The Fourteen Stages of HACCP

To establish a HACCP plan, it is recommended to follow a logically structured sequence of steps. In several books and articles, different types of plans with 12 or 14 stages can be found. However, most of them are based on the internationally accepted system as described in the Codex Alimentarius, which includes 12 stages.

The plan that will be used in this course consists of 14 stages and is based on the FLAIR- document (Food Linked Agro-Industrial Research):

Step 0: A policy statement Step 1: Assemble a HACCP team Step 2: Define the scope of the study Step 3: Describe the product Step 4: Identify the intended use of the product Step 5: Construct a flow diagram Step 6: Confirm flow diagram on site

Step 7: Identify and list all relevant hazards and preventive measures Step 8: Identify the CCP's Step 9: Establish critical limits for the CCP's Step 10: Establish a monitoring system for the CCP's Step 11: Establish a corrective action plan Step 12: Establish a documentation system Step 13: Verify the HACCP plan Step 14: Review the HACCP plan

Step 0: Policy Statement

What? Quality management is part of the policy of the company and is consequently a responsibility of the management. In the policy statement, it is clearly indicated what the company wants to achieve on the level of food safety. Therefore, clear, concrete, measurable objectives towards food safety need to be established. This policy and objectives need to be known in the company.

Importance of the Policy Statement

Quality objectives can only be realised when the company culture is focused on quality improvement. Therefore, a top-down strategy is necessary, of which the success depends on the policy of the board of directors. When the board is not convinced of the importance and the use of the implementation of the HACCP approach, then the efforts of the co-workers will not have priority.

The commitment of the management is crucial for the success of the HACCP project, and this is the case for both the definition of the quality policy and the disposal of means. The disposal of personnel and time to get familiar with the HACCP principles and to implement the system is crucial for the success of the project. Also, the investment in training is necessary to create awareness and motivation for the food safety of the personnel. Only then, a successful quality management system based on HACCP can be realized.

Content

WHAT do we want to reach?

Sound products of high quality

Safe products for humans, animals and the environment

For which products, which services, which production processes

HOW will we reach that?

Implementation and maintenance of the GMP measures

Comply with the legal requirements of feed

Selection of suppliers and establishment of specifications

Development of a traceability system

Development and implementation of a HACCP plan

WHO is responsible?

HACCP coordinator; HACCP team; quality team.

WHICH means are available?

Personnel: Members of the HACCP team and the HACCP co-ordinator can participate in meetings and have time to develop and implement the HACCP handbook; training: When necessary the involved persons can participate in training courses; information: all internal information is available and when necessary external information is available or can be requested; external guiding: when necessary an appeal to an external expert can be made; financial: extra financial means are available to improve product safety (changes of the infrastructure, automation, alarm, etc.)

WHEN do we want to reach the objectives?

The target date for the handbook

The target date for implementation

The target date for the first internal audit

The target date for the external audit

WHAT will receive extra attention (measurable aims)?

Adaptations of the infrastructure to avoid cross-contamination

Shelf life test

Purchase specifications; supplier selection; traceability

Evaluation

The policy statement is signed and dated by the board. When the complete HACCP system is developed and implemented, the management has to supervise the maintenance and the review of the system.

In the framework of the HACCP verification (step 13) and the management review, the policy statement is evaluated, and it is verified if the objectives are reached. On the base of this evaluation, the policy statement is adjusted, and new or adjusted objectives are formulated.

Step 1: Assemble A HACCP Team

The first step in the establishment of a HACCP plan is the selection of a HACCP team. This team has to consist of persons with a specified knowledge and experience with the product, the production process and the related hazards. It is the task and the responsibility of the team to develop and establish each step of the HACCP concept.

The management is responsible for the assembly of the HACCP team and has to take care that the members of the HACCP dispose of enough time and financial means to develop and implement a HACCP plan.

For big companies, the composition of the HACCP team is in a lot of cases obvious. For smaller companies, this is more a problem, since the limited number of personnel. However, a big company, as well as a small company, need to have a HACCP team.

In a big company, the HACCP team can be composed of more or less 6 persons or a core team of 2 to 3 persons that can be supplemented with other team members that have specific expertise.

In a small company, the HACCP team can be limited to 2 to 3 persons. At least 2 persons are necessary to exchange thoughts.

As it was quoted before, a HACCP team should be multidisciplinary. In this way, the available knowledge and experience in the company are used as much as possible. It is important to realise that this knowledge is not only present on the management level, but the people who are working on the work floor have also a lot of useful and usable knowledge. As a consequence, it is important that the members of the HACCP team belong to different hierarchic levels of the company.

Besides the necessary knowledge, this has also the advantage that the HACCP-thought is present in every level of the company, which will facilitate the implementation afterwards. A HACCP plan that is developed on the level of the board and the quality service is doomed to fail.

The essential knowledge that should be present in every HACCP team is:

• A representative of the board because of power for decisions;
• Knowledge of the production process and the work methodology on the work floor (Production responsible persons)
• HACCP Coordinator: leader of the team, takes care of the follow-up and has insight into the quality of the raw materials, the process and the end products.

Furthermore, it is recommended to include additional knowledge:

• Purchase
• Sales
• Technical service; lab responsible; transport
• When necessary, external knowledge can be used.

In the HACCP-handbook de functions of the HACCP team and the necessary knowledge should be included. The presence of this required knowledge in the current team, need to be demonstrated with diplomas, certificates and work experience.

Step 2: Define Scope Of The Study

When defining the scope of the study, three parts should be considered:

Part 1: On What Focuses The Study?

First, an overview should be made of all the activities that are included in the HACCP study. Basically, for every food product, a HACCP study should be developed from raw material until the final product. Because this is practically not feasible in a lot of cases and this would lead to overlap, the final products are divided into product groups. For every product group, a HACCP plan is developed. The division in product groups corresponds with the nature of the process and the related risks or the used equipment. The same end product produced in a company where there is no logic product or personnel flow or an old infrastructure will result in a complete different hazard analysis than when that product would be produced in an optimally organised company. The division in product groups needs to be considered well. Moreover, it should be explained in the HACCP book why this division was chosen.

Part 1 Should Include:

• On which product; on which process/process line; on which production and storage location the HACCP study applies to.
• Which product groups are distinguished and how many HACCP plans are elaborated?
• Why this division was chosen.

Part 2: Which Hazards Will Be Included In The HACCP Study?

HACCP is a management system that focuses on food safety. Within a HACCP analysis, all attention will go to the prevention and control of hazards that can be a risk for public health. The general objective of HACCP is the production of foods that are safe for human consumption.

Four types of hazards are distinguished: allergens and microbiological, chemical and physical hazards.

Preferably HACCP studies are limited to these 3 hazards. Other aspects that are more related to quality e.g., presentation, right amounts, … are strictly spoken not included in a HACCP study. However, some companies choose to incorporate these facets in their HACCP study. When this is the case, this should be clearly indicated in the scope and during the complete study, a distinction should be made between safety aspects and quality aspects.

This part needs to include an overview of the relevant hazards that are considered in this study.

Part 3: What is The Begin And Endpoint Of The HACCP study?

In this part, the beginning and endpoint of the study are determined. In other words:

• • For which process steps are we responsible
  • At which point do we connect with the previous link in the chain
  • At which point do we hand over the responsibility to the next link in the chain?

