6.Guide To HACCP Implementation For The Food Proc
GUIDE TO HACCP IMPLEMENTATION FOR THE FOOD PROCESSING INDUSTRY (Case Study)
Hazard Analysis and Critical Control Point (HACCP) is a science based and systematic system used to identify:
- Specific hazards to food safety,
- Measures for the control of hazards to ensure the safety of food.
HACCP principles are used as a tool to assess hazards and establish control-systems that focus on preventing the production of unsafe food, rather than relying on end product testing. The system can be applied throughout the food chain from primary production to final consumption and implementation should be guided by scientific evidence of risks to human health.
As well as enhancing food safety, implementation of HACCP can provide other significant benefits, such as:
- Promoting international trade by increasing confidence in food safety.
- Aiding inspection by regulatory authorities
The successful application of HACCP requires the full commitment and involvement of both executive-level management and the total work force. It also requires a multidisciplinary approach; this multidisciplinary approach should include, (when appropriate), expertise in agronomy, veterinary hygiene, fruit and vegetable production, microbiology, medicine, public health, food technology, environmental health, chemistry and engineering.
The intent of HACCP is to focus control at critical control points (CCP’s). HACCP should be:
- applied to each specific production procedure separately.
- flexible where appropriate
- taking into account the nature and the size of the implementing company/organization.
- capable of accommodating change, such as advances in equipment design, processing procedures or technological developments.
- reviewed, and necessary changes made when any modification is made in the product, process, or any step.
During hazard identification, evaluation, and subsequent operations in designing and applying HACCP, 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.
HACCP systems must be built upon a firm foundation of existing compliance with Good Manufacturing Practices (GMPs), acceptable Sanitation Standard Operating Procedures (SSOPs) and appropriate industry practices.
GMPs are the minimum sanitary and processing requirements necessary to ensure the production of wholesome food. The areas addressed through GMPs are good hygiene practices, personal hygiene, buildings and facilities, equipment and utensils, and production and process controls.
SSOPs (Sanitation Standard Operating Procedures) are part of documented GMPs for hygiene and sanitation, required to meet regulatory requirements for food control. The written SSOP plan should explain the sanitation concerns, controls, in-plant procedures and monitoring requirements. They are also required to monitor these conditions and practices, correct unsanitary conditions and practices in a timely manner, and maintain sanitation control records.
The SSOP should address at least the following conditions and practices: safety of water and ice, condition and cleanliness of food contact surfaces, prevention of cross contamination from unsanitary objects to food, maintenance of facilities for personal hygiene, protection of food and food contact surfaces from adulteration, proper labeling, storage and use of toxic compounds, control of employee health conditions, exclusion of pests.
Without the application of GMP and SSOP principles, an effective HACCP program cannot be conducted.
2.0 THE SEVEN PRINCIPLES OF HACCP
HACCP systems are designed to identify and control food safety hazards associated with food from the time a company receives raw material, through processing to distribution to the consumer.
HACCP systems are based on the following seven principles:
3.0 Developing a HACCP Plan
In order to develop a HACCP system, the seven HACCP principles are applied in twelve steps:
4.0 STEP 1 – ASSEMBLE A HACCP TEAM
A company wishing to implement a HACCP system should ensure that the appropriate product specific knowledge and expertise is available for the development of an effective HACCP plan.
The company should also understand that the implementation of a HACCP system requires a whole-company, team approach. It is not possible for one person alone to implement such a system. The HACCP team should be multidisciplinary, and include a motivated executive- level management member, capable of ensuring the necessary funding and overall company determination to ensure successful HACCP implementation.
The HACCP team will also require a Team Leader. It may be possible that within an organization, a well-trained individual, with access to HACCP literature and HACCP guidance (including sector-specific HACCP guides), will be able to lead the HACCP implementation team. However, in the absence of a suitably informed and capable in-house individual, a HACCP implementation consultant should be employed, whose role will be to:
- train a HACCP team leader;
- train the HACCP team;
- guide the design and implementation of a
The team should include experts covering all specific knowledge appropriate to the product under consideration, its production/ manufacture, storage, distribution, and its consumption and associated potential hazards. The team may include multidisciplinary specialists:
- who understand the biological, chemical or physical hazards connected with a particular product group;
- who have responsibility for, or are closely involved with, the technical process of producing/manufacturing the product under study,
- who have a working knowledge of the hygiene and operation of the process plant and equipment,
- any other person with specialist knowledge of microbiology, hygiene or food technology.
