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HACCP

Development – To define detail, scope and purpose.

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Training participants will gain a basic understanding of HACCP and its applications within food safety and quality systems. Basic knowledge competency will be verified through successful completion of the accompanying HACCP assessment activity. Basic skill competency can be verified through the HACCP competency checklist available as a resource for this training activity.

Key Definitions for HACCP
- Codex Alimentarius: The Codex Alimentarius, Latin for "food code" or "food book", is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety.
- Control Point or CP: Any step at which biological, chemical, or physical factors can be controlled.
- Critical Control Point or CCP: A Critical Control Point is a point, step or procedure at which controls can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels.
- Critical Limit: A critical limit is a criterion or boundary that is used to distinguish between what is acceptable or safe, and what is unacceptable or unsafe. A critical limit is a measurable value of a parameter or variable.
- Food and Agriculture Organisation or FAO: The Food and Agriculture Organization is the United Nations agency concerned with the international organization of food and agriculture.
- HACCP: Hazard Analysis Critical Control Point or HACCP as it is commonly known, is a science based risk management system, relying on identification and recognition of specific hazards, and nominates measures for their control to ensure the safety of food.
- Microbiological Pathogens: Any microbiological entity including viruses, bacteria or other micro-organisms that can cause food borne illness in humans.
- NASA: NASA or National Aeronautics and Space Administration are an independent agency of the United States government responsible for aviation and spaceflight.
- pH: From potential of Hydrogen. The logarithm of the reciprocal of hydrogen-ion concentration in gram atoms per litre; provides a measure on a scale from 0 to 14 of the acidity or alkalinity of a solution where 7 is neutral and greater than 7 is more alkaline and less than 7 is more acidic.
- Quality Control Point or QCP: A Quality Control Point, commonly known as a QCP or CQP is a point, step or procedure at which controls can be applied and a food quality hazard can be prevented, eliminated or reduced to acceptable levels.
- Quality Point or QP: Any step at which product or process quality factors can be controlled.
- Regulatory Control Point or RCP: A Quality Control Point, commonly known as a RCP is a point, step or procedure at which controls can be applied and a food regulatory hazard can be prevented, eliminated or reduced to acceptable levels.
- Water Activity or aw: Water activity is a measurement of water content; free or unbound water available in a food for microbial growth. It is defined as the vapour pressure of water divided by that of pure water at the same temperature; therefore, pure distilled water has a water activity of exactly one.
- World Health Organisation or WHO: An organization attached to the United Nations that is concerned with the health and well-being of all people. The organization works in developing nations to curb disease and other health related problems.

HACCP Development
When considering the development, documentation and implementation of HACCP within food safety and quality management systems, the following information should be considered to ensure effective outcomes:

About HACCP
HACCP is an internationally recognised effort approved by the scientific community, regulatory and food industry practitioners. HACCP is a food safety methodology that relies on the identification of Critical Control Points or CCP’s in all stages of food business processes. The CCP’s are then closely monitored in order to ensure that food is safe for consumption. This differs from traditional produce and test quality assurance methods that can lead to expensive recall of suspect food produce.

HACCP is a term that has become synonymous with guaranteeing food safety. The goal of any HACCP system is to prevent potential food safety issues from occurring during processing, rather than relying on end product testing or assessment to confirm the safety of food. The application of HACCP systems need to be flexible enough to cope with changes, such as advances in equipment design, processing procedures and technological developments. The principles of HACCP can be used in applications throughout the food chain from primary production through to the final consumer, and its management should be guided by science based applications; their ultimate goal to preserve human health. As well as the distinct purpose of nurturing food safety, HACCP can provide other benefits to its users, including aiding regulatory and non-regulatory inspections and promoting business through an increased confidence in food safety. HACCP relies on the full and dedicated commitment of management and workforce involved in all areas of food production to reach its full application potential. It also requires a multidisciplinary approach; the use of specialised sources including microbiology, medicine, public health, food technology, environmental health, chemical engineering and veterinary health to name a few, to validate its use within a food safety system. While the HACCP concept is primarily concerned with food safety, its application is also successful in addressing quality issues within food production. With the assurance of food safety in mind, HACCP is now the most utilised systematic and preventative approach to controlling biological, physical and chemical hazards in food production.

Extended Applications for HACCP
Whilst HACCP was originally developed around the identification and control of food safety hazards, modern applications of the HACCP methodology within food businesses have extended to the inclusion of the identification and control of additional hazard types, such as quality and regulatory hazards. Where applied, this extension produces a strong risk management to all hazards applicable to any food business. In this context, the following content includes referenced to hazard analysis and controls, for which CCP examples can equally be applied for Quality Control Points and Regulatory Control Points.

The History of HACCP
1959 in the USA saw NASA approach a large American food and beverage company to produce foods that could be eaten in space. The company, Pillsbury Foods, was given a number of specifications for the food; the aim being food that was 100% safe for consumption by astronauts. The food had to also be designed in a way that could be eaten in zero gravity, without the creation of food particles that may compromise the comfort of the astronauts and the operation of their vessel. The reaction of the Pillsbury Company was to test finished product samples for pathogens, but it was soon realised that the only way to guarantee safety of the food was to test 100% of the food. It was realised that a controlled preventative approach to food safety could prevent food safety hazards from occurring. HACCP was developed by Pillsbury as a result of this realisation, and was presented to the US food industry in 1971. Soon after, several food companies adopted the HACCP system theories. HACCP was not in common use outside the US until the mid 1980’s. The World Health Organization was convinced that HACCP had the potential to considerably improve food safety issues in developing nations, and therefore save lives. In 1993, the Codex Alimentarius Commission developed Codex Guidelines for the application and implementation of HACCP. The Codex Alimentarius Guidelines now provide a standardised foundation upon which food businesses around the globe incorporate HACCP into their food industries.