In most companies, the HACCP study starts with the receipt of the raw materials. The endpoint of the study can be different: end storage, transfer, transport and delivery at the client.

Step 3: Describe The Product

For each product(group), a short description indicating the sensitivity towards safety risks

(From raw material to distribution) should be written.

To establish a HACCP plan it is necessary to collect as much data on the products/product groups as possible. In this way, a detailed description of all ingredients, raw materials, packaging materials, processing conditions, distribution, shelf life, etc. can be given.

End Product Specifications

Information on the end products is necessary to assess which hazards can occur in the production process or which hazards can be present in the end product.

The HACCP team will collect as much information as possible. Therefore, it will use all the information that is present in the company like analysis results and legislation.

The aim of end-product specifications is twofold;

• In the first phase, it is the intention to gather product characteristics and product requirements. For example, the pH, water activity, humidity of the end product can be very important information to estimate if the growth of microorganisms is possible during the storage of foods.
• In the final phase, the end product specification is a passport, manual, information leaflet of the product. It indicates which characteristics are connected with the product, but it also indicates how the product should be stored and used under optimal conditions. It is a kind of contract, an agreement that is made with the client: ‘We guarantee you that we will deliver you this.’

In the framework of HACCP, end product specifications should include the following information:

Name product/product group

Article number

Ingredients

General product characteristics

External characteristics (shape, sensorial properties, weight)

Nutritional composition (calorific value, fat, proteins, carbohydrates; physical and chemical characteristics (pH, humidity, water activity, etc); microbiological characteristics; the presence of ingredients with respect to diet/allergens; the presence of genetically modified organisms (GMO)

Packaging material and methodology

Labelling and batch identification

Shelf life

Transport conditions

Storage conditions

Purchase Specifications

The quality of the raw materials determines the quality of the end products. As a consequence, to make the end product specifications one need to know the characteristics of the raw material. For example, to determine the level of contaminants that is present in the end product, one needs to know the level in the raw material. Therefore, purchase specifications are necessary.

Purchase specifications need to be asked for by the suppliers or traders. These products are for their final products. They should be able to make such specifications based on their quality management system and the legal requirements. Purchase specifications are an agreement between client and supplier, in which it is described what is delivered, in which form, etc.

When the supplier is not able to place specifications at the disposal of the client, the supplier and client need to establish them in mutual agreement.

For the making of specifications, the following information needs to be taken into account:

• Legislation
• Own research results
• Databases, sector studies

Step 4: Identify Intended Use of The Product And The Consumers Use

The aim of this step is to determine what happens with the products when they leave the company; which abuse/contaminations occur and which measures can be taken to reduce this to a minimum.

First of all, it should be determined what the following link is in the chain. It can be the processing sector, wholesale business, retail trade or a supermarket. When transport is included in the scope of the study, it should be included in this analysis. It is also necessary to describe who will handle and use the products.

Next, it should be questioned which forms of abuse or maltreatment in these links can occur, for example:

• Temperature abuse;
• Incorrect preparation;
• Incorrect storage;

For every misuse, it should be checked whether control measures can be taken, e.g.; determination of the shelf life based on a microbiological analysis in which a short temperature abuse is included; clear storage prescriptions on the label; clear instructions for use; traceability and recall plan.

Consumer Group

Also, the consumers or target group are important. Within the food industry especially the microbiological hazards get attention. Some consumer groups are more sensitive to food poisoning than others.

This sensitive group is called the YOPIs:

Young Old Pregnant

When a product is destined for one of these consumer groups, most care should be taken, since an unsafe treatment can affect the health of the complete consumer group, while for the average consumer group this will be only a small percentage. Special control measures should be implemented to guarantee the safety of such products.

Step 5: Construct A Flow Chart

Flow Chart

A flow diagram (flow chart) of the complete process is the basis of the hazard analysis.

For every product or product group, a flow chart is made, in which all the process steps from raw material to end product are represented in a systematic way.

Moreover, all incoming streams (raw materials, auxiliary materials, packaging material, water, air, etc.) and all outgoing streams (intermediate products, rework, returned goods, waste, etc.) should be included in the flow chart.

The way in which the flow chart is represented is free to choose. It is important that everything is clean and orderly. More detailed technical information and product data can be collected and noted separately.

Floor Plan

Besides a flow chart, a floor plan should be included, to make it more visual. Knowledge of the infrastructure and layout is important for effective hygiene management. On the floor plan the different departments, facilities, sewer systems, should be indicated.

The most important aim of the floor plan is to draw the routes of the different streams throughout the process:

• From raw material to final product
• Personnel
• Dirty and clean material; packaging material; waste
• To search for cross-contamination and illogical routes

On the floor plan, the water pipes, draw-off valves, and the places where pest management is located should be indicated and numbered. Also, the presence of warning signs (handwashing, no smoking, etc.) can be indicated.

Step 6: Confirm Flow Chart On-Site

In a lot of cases, flow charts are made during a meeting, and they are drawn like the members of the HACCP team think it is done or how they think it should be done. Since the flow charts are the starting point for the hazard analysis, they should be complete, correct and in accordance with the real situation.

Therefore, the HACCP team should check the flow charts on-site and under different production conditions. It is for example important to check if different persons or different shifts work in the same way.

When the verification demonstrates that some faults were made, the charts need to be adapted before the HACCP team can continue with the following steps.

This verification is also necessary for the floor plans.

It is important that for existing lines, the HACCP team verifies that each step in the flow diagram is an accurate representation of the operation. This should include verification during the night shift or weekend. The flow diagram should be amended for every deviation found from the original diagram. All members of the HACCP team should be involved, and the verification should be repeated at regular times.

Step 7: Identify And List All Relevant Hazard Analysis And Preventive Measures

Using the flow diagram as a guide, the HACCP team should list all the hazards for food safety that may be reasonably expected to occur at each process step. Hazards considered in the study must be such that their elimination or reduction to acceptable levels is essential to the production of safe food. Hazards with a low risk, which are not occurring often, are not taken into account.

Hazard Inventarisation

A hazard is a biological, chemical or physical agent in or condition of food with the potential to cause an adverse health effect.

To be able to perform a hazard analysis, some knowledge about the potential hazards should be present. Four groups of hazards can be distinguished: biological, chemical, physical and allergens.

Biological Hazards

The biological hazards can be further divided into three types: microbial, viral and parasitic (protozoa and worms).

When establishing a HACCP plan, three objectives concerning biological hazards are important:

• Destruction, elimination or reduction of the hazard;
• Prevention of post contamination;
• Prevention of growth and toxin production.

Preventive measures should be taken to meet these objectives.

Micro-organisms can be destroyed or eliminated by heating, freezing or drying. After the destruction, measures to prevent post contamination should be taken. Finally, when it is not possible to eliminate the hazard completely, microbial growth and toxin production should be avoided. Growth can be avoided by modifying the intrinsic characteristics of the food product such as pH or aw or by the addition of preservatives. Conditions under which the food is packaged (aerobic or anaerobic) and the storage temperature (cooling or freezing) can also be used to inhibit growth.

