There are twelve tasks required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly. Principle 1, which is to conduct a hazard analysis, requires that the first five tasks have all been addressed in a logical and honest manner so that all real hazards associated with the commodity have been identified. The twelve tasks are discussed briefly below, and listed in Appendix II.
Task 1 - Establish a HACCP team
To fully understand the commodity system and be able to identify all likely hazards and CCPs, it is important that the HACCP team is made up of people from a wide range of disciplines. The team should include:
A team leader to convene the group and to direct the work of the team ensuring that the concept is properly applied. This person must be familiar with the technique, be a good listener and allow all participants to contribute.
A specialist with a detailed knowledge of the commodity system is required. This specialist will have a major role in the production of the commodity flow diagrams.
Several specialists, each with an understanding of particular hazards and associated risks, e.g. a microbiologist, a chemist, a mycotoxicologist, a toxicologist, a QC manager, a process engineer.
People, such as packaging specialists, raw material buyers, distribution staff or production staff, farmers, brokers, who are involved with the process, and have working knowledge of it, may be brought into the team temporarily in order to provide relevant expertise.
The team's progress and results of the analysis should be recorded by a technical secretary.
If any changes are made to composition or operational procedures, it will be necessary to re-assess the HACCP plan in the light of the changes.
The first activity of the HACCP team is to identify the scope of the study. For example, will the whole commodity system be covered, or only selected components? This will make the task more manageable and specialists can be added to the team as and when they are required.
Task 2 - Describe the product
To start a hazard analysis, a full description of the product, including customer specification, should be prepared using a form such as that given in Appendix III. This should include information relevant to safety, e.g. mycotoxin regulation/target level, composition, physical/chemical properties of the raw materials and the final product, the amount of water available for microbial growth (aw), the amount of acid or alkali in the product (pH). Also information regarding how the product is to be packaged, stored and transported should also be considered together with facts regarding its' shelf life and recommended storage temperatures. Where appropriate, labelling information and an example of the label should be included. This information will help the HACCP team to identify 'real' hazards associated with the process.
Task 3 - Identify the product's intended use
How the product is intended to be used is an important consideration. Information on whether the product will be consumed directly, or be cooked, or be further processed, will all have a bearing on the hazard analysis, see task 6). The nature of the target group for the product may also be relevant, particularly if it includes susceptible groups such as infants, the elderly, and the malnourished. The likelihood of misuse of a product should also be considered, such as the use of pet food as a human food, either by accident or design. This information can be recorded on the same form as the product description, see Appendix III.
Task 4 - Draw up the commodity flow diagram
The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the commodity system, or that part of it which is relevant. The expertise of the commodity specialist is important at this stage. Commodity systems will differ in detail in different parts of the world, and even within one country there may be a number of variants. Secondary processing will need to be detailed for each factory, using generic flows only as a guide. Examples of commodity flow diagrams are included in the case studies presented in Chapter 3.
Task 5 - On site confirmation of flow diagram
Upon completion of the CFD, members of the team should visit the commodity system (e.g. farm, store or manufacturing area) to compare the information present on the CFD with what actually happens in practice. This is known as "walking the line", a step by step practice to check that all information regarding materials, practices, controls etc. have been taken into consideration by the team during the preparation of the CFD. Information such as time of harvest, drying procedures, storage conditions, the marketing chain, socio-economic factors, grading systems and any incentive for improved quality or safety, and processing systems, should be collected and included in the CFD as appropriate. The site for which the HACCP plan is being designed should be visited as many times as possible to ensure that all relevant information has been collected.
Task 6 - Identify and analyse hazard(s) - (Principle 1)
Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan. All real or potential hazards that may occur in each ingredient and at each stage of the commodity system should be considered. Food safety hazards for HACCP programmes have been classified into three types of hazards:
Biological: typically foodborne bacterial pathogens such as Salmonella, Listeria and E. coli, also viruses, algae, parasites and fungi.
Chemical: There are three principle types of chemical toxins found in foods: naturally occurring chemicals, e.g. cyanides in some root crops, and allergenic compounds in peanuts; toxins produced by micro-organisms, e.g. mycotoxins, and algal toxins; and chemicals added to the commodity by man to control an identified problem, e.g fungicides or insecticides.
Physical: contaminants such as broken glass, metal fragments, insects or stones.
The probability that a hazard will occur is called a risk. The risk may take a value from zero to one depending on the degree of certainty that the hazard will be absent or that it will be present. After hazard identification, a hazard analysis must be conducted to understand the relative health risk to man or animal posed by the hazard. It is a way of organizing and analyzing the available scientific information on the nature and size of the health risk associated with the hazard. The risk may have to be assessed subjectively and simply classified as low, medium, or high. Only those hazards considered by the HACCP team to present an unacceptable risk of being present are taken forward to Stage 7, Principle 2.