Management and Review of the official HACCP Guidelines
The official HACCP guidelines are managed and reviewed by The Codex Alimentarius Commission, an international organisation almost unknown to the general public. The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO and WHO Food Standards Program for the United Nations. The main purposes of this Program are protecting health of the consumers and ensuring fair trade practices in food and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations. Nevertheless, while working in the shadow of more prominent United Nations organisations, the impact of its work is felt by consumers every day. The mission of the Codex Alimentarius Commission is to set international food standards that help governments to achieve adequate consumer protection. In addition, the commission helps to raise the awareness of governments on food safety issues and serves as a point of reference for food safety standards and food regulations. The Codex Alimentarius Commission meets every two years, during which delegations from the different countries convene in Geneva, Switzerland, Rome, the seats of the World Health Organisation or the Food and Agriculture Organisation. The delegations consist of government officials but can also include industry or consumer representatives, as well as academic experts. Between the Commission’s meetings, the Executive Committee conducts business on behalf of the Codex Alimentarius Commission.

Why do we Require HACCP?
Consumers are becoming continually more aware of food safety related issues in the context of the food that they eat. The main concerns involve the potential presence of pathogenic micro-organisms, chemical residues including pesticides, artificial flavourings, colourings, preservatives. It is a basic right of consumers to be presented with safe food; food that will not cause them harm. Occurrences of food borne illness have been well publicised in the past, and while some have been overstated by the media, others have caused harm; even fatalities to large numbers of people around the world. The apparent increasing rate of food related illnesses highlights the need for food businesses to become more diligent in ensuring the production of safe and suitable foods. The prevention and control of hazards causing potential problems within foods is the basis on which HACCP can provide support for safe food production. HACCP in conjunction with quality controls provides assurance that the end product will satisfy the consumers’ requirements, their right for a high quality product. In addition to controlling hazards in food production as a moral and legal obligation, HACCP offers a variety of other benefits that are not totally consumer driven. The food industry, involved businesses and the food regulatory bodies can all benefit from its continued use within the industry.

HACCP Pre-requisite Programs
The application of HACCP into food production requires that pre-requisite programs for its implementation be documented and applied before the introduction of HACCP plans into the process. HACCP support plans are those that control the operational conditions within a food establishment, allowing a safe environment for food production. When implementing HACCP into a food premises, the primary step is to assess pre-existing programs as to their adequacy and conformance to requirements, and their documented monitoring effectiveness. These support programs form the basis on which HACCP is integrated into the food safety system, and their validation/adequacy will provide success to the system. If the support programs are not controlled as prescribed, the HACCP information, for example, critical control points may need to be altered. The importance of such programs cannot be overlooked in the scheme of HACCP planning and implementation, as they provide intrinsic support to all facets of the food safety management system.

HACCP support programmes include relevant systems incorporating food hygiene, codes of practice and food safety legislation such as:
- Premises: External and internal premises, water supply, sanitation facilities;
- Equipment: Equipment design, installation, maintenance and calibration;
- Cleaning and Sanitation: Cleaning and sanitation programs;
- Pest Control: Pest control program;
- Personnel: Training, personal hygiene, task requirement;
- Transportation and Storage: Food transportation and storage requirements and monitoring, chemical and packaging storage;
- Approved Supplier: Approved supplier program;
- Product Recalls: Distribution records and product recall procedures.

Premises
The physical state of the premises as well as the facilities in and around the premises must be designed and maintained to prevent potential contamination of food during processing, handling and storage. Documentation and records regarding the monitoring and maintenance of the premises should be kept to verify the suitability of the premises for safe food production. The premises include all elements within and outside the physical structure of a food business and its surroundings including property, car parks and sanitation facilities. The adherence to the premises related requirements can be verified by the documentation that specifies the procedures that will be conducted to ensure that conditions are maintained to a satisfactory standard.

General HACCP requirements for premises include:
- Areas to be inspected and at what frequency;
- Tasks to be performed;
- People responsible;
- Verification records to be maintained.

Equipment
All equipment associated in food production must be appropriately constructed and maintained with the safety of food as the primary concern. The installation and use of such equipment also needs to be addressed as food safety can be compromised through improper application.

General HACCP requirements for equipment include:
- Documentation and record keeping;
- Monitoring equipment for maintenance, cleanliness and calibration;
- Staff training in use of specific equipment;
- Design of equipment for intended purpose, and for effective cleaning and sanitising;
- Reliability and adequacy of equipment for intended purpose.

HACCP Cleaning and Sanitation
Documented cleaning and sanitation procedures need to be in place to monitor and control related issues. Such documentation must outline the boundaries that need to be addressed in ensuring safe and suitable food production. Cleaning and sanitation procedures need to be developed and implemented for all areas of consequence to food safety.

General HACCP cleaning and sanitation requirements include:
- Documentation and record keeping of procedures and outcomes;
- Reliance on appropriate chemical usage in the procedure;
- Staff training in cleaning procedures and use of specified materials in cleaning;
- Procedures in cleaning and sanitation should include where appropriate:
- Equipment;
- Utensils;
- Premises structure;
- Sewage and drainage;
- Lighting devices;
- Refrigeration;
- Cooking equipment;
- Packaging and storage.

Environmental Hygiene
Potential sources of contamination from the environment should be considered. In particular, primary production of food should not be carried on in areas where the presence of potentially harmful substances would lead to an unacceptable level of such substances in food.

HACCP Pest Control
The pest control program in its aims will ultimately prevent pest issues within the premises, and will eliminate evident pests. The relevance of the program will include parameters of involvement, nominate control issues significant to using items that may be hazardous to foods, and identify areas of specific concern.

General HACCP pest control requirements include:
- Documentation and record keeping of control applications and of pest sightings;
- Nominated pest control schedules;
- Use of acceptable methods, including the use of nominated and regulated chemicals in controlling pests.

Exclusion of Pets and Other Animals
It is important to understand that pets and other animals harbour disease organisms, both internally and externally, that can be transmitted to humans. For this reason, pets and other animals are excluded from all food establishments.

