ȘI MEDICINĂ VETERINARĂ CLUJ NAPOCA FACULTATEA DE ȘTIINȚA ȘI TEHNOLOGIA ALIMENTELOR Departamentul de Ingineria Produselor Alimentare PROGRAM MASTER:… [622491]

UNIVERSITATEA DE ȘTIINȚE AGRICOLE
ȘI MEDICINĂ VETERINARĂ CLUJ NAPOCA

FACULTATEA DE ȘTIINȚA ȘI TEHNOLOGIA ALIMENTELOR

Departamentul de Ingineria Produselor Alimentare

PROGRAM MASTER: MANAGEMENTUL CALITĂȚII ALIMENTELOR

LUCRARE DE DISERTAȚ IE

Coordonator științific
Titlul didactic, titlul științific, Dan VODNAR

Absolvent: [anonimizat]
2017

UNIVERSITATEA DE ȘTIINȚE AGRICOLE
ȘI MEDICINĂ VETERINARĂ CLUJ NAPOCA

FACULTATEA DE ȘTIINȚA ȘI TEHNOLOGIA ALIMENTELOR

Departamentul de Ingineria Produselor Alimentare

PROGRAM MASTER: MANAGEMENTUL CALITĂȚII ALIMENTELOR

SISTEME DE CALITATE AGRO ALIENTARA IN
INDUSTRIA LAPTELUI

AGRIFOOD QUALITY SYS TEMS IN MILK
INDUSTRY

Coordonator științific
Titlul didac tic, titlul științific, Prenume, NUME

Absolvent: [anonimizat]
2017

CUPRINS

REZUMAT …………………………………………………………………………………………………… XX
ABSTRACT ………………… ………………………………………………………………………………. XX
I.INTRODUCERE …………………………………………………………………………………………… XX
II.STUDIU DE LITERATURĂ ………….. ……………………………………………………………. XX
II.1. Titlu subcapitol…
II.2. Titlu subcapitol…
III.CONTRIBUTII PERSONALE……………………………………………………………………… XX
III.1 MATERIAL SI M ETODA
III.2. REZULTATE
III.3. CONCLUZII
MULTUMIRI (daca e cazul )…………………………………………………………………………….. XX
BIBLIOGRAFIE …………………………………………………………. ……………… ……….. ……….. XX
ANEXE (daca exista) ……………………………………………………………………………………… XX

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4/34

REZUMAT

Laptele, din punct de vedere organoleptic și fizico -chimic se prezintă sub forma unui
lichid fiziologic de culoare albă cu gust zaharat, constituind o soluție apoasă în care se
găsesc emulsionate globule de grăsime, suspendate micele proteice și dizolvate glucide,
vitamine, precum și substanțe minerale. (Gh. Georgescu, 2000) .
Laptele a devenit o materie prima foarte importantă pentru obținerea unei game foarte largi
de produse cum ar fi: smântână, iaurt, brânză, unt, înghețată etc. Evoluția proceselor
tehnologice, tehnicile de conservare și circuitele de distribuție au permis elaborarea de noi
produse, care nu toate sunt destinate acelorași utilizări, dar care prezintă un interes
deosebit.

Laptele si produsele din lapte sunt cele mai importante produse de baza care se regasesc in
alimentatia de zi cu zi. Din cauza posibilelor contaminari fizice , chimice sau biochimice
care pot pune in pericol sanatatea consumatorilor de produse lactate se recurge la multiple
metode de preventie a acestor contaminari. Cele mai eficiente modalitati de a garanta
siguranta alimentelor sunt preventia si imbunatatire a procesului de fabricatie.
Unul dintre cele mai eficiente sisteme de calitate si siguranta alimentara este analiza
punctelor critice de control, principalul obiectiv fiind identificarea problemelor inaintea
aparitiei acestora.
Un aliment să fie sigur pentru consum trebuie să respecte anumite condiții privind calitatea
lui igienică. În mod curent se fac examenele: organoleptice, fizice, chimice și
microbiologice. Prin aceste examene se obțin informații în scris despre produs desp re
calitatea produsului și dacă este consumabil. Un aliment conform concepției moderne
privind calitatea unui produs alimentar este testat. Aceste teste clasice asupra produselor
alimentare au o semnificație și o experiență redusă. Pe când se observă că pr odusul
alimentar nu este de calitate este prea târziu să se poată interveni. De aceea acest fenomen
se poate evita dacă elementele cheie ale procesului de fabricație sunt în permanență
urmărite și controlate, permițând atunci când se impune aplicarea în ti mp util a unor măsuri
corective. Elementul cheie prin care se poate controla tot procesul tehnologic se poate
printr -o analiză HACCP, indicându -se punctele critice pe flux.

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5/34 HACCP sunt ini tialele sistemului Hazard Analysis Critical Control Point ( Sistemul de
Analiz a Întâmpl atoare în Punctele Critice de Control), sistem recunoscut interna tional,
care ajut a la producerea de alimente sigure . HACCP se concentreaz a asupra prevenirii,
prin evitarea problemelor legate de securitatea alimentelor. Sistemul combin a bunul sim t
cu evaluarea riscurilor, în vederea identific arii de -a lungul lantului de produc tie alimentar,
a punctelor unde hazardul, întâmplarea pot s a apara si apoi a controlului si monitoriz arii
stricte a acestor puncte, pentru a fi sigur ca întregul proces este sub control. HACCP are cel
mai mare succes în p astrarea siguran tei lan tului alimentar atunci când este folosit în
întregul proces de produc tie, din ferm a pâna pe masa consumatorului .
Utilizarea metodei HACCP s -a demonstrat că este extrem de utilă și eficientă, deoarece
întreprinderea producătoare nu -și poate permite și nici nu are cum să verifice produsele
finite în procent de 100%. Chiar dacă, ipotetic ar fi controlat prin metode de laborator
întreaga producție, există încă probabi litatea existenței unor abateri.
In cadrul acestui studiu sunt analizate punctele de control in industria laptelui crud, si a
celui pasteurizat , precum si identificarea tuturor potentialelor contaminari ce pot interveni
pe parcursul intregului proces teh nologic.

Cuvinte cheie: lapte, puncte critice, HACCP.