Bacterial Hazards

Bacterial hazards can result either in foodborne infections or intoxications. A foodborne infection is caused by ingesting a number of pathogenic micro-organisms sufficient to cause infection. Examples of bacteria that cause food infections are Salmonella spp. Listeria monocytes, Campylobacter jejuni, Shigella spp., Vibrio parahaemolyticus, Vibrio cholera, Yersinia enteroliths and Escherichia coli O157:H7. A foodborne intoxication is caused by the ingestion of preformed toxins produced and excreted by certain bacteria when they multiply in foods. Examples of pathogens that cause food intoxication are Clostridium botulinum, Clostridium perfringens, Staphylococcus aureus and Bacillus cereus.

Many food commodities have unique microbiology and group of associated pathogens. Processors of specific foods should consult literature in those areas.

Viral Hazards

Viruses are very small particles that cannot be seen with a light microscope. They are obligate intracellular parasites that are unable to reproduce outside the host cell. Thus, they are inert in foods and do not multiply in them. However, viruses may be transmitted to foods via the faecal-oral route, either directly or indirectly. Some viruses may be inactivated in foods by thorough cooking and some by drying. However, contamination of foods with viruses should be avoided. Direct contamination can occur when an infected food handler contaminates food. Indirect contamination can occur when foods such as bivalve molluscs become contaminated in waters infected by untreated sewage. The viruses most commonly recognized as foodborne disease agents are Hepatitis A virus Norwalk virus Rotavirus; Other viruses associated with gastroenteritis.

Parasitic Hazards

Parasites of concern to food microbiologists belong to protozoa, nematodes, cestodes and trematodes. Some foodborne parasites may be transmitted through food and water contaminated by faucal material that contains parasites shed by infected hosts. Other parasites spend a portion of their life cycle in food animals and are thus ingested along with the food. Methods for preventing transmission of parasites to foods via the faucal contamination route include good personal hygiene practices by food handlers, proper disposal of human faeces, eliminating the use of insufficiently treated sewage to fertilize crops, and proper sewage treatment. Thorough cooking of foods will eliminate all foodborne parasites. Freezing, and in specific instances bringing, may be used to destroy various parasites in foods.

Chemical Hazards

All food products are made up of chemicals and all chemicals can be toxic at some dosage level. However, several chemicals are not allowed in food and others have established allowable limits. Different groups of chemical hazards can be distinguished.

Naturally Occurring Chemicals

The naturally occurring toxicants include a variety of chemicals of plant, animal, or microbial origin. Although many naturally occurring toxicants are biological in origin, they have traditionally been categorized as chemical hazards.

Mycotoxins

Several fungi produce compounds toxic to man. Among some of the better known and studied groups of mycotoxins are the aflatoxins, which include a group of structurally related toxic compounds produced by certain strains of the fungi Aspergillus flavus and Aspergillus parasiticus. Under favourable conditions of temperature and humidity, these fungi grow and produce aflatoxins on certain foods, grains, nuts and feeds. Other important mycotoxins are trichothecenes, fumonisins, zearalenone, ochratoxin A, ergot alkaloids, sterigmatocystin and patulin.

Scombrotoxin (Histamine)

Scombroid poisoning or histamine poisoning occurs when foods that contain high levels of histamine (or possibly other vasoactive amines and compounds) are ingested. Histamine is produced by the microbial degradation of histidine, a free amino acid found in abundance in dark-fleshed fish, including members of the Scombridae family from temperature and tropical regions. Fish that have been temperature abused are the most implicated foods. Other foods, such as Swiss cheese have been reported to cause illness as well. Fish most often implicated are tuna, mackerel, bluefish and amberjack.

Shellfish Toxins

Shellfish poisoning is caused by a group of toxins elaborated by planktonic algae (dinoflagellates, in most cases) upon which the shellfish feed. Under the appropriate conditions, toxic dinoflagellate populations may increase to high levels and persist for several weeks. The shellfish may accumulate and metabolize these toxins during their filter-feeding. Ingestion of contaminated shellfish results in a wide variety of symptoms, depending upon the toxin(s) present, their concentrations in the shellfish and the number of contaminated shellfish consumed. All shellfish could potentially become toxic. Control methods include effective monitoring of shellfish lots or growing areas and, in some instances, depuration.

Residues

These compounds are unwanted present as a result of (fyto) sanitary, medical or comparable treatments of the agricultural crop, animal or food (e.g., antibiotics, hormones, pesticides, detergents, disinfectants, etc.).

Contaminants

Contaminants are unwanted contaminations, that come in a product as a result of another reason than the above mentioned (e.g., contamination of the environment (dioxins, PCB’s, heavy metals), or as a consequence of the used process (polyaromatic hydrocarbons/PAH, acrylamide, etc.).

Food Additives

Food additives are deliberately added to serve a specific function in the food (e.g., colourants, preservatives, flavour enhancers, etc.).

Physical Hazards

Physical hazards are often described as extraneous matter or foreign objects and include any physical matter not normally found in food, which may cause illness or injury to an individual. Although the discovery of filth in a product may not itself present an unacceptable health risk, the conditions of manufacture, packaging, or storage that permitted its entry to present an unacceptable health risk.

Methods involved in controlling physical hazards include raw material specifications and inspections along with vendor certification and guarantees. Metal detectors can be used to locate ferrous and nonferrous metals in foods, especially bone fragments can be found through X-ray technology.

Effective pest control and foreign object removal from plant environments are also essential. Preventive maintenance and sanitation programmes, proper storage, and distribution procedures, as well as packaging material handling practices, are required.

Allergens

More and more people become sensitive to different allergens. Therefore, allergens are also included in the different hazards (besides, physical, chemical and biological).

Since traces of allergens can cause reactions in sensitive persons, allergens are very difficult to control in a company. Cross-contamination with for example an allergen ingredient, a recipient, hands of a member of the personnel, etc. can result in the presence of traces of allergens in the food.

A relatively small number of foods and food products are responsible for most cases of food allergy. In approximate order of frequency, they are as follows:

• In children: cow’s milk, egg, soy, peanut, tree nuts, fish and crustaceans;
• in adults: peanut, tree nut, crustaceans, fish and egg.

Many other foods are allergenic in smaller numbers of individuals, and the pattern of food allergy varies widely in other parts of the world.

Hazard Analysis and Hazard Evaluation

Hazard analysis consists of a systematic evaluation of specific food and its raw materials or ingredients to determine the risk from biological, chemical and physical hazards. The hazard analysis is a two-step procedure, hazard analysis and hazard evaluation.

The Codex Alimentarius describes the first of the 7 HACCP principles as:

• List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards.
• The HACCP team should list all of the hazards that may be reasonably expected to occur at each step according to the scope from primary production, processing, manufacture, and distribution until the point of consumption.
• The HACCP team should next conduct a hazard analysis to identify for the HACCP-plan, which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of safe food.

In conducting the hazard analysis, wherever possible the following should be included:

• The likely occurrence of hazards and severity of their adverse health effects; the qualitative and/or quantitative evaluation of the presence of hazards; survival or multiplication of micro-organisms of concern;
• Production or persistence in foods of toxins, chemicals or physical agents; and,
• Conditions leading to the above.

This document shows that a hazard analysis consists of 2 parts:

• An inventarisation of the hazards;
• An analysis of the identified hazards.

Inventarisation of the Hazards

For each process step, the HACCP team will brainstorm about the potential hazards, which can arise.

