According to the Department of Public Relations of Derzhprodpozhivsluzhby, since the legislation of Ukraine is only beginning to adapt in the field of sanitary and phytosanitary measures in accordance with the requirements of the European Union, work is underway to reform the system of state control and monitoring of food safety. The Law of Ukraine 07.22.2014 No. 1602-VII "On the Basic Principles and Requirements for the Safety and Quality of Food" entered into force a year ago. The implementation of the provisions of the designated Law of Ukraine ensured the establishment of an illusory mechanism for providing state pledges for the safety and quality of food products. In addition, there is state control in the sphere of sanitary and phytosanitary measures, again, in accordance with the requirements of euro legislation.
In order for manufacturers to gradually move to the implementation of the procedures of HACCP, the legislation of Ukraine defines a transitional stage of their implementation, in particular for:
- Capacities working with food products, which include untreated components of animal origin (except for small capacities), - 3 years from the date of promulgation of the Law (from 20.09.2017),
- Capacities working with food products that do not contain untreated components of animal origin (except for small capacities) - 4 years after the Law was published (from 20.09.2018),
- Small capacity - 5 years after the promulgation of the Law (from 20.09.2019).
Transition periods provide market operators with a chance to reorient themselves to fresh requests and, if necessary, produce food products in accordance with the provisions of the new Law.
Principle 1. Risk analysis
The essence of the principle lies in the analysis of hazardous factors in relation to each process. Such an analysis involves identifying and comparing a list of risks and hazards that may be the cause of a particular food product being infected during the manufacturing process, and developing preventive measures to prevent the development of risks. To ensure food safety, the negative effects of biological, chemical and physical factors should be excluded.
The degree of uncontrollability of these factors is decisive in the occurrence of risks in production activities that can cause changes in the composition of the final food product and, accordingly, make it unsafe for human consumption.
Principle 2. Critical control points (CCP)
The task is to identify critical control points (CCP) in each phase of the process.
The concept of CCV describes a stage, moment or operation, during which it is possible to apply control mechanisms to eliminate or reduce risks and hazards to an acceptable level, after which possible contamination of the food product is excluded. Adequate measures are developed and taken for each established risk factor.
After analyzing the risks and hazards, the information obtained is used to determine the specific stages of the production process, which are critical points.
Healthcare statistics indicate that the main cause of human infection is the use of unsafe food, therefore, the regulations and rules for identifying CCP first determine strict control of the risks of microbiological contamination of raw materials and ingredients throughout the entire manufacturing process.
Especially for the determination of those described by the CCT by the NACMCF committee, a “decision graph” method was developed. However, no one obliges the company to use this particular model of research.
Principle 3. Establishment of critical limits for CCP
The task is aimed at the establishment of critical limits, upon reaching which measures should be taken to prevent the development of identified risks at one or another critical control point.
The critical limit in this case is the highest or lowest value of any indicator in the CCP, which, if corrected, can prevent, eliminate or reduce to an acceptable level the risk factors threatening the safety of the food product. Such limits are based on technological indicators, such as:
- water activity and its quantitative indicator
- level of acidity and pH,
- concentration of salt, chlorine,
- temperature readings
- production time,
- the presence of unsafe microorganisms to be eliminated.
All parameters of critical limits are based on applicable FSIS regulations or guidelines. Such recommendations and schemes are described in the scientific and technical literature and reviews of reputable experts who are members of industry structures, academia and professional associations.
The food processing industry should strive to set stricter critical limits compared to the stipulated FSIS documents and expert opinion in order to comply more closely with all regulatory requirements. Such a reliable stock of indicators is guaranteed to eliminate the smallest deviations from the established rules and regulations.
Principle 4. Control
After determining the critical control points and optimizing their performance, a control procedure is developed. This monitoring system includes all observations and measurements of the state of the CCP in order to meet critical limits.
The preferred option, of course, is a continuous method of control. In cases where continuous monitoring does not justify itself either from a technical or an economic point of view, it is acceptable to conduct periodic control procedures with a frequency sufficient to coordinate the risks in the CCP.