ABSTRACT

The milk from the point of view of physico -chemical and organoleptic is in the
form of a physiological liquid, white colour, sweet taste, being an aqueous solution in
which a re emulsified fat globules, protein micelles suspended and dissolved carbohydrates,
vitamins, as well as substances minerals.(Gheorghe Georgescu, 2000)
Milk and milk products are the most important and necessary products in the food
supply chain . Due to physical, chemical or microbiological hazards of possible
contamination, many people in the world are exposed to these risks quite clearly.

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6/34 Therefore, sufficient quality and food safety practices are important for food se curity in the
dairy industry. The most effective way to achieve food safety is to focus on prevention of
possible hazards and to improve the process. The Hazard Analysis and Critical Control
Points (HACCP) system has been indicated as on e of the most effective ways to guarantee
high quality and safe food. The main objective of Critical Control Points (CCP) is to
identify problems before they occur, establishing control measures that are critical to
maximizing food safety at each stage in the production process. In this study, the
identification of critical control points in dairy sector, the identification of all potential
hazards in raw milk, pasteurized milk, Ultra High Temperature (UHT) milk production are
reviewed. Description of criti cal control points, evaluation and orientation applied to
prevent and control the critical points were presented.

Key words : milk, HACCP , CCP

I. INTRODUCERE

Milk is a nutritive beverage obtained from various animals and consumed by
humans. Most milk is obtained from dairy cows, although milk from goats, water buffalo,
and reindeer is also used in various parts of the world. In the United States, and in many
industrialized countries, raw cow's milk is processed before it is consume d. During
processing the fat content of the milk is adjusted, various vitamins are added, and
potentially harmful bacteria are killed. In addition to being consumed as a beverage, milk
is also used to make butter, cream, yogurt, cheese, and a variety of ot her products.
There are many different types of milk. Some depend on the amount of milk fat
present in the finished product. Others depend on the type of processing involved. Still
others depend on the type of dairy cow that produced the milk.

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7/34 Milk can show large quality differences, which milk processors, must take into account.
Two types of criteria are used for paying by quality physio -chemical and bacteriological.
Physio -chemical criteria usually relate to the fat and protein content, the ba sic rate of
which per kilo of milk varies from one to another. Testing for better bacteriological quality
could result in finding specific bacteria such as Coliforms, Staphylococcus, Listeria and
Butyric spores. Similarly, the presence of antibiotics and t he milk temperature during
collecting can be used as quality criteria and for price reduction. In addition, the presence
of chemical residues could alter the process of elaboration of derived fresh milk products.
(Karakok 2007; Vilar 2011).

Milk quality is all about prevention on each step of production. Quality control systems
aimed the prevention of defects, rather than their detection. Quality control occurs at every
step in the production, as a raw material on farm condition. Consumers, processors and
regulatory agencies are increasingly interested in the safety and wholesomeness of milk
resulting in increased emphasis on the farm management to insure the production of milk
quality (Noordhuizen and Metz 2005).

The consumer demands safe and wholesome dairy products that can be purchased without
any doubt. For raw milk the term quality is extremely comprehensive. There is a quality
pyramid based for dairy products based on these kinds of perimeters. In summary, firstly
the basic foundation of this pyram id is about the safety of these products, the second is the
nutritional value and thirdly there must be the service to satisfy consumers for the long
term. Some of the most important quality aspects are quality of content and physical –
chemical condition, h ygiene quality (bacteriological and cytological traits, absence of
pathogens and other contaminants), sensorial quality, nutritional quality and technological
quality (processing ability) (Karakok 2007).

The average composition of cow's milk is 87.2% water, 3.7% milk fat, 3.5% protein,
4.9% lactose, and 0.7% ash. This composition varies from cow to cow and breed to breed.

The advantages of milk processing are:

• Provides regular income
• Improves nutrition

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8/34 • Selling processed milk products is more profitable than selling fresh milk
• Generates employment
• Improves quality and safety

Pasteurization is the first step in milk processing. Pasteurization means heating every
particle of the milk or milk product to a specific tempe rature for a specified period of time
(63°C for 30 minutes). This destroys bacteria and other micro -organisms that may affect
consumers' health. It makes the milk safe and healthy, and also improves the keeping
quality, so that milk and milk products can b e stored forlonger periods without being
spoilt.

Many farmers pasteurize their milk by direct boiling. However, direct boiling is
unhygienic, because it can lead to contamination from outside particles or bacteria. Direct
boiling is also inefficien t, i.e. it requires more energy (more fuel or firewood).

Indirect heating is a better way to pasteurize milk. Place the milk can inside a larger metal
vessel containing water, so that the water forms a jacket around the milk can. Heat the
larger outside vessel using an open flame, or gas stove, or electrical hot plate.

Other methods of pasteurization:

• Batch pasteurization: 63°C for at least 30 minutes. This is suitable for small -scale
producers and
farmer cooperatives.
• High temperature short time (HTST) pasteurization: 72°C for at least 15 minutes. This is
suitable for
processing large quantities of milk, e.g. more than 250 liters at a time.
• Ultra high temperature (UHT): 135°C. This is used by big factories. It requires special
machinery. UHT
milk can be stored for 6 months even without refrigeration.

Two methods of separation of cream from milk are commonly used: (A) gravity separation
and (B) centrifugal separation. Both these methods rely on the basic principle of separation

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9/34 of two immiscible liquids having different densities, under the influence of gravitational or
centrifugal force.

Gravity Separation: As mentioned above, when milk is allowed to stand undisturbed for
some time, a layer of cream forms on the top due to rising of the fat glob ules which are
initially dispersed throughout the bulk of milk. The upward movement of the lighter fat
globules (density, 0.93 g/cc at 20oC) in the heavier serum (density, 1.035 g/cc) takes place
owing to gravity. Creaming may become evident in as short ti me as half an hour.

Centrifugal Separation: In principle, this method of cream separation is similar to gravity
separation but gravity as the driving force is replaced by the centrifugal force for which a
rotational machine is used. Since the latte r force is much larger than the gravitational force,
separation is greatly accelerated.