As the HACCP concept is focused on food safety, the hazards related to public health should have priority. However, it is advisable to include also hazards related to food spoilage. Some companies prefer to include also hazards, which are only affecting food quality. However, this is not advisable as the HACCP plan is unnecessarily extended, especially when it concerns the first HACCP plan.

If a company chooses to include quality aspects, it is necessary to be able to distinguish these aspects from the other safety hazards.

Questions Which Help To Make An Inventory Of Hazards:

A. Ingredients:

Does the food product contain ingredients that can result in microbial (e.g., Salmonella, Listeria monocytogenes, Staphylococcus aureus), chemical (aflatoxins, antibiotics) or physical (glass, metal) hazards?

Is only potable water used for the production or treatment of foods?

B. Intrinsic Factors

Physical characteristics and composition of the food product (pH, preservatives, etc) during and after production.

Which intrinsic factors of the food product should be kept under control in relation to food safety?

Are survival, multiplication and/or toxin production possible during production?

Is this the case for successive production steps?

Are there similar products on the market, which have been involved in food infections?

C. Production Procedures

Is there a production step, which destroys pathogens (both spores and vegetative cells)?

Can there be recontamination of the food product between production and packaging?

D. Microbial Flora of the Food Product

Is the food product commercially sterile?

Does the food product contain (spore-producing) pathogens?

What is the normal microbial load of the food?

Does the microbial flora change during the normal storage period before consumption?

Is this change good or bad for the safety of the food product?

E. Lay-Out of the Production Area

Does the layout exclude cross-contamination?

Is overpressure used in the packaging area?

Can the flow of personnel through the company be a source of contamination?

F. Equipment/Facilities

Is the equipment provided with time/temperature controls?

Can the equipment be controlled in a way that the variations are smaller than the tolerances?

Are defects occurring often?

Can the equipment be cleaned and disinfected well?

Our safety barriers included in the production process: metal detectors, magnets, filters, sieves, thermometers?

G. Packaging

Does the packaging influence the development of pathogens and/or the production of toxins?

Is it clearly indicated that the product should be stored in a cooled way?

Is the preparation method mentioned?

Is the packaging resistant to damage?

Is each package clearly labelled?

H. Cleaning

What is the influence of cleaning on the process?

Can the equipment be cleaned sufficiently?

Can the necessary cleaning be performed?

I. Health, Hygiene and Education of Personnel

Has the health and hygiene of personnel had an influence on the safety of the product?

Does personnel understand the production steps being responsible for?

Will the personnel report mistakes or deviations?

J Storage

Can the product be stored at the wrong temperature?

Can a bad way of storing cause a microbial unsafe product?

K. Use

Is the food product heated?

Are there remains, which should be reheated?

L. Consumer

Is the food product meant for normal consumers?

Is the food product meant for sensitive consumers?

M. Control Measures/Preventive Measures

Codex Alimentarius:

• Here is also a reference towards the Codex Alimentarius:
• Consideration should be given to what control measures if any exist, can be applied to each hazard.
• More than one control measure may be required to control a specific hazard and more than one hazard may be controlled by a specified control measure.’
• At the beginning (the first version of 1993) the term ‘preventive measures’ was used. The measures that were used to prevent hazards were in contrast with the controls of the final product. Over the years, the preventive measures become broader, and it concerns now all measures that are used to control the process and the production circumstances in a way that safe products are guaranteed. The term “preventive measure” is now replaced by “control measure”.
• Control measures are measures that are necessary to guarantee the safety and the suitability of the final products, about the most probable use.

Different Types of Control Measures

Depending on the content and the effect of the measures a distinction can be made into 3 groups:

Once-Only Measures That Are Used To Eliminate The Hazard

These measures concern in a lot of cases the infrastructure and demand little or no observation. The hazard is eliminated, and the control measure needs little or no observation. These measures need to be evaluated periodically about the actual situation. Some examples:

• A complete physical separation between the clean and dirty area
• Making two separate production lines or divisions for products that can cause cross-contamination
• Take care that lubrication points are covered, provided with an oil trough or situated under the product stream

Measures That Are Used To Limit The Risk, By Controlling The Hazards

By this, a lot of general measures are covered that are not process or product-related. The objective of these measures is to avoid or reduce:

• additional contamination (chemical, physical and biological);
• cross-contamination to a minimum.

Measures To Limit The Risks By Eliminating The Hazards Or By Reducing Them To An Acceptable Level

These measures are more specific and more directed towards the process. The hazards that can lead to high risk are kept under control. The maintenance of measures should be followed closely.

Examples of specific control measures are:

• Heat treatments, cooling rate;
• Product composition (pH, aw, etc);
• Preservation technique;
• Packaging material, metal detection;
• in most cases, these are critical control points.

N. Hazard Analysis

When all potential hazards have been identified, they should be analysed. It is necessary to assess the risk of each identified hazard. In a lot of HACCP plans, established in the starting period, this part of the hazard analysis is missing or is insufficiently established. In these cases, there is no additional step between the inventory of the hazards and the identification of the critical control points.

The Codex Alimentarius:

‘The HACCP team should next conduct a hazard analysis to identify for the HACCP-plan which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of safe food.

In conducting the hazard analysis, wherever possible the following should be included: the likely occurrence of hazards and severity of their adverse health effects; the qualitative and/or quantitative evaluation of the presence of hazards; survival or multiplication of micro-organisms of concern; production or persistence in foods of toxins, chemicals or physical agents; and conditions leading to the above.'

For all listed hazards, the food industry should investigate the chance or probability that the mentioned hazard is occurring and if it occurs, what the effect on public health may be. In other words, the risk depends on the probability and the effect: risk = probability effect.

What is the possibility of a negative effect when the control measure does not work well?

Probability = the risk that the hazard occurs in the end product when the control measures are not present or are failing and taken into consideration the implemented PRP measures.

With the End product, all next steps in the production process are taken into consideration. Correction in the next step in the production process is possible.

Effect = the effect of this hazard on the health of the consumer.

The literature describes a whole range of approaches for hazard analysis. A simple method is the use of a matrix, in which a figure is given to the assessed probability and effect and in which the risk category can be seen on a scale from 1 to 7.

The effect of the hazard can be assessed by indicating that the effect is very limited, moderate, serious or very serious. The chance that the hazard is occurring is indicated as very small, small, real or large.

O. Information Sources

When a hazard analysis is carried out, it is important to know why a certain gradation of possibility and effect is chosen. This is to avoid those arbitrary gradations being chosen, without concentrating on concrete information.

Therefore, different information sources can be used.

First of all the knowledge and experience that is present in the company can give interesting information: complaints from clients, the frequency of some complaints, the occurring deviations. These examples give an indication of to which risk some hazards can lead.

Scientific Literature is also an important source of information, to demonstrate why a certain estimation of the possibility and effect were made. Based on generation times of pathogens, that was determined in vitro or in foods, after comparison with the own production process and storage conditions, a quantitative risk estimation of a microbial hazard can be made. Predictive modelling is another technique that is used to estimate microbial risks in a quantitative way. Through mathematical equations, it is shown how bacterial populations vary in time and how the rate of these changes is influenced by intrinsic and extrinsic factors. Some models are even available on the Internet (e.g., USDA Pathogen Modeling Program). Furthermore, a lot of other interesting information is available on the Internet: e.g., occurred food poisoning, recalls, the text of the law and possible microbial, chemical, and physical hazards.

