HACCP (HAZARD ANALYSIS CRITICAL CONTROL POINT)
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WHAT IS HAZARD?
Hazard is a biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
HAZARD ANALYSIS
The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.
CONTROL MEASURE
Any action or activity that can be used to prevent, eliminate or reduce a significant hazard
CRITICAL CONTROL POINT
It is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
CRITICAL LIMIT
A critical limit is the criterion which separates acceptability from unacceptability.
HACCP PLAN
A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration.
WHAT IS HACCP
Hazard Analysis and Critical Control Point system (HACCP), is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.
The Hazard Analysis Critical Control Points (HACCP) system is a logical, scientific system that can control safety problems in food production.
HACCP system is an international preventive system concerning with food safety. Essentially, HACCP is a system that identifies and monitors specific food borne hazards (biological, chemical, or physical properties) that can adversely affect the safety of the food product Codex, (1997).
The hazard analysis and critical control point (HACCP) system is a preventative measure that assesses hazards, estimates risks and establishes specific control measures that emphasize prevention rather than reliance on end-product testing (International Life Sciences Institute, 1993) .
In the last decade, the HACCP system has been recognized as a cost-effective procedure for ensuring food safety. Today, this methodology is internationally accepted as a food safety tool which is applied during full food production process (Bertoloni et al. 2007).
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RISK ASSESSMENT
It is a systematic process of evaluating the potential risks that may be involved in a projected activity or undertaking.
QUALITY RISK MANAGEMENT
It is a systematic process for the identification, assessment and control of risks to the quality of pharmaceutical products across the product lifecycle.
The Hazard Analysis Critical Control Points (HACCP) concept is a systematic, scientific approach to process control. The Food Safety Inspection Service (FSIS) views HACCP as a means of preventing the occurrence of health and safety hazards in plants producing meat and poultry products. It does this by ensuring that controls are applied at any point in a food production system where hazardous situations could occur. These hazards may include
Biological, chemical, or physical adulteration of food products
THE ORIGIN AND DEVELOPMENT OF THE HACCP CONCEPT
At the beginning of the nineties of last century, prevention system that is used in food production has found wide application, as a system of quality assurance of healthy food safety. This concept is known as HACCP, and it began to develop in 1959. , when the USA’s Pillsbury Company in cooperation with National Aeronautics and Space Administration (NASA) for the purpose of space exploration has received an order to produce foodstuffs intended for cosmonauts consumption. Food had to be safe, not infected by viruses, bacteria or toxic substances, without chemical and physical hazards that could lead to some disease of cosmonauts. Practical application as an integrated system in the production of food in most western countries started in 1991. (Vucic et al., 2006).
The HACCP concept was introduced to the public in 1971 on the public National Conference on Food Protection USA, after which the Pillsbury Company entered into an agreement to conduct training for staff of the Food and Drug Administration (FDA) in the field of the basis of the HACCP system (Vucic et al., 2006).
THE IMPORTANCE OF APPLICATION AND BENEFITS OF INTRODUCTION OF THE HACCP CONCEPT
The main goal of the HACCP concept is to produce a safe product. The microorganisms that cause various diseases, as well as a number of harmful chemicals, are examples of some of the dangers that the HACCP concept can reduce or eliminate completely. There isn’t a process that is 100% safe, but constant effort for avoiding errors must always be present (Swanson et al., 2000).
HACCP system provides:
Identification and assessment of any physical, chemical or biological risk, at all stages of food production, including all mid-processes and distribution;
Determination of the necessary measures for their prevention and control;
Ensuring that these measures will be successfully and effectively implemented.
HACCP concept as a preventive system ensures food safety in every step of the production process. It is developed specifically for each product / product group or process and must be defined to fit the specific conditions of production and distribution of each product separately. This concept attempts to reduce the need for testing of the final product. Before this system was developed, many manufacturers could find out whether their product meets certain standards only after the testing of the final product. The testing of final product can be extremely time-consuming, and can lead to the loss of a portion of the product, since some forms of the testing are extremely destructive (Bowman, 1990).
HACCP concept is trying to reduce the need for testing of the final product by conducting a series of checks during the process. The simplest defined, HACCP is a system that can be used as a set of procedures for the process control and sensitive points in the chain of food production, with the ultimate goal is that the consumer consumes food in the state and in a manner that will be safe for his health. This system provides production and marketing of healthy food. Implementation of the HACCP system involves the safer approach to the production, starting from the procurement process of primary materials and production of finished products, to the mode of management and employees, and their attitude towards the ultimate consumer. In other words, companies in the implementation of HACCP systems are required to meet all of the technical-technological standards that enable the implementation of this program.
According to the FDA - Food and Drug Administration benefits of the HACCP concept in relation to other food safety system are that this prevention program
(http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm):
It is based on identifying and preventing hazards that contaminate food
It is based on healthy science
Enables more effective supervision of the competent agency because recordkeeping allows inspections to conclude how companies comply with regulations on food safety during the period.