General exceptions to the exclusion of pests and other animals are the following:
- Edible fish or decorative fish, shellfish and crustaceans in an approved life support system,
- Live shellfish and crustaceans on ice or under refrigeration,
- Patrol dogs accompanying security or police officers in offices and dining or sales and storage areas, sentry dogs running loose in outside fence areas, and assistance dogs accompanying blind or hearing impaired persons in dining and sales areas.

The pest control program in its intended scope and purpose must ultimately prevent pest entry to the premises, and will also eliminate any existing pests. The relevance of the program will include parameters of involvement, nominate control issues significant to using items that may be hazardous to foods, and identify areas of specific concern. Requirements for pest control may include: documentation and record keeping of controls initiated, and of pest sightings; established pest control schedules; and the use of acceptable methods in controlling pests.

Personnel
Adequate relevant programs must be in place to monitor and control the dealings of personnel regarding the production of safe and suitable food. The goals of such programs will ensure safe food handling practices, and rely on quality training to be successful. Training itself must be verified as to its relevance and accuracy in specific tasks, and in making people responsible for their actions within the holistic process. Ongoing training, particularly in personal hygiene, personal conduct and hygienic handling of food will reinforce the positive nature of outcomes relating to food safety.

HACCP Training
The training of personnel in industry, government and the academic world in HACCP principles and applications, and increasing awareness of consumers are essential elements for the effective implementation of HACCP. As an aid in developing specific training to support a HACCP plan, working instructions and procedures should be developed which define the tasks of the operating personnel to be stationed at each Critical Control Point. Cooperation between primary producer, industry, trade groups, consumer organisations, and responsible authorities is of vital importance. Opportunities should be provided for the joint training of industry and control authorities to encourage and maintain a continuous exchange of communication and create a climate of understanding in the practical application of HACCP.

General HACCP training requirements include:
- Maintenance of documentation for staff having undertaken training, and the relevant content of the training information issued;
- Personnel training policy, including requirements of on-the-job training, task specific related training.

HACCP Transportation and Storage
All incoming materials, along with processed and departing products, need to be transported and stored in a manner that prevents conditions that may affect the safety of food. Programs must be in place for monitoring and controlling transportation and storage issues, and appropriate documentation must be maintained. Materials rely on appropriate storage and transportation in reducing potential biological, chemical or physical contamination from occurring.

General HACCP transportation and storage requirements include:
- Receipt and delivery policies: including inspections for hygiene, temperature and regulatory compliance, documentation of receipt for potential product recall or withdrawal traceability;
- Stock control: stock rotation and auditing, storage conditions, product labelling;
- Appropriate storage: correct conditions and storage areas, including chemical and packaging storage in designated areas;
- Transportation in appropriate vehicles: well maintained and without the risk of food contamination.

Approved Suppliers
Approved supplier listings are important in controlling the ingredients and other supplies required for food production and storage. Specified requirements should be made to suppliers for items to be supplied in conjunction with the receipt protocols, for acceptance of goods.

General HACCP approved supplier requirements include:
- Supplier audits including assessments of suppliers’ capability to supply safe and suitable items for production, products to nominated specifications, and their adherence to licensing requirements for ability to supply;
- Approved supplier listings;
- Procedures for approving and verifying approved suppliers.

Product Recalls and Withdrawals
The documented recall procedures outline the anticipated actions to be taken in the event of a product being recalled for whatever reason. The nominated strategies for such an event will ensure that all relevant steps are followed to remove the food from causing potential harm.

General HACCP product recall and product withdrawal requirements include:
- Documented product recall program outlining specifically the requirements for who, what, when, where, why, how in a recall situation.

HACCP Requirements
Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system. During hazard identification, evaluation, and subsequent operations in designing and applying HACCP systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety. The intent of the HACCP system is to focus control at CCP's. Redesign of the operation should be considered if a hazard which must be controlled is identified but no CCP's are found. HACCP should be applied to each specific operation separately. CCP's identified in any given example in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application or might be of a different nature. The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying HACCP to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation.

HACCP Scope and Purpose
A documented Scope and Purpose for the HACCP Plan is necessary to ensure all required products, processes are covered by the associated documentation and management systems.

HACCP Scope
The Scope of the HACCP Plan should define the major process steps which are intended to be covered by the extent of the HACCP Plan.

The following examples are indicative of common HACCP scopes as relevant to each nominated industry sector:
- Primary Production: Produce; Receival of Raw Materials, Storage, Soil Preparation, Planting, Growing, Harvesting, Washing, Grading, Packing, Storage, Dispatch and Distribution of Produce;
- Primary Production: Livestock; Breeding, Birthing, Feeding, Grow Out, Dispatch and Distribution of Livestock;
- Abattoir and Boning: Receival of Livestock and Raw Materials, Storage, Slaughter, Storage, Boning, Packaging, Storage, Dispatch and Distribution of Meats;
- Manufacturing: Receival of Raw Materials, Storage, Preparation, Processing, Packaging, Storage, Dispatch and Distribution of Food Stuffs;
- Food Service: Receival of Raw Materials, Storage, Preparation, Processing, Packaging, Storage, Assembly and Service Food Stuffs.

HACCP Purpose
The Purpose of the HACCP Plan should define the intent of the HACCP Plan regarding the identification and control of hazards. In the context of contemporary food safety management systems, it is quite common to see quality and regulatory aspects included within the Purpose of the HACCP Plan. Some HACCP Purposes may require a mention of specified hazards or hazard types, especially where high risk products are concerned.

An example of a HACCP Purpose which is generally suitable for most HACCP Programs is as follows:
- The purpose of the HACCP Plan is to identify and control all relevant Microbiological, Chemical, Physical, Allergen, Quality and Regulatory hazards.

