The Importance of HACCP
HACCP should not be Seen as a Measure for Authorities or Certification Bodies
Sometimes, HACCP is implemented mainly with the objective of satisfying the requirement of authorities, or is seen as a task that is mandatory, without the management of the business really seeing its value, understanding its principles and truly endorsing its implications. HACCP can be helpful only if it is carried out with the specific objective of managing food safety in an effective manner, i.e. taking the right decision, ensuring that the decisions are actually effective and correctly implemented. In particular, it can help managers to identify those steps in the process that should receive the highest degree of attention and surveillance. When HACCP is applied only with the objective to meet the satisfaction of authorities, it will lead to a massive amount of paperwork without much added value. In this case, it has very little chance to become a meaningful exercise and there is a real risk that it will be seen as a burden by all personnel.
[ BRSM Certification is accredited for QMS ISO 9001, EMS ISO 14001, OSHMS ISO 45001, FSMS ISO 22000 and QMSMDD ISO 13485 ]
HACCP should not be Reduced to Simply Paperwork
Although the HACCP study includes desktop activities, HACCP is not a paper exercise. The proper application of HACCP implies scientific and technical expertise, monitoring of critical control point (CCP) parameters, verification of good manufacturing practice (GMP) on the factory floor, reviewing verification data (e.g. results of raw material monitoring, monitoring consumer complaints and calibration of key equipment), training of people, etc. HACCP should also not be equated with filling forms. In many cases, a number of forms have been created to facilitate the systematic approach and thinking process. However, this should not replace the critical thinking and scientific and technical expertise required to carry out a HACCP study – it is the quality of content that is important, not the form itself.
HACCP is not One Man’s Job
As mentioned above, one of the biggest added values of HACCP is the promotion of multidisciplinary teamwork. To carry out a proper HACCP study, it is fundamental to draw on the right and adequate expertise. The importance of a multidisciplinary team is particularly high when safety is considered at the product and process development. It is at this stage that many potential hazards have to be considered and managing the safety of the product needs to be thought through. As an example, microbiologists and veterinarians usually have not been educated and trained in equipment and process line design, nor in process measurement, control and monitoring. They will therefore never be able to do a useful HACCP exercise on their own. The involvement of somebody with an adequate engineering background is in most cases essential, as is the inclusion of personnel with appropriate operations and food safety knowledge.
HACCP is not a Stand-Alone System
A major misunderstanding or error in the application of HACCP is that it is viewed as a separate system. HACCP should be seen as an approach to food safety assurance; its application draws on an array of measures such as GMP, audits, monitoring, traceability, etc. (Figure 1). Therefore, it is essential that as part of a HACCP study, the state of these different measures be carefully considered. For instance, during the hazard analysis, the decision on the likelihood of the presence of a given pathogen in the ingredient will depend on its source. Knowledge about the origin of the raw material and conditions of production, previous record of safety, all audit and monitoring data of the supplier are essential for deciding on the significance of a pathogen. These require having traceability of the ingredient and information on the epidemiological situation of the country where the raw material is produced or on processing conditions of the supplier, should the ingredient be a semi-processed product. Similarly, the likelihood of recontamination of the food product is related to the cleaning procedures and the state of application of the good hygienic practices.
