Project Report HACCP

RPF-III
Development of HACCP procedures for the production of soy based

foods and their evaluation
Project No: 583

ICAR Code: PI-2007/6-IAE.Q00 Institute Code: CIAE/PHT/SPU/2007-6
Period: April 2007 to March 2009
Dr.A.P.Gandhi
Principal Scientist (Biochemistry)
Soybean Processing and Utilization Center

Central Institute of Agricultural Engineering
Nabi Bagh, Berasia Road
Bhopal-462038 (MP)
1
RPF-III
1. Project No: 583
2. Institute Code No: CIAE/PHT/SPU/2007-6
3. ICAR Code No: PI-2007/6-IAE.Q00
4. Name and address of the Research Institute:
Central Institute of Agricultural Engineering, Bhopal.
5 Title of the project:

Development of HACCP procedures for the production of Soy based
foods and their evaluation.
6. Title of the sub project: Nil
7. Name and designation of the leader: Dr. A.P. Gandhi

Principal Scientist (Biochemistry)
8 Name(s) and designation(s)
Project Leader and associate(s)
together with time proposed
to be spent and work to be done
Sl. No Name Designation Time to Work to be done

be spent
1 Dr.A. P.Gandhi Principal 25% Drafting of
Scientist process flow
(Biochemistry) sheets, preparation
of HACCP charts,
evaluation of
production
processes and
report writing.
9. Location of the research project with complete address:
Soybean Processing and Utilization Center, Central Institute of Agricultural

Engineering, Bhopal.
10. (a) Objectives:

i. To develop HACCP procedures for the production of different
soy based foods.
2
ii. To test the developed procedures with a few soy-based foods
such as full fat soy flour, soy milk, soy paneer (tofu), soy nuts and
soy sprouts.
iii. To document the developed procedures and final report writing.
(b). Practical utility

All the aspects of food quality and safety through out each stage of food production,
storage, and transportation, processing and marketing are very important. Hence food
quality and safety assurance programmes include specific food risk control procedures
such as Hazard Analysis and Critical Control Point (HACCP). HACCP systems can only
be effective when they are a part of a broader food quality and safety programme based
on the General Principles of Food Hygiene and Good Manufacturing Practices. HACCP
has become synonymous with food safety. It is now recognized world wide a systematic
and preventive approach that addresses biological, chemical and physical hazards through
anticipation and prevention, rather than through end-product inspection and testing.
These controls are internationally recognized as essential to ensuring the safety and
suitability of food for human consumption and international trade. However such
HACCP procedures are not available for soy based foods which are getting importance
now days. Hence there is a need to develop these action plans for all the soy foods. In the
present investigation, efforts will be made to draft HACCP procedures for different soy
based foods.
11. (a). Technical program

The drafting of procedures include the identification of hazards and control measures,
determination of critical control points, preparing the decision tree, establishing the
critical limits and marketing procedures, finding the corrective action, responsibilities and
verification procedures and preparation of HACCP chart documentation and record
keeping for the soy based foods.
Flour (Full fat soy flour and medium fat soy flour).
Soymilk and analogs (Soymilk (Plain) and, Soy paneer)
3
Fermented foods (Tempeh and soy sauce)
Bakery products (Cookies and bread)
Soy nuts
Soy sprouts
Soy protein isolates
(b). Observations to be recorded:
Protocols of HACCP for identified critical controls, product quality assessment and
comparison with the traditional processes using the standard procedures.
12 Date of start April 2007
13. Date of completion March 2009
14 Final report of the Project
4
14.1 Review of literature
5
About 840 million people were undernourished and 799 millions were from the
developing countries. In India 233.3 millions were under nourished comprising about
24% of the total population (FAO, 2002). Hence there is every need to save millions of
lives every year. This can be combated through dietary diversity and food fortification
along with supplements. In this context soybean (Glycine max M) with 40% protein and
20% fat assumes the most predominant position in solving the nutritional imbalances
prevailing. It not only provides the quality macronutrients but also various other
micronutrients, which are otherwise required to fight against the hidden hunger.
Efforts are being made to popularize various soy-based foods besides the oil, which is
very popular in India. In India about 9.3 million tones of soybeans are produced annually
and 80% is utilized for oil extraction. Only 10% is available for direct food uses (Gandhi,
2006). The extruded soy chunks are very popular but too expensive and beyond the reach
of a common man. Among various foods full fat soy flour is having a
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great potential, as it can be prepared at domestic level using the assets available. Simple
methods were developed and scaled up for the production of a number of soy-based
products by the investigator. Now with the introduction of food quality and safety
systems HACCP has become synonymous with food safety. (FAO 1995). It is a world
wide recognized systematic and preventive approach that addresses biological, chemical
and physical hazards through anticipation and prevention rather than through end-product
inspection and testing. Prior to application of HACCP the production of soy based should
be according to Codex General Principles of Food Hygiene, the appropriate Codex Codes
of practice and appropriate food safety legislation. Management commitment is necessary
for implementation of an effective HACCP system.
Hazard Analysis Critical Control Point: The very beginning
The HACCP as it applies to food is considered to be a food safety management system
using the approach of controlling critical points in food handling to prevent food safety
problems. It is a system, which can be used to assure food safety at all levels of food
handling, and is an important element in the overall management of food quality and
safety more commonly referred to as Good Manufacturing Practices (GMP). The HACCP
concept was developed in late 1960s as a quality assurance system to enhance food
safety. The basic principles underlying the concept were not new, but the introduction of
HACCP signaled a shift in emphasis from resource intensive end product inspection and
testing to preventive control of hazards at all stages of food production. HACCP was
initially developed by the food industry for use by food processors to prevent or control
hazards, there by improving food safety. The application of HACCP system has been
evolving and expanding to form a basis for official food control and for establishing food
safety standards for the international trade as well. HACCP is considered to be one of the
most effective ways to enhance food safety. Recognizing the importance HACCP to Food
Control, the twentieth session of the codex Alimentarius Commission (CAC) held in
Geneva 28 June to July 1993, adopted “Guidelines for the application of the Hazard
Analysis Critical Control Point (HACCP) System.
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The food industry has traditionally ensured the quality of its products by employing the
inspection and test methods managed under the banners of quality assurance and quality
control. The evolution of food industry and the explosion of food poisoning out breaks
made apparent and imperative the need for improved and more exhaustive controls over
quality and safety. The need for a systematic approach to the production of food that
meets the criteria of quality, safety and wholesome ness were addressed by the
development of the ISO 9000 series and the HACCP system (Barendsz, 1998). The
Pillsbury Corporation, with the participation of NASA and the US Army Natick
Laboratories, first introduced the concept of the HACCP system in USA in 1959. The
main stimulus for devising the HACCP system was the development of a preventive
system for the production of foods with a high degree of safety, which is extremely
crucial for a space mission (Pieson and Corlett, 1992).
Principles of the HACCP system
The HACCP consists of seven principles namely conducting a hazard analysis,
determining the critical control points, establishing critical limit(s), identifying a system
to monitor control of CCP, proposing the corrective action to be taken when monitoring
indicates that a particular CCP is not under control, finding procedures for verification to
confirm that the HACCP system is working effectively and finally put forth
documentation concerning all procedures and records appropriate to these principles and
their application. It enables the industry to establish a close relationship with consumers,
which eventually contributes to the improvement of food quality and deals with
legislative problems related to the internal quality standards of a firm (Arvanitoyannins
and Hadjicostas, 2001).
How ever prior to HACCP implementation it often proved very advantageous that
several prerequisite programs, such as Total Quality Management (TQM), ISO 9000/
ASQ 9000 and BS 5750 and Good Manufacturing Practice (GMP) had already been in
place. TQM is the most comprehensive approach towards improving competitiveness,
effectiveness and flexibility through planning, organizing and understanding each activity
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at each level. On several occasions, TQM can comprise ISO 9000.ASQ 9000, which
include management responsibility, design and document control, purchasing,
identification, checking incoming materials, intermediate products and end products, non
conforming products, quality records, audits and reviews, training, servicing and
statistical techniques (Oakland, 1993; Ishikawa, 1989; Jouve, 1998).
The problems that might appear in the food industry are caused by several factors
such as the low quality raw, packaging and other materials used in the food processes,
inappropriate methods adopted in the food production such as measurement systems,
inadequate and/or unacceptable environmental conditions (contaminated or polluted
environment)(Bonnel, 1994). The topic that became the subject of a long debate,
especially recently, is the exact definition of the term quality. Many different aspects were
put forward, ranging from consumer related statements to sensory definitions, concluding
that the meaning of quality varies according to the group of people asked. However, it is
realistic to define it as the measurement of whether a product meets the consumers’
expectations.
HACCP has been evolving through the last four decades. In 1971, the system was
outlined for the first time, further elaborated by ICMSF in publications for WHO and
finally published in a book in 1988(Huss, 1992). In general HACCP system is a new
preventive approach to food control to be tailored for each specific case. HACCP focuses
only on the necessary things required from the plant management to be more concerned
with the process rather than the finished product and it requires study and investigation. It
cannot be emphasized often enough that any avoidable contamination of raw products un
necessarily increases the severity of processing and annihilates all previous efforts.
Therefore the prevention of contamination referred as sanitation is essential at all stages.
However like any other system HACCP has some vulnerable points and they may be the
major drawbacks for its non-international during recent years. A brief description of some
of the suspicious areas of the HACCP concept is the following:
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• Non uniform understanding of HACCP both nationally and internationally due to
lack of an internationally accepted definition of the system.
• Disagreement among the different Institutions about what constitutes the hazard.
• Need for implementing HACCP through out the whole production process from
raw material to consumption.
• Need for establishing the mutual trust between the government and the industry.
• Lack of coordination among the responsible authorities, public and private
sectors.
• Regulations and procedures that are not very fruitful.
• Insufficient education and motivation of consumers and food handlers on food
protection task.
• It has been shown in several cases that the appropriate implementation of HACCP
is quite lengthy procedure.
• Efficiency of the system is frequently low, due to lack of political will and
commitment, un willingness of industry representatives and over lapping of
several institutions.
On the other hand HACCP becomes increasingly appealing considering that industry
can acquire many benefits from implementation, such as productivity increase, waste
decrease, developing a responsible personnel and motivating raw material suppliers to
comply with sanitary measures. Food safety in today’s’ world is paramount. HACCP
programmes go a long way to ensuring this. We rely on food to nourish and sustain us.
We want food that is appealing and pleasurable to eat. We need food that will not cause
us injury or illness or severe cases cause death. There are members of our community-
the young, the not so young, the immunocompromised and those who are susceptible to
allergies and intolerances that rely on us in the food industry to supply them with safe
food. May our efforts be not in vain as we meet this responsibility each day?
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PRINCIPLES OF THE HACCP SYSTEM
The HACCP system consists of the following seven principles:
PRINCIPLE 1
Conduct a hazard analysis.
PRINCIPLE 2
Determine the Critical Control Points (CCPs).
PRINCIPLE 3
Establish critical limit(s).
PRINCIPLE 4
Establish a system to monitor control of the CCP.
PRINCIPLE 5
Establish the corrective action to be taken when monitoring indicates that a particular
CCP is not under control.
PRINCIPLE 6
Establish procedures for verification to confirm that the HACCP system is working
effectively.
PRINCIPLE 7
Establish documentation concerning all procedures and records appropriate to these