Once a food safety hazard has been identified, then appropriate control measures should be considered. These are any action or activity that can be used to control the identified hazard, such that it is prevented, eliminated, or reduced to an acceptable level. The control measure may also include training of personnel for a particular operation, covered by GAP, GMP, and GHP.
Task 7 - Determine the critical control points (ccps) - (Principle 2).
Each step in the commodity flow diagram, within the scope of the HACCP study, should be taken in turn and the relevance of each identified hazard should be considered. It is also important to remember the stated scope of the HACCP analysis at this stage. The team must determine whether the hazard can occur at this step, and if so whether control measures exist. If the hazard can be controlled adequately, and is not best controlled at another step, and is essential for food safety, then this step is a CCP for the specified hazard. A decision tree can be used to determine CCPs, and an example of the Codex decision tree is included in Appendix IV. However, the HACCP team's judgement, expertise and knowledge of the process are the major factors in establishing CCPs.
If a step is identified where a food safety hazard exists, but no adequate control measures can be put in place either at this step or subsequently, then the product is unsafe for human consumption. Production should cease until control measures are available and a CCP can be introduced.
Task 8 - Establish critical limits for each ccp - (Principle 3)
Critical limits must be specified and validated for each CCP. Criteria often used include measurements of temperature, time, moisture level, pH, water activity, and sensory parameters such as visual appearance. In the case of mycotoxins for example, they may include the moisture content or the temperature of the commodity. All critical limits, and the associated permissible tolerances, must be documented in the HACCP Plan Worksheet, and included as specifications in operating procedures and work instructions.
Task 9 - Establish a monitoring procedure - (Principle 4)
Monitoring is the mechanism for confirming that critical limits at each CCP are being met. The method chosen for monitoring must be sensitive and produce a rapid result so that trained operatives are able to detect any loss of control of the step. This is imperative so that corrective action can be taken as quickly as possible so that loss of product will be avoided or minimised.
Monitoring can be carried out by observation or by measurement, on samples taken in accordance with a statistically based sampling plan. Monitoring by visual observation is basic but gives rapid results, and can therefore be acted upon quickly. The most common measurements taken are time, temperature and moisture content.
Task 10 - Establish corrective action - (Principle 5)
If monitoring indicates that critical limits are not being met, thus demonstrating that the process is out of control, corrective action must be taken immediately. The corrective action should take into account the worst case scenario, but must also be based on the assessment of hazards, risk and severity, and on the final use of the product. Operatives responsible for monitoring CCPs should be familiar with and have received comprehensive training in how to effect a corrective action.
Corrective actions must ensure that the CCP has been brought back under control. They must also include appropriate disposition of any affected commodity or product. Whenever possible an alarm system should be introduced which will activate when monitoring indicates that the critical limit is being approached. Corrective action can then be applied to pre-empt a deviation and prevent the need for any product disposition.
Task 11 - Verify the HACCP plan - (Principle 6)
Once the HACCP plan has been drawn up, and all of the CCPs have been validated, then the complete plan must be verified. Once the HACCP plan is in routine operation, it must be verified and reviewed at regular intervals. This should be a task of the person charged with the responsibility for that particular component of the commodity system The appropriateness of CCPs and control measures can thus be determined, and the extent and effectiveness of monitoring can be verified. Microbiological and/or alternative chemical tests can be used to confirm that the plan is in control and the product is meeting customer specifications. A formal internal auditing plan of the system will also demonstrate an ongoing commitment to keep the HACCP plan up to date, as well as representing an essential verification activity.
Ways in which the system can be verified include:
collecting samples for analysis by a method different from the monitoring procedure
asking questions of staff, especially CCP monitors
observing operations at CCPs
formal audit by independent person
It is important to remember that the HACCP system is set up for a particular formulation of product handled and processed in a given way.
Task 12 - Keep record - (Principle 7)
Record keeping is an essential part of the HACCP process. It demonstrates that the correct procedures have been followed from the start to the end of the process, offering product traceability. It provides a record of compliance with the critical limits set, and can be used to identify problem areas. Furthermore, the documentation can be used by a company as evidence of 'Due Diligence Defence' as required, for instance, by the Food Safety Act 1990 (HMSO), in the UK.
Records that should be kept include: all processes and procedures linked to GMP, GHP, CCP monitoring, deviations, and corrective actions.
Documents should also include those that recorded the original HACCP study, e.g. hazard identification and selection of critical limits, but the bulk of the documentation will be records concerned with the monitoring of CCPs and corrective actions taken. Record keeping can be carried out in a number of ways, ranging from simple check-lists, to records and control charts. Manual and computer records are equally acceptable, but a documentation method should be designed that is appropriate for the size and nature of the enterprise. A template of a form to document product description and intended use is given in Appendix III, and a template of a HACCP Plan Worksheet is given in Appendix V. Examples of the use of these forms are provided in the case studies presented in Chapter 3.
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