Measurements and Analyses. The use of microbial challenge tests is the most appropriate method to estimate the risk of microbial hazards in the own product. Microbial challenge tests are used a lot to simulate what will happen with food during production, storage, distribution, etc. by contaminating the food with certain micro-organisms in well-known amounts. The contaminated food is then processed, stored, or treated under controlled conditions. When such a test is done in a proper way, it gives a lot of interesting information on the growth or survival of microorganisms under the tested conditions and the corresponding effect. Other important measurements are the follow up of the product temperature and the time at which a certain product is kept during storage, processing, and transport. Based on this, a realistic estimation can be made of the possibility and the effect of a certain hazard. Also, microbial analyses of raw materials, intermediate products, end products and the results of the follow up of the surrounding conditions and control of the cleaning and disinfecting are important information sources to support the hazard analysis.

Step 8: Identify Critical Control Points (CCP’S)

A critical control point is generally defined as any point, process step or activity where a potential hazard for food safety can be eliminated, prevented, or reduced to an acceptable level. This definition combined with the application of the decision tree can result in a high number of CCPs, making the HACCP plan unclear. The number of critical control points depends on the presence of PRP, the nature of the product, the complexity of the process and the accepted risk. A company can choose to indicate each point, process or process step that influences a certain hazard, as a CCP. This makes sense only when the company can control each point, and this is most often not the case. Furthermore, in this system, the most important critical control points are not getting the needed attention.

For this reason, there is a trend in the identification of CCPs to consider as a CCP only these steps, points or processes where the loss of control results in an unacceptable risk for public health and whereby means of concrete measures an efficient and quick control is possible. The other points, where the loss of control doesn't result in an unacceptable risk for public health and where no immediate adjustment of the product happens, is considered as a control point (CP). However, at these control points, inspection is still needed and at regular times, control should be performed. Furthermore, the probability of the occurrence of a serious hazard can only be kept under control, when at these points good preventive measures are present, such as a detailed cleaning and disinfection plan, rules for hygiene, clear work instructions, etc.

In summary:

CCPs are points where continuous control is necessary to eliminate or reduce the hazard to an acceptable level. When control of these points is lost,

• there is a high probability that the products are a risk for public health or are of no-good quality or
• the effect of a certain hazard is serious.

The performed controls should be demonstrable by means of registrations. Points, which are only controlled once a month, are no real CCPs.

CCPs are points, which need continuous attention, but the risks can be controlled by general preventive measures, belonging to basic rules for hygienic and safe operation in a food company (PRP). When the observation of these preventive measures is controlled frequently, the risks are considered as being sufficiently under control.

The identification of CCPs is a complex and critical process. Some production lines are rather extended and are processing a high number of ingredients. However, the number of CCPs should be limited to 5-10. At a higher number, control becomes too complex.

Different companies, producing the same product, can differ in their hazards, risks and also in their CCPs (as a consequence of different layout, equipment, ingredients, work condition). A general HACCP plan can be used as a guide. However, it is still necessary to consider the specific conditions belonging to a specific production line and that each company identifies its own CCPs.

Determination of CCPs using a Decision Tree

For the identification of CCPs, a decision tree can be used. Each process step and each identified hazard must be considered, in sequence, using the decision tree.

Question 1: Do preventive measures exist for the hazard(s)?

If the answer is YES, the team should then consider question 2.

If the answer is NO, the team must ask a supplementary question to determine if control is necessary at this step for product safety. If control is not necessary, then the step is not a CCP, and the team should apply the decision tree to the next identified hazard. If, however, the answer to this supplementary question is YES, then it is necessary to modify the step, process, or product so that control is obtained over the specified hazard. During the analysis, the team may recommend several changes to the step, process or product that would allow control to be achieved and the analysis to proceed.

Question 2: Does this step eliminate or reduce the likely occurrence of the hazard to an acceptable level?

The team should use the flow diagram data to answer this question for each process step. The question will identify the processing steps that are designed to eliminate or reduce the hazard to an acceptable level.

When considering this question for microbiological hazards the team should take account of the appropriate product technical data (e.g., pH, aw, level and type of preservatives, time, temperature) as well as the physical process being applied.

Pasteurization, cooking, aseptic packaging, evisceration are examples of process steps that could be microbiological CCPs.

If the team considers the answer to question 2 to be YES, then the process step under consideration is a CCP. The team must identify precisely what is critical (ingredient, process step, the location or a practice/procedure associated with the process step).

If the answer is NO, then question 3 must be considered for the same process step.

Question 3: Could contamination with identified hazard(s) occur at unacceptable levels or increase to unacceptable levels?

The team should first consider whether any of the ingredients used could contain any of the hazards under discussion more than an acceptable level. The team should also consider whether the immediate processing environment might be a source of the hazard under study.

When considering a possible increase in levels of the hazard, the team should be aware that it is possible that a single process step will not allow the development of the hazard to unacceptable levels, but over several process steps, the amount of increase may reach unacceptable levels due to cumulative time and temperature of holding the product during processing. The team must therefore take account of not only the specific process step under discussion but also the accumulated effect of subsequent process steps when answering this question.

If the answer is NO, the step is no CCP.

If the answer is YES, then the team should consider question 4 for the same process step.

Question 4: Will a subsequent step eliminate or reduce the hazard to an acceptable level?

Question 4 will only be considered if the team believes the answer to question 3 to be YES. The team must then proceed sequentially through the remaining process steps of the flow diagram and determine if any subsequent processing step(s) will eliminate the hazard or reduce it to an acceptable level.

If the team judges that the answer is YES, they should then apply the decision tree to the next hazard or to the next process step.

If the answer is NO, then a CCP has been identified. In this case, the team must identify precisely what is critical, i.e., is its raw material, a process step, the location or a practice/procedure associated with the process step.

Using Hazard Analysis

The identification of CCPs can also be done by using the risk analysis and the obtained risk categories. For example:

• Risk category 1 and 2: no specific actions, controlled through PRP
• Risk Categories 3 and 4: Additional question: Is the general control measure, as it is described in the PRP-principles, sufficient to control the identified hazard? When Yes: PRP, When No: CP
• Risk category 5, 6 and 7: Critical control point (CCP)

Step 9: Establish Critical Limits For CCPs

For the identification of target values and critical limits for each CCP, two questions need to be answered.

What are the critical factors associated with the CCP?

Critical factors associated with a CCP are those factors critical to safety, where failure to provide sufficient control may result in a safety hazard. Prior to determining critical limits, all components or factors associated with the CCPs must first be identified, the critical limits can then be established for each of these components.

Example 1: A canned food product would have a recommended thermal process that specifies a minimum cook to assure safety. The thermal process is identified as a CCP since the loss of control at this point would likely result in the development of a health hazard (i.e., Clostridium botulinum toxin). Critical components of this CCP would be those factors that have an influence on the proper thermal processing of this product (initial temperature, fill weight, viscosity, etc). With each of these critical components, a critical limit is associated.

Example 2: An acidified beverage may have the acid addition to the batch process specified as a CCP. Failure to add the acid at this step would result in a final product pH that would be unacceptably high. Since the thermal process of the beverage is determined by this pH, an elevated pH may result in an underprocessed product or a product that would support the growth of pathogenic spore-forming bacteria. The critical limit at this CCP would be pH 4.6. The critical limit is not necessarily the target pH at which the product was intended to be produced (e.g., pH 3.8) but rather the pH at which the product could become a health hazard.