In order to exercise full control over each critical control point, responsibility is placed on one or another employee of the organization. Personnel involved in the solution of such tasks must undergo appropriate training, including the provision of reliable accounting of all the results obtained and the identified deviations. The quality and level of organization of the accounting system will determine the speed of responding to possible deviations from critical limits.
Principle 5. Corrective actions
In the developed HACCP plan, corrective actions should be clearly defined, which should be taken immediately if the values of its indicators for a specific CCP go beyond the established limits. This principle implies that for the safe production of food products, a clear concept of production organization with a quick response to the prevention of risk factors is imperative.
The HACCP plan lying on the table at the director of an enterprise does not yet guarantee the absence of problems. Therefore, one of the important components of the HACCP plan is the planning of comprehensive measures aimed at eliminating possible deviations. It is for emergency cases that an action plan is developed in which the cause of deviations is identified and the procedure for neutralizing products that are potentially dangerous or inappropriate are determined.
Principle 6. Accounting
This principle obliges to develop an effective procedure for accounting for the organization and functioning of the entire HACCP system with the maintenance of relevant documentation. The HACCP system is aimed at optimizing the process of manufacturing food products in the field of identifying risk factors and responding to their elimination. In view of this, the productivity of the system will depend directly on the ability to keep a systematic and reliable record of the implementation of planned procedures. Accounting documents should be publicly available. Familiarization with the documents should be available to both employees of the enterprise, and for control instances.
Principle 7. Systematic revisions.
Effective adherence to the HACCP plan implies systematic audits. During the first inspection, the audit commission confirms the ability of the system to adequately and fully withstand the existing risks.
Further periodic audits are conducted using additional tests, methods and procedures, the tasks of which include determining the compliance of the HACCP system with the HACCP plan and possible corrections with repeated approval to ensure food safety.
You can order the development of the HACCP system implementation program (HACCP), obtain the necessary certificates and complete implementation documentation with the subsequent possibility of using them, you can at our Certification Center - just contact us by calling the hotline or leave a request on the website.
How to document the HACCP system?
First of all, you need to understand what kind of system you will be implementing at your enterprise - the HACCP system in accordance with GOST R 51705.1-2001 “Quality Systems. Food quality management based on the principles of HACCP. General requirements "or food safety management system (SIPPP), which includes all the principles of HACCP according to GOST R ISO 22000-2007 (ISO 22000: 2005). In order to decide on the version of the system being implemented, you need to familiarize yourself with the requirements of these standards, analyze which version is applicable to your production and draw up a plan for development and implementation.
Let's try to understand what is the difference between HACCP and the SMSP (ISO 22000)
The main difference of HACCP according to GOST R 51705.1-2001 from the food safety management system according to GOST R ISO 22000-2007 is that HACCP is a set of principles on the basis of which each organization can build a food safety management system. The structure of this system will depend on the choice and capabilities of the organization. ISO 22000 is a standard that includes all the principles of HACCP and itself defines the structure of the food safety system. If an organization applies ISO 22000, then its food safety system should contain all the elements of the structure, in accordance with GOST R ISO 22000-2007 (ISO 22000: 2005).
In addition to the above, ISO 22000 differs from HACCP as follows:
- ISO 22000 is a complete management system built on the basis of the ISO 9001 structure. It includes the key elements of this system - a clear definition of the scope, goal setting, analysis of the system’s work, process management, documentation, the establishment of effective channels of interaction with customers, suppliers and all interested parties.
- GOST R 51705.1-2001 is rational for small businesses. Flow charts of production processes, HACCP worksheets, reports of the HACCP group, documents reflecting the functioning of the HACCP system are the main documentation of the system.