Milk can show large quality differences, which milk processors, must take into account.
Two types of criteria are used for paying by quality physio -chemical an d bacteriological.
Physio -chemical criteria usually relate to the fat and protein content, the basic rate of
which per kilo of milk varies from one to another. Testing for better bacteriological quality
could result in finding specific bacteria such as Coliforms, Staphylococcus, Listeria and
Butyric spores. Similarly, the presence of antibiotics and the milk temperature during
collecting can be used as quality criteria and for price reduction. In addition, the presence
of chemical residues could alter the p rocess of elaboration of derived fresh milk products.
(Karakok 2007; Vilar 2011).

Milk quality is all about prevention on each step of production. Quality control
systems aimed the prevention of defects, rather than their detection. Quality co ntrol occurs
at every step in the production, as a raw material on farm condition. Consumers, processors
and regulatory agencies are increasingly interested in the safety and wholesomeness of
milk resulting in increased emphasis on the farm management to i nsure the production of
milk quality (Noordhuizen and Metz 2005).

The consumer demands safe and wholesome dairy products that can be purchased
without any doubt. For raw milk the term quality is extremely comprehensive. There is a

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10/34 quality pyr amid based for dairy products based on these kinds of perimeters. In summary,
firstly the basic foundation of this pyramid is about the safety of these products, the second
is the nutritional value and thirdly there must be the service to satisfy consumers for the
long term. Some of the most important quality aspects are quality of content and physical –
chemical condition, hygiene quality (bacteriological and cytological traits, absence of
pathogens and other contaminants), sensorial quality, nutritional qua lity and technological
quality (processing ability) (Karakok 2007).

II. ANALIZA STADIULUI ACTUAL AL TEMEI

II.1. HACCP: Principles and stages

Hazard Analysis Critical Control Point (HACCP) is a food safety management system,
which concentrates preve ntion strategies on known hazards and the risks of them occurring
at specific points in the food chain. It is this specificity which makes HACCP so effective
and the approach easily integrates into Total Quality Management or ISO 9000.
Developing HACCP ass ists companies to comply with legislation, supports due diligence
and fulfils customer requirements for a food safety management system. The introduction
of common food hygiene rules across the European Community through Directive
93/43/EEC was achieved wi thin the UK in 1995 by the Food Safety (General Food
Hygiene) regulations, which legally require the HACCP approach. Industry guides to good
hygienic practice are voluntary guides providing more detailed advice on complying with
the regulations as they rel ate to specific sectors.
Food safety should be given the highest priority, however companies are often
short of time and appropriate personnel require training, especially in food
safety, which needs to be widely disseminated throughout their company.
Food safety management systems are much more likely to be effective if they are owned
by all in production and management.

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11/34 History of HACCP

The HACCP system was introduced in the United States in 1971 by the Pillsbury
Company in collaboration with the Nation al Aeronautics and Space Administration
(NASA) and the US Army Natick Research and Development Laboratories. These
agencies had the initial responsibility of designing and manufacturing food products and
hardware which were to provide 100 percent assurance that either the food products would
not be contaminated with pathogens, bacteria or viruses which could cause illness or that
the equipment would function with zero defects.
After extensive evaluation, it was decided that the only way success could be ach ieved
was by controlling the process and the personnel as early as possible in the production
system. This preventative system was perceived to offer the highest degree of assurance
that the products manufactured were safe as it eliminated the need for any further end –
product testing and emphasis was placed on monitoring. The HACCP concept for food
safety was developed based on this approach.

Internationalization of HACCP

The HACCP system has become the internationally recognized system for the management
of food safety for all companies involved in the production, transformation, storage and
distribution of food for human consumption. It has been adopted by the European Union
(EU) for all food processors and the Codex Alimentarius Commission as the princi pal
food safety system (EU Directive 93/43/EEC; Codex Alimentarius – Alinorm 93/131,
1993).
The EU directive mandated the implementation of HACCP in all local legislation by
December 1995. All European companies involved in the food chain from the primary
producer to the final consumer are now legally bound to have a HACCP plan or system.
The European directive also advises that all countries which are desirous of exporting food
products to the EU must “critically examine their production processes in the s ame
thorough way by making a HACCP plan and/or system of operation”.
Some European countries conformed and introduced the necessary legislation within
the stipulated deadline. The Netherlands complied and established the requirement for the
introduction of HACCP as Article 30 of the “Directive on the Hygiene of Foodstuffs”. The

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12/34 Dutch Government also included an additional clause which specifies which records must
be maintained, as follows: “ The documentation of both the analysis and the actual control
has to be complete and easy to access ”.
The HACCP concept involves the identification of specific hazards throughout the
entire process involved in the production of a food product and focuses on the preventative
measures for their control to assure t he quality and safety of the food. This includes
analysis of raw material sources and usage, processing equipment, operating practices,
packaging and storage, together with marketing and conditions for intended use. There is
less reliance on the traditiona l system of end product testing and food safety is built into
the product from conception through design and distribution.
An effective implementation of HACCP leads to:
a) institution of controls at different stages of processing which reduce rejections a t the
end of the production line;
b) identifying the critical control points to limit technical resources targeted at the
management of food safety program;
c) encouraging people to recognize and become aware of food hazards that might be a
threat and how to take speedy remedial measures; and
d) disciplined approach for continuous improvement in product safety and quality.

HACCP Concept, Purpose, Implementation and Benefits

The HACCP concept involves the identification of specific hazards throughout the
entire process involved in the production of a food product and focuses on the preventative
measures for their control to assure the quality and safety of the food. This includes
analysis of raw material sources and usage, processing equipment, operating p ractices,
packaging and storage, together with marketing and conditions for intended use. There is
less reliance on the traditional system of end -product testing and food safety is built into
the product from conception through design and distribution. The purpose of HACCP can
therefore be summarized thus: “to identify potential problems which could occur in an
operation, consider each and establish controls to minimize or prevent its occurrence”.