For the production of safe food, a manufacturer or a distributor is considered to be responsible.
THE BASIS OF THE HACCP CONCEPT IMPLEMENTATION IN A FOOD INDUSTRY
In order to successfully apply the HACCP concept in a food industry, it is necessary to implement the appropriate preparations of the activities:
Raising awareness to the management about the need for the establishment of the HACCP concept. The HACCP concept is accepted voluntarily and with the aim to improve the quality of food product.
Raising awareness about the need for the establishment of the concept among other employees in the production line, procurement, transport, warehouses, kitchen-restaurant-block and laboratory.
Training of management and systematic training of employees. This stage is very useful because it is one of the elements of effective implementation of the HACCP concept. Opportunities should be created for joint training of the management, employees, suppliers, inspection bodies and all those entities that are in some way related to food.
Establishment of the HACCP teams
The main HACCP team and teams per individual processes. In order to introduce the HACCP concept it is necessary to include all employees, who are in some way related to food, in the application process and to establish a HACCP team that will take over all the activities regulated by this concept. Management appoints the HACCP team, defines its leader, defines the scope of the team and deadlines, ensures resources for the establishment for the team, implementation and validation of the HACCP system, adopts and implements a policy of food safety (Buncic, 2009).
PREREQUISITE PROGRAMS
Prerequisite programs (PRPs) are the basic environmental and operating conditions essential for the safe production of food. Unlike HACCP which is product and process specific, prerequisite programs are more general and apply to all areas in a food production facility. Examples of prerequisite programs include, but are not limited to, Good Manufacturing Practices (GMPs), Good Hygiene Practices (GHPs), Standard Operating Procedures (SOPs) and Sanitation Standard Operating Procedures (SSOPs). The design and construction of food premises are also part of the prerequisite programs.
HACCP is not a standalone system. Prerequisite programs are critical to the successful application of HACCP as they provide the foundations for developing effective HACCP systems. Prior to implementing HACCP and also after a HACCP plan is implemented, it is imperative that prerequisite programs are in place (E.S.,2005b)
Before developing the HACCP program, one prerequisite program is required. The minimum allowable sanitary conditions for the equipment and facilities are identified as Sanitation Standard Operating Procedures (SSOPs). SSOPs consist of written cleaning and sanitizing procedures, validation procedures, and records regarding sanitary conditions both pre-processing and during processing.
The SSOP verifications are carried out daily.
The production of safe food products requires that the HACCP system be built on a solid foundation of prerequisite programs. Each segment of the food industry must provide the condition necessary to protect food while it is under their control.
Prerequisite Programs
The prerequisite programs to have a safe food produced in a food industry include (may vary according to industry)
• Facilities
• Supplier control
• Specifications
• Equipment
• Sanitation
• Personnel hygiene
• Training
• Chemical control
• Reception, storage and transport
• Traceability and recalls
• Pest control
Prerequisite HACCP Activities
Assemble HACCP team
Describe product
Identify intended use
Construct flow diagram
Verify flow diagram onsite
Assemble the HACCP team
The team consists of individuals, who have specific knowledge and expertise appropriate to the product and process. Other team members include the person(s) responsible for plan maintenance. One person on the HACCP team must be HACCP-trained. A team can be as few as one or two people.Describe product
This provides information on the ingredients, processing methods, and distribution methods Classification of the product into a process allows the processor to focus on likely hazards associated with this type of product.Identify the intended use and consumer
Identify the intended consumer or user of the product. The intended consumer may be the general public or a particular segment of the population, such as infants or the elderly. The intended user may also be another processor that will further process the product.Develop a flow diagram describing the process
This diagram provides a clear, simple outline of the steps involved in the making the product. A block flow diagram is usually sufficient.Verify the flow diagram
The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness on the flow diagram. Perform a walk-through of the process to make sure all process steps are covered. Once these preliminary tasks are completed, HACCP plan can take the next steps.
PRINCIPLES OF HACCP
- Conduct hazard analysis
- Determine/ Identify the critical control points (CCP’S)
- Establish critical limit for each critical control point (CCP)
- Establish monitoring system for each critical control point (CCP)
- Establish corrective actions
- Establish verification procedures
- Establish documentation and record
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Conduct hazard analysis
The first principle involves conducting a hazard analysis, which involves assessing certain risks involved in production of a product. The first principle relates to the implementation of the Hazard Analysis and the HACCP team must identify all potential hazards in terms of threats to food safety. Risks may occur at any stage of the process.“Hazard Analysis is defined as ‘the process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan’. The first part of conducting a hazard analysis involves identifying all possible hazards that could occur within the product. The HACCP team should hold a brainstorming session to identify every possible hazard. During this session, the team should not consider the significance of a particular hazard. That will be dealt with during the risk assessment. The Hazard Analysis is probably the key principle in the whole HACCP system and the one people find to be the most difficult.”