- GOST R ISO 22000-2007 is identical to ISO 22000: 2005 (is an international standard) has more extensive documentation and having implemented it, you can confidently count on passing an inspection of Rospotrebnadzor. Along with the HACCP documentation, ISO 22000 requires a number of system and specialized documents, such as:
- programs of mandatory preliminary measures for safe production planning,
- documents on the management of these events,
- procedures for managing records and records,
- management procedures in emergency and emergency situations that affect product safety,
- a description of the monitoring system, including a description of the hazard assessment methods used and instructions,
- procedures for handling potentially hazardous products, making corrections and corrective actions, withdrawing products, notifying the customer in case of non-compliance after the products are delivered to the customer.
- records of information exchange, traceability of the product and its subsequent verification,
- records of the conduct of internal audits, corrections and corrective actions taken, as well as other documentation, taking into account the specifics of the organization.
The first step in the development and implementation of a product quality management system is the creation of a HACCP working group which will include competent specialists trained to apply the HACCP principles
HACCP group: A group of specialists (with qualifications in different areas), which develops, implements and maintains the HACCP system (GOST R 51705.1-2001).
Members of the HACCP group should have sufficient knowledge and experience in such areas as: food production technologies, engineering aspects, veterinary medicine (for animal products), microbiology, chemistry, toxicology, environment and ecology, legislation and other mandatory requirements established for food products, as well as understanding the principles of HACCP and capable of logical analysis. It is necessary to understand the existing and most likely risk factors, as well as ways to control them.
The effectiveness of the HACCP system depends on the competence of the staff. Consequently, when creating a working HACCP system, the most important element is the education and training of personnel. In the absence of relevant specialists in the organization, you can use the help of third-party expert consultants with knowledge of the potential risks associated with this product.
Step two - description of raw materials, ingredients, products, production processes. At this stage, the HACCP group describes in detail all the used raw materials, ingredients, packaging materials, and products. In addition, we must not forget about allergens that are part of the raw materials and assess the ingress of allergens in the finished product. The most common components, the use of which can cause allergic reactions or is contraindicated in certain types of diseases are specified in the Technical Regulations of the Customs Union TR TS 022/2011 "Food products in terms of its labeling".
Members of the HACCP team should know the products and technologies for their production, how to use the product, as well as describe the improper handling and misuse of the final product. For example, everyone knows that the dough is not consumed raw, but some people ignore this requirement and this can cause poisoning. You can not use the "effervescent" candy with carbonated drinks, because candy can react with the gases of the drink and this can lead to severe pain in the stomach and other rather dangerous consequences.
The third step should be the development of flowcharts. It is necessary to involve employees directly working in the process areas (cooks, storekeepers, etc.) in drawing up flowcharts. Flowcharts do not have to be complex and cluttered.
The next, fourth step will be the identification of potential hazards and their analysis. The purpose of the analysis is to identify all possible risks, their comparison, which is important for product safety and consumer health.
risk: The combination of the probability of realization of a hazard and the severity of its consequences (GOST R 51705.1-2001).
Hazardous factors are divided into biological, chemical or physical, the presence of which in food can make products dangerous to the health of the consumer. Dangerous biological factors are bacteria, viruses, mold and other fungi, as well as insects. The source of their occurrence can be used in the production of water, technological equipment, can get into the raw materials and finished products from the air.
Chemical hazards are allergens, antibiotics, toxic substances, pesticides, food additives that have not been approved for food production, disinfectants, lubricants, etc.
Physical hazards are metal, broken glass and fragile objects, pebbles, etc., which can lead to physical injuries (for example, cuts in the mouth, suffocation, etc.) or cause aesthetic dislike (hair). Physical factors can get into production with raw materials, from equipment, premises, from employees.
Further steps will be: determination of critical control points (CCV) - establishment of critical limits for each critical control point - establishment of a monitoring system for each critical control point - establishment of corrections / corrective actions in case of deviation from critical limits - development of a HACCP plan - mandatory maintenance of documented records .
To determine the CCP, you can use the decision tree, which is a series of questions, the answers to which relate to certain risk factors.