Principles of the HACCP System
The HACCP system relies of the following seven principles:
- Principle 1: Conduct a hazard analysis;
- Principle 2: Determine the Critical Control Points;
- Principle 3: Establish critical limits;
- Principle 4: Establish a system to monitor control of the CCP's;
- Principle 5: Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
- Principle 6: Establish procedures for verification to confirm that the HACCP system is working effectively.
- Principle 7: Establish documentation concerning all procedures and records appropriate to these principles and their application.

The 12 HACCP Steps
The following identifies the tasks identified as being the logical sequence in HACCP application and management.
- Step 1: Assemble the HACCP team;
- Step 2: Product description;
- Step 3: Identify intended usage;
- Step 4: Construct production process flow diagram;
- Step 5: Conformation of the production process flow diagram;
- Step 6: List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control the identified hazards - Principle 1;
- Step 7: Determine the critical control points - Principle 2;
- Step 8: Establish critical limits for each critical control point - Principle 3;
- Step 9: Establish a monitoring system for each critical control point - Principle 4;
- Step 10: Establish corrective actions - Principle 5;
- Step 11: Establish verification procedures - Principle 6;
- Step 12: Establish documentation and record keeping - Principle 7.

Developing the HACCP Team: HACCP Step 1
The first step in the integration of HACCP into a food safety system is to nominate the team that will oversee the implementation. It is of great importance to include as much knowledge and skill as possible in the team, while also including senior management. The size and scope of the HACCP team will depend on the specific food industry sectors involved and classes of hazards to be addressed of the food business to which the HACCP system is being applied. As well as internal members, external sources, such as those with relevant experience and / or specialist training can be of great benefit to providing relevance in HACCP implementation. Overall, the team should be efficient, appropriate, and well informed in its addressing of all the relevant aspects of the HACCP guidelines.

The composition of the HACCP requirements that will be addressed by the HACCP team will need to be suitable and appropriate to include operational aspects of the food business, and display confidence in accounting for technologies, equipment and expertise used in processing. The specific knowledge and skills of the individuals in the HACCP team should allow this, providing the composition of the team is adequate. The food operation should assure that the appropriate product specific knowledge and expertise is available for the development of an effective HACCP plan. Optimally, this may be accomplished by assembling a multidisciplinary team. Where such expertise is not available on site, expert advice should be obtained from other sources. The scope of the HACCP plan should be identified. The scope should describe which segment of the food chain is involved and the general classes of hazards to be addressed.

Management and Staff have a legally bound responsibility to provide and maintain an environment in which safe food may be produced. Teamwork will be the foundation on which any successful food safety program is based. A designated HACCP Team which is made up of both management and other staff are required to ensure the food safety program policies and procedures are continuously improved. Whilst the program must be managed in its entirety, special emphasis must be put on assurance that the nominated Critical Control Points are monitored and maintained as per the specifications of the program.

HACCP Team Member Considerations
- Do you have or can you obtain the skills necessary to identify the hazards and controls?
- Do you have a person with overall responsibility for the food safety program?
- Is the person responsible trained in the requirements of the HACCP system?
- Does this person have the authority to establish and maintain the program?
- Are the HACCP team members aware of the importance of food safety and hygiene?
- Does your food business have a training program?
- Do the HACCP team members know what to do if something goes wrong?

The HACCP Team and Food Safety Information
The conveyance of relevant HACCP based food safety information is an important factor in a successful food business.

The communicative process for information can take many forms including:
- Notices;
- Verbal, written, audio visual presentation;
- Personal and general staff memos;
- Incident reports and Corrective actions initiated;
- Food Safety Meetings;
- Food Safety Program Master Document;
- Shift diary for communication between production shift staff and cleaning staff;
- It can quite often be advantageous to install a Food Safety Notice Board, upon which relevant and current information can be displayed for food safety team members and other staff alike. Information such as team members, changes to the operational program, approved supplier listings may be added to the board to keep all relevant staff informed.
- HACCP food safety team meetings provide a strong foundation on which your food business can facilitate ongoing management and continuous improvement of general and specific agenda items. HACCP Food Safety Meetings may cover the following agenda:
- Incident reports, including:
- Corrective actions initiated;
- Preventative actions initiated.
- HACCP Procedures;
- Food Safety Program documentation and records;
- Food Safety Program management;
- Food Safety Program review;
- Food Safety Program future prospects;
- HACCP Plan verification and review.

Product Description: HACCP Step 2
The second step in HACCP implementation involves assessment of the food products that are being produced or handled by the food business. Where a service is being provided rather than a product, a similar method can be applied. The information gathered will assist in the identification of hazards that may be present in either ingredients or materials used in the processing of food. The use of comprehensive standard recipe forms can simplify this task, allowing all input materials and ingredients, as well as processing, storage and treatment methods to be plainly viewed. This step should also include references to appropriate legislative and industry guidelines, or scientific validations regarding the documented Product Description and Intended Use. Generic Product Descriptions may be developed for product groups rather than each individual line where applicable.

When compiling a Product Description, the following should be addressed as a minimum:
- Product name: Including its menu name or other names that are used to describe it within the workplace or by consumers;
- Product composition: A comprehensive listing of all ingredients and materials for the product including ingredient specification, packaging, supplier listings and relevant ingredient substitutes;
- Compositional information: It is quite often helpful to include compositional information such as physical or chemical structure, as well as treatments undertaken during processing. May include preservation methods;
- Packaging type: The variety of packaging that is used to contain the product, including both primary and secondary packaging;
- Storage and Handling conditions: The conditions under which the product is stored and handled, which may include several process steps;
- Distribution method: Distribution procedures and documentation;
- Anticipated shelf life: The maximum shelf life under optimum storage conditions;
- Labelling requirements: Includes relevant and required information for consumers required by legislation and industry guidelines. This must include information for at risk consumers;
- Specific requirements: Any extra information that may affect the safety of the product;
- Intended consumers: A nominated scope of consumers for which the product is intended for, or not intended for. Allergens or targeted suitability should be included as specific nominations

In preparing a Service Description, the following should be addressed as a minimum:
- Service Name: This could be referenced to a Service Contract or Agreement;
- Service Description: This section defines what is included as components of the service to be provided;
- Service Provider Business Details: Identify the Business Legal Entity details of the service provider;
- Service Provider Personnel: Identify the personnel who will provide the service, including contacts. Nominations for specified skills and knowledge for the participating service providers of the services may be listed here;
- Service Requirements: Requirements necessary to facilitate the provision of the service, for example, after-hours access or access to data and information;
- Service Life: Service contract length;
- Service Frequency: How often will the service be provided?
- Service Responsibility: Who is responsible for the service being provided?
- Service Background: Why is the service being provided

The Scope of the HACCP Plan and Purpose of the HACCP Plan are often included within the format of a Product Description and Intended Use and Service Descriptions.