[ BRSM Certification is accredited for QMS ISO 9001, EMS ISO 14001, OSHMS ISO 45001, FSMS ISO 22000 and QMSMDD ISO 13485 ]
FIGURE 1. Schematic illustration to explain the relationship between GMP, CCP and verification activities. The figure shows that HACCP helps all necessary control measures often considered as part of GMP. It also gives weight to the control measures that are particularly important in terms of food safety
HACCP is not a One-off Exercise
Many see HACCP as a one-time exercise, and once the study is carried out, it is rarely reviewed or updated. First, HACCP is a tool for decision-making. As such, it should be flexible and should be part of the everyday thinking process. As the situation evolves, decisions may also need to be changed. For instance, a step in the process may temporarily need to be considered as a critical control point (CCP) until there is enough assurance that the risks are adequately under control. Or, the frequency of the verification of a supplier’s products could be modified as the supplier confidence increases
Second, maintenance of a HACCP plan is as important as its development and implementation. Each time a factor related to food production, e.g. supplier, an ingredient, the process, the equipment, target consumer, etc. is changed, the consequence of this change on the hazard analysis needs to be considered and if necessary the HACCP plan needs to be changed. Similarly, when new information becomes available, for instance when authorities communicate an alert about a new hazard or when verification data (e.g. pathogen monitoring, consumer complaints, raw material monitoring, audit reports of suppliers, industry information, etc.) indicate a new threat, such information should prompt the HACCP team to revisit their study and evaluate the adequacy of their measures. For instance, if verification data (e.g. audit report of the supplier) or raw material monitoring indicate that the supplier’s food safety assurance is inadequate, this may necessitate a change of supplier or increased frequency of verification of the supplier’s products.
[ BRSM Certification is accredited for QMS ISO 9001, EMS ISO 14001, OSHMS ISO 45001, FSMS ISO 22000 and QMSMDD ISO 13485 ]
Documentation and Record Keeping are not Bureaucratic Work
Documentation and records play a pivotal role in food safety as they are an important and effective means of communication. They allow communication with other colleagues or provide evidence to customers or regulatory authorities on how food safety is planned and implemented and on what the bases for decisions are. Documentation can play an important role in maintaining the HACCP plan, i.e. reviewing and if necessary revising decisions, providing evidence that appropriate measures have been taken in times of problems. However, the value of the documentation lies in the quality and quantity of information that it contains. If the information is superficial or not adequate, the documentation becomes more a bureaucratic work than a tool for communication. In case of incidents, HACCP records provide evidence that the appropriate actions have been taken and facilitate the investigation of the causes of problems.
HACCP does not Work if there is no CCP during the Food Chain from Farm to Fork
A fundamental principle of HACCP is to identify significant hazards and control measure(s) that are essential to eliminate or reduce the hazards to acceptable levels. Where such a control measure(s) is not in place, it is important to modify the production process and/or its conditions (e.g. labeling or providing information on the storage conditions or instruction of use). In many instances (particularly in the case of raw foods), significant hazards are identified, but there is no CCP during the food chain at which point the reduction of the hazard to an acceptable level can be achieved and no modification is, or can be, made to the food chain. For example, the CCP for hamburgers is at the preparation step, there is no real CCP at the slaughterhouse or meat plant level. Unless the meat is irradiated, cooking of hamburgers by consumers must become a CCP and consumers should be imperatively and adequately informed about their role. In these cases, if it is not acceptable to have a CCP at consumer level, the application of HACCP per se will not make food safe.
HACCP is not only Qualitative
There is a general misconception that the decisions taken within HACCP studies are qualitative. However, during the hazard analysis, the likelihood (possible, probable or likely) of contamination with a chemical contaminant, survival or growth of an organism or production of toxin and the magnitude of these events can also be estimated. Moreover, the efficiency of control measures has to be determined, i.e. how effectively a processing step can eliminate or reduce a pathogen to an acceptable level (evaluated in terms of log reduction), or what the extent of microbial growth will be during the shelf-life of a product under given conditions. These concepts are generally addressed under the principle of validation of the control measures (CAC, 2008) and should not be mistaken for the concept of microbial risk assessment. The latter, recommended in the framework of Codex Alimentarius as one of the three elements of “risk analysis,” is a governmental activity with the aim of integrating scientific facts into the decision-making process.
COMMON ERRORS OR SHORTCOMINGS IN THE APPLICATION OF HACCP
There are also a number of systematic weaknesses in the application of HACCP. The root cause of many major or international incidents can be attributed to these errors or shortcomings.