After the detection of CCPs, critical limits are determined.
critical limit (critical limit): Критерий, позволяющий отделить приемлемость от неприемлемости (ГОСТ Р ИСО 22000-2007)
К критическим пределам относятся такие показатели, как габариты продукта фактические, объем, присутствие болезнетворных микроорганизмов, вязкость, температура, время, концентрация соли, степень окисления фритюрного жира, отсутствие частиц металла и др.
Для каждой критической контрольной точки устанавливается система мониторинга. В зависимости от типа ККТ, особенностей процедуры мониторинга и технологического процесса определяется частота проведения мониторинга.
monitoring (monitoring): Implementation of a planned sequence of observations or measurements in order to assess that the control measures provide the expected effect. (GOST R ISO 22000-2007)
The monitoring results are documented in HACCP journals and / or worksheets and must be signed by the implementers.
In case of exceeding the critical limits, corrections and corrective actions are required. These actions are procedures that allow to avoid the occurrence of low-quality products in the consumer's home.
Be sure to keep a permanent record. This allows you to establish: the effectiveness of HACCP, following the HACCP plan.
In addition to monitoring, it is necessary to establish internal audit procedures (audits). Verification procedures are tests, tests, and other ways to assess the compliance of a system with a HACCP plan. The audit of the implemented HACCP system is one of the verification methods, as it helps to identify system malfunctions and make the appropriate corrective actions.
verification (verification): Verification of compliance with established requirements through the submission of objective evidence (GOST R ISO 22000-2007)
When developing procedures based on the principles of HACCP, you can use the following documents:
HARDWARE 021/2011 TR "About safety of food products"
GOST R 51705.1-2001 Quality Systems. Food quality management based on the principles of HACCP. General requirements
GOST R ISO 22000-2007 (ISO 22000: 2005) Food safety management systems. Requirements for organizations involved in the food production chain
GOST R ISO / TU 22004-2008 / ISO 22004: 2005 Food safety management systems. Guidelines for the application of ISO 22000: 2005 ″ (GOST R ISO 22004-2017 Food safety management systems. Guidelines for the application of ISO 22000 will come into force on April 1, 2017)
GOST R ISO 22005-2009 / ISO 22005: 2007 Traceability in the food industry supply chain. General principles and basic requirements for the design and implementation of systems
GOST R 54762-2011 / ISO / TS 22002-1: 2009 Programs for preliminary requirements for the safety of food products. Part 1. Food production
GOST R 56746-2015 / ISO / TS 22002-2: 2013 Program prerequisites for food safety. Part 2. Catering
GOST R 55889-2013 Catering services. Security management system for catering products. Recommendations for the application of GOST R ISO 22000-2007 for the food industry
GOST 33182-2014 Meat industry. The procedure for developing a HACCP system in the meat industry
GOST R 56671-2015 Recommendations for the development and implementation of procedures based on the principles of HACCP
GOST R 53755-2009 (ISO / TS 22003: 2007) Food safety management systems. Requirements for bodies performing audit and certification of food safety management systems
MR 5.1.0096-14 Methodical approaches to organizing the assessment of food production (manufacturing) processes based on the HACCP principles
A list of the main documents under development is presented in GOST R 56671-2015 “Recommendations for the development and implementation of procedures based on the principles of HACCP” Appendix A (mandatory).
1) Input control
2) Ensuring the operability of measuring instruments, sieves and metal catchers
3) Preventing physical contamination
4) Documenting Information
5) Storage of raw materials, materials and finished products
6) Sanitization of equipment and inventory
7) Cleaning and sanitizing of premises
8) Staff hygiene requirements
9) Pest Control
11) Waste disposal
12) Management of non-conforming products
What problems can arise in the process of developing and implementing the HACCP system and how to solve them?
