Developing a HACCPplan
There are twelve tasks required to develop a HACCP plan andthese are designed to ensure that the seven principles are applied correctly.Principle 1, which is to conduct a hazard analysis, requires that the first fivetasks have all been addressed in a logical and honest manner so that all realhazards associated with the commodity have been identified. The twelve tasks arediscussed briefly below, and listed in Appendix II.
Task 1 - Establish a HACCP team
To fully understand the commodity system and be able toidentify all likely hazards and CCPs, it is important that the HACCP team ismade up of people from a wide range of disciplines. The team shouldinclude:
A team leader toconvene the group and to direct the work of the team ensuring that the conceptis properly applied. This person must be familiar with the technique, be a goodlistener and allow all participants to contribute.
A specialist with a detailedknowledge of the commodity system is required. This specialist will have a majorrole in the production of the commodity flow diagrams.
Several specialists, each withan understanding of particular hazards and associated risks, e.g. amicrobiologist, a chemist, a mycotoxicologist, a toxicologist, a QC manager, aprocess engineer.
People, such as packagingspecialists, raw material buyers, distribution staff or production staff,farmers, brokers, who are involved with the process, and have working knowledgeof it, may be brought into the team temporarily in order to provide relevantexpertise.
The team's progress andresults of the analysis should be recorded by a technical secretary.
If any changes are made to composition or operationalprocedures, it will be necessary to re-assess the HACCP plan in the light of thechanges.
The first activity of the HACCP team is to identify the scopeof the study. For example, will the whole commodity system be covered, or onlyselected components? This will make the task more manageable and specialists canbe 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 thatgiven in Appendix III. This should include information relevant to safety, e.g.mycotoxin regulation/target level, composition, physical/chemical properties ofthe raw materials and the final product, the amount of water available formicrobial growth (aw), the amount of acid or alkali in the product(pH). Also information regarding how the product is to be packaged, stored andtransported should also be considered together with facts regarding its' shelflife and recommended storage temperatures. Where appropriate, labellinginformation and an example of the label should be included. This informationwill help the HACCP team to identify 'real' hazards associated with theprocess.
Task 3 - Identify the product's intendeduse
How the product is intended to be used is an importantconsideration. Information on whether the product will be consumed directly, orbe cooked, or be further processed, will all have a bearing on the hazardanalysis, see task 6). The nature of the target group for the product may alsobe relevant, particularly if it includes susceptible groups such as infants, theelderly, and the malnourished. The likelihood of misuse of a product should alsobe considered, such as the use of pet food as a human food, either by accidentor design. This information can be recorded on the same form as the productdescription, see Appendix III.
Task 4 - Draw up the commodity flowdiagram
The first function of the team is to draw up a detailedcommodity flow diagram (CFD) of the commodity system, or that part of it whichis relevant. The expertise of the commodity specialist is important at thisstage. Commodity systems will differ in detail in different parts of the world,and even within one country there may be a number of variants. Secondaryprocessing will need to be detailed for each factory, using generic flows onlyas a guide. Examples of commodity flow diagrams are included in the case studiespresented in Chapter 3.
Task 5 - On site confirmation of flowdiagram
Upon completion of the CFD, members of the team should visitthe commodity system (e.g. farm, store or manufacturing area) to compare theinformation present on the CFD with what actually happens in practice. This isknown as "walking the line", a step by step practice to check that allinformation regarding materials, practices, controls etc. have been taken intoconsideration by the team during the preparation of the CFD. Information such astime of harvest, drying procedures, storage conditions, the marketing chain,socio-economic factors, grading systems and any incentive for improved qualityor safety, and processing systems, should be collected and included in the CFDas appropriate. The site for which the HACCP plan is being designed should bevisited as many times as possible to ensure that all relevant information hasbeen collected.
Task 6 - Identify and analyse hazard(s) - (Principle1)
Effective hazard identification and hazard analysis are thekeys to a successful HACCP Plan. All real or potential hazards that may occur ineach ingredient and at each stage of the commodity system should be considered.Food safety hazards for HACCP programmes have been classified into three typesof hazards:
Biological:typically foodborne bacterial pathogens such as Salmonella,Listeria and E. coli, also viruses, algae, parasites andfungi.
Chemical: There are threeprinciple types of chemical toxins found in foods: naturally occurringchemicals, e.g. cyanides in some root crops, and allergenic compounds inpeanuts; 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 asbroken glass, metal fragments, insects or stones.
See AlsoHACCP Prerequisites
The probability that a hazard will occur is called a risk. Therisk may take a value from zero to one depending on the degree of certainty thatthe hazard will be absent or that it will be present. After hazardidentification, a hazard analysis must be conducted to understand the relativehealth risk to man or animal posed by the hazard. It is a way of organizing andanalyzing the available scientific information on the nature and size of thehealth risk associated with the hazard. The risk may have to be assessedsubjectively and simply classified as low, medium, or high. Only those hazardsconsidered by the HACCP team to present an unacceptable risk of being presentare taken forward to Stage 7, Principle 2.