1. Expertise. The success of a HACCP study and resulting plan depends on the expertise employed. A HACCP study is a task requiring both scientific and technical expertise (agronomy, veterinary science, food safety microbiology and chemistry, engineering and technology, consumer knowledge) and operational information and experience. When there is no access to such experts on site, the HACCP study can be reviewed by relevant experts.
2. Past record of safety. Analysis of foodborne disease outbreaks and incidents, even certain cases of fraud which a priori may seem unpredictable, are often repetition of previous events and in most cases preventable if they were better examined and taken into account in HACCP studies. Therefore during a hazard analysis, data on the past record of the safety of the product, including any incident, case report of illness or outbreaks, epidemiological data on the event and its root causes need to be considered.
3. Farm to fork approach. Although the importance of an integrated approach to food safety and consideration of all steps from farm to fork has been stressed time and again in recent years, nevertheless, frequently HACCP plans are developed without fully considering this principle. For instance, HACCP plans are developed without fully considering the supplier food safety assurance, and subsequently, hazards that may be present in the raw material are overlooked.
Similarly, those steps following manufacturing are frequently omitted during HACCP studies, for example hazards that may occur during transport, distribution and most importantly during preparation by consumers. For certain types of products, factors such as the conditions for storage of the product during distribution, target customer/consumer or the potential mishandling of the product may be crucial for designing safety, including the necessity for providing information on the safe use of the product.
Shortcomings in the application of this point have been the source of numerous reported incidents: salmonellosis and chicken pie in 2006, E. coli infection and cookie dough 2008.
The implication of this principle is that as far as feasible, one should investigate and nderstand:
a. The source, origin, conditions of production of raw materials and ingredients;
b. Conditions of transport and distribution; and
c. Handling, storage and preparation practices by consumers and customers.
This insight is essential for determining what control measures (including labeling and handling instructions) need to be considered outside the factory, e.g., at the supplier, transport, distribution and consumer/customer levels. Based on these, we should then define and communicate the:
a. requirements to suppliers;
b. expectations to transporters and distributors; and provide
c. validated instructions for safe preparation and handling of products to caterers and consumers.
4. Flow diagram. Very often, flow diagrams used for the HACCP study do not reflect the real processing and manufacturing conditions of the product. Lack of accuracy and detail may seriously jeopardize the quality of the HACCP study and the validity of decisions.
5. Product description. Validity of hazard analysis relies on the precision with which various aspects of the product are described, e.g. the raw ingredients and their source, the supplier assurance system (e.g. availability of an audit report), manufacturing steps and conditions, description of packaging and other auxiliary products, potential use or abuse by target consumers. Too often these descriptions are not detailed enough to allow an in-depth hazard analysis. In absence of such information, important hazards may be missed during hazard analysis.
6. Consideration of circulation of air and water and employee traffic. When conducting the HACCP study, the flow diagram is often limited to the product. It is important also to consider how the circulation of water and air and employee traffic (or zoning) can impact on the safety of the product. In this context, all building or reconstruction activities should also be considered as they may often lead to increased contamination of the environment with pathogens, as well as foreign materials. For these reasons it is useful also to consider site layout diagrams and to spend time observing the operation in practice.
7. Hazard analysis. Hazard analysis is a process of describing and evaluating potential hazards. Very often hazards are described in general terms, e.g. “microbiological hazard” instead of specifying Salmonella, S. aureus, hepatitis A virus, etc. Although such an approach may in some cases be practical, it is often misleading and in regard to microbiological hazards, it may even be dangerous. The reason is that microorganisms differ in their behavior, ecology and control measures. For instance, the ecology and thus control measure for S. aureus is much different than that for Salmonella or viruses. Thus, unless organisms share similar ecology and epidemiology, as far as possible they should be considered specifically. Similarly, chemical contaminants should be clearly defined so that valid safety limits and methods of testing can be identified.