Specifications
Specifications are commonly linked with the Product Description and Intended Use, although are not a nominated HACCP requirement. Whether these specifications be for Raw Materials such as Ingredients and Packaging, Internal or External Customer Finished Products, it is important that they include all components of the finished product. Where specifications are developed, one for each individual line is appropriate, as opposed to Product Descriptions where similar food types may be grouped.

The format of Specifications commonly include:
- Product name;
- Ingredient statement in accordance with applicable legislation and industry guidelines;
- Packaging specifications which includes tamper protection where applicable;
- Labelling information;
- Transport, storage and handling criteria;
- Shelf life;
- All quality parameters including specified branding requirements;
- All safety parameters including microbiological and chemical criteria.

Product Description and Specification Considerations
- What are your products and what are the associated risks?
- Have all the steps in your food business been considered?
- Have you considered processes carried out, and ingredients added, by your suppliers?
- Have you missed any steps in the process?

Identify the Intended Usage: HACCP Step 3
This step allows us to assess whether the product is to be served and consumed immediately, stored or further processed; the expected use of the product by the end consumer. The intended product usage will provide an abundance of information regarding potential hazards throughout its processing. Information on intended use is often documented in tabular format with the Product Description.

Intended Usage Consideration
- Have you thought of all the possible end uses of your product?
- Have you considered all who may use your product and have you provided the appropriate information with the product?

Production Process Flow Diagram: HACCP Step 4
The next step is to construct a production process flow diagram using the information gathered above, in conjunction with operational knowledge of the process systems. The production process flow diagram must identify every step that is used to produce the product through the process, from receipt of materials and ingredients to service of the consumer. The diagram need not be complex in its compilation, but must involve all processing steps from beginning to end. To assess the validity of the flow diagram it is advantageous to closely follow the process from start to finish by physically walking the process. Products may be grouped in the process flow diagram if they are nominated as being suitable to include.

Process Flow Diagram Considerations
- Do you have set procedures for checking and approving suppliers?
- Do you have a system for monitoring the quality of products from suppliers?
- Do you have all the information you need to identify potential hazards?
- Have all process inputs and outputs been included within the process flow diagram format, including:
- Water or ice;
- Rework;
- Packaging;
- Pre or post processing treatments;
- Designated waste streams.

Confirmation of the Production Process Flow Diagram: HACCP Step 5
The production process flow diagram must be validated against on-site observation of production during all stages and hours of operation. The pre-conceived flow diagram must be altered if required for its validation into the food safety system. Reconfirmation of the Process Flow Diagram must be undertaken annually as a minimum or at any time where processes, products or inputs change.

Production Process Flow Confirmation Considerations
- Have any steps, inputs, outputs, or other information been missed?
- Are all process inputs identified?
- Does production actually follow way the documented flow diagram?

List all Potential Hazards Associated with Each Step, Conduct a Hazard Analysis, and Consider any Measures to Control Identified Hazards: HACCP Step 6
All hazards that may reasonably be expected to occur at each step from primary production, processing, and distribution until the point of consumption. Nominated hazards must then be analysed as to their potential to reach unacceptable levels for the production of safe food. This process should also include emerging issues, which may not be historically evident within a particular product, but which may be of concern, regarding the Product Description and Intended Use.

The hazard analysis should include the following where applicable:
- The potential for hazards in their occurrence and severity to cause adverse health effects;
- The qualitative and quantitative evaluation of the hazard presence;
- Survival and growth factors regarding the micro-organisms concerned;
- Production of or existence of toxins caused by micro-organisms;
- Chemicals and physical hazards within foods or associated with the food business and process, for example fertilizers, pesticides or cleaning and sanitation chemicals.

When the hazard analysis has been completed, the HACCP team must then consider what control measures, if any, are applicable for each hazard. It is acceptable that there may be more than one control measure nominated for a specific hazard, and that more than one hazard may be controlled by a specified control measure.

List all Potential Hazards Considerations
- Have you examined all sources of hazards including suppliers?
- Have you used diagrams of the premises and its surroundings to identify hazards?
- Have you used the flow diagram to identify possible hazards in the processes involved?
- Have you identified risks attached to the product itself, such as the potential for misuse or abuse?

Hazard Analysis
Any food hazard analysis should take into account the prior history of all raw material inputs in regard to both the processing and handling aspects. If the processing of a food item does not involve an appropriate control process step, which will render it safe from potentially harmful hazards, a significant food safety risk may exist. Nominated control steps must be under constant control and the control responses flexible in their applications to cope with change. All relevant documentation and records must be compiled, either by human observation and / or automated mechanical instrumentation. The effectiveness and prevalence of controlling hazards under constant conditions depends on sourced qualitative and quantitative values, as specified terms of relevance to the food safety system. Should the constancy of conditions be altered in the process, nominated values may need to be adjusted to re-validate the system as being current and effective.

There are two fundamental components to the Food Safety Hazard Analysis process:
- Biological Critical Process Point: An operational point in a given process, which, if not maintained within the nominated parameters, may result in the production of food that is potentially hazardous from a microbiological standpoint; and
- Physical Control Point or Chemical Hazard Control Point: An element of process equipment, or environment of a production process, which, if not sufficiently monitored and maintained, may result in the introduction of foreign materials or chemicals into a product, making it unsafe. It should also be considered that some naturally occurring chemicals may be linked to the Biological Critical Process Point.