principles and their application.
GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM
Prior to application of HACCP to any sector of the food chain, that sector should be
operating according to the Codex General Principles of Food Hygiene, the appropriate
Codex Codes of Practice, and appropriate food safety legislation. Management
commitment is necessary for implementation of an effective HACCP system. During
hazard identification, evaluation, and subsequent operations in designing and applying
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HACCP systems, consideration must be given to the impact of raw materials, ingredients,
food manufacturing practices, role of manufacturing processes to control hazards, likely
end-use of the product, categories of consumers of concern, and epidemiological
evidence relative to food safety.
The intent of the HACCP system is to focus control at CCPs. Redesign of the operation
should be considered if a hazard, which must be controlled, is identified but no CCPs are
found. HACCP should be applied to each specific operation separately. CCPs identified
in any given example in any Codex Code of Hygienic Practice might not be the only ones
identified for a specific application or might be of a different nature. The HACCP
application should be reviewed and necessary changes made when any modification is
made in the product, process, or any step. It is important when applying HACCP to be
flexible where appropriate, given the context of the application taking into account the
nature and the size of the operation.
APPLICATION
The application of HACCP principles consists of the following tasks as identified in the
Logic Sequence for Application of HACCP (Figure 1).
1. Assemble HACCP team
The food operation should assure that the appropriate product specific knowledge and
expertise is available for the development of an effective HACCP plan. Optimally, this
may be accomplished by assembling a multidisciplinary team. Where such expertise is
not available on site, expert advice should be obtained from other sources. The scope of
the HACCP plan should be identified. The scope should describe which segment of the
food chain is involved and the general classes of hazards to be addressed (e.g. does it
cover all classes of hazards or only selected classes).
2. Describe product
A full description of the product should be drawn up, including relevant safety
information such as: composition, physical/chemical structure (including Aw, pH, etc.),
microcidal/static treatments (heat-treatment, freezing, brining, smoking, etc.), packaging,
durability and storage conditions and method of distribution.
3. Identify intended use
The intended use should be based on the expected uses of the product by the end user or
consumer. In specific cases, vulnerable groups of the population, e.g. institutional
feeding, may have to be considered.
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4. Construct flow diagram
The HACCP team should construct the flow diagram. The flow diagram should cover all
steps in the operation. When applying HACCP to a given operation, consideration should
be given to steps preceding and following the specified operation.
5. On-site confirmation of flow diagram
The HACCP team should confirm the processing operation against the flow diagram
during all stages and hours of operation and amend the flow diagram where appropriate.
6. List all potential hazards associated with each step, conduct a hazard analysis, and
consider any measures to control identified hazards. (SEE PRINCIPLE 1)
The HACCP team should list all of the hazards that may be reasonably expected to occur
at each step from primary production, processing, manufacture, and distribution until the
point of consumption. The HACCP team should next conduct a hazard analysis to
identify for the HACCP plan, which hazards are of such a nature that their elimination or
reduction to acceptable levels is essential to the production of a safe food.
In conducting the hazard analysis, wherever possible the following should be included:
• the likely occurrence of hazards and severity of their adverse health effects;
• the qualitative and/or quantitative evaluation of the presence of hazards;
• survival or multiplication of microorganisms of concern;
• production or persistence in foods of toxins, chemicals or physical agents; and,
• conditions leading to the above.
The HACCP team must then consider what control measures, if any, exist which can be
applied for each hazard. More than one control measure may be required to control a
specific hazard(s) and more than one hazard may be controlled by a specified control
measure.
7. Determine Critical Control Points (SEE PRINCIPLE 2)
There may be more than one CCP at which control is applied to address the same hazard.
The determination of a CCP in the HACCP system can be facilitated by the application of
a decision tree (Figure 2), which indicates a logic reasoning approach. Application of a
decision tree should be flexible, given whether the operation is for production, slaughter,
processing, storage, distribution or other. It should be used for guidance when
determining CCPs. This example of a decision tree may not be applicable to all
situations. Other approaches may be used. Training in the application of the decision tree
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is recommended. If a hazard has been identified at a step where control is necessary for
safety, and no control measure exists at that step, or any other, then the product or process
should be modified at that step, or at any earlier or later stage, to include a control
measure.
8. Establish critical limits for each CCP (SEE PRINCIPLE 3)
Critical limits must be specified and validated if possible for each Critical Control Point.
In some cases more than one critical limit will be elaborated at a particular step. Criteria
often used include measurements of temperature, time, moisture level, pH, Aw, available
chlorine, and sensory parameters such as visual appearance and texture.
9. Establish a monitoring system for each CCP (SEE PRINCIPLE 4)
Monitoring is the scheduled measurement or observation of a CCP relative to its critical