After identifying the factors or components for each CCP, the second question that needs to be answered to identify the critical limits is:

• At what point or level would each of these critical factors become a hazard for public health?
• The fixing of the critical limits must be done in a well-considered way and needs to be clearly motivated. When these limits are established, it is important that they comply with the legislation – if it is available – concerning food safety.
• Therefore, it is essential that the members of the HACCP team that need to establish the critical limits have knowledge and experience concerning the raw materials and the entire production process as well as the legal obligations.
• Preferably quantitative values (figures) are used, although quantitative information from observation can also be used. However, clear agreements (through procedures, instructions, pictures, reference samples, training, etc) are necessary to determine what is acceptable and what is not.
• When a CCP is associated with equipment, it is necessary to know the variation on the equipment before the critical limits are fixed.
• It is important that a CCP is easy to measure. In most cases, such measurements can be done with automated equipment, which facilitates the monitoring.
• Critical limits can be based on legal norms, guidelines, literature, experiments or experts. One has to be aware that critical limits are linked to established critical product and process parameters en not to the final product.

Types of Critical Limits

Microbiological Limits

Some CCPs have identified microbial hazards, which need to be monitored and controlled to assure product safety. To assure product safety, microbiological control at these CCPs will need to be monitored and verified. However, microbiological testing is not the method of choice for controlling CCPs. Microbiological testing is seldom effective for monitoring CCPs or their critical limits due to the time-consuming nature of the testing. Rapid microbiological screening tests for pathogenic microorganisms generally take 48 hrs. Most product contamination by pathogenic microorganisms will probably be at a low level (<1%). The probability of detecting a microbiological pathogen that is contaminating a product at such a low level is extremely low.

Therefore, instead of the time-consuming microbiological testing, physical and chemical measurements can be used as indirect measures of microbiological control. The correlation between the physical or chemical parameters with the microbiological parameters should first be determined. With this correlation, exceeding the physical or chemical limit would mean that the corresponding microbiological limit also would have been violated; a potential health hazard may then exist or develop. Instead of measuring the microbiological sterility of a canned food product after thermal processing, the physical measurement (e.g. time/temperature) would be used to indicate whether a microbiological problem might exist. An effective HACCP program will use continuous monitoring of physical (e.g., time and temperature parameters, etc.) and/or chemical (e.g., pH, salt level, etc.) measurements to provide such assurance.

Microbiological testing may need to be done initially to identify the microbiological safety limits in the manufacturing process. This may be particularly true with new, innovative products for which safety information is nonexistent. Experimental studies will be used to determine the parameters (time, temperature, pH, etc.) at which the microorganisms reach a health hazard level, or to verify that the critical limits are adequate to control the hazardous microorganisms.

Microbiological testing can also be used to check if the identified microbial safety levels still apply and to check if the identified CCPs are under control. Microbiological analyses are very useful in the verification step of the established HACCP system.

Some manufacturers regard microbiological specifications on incoming ingredients as a critical control point and thus require a certificate of guarantee from the supplier. This may be particularly important when neither the manufacturing process nor the consumer preparation process contains a kill or destruction step to destroy microbial pathogens. However, this is only meaningful, when the supplier uses a functioning HACCP program. The alternative approach of using end-product testing to assure microbiological safety provides little assurance that the ingredient is safe.

Chemical Limits

In contrast to the microbial limits, more legal limits are available for chemical hazards. As for microbial hazards, the legal limits are limits for the final product, but in most cases, these are not the limits that are checked and controlled during the process.

To guarantee that the product complies with the legislation concerning the composition of the final product, limits need to be established for:

• the method of preparation;
• maintenance;
• manufacturers who rely on supplier certificates of guarantee for their incoming ingredients must assure themselves that monitoring was done via a HACCP programme rather than end-product testing.

Physical Limits

Physical hazards are removed from the product as much as possible. The final objective is absent or undetectable in the final product. The control measures to control physical hazards are for example:

• Detection of Ferro and non-Ferro particles > 1.5 mm;
• Presence of an undamaged sieve.

The most important task here is not to fix a limit, but to determine the most suited place for the detection apparatus in the production process, the calibration of the equipment, control of the detected and/or removed foreign objects and the maintenance of the equipment.

Manufacturers who rely on supplier certificates of guarantee for their incoming ingredients must assure themselves that monitoring was done via a HACCP programme rather than end-product testing.

Step 10: Establish A Monitoring System For CCPs

What is monitoring?

Within a HACCP system, monitoring has been defined as:

• checking that the processing or handling procedure at a CCP is under control (ICMSF)
• the scheduled testing or observation of the effectiveness of a process to control CCPs and their limits (FDA)
• a planned sequence of observations or measurements of critical limits designed to produce an accurate record and intended to ensure that the critical limit maintains product safety (NACMCF).

All these definitions agree that monitoring is an action. While monitoring may be done by a continuous instrument, it is not the same as continuous observation. Monitoring requires management action. It is not something that can be set up, turned on, and ignored.

Why do we Monitor?

Obviously, monitoring is done to collect data and subsequently have information upon which a decision is based. But monitoring also provides an early warning that a process is losing or out of control. When done properly, monitoring can help to prevent or minimize loss of product when a processor handling deviation occurs. It can also help to pinpoint the cause of the problem when control is lost. Without effective monitoring and recording of data or information, there is no effective HACCP system.

How do we Monitor?

Monitoring can be done by observation or measurement. In general, observations give qualitative indices and measurements result in quantitative indices. Thus, the choice of whether the monitoring will be an observation or measurement depends upon the established critical limit and available methods as well as real-time delays and costs.

Observation

Data collection by observation is the most basic. While monitoring by measurement is recommended because it gives unbiased numbers, the importance of observations cannot be overlooked.

Visual Observation

Visual monitoring does not require expensive equipment. It is useful in a simple food company of a non-industrialized country as well as in a sophisticated food processing company. To work efficiently, visual monitoring should be organized well and the personnel responsible for the monitoring should receive an education in a way that they know what they should take care of, how deviations of the established criteria should be determined and what actions should be taken.

Visual monitoring is especially important to control if rules for hygiene are taken into account by personnel and to control the cleaning and disinfection process.

It is important to distinguish visual monitoring of CCPs and routine control of the production process. The objective of monitoring is to check control measures and criteria of the CCP. Such visual monitoring differs from the general control because a prior established programme or checklist is followed and because the obtained results are written down and registered.

Sensorial Evaluation

The observation of the colour, odour and/or texture of a product can indicate a mistake rather fast. A putrid odour, observed for fresh meat, is a clear indication that time/temperature parameters during storage or distribution are insufficiently controlled.

If the sensorial evaluation is used as a monitoring tool, some considerations should be considered:

• The transport of raw vegetable products or fish and fish products is done in large baskets or with pallets on which a high number of boxes are piled. It is important to take a representative sample of the complete load.
• Raw products, sensitive to spoilage, are most often transported cooled or frozen. Most often, immediately after receipt, they are stored in cooling or freezing rooms. The observation of a deviating odour in such an environment (odour compounds are less volatile and the sensitivity of the nose is less at low temperatures) is very difficult. Therefore, it is advisable to first heat the analysing material and to do an observation in another room than the cooled storage rooms.