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13/34
Benefits of an HACCP System

Some benefits of the HACCP concept in general and for food inspection:
– The system is preventive, proactive, systematic, scientific and cost -effective;
– It is a management tool;
– The system is internationally acknowledged (FAO/WHO);
– The system is applicable throughout the food chain;
– The system leads to increased awareness and subsequent higher involvement and
commitment of the employees;
– The official control based on HACCP programs is more efficient than a traditional
inspection or end -product testing alone. Hence, health protection of consumers is
enhanced;
– Harmonization of food inspection practices on an international level;
– Facilitation of regulatory/customer inspection;
– It leads to greater confidence in product safety; and
– The system has a preventive approach; r eduction of rework and losses are achieved.
Subsequently cost reduction is achieved.
Implementation of HACCP in a processing factory will require the commitment of all
involved and has a deep impact on the entire chain (see Appendix).

Certification of HA CCP

Eventually the HACCP system can be certified based on the criteria laid down in the
document: “Criteria for the Assessment of an Operational HACCP System” compiled by
the Dutch National Board of Experts HACCP, September 1998. The certification will be
carried out by a company accredited by the Board of Accreditation. A successful audit will
result in a certificate. The certificate is not permanent and repeat audits will be carried out
within a period of three years by the same certifying body. If certi fication is not achieved
during this period the company will have to start all over again with the procedure of
certification.

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14/34
IMPLEMENTATION OF HYGIENE GUIDES OR CODES

The general rules of hygiene are laid down in 17 articles. Article 3 specifically elaborates
on HACCP and Article 5 elaborates on hygiene guides; “Member states shall encourage
the development of guides to Good Hygiene
Practices, which may be used voluntarily by food businesses as a guide to compliance with
the provisions in Article 3”.
There is no clear connection between the implementation of a complete HACCP
system and a hygiene guideline. The information below, however, provides further
explanation.
Objective of a Hygiene Code
To implement hygiene guides the first question, which ari ses is: What are the
objectives of a hygiene guide? They are as follow:
– In general hygiene codes work with a common HACCP system with predetermined
CCPs.
– Hygiene guides are basically, but not exclusively, established for the SMEs or even
shops like but cheries and bakeries with limited manpower, where the CCPs have been
predetermined. A common HACCP system for a group of products or enterprises as
mentioned above (branch) is applied whereby the Hazard Analysis and Risk
Assessment is developed for that gr oup community and whereby the standard control
and preventive measures and corrective actions are laid down in the hygiene guide.
This hygiene guide can be directly applied by the operators of the group or branch.
– Hygiene guides cover in a systematic way those elements which are laid down in the
legislation to comply with the basic matters on Hygiene and Good Manufacturing
Practices and to provide the conditions to ensure the safety of food products.
– Hygiene guides facilitate inspection bodies on their assignment to inspect the relevant
items of the implemented system.
Therefore it is recommended that the standard hygiene guides should at least contain
the following aspects, which are actually the so called prerequisite measures of a HACCP
system:
1) Asp ects of personnel hygiene:
– Clothing
– Being healthy

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15/34 – Jewelry
– Rules of conduct
2) Requirements for the elements of building infrastructure such as:
– aspects on the location and environment
– requirements for the construction and design of buildings
– a plan or procedure for cleaning and sanitation
– a pest control system
– a procedure for water quality
– requirements for processing equipment
3) HACCP:
– Type of hazards (microbiological, physical and chemical)
– Standard control and preventive measures
– Predetermined CCPs
– Monitoring system
– Registration forms or checklists
– Standard Operating Procedures (SOPs) for consumer complaints, non -conformities and
calibration
– Training.

HACCP PRINCIPLES

Hazard Assessment of Critical Control Points (HACCP) aims the identification, evaluation
and control of steps that are critical to product safety in the food technological chain.
HACCP enables the management of a costeffective, ongoing food safety programme.
HACCP is a tool to assess hazards and establish c ontrol systems that focus on prevention
rather then end product testing. For the implementation of a HACCP based approach to
food safety, the responsibility involves:
• Industries involved in food chain
• Policy makers and mangers who can facilitate the ad option of HACCP
systems
The many activities involved in constructing a HACCP plan will be discussed
in detail. The following 7 principles should be used and considered by anyone
involved in hazard analysis
1. Conduct Analysis

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16/34 2. Identify CCPs
3. Establish target levels and critical limits
4. Establish monitoring system
5. Establish corrective action
6. Establish verification
7. Establish documentation

The HACCP system consists of the following seven principles:
1. Conduct a hazard analysis. A multidiscipl inary HACCP team identifiers all the hazards
that may be reasonable expected to occur at each step from primary production,
processing, manufacture, and distribution up to consumption; should identify which
hazards are such nature that their elimination or reduction to acceptable levels is essential
to the production of safe food; should evaluated likely occurrence of hazards and severity
of their adverse effects.
2. Identification of the Critical Control Points (CCPs) which are “steps at which control
can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to
an acceptable level’. A decisional tree to identify CCPs is presented as example in Fig 6.
3. Establishment of the critical limit(s) as criteria that separate acceptab ility from
unacceptability. A critical limit represents the boundaries that are used to judge whether an
operation is producing safe products.
4. Establishment of the system which monitor the CCPs in order to allow adjustment of the
process, preventing los s of its control.
5. Establishment of the corrective action to be taken when monitoring indicates that a
particular CCP is not under control. Procedures should be in place to identify, isolate and
evaluate products when critical limits are exceeded.
6. Establishment of the verification procedures to confirm that the HACCP system is
working effectively, allowing the producer to challenge the control measures.
7. Establishment documentation concerning all procedures and records appropriate to these
principles and their application.

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17/34

Figura 1.