limits. The monitoring procedures must be able to detect loss of control at the CCP.
Further, monitoring should ideally provide this information in time to make adjustments
to ensure control of the process to prevent violating the critical limits. Where possible,
process adjustments should be made when monitoring results indicate a trend towards
loss of control at a CCP. The adjustments should be taken before a deviation occurs. A
designated person with knowledge and authority to carry out corrective actions when
indicated must evaluate data derived from monitoring. If monitoring is not continuous,
then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in
control. Most monitoring procedures for CCPs will need to be done rapidly because they
relate to on-line processes and there will not be time for lengthy analytical testing.
Physical and chemical measurements are often preferred to microbiological testing
because they may be done rapidly and can often indicate the microbiological control of
the product. All records and documents associated with monitoring CCPs must be signed
by the person(s) doing the monitoring and by a responsible reviewing official(s) of the
company.
10. Establish corrective actions (SEE PRINCIPLE 5)
Specific corrective actions must be developed for each CCP in the HACCP system in
order to deal with deviations when they occur. The actions must ensure that the CCP has
been brought under control. Actions taken must also include proper disposition of the
affected product. Deviation and product disposition procedures must be documented in
the HACCP record keeping.
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11. Establish verification procedures (SEE PRINCIPLE 6)
Establish procedures for verification. Verification and auditing methods, procedures and
tests, including random sampling and analysis, can be used to determine if the HACCP
system is working correctly. The frequency of verification should be sufficient to confirm
that the HACCP system is working effectively. Examples of verification activities
include:
• Review of the HACCP system and its records;

• Review of deviations and product dispositions;
• Confirmation that CCPs are kept under control. Where possible, validation
activities should include actions to confirm the efficacy of all elements of the
HACCP plan.
12. Establish Documentation and Record Keeping (SEE PRINCIPLE 7)
Efficient and accurate record keeping is essential to the application of a HACCP system.
HACCP procedures should be documented. Documentation and record keeping should be
appropriate to the nature and size of the operation.
Documentation examples are:
• Hazard analysis;
• CCP determination;
• Critical limit determination.
Record examples are:
• CCP monitoring activities;

• Deviations and associated corrective actions;
• Modifications to the HACCP system.
(Figure 3)
TRAINING
Training of personnel in industry, government and academia in HACCP principles and

applications, and increasing awareness of consumers are essential elements for the
effective implementation of HACCP. As an aid in developing specific training to support
a HACCP plan, working instructions and procedures should be developed which define
the tasks of the operating personnel to be stationed at each Critical Control Point.
Cooperation between primary producer, industry, trade groups, consumer organizations,
15
and responsible authorities are of vital importance. Opportunities should be provided for
the joint training of industry and control authorities to encourage and maintain a
continuous dialogue and create a climate of understanding in the practical application of
HACCP.
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Figure-1 LOGIC SEQUENCE FOR THE APPLICATION OF HACCP
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Figure 3. A HACCP WORKSHEET
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14.2 MATERIALS AND METHODS
The soybean variety JS 335 was obtained from the Institute Farm. It was cleaned
thoroughly and made free from all the dirt, stubbles and other foreign matter. It was
stored in airtight containers till further use. Various soy-based foods were prepared using
the procedures developed by the investigator at this Center since 1979.AOAC (1990)
methods were used for analyzing various chemical constituents and APHA (1984)
recommended methods were used for microbiological examination of the products. All
the chemicals used were of the analytical grade and the experiments were conducted in
triplicate and the mean values were computed for assessment. FAO/WHO (2006)
guidelines were used for the preparation of HACCP plans.
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SOY BASED FOODS
21
15. RESULTS AND DISCUSSION
The HACCP protocols were prepared for making various soy based foods and the details
were as under:
Full Fat Soy flour:
Table 1.Product description
1. Product name Full Fat Soy flour

2. Important product characteristics of end Aw < 0.5;FFA < 1%; Total microbial counts
product < 50000/g
3. How the product is to be used Normally fortified with other
cereals/millets/pulses at 10-15% level in
the preparation of traditional recipes.
4. Packaging Sealed polythene bags/ hermetically sealed
metal containers.
5. Shelf-life One month at normal retail shelf
temperatures.
6. Where the product will be sold Retail, institutions and food service. Could
be consumed as a health food.
7. Labeling instructions Required to ensure product safety.
8. Special distribution control No physical damage, excess humidity or
temperature extremes.
Full Fat Soy flour
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Figure-1
Plant Schematic/Floor Plan
Wet Processing Area Dry Processing Area

Preparatory Area
Dryers
Silos/Storage Bins
Soaking in vats
Cleaners
Milling
Equipment
Blanching
Dehuller
Sifters
Retorts/Boilers
Filling/Weighing/Sealing
Transport
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Hazard identification:
Biological Hazards
Food borne biological hazards include microorganisms such as bacteria, viruses, fungi
and parasites. These organisms are commonly associated with humans and with raw
products entering the food establishment. Many of these microorganisms occur naturally
in the environment where foods are grown. Most are killed or inactivated by cooking and
numbers can be minimized by adequate control of handling and storage practices
(hygiene, temperature and time). Pathogenic bacteria cause the majority of reported food
borne disease outbreaks. A certain level of these organisms can be expected with raw
soybeans. Improper storage and handling can contribute to a significant increase in the
level of these microorganisms. Viruses can be food borne, water borne or transmitted to
food by human, animal or other contact. Unlike bacteria, viruses are unable to reproduce
outside a living cell. They cannot therefore replicate in food, and can only be carried by
it. Fungi include moulds and yeasts. Fungi can be beneficial as they can be used in the
production of certain foods (e.g. cheese). However some fungi produce toxic substances
(mycotoxins), which are toxic for humans and animals.
Examples
Bacteria (spore forming) Viruses
Clostridium botulinum Hepatitis A and E
Clostridium perfrigens Norwalk virus group
Bacillus cereus Rotavirus
Bacteria (non spore forming) Protozoa and parasites

Brucella abortis Cryptosporidium parvum
Brucella suis Diphyllobothrium latum
Campylobacter spp Entamoeba histolytica
Pathogenic Escherichia coli Giardia lamblia
Listeria monocytogenes Ascaris lumbricoides
Salmonella spp (S.typhimurium, S.enteriditis) Taenia solium
Shigella (S.dysenteriae) Taenia saginata
Staphylococcus aureus Trichinella spiralis
Streptococcus pyogenes
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Vibrio cholerae
Vibrio parahaemolyticus
Vibrio vulnificus
Yersinia enterocolitica
Chemical hazards
Chemical contaminants in food may be naturally occurring or may be added during the
processing of food. Harmful chemicals at high levels have been associated with acute
cases of food borne illnesses and can be responsible for chronic illness at lower levels.
Examples:
Naturally occurring chemicals
Allergens
Mycotoxins
Added chemicals Toxic elements and compounds
Polychlorinated biphenyls (PCBs) Lead
Agricultural chemicals Zinc
• Pesticides Cadmium
• Fertilizers Mercury
• Antibiotics Arsenic
• Growth hormones Cyanide
Prohibited substances Food additives
• Direct Vitamins and minerals
• Indirect Contaminants
o Water or steam treatment
chemicals
o Pest control chemicals
From packaging materials