For the adequate control of hazards, 3 steps are necessary:
- Identification of hazards to food safety;
- Determination of hazard significance in food safety; and
- Identification of control measures for hazards in food safety.

Identifying Hazards
All hazards that may be reasonably expected to occur within each step in the nominated process must be identified within the HACCP Hazard Analysis.

The following points should be addressed in identifying potential hazards:

Raw Materials as Process Inputs
The following questions should be considered when reviewing raw materials as process inputs:
- Are there any raw materials in this step in the process?
- What, if any hazards are likely to be present in each raw material and are they of relevant concern to the process and / or product?
- Are any of the raw materials themselves hazardous if quantities are in excess?

Raw materials as process inputs may include:
- Ingredients
- Water and Ice;
- Steam;
- Air;
- Processing aids including gases and other substances;
- Rework;
- Processing additives;
- Cleaning and sanitation chemicals;
- Pesticides and fungicides;
- Insecticides;
- Fertilisers;
- Packaging.

Premises and Equipment Design
The following questions should be considered when reviewing premises and equipment design:
- Are there any risks of cross contamination during the process during handling, storage, processing or packaging stages?
- Where are they?
- Are there any stages where microbiological hazards might grow to dangerous levels or produce toxins?
- Can the equipment be effectively controlled within the required tolerances to ensure safe food production?
- Can effective and appropriate cleaning be carried out?
- Are there any specific hazards associated with particular equipment?

Intrinsic Product Factors
Do the factors intrinsic to the product, for example, pH or water activity effectively control all microbiological hazards that are likely to be present in the raw materials, or which could enter the product as cross contaminants during the process?

The following questions should be considered when reviewing intrinsic product parameters:
- Which integral product factors must be controlled to guarantee product safety by controlling microbiological growth?
- Will microbiological hazards be able to survive and or grow within the product?
- Will such growth allow the production of toxins which may impact upon the safety and suitability of the finished product?

It is very important here to consider that different types of micro-organisms are controlled in different ways; The method used to control one, may not be appropriate in the control of another.

Process Design
The following questions should be considered when reviewing process design:
- Will any microbiological hazards survive any heating in the process, or is there a nominated step that will destroy relevant microbiological pathogens?
- Does the use of reworked or recycled product during the process or in conjunction with raw materials cause a potential hazard?
- Is there a risk of re-contamination between the process steps?

Both microbiological hazards and the toxins they produce need to be included within process design considerations.

Food Handling Employees
The following questions should be considered when reviewing food handling employees:
- Could employees either directly or indirectly influence the safety of the product?
- Are all nominated food handlers trained in the aspects of food hygiene?
- Are occupational food health related procedures in place?
- Do all employees understand the goals and significance of the food safety system, along with their specific roles and responsibilities within the process?

It is vital that hazards are not missed, for in the circumstance that they are overlooked, the HACCP based food safety system loses its integrity, and is unable to operate within its intended scope and purpose.

Determining Hazard Significance within the HACCP Process
A food safety system should identify which hazards out of those listed within the Hazard Analysis, are such that their elimination or reduction to acceptable levels is essential for the production of safe food.

In order to ascertain which control measures need to be in place to lessen or prevent hazards occurring, and to determine the appropriate associated control measures, the significance of each hazard must be determined.

Hazard significance is generally based on the question: What is the likelihood that the hazard will occur?

The answer to this question is regarded as the risk. The HACCP system relies on consideration of the risk against factors such as likelihood, severity and significance for each hazard that has been identified.

The hazard risk assessment may be derived from any combination of the following:
- The knowledge and technical skills of the individuals involved within the HACCP team;
- Reference text relating to food microbiology, HACCP, food production and food processing;
- Scientific journals and research papers;
- A hazard significance matrix reference;
- Industry Codes of Practice;
- Academic and government studies;
- Other food producers or processors;
- Food product recalls and customer complaints case studies;
- Areas of pre-existing processes, raw materials or products that have been previously nominated as hazards.

The likelihood of a food hazard occurring may also be rated as high, medium or low. High, medium or low expressions may be described as follows:
- Low: negligible or minor impact on health;
- Medium: major impact on health;
- High: critical impact on health.

Although a hazard has been given a low rating, its associated effects on consumers may be classed as high. For example, the likelihood of Clostridium perfringens being found in a nominated product may be considered low, but it could realistically cause serious implications or even kill those who consumed it. It becomes important, and helpful in hazard assessment, to consider the severity of the hazard with respect to its impact on consumer health, and consequently, its potential effect on the reputation of your business. The seriousness of the hazard may also be expressed as a high, medium or low rating. Combining the likelihood with the severity allows us to determine the degree of significance the hazard presents, which may also be given a high, medium or low rating. This type of approach allows a business to establish the type of control measures required. At this point, the business must also consider and how much time and effort and capital expense will need to be invested in order to control the hazard, including the monitoring of the hazard and re-validation.

Determine Critical Control Points: HACCP Step 7
The nomination of a significant hazard should be given consideration for nomination as a Critical Control Point within the HACCP system. This can be determined through application of a CCP Decision tree, commonly based on the Codex CCP Decision Tree. The accompanying CCP decision tree plan indicates a logical approach in reasoning. The use of the decision tree should be flexible, allowing for differences in the operational specifics of different production areas. It should be used for guidance while also relying on the intimate operational knowledge available from the HACCP team. Decision tree structures may need to be altered for certain applications where the appropriateness of the critical control point determination is not suitable for verification. Specified training in the use of the decision tree is recommended for appropriate recognition of critical control points. If a hazard has been identified at a step where a control measure is needed for food safety, and there is no existing control measure at that step, or any other, the product or process must be modified at that step, or an earlier or later stage to incorporate a control step.

