-Risk area via a sanitation process, such as a flume, conveyor or bath. The sanitation process must be validated and verified to ensure its ongoing effectiveness, including time, temperature and chemicals where applicable;
• Transfer of fully packaged, double bagged items from a High-Risk supplier into the High-Risk area via a sanitation process. This may include scenarios in which blanching, UV treatment, irradiation, chemical sanitation or HPP (High-Pressure Processing) has been used by the supplier;
• Transfer of produce into the High-Risk area via a validated sanitation process, such as a flume or bath, where the process is designed to reduce microbiological load;
• Transfer of bulk materials, such as pH-controlled liquids, through piping from the Lower Risk area to the High-Risk area.

Where equipment requires settings for the transfer of items from lower risk to High-Risk areas, it is preferable that these settings can be controlled only from the lower risk or the High-Risk side, as defined in the risk assessment. Where a system transfers items through a wall, it should be possible to clean it from both sides.

Adequate and effective storage and work-in-progress facilities must be provided within the High-Risk area for transferred items, particularly where rapid cooling is required to control spore-forming pathogens. Post heat treatment cooling temperature and time profiles must meet legal and product-specific requirements. Validation and verification of transfer methods are required on an ongoing basis. See Validation Activities and Verification Activities.

High-Risk Design and Construction

Above and beyond the construction and design requirements of all food businesses, sites facilitating High-Risk processes and products require additional facilities and functions to ensure microbiological risks are controlled. Examples of High-Risk design and construction considerations are provided as follows:

• Full segregation should be facilitated, ensuring physical separation of lower risk and High-Risk Areas;
• Construction and design of High-Risk areas should not allow the use of scenarios that may encourage the harbourage, growth, or spread of microbiological concerns;
• High-Risk scenarios should be designed and constructed to allow a genuine one-way process flow where applicable;
• Drainage systems in High-Risk areas should be independent of drainage systems within, or linked to lower risk areas;
• Where drainage segregation is not available, drains must run from the High-Risk areas towards the lower risk areas;
• Anti-backflow devices must be fitted within drainage systems where practicable;
• Drainage systems, including flow direction and gradients, should be maintained and reviewed on an ongoing basis;
• Drainage channels should be smoothly constructed from non-corrodible materials to exclude any crevices, have recessed top grates and removable drainage filter baskets;
• Premises piping must be sealed, include applicable liquid and air anti-backflow devices, and have an adequate fall away from the High-Risk areas of the site;
• Flooring must be smooth and impervious and fitted to allow effective drainage without any pooling;
• Flooring on the lower risk side of High-Risk partitions, walls, or barriers must drain away from the higher risk area;
• Doors, panels, and hatches should be of solid construction, must include effective seals, and must be able to be effectively cleaned and sanitised on an ongoing basis;
• Openings into High-Risk areas should be no larger than what is required to facilitate the required task;
• Interlock or airlock doors should be fitted where practicable to control the ingress of unfiltered air into the High-Risk area;
• Equipment and other items that are not captive to the High-Risk area must undergo a validated cleaning and sanitation step before they are introduced to the High-Risk area;
• Air introduction and reticulation systems within the High-Risk areas should be filtered to an appropriate standard based on risk assessment outcomes;
• Positive pressure air systems for High-Risk areas should be implemented and verified on an ongoing basis to ensure the ingress of unfiltered air into the High-Risk area is minimised;
• Equipment sited and maintained within High-Risk areas should ideally be captive to that area and identified as such;
• Equipment sited and maintained within High-Risk areas should be constructed to avoid potential microbiological growth and harbourage;
• Where possible, equipment such as metal detectors and check weighers should be located outside of High-Risk areas;
• Where laboratories are located within the vicinity of High-Risk facilities, these laboratories must have full segregation and designated drainage and waste handling services;
• Where laundries are located within the vicinity of High-Risk facilities, these laundries must have full segregation and designated drainage and waste handling services;
• Prospective changes to the construction and design of High-Risk areas should include defined processes for how such changes are specified, commissioned, and validated in alignment with microbiological controls, and with the controls required for other relevant hazards.

Cleaning and Sanitation Procedures

Cleaning and sanitation in High-Risk areas needs additional attention to detail. The principles are set out in Cleaning and Sanitation. The following apply in High-Risk scenarios:

• Along with post-use cleaning and sanitation, High-Risk areas and equipment should be cleaned and sanitised before use using verified and validated methods;
• Where fittings and equipment may be a harbourage and growth risk because of design limitations, post-cleaning routines should include no-rinse sanitiser solutions or gels where practicable;
• Air socks and filters used in High-Risk areas must be inspected, maintained and laundered on an appropriate schedule;
• Maintenance and other tools and equipment that are not captive to the High-Risk area must be cleaned and sanitised using validated methods before entry.

Cleaning schedules for High-Risk areas should specify the areas and items to be cleaned, responsibilities, method and frequency, chemicals and dilution rates, utensils to be used and monitoring arrangements. They should be developed with specialist advice, including from your cleaning chemical suppliers where applicable.