One person may fulfill several of these roles, provided all relevant information is available to the team, and is used to ensure that the system developed is reliable. Optimally, a multidisciplinary team will be assembled on-site. However, where the required expertise is not available on site, the team should be assisted by specialists who will help it solve difficulties, including assessment and control of critical points. Sources of expertise will include: trade and industry associations, independent experts and regulatory authorities.
The scope of the HACCP plan should be identified. The scope should describe which segment of the food chain is involved and which process of the business and the general classes of hazards are to be addressed (biological, chemical and physical).
5.0 Step 2 – Description of the Product
A full description of the product should be drawn up, including relevant safety information such as:
- composition (e.g. raw materials, ingredients, additives, etc.);
- physical/chemical structure (including Aw, pH, etc;
- processing (e.g. heating, freezing, drying, etc. and to what extent),
- any microbiological or chemical criteria applicable including microbial /static treatments (cooling, freezing, brining, heat-treatment, etc.
- packaging (e.g. carton, hermetic/canning, vacuum, modified atmosphere
- storage and distribution conditions, methods of distribution;
- required shelf life (e.g. “use by date” or “best before date”);
- instructions for use.
Within businesses with multiple products, it may be effective to group products with similar characteristics or processing steps, for the purpose of development of the HACCP plan.
Suggested records include description of the product and identify intended. These records may be adapted for individual company use.
6.0 Step 3 – Identify Intended Use
The HACCP team should also define the normal or expected use of the product by the customer, and the consumer target groups for which the product is intended. In specific cases, the suitability of the product for particular groups of consumers, such as institutional caterers, travelers, etc. and for vulnerable groups of the population, including babies, may have to be considered.
Suggested records include description of the product and intended end-consumers.These records may be adapted for individual company use.
7.0 Step 4 – Construct a Flow Diagram
A product flow diagram should be constructed by the HACCP team. The flow diagram should cover all steps in the operation for a specific product. The same flow diagram may be used for a number of products that are manufactured using similar processing steps. When applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation.
The diagram shows a flow of steps that may occur during storage and packing of fresh produce and the inputs for each step that could introduce a food safety hazard. Whatever the format chosen all steps involved in the process, should be studied in sequence and presented in a detailed flow diagram together with relevant technical data. Steps in the process may include receiving the raw materials, preparation, processing, packaging, storage and distribution, and placing the end product on the market; delays during or between steps should also be recorded.
Types of technical data may include but are not limited to:
- plan of working premises and ancillary premises.
- equipment layout and characteristics.
- sequence of all process steps (including the incorporation of raw materials.
- ingredients or additives and delays during or between steps).
- technical parameters of operations (in particular time and temperature,including delays).
- flow of products (including potential cross-contamination).
- segregation of clean and dirty areas (or high/low risk areas).
The following GMP/SSOP requirements are prerequisites and can be integrated in the HACCP system:
- cleaning and disinfection procedures.
- hygienic environment of the establishment.
- personnel routes and hygiene practices.
- product storage and distribution conditions.
8.0 Step 5 – On-site Confirmation of the Flow Diagram
Steps must be taken to confirm the processing operation against the flow diagram during all stages and hours of operation, and the flow diagram amended where appropriate. The confirmation of the flow diagram should be performed by a person or persons with sufficient knowledge of the processing operation, and/or the multidisciplinary team as appropriate.
Any observed deviation must result in an amendment of the original flow diagram to make it accurate.