Similarly, control measures must also be defined and detailed as much as possible. For instance, instead of stating good hygiene practice (GHP), it should specify washing, disinfecting and drying hands or hand hygiene.
The hazard analysis must include an evaluation of likelihood of occurrence and severity of effect of each hazard identified. This allows the identification of the significant hazards (see also point 8 below), which must be controlled for the food to be safe. Companies who do not take the time to do a thorough evaluation often struggle with establishment of the correct CCPs for the process concerned and their accompanying control and monitoring procedures. As mentioned before, hazard analysis must also be carried out taking into consideration the status and effectiveness of prerequisite activities, e.g. GMP, supplier quality assurance (review of the supplier audit report, ensuring that the audit has addressed the concern considered in the hazard analysis).
The hazard analysis should also take into consideration relevant historical information, such as the previous safety record of a product or its ingredients or previous food safety incidents involving similar products and processes.
8. CCPs or just good manufacturing practices. One of the major difficulties in HACCP is the differentiation or understanding of what is at a certain production step a GMP and what is a CCP. Sometimes, operators have reported that a step, which is considered as a GMP, cannot be a CCP. To explain this, we need to go back to the time before HACCP. Food safety in the food processing and manufacturing industry was ensured through a number of measures referred to as good manufacturing practices (GMP). Some processing operations, today referred to as control measures, such as heat treatment (e.g. pasteurization), were then considered a good manufacturing practice. Thus, what in the past was referred to as GMP in HACCP terminology may today be referred to as control measures. In the context of HACCP, some of these control measures (or GMP), which play a significant role in controlling a specific hazard, received higher weight and the step at which the control measure is applied is thus now considered a CCP (Figure 2). In other words, a hazard analysis can actually permit to identify which good manufacturing practices are of direct relevance to food safety and if there is any additional measure which should be considered as part of GMP or with today’s terminology prerequisites
FIGURE 2 Schematic illustration to explain that different measures implemented as part of food safety
assurance system are interrelated and need to be considered as part of the HACCP study programs. Therefore the question of CCP or GMP is a wrong question as both are interrelated. With the HACCP system we can strengthen the GMP to cover food safety concerns and also identify those GMP practices that are of importance for a close surveillance. This thinking process has been the basis for developing HACCP-based codes of practices for the small and developing businesses.
Part of this confusion comes from mistaking the term CCP for control measures (see below).
9. Meaning of terms: significant hazards, CCPs and monitoring. Lack of understanding or inconsistent use of terms often leads to confusion. Frequently, the term significant hazard is confused with CCP (e.g. aflatoxin is referred to as a CCP) or a control measure is taken for a CCP. This confusion also contributes to misconceptions mentioned above in relation to GMP versus control measure or CCP. To be crystal clear: a CCP is a step in the food operation whereas a control measure is an intervention specifically designed to prevent, reduce or eliminate the hazard. To differentiate these two concepts, a CCP is usually a step in the flow diagram of the food production, while for the control measure this is not always the case. For instance, CIP of an installation is a control measure to eliminate the risk of contamination of food, but does not enter in the process of food production itself and is thus not a step or CCP. This does not preclude the fact that the processing step at which the CIP is applied can be a control measure and that the CIP is mentioned as a comment on the flow diagram. It has also been experienced that some important steps in the operation have not been considered as CCPs on the grounds that they cannot be monitored “continuously” or a physical measurement method is not available. It is certainly much better to measure control parameters in an objective manner, e.g. using a temperature recorder. However, a lack of such methods for monitoring should not be a reason for not considering a step in the process as CCP. If control at that step is important and that visual/off-line control can be effective in detecting deviations from acceptability, then the step can be considered as CCP. The concept of continuity is also misunderstood. The recording of a parameter leading to a line between two measurements is often mistaken for the concept of continuity. Monitoring a CCP should be carried out with specific and predetermined frequency. This may be every second, hour, day or defined moments as applicable. However, this has to be set such that if a deviation is observed and critical limits are violated, the corrective actions can be implemented in a timely manner before the product is released.