Critical Control Point Decision Tree
Since the publication of the decision tree by the Codex HACCP working group, its use has been implemented many times for training purposes. While this tree has been useful to explain the logic and depth of understanding needed to determine CCP’s, it is not specific to all food operations, for example slaughter. It should therefore be used in conjunction with professional technical judgement, and modified in some cases. It is often advantageous to use the CCP Decision Tree in conjunction with a Hazard Analysis Matrix.

Important considerations when application a CCP decision tree method:
- The decision tree is used after the hazard analysis;
- The decision tree then is used at the steps where a hazard that must be addressed in the HACCP plan has been identified;
- A subsequent step in the process may be more effective for controlling a hazard and may be the preferred CCP;
- More than one step in a process may be involved in controlling a hazard;
- More than one hazard may be controlled by a specific control measure.

Considerations in Determining HACCP Critical Control Points
- Have controls been identified for each hazard?
- Do they effectively remove, or minimise the likelihood of each hazard occurring?
- Can you alter the process where preventable measures don’t exist?
- Do your employees understand what the CCP requirements are?

Establish Critical Control Limits for Each Critical Control Point: HACCP Step 8
Critical limits for each Critical Control Point must be specified and validated. It may occur that more than one critical limit is nominated at a particular step.

The criteria commonly applied when implementing critical control limits include:
- Temperature and Time;
- Water activity;
- Visual appearance and Texture;
- pH;
- Available chlorine;
- Chemical residues;
- Approved suppliers;
- Product specification requirements;
- Pre-requisite Program implementation.

It is important with the determination and nomination of Critical Limits, that only measurable parameters are chosen. This is to ensure that the Critical Limits chosen can be documented as part of monitoring procedures, and that they can be measured at the Critical Control Point, against the nominated Critical Limit, which in turn verifies control of the identified significant hazard. Where non-measurable parameters are chosen, it is difficult to establish whether or not a Critical Control Point is actually under control.

When using numerical values to define limits of acceptability at a CCP, it is important to define the critical limits with an acceptability variant. This may include using symbols of wording which define limits of acceptability, for example:
- Equal to (=);
- Less than or equal to (=<);
- Greater than or equal to (=>);
- Less than (<);
- Greater than (>).

This will ensure that the intended Critical Limits have a clear distinction between being acceptable and unacceptable.

Considerations in Establishing Critical Limits
- Have controls been identified for each hazard?
- Do they effectively remove, or minimise the likelihood of each hazard occurring?
- Can you alter the process where preventable measures don’t exist?
- Do your employees understand what the CCP requirements are?

Establish a Monitoring System for Each Critical Control Point: HACCP Step 9
Monitoring is the scheduled observation or measurement of a CCP in relation to its critical limits. What, How, Where, When and Who should all be considered when developing the monitoring systems for CCP's. The nominated monitoring procedures must be relevant in their ability to detect the loss of control at the CCP. Monitoring should ideally provide information that allows process control to prevent the violation of critical limits. Process adjustments must be made when monitoring indicates a potential loss of control at a CCP before a deviation occurs. All data collected through monitoring must be evaluated by a person who is adequately qualified knowledge and authority to initiate corrective actions when needed. The monitoring frequency, amount and continuity of monitoring must be sufficient to guarantee the CCP is under control. The monitoring of CCP’s will need to be done rapidly in most cases, as they most often relate to on-line processing, and don’t allow time for diagnostic testing. Physical and chemical measurements are often preferred to biological testing because they can be done quickly and can be indicative of microbiological control of the product. All documentation and records associated with monitoring must be signed by the person doing the monitoring, and then by those reviewing the system as elements of the verification process.

Monitoring is the on-going collection of information on a control measure at the step the control measure is applied, for example, determining product temperature during cooking, cooling, or storage. The information establishes that the measure is meeting or functioning within established limits. Monitoring activities are typically focused on real-time measurements and are generally focused on the performance of a specific control measure.

Monitoring System Considerations
- Have you established limits for each critical control point?
- Are your employees following the limits set down?
- Are your measuring instruments sufficiently accurate?
- Do your measurement systems meet recognised standards?
- Has corrective action been decided on for each out-of-control condition?
- Do you have procedures for learning from food safety problems?
- Do you have a system for handling customer complaints?
- Is the frequency of your monitoring and recording appropriate?
- Do you have a system for recalling your products?

Establish Corrective Actions: Step 10
Corrective actions must be nominated for each CCP in the HACCP system to confront deviations when they occur. The corrective actions must ensure that the CCP has been controlled, or brought back into controlled critical limits. All deviation and product character related procedures must be documented as part of HACCP record keeping.

Common motivators for Corrective Action applied within a food business at any given time include:
- Customer complaints;
- Process or Procedure deviations;
- Product non-conformance;
- Critical employee observations.

Corrective Action Considerations
- Have you established limits for each critical control point?
- Are your employees following the nominated critical limits?
- Are your measuring instruments sufficiently accurate?
- Do your measurement systems meet recognised standards?
- Has corrective action been decided on for each out-of-control condition?
- Do you have procedures for learning from food safety problems?
- Do you have a system for handling complaints?
- Is the frequency of your monitoring and recording appropriate?
- Do you have a system for tracking and recalling your products?

Establish Verification Procedures: HACCP Step 11
Verification includes auditing and assessment, procedures and testing, sampling and analysis. Such techniques are important in determining whether or not the HACCP system is working correctly. The frequency of verification must be sufficient to validate that the HACCP system is working effectively. The verification process is commonly linked to the Continuous Improvement processes nominated within the food safety and quality management systems. Often a Verification Schedule format is developed and documented to define all the verification activities, including frequencies and the responsibilities.

Verification activities may include:
- HACCP system and records review;
- Product deviation and characteristics;
- Critical Control Point management confirmation;
- HACCP plan validity confirmation.