9.0 Step 6 – Conduct a Hazard Analyses (HACCP Principle 1)
The first principle of HACCP is to conduct a hazard analysis. Before beginning the process, the HACCP team should review the definitions of food safety hazard. Hazards are usually grouped into three categories: Biological, Chemical, and Physical. A useful approach to hazard analysis it to divide the analysis into two activities - hazard identification and hazard analyses.
a. Hazard Identification
This first step in identifying hazards which might be associated with a production process might be considered a “brainstorming” session. The HACCP team should use the flow diagram and product description, which was created in the preliminary steps, and systematically think about what could occur at each step in the process. Records should be maintained having checklist of questions which might help the team to be as thorough as possible in considering the hazards which might be associated with process.
Hazard identification should result in a list of potential hazards at each operation’s step (use the HACCP plan flow diagram) in the process from the receipt of raw materials to the release of the finished product.
During hazard identification, the team need not be confined by the hazard’s likelihood of occurrence or its potential for causing disease. All potentially significant hazards must be considered. To assist in this, the following list of hazards will be valuable.
i. Biological Hazards
Biological hazards are living organisms that can make food unsafe to eat. Biological hazards may be bacterial, parasitical, or viral. Identifying the biological hazards to which your production processes might be subjected is clearly a difficult and important task - one that requires all the expertise that your HACCP team can bring to it. Indeed, outside expertise may be recommended for this process. Currently, there is a great deal of emphasis on microbial hazards associated with fresh fruit and vegetable products. Some of the major pathogens that may be associated with fresh fruit and vegetable products are: Pathogenic bacteria associated with fruits and vegetables include: Salmonella, Shigella,· Escherichia coli (pathogenic),· Campylobacter species,· Yersinia enterocolitica,· Listeria Monocytogenes,· Staphylococcus aureus, Clostridium species, Bacillus cereus,· Vibrio species. A large number of bacterial pathogens have been implicated in food borne outbreaks associated with the consumption of fresh fruits and vegetables.
ii. Chemical Hazards
Chemical hazards may be the result of something naturally occurring in foods or added during the processing of foods. Harmful chemicals have been associated with both acute cases of food borne illness and chronic illness. Naturally occurring chemical hazards are those that are natural constituents of foods (e.g. apple, nuts) and not the result of environmental, industrial, or other contamination. They include Patulin, and Aflatoxin.
Added chemical hazards are those which are intentionally or sometimes unintentionally added to food during the growing, harvesting, storage, processing, packaging, or distribution phases of production. This group of chemical hazards is very broad and
might include components of animal feed or drinking water, pesticides, food ingredients themselves, or chemicals used in the processing establishment such as lubricants, cleaners, paints, and coatings.
iii. Physical Hazards
A physical hazard is a physical component of a food that is unexpected and may cause illness or injury to the person consuming the food. Foreign materials such as glass, metal, or plastic are familiar physical hazards in fresh fruit and vegetable growing products, usually found because a
process or a piece of equipment has not been properly controlled while the food was being produced.
There are a number of situations that can contribute to physical hazards in foods; they include:
- Contaminated raw materials.
- Poorly designed or poorly maintained facilities and equipment.
- Contaminated packaging materials.
- Inattention to details by employees with key responsibilities.
b. Hazard Analyses
The second step in performing a hazard analysis is to identify preventive measures that could be used to control each hazard. Preventive measures are the physical, chemical, or other means that can be used to control a food safety hazard. A Record form which you can use to go through your process systematically, identify the hazards which might occur at each step in the process and the preventive measures which might be used to prevent, eliminate, or reduce each hazard to an acceptable level. Consider and describe what control measures exist, if any, which can be applied for each hazard. Control measures are those actions and activities that can be used to prevent hazards, eliminate them or reduce their impact or occurrence to acceptable levels.
More than one control measure may be required to control an identified hazard and more than one hazard may be controlled by one control measure e.g. pasteurization or controlled heat treatment may provide sufficient assurance of reduction of the level of both Salmonella and Listeria. Control measures need to be supported by detailed procedures and specifications to ensure their effective implementation.
Examples of procedures/specifications may include : detailed cleaning schedules, precise heat treatment specifications, maximum concentrations of preservatives etc. These should be in compliance with the applicable hygiene regulations, or standards required by clients, (when the product will be exported) based upon which is the higher standard.