Once a food safety hazard has been identified, thenappropriate control measures should be considered. These are any action oractivity that can be used to control the identified hazard, such that it isprevented, eliminated, or reduced to an acceptable level. The control measuremay also include training of personnel for a particular operation, covered byGAP, GMP, and GHP.
Task 7 - Determine the critical control points (ccps) -(Principle 2).
Each step in the commodity flow diagram, within the scope ofthe HACCP study, should be taken in turn and the relevance of each identifiedhazard should be considered. It is also important to remember the stated scopeof the HACCP analysis at this stage. The team must determine whether the hazardcan occur at this step, and if so whether control measures exist. If the hazardcan be controlled adequately, and is not best controlled at another step, and isessential for food safety, then this step is a CCP for the specified hazard. Adecision tree can be used to determine CCPs, and an example of the Codexdecision tree is included in Appendix IV. However, the HACCP team's judgement,expertise and knowledge of the process are the major factors in establishingCCPs.
If a step is identified where a food safety hazard exists, butno adequate control measures can be put in place either at this step orsubsequently, then the product is unsafe for human consumption. Productionshould cease until control measures are available and a CCP can beintroduced.
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 thecase of mycotoxins for example, they may include the moisture content or thetemperature of the commodity. All critical limits, and the associatedpermissible tolerances, must be documented in the HACCP Plan Worksheet, andincluded as specifications in operating procedures and workinstructions.
Task 9 - Establish a monitoring procedure - (Principle4)
Monitoring is the mechanism for confirming that criticallimits at each CCP are being met. The method chosen for monitoring must besensitive and produce a rapid result so that trained operatives are able todetect any loss of control of the step. This is imperative so that correctiveaction can be taken as quickly as possible so that loss of product will beavoided or minimised.
Monitoring can be carried out by observation or bymeasurement, on samples taken in accordance with a statistically based samplingplan. Monitoring by visual observation is basic but gives rapid results, and cantherefore be acted upon quickly. The most common measurements taken are time,temperature and moisture content.
Task 10 - Establish corrective action - (Principle5)
If monitoring indicates that critical limits are not beingmet, thus demonstrating that the process is out of control, corrective actionmust be taken immediately. The corrective action should take into account theworst case scenario, but must also be based on the assessment of hazards, riskand severity, and on the final use of the product. Operatives responsible formonitoring CCPs should be familiar with and have received comprehensive trainingin how to effect a corrective action.
Corrective actions must ensure that the CCP has been broughtback under control. They must also include appropriate disposition of anyaffected commodity or product. Whenever possible an alarm system should beintroduced which will activate when monitoring indicates that the critical limitis being approached. Corrective action can then be applied to pre-empt adeviation and prevent the need for any product disposition.
Task 11 - Verify the HACCP plan - (Principle6)
Once the HACCP plan has been drawn up, and all of the CCPshave been validated, then the complete plan must be verified. Once the HACCPplan is in routine operation, it must be verified and reviewed at regularintervals. This should be a task of the person charged with the responsibilityfor that particular component of the commodity system The appropriateness ofCCPs and control measures can thus be determined, and the extent andeffectiveness of monitoring can be verified. Microbiological and/or alternativechemical tests can be used to confirm that the plan is in control and theproduct is meeting customer specifications. A formal internal auditing plan ofthe system will also demonstrate an ongoing commitment to keep the HACCP plan upto date, as well as representing an essential verification activity.
Ways in which the system can be verified include:
collecting samplesfor analysis by a method different from the monitoring procedure
asking questions of staff,especially CCP monitors
observing operations atCCPs
formal audit by independentperson
It is important to remember that the HACCP system is set upfor a particular formulation of product handled and processed in a givenway.
Task 12 - Keep record - (Principle 7)
Record keeping is an essential part of the HACCP process. Itdemonstrates that the correct procedures have been followed from the start tothe end of the process, offering product traceability. It provides a record ofcompliance with the critical limits set, and can be used to identify problemareas. 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 andprocedures linked to GMP, GHP, CCP monitoring, deviations, and correctiveactions.
Documents should also include those that recorded the originalHACCP study, e.g. hazard identification and selection of critical limits, butthe bulk of the documentation will be records concerned with the monitoring ofCCPs and corrective actions taken. Record keeping can be carried out in a numberof ways, ranging from simple check-lists, to records and control charts. Manualand computer records are equally acceptable, but a documentation method shouldbe designed that is appropriate for the size and nature of the enterprise. Atemplate of a form to document product description and intended use is given inAppendix 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 inChapter 3.