THE FOURTEEN STAGES OF HACCP

It is possible to implement the seven principles of HACCP in 14 separate stages. The
Codex documentation identifies 12 stages; an additional stage has been added at the
beginning and end wi thin the UK HACCP approach. The approach outlined here reflects
the sequence of the Codex documentation with verification procedures preceding record
keeping.
1. Define the terms of reference. Choose the product and start with safety hazards
2. Assemble a HACCP team / if relevant

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18/34 3. Describe the product / attach label
4. Identify intended use
5. Construct a flow diagram
6. Confirm on site
7. Identify and list all relevant hazards and preventative measures
8. Identify CCPs and apply the decision tree
9. Establish target levels and critical limits for CCPs
10. Establish monitoring system
11. Establish corrective action plan
12. Establish verification procedures
13. Establish documentation and record keeping
14. Review HACCP plan

Stage 1
Define the Terms of Re ference and Scope of the Plan .
It is better to complete a simple HACCP plan which can be expanded later than a complex
plan which is never implemented or finished.
Therefore, the terms of reference should be outlined clearly at the outset.
Decide upon the process line, product and whether physical, chemical and microbiological
hazards are to be considered.
When developing a HACCP plan for the first time, consideration of only one of these types
of hazard is often practical.
The end point of the plan also n eeds to be defined, i.e. does the plan finish when the food
leaves the factory. Initially this may be simpler and the plan may be subsequently
developed to include reasonable expected abuse at later stages e.g. by retailers, caterers or
consumers.
Stage 2
Select and Assemble a Team
Assembling the team provides a useful opportunity to motivate and inform employees
about HACCP. Team selection should be done by the chairperson or an external HACCP
specialist. It is essential to get the right blend of expertise as the team will collect, collate
and evaluate technical data, and identify hazards and identify critical control points. People
typically involved include quality assurance or control staff, production personnel, an
engineer and a microbiologist.

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19/34 In smal ler companies, one person may fulfil several roles or even constitute the whole
team. In the latter case use of external consultants or advice may be necessary. Ideally the
team should not be larger than about six, although additional members may be co -opted
when necessary. The team should have some initial training in HACCP. Adequate financial
and human resources should be available to the team.
Stage 3
Describe the Product
The HACCP team needs to have as complete an understanding of the product as possibl e.
All details of the product composition and processing should be known and understood.
This information will be essential for microbiological hazards because the products
composition needs to be judged in relation to the ability of different pathogens to grow
(Stage 7).
This can be summarized as:
Know your friends (the food – its composition and processing)
Know your enemies (the hazards – their severity and risk)
The following structured checklist can help the HACCP team to record comprehensive
informati on although small business may only be able to complete the general checklist.
Stage 4
Identify the Intended Use
It will be useful if you identify who are the likely purchasers or consumers of the product.
Some groups of the population, elderly, very young , sick or immunologic ally
compromised are much more susceptible to some hazards. You may need to label
appropriately. If there is a risk of Listeria monocytogenes being present, label “not
recommended to be eaten during pregnancy”. Other examples include specific reactions to
the product or its constituents e.g. nuts, azo -dyes, histamine, phenylalanine etc. The
intended consumer group may affect your “level of concern”.
It will also be of benefit to understand how the food is likely to be handled or abused by
consumers.
Stage 5
Construct a Flow Diagram
It will be much easier to understand the life history of the product if you produce a
comprehensive flow diagram.
It is easier to identify routes of potential contamination, suggest controls and
discuss this with others if you are looking at a diagram. The level of pictorial

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20/34 information on a flow diagram can be more detailed, if needed at specific stages, to enable
a more thorough discussion.
Stage 6
Confirm the Flow Diagram
Once a flow diagram has been produc ed it needs to be checked for accuracy.
Variations in work practices often occur when different line managers are in control, for
example small differences can easily occur between one shift and another. The original
flow diagram may have been produced fro m outdated documentation and may not include
new machinery which may have been installed.
This check will involve all members of the HACCP team and at different times with
different shifts and can vary from simple inspection to a completion of comprehensiv e
checklists. The more through the assessment the more likely the accuracy of the HACCP
plan. The completed checklists can form a record of the assessment and provide a baseline
for the assessment of change. Amendments or discrepancies from the original fl ow
diagram should be noted.
Stage 7
Identify and List all Relevant Hazards and Preventative Measures
This stage is often the first problem for people producing their first HACCP plan,
especially if they do not have access to current microbiological informa tion and data. It is
at this point that the chairperson has to ensure the HACCP team sticks to their terms of
reference .
Additionally operational malpractices and contamination points such as improper cleaning
also need to be identified. Identification of hazards should start with raw materials and may
finish, for example, with the product leaving the plant, or at the point consumption.
Once the hazards have been identified, preventative control measures based on knowledge
of the hazards, and their normal s ources and contamination points can be constructed.
Stage 8
Identify CCPs – Apply the Decision Tree
The HACCP team by now will have completed stages 1 to 7. A complete list of hazards
will have been identified along with how the hazards can contaminate the food, plus a list
of preventative measures. If a hazard does not have a preventative measure then the
product or process should be re -designed. It is likely that a large number of preventative
measures will have been identified and for the sake of good ma nufacturing practice (GMP)
it may be desirable to implement many or all of them.

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21/34 The raw material tree can be used to identify critical raw materials and ensure that the
appropriate preventative measures are included within the final Supplier Quality Assur ance
system.
Not all however, will be essential for food safety and the next stage in the HACCP is to
identify those points in the process at which safety control is critical.
These points can be identified by using the codex decision tree or other means and are
known as critical control points (CCPs). They highlight for the manufacturer where
particular care has to be concentrated in the implementation of preventative measures.
There is no limit to the number of CCPs and it will vary considerably on the c omplexity of
the process and the type of product.
Stage 9
Establish Target Levels and Critical Limits
The HACCP team will now have identified those preventative measures and specific points
which are deemed critical to the safety of the product.
In some ca ses it will be relatively easy to establish a target value, and there may be no
critical limit. For example, absence of metal determined by metal detection. The presence
of metal indicates unacceptable, absence is therefore acceptable; the target has no me tal
present .
In other instances setting target levels and critical limits is not as easy. For example if the
preventative measure is heat processing, a target temperature has to be selected and the
critical limits (acceptable tolerance) stated.

Stage 10
Establish Monitoring System
Monitoring is the series of observations or measurements to ensure that the
preventative measures are being implemented correctly.
Monitoring enables management to detect loss of control at a CCP. Therefore,
it is important to f ully specify who, how and when monitoring is to be performed and
recorded. Result from monitoring should be used pro -actively and illustrate how statistical
process control (SPC) can be incorporated into HACCP. For example, results from
cleaning at a criti cal control point, can be used to produce a process control chart. Some
luminometers include software which automatically record results. These can be plotted to
illustrate mean or range values. A low coefficient of variation (CV) indicates the
consistency of the cleaning process.