Deliberations of the HACCP team during the hazard analysis must be documented. A useful way for documenting decisions during the hazard analysis is to use a hazard analysis worksheet.
10.0 Step 7 – Determine Critical Control Points (HACCP Principle 2)
The second HACCP principle is to identify the critical control points (CCPs) in the process. A CCP is a point, step, or procedure in a food process at which control can be applied and, as a result a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.
So far, in developing the HACCP plan, the HACCP team should have identified biological, chemical, and physical hazards in the raw materials and the ingredients used, as well as in the steps of the process. For each food safety hazard reasonably likely to occur, a preventive
measure must be identified. The next step is to find the point or points in the process where these preventive measures should be applied. The identification of a critical point for the control of a hazard requires a logical approach. Such an approach can be facilitated by the use of a decision tree (other methods can be used by the team, according to their knowledge and experience.
Example of Decision Tree to Identify CCPs
(*) Proceed to the next identified hazard in the described processes.
(**) Acceptable and unacceptable levels need to be defined within the overall
objectives in identifying the CCPs of HACCP.
For the application of the decision tree, each process step identified in the flow diagram should be considered in sequence. At each step, the decision tree must be applied to each hazard that may be reasonably expected to occur or be introduced and each control measure identified.
Application of the decision tree should be flexible, and consideration given to the whole manufacturing process in order to avoid, whenever possible, unnecessary critical points.
11.0 Step 8 – Establish Critical Limits (HACCP Principle 3)
Each control measure associated with a critical control point should give rise to the specification of critical limits. Critical limits:
- correspond to the extreme values acceptable with regard to product safety.
- separate acceptability from unacceptability
- are set for observable or measurable parameters which can demonstrate that the critical point is under control
- should be based on substantiated evidence that the chosen values will result in process control.
Examples of parameters include temperature, time, pH, moisture content, additive, preservative or salt level, sensory parameters such as visual appearance or texture, etc. In some cases, to reduce the risk of exceeding a critical limit due to process variations, it may be necessary to specify more stringent levels (i.e. target levels) to ensure that critical limits are observed. Critical limits may be derived from a variety of sources. When not taken from regulatory standards or from guides of good hygiene practices, the team should ascertain their validity relative to the control of identified hazards at CCP’s, and include them in the relevant monitoring.
12.0 Step 9 – Establish Monitoring Procedures (HACCP Principle 4)
An essential part of a HACCP system is a program of observations or measurements performed at each critical point to ensure compliance with specified critical limits. Observations or measurements must be able to detect loss of control at critical points and provide information in time for corrective action to be taken. Where possible, process adjustments should be made when monitoring results indicate a trend towards loss of control at a CCP.
The adjustments should be taken before a deviation occurs. Data derived from monitoring must be evaluated by a designated person with knowledge and authority to carry out corrective actions when indicated. Observations or measurements can be made continuously or intermittently. When observations or measurements are not continuous, it is necessary to establish a frequency of observations or measurements which provides reliable information.
In summary, for each CCP, the monitoring program should:
- describe the methods of monitoring.
• the frequency of observations or measurements.
- the recording procedure.
- who is to perform monitoring and checking.
- when monitoring and checking is performed.
- how monitoring and checking is performed.
- parameters for hazards.
- corrective actions if trends indicate a loss of control.
Records associated with monitoring CCP’s must be signed by the person(s) doing the monitoring and when records are verified by a responsible reviewing official(s) of the company.
13.0 Step 10 – Establish Corrective Actions (HACCP Principle 5)
For each critical control point corrective actions have to be planned in advance by the HACCP team, so that they can be taken without hesitation when monitoring indicates a deviation from the critical limit. Such corrective action should include:
- proper identification of the person(s) responsible for the implementation of the corrective action,
- description of means and action required to correct the observed deviation,
- action to be taken with regard to products that have been manufactured during the period when the process was out of control,
- written record of measures taken indicating all relevant information (for example: date, time, type of action, actor and subsequent verification check).
Monitoring (checking equipment, checking the person handling the food, checking the efficacy of previous corrective measures, etc.) may indicate that preventive measures need to be put in place, if corrective actions for the same procedure have to be implemented repeatedly.