Laundering of Uniforms

Uniforms, including protective clothing, footwear and headwear, must be suitable for the intended use, made of materials that do not pose a risk to food, and changed into and out of in a designated area. Overalls should not have external pockets and should have cuffed sleeves. General requirements are set out in Personal Hygiene Standards. In High-Risk scenarios:

• High-Risk uniforms must be laundered separately from lower risk items;
• Laundering, handling and storage must be defined in documented procedures and supported by verification and validation;
• Uniform service providers should be included in the approved supplier program, and laundering chemicals must be food industry approved;
• Laundered uniforms for High-Risk areas should be protected from contamination, for example in a sealed sanitary plastic bag.

Purchased Inputs

High-Risk processes may use components that are raw or have not undergone a heat based microbiological reduction step. Where such items are used in a High-Risk environment, confidence in their microbiological safety must be based on risk assessments conducted by a technically competent individual or team. The criteria must address the specific microbiological hazards of each raw material and refer to the raw material specification, including microbiological status and relevant pathogens.

Outcomes must be documented, included in ongoing reviews of raw materials and the approved supplier program, and supported by validation and verification records. These assessments must be completed as part of product design and development, before production trials or receipt of any raw material.

Non-heat-treated items used in High-Risk scenarios should receive more scrutiny at receival and pre-use inspection. This may include:

• Assessment at a higher frequency than lower risk items;
• Assessment at a higher sampling rate than lower risk items;
• Review of suitable Certificates of Analysis;
• Targeted microbiological testing.

Waste and Recyclables Management

Waste must not accumulate in food handling, storage or operational areas, and waste areas must be kept clean. Full requirements are set out in Waste and Recyclables Management. High-Risk applications require prompt removal of waste, recyclables and other items that may affect microbiological controls:

• Waste is commonly removed from High-Risk areas through hatches, interlock or airlock doors or designated transfer conveyors;
• Waste bins, tubs and containers should be captive to their area of use, and must not leave it without a validated cleaning and sanitation process that does not increase contamination risk;
• New containers should receive the same validated cleaning and sanitation before entering High-Risk areas;
• Out-of-specification product is waste that may need to be held until a disposal decision is made.

Poorly managed waste, particularly outside the premises, can also harbour pests. See Pest and Vermin Control.

Training, Competency, and Resources Requirements

Because of the enhanced risk in High-Risk scenarios, everyone entering or working in these areas must be trained and assessed as competent. Training should cover operational tasks as well as entry, exit and transfer to and from High-Risk areas, in addition to hygienic food handling and personal hygiene. General requirements are set out in Training, Competency and Resources Requirements. Management is responsible for ensuring all employees understand the food safety and hygiene practices important to their job.

About Chemical Control

Chemical use in High-Risk areas must promote food safety as well as the safe use, handling and storage of cleaning, sanitation, pest control and maintenance chemicals. Chemical usage procedures should be documented and available to everyone using chemicals. In High-Risk areas, chemicals should be brought in only as needed, stored away from food and packaging, and clearly labelled when decanted or diluted. See Chemical Control for full requirements.

About Food Microbiology Management

People who take part in developing, implementing and reviewing HACCP plans and finished product testing need at least a basic understanding of food microbiology. This ensures microbiological hazards are controlled and do not affect the safety or quality of finished food. See Food Microbiology Management.

Microbiological Cross Contamination

Pathogens can be transferred between foods by direct contact, food handlers, contact surfaces or air. In High-Risk areas this is controlled by:

• Physical or time separation of raw and ready to eat foods, with effective intermediate cleaning and disinfection;
• Restricted access to processing areas, normally only through a changing facility;
• Clean protective clothing, footwear and hand washing before entry;
• Thorough cleaning and, where necessary, disinfection of surfaces, utensils and equipment after raw food, particularly meat and poultry, has been handled.

About Visitor and Contractor Management

Visitors and contractors, and their actions, are the responsibility of management. Those entering food production areas should wear protective clothing and follow personal hygiene provisions. A documented policy should be given to each visitor and contractor before entry. See Visitor and Contractor Management for full requirements. For High-Risk areas:

• Visitors and contractors should be signed in and identified by a badge;
• They may be required to review food safety and workplace health and safety materials before admission;
• A fresh lab coat or full uniform may be required;
• They should be accompanied by an authorised staff member at all times unless inducted and screened.
• Anyone who is unwell, particularly with vomiting or diarrhoea, should not enter High-Risk areas, and should report their illness to a manager before entry.

Visitor and Contractor Awareness

For higher risk or larger food businesses, an induction process for visitors and contractors should be developed, documented and implemented. Long term contractors who work unaccompanied should be re-inducted on a schedule, with records kept. Where labour hire companies train staff on the business's behalf, the business should verify and validate the training as part of its approved supplier of service program.

About Water and Ice Quality Standards

An adequate supply of potable water, with suitable storage, distribution and temperature control, must be available. Potable water meets the criteria of the most recent edition of the World Health Organization Guidelines for Drinking Water Quality, or a higher prescribed standard, and the potability standards of the countries where products are processed and sold. Non-potable water used for fire control, steam production or refrigeration needs a separate, identified system that does not connect with potable water. See Water and Ice Quality Standards.

Food Contact Water and Steam

Only verified potable water should be used in food handling and processing, except for non-food-contact steam, fire control and similar purposes, and certain processes such as chilling or brining where it does not create a hazard. An example is the use of clean seawater in seafood processing. Recirculated water must be treated and maintained so it poses no risk to food, and treatment processes must be documented, monitored, recorded and verified.

References

• ISO 22000:2018 Food safety management systems
• Codex Alimentarius codes of practice
• World Health Organization food safety fact sheet