Verification procedures may include:
- Establishment of appropriate verification schedules;
- Review of the HACCP plan for completeness;
- Confirmation of the accuracy of the process flow diagram;
- Review of the HACCP system to determine if the food business is operating according to the HACCP plan.
- Review of CCP monitoring records;
- Review of records for deviations and corrective actions;
- Validation of critical limits to confirm that they are adequate to control significant hazards;
- Scheduled microbiological testing of product, process inputs and environmental areas including food handling, production and storage areas and water used for hand washing, cleaning and sanitation and production;
- Scheduled shelf life testing, including microbiological and organoleptic criteria where applicable at appropriate interval;
- Validation and re-validation of the HACCP plan;
- Internal audits;
- Scheduled assessments of produce or products against the Product Description and Intended Use, Internal Specifications and Customer Specifications;
- Review of Corrective Action and Customer Complaints;
- Review of modifications of the HACCP plan;
- Sampling and testing to verify CCP effectiveness;
- Management and system review activities.

Verification should be conducted:
- Routinely, or on an unannounced basis, to ensure CCP's are under control;
- At a frequency to meet any government and standard requirements;
- When there are emerging concerns about the safety of the product;
- When foods have been implicated as a vehicle of food borne disease;
- To confirm that changes have been implemented correctly after a HACCP plan has been modified;
- To assess whether a HACCP plan should be modified due to a change in the process, equipment and process inputs.

Verification record formats may include information on the presence and adequacy of:
- The HACCP plan and the positions responsible for administering and updating the HACCP plan;
- The records associated with CCP monitoring;
- Direct recording of monitoring data of the CCP while in operation;
- Certification that monitoring equipment is properly calibrated and in working order;
- Corrective actions for deviations;
- Sampling and testing methods used to verify that CCP's are under control;
- Modifications to the HACCP plan;
- Training and knowledge of individuals responsible for monitoring CCP's;
- Validation activities.

HACCP Verification Considerations
- Do you have a satisfactory level of record keeping?
- Do you file and store records safely?
- Do you record and action critical control points?
- Have you recorded the limits for each CCP?
- Are your control measures properly recorded?
- Are you monitoring and evaluating your methods?
- Do you keep records of your calibrations?
- Do you get independent checks of your food safety program?
- Do you have checks of your products in the marketplace?
- Do you have a procedure for recording the detection of unsafe products?
- Do you have written instructions for handling unsafe food products?
- What measures do you take to check that your food safety program is being carried out?
- Do you keep records of your system checks?

HACCP Audit and Review
The establishment of a review and audit program is also an important concept regarding HACCP based food safety systems. Considerations for this process may include the following:
- Does your system work as planned?
- Do your processes match your procedures?
- Have any changes been made or shortcuts taken?
- Have you had any complaints?
- What did you do about any complaints?
- Have any complaints been effectively and fully resolved?
- Have any similar products been involved in a public health issue, product recall or product withdrawal?

In addition to the nominated HACCP verification procedures outlined above it is necessary to have a system in place that will automatically initiate a review of the HACCP plan prior to any changes which may impact upon the safety of the finished product, including changes in:
- Raw material or product formulation;
- Processing system;
- Factory layout or environment;
- Packaging, storage or distribution system;
- Cleaning and sanitation procedures;
- Staff or defined responsibilities;
- Intended consumer and consumer handling and use; and
- Information indicating a health risk associated with the food product.

Information arising from HACCP reviews must be documented and form part of the HACCP record-keeping system. Any changes arising from a HACCP review must be fully incorporated into the HACCP plan. This is because these changes may mean that certain CCP's control measures or specified critical limits or target levels may have to be changed and / or additional CCP's or control measures may have to be put in place. Senior management will usually expect that resources used to establish HACCP are not wasted and that record-keeping and documentation reflect the actual operation of the process. A system of management for the maintenance of the HACCP record-keeping system is, therefore, required and its proper operation is essential.

Establish Documentation and Record Keeping: HACCP Step 12
Accurate and efficient record keeping is critical to the validity of any HACCP system. All HACCP documentation and record keeping should be appropriate in its format, content, control and application to the nature of the food business for which it is constructed.

HACCP Documentation may include:
- HACCP team listing;
- HACCP scope and purpose;
- Product description and intended use;
- Process flow diagram;
- Hazard analysis;
- CCP determination;
- Critical limit determination;
- HACCP audit table;
- Critical limit and control measure verification;
- HACCP verification schedule.

HACCP Records may include:
- CCP monitoring activities;
- Deviations and associated corrective actions;
- HACCP system modifications;
- Outcomes of HACCP verification activities;
- Supplier certification records documenting compliance of an ingredient with a critical limit;
- Audit records verifying supplier compliance;
- Processing, storage and distribution records;
- Information that establishes the ability of a CCP to maintain product safety;
- Data establishing the safe shelf life of the product; if the age of a food product can impact upon its safety;
- Records indicating compliance with critical limits when packaging materials, labelling or sealing specifications are necessary for food safety;
- Monitoring, Verification, Deviation and Corrective Action records;
- Employee training records that are pertinent to CCP's and the HACCP plan;
- Documentation of the adequacy of the HACCP plan from a knowledgeable HACCP expert;
-HACCP Verification schedule.

HACCP Documentation and Record Keeping Considerations
- Is the format and content of your HACCP system documentation and records appropriate?
- Do you have a satisfactory level of record keeping?
- Do you file and store records safely?
- Do you record and action critical control points?
- Have you recorded the limits for each CCP?
- Are your control measures properly recorded?
- Are you monitoring and evaluating your methods?
- Do you keep records of your calibrations?
- Do you get independent checks of your HACCP system?
- Do you conduct checks of your products in the marketplace?
- Do you have a procedure for recording the detection of unsafe products?
- Do you have written instructions for handling unsafe food products?
- What measures do you take to check that your HACCP system requirements are being completed?
- Do you keep records of your HACCP system checks?

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific HACCP Development requirements in relation to their items. 


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