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22/34 %CV = SD x 100

Stage 11
Establish Corrective Action Plans
Work completed in Stages 9 and 10 will have specified the test to be implemented and
monitored as well as target levels and critical limits.
A corrective action plan descr ibes what should happen if a deviation is found , if the value
of a measurement lies outside the critical limit. For this to have occurred there must have
been a loss of control , failure to achieve a specified pasteurization temperature or failure to
clean properly.
Additionally, corrective action plans are used to specify what should occur if the results
obtained at a critical control point are not outside the critical limit.
The action plan should contain written details of:
_ immediate action to be taken, who is to be informed and the type of report to be
produced
_ what to do with the product that has been produced
_ investigate how loss of control occurred i.e. what has caused the problem and how a
recurrence is to be prevented. (Prevention of recurrence should be an essential element of
any HACCP plan)
_ who is to assume responsibility for decision making.
Ideally the person who assumes responsibility should have been involved in the original
HACCP plan construction. Advice given on what to do with the product, produced under
loss of control conditions, should be based on facts or deduction and not guesswork. For
microbial hazards, predictive modeling packages e.g. MAFF micro model, may be useful.
A full corrective action plan requires that, either based on experience, prediction or
modelling, all the likely problems have been anticipated. Details of how the defective
product is handled and whose responsibility it is should be specified.

Stage 12
Establish Verification Procedures
Microbial examination and analysis of both intermediate and final products can play a very
important role in verification. The results obtained, especially if combined with
computerized storage of data and trend analysis, can be very useful. They can indicate if

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23/34 the HACCP process is working and, if cross referenced to other data, can help to match
loss control with possible causes.
Counts of end products before the introduction of HACCP tend to be much higher and
more variable. If HACCP is being implemented correctly and is workin g, counts should be
lower and much more consistent (show a lower coefficient of variation). It is likely
therefore that the main use of microbiological product release or clearance to verification
of HACCP, raw materials testing and providing information f or use in the decision trees
e.g. on effectiveness of preventative measures.

Stage 13
Establish Documentation and Record Keeping
Efficient and accurate record keeping within HACCP is essential and should provide the
manufacturer with confidence that their product is safe and allow auditors to do their job.
Auditors may wish to undertake a compliance audit i.e. is the HACCP plan being
implemented correctly. Alternatively they may wish to undertake a system audit i.e. is the
HACCP plan appropriate and suitab le. For these reason full details of the component raw
materials, the processing and the final product are required. Additionally full details of the
HACCP plan, staff training, audit and verification details are needed. A number of
software packages exist for computerized record keeping and if they are used, backup
copies of data should be made. A person should be designated with responsibility for
record keeping.

Stage 14
Review the HACCP Plan
A review of the HACCP plan is used to determine whether the p lan is still appropriate and
is additional to the process of verification. Reviews are carried out at predetermined
intervals and when changes occur e.g. change in processing, processing equipment or raw
materials, whatever the trigger for the review it is important that the results of review are
recorded and fed back into the extant HACCP plan.

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24/34
HACCP IMPLEMENTATION

An evaluation of a company’s HACCP system is necessary to ensure that it is being
implemented effectively and is suitable to achieve the objectives. An audit, which is
defined as a systematic and independent examination to determine whether the activities
and related results comply with the planned objective, is an effective evaluation of a
company’s quality and safety management system. I t brings out whether the documented
system has adequate evidence to demonstrate the effectiveness of its implementation.
A well conducted audit both as an in -house activity and a third party assessment provides
an objective view of operations of an organiz ation. It reveals the strong and weak points
and also the non -conformities in the documented system and in its implementation.
Either way, it affords opportunities for improvement. An audit is therefore, a constant
measure of achievement of food safety goa ls and objectives set out by the management in
their quality policy. The management gets an objective feedback based on facts, enabling it
to make informed decisions towards improvement.

The purpose an audit is to prove an independent assurance that:
a) the documented HACCP system meets the specified policy and objectives;
b) documented HACCP plans are such that the intended safety will be achieved;
c) products are safe and fit for their purpose;
d) all statutory requirements are met;
e) the documented pro cedures and work instructions are being followed;
f) objective quality data are recorded to demonstrate achievement of the specified
requirements;
g) any deficiency in the HACCP system, processes, practices or products are identified
and appropriate correc tive action is taken;
h) information flow and communication; and
i) future strategic planning.
Audit data may also be used for effective control of quality costs, allocation of appropriate
levels of staff and equipment resources, identifying training needs and, as appropriate,
providing opportunities for greater staff involvement in the achievement of goals.

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25/34 Types of Audit

There are basi cally three types of audit: internal, external or third party.

1. Internal Audit
First Party Audit or the internal audit is carried out by an organization on itself, by auditors
usually from within the organization, who are independent of the area being audited, but
have some knowledge of the area being audited. If internal auditors are not available,
outside qualified a uditors may also be hired.
2. External Audit
An audit is being carried out by an external organization – this could be:
(a) Second Party Audit : the customer auditing the supplier or a supplier auditing its sub
contractors to assess their performance agains t contracted specified requirements; or
(b) Third Party Audit : an independent organization (independent of both customer and
supplier) is carrying out the audit. Independent third party audits are carried out on a
manufacturer by third party auditors repr esenting the purchaser, regulatory bodies or
inspection agencies to give third party assurance that the food safety management systems
are being implemented effectively.
Audit Planning
Once an organization registers itself with third party inspection/certi fication agencies,
a number of steps are involved: i) Scrutiny of Application; and ii) Audit Planning.
Scope of Audit
1. Adequacy Audit
The main documents for adequacy audit are:
a) quality manual
b) HACCP plan
c) standard operating procedures
d) raw mater ial specification
e) good manufacturing practices
f) plant and equipment hygiene.
2. Preliminary Visit
After an adequacy audit is completed, an auditor is expected to take a preliminary visit
of the unit, prior to the compliance audit. The purpose of this visit is to establish an initial