Other examples of sensorial evaluation are the inspection of cereals, fruits, nuts and cheese on the presence of moulds and the detection of deviations in the texture of vegetables and fish.

A sensorial analysis must be performed by a good-trained taste panel or by a person with sufficient experience.

Measurements

Monitoring by measurement can include physical, chemical or microbiological indices. A high number of physical and chemical measurements, which can be used online or off-line, exist and through their application usage information is obtained in a short time. Quick chemical tests such as determination of pH, water activity and moisture level or quick physical tests such as temperature measurement, pressure measurement, time measurement, can be used to check if a CCP is under control.

Most of these physical and chemical determinations are standard methods. However, in some cases, it is advisable to adapt these methods.

Microbiological analyses are not so often applied as a monitoring tool for CCPs as the time between the start of the test and obtaining the results is long in a way that, when mistakes are found, actions are too late. In some cases, however, microbiological analysis of the critical raw materials and end products is done. These raw materials and/or final products are only brought onto the market when the results of the microbiological analyses are known.

Microbiological analyses of products are also a part of the verification process. The results of these tests indicate that the HACCP system is working correctly or that the identified CCPs have been kept under control. When these tests reveal an unexpected hazard, the cause needs to be investigated. If it is not possible to find the cause by using the monitoring results, it can be that a CCP has been forgotten during the hazard analysis.

Microbiological analyses are also important to control cleaning and disinfection activities. Microbiological analyses by using swabs or RODAC-plates, taken from a cleaned surface, are a verification of the performed cleaning.

In most cases, microbiological analyses are an additional tool for visual and sensorial observations and for quick physical or chemical determinations.

Besides observation and measuring, process automation can be used to monitor. Some steps in the process can be programmed in such a way that through automation the occurrence of faults and errors is minimized. The equipment conducts the monitoring and gives a warning when there is a deviation or in some cases, it can adapt in an independent way.

Requirements for Measuring Equipment

Depending on the fixed critical limits it should be determined which measurement apparatus is appropriate to measure: precision and reliability of the used equipment is necessary. It is not useful to have unnecessary high demands towards the equipment. The precision and reliability must be in such a way that they allow to make a decision whether the result is acceptable or unacceptable for public health.

Also, the detection limit is important. In some exceptional cases, the critical limits need to be adapted to this limit.

The procedure and the frequency to calibrate the equipment are important parameters for the choice of the apparatus.

When online sensors are used, the placing of these sensors is very important to have relevant and reliable information and to be able to take corrective actions. For example, the temperature can vary depending on the place where you measure it. For heating processes, the sensor needs to be placed in the coldest place or a good correlation must be established between the temperature in the coldest point and the surrounding temperature. For cooling processes, the sensor should be placed in the hottest place. In cooled chambers, sensors that are in or between the product give more relevant information than a sensor that is measuring the temperature of the surrounding.

What is the Frequency Of Monitoring?

Continuous monitoring is an ideal situation. As soon as the product or process parameters exceed the critical limits, a warning is given, and corrective actions can be taken before the product is rejected.

However, continuous measuring is not always possible. For discontinuous monitoring, the frequency has to be considered very carefully by the HACCP team.

The following factors need to be taken into consideration:

• The results have to be representative
• Intervention should be possible before the products are delivered
• The production rate and the time between storage and delivery are determined
• Financial aspects
• When the critical limits are exceeded the products that were produced since the last measuring point have to be blocked
• The variation in the production parameters - when on one production line several products with other production parameters are produced, the monitoring frequency will be higher than when the same product is produced and no changes of the production parameters have to be carried out

Registration of the Data

The results that are obtained during monitoring need to be demonstrable and have to be registered. The way in which this is done is free to choose but has to be controlled (step 13: documentation).

Data can be registered in many different ways. The easiest one is with data sheets or registration forms on which the data are clearly reproduced.

The registered data need to be stored during at least the shelf life of the product and preferably for 2 years.

Conditions for a Reliable Monitoring

First, the user equipment should be reliable. To have reliable monitoring:

• The work methodology and the operation of the apparatus should be described (work instructions, operation instructions)
• The used equipment should be maintained periodically (maintenance plan)
• The used apparatus should be calibrated on a regular basis (calibration plan)

For every monitoring activity, a response should be assigned. The person who is responsible for the monitoring should have good knowledge, not only of the production process but also of the aim, the importance and the way in which the monitoring should be carried out. In the case of sensorial, physical, chemical and microbial analysis the person should be trained or need a lot of experience. In other words, the person who is responsible for monitoring, should have enough knowledge, be able to take responsibility, be reliable and be able to adapt to the process when this is one of his competencies.

In summary, it can be stated that for every CCP a monitoring instruction (or a reference to existing instructions or procedures) should be established in which the following information should be included:

• How the monitoring is executed;
• Which apparatus is used and how it is operated;
• With what frequency should be measured;
• Who is responsible for the monitoring;
• What has to be registered;
• Who can take the corrective actions and what are the corrective actions (step 11: corrective actions).

Step 11: Establish Corrective Action Plan

What are Corrective Actions

Corrective actions are actions that need to be taken as soon as possible when during the monitoring is observed that the critical limits are exceeded.

Establish and Execute the Corrective Actions

After fixing the critical limits and drawing up the monitoring program, it should be determined which corrective actions should be executed when a critical limit is exceeded because the safety of the final product cannot be guaranteed anymore.

To act as soon and efficient as possible, it is necessary that the corrective actions – as much as possible – are determined in advance.

The following subjects are part of the corrective actions:

• The process must be adapted, in a way that the critical process and product parameters comply with the critical limits as soon as possible.
• Products or batches that deviate need to be blocked and identified in such away. When necessary, the delivered parties need to be recalled.

Blocked batches must be unblocked. Depending on the seriousness of the situation, this can lead to:

• Recovery of the product (rework, follow-up treatment)
• Destruction of the product/batch.

Like for the monitoring, the responsibilities and the competencies that belong to (the different parts of) the corrective actions should be clearly indicated.

Registration

Occurring deviations need to be registered. Therefore, a separate registration form is used. On this form the following information is necessary:

• The date
• The product, production process, process steps
• Description of the deviation
• The persons that concluded the problem
• The taken actions
• The signature of the HACCP coordinator/responsible person.

This information can also be noted on the registration form that is used during monitoring.

Corrective (prevention) Measures

Learn from arisen problems. The HACCP team should evaluate the occurring deviations on a regular base. Herewith, it should be traced what the cause was, and which measures can be taken to avoid that they will occur in the future again.

Possible corrective (prevention) measures are: raise the frequency of monitoring; automate the monitoring; modernize the infrastructure; change the product composition.

Step 12: Establish Documentation System

Reasons for Keeping Records

The reasons for keeping HACCP-records relate to:

• Evidence of product safety about the present procedures and processes
• Assurance of regulatory compliance
• Ease for product traceability and
• Verification or record review.

Well-maintained records provide the best evidence that procedures and processes are being followed in strict accordance with HACCP requirements.

Since HACCP records focus only on safety-related issues, problem areas can be quickly identified because these records provide an uncluttered view of product safety issues. All HACCP records should be kept separate from quality assurance documents so that regulatory compliance officers will view only the product safety records during HACCP audits.