Plasticizers
Vinyl chloride
Printing/coding inks
Adhesives
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Physical hazards
The physical hazards can result from contamination and / or poor practices at many
points in the food chain from harvest to consumer including those with in the food
establishment.
Examples
Glass, wood, stones, metal, plastic etc.
Table 2.Product ingredients and incoming material
Raw material Packaging material Dry ingredients

Soybeans B, C, P Polythene bags B, C, P Sodium bicarbonate B, C, P
Other
Water (municipal) B, C
Table 3.Flow diagram
Soybeans Packaging material Dry ingredients Water

1. Receiving P 2.Receiving P 3. Receiving P 4. In taking
5.Storing B P 6.Storing B C P 7. Storing B C P
8. Cleaning P 9.Inspecting B P 10. Dumping
11. De hulling P
12. Soaking B C 13. Chlorinating
14. Blanching B C
15.Drying B P C
16. Milling B P C 17.Filling C P
18.Weighing B
19.Closing/sealing B
20.Inspecting B P
21. Labeling B
22. Storing B
23.TransportB
P=physical; B=biological; C=chemical
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HAZARD IDENTIFICATION: BIOLOGICAL HAZARDS
Identified Biological Hazards
Ingredients/materials:
Soybeans
- could contain soil borne/ air borne pathogenic organisms, yeasts or
moulds.
Dry ingredients
- could contain microbial contaminants.
- could contain rodent excrements.
Water
- could contain microorganisms
Packaging materials
- could contain defects that could result in leakage.
Processing steps:
Dehulling
- could be contaminated with microorganisms.
Soaking
- could contain microorganisms.
Blanching
- could contain heat resistant spores.
Drying
Weighing
- overfilling may lead to leakage and prone to contamination.
Transport
- physical damage to packages results in leakage and contamination of
product.
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HAZARD IDENTIFICATION: CHEMICAL HAZARDS
Identified Chemical Hazards
Soybeans
- could contain pesticide residues.
- could contain mycotoxins.
Water
- could be contaminated with toxic substances.
Processing steps:
Dry ingredients storage

- could be contaminated with non-food chemicals as a result of improper
storage.
Blanching
- cleaning chemical residues could contaminate the beans.
- if live steam is used, boiled water additives could carry over and
contaminate the product.
HAZARD IDENTIFICATION: PHYSICAL HAZARDS

Identified Physical Hazards:
Ingredients/ materials
Soybeans
- could be contaminated with harmful extraneous materials namely glass,
metal, plastic, wool etc.
Dry ingredients
- could be contaminated with harmful extraneous materials
Soybean receiving
- inadequate protection against harmful extraneous material could result in

contamination.
Dry ingredient receiving
- in adequate protection against harmful extraneous material could result in

contamination.
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Table 4.CCP determination:
Process Category Q1 Q2 Q3 Q4 CCP

step/incoming and
materials identified
hazard
Soybeans B=Pathogens Yes Yes Yes Yes,
thermal
processing
C=Pesticides No
(farmers/growers
C= heat level-GPP)
stable toxins No
(farmers/growers
P= harmful level-GPP) Yes Yes No
extraneous
material Yes (visual
(HEM) inspection and
foreign object
removal)
Packaging B=pathogens Yes Yes Yes Yes,
materials sterilization
Dry B= bacterial Yes N/a Yes Yes,
ingredients as spores thermal
delivered processing
B=rodent
excretes
(GMP)
P=HEM
(GMP)
Water at B= GMP
intake C= heavy
metals &
other toxins
(GMP)
Instructions:
• Category and identified hazard: Controlled by Codex General Principles of Food
Hygiene, if yes indicate GMP and proceed to next hazard. If no proceed to
question 1.
• Q1: Do control preventive measures exist, if no, not CCP; if yes proceed to next.
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• Q2: Is this operation specifically designed to eliminate, if no proceed to Q3. if yes
CCP and identify it in the last column.
• Q3: Could contamination with identified hazards occur in excess of acceptable
levels, if no, not CCP. If yes Proceed to Q4.
• Q4: Will subsequent operation control the contamination levels, if no CCP; if yes
not CCP.

step/incoming and
hazard
Cleaning and P=GMP
grading of
soybeans
Dehulling of B Yes Yes Yes No CCP-1
soybeans (Hulls %)
Soaking of Water
soy splits (GMP)
Sodium bi
carbonates
(0.5%)
Blanching in B Yes Yes Yes No CCP-2
water C (time and
temperature
of water)
Drying B Yes Yes Yes No CCP-3
C (Moisture
content and
time
allowed for
drying)
Attrition B (GMP)
Sifting P (GMP)
Filling P (GMP)
Weighing P (GMP)
Packaging and B Yes Yes Yes No CCP-4
sealing (Proper
gauge and
sealing
30
clearance)
Instructions:
question 1.
not CCP.
Table 5.Unaddressed Hazards:
Product: Full Fat Soy flour
Unaddressed hazard from previous list Identified methods of addressing the
hazard
Soybeans could contain pesticide residues Up stream (farm level) programs such as
A: Training persons who apply pesticides.
B: Purchasing registered pesticides for
growers.
C: Auditing growers application of
pesticides and records there of.
D: Requiring periodic pesticide residual
analysis reports.
31
Table 6.HACCP Plan
Product name: Full Fat Soy Flour

Process step Hazard Critical Monitoring Deviation HACCP
description limits procedure procedures records
De hulling Inefficient de Less than On line Line Operator
hulling may 0.1% check of the operator to log book
cause the sample. adjust the
contamination clearance of
of the product the de
with the huller
microorganisms. drums.
Blanching/cooking In adequate heat Cook the Check the Operator Operator
treatment splits as quality of should logbook.
specified in splits for adjust the
the scheduled urease test time and
process temperature
(under as per the
pressure/open authorized
vessel contingency
boiling) plan and to
inform the
QC.
Drying Improper drying The moisture Check the If moisture Operators
(Sun/mechanical) content moisture content is log book.
should be less content as greater the
than 8%- per the splits may
10%. guidelines. be dried
again and
inform QC
Packaging and Over filling, Max fill On line Line Operators
sealing improper gauge weight as check to operator to log book
polythene and specified in reject over adjust the and
improper the scheduled and under settings. quality
sealing process. filled bags control
Proper and report.
sealing improperly
leaving sealed bags.
recommended
space.
32
Table 7.HACCP for general activities:
Stage Activity Control activity