10. Significance of CCPs. As stated above, CCPs are steps in the food production that must be under control to produce a safe product. For each CCP critical limits are established to define the parameters that must be achieved to ensure safety. As such these limits define the acceptability or unacceptability of a product or a process. For food safety, CCPs and their associated critical limits are the most important steps and aspects of the operation. Where a critical control point is violated, the product must be considered as potentially unsafe. Therefore it is extremely important that:
a. These steps are identified and controlled correctly, i.e. all parameters need to be controlled and identified and that the critical limits are validated, including consideration of any regulatory requirement.
b. Monitoring of CCPs provides assurance that the control measures(s) are correctly implemented and are within the defined critical limits. Therefore:
– The monitoring of CCPs must be carried out under the responsibility of trusted and well-trained operators.
– Responsibility and the consequences of failures of CCPs must be clearly communicated to operators, including the corrective actions that must be taken in the event of a CCP failure.
– Methods and procedures used for monitoring, be it a physical measurement, visual inspection or chemical analysis, must be up to date, and valid for the intended use (including sampling and sensitivity of method).
– Microbial testing is verification and is generally not suitable for CCP testing. An exception is for the release of certain high-risk raw materials;
– Equipment and materials used for monitoring must function correctly, be well maintained and calibrated. The frequency of monitoring must be set so as to ensure that if there is a deviation, corrective action is applied in time to correct the problem during production and/or to assure that unsafe product does not leave the factory.
– Results of CCP monitoring are part of release criteria.
11. Monitoring of CCPs. When establishing a monitoring procedure for a CCP, care should be taken to identify all the parameters that will impact the efficiency of the control measure. For instance, it is frequently observed that at the pasteurization step, which is often a CCP, only the temperature is monitored and the residence time is ignored. Or for water disinfection, only residual chlorine is considered and other factors such as contact time, pH of water and turbidity, which impact on the chlorination efficiency, are not considered.
12. Corrective actions. While it is a good practice that in times of problems the operator consults his superior, it is nevertheless essential that corrective actions needed to restore control be clearly and precisely defined in the HACCP study. For instance, it should be stated “reheating the product” or “sieving the product” rather than “call the QA or production manager.” Also, the procedures for blocking and eventually reworking or disposing of products that have not met safety or quality criteria should be carefully examined to prevent or minimize the possibility of any human error or accidental release. The efficacy of the corrective actions applied must be validated.
13. Effectiveness of HACCP cannot be ensured without validation and verification. One of the greatest weaknesses in the application of HACCP has been that very little attention has been given to validation and verification activities.
a. Validation. A HACCP study whose elements are not valid will have limited benefits. Validation brings assurance in the design of the food safety assurance system. In absence of validation, there is no assurance that control measures will be effective in ensuring food safety and the HACCP studies may indeed become a paper exercise. Validation consists of proving evidence and documenting that the elements of the HACCP are effective and/or have a scientific and technical basis. It should include:
– Identification and evaluation of hazards
– Effectiveness of control measures (including corrective actions)
– Correctness of CCPs
– Critical limits
– CCP monitoring
– Corrective action
– Suitability of verification activities
Validation does not necessarily require an experimental approach or complicated tests (such as challenge tests) but may simply consist of confirming consistency with regulatory requirements, examining scientific literature, consulting experts, providing historical data and so on to substantiate the elements of the HACCP plan.
b. Verification. An equally important principle of HACCP that is sometimes overlooked or carried out independently from HACCP is verification. Verification is the application of methods, procedures, tests and other evaluations, in addition to monitoring at CCPs to determine compliance with the HACCP plan. Verification provides confirmation that HACCP is implemented according to the plan, and is
effective. Verification includes activities such as:
– Environmental monitoring
– Pathogen monitoring
– End-product testing
– Raw material testing for chemical contaminants
– Audit of the factory and its food safety management systems
– Calibration of equipment
– Consumer complaints monitoring
These activities, even if not part of the release procedures are essential to ensure that preventive measures are implemented correctly.