The HACCP Handbook

The HACCP handbook or HACCP manual consists of 14 chapters in which the 14 steps are elaborated. Companies that have an ISO 9000 quality management system need to integrate HACCP into the existing documentation systems. However, it is recommended to have an overview of where the different steps of the HACCP system can be found.

Additional HACCP Documents

The practical translation and implementation of the HACCP plan are done with some additional documents. Four types of documents are distinguished:  specifications; instructions; procedures; registration forms.

Specifications

Specifications are an engagement between the client and the supplier (intern and extern) about products (raw materials) and processes. This also means that the criteria for approval and rejection are determined.

Three types of specifications are distinguished :

• Product specifications - In this specification, the properties of the product are described (step 3).
• Process specifications - In this specification, the treatments, the order, the operation properties of the equipment, are described.
• Raw material specifications (purchase specifications) - In this specification, the properties and the standards are given to which the raw and auxiliary materials have to comply. The purchase specifications of the customer can be product specifications of the supplier.

Management of these specifications is necessary to keep them complete and current.

Instructions

Instructions are working instructions with indications of how you can or must work in the most efficient way.

Instructions are in most cases meant for one person and are bound to a place in the company, where they should be present.

The best instructions are short and concise and are made following the KISS and SMART principles:

KISS: Keep It Straight and Simple

SMART: Specific, Measurable, Achievable, Relevant, Time-bound

Preferably the persons who have to use the instruction, help to develop the instruction. This improves motivation and implementation.

Three types of instructions can be distinguished:

• Working instructions - Working instructions describe the execution of the separate operations in a logical order.
• Operation instructions - Operation instructions describe how a certain apparatus or machine has to be operated.
• Control instructions - Control instructions contain indications of how control tests have to be carried out.
• Procedures - Procedures are engagements between employees of different departments. Some examples: purchase procedure; cleaning procedure; pest control procedure; training procedure; maintenance procedure; complaints procedure; recall procedure; procedure for construction and the maintenance of the HACCP plan.

Registration Forms

Registration forms need to be present in the workplace where they are needed. They are part of the above-mentioned instructions and procedures.

In the HACCP system, all the registration forms must be collected and evaluated on fixed moments. Registration forms that are filled in correct are essential for the judgement of an operational HACCP system.

Some examples:

• Pursuit of CCP’s and POA’s cleaning scheme;
• Pest control plan grease plan calibration plan audit form complaints form.

The information on the registration forms is one of the starting points of the HACCP verification.

Document Control

Using documents is only useful and meaningful when there is a management system.

Important points in a procedure for document control are:

• Arrangement of the competencies;
• Who is allowed to change documents;
• How are changes noted and communicated;
• Version number and date when the document was changed;
• Take care that the right documents are in the right place;
• Remove the old documents.

An overview should be made of all the available documents with the latest, valid version (survey matrix).

In a second matrix (destination matrix) it should be indicated for every document (specifications, procedures, instructions, forms) on which place in the department they should be present.

These matrices are used during the verification to see whether:

• Only the most recent documents are used
• The right documents are in the right place

Record Keeping

All documents that are related to HACCP, need to be filed in a well-organized way so that they can be found in a quick way.

Registration forms must be kept during at least the shelf life of the product. In function of the verification, it is advised to keep all documents for at least 2 years.

Step 13: Verification Of The HACCP System

Verification Versus Validation

Although these terms are confused in a lot of cases, there is a clear difference between validation and verification.

Validation means declaring valid. It is a procedure that is carried out in advance, to examine if the fixed critical limits can control the risk in practice.

Verification is the determination of the correctness. It is the procedure that is used afterwards to control the efficiency of the HACCP plan.

Verification Versus Monitoring

There is a clear difference between verification and monitoring.

Monitoring is like ‘quality control’: monitoring is going on during the process and adjustments can be made in the process before the product leaves the process line and reaches the consumer.

Verification is like ‘quality assurance’: it is a check of the system to confirm that the established critical control points were properly verified and corrective action, if needed, was properly taken.

Verification Versus Review

Periodically, verification of the entire HACCP program must be conducted. The objective of the verification is to check whether the established HACCP plan and the performed controls are appropriate and if the identified hazards are under control.

A review is carried out when:

• The verification points out that the HACCP plan is not appropriate any more changes are occurring in raw materials;
• Product composition equipment;
• Cleaning and disinfection infrastructure.

Verification of the HACCP Plan

Verification has a threefold aim:

• Maintenance of the HACCP system: complete and adapt the HACCP plan as a result of product or process changes, reorganizations, new insights in food safety.
• Testing of the HACCP system: check if the HACCP system is followed as it is described and if the implemented HACCP system is appropriate to control specific hazards of the product and process.
• Improvement: as a result of the verification activities, the HACCP plan should be adapted, and the quality policy should be reviewed.

The verification should include:

Verification of the CCPs: at least once a year the results of the monitoring should be analysed. By carrying out a trend analysis new information can be found (correlation between certain deviations and certain products, process circumstances, periods of the year, etc).

Verification of the handbook: at least once a year the HACCP handbook and especially the HACCP specific elements should be reconsidered. Is the information still up to date? Is the hazard identification and analysis still in accordance with the current opinions?

Verification can be carried out through:

Sampling and analysis: An analysis scheme for final products and raw materials is necessary.

Audits: a GMP-audit, a HACCP-audit or an external audit can be carried out.

Complaint analysis: complaints can be an interesting source of information concerning the well-functioning of the HACCP system.

Report

The HACCP team has to register all the results of the different verification activities and has to evaluate them. From this, conclusions will be made, that are included in the general verification report. This report has to be given to the board and is the starting point for the management review.

Improvement and Management Review

HACCP is a growth process and one of the objectives is to improve continuously. The results of the verification process need to keep the system up to date and help to improve it to increase product safety. The decisions concerning this topic need to be taken by the board.

The board of the company has to take care that the HACCP system is maintained and reviewed when it is necessary. Based on the information in the verification report the objectives of the quality management can be adapted and new objectives can be included.

Step 14: Review Of The HACCP Plan

The aim of the last step ‘Review’ is to keep the HACCP system as up to date as possible.

In the previous step, it was stated that the HACCP plan should be verified at least once a year. When there are important changes in between two verifications, one has to determine as soon as possible to what extent these changes have an influence on the current HACCP plan and how the adaptations should be implemented.

Examples of changes at which a review of the HACCP is necessary:

• Changes of the raw material;
• Changes of the product/process (other product characteristics, other packaging material);
• New products;
• Changes in the production process (changes of the process parameters, other conservation techniques);
• Infrastructural changes;
• Reorganizations;
• Calamities;
• New insights in food safety;

When there are technical changes in the process or product, new suppliers, new transportation firms or changes in the infrastructure, it is recommended to involve the HACCP team. In this way, it can be avoided the changes create a new risk.

Besides the review because of changes, it is also necessary to review when the verification shows that the current system is not sufficient.

Through the documentation system, it should be demonstrable that there is a review on a regular base. Therefore, it can be registered on a form when something was reviewed, for Hazard Analysis Critical Control Points which reason and which changes were made. Also, on the adapted documents the review should be recognizable (e.g., via a version number).

Click here to download a handout that contains a checklist designed for food processing and drying facilities.