Raw material harvest Liaison with the farmers for Specifications of grain
unit operations like quality are required.
harvesting, threshing and Rejection of under sized
winnowing. seeds.
Raw material transport Transport in sacks to drying Correct sacking and
area. handling.
Raw material inspection Sampling and routine Correct sampling methods,
inspection. training and inspection
methods.
Preparation of seeds Cleaning, grading, Training operators for
dehulling, conditioning and equipment, preventing
blending. insect infestations, check for
moisture content.
Milling and sieving, Separation of components Training in hygiene,
dehulling and expelling of seeds implementation of cleaning,
and assessment of product
quality.
Packaging Filling in to containers and Establish specifications for
sealing. labels and fill weights.
33
Description of full fat soy flour manufacturing process: Implementation of HACCP.
Receiving soybeans (CCP-1): Soybeans must come from approved dealers. At the time
of its receipt it must be accompanied with its complete quality certificate and
microbiological assessment reports. The certificates should indicate the moisture content
of the beans, degree of foreign materials and the microorganisms present (number of
colonies), insects etc as compared to the upper approved standards of BIS/ISO. At the
time of receipt, visual control of soybeans must be carried out to find out the
contaminants if any. Further more the proximate composition of the beans must be
established with reference to its macro and micronutrients. Defective beans mean that the
soy flour will be most likely unsafe for the consumption.
Storage of soybeans in silos (CCP-4): The temperature (<20oC) and the relative
humidity (<65%) during the storage must be low. They should be recorded at regular
intervals. If any deviation from the safer limits, must be immediately rectified. When
soybean is stored for a long period, microbiological analysis should be carried out.
Receiving secondary materials (greasing, detergents, insecticides, pesticides and
sacs) (CCP-2): These materials must be procured from the approved suppliers with
quality certificates. These materials must be suitable for using them with food items. No
contamination must come from the packaging materials. If these materials do not comply
with the standard specifications, must be returned to the suppliers and a new order should
be placed with other suppliers.
Storage of secondary materials (CCP-3): The temperature and relative humidity during
storage must be below 20oC and 65% respectively. The place should be air-conditioned.
The temperature and RH should be continuously recorded and corrective actions must be
undertaken whenever any deviation occurs.
Application of anti insect methods (CCP-5): Any chemicals used during storage along
with the soybeans should comply with the safety legislations. The quantity should be with
in the prescribed concentrations.
Cleaning & grading of soybeans (CCP-6): All the physical contaminants should be
removed. They should be graded. Only sound soybeans should be taken for processing.
34
Removal of stones: The stones, metals and dust must be removed from the soybeans so
that the final product will comply the quality standards as prescribed by BIS/ISO.
Weighing: the soybeans are weighed and passed through a magnetic system so that the
magnetic materials are removed.
Milling (CCP-7): The grinding is done in a burr/hammer mill. The clearance between the
burrs should be adjusted so that the flour must be having particle size <140 micrometers.
Similarly with the hammer mill, the sieve below the grinding system must allow flour
particles less than 140 micrometers. The sieves should be of SS. The temperature during
grinding should not rise too much, which affects the quality of the flour. Normally a
temperature rise of less than 5oC is desirable. So arrangements must be made to maintain
the temperature while grinding.
Packaging (CCP-8): During packaging the flour can possibly be contaminated with the
microorganisms causing quality deterioration. Hermetic sealing and upright position of
the packaging material can avoid this. There should not be any migration of the low
molecular weight substances from the packages. Further more contamination can take
place from foreign materials like insects and rodents that accidentally happen to be
packed with the flour. The personnel should comply with the GMPs.
Storage of full fat flour (CCP-9): Both the temperature and relative humidity must be
below 20oC and 65% respectively. They should be recorded and corrective actions must
be taken when deviating. When the flour is stored for a long period, microbiological
analysis is required.
Metal detector (CCP-10): The packed product passes through a metal detector. The
product is then checked for its weight and placed in boxes (secondary packaging). The
boxes are placed on the pallets and the packets are wrapped with film.
35
Table 8.Quality Standard Expected:
Composition:
Protein: a minimum of 35%
Fat: a minimum of 18%
Crude Fiber: a maximum of 4%
Ash: a maximum of 6.5%
Moisture: a maximum of 10%
Physical parameters:
Granulation: 90% minimum pass thru US sieve 200(0.074 mm)
Microbiology:
Total plate count: 20,000/g max
Total coli forms: 100/10g max
Salmonella: Negative/100g
E.coli: Negative/100g
Staphylococcus: 100/10g maximum
Yeast: 100/10g maximum
Mold: 100/10g max.
Protein solubility: PDI 20-80%
TI: less than 75% of original.
Urease activity: Nil
Available lysine: Min 5.5g/6g N
Sensory parameters:
Color: Creamy to yellow
Odor: Less beany
Taste: Nutty
Defects:
Insect parts: Total absence.
Foreign material: Total absence.
Black specks: Total absence.
36
Table 9. Quality assessment of the Full Fat Soy Flour
Quality standard expected With out HACCP With HACCP
Composition:
Protein:
a minimum of 35% 35% 40%
Fat:
Crude Fiber:
a maximum of 4% 5.2% 3.8%
Ash:
a maximum of 6.5% 5.4% 6.3%
Moisture:
a maximum of 10% 10% 8%
Granulation:
90% minimum pass 75% 95%
thru US sieve 200(0.074
mm)
Microbiology:
Total plate count:
20,000/g max 50,000/g 10,000/g
Total coli forms:
100/10g max 120/10g Nil
Salmonella:
Negative/100g 10/100g Nil
E.coli:
Staphylococcus:
100/10g maximum 135/10g Nil
Yeast:
Mold:
100/10g max. 123/10g Nil
Protein solubility:
PDI 20-80%
TI: 25% 75%
less than 75% of original.
Urease activity: 50% 80%
Nil
Available lysine: Min Nil Nil
37
5.5g/6g N 4.2g/6gN 6.2g/6gN
Sensory parameters:
Color:
Creamy to yellow
Odor: Yellow Creamy
Less beany
Taste: Beany Less beany
Nutty
Defects: Nutty Nutty
Insect parts:
Total absence.
Foreign material: Absent Absent
Total absence.
Absent Absent
38
Medium Fat Soy Flour
Medium fat soy flour is made entirely from soybeans through extrusion cooking and expelling a
certain amount of oil from the extrudates. It is used as an important ingredient and supplement to
cereal products (wheat/corn/rice). It can be used in a wide variety of products including bread,
weaning foods, cereals, cookies, muffins, cakes, pastas and others. It is currently being used world
wide by commercial processors. It is also a common ingredient in blended foods aid products. Soy
fortified wheat flour etc. It can also be fortified with various micronutrients and minerals.
Process Flow Chart for making MFSF

Soybeans, 10%mc
Cleaning dirt, foreign matter
Hulls De hulling CCP-1
Steam Preconditioning CCP-2
Splits with 40% mc
Extrusion expelling
(Temperature and time) CCP-3
Extrudate
Fed to mechanical expeller CCP-4

(clearance, time &no of passes)
Miscella Marc
Filtration Drying/air cooling CCP-5

(temperature &time)
Foots Filter oil Grinding CCP-6

(temp)
(ready for use)
Chemical Refining Sifting (size)
Refined oil MFSF
39
Weighing &filling
Packaging
Storage Distribution
Table 11Product description
1. Product name Medium Fat Soy flour

product < 50000/g, protein-min 45%, fat-min 6%
3. How the product is to be used Normally fortified with other
cereals/millets/pulses at 10-15% level in
the preparation of traditional recipes. In
chickpea flour and papad it can be added
up to 20-40% respectively.
4. Packaging Sealed polythene bags (HDPE 400
microns)/ hermetically sealed metal
containers.
5. Shelf-life Six months at normal retail shelf
temperatures and use with in a month after
opening the packet.
7. Labeling instructions Required to ensure product safety. It should
give all the nutritional information and the
ways to use it.
temperature extremes. Controlled
o
conditions of temperature (<25 C and RH
<13%)
40
Medium Fat Soy flour
Raw material Packaging material Secondary materials