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26/34 contact with the audited company and to find o ut whether any non -conformities
highlighted during the adequacy audit have been resolved and also to gather the necessary
information to plan the compliance audit.
This visit al so establishes whether the audit would be viable or the organization would
take more time to get ready.
3. Compliance Audit
A compliance audit is the systematic and independent examination undertaken to assure
that all aspects of the prescribed quality sys tem are being complied with by the
manufacturers. Based on the results of such an audit the audit adjudges whether the system
is effective or not.
Audit Preparation
Preparatory steps to be taken are:
a) Audit Team Selection
b) Audit Strategy
c) Audit Sched ule
d) Notification of Audit
This includes:
i. the name of organization/department to be audited
ii. purpose and scope of audit
iii. date of visit
iv. time of visit of the team
v. duration of audit
vi. leader of the team and team member(s)
vii. schedule of audit
viii. criteria document or standard and applicable background papers.
e) Checklists.
Audit Execution
1. Review of Documentation
Auditors should be familiar with and have access to all audit documents. These
include:
– quality manual and procedures
– prerequisite program
– flow diagram
– HACCP plan

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27/34 – HACCP monitoring chart.
2. Process of Audit
1) Opening Meeting
2) Initiation of Audit
a) The auditors are introduced to the functional hand. The interview with departmental
head involves discussion of imp lementation of procedures, checking of records to
established evidence of implementation. The main aspects of evaluation include:
– checking currency of documents being used in the department and document control
system in operation;
– quality and HACCP mo nitoring records and how are they maintained and disposed off
after retention period is over;
– selection of CCPs;
– review of CCP procedures, practice and records;
– examination of test results and comparing with the contract/specified requirements. This
would reveal quality and food safety status of product or service;
– occurrence, review and disposition of non -conforming products; and
– internal audit reports and corrective action on non -conformities.
b) After the initial discussion with departmental he ad, the auditors move on to the actually
performing personnel and gather information from them
regarding:
– finding out what actually happens and how activities are performed;
– speaking to personnel at the work place gives them a feeling that auditors are concerned
with fact finding; and
– level of understanding of the system and training.
c) Process of Information Gathering
– Interviewing people
– Witnessing operators and verification of facts
– Recording facts.
3) Collection of Findings
a) Identifying no n-conformities
b) Non -fulfillment of specified requirements is termed as a non -conformity. A non-
conformity could be due to one of four reasons:
– The auditee’s documented systems do not comply with the specified requirements;
– The auditee has not impleme nted documented systems;

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28/34 – The documented systems implemented are not effective; and
– The statutory requirements have either not been addressed or complied with.
c) Recording non -conformities
d) Categorization of non -conformities
Based on the extent to wh ich a non -conformity has impact on the system, it is classified
into two categories:
* Minor non -conformity
– An isolated minor incidence of failure to comply with procedural requirement;
– A minor departure from quality management or HACCP systems
require ment; and
– A witnessed minor problem area in the system operation.
* Major non -conformity
– A significant departure from a specified requirement in the relevant standard (ISO 9001
and HACCP);
– A complete break down of operation of the documented system;
– Absence of a quality or food safety management system requirement; and
– A number of minor non -conformities of similar type spread in most of the activities
constitute a major nonconformity.
4) Evaluation of System Effectiveness
The information from the findings during the audit, when analyzed in a decision -making
sequence, provides the necessary basis to arrive at a reasonable conclusion. These may
include:
a) number of system non -conformities violating specified requirements against
which system is eval uated;
b) number of implementation non -conformities suggesting that stated system
exists but is not operating effectively;
c) number of non -conformities against each criterion which would indicate
weakness with respect to certain requirements;
d) number of non-conformities in each functional area or department suggesting
lack of effectiveness of practices; and
e) number of non -conformities indicating deviations on CCPs.
5) Closing Meeting
A closing meeting is held with the executive management and managers responsible for
the functions audited, i.e., HACCP team. The objective of this

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29/34 meeting is to present the audit observation in such a manner that the organization clearly
understands the outcome of the audit.
Audit Report
The audit report provides the findi ngs and recommendations of the auditors in an
impersonal form. The final recommendations are based on the findings of the audit. The
team either recommends the granting of a certificate or specifies conditions to be complied
with by the auditee prior to gr anting of certification.
Surveillance
Once a unit is granted certification, it is maintained through periodic surveillance audits of
identified areas in order to ensure that the unit continues to follow the systems. The license
renewed every three years.

ROLE OF THIRD PARTY CERTIFICATION

Official and officially recognized inspection and certification systems are fundamentally
important and a widely used means of food control. The effectiveness of the food control
measures provides confidence to the consum er about the quality and safety of the food
supply. Certification is the procedure by which official certification bodies or officially
recognized certification bodies provide written, or equivalent, assurance that the food or
food control systems conform to requirements.
The Bureau of Indian Standards (BIS), the officially recognized certification body in India,
besides offering product certification, also offers system certification schemes to the
industry. These include:
1. Quality System Certification ( against IS/ISO 9000)
2. Environmental Management System Certification (IS/ISO 14000)
3. HACCP Integrated ISO 9000 System Certification against IS/ISO 9000 and IS
15000:1998 Food Hygiene – Hazard Analysis and Critical Control Point (HACCP)
System and Guidel ines for its application.
BIS operates its certification scheme through its five regional offices and 24 branch
offices spread over the country. It has a pool of trained auditors and HACCP experts who
are able to provide service to the industry and provide certification of those units who have
documented, demonstrable and transparent quality/ safety management systems that ensure
customer satisfaction through an inter alia complaint redress mechanism. More than 850
units representing a wide spectrum of indu strial and infrastructural activities have been

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30/34 certified. Of these, around 53 belong to the food and beverage industries, out of which 26
units have so far also taken HACCP Certification. These include 21 dairy units, two spices
units, one processed meat export unit and one unit processing tomato puree and fruit -based
drinks.
Conscious of the requirement of the food industry to be able to demonstrate compliance of
food safety requirements through HACCP implementation, BIS is likely to launch the
stand alon e HACCP certification against IS 15000 shortly, for which policy level work is
underway.

II.2. SUBCAPITOLUL 2

II.3. OBIECTIVELE LUC RĂRII

Establishment of GMP in milk industry

There are three main categories of milk processing plants:
1. Heat processing plants: raw milk is only heat -treated (pasteurised) for packaging and for
further processing.