Based on the experience of working with manufacturers, it can be argued that the main problem in developing a HACCP system is the difficulty of analyzing risks and identifying hazards, as well as documenting them. Despite the fact that there are GOSTs for which the HACCP system is being developed, a sufficient level of knowledge and experience is still necessary for the correct identification of control critical points. And here the next problem immediately arises - insufficient qualification of personnel or their absence at all. The usual practice in small and medium-sized enterprises is the absence in the staff schedule of the production manager, technologist, master, not to mention the person responsible for quality. In this case, who will monitor the quality of the product, take corrective actions, from whom to form a Quality Council, remains a mystery. If for the development and implementation you can resort to the help of outside experts, then to maintain the system you still need qualified personnel of the enterprise itself. Therefore, heads of organizations implementing the HACCP system should employ experienced and professionally trained staff or train HACCP principles to existing staff.
Needless to say, often even the management of enterprises themselves sees in the HACCP system another whim of the government, designed to make life difficult for entrepreneurs, and the system itself begins to be engaged after the instructions of the inspection bodies or consumer complaints about the quality of the product. But it is worth explaining that the developed HACCP system serves to assist the manufacturer in managing food safety, and not to complicate his activities.
A lot of enterprises work on outdated equipment and in premises left from Soviet times, entrepreneurs open production in rooms that are often completely unsuitable for implementing the requirements of the HACCP system. But despite the fact that the development and implementation of a fully functioning system is possible only under good conditions to ensure the safety of food products, less developed enterprises need the HACCP system. Analysis of risk factors in such enterprises will allow to prioritize the improvement of production and a better understanding of the general problem of food safety. You should also be aware that the food product must be safe for human health, regardless of where it was produced on a large "perfect" production or in a small shop of an individual entrepreneur.
It is necessary to mention the various misconceptions that arise among many manufacturers who have decided to begin developing a HACCP system. Among them, the idea is widespread that the HACCP system is an expensive pleasure. In fact, payment of fines for the lack of a system, compensation for possible damage or reputational losses from consumer complaints is much more expensive. In the end, it will pay off by increasing the competitiveness of products.
Another misconception is that the HACCP system is based on a huge amount of writing. Here you can argue - the number of documents can vary greatly, the manufacturer must determine how many documents will provide guarantees for the release of a safe product.
Very often, manufacturers are mistaken in that it is enough to create a HACCP system once and it will be suitable for the entire period of existing production. This is incorrect, in the HACCP system itself it is envisaged that it must constantly be kept up to date, making adjustments depending on the results of monitoring and internal audits. It would be a particular mistake to think that developing a HACCP plan is the same as creating a HACCP system. It is not enough one formal development, it is necessary to work continuously on improvement of quality of products. Very often you can hear the following phrase: “Development of the HACCP system requires a large amount of resources” - this is not a completely correct statement. The main resources are attracted only at the beginning of development and implementation, then the need for them is sharply reduced.
There is a persistent myth that the HACCP system is able to guarantee that there is no risk of producing low-quality products. Not a single system will cope with this task, the goal of HACCP is somewhat different - to reduce risks to an acceptable level.
How is the audit of the HACCP system by the bodies of Rospotrebnadzor?