Soybeans B, C, P Polythene bags B, C, P Greasing agents,
disinfactants, C, P
Other
Soybeans Packaging material Secondary materials Water

11. De hulling P
12. Extrusion cooking B C 13. Chlorinating
14. Expelling B C
15.Cooling/Drying B P C
16. Milling B P C 17.Filling C P
18.Weighing B
20.Inspecting B P
21. Labeling B
22. Storing B
23.TransportB
41
42
Extrusion cooking Area Dry Processing Area

Preparatory Area
Coolers/Dryers
Silos/Storage Bins
Extrusion cooking
Cleaners
Milling
Equipment
Thermo
plastic
Dehuller Extrudates
Sifters
Expeller
Grits
Crude oil Cake Filling/Weighing/Sealing
Refining
Transport
Consumption
Soybeans
moulds.
Secondary materials
Water
Packaging materials
- may contain low molecular weights compounds that may migrate.
Processing steps
Dehulling
Extrusion cooking
- cross contamination with microorganisms.
Expelling
Cooling/Drying
Weighing
Transport
product.
Soybeans
Water
Processing steps
Secondary materials/packaging materials storage

- improper storage may add to the release of chemicals.
Soybean storage
- improper storage may lead to the formation of toxins due to invasion of
microorganisms.

Soybeans
-could be contaminated with harmful extraneous materials namely glass,
Secondary materials
Soybean receiving

contamination.
Secondary materials receiving

contamination.
Table 14.CCP determination
Processing Category and Q1 Q2 Q3 Q4 CCP
step/incoming identified hazards no.
materials
Soybeans as B= Pathogens Yes, heat N/ Yes Yes C
delivered treatment A thermal CP-
processi 1
No, control is ng
C= Pesticides at
farms/grower
s
C= Heat stable No, control is
toxins at
farms/grower
s
Yes, visual Yes No
P=Harmful inspection &
Extraneous foreign object
Materials (HEM) removal
Water in take B= faecal

coliforms (GMPs)
C= heavy metals
and other toxic
chemicals(GMPs)
Soybean receiving P= HEM (GMPs)
Packaging C=Low m.w
materials compounds (Food
quality)
Filling C= cleaning
chemicals,
lubricants (GMPs)
P= Metal
fragments (GMPs)
Weighing B= products Yes, Yes Yes No
heavier than max weighing
fill weight in
scheduled process.
Extrusion B= non validated Yes, control Yes Yes No C
cooking/thermal process schedule critical CP6
processing could result in factors of
under processing scheduled
and survival of process.
pathogenic
microorganisms
(GMPs)
B= lack of
adherence to time,
temperature and
other critical
factors of
scheduled process
could result in
inadequate heat
treatment and
growth of
pathogens.
Expelling B= lack of Yes, control Yes Yes Yes C
adherence to time, critical CP7
speed and factors of
clearance & other scheduled
critical factors of process.
scheduled process
could result in
inadequate
expelling and
effect the quality of
the meal.
Cooling of B= insufficient or
expelled cake excessive cooling
could result in
thermophilic
spoilage or
contamination.
(GMPs)
Conveying/drying B= un clean wet
equipment could
lead to
contamination.
Milling P=HEM (GMPs)
Sieving P=HEM (GMPs)
Packing C= migration of
low molecular
weight substances
from packaging
materials (food
grade)
Labeling/storing B= Post process
contamination
because of
damaged packages
(GMPs)
B= Growth of
thermopiles
(GMPs)
Transportation B= Post process
contamination
because of
damaged packages
(GMPs/GFHPs)
Table 15.Unaddressed Hazards:

Product: Medium Fat Soy flour

hazard
growers.
analysis reports.
Description of medium fat soy flour manufacturing process: Implementation of

HACCP.
Extrusion (CCP 7): Conditioning of the grits with live steam is done prior to extrusion
cooking. The quality of water is very critical. The moisture content of the feed must be
20-25%wb). The temperature of the barrel must be 150-180oC to attain the thermoplastic
melt of the grits. The cooking time max 60 min.
Expelling (CCP 8): The extrudate is passed immediately to the expeller. The speed and
clearance of the rollers are very critical for getting maximum extraction efficiency.
Milling (CCP-9): The cake is ground. The grinding is done in a burr/hammer mill. The
clearance between the burrs should be adjusted so that the flour must be having particle
size <140 micrometers. Similarly with the hammer mill, the sieve below the grinding
system must allow flour particles less than 140 micrometers. The sieves should be of SS.
The temperature during grinding should not rise too much, which affects the quality of
the flour. Normally a temperature rise of less than 5 oC is desirable. So arrangements must
be made to maintain the temperature while grinding.
Packaging (CCP-10): During packaging the flour can possibly be contaminated with the
packed with the flour. The personnel should comply with the GMPs.
Storage of MFS flour (CCP-11): Both the temperature and relative humidity must be
be taken when deviating. When the flour is stored for a long period, microbiological
Composition:
Fat: a maximum of 7%
Crude Fiber: a maximum of 5 %
Ash: a maximum of 8%
Granulation: 90% minimum pass thru US sieve 200(0.074 mm)
Microbiology:
Mold: 100/10g max.
Protein solubility: PDI 20-80%
Sensory parameters:
Color: light brownish
Odor: Less beany
Taste: Nutty
Defects:
Table 17. Quality assessment of the Medium Fat Soy Flour

Composition:
Protein:
Fat:
Crude Fiber:
Ash:
a maximum of 8.0% 7.4% 6.0%
Moisture:
Granulation:
90% minimum pass 80% 95%
thru US sieve 200(0.074
mm)
Microbiology:
Total plate count:
20,000/g max 40,000/g 8,000/g
Total coli forms:
100/10g max 150/10g Nil
Salmonella:
Negative/100g 15/100g Negative
E.coli:
Staphylococcus:
Yeast:
Mold:
100/10g max. 130/10g Nil
Protein solubility:
PDI 20-80% 28% 80%
TI:
less than 75% of original. <60% <80%
Urease activity:
Nil Nil Nil
Available lysine:
Min 5.5g/6g N 5.2g/6gN 6.2g/6gN
Sensory parameters:
Color:
light brownish Brownish light brownish
Odor:
Less beany Beany Less beany
Taste:
Nutty Nutty Nutty
Defects:
Insect parts:
Total absence. Absent Absent
Foreign material:
Table 10.Synoptical presentation of hazards, critical control limits, observation procedures and control actions for the
production of Full Fat soy flour
Processing step Hazard description CClimit Observation procedures Responsible Monitoring procedures Corrective actions
Control of CCP Frequency
(CCP)
Receiving of soybean Presence of foreign material 5% Visual control of Per lot QAM Control of specifications Rejection of lot or change
(CCP-1) in soybean (P) sample/control and procure quality supplier
of the certificates from suppliers
certifications per Evaluation of supplier
lot
Growth of micro organism Absence “ “ “ “ “