14.0 Step 11 – Establish Verification Procedures (HACCP Principle 6)
The HACCP team should specify the methods and procedures to be used for determining if the HACCP is working correctly. Methods for verification may include random sampling and analysis, reinforced by analysis or tests at selected critical points, intensified analysis of intermediate or final products, surveys on actual condition during storage, distribution and sale, and on actual use of the product. The frequency of verification should be sufficient to confirm that HACCP is working effectively.
The frequency of verification shall depend on the characteristics of the business (output, number of employees, nature of the food handled), the monitoring frequency, the accuracies of the employees, the number of deviations detected over time and the hazards involved. Verification procedures include:
- audits of HACCP and its records.
- inspection of operations.
- confirmation that CCP’s are kept under control.
- validation of critical limits.
- review of deviations and product dispositions; corrective actions taken with regard to the product.
The frequency of verification will greatly influence the amount of recheck or recall required should a deviation exceeding the critical limits be detected. Verification shall comprise all of the following elements, but not necessarily all at the same time:
- Check on the correctness of the records and analysis of deviations.
- Check on the person monitoring processing, storage and/or transport activities.
- Physical check on the process being monitored.
- Calibration of instruments used for monitoring.
Verification should be carried out by someone other than the person who is responsible for performing the monitoring and corrective actions. Where certain verification activities cannot be performed in house, verification should be performed on behalf of the business by external experts or qualified third parties.
Where possible, validation activities should include actions to confirm the efficacy of all elements of the HACCP plan. In case of change, it is necessary to review the system, to ensure that it is (or will be) still valid. Examples of change include:
- change in raw material or in product, processing conditions (factory layout and environment, process equipment, cleaning and disinfection program).
- change in packaging, storage or distribution conditions.
- change in consumer use.
- receipt of any information on a new hazard associated with the product.
Where necessary, such a review must result in the amendment of written procedures. The changes should be fully incorporated into the documentation and recordkeeping system, in order to ensure that accurate up-to-date information is available.
The HACCP team needs to decide on what procedures the plant will perform to verify that the HACCP system is working effectively and how often these actions will be performed. Verification uses methods, procedures, or tests in addition to those used in monitoring to see whether the HACCP system is in compliance with the HACCP plan or whether the HACCP plan needs modification. There are three types of verification.
Validation is the initial phase in which the plan is tested and reviewed. The choices made while working through the preliminary steps and HACCP principles must be repeatedly tested and shown to prevent or control identified hazards in the “real world”. In this phase, microbial or
residue testing can be used effectively to verify that the process is under control and is producing acceptable products. Such testing provides clear evidence that the techniques and methods adopted by the plant to control hazards are not just effective in theory but will work in this specific plant.
Ongoing verification ensures that the HACCP plan is working effectively on a day-to-day basis. This type of verification includes such tasks as calibrating monitoring instruments, observing monitoring activities and corrective actions, and reviewing HACCP records to see that they are being made and kept according to the plan.
Reassessment is an overall review of the plan that must be performed at least annually, or whenever any changes occur, that could affect the hazard analysis or alter the HACCP plan. Reassessment is similar to validation in that it considers whether the plan is adequate in general rather than focusing on the plan's daily operations. It is also similar to validation in that it must be done by a HACCP-trained person.
15.0 Step 12 – Establish Documentation and Record Keeping (HACCP Principle 7)
Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP procedures should be documented.
Documentation and record keeping should be appropriate to the nature and size of the operation and sufficient to assist the business to verify that the HACCP controls are in place and being maintained. Documents and records should be kept for a sufficient time to allow the competent authority to audit the HACCP system. Documents should be signed by a responsible reviewing official of the company. Expertly developed HACCP guidance materials (e.g. sector-specific HACCP guides) may be utilized as part of the documentation, provided that those materials reflect the specific food operations of the business.
Documentation examples include:
- Hazard analysis;
- CCP determination;
- Critical limit determination.
Record examples are:
- CCP monitoring activities;
- Deviations and associated corrective actions;
- Verification activities;
- Modifications to the HACCP system.