The three types of hazards that must be considered during a hazard analysis are biological, chemical and physical. Hazards may include biological (bacteria, viruses, mold, parasites, toxins, micro-organisms), chemicals (natural plant and animal toxins, artificial fertilizers, pesticides, additives, chemical cleaning agents), physical (glass, stones, metals), and other hazards (radiation, hazardous transport conditions, storage). All potential hazards should be recorded and assess - this is the process of the hazard assessing. The better hazard analysis is performed, the more risk is taken into account, it will facilitate the practical operation of the catering facility. The result of this activity is adequate documentation. When determining the likelihood of a hazard, the HACCP team must research each hazard and identify any trends. If the literature indicates that this hazard does not occur often, the team can indicate that the likelihood of occurrence is low. The team must also research a hazard to understand the severity if it is not properly controlled.
Determine/ Identify the critical control points (CCP’S)
When the hazard analysis is complete, the HACCP team must go over the flow diagram and decide which steps are critical control points (CCPs). A CCP can be a point in the process where a significant hazard can be eliminated or reduced to an acceptable level. A CCP is also a point where loss of control will lead to a significant hazard. CCPs require a lot of careful development and extra documentation and that is why they should be limited to only those that are truly critical.
When determining the steps are critical control points, some companies use what is called the shotgun approach. This is a method is not based on any true reasoning; rather CCPs are chosen based on the opinions of the team. This may lead to an excessive number of CCPs resulting in problems for the plant. A more accurate and feasible method that can reduce the number of CCPs is use of the decision tree. This approach asks several questions about each processing step where a hazard is significant. The questions are in “yes or no” format, and will eventually determine whether that step is a CCP.
Establish critical limit for each critical control point (CCP)
Once the CCPs are determined, critical limits are required for each step that is a CCP. A critical limit is a maximum or minimum value to which a specific parameter must be no controlled at each CCP. Common critical limits are temperature, time, moisture, pH and salt concentration. Critical limits are rarely a range of values.
Establish monitoring system for each critical control point (CCP)
The next step is to monitor each CCP and critical limit. Monitoring of each critical limit is very important because it helps to ensure that the CCPs are in compliance and the critical limits are not exceeded.
Critical limits can be monitored continuously or non- continuously. If a critical limit were monitored continuously, a temperature monitoring system would be a good investment.
If non-continuous monitoring is utilized, a member of the HACCP team must conduct checks at regular increments (i.e. every 30 minutes or every hour). Because non - continuous monitoring is being used, it is important that the frequency of monitoring be adequate to ensure control of the CCP.
Establish corrective actions
If there is a deviation from the set standards of a critical limit, corrective actions must be taken. Corrective actions are procedures carried out when a loss of control has occurred at a particular CCP.
Suggested that all corrective actions as well as responsibilities should be clearly outlined before HACCP is implemented. All records and corrective actions should be documented to prove that corrective actions are being conducted.
Establish verification procedures
The principle addresses this verification. Verification is the application of methods, procedures and tests to determine the company’s compliance with the HACCP plan. Verification covers all internal daily activities with regards to HACCP. A few verification procedures include a review of the HACCP system and records, any deviations and product dispositions, and confirmation that the CCPs are kept under control. The only way to be confident that a safe product is being produced is to verify that the personnel have control at each step. Verification can be performed by plant audits with the use of microbial, physical and chemical tests. Government agencies will sometimes review HACCP plans to ensure compliance with standards. The frequency of such audits should be sufficient to verify that the HACCP program is functioning properly. There is often some confusion about how validation differs from verification. Verification determines compliance with the HACCP plan, where validation merely determines that the end results can be achieved.
Establish documentation and record
The seventh principle of HACCP is to establish adequate record keeping procedures. Without records, there is no proof that a plant is doing what their HACCP plan indicates. Records are useful in providing a basis for trends and for systematic improvement of the process over time. All forms pertaining to monitoring results, corrective action logs, or training records must be kept on file for at least 1 year. Any modifications to, or audits of, the HACCP plan must be documented as well.
REFERENCES
Glory Bansal, Bharat Parashar, Hitesh Dhamji. The application of HACCP and risk management in the pharmaceutical process. Asian Journal of Pharmaceutical and Clinical Research, 6, 2013, Issue 2.
Hazard analysis critical control point (HACCP) plan, corporate procedure PHARMACO APPER.
Kevin Keener Ph.D., P.E. Overview of HACCP Hazard Analysis Critical Control Point Purdue extension, Purdue University.
A short guide to completing HACCP Plan is available from: <http://www.food.gov.uk/sites/default/files/pdfs/guidehac cpplan.pdf
Bauman, H. (1990). HACCP – concept, development and application. Food technlogies, 156-158.
Bunčić, S. (2009). Guide for the development and implementation of prerequisite programs and the HACCP principles in food production. Republic of Serbia: Ministry of Agriculture, Forestry and Water Management, Belgrade, Serbia.
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