(B)/insects
Fungi (B) Out of five Control of the “ “ “ “

samples two certificates per
of them 102- lot
4
10 .
Humidity
<13%
Protein
content 38-
40%
Other macro
and micro
nutrients
Receiving secondary Chemical substances Materials “ “ “ “ “
materials (greasing migrating from the suitable for
agents, detergents, secondary materials. food items.
insecticides, pesticides,
sacs etc (CCP-2)
Water Total Coli forms (B) In Lab control of Monthly QAM New drilling at greater New drilling
agreement water quality depths, chlorination of
with the water
community
legislation
80/778 for
potable
water (B)
Faeces Coli forms (B) “ “ “ “ “ “
Faeces Streptococcus (B) “ “ “ “ “ “
Sulphur reducing “ “ “ “ “ “
Clostridium (B)
Presence of undesirable and “ “ “ “ “ “
toxic substances in water
(eg. Heavy metals,
ammonia, hydrocarbons,
parasites, nitrate). Excessive
quantity of residual
chlorine(C)
Presence of foreign material

in water (P) “ “ “ “ “ “
Storage of soybeans Growth of micro organisms Absence Immediate Per lot QAM Control specifications Use them immediately
in silos (CCP-3) (B)/insects control
Fungi In five Notices of the Daily

samples two results of
of them 102- measuring.
4
10
Humidity
<13%
Temperature
<25oC
Air
conditioning
Application of anti Residues of the used Tolerant Measuring the Per QAM Control of the indication “
insect methods at chemicals levels as amount of application of the weighing machine.
soybean (CCP-4) prescribed chemical
by BIS/ISO
Presence of physical Residues of substances of Absence Control of Daily QAM Monitoring maintenance Repetition of produces.
contaminants physical origin in soybean. equipment for of the equipments Calibration of equipment.
appropriate
functioning
Magnet Metal residues Absence Control of Every hour QAM “ Repairing of the equipment
equipment
Storage of products Control of temperature and Temperature Temperature and
(CCP-13) RH < 20oC RH should be
RH < 65% regularly tested.
AC unit must be
checked
regularly for it’s
functioning.
Transportation of GMP/GFHP Vehicle for Use anti insect
products food methods and
transport. disinfection of
the vehicle
regularly for
maintaining
GFHPs.
Cleaning in Place Automatic/manual cleaning CIP plant Use the set
of pipe lines, tanks etc. must be SS practices like:
and consists Pre rinse with
of tanks for water, rinsing
water, lye & with lye, 70oC,
acid, flushing with
disinfectant water, rinsing
dosing with acid 70oC,
system, SS flushing with
centrifugal water and finally
pump, SS air disinfection with
operated disinfectant.
valves and
steam
heating
system.
Dehulling of soybeans Presence of hulls in the 5% or Control of Every run Production Monitoring and Precautionary maintenance
(CCP6) splits. absence. dehuller, Manager maintenance of the or else replace with new
adjustment of dehuller system.
clearance.
Steeping in water Water quality, operational Good Quality check Every run Production Quality assessment of the Repetition of the testing
(CCP-7) parameters quality of and observation Manager ingredients and recording results and incase of
water. of scheduled of temperature and time deviation rejection of lot.
Dry parameters. schedules.
ingredients
of food
quality
Time/temp
of soaking
Blanching/steaming Water quality, operational Good QC and Every run. Production Constant monitoring of Repetition of the testing
(CCP-8) parameters. quality of recording of Manager. the scheduled process. results and incase of
water, time parameters. deviation rejection of lot.
and
temperature
of holdings.
Drying (CCP-9) Drying temperature and Low QC and Every run. Production Evaluation of moisture of Repetition of the testing
time temperature recording of Manager the dried splits in the lab. results and incase of
drying for parameters. deviation rejection of lot.
qood quality.
MC around
10 %( wb).
Attrition (CCP-10) Grinding system and Minimum QC of the milled Every run. QAM Laboratory check up and Repetition of the assessment
temperature rise temp rise. product. evaluation. and in case of deviation
rejection of the lot.
Sifting (CCP-11) Desired granular size. As per QC of the final Every run. Production Regular monitoring. In case of deviation the
recommende product. Manager system may be replaced.
d mesh size.
Packaging (CCP-12) No migration of low Food grade QC Every lot QAM Regular monitoring. Replace the lot.
molecular weight film.
compounds.
production of Medium Fat soy flour
Processing step Hazard description CClimit Observation procedures Responsib Monitoring Corrective actions
Control of CCP Frequency
(CCP) le procedures
Receiving of soybean (CCP1) Presence of foreign 5% Visual control of Per lot QAM Control of Rejection of lot or
material in soybean (P) sample/control specifications and change supplier
of the procure quality
certifications per certificates from
lot suppliers
Growth of micro
organism (B). insects Absence “ “ “ “ “
Fungi Out of five Control of the “ “ Evaluation of “

samples two certificates per supplier
2
of them 10 - lot
4
10 .
Humidity
<13%
Protein
content 38-
40%
Other macro
and micro
nutrients
Receiving secondary materials Chemical substances Materials “ “ “ “ “
(greasing agents, detergents, migrating from the suitable for
insecticides, pesticides, sacs etc secondary materials. food items.
(CCP2&3)
Water Total Coli forms (B) In Lab control of Monthly QAM New drilling at New drilling
agreement water quality greater depths,
with the chlorination of
community water
legislation
80/778 for
potable
water (B)
Faeces Streptococcus “ “ “ “ “ “
(B)
Clostridium (B)
Presence of undesirable “ “ “ “ “ “
and toxic substances in
water (eg. Heavy
metals, ammonia,
hydrocarbons, parasites,
nitrate). Excessive
chlorine(C)
Presence of foreign “ “ “ “ “ “
material in water (P)
Storage of soybeans in silos Growth of micro Absence Immediate Per lot QAM Control Use them
(CCP4) organisms (B)/insects control specifications immediately.
Otherwise rejection
of the lot.
Fungi In five Notices of the Daily
samples two results of
4
10
Humidity Precautionary repair
<13% and maintenance of
Temperature AC system.
o
<25 C Otherwise replace
Air with alternate.
conditioning
Application of anti insect methods Residues of the used Tolerant Measuring the Per QAM Control of the Rejection of the lot if
at soybean chemicals levels as amount of application indication of the exceeds the limits.
prescribed chemical weighing machine.
by BIS/ISO
Presence of physical contaminants Residues of substances Absence Control of Daily QAM Monitoring Repetition of
of physical origin in equipment for maintenance of the produces. Calibration
soybean. appropriate equipments of equipment.
functioning
Cleaning of soybeans (CCP-5) Metal residues Absence Control of Every hour QAM “ Repairing of the
equipment equipment
Dehulling of soybeans (CCP-6) Presence of hulls in the 5% or Control of Every run Productio “ “
splits. absence. dehuller, n Manager
adjustment of
clearance.
Extrusion cooking (CCP 7) Destruction of Temp: 150- Recording the “ “ “ “
o
pathogens (B) 180 C schedules.
30-60 min. Adjust the mc of “ “ Observation of mc Repetition of the test
Moisture content of the 20-25%(wb) the grits before in the lab. and adjust the mc in
grits. the run. case not observed
optimal.
Expeller (CCP 8) Speed (rpm) As per the Adjust the speed “ “ “ “
Clearance9mm) scheduled and clearance of
between the rolls. runs the rollers.
prescribed.
Storage of products (CCP-9) Control of temperature Temperature Temperature and Every half Productio Precautionary Rejection of the
and RH < 20oC RH should be an hour. n Manager maintenance of air doubtful lot.
RH < 65% regularly tested. conditioning unit.
AC unit must be
checked
regularly for it’s
functioning.
Transportation of products GMP/GFHP Vehicle for Use anti insect Per lot Productio Precautionary Rejection of the lot if
food methods and n Manager maintenance of the not maintains the
transport. disinfection of vehicle. quality as required by
the vehicle the food laws.
regularly for
maintaining
GFHPs.
Cleaning in Place Automatic/manual CIP plant Use the set Must be of best SS
cleaning of pipe lines, must be SS practices like: and other
tanks etc. and consists Pre rinse with equipment from
of tanks for water, rinsing reputed Dealers
o
water, lye & with lye,70 C,
acid, flushing with
centrifugal water and finally
pump, SS air disinfection with
operated disinfectant.
valves and
steam
heating
system.
Soy biscuits:
Biscuits have been manufactured and consumed for hundred years. However, soy based
biscuits are of recent origin and getting importance as neutraceutical foods. The main
ingredients employed in the manufacturing of biscuits are soy flours
(FFSF/MFSF/DFSF), wheat flour, fat and sugar. The industrial manufacture comprises a
series of automated operations converting the raw materials in to finished varied
categories of biscuits. A representative flow diagram of soy biscuit production
accompanied with identification of CCPs is shown in Figure. All the hazards, critical
control limits, observation of practices and corrective actions are given synoptically in
the table.
1. Product name Soy biscuits

product < 50000/g, protein-min 12%.
3. How the product is to be used It is consumed directly at any time either
with tea or alone.
microns)/laminated packages/ hermetically
sealed metal containers.
5. Shelf-life Six months at normal retail shelf
temperatures and use with in a month after
opening the packet.
give all the nutritional information.
conditions of temperature (<25oC and RH
<13%)
Soy biscuits
Table 20 Product ingredients and incoming material