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31/34 2. Standardisation plants: heat treated and standardise chemical composition of raw milk
for packaging and further processing.
3. Milk processing plants: heat -treated and processing of raw milk for production of
different milk products.

III. REZULTATE ȘI DISCUTII

III. 1 MATERIAL ȘI M ETODĂ

The study to be presented focuses on raw cow milk produceing farms. The emphasis in this
study was laid on small farms from Hungary (having 1 -20 cows).

III.1.2. Metode

III.2. REZULTATE

During the past few decades, food safety related events: infections, intoxications,
adulterations in connection with food have occurred more frequently throughout the whole
world. Previously, ensuring food safety was a governmental duty, carried out by a

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32/34 controlling apparatus assigned by the state. The controlling process mainly comprised on –
site inspections and laboratory analyses based on sampling.

BIBLIOGRAFIE

1. A manual of good practices in food quality management .Concepts and Pra ctical
Approaches in Agrifood Sectors , Mr. Iain C. Muse, CEO/Chairman, EMonument and
USAMV -CN
2. Quality Enhancement in Food .Processing Through HACCP(Hazard Analysis and
Critical Control Point) ; 2005 Asian Productivity Organization Tokyo
3. Bra dford M., 1976, A rapid and sensitive method for the quantitation of
microgram quantities of protein utilizing the principle of protein -dye binding, Anal.
Biochem. 72:248 -54
4. Bovine whey proteins – Overview on their main biological properties. Ana R.
Madureira, Cla´udia I. Pereira, Ana M.P. Gomes, Manuela E. Pintado, F. Xavier Malcata
*Escola Superior de Biotecnologia, Rua Dr. Anto´ nio Bernardino de Almeida, P -4200 -072
Porto, Portugal
5. Camelia Guș, 1998, Controlul calității laptelui și a produselor lactate, Ed.
Risoprint, Cluj Napoca
6. Camelia Guș, 2002, Laptele și produsele lactate, Ed. Risoprint, Cluj Napoca
7. Camelia Guș, 2005, Laptele și produsele lactate, Ediția a II -a, Ed. R isoprint, Cluj
Napoca
8. Camelia Guș, AnaMaria Cristina Semeniuc, 2010, Stabilirea calității laptelui și a
produselor lactate, Ediția a II -a, Ed. Risoprint, Cluj Napoca
9. Constantin Banu, Camelia Vizireanu, 1998 Procesarea industrială a laptelui, Ed.
Tehnică, București
10. Constantin Banu, 2007, Tratat de inginerie alimentară, Ed. Agir, București

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33/34 11.Logistics and Supply Chains in Agriculture and Food, Girma Gebresenbet and
Techane Bosona, Department of Energy and Technology, Swedish Univers ity of
Agricultural Sciences, Uppsala Sweden
12. Froman B., "Manualul calit atii: instrument strategic al abord arii calit atii",
Editura Tehnic a, Bucure rti, 1998.
13. Dorin Țibulcă, Mirela AnaMaria Jimborean, 2008, Tehnologia de obținere a
produse lor lactate, Ed. Risoprint, Cluj Napoca
14. Gheorghe Georgescu, 2000, Laptele și produsele lactate, Ed. Ceres, București
15. Ilarie Ivan și colab., 2007, Tehnologia prelucrării produselor agroalimentare,
Ed. U.T.Press, Cluj Napoca
16. Marius Giorgi Ustu roi, 2007, Tehnologia laptelui și a produ selor derivate, Ed.
Alfa, Iași
17. Gheorghe Stețca, Pop Anamaria, Nicolae M ocuța , Strategii de management
privind calitatea alimentelor, Editura R isoprint Cluj-Nnapoca, 2012
18. Vasile Stănescu, S. Apost u, 2010, Igiena, inspecția și siguranța alimentelor de
origine animală ”Practicum”, Ed. Risoprint, Cluj Napoca
19. European network for hygienic manufacturing of food (www.ehedg.org )
20. Ministry of Agriculture and Rural Development Department of Food Industry.
Act LXXXII of 2003 on Food. June, 2004. http://www.fvm.hu/doc/upload/200412/act
on_food.pdf

• Bibliografia tezei va conține cel puțin 30 de titluri

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34/34 ANEXA 1

DECLARAȚIE PE PR OPRIE RĂSPUNDERE, PR IVIND ORIGINALITATEA
LUCRĂRII ȘI RESPECTA REA DREPTURILOR DE A UTOR

Subsemnatul/ subsemnata…………….…………………………, student(ă) la
Universitatea de Stiințe Agricole si Medicină Veterinară Cluj -Napoca, Facultatea de Știința
și Tehnologia Aliment ului, Programul de Master
….………………………………………… declar pe propria răspundere, cunoscând
prevederile art. 292 Cod Penal, privind falsul în declarații, că lucrarea de disertație cu
titlul……………………………. …………………………………………………… ……………………………
…………… ………………… …………………………………………………………………..
……… ………………………………………… …………………………………………………………….
………………………………………….………………………………………………………………
nu este un p lagiat, fiind rezultatul cercetărilor proprii efectuate în acest sens.
Lucrarea este elaborată de mine si nu a mai fost prezentată niciodată la o altă
facultate sau instituție de învățământ superior din țară sau străinătate.
De asemenea, declar că toate su rsele bibliografice utilizate, inclusiv cele consultate
pe Internet sau din jurnale el ectronice, sunt menționate detaliat în lista bibliografică, cu
respectarea regulilor de evitare a plagiatului, respectiv:
 toate fragmentele de text reproduse exact, chiar si în traducere proprie din altă
limbă dețin referința precisă a sursei;
 reformularea în cuvinte proprii a textelor scrise de către alți autori este menționată
cu referința corespunzătoare în textul lucrării;
 rezumarea ideilor altor autori este specificat ă cu referința la textul original al
articolului sau manualului consultat.
Prin prezenta Declarație confirm că am luat la cunostință faptul că, în cazul în
care se va dovedi cu probe concrete că lucrarea a fost plagiată, voi fi exmatriculat(ă) din
examenul de disertație .

Cluj-Napoca Absolvent ,
Data………………… _________________________
(semnătura în original)