Basically, the bodies of Rospotrebnadzor conduct inspections in accordance with MR 5.1.0096-14 “Methodological approaches to organizing the assessment of food production (manufacturing) processes based on the principles of HACCP”, which include:
a) checking the availability of basic documents confirming the development of procedures based on the HACCP principles in the Management System in accordance with Article 10 of the ТР ТС 021/2011 TR:
- policies and / or documented statements, intentions of the guide to ensure food safety, a guide to safety (voluntary),
- the organizational structure of the enterprise (indicating the structural units, their subordination and interaction),
- developed and documented procedures based on the HACCP principles in the Management System, including the production control program,
- regulatory documents regulating product safety,
b) safety assessment of products with sampling and laboratory tests on the basis of an accredited (independent) laboratory in order to confirm the compliance of products with regulatory documents and confirm the effectiveness of the management system. In order to ensure the objectivity of the results, the rules and methods of research (testing) and measurements should be used, including the rules for sampling necessary for the application and execution of the adopted technical regulation and the implementation of conformity assessment, the list of which is defined in a specific decision of the Customs Union Commission that approved the technical regulation Customs Union for a certain type of product,
c) verification of the implementation and maintenance of procedures based on the principles of HACCP, including the implementation of the production control program,
d) analysis of the submitted documents for compliance with the requirements of TR TS 021/2011, TR TS 022/2011, TS TS 005/2011 and technical regulations of the Customs Union for certain types of food products and the requirements established by the legislation of the Russian Federation,
e) assessment of information exchange with interested parties in the organization and beyond its borders,
e) checking the availability of developed procedures for validation, verification and continuous improvement of the management system. Criteria of efficiency and continuous improvement of the management system are presented in Appendix 2,
g) inspection of the object,
h) risk assessment of the release of hazardous products in order to determine the administrative measures and the selection of priority objects of supervision,
i) checking the availability and assessment of regulatory documents in the enterprise, their updating, determining priority regulatory documents that are the basis of the Management System implemented in the enterprise. At the same time, the type and volume of documents that confirm the existence and operation of procedures is determined by the enterprise independently,
j) assessment of the functioning of the safety management system based on the principles of HACCP, and the procedures regulated by the requirements of Article 10, Part 3, Article 11, Part 3, Part 4 of the TS TS 021/2011, is documented and visually confirmed during the inspection of the object.
When establishing the absence of procedures developed and implemented at the enterprise, based on the principles of HACCP in the management system, in accordance with Part 2 of Article 10 of the ТР ТС 021/2011, the enterprise is classified as unacceptable or critical risk (4 or 5 category) already in the first stage verification. Such enterprises require the development of corrective measures for virtually all procedures. (Mr 5.1.0096-14, Clause 4, Subclause 4.2.).
If the manufacturer of food products does not comply with the requirements of TR TS 021/2011, then it falls under Article 14.43 of the Code of Administrative Offenses of the Russian Federation.
Is it necessary to certify the HACCP system?
Certification is currently not required.but a certificate is required if:
- Your organization takes part in tenders,
- You enter into a contract with a foreign company,
- You are going to export products,
- You intend to place the HACCP badge on the packaging or on the website page,
- You want to get an independent assessment of the quality of functioning of the HACCP system,
- You plan to cooperate with a company that requires its suppliers certified food safety system.
You can be certified for compliance with GOST R 51705.1-2001 and GOST R ISO 22000-2007 These standards provide for safe activities, and certification for compliance with GOST R ISO 22000-2007 allows you to strengthen your position not only in the domestic, but also in the external market.
When choosing a certification body, pay attention!
- whether the certification body has a certificate of accreditation of management systems for compliance with the requirements of GOST R ISO / IEC 17021-2012, issued by the Federal Accreditation Service (Rosaccreditation).
- whether the certification body has the right to conduct certification in the registered Voluntary Certification System. The registry functions for registered voluntary certification systems belong to the Federal Agency for Technical Regulation and Metrology (Rosstandart). The certification body (legal entity) must either be the holder of the voluntary certification system or be authorized to carry out certification work for any registered system (the fact of authorization must be confirmed).
- the presence of sufficient experience and a positive reputation from the certification body.
In conclusion, I would like to say that despite the legislative pressure and a lot of problems in developing and implementing the HACCP system, organizations producing, storing and selling food products need to remember that nothing is more important than a real desire to provide the consumer with safe and quality food products a well-implemented HACCP system can help.
The report says that agriculture, especially meat and dairy products, accounts for 70% of global freshwater consumption, 38% of total land use, and 19% of global greenhouse gas emissions.
Last year, the Food and Agriculture Organization of the United Nations stated that by 2050 food production should increase globally by 70% to feed the growing world population. It is also reported that efficiency gains in agriculture will be overwhelmed by expected population growth.
Professor Hertvich, who is also the director of the industrial ecology program at the Norwegian University of Science and Technology, said that developing countries, where most of this population growth will take place, should not follow the pattern of growing consumption in the western world: "Developing countries should not follow our model . But we need to develop technologies, for example, in the field of renewable energy or irrigation. ”
- Nothing to say78