FFSF/MFSF/DFSF B, C, P Polythene bags/laminated Greasing agents,
packages/tin containers B, disinfectants, C, P
C, P
Other
Soy flours Packaging materials Secondary materials Water

8. Dough B P 9.Inspecting B P 10. Dumping
11. Patternization B P
12. Baking B C 13. Chlorinating
17.Filling C P
18.Weighing B
20.Inspecting B P
21. Labeling B
22. Storing B
23.TransportB

Baking Area Dry Processing Area

Preparatory Area
Coolers/Dryers
Silos/Storage Bins
Dough Making
Sifting of flours
(Wheat/Soy
flours)
Weighing
Patternizing
Flour mixing
Filling
Baking
Sealing
Transport
Soy flour/wheat flour
- could contain air borne pathogenic organisms, yeasts or moulds.
Secondary materials
Water
Packaging materials
- could contain defects, which could result in leakage.
Processing steps
Flour mixing
Dough making/patternization
Baking
Cooling/Drying
Weighing
Transport
product.
Water
Processing steps

Flour storage
microorganisms.

Soy flour/ wheat flour

Secondary materials
Flour receiving

contamination.

contamination.
Description of manufacturing process-Implementation of HACCP:
Receiving flours (CCP-1): Flours must come from approved suppliers. Their receipt
should be with quality certificates and microbiological analysis. The certificate should
include the moisture content and absence of B, P and C contaminants. Up on receipt
visual inspection must be carried out to detect any undesirable items. Probable defective
flours mean that the final product will be most likely unsafe for the consumer.
Receiving secondary materials and packaging materials (CCP-2&3): These materials
must be procured from the approved suppliers. They should be accompanied with
certificates. They should be suitable for use in food industry. There should not be any
contaminants (B, C, and P), which affect the quality of the biscuits. If they do not comply
with the specifications, they may be returned to the supplier and a fresh order should be
placed with other supplier.
Receiving and control of A/B materials (CCP-4): These materials should be conveyed
to the factory through the vehicles employed exclusively for the transportation of food
items. All the vehicles should be thoroughly sanitized. Prior to the receipt the QAM
should check the suppliers’ specifications in order to confirm whether they comply with
current legislation.
Storage of flours in polypropylene sacs (CCP-5): The room temperature and humidity
must be low (below 20oC and 65% respectively). They should be recorded and corrective
actions should be taken whenever needed. When flours are stored over a long period,
microbiological analysis should be conducted.
Storage of secondary materials (CCP-6): The room temperature and humidity must be
low (below 20oC and 65% respectively). They should be recorded and corrective actions
should be taken whenever needed.
Weighing/mixing of dough (CCP-7), preparation of dough and patternization:
Correct weighing measures should be under taken. All the materials are kneaded and the
dough is patternized in to various shapes as desired. During the kneading the wheat flour
and soy flour absorb water resulting in inflation of the protein (glutin). Mixing induces
the formation of a three-dimensional network by hydrated proteins that is responsible for
its viscoelastic properties. The butter reduces the amount of water required for mixing the
components and contributes to the characteristic taste of the biscuits. Sugar is added to
impart the color and taste to the biscuits. Additives can adjust the pH, inflate the dough
and provide taste to the biscuits. During mixing the workers should comply with GMPs.
A strict cleaning schedule should be applied in the plant operations. The water and the
flours should be thoroughly mixed so that the proteins of flour do not promote the
formation of gluten network. The mixing should be done in a high-speed mixer. The
water employed should be cold (temp < 15-20oC) and the addition of flour should take
place slowly. If yeasts are added, it will be kept for one hour otherwise with the
chemicals it needs 10-20 minutes rest time. Other ingredients like oil 2.38%, lecithin
0.95%, NaCl 0.24%, Na H CO3 0.32%, soy flour/wheat flour (20g/100g) and water 47 %.
(as required for making good dough). The added water promotes the gelatinization and
the whole fission of the starch grains. As the water turns in to vapor, the material is
spread on the plates thus leading to the formation of porous structure of the final product.
Both the salt and sugar (6%) are added for improving the taste and increasing the
crispiness.
Baking at 150-230oC (CCP-8): The biscuits are baked at 150-230oC for 10 minutes and
cooled to room temperature. The material on the disc is fit on the moving tempered
plates. During the baking the pressure amounts to 20-30 psi. Every plate has a carved
structure with parallel or crossed stripes. The distance among the plates is the major
factor that affects the depth of baking pastry sheet during baking .the temperature is 180-
200oC for 1.5-3.0 minutes. After the end of baking the humidity is 1-3%.
Cooling (CCP 9): First cooling of puff biscuits sheets at both sides of every sheet
exposed to the atmosphere is accompanied by a quick adjustment of humidity at the
sheet.
Packaging and labeling (CCP-10): During the packaging the product could be
contaminated with pathogenic microorganisms or microorganisms causing deterioration.
This can be avoided by employing hermetic sealing in conjunction with the up right
position of the packaging. Packaging material should be suitable for food contact. The
workers should comply with the GMPs in order to exclude the foreign materials such as
insects and rodents with in the product.
Palleting: The product in weighed (weight checking) and put in boxes (secondary
packaging). The boxes are placed on the palette and are wrapped with cellophane film.
Storage of packed product (CCP 11): The temperature during storage must be < 20oC
and RH must be < 65%. The place should be air-conditioned. Both the temperature and
RH should be recorded. Corrective actions should be taken if any of the conditions are
not controlled.
Composition:
Fat: a minimum of 50 %
Microbiology:
Mold: 100/10g max.
Sensory parameters:
Odor: Less beany
Taste: Nutty
Texture: Crunchy
Defects:
Table 23. Quality assessment of the soy biscuits
Composition:
Protein:
a minimum of 12% 12% 12.8%
Fat:
a minimum of 50% 51.0% 52.8%
Crude Fiber:
Ash:
a maximum of 6.5% 5.9% 6.2%
Moisture:
Microbiology:
Total plate count:
20,000/g max 30,000/g 9,000/g
Total coli forms:
100/10g max 110/10g Nil
Salmonella:
E.coli:
Staphylococcus:
Yeast:
Mold:
100/10g max. 125/10g Nil
TI:
Urease activity:
Nil Nil Nil
Available lysine:
Min 5.5g/6g N 4.0g/6gN 6.0g/6gN
Sensory parameters:
Color:
Creamy to yellow Creamy Creamy
Odor:
Less beany Less Beany Less beany
Taste:
Nutty Nutty