Therefore, data collected through verification activities should be carefully examined and analyzed in terms of compliance and trends. Where a deviation from acceptable conditions is observed or the trend indicates an abnormal situation, implications for product safety should be evaluated, an investigation should be carried out as to the root cause of the problem, and the situation should be corrected. The cause may be failure in implementation or shortcomings in validation.
14. Maintenance. Maintenance of a HACCP is a means for addressing management of change. The environment and conditions under which food is produced is constantly changing. Examples of changes are:
a. Emergence of new hazards and/or new information about existing hazards, e.g. knowledge about outbreaks in a sector of the food chain.
b. Changes in the regulatory requirements.
c. Changes in the intended use of the product and/or consumer/customer.
d. Change and differences in the climatic conditions (where the raw material is produced and where the final product is transported and consumed).
e. Change in the country where the product is to be exported to leading to a number of other changes as mentioned above.
f. Changes in the source of the raw material.
g. Changes in practices at the supplier.
h. Changes in recipe, process or equipment.
i. Changes in the factory environment, e.g. reconstructions, change of personnel.
To ensure that the hazard analysis and control measures remain valid, it is important that each time a change is reported, the HACCP study is reviewed and the validation of control measures, critical limits, monitoring procedures, corrective action and verification procedures are reconfirmed. This means that each change should prompt are flection on possible consequences for food safety and the need for amending existing control measures or setting up new measures. Review of the HACCP study does not necessarily mean an immediate and full revision of the HACCP study and associated plan. In many cases, it can be simply a note to document that:
a. The change in question has been considered and control measures have been modified as follows, or
b. It has been concluded that the change did not impact on food safety on the following grounds.
The various notes can be consolidated during the annual review of the HACCP study.
15. Different (Modular) HACCP plans. Often, due to the complexity of the production, it is easier to develop different HACCP plans for different parts of the production. This is usually known as Modular HACCP plans as the process is split into “process modules”
and HACCP principles are applied to each one. It is important to ensure that a proper link between the different HACCP plans exists and that errors do not occur as a result of this practice, e.g. skipping a step, omitting certain hazards.
The advance of HACCP has had a significant and positive impact on the management of food safety. However, to fully benefit from the advantages of HACCP, a proper understanding, application and true commitment is needed.
Some of the major shortcomings in the design and implementation of the HACCP plans have been:
● Lack of experience and expertise in the design of the HACCP plan.
● Ignoring previous records of safety of the product, e.g. incidents associated with the products.
● Failing to consider the regulatory or customer requirements.
● Overlooking implications of practices upstream, i.e. at the suppliers, or downstream (transport, distribution, handling and preparation).
● Gaps in the validation of the hazard identification and control measures and taking into consideration the state of prerequisites programs.
● Shortcomings in the review of the verification data (e.g. pathogen and environmental monitoring of food production premises) or end-product testing.
● Shortcomings in the maintenance of the HACCP plan in the light of verification data or changes. It must be reiterated that HACCP is not a panacea to all problems and it is not a magic wand. It is a tool, among many others, to manage and enhance food safety. Its effectiveness in eliminating or reducing hazards to an acceptable level depends on how it is used.
– Motarjemi, Y., Käferstein, F.K., 1999. Food safety, HACCP and the increase in foodborne diseases: a paradox? Food
Control 10, 325–333.
– CAC (Codex Alimentarius Commission), 2008. Codex Guidelines for the Validation of Food Safety Control
Measures, CAC/GL 69 – 2008. Joint FAO/WHO Food Standard Programme, Codex Alimentarius Commission,
the Food and Agriculture Organization of the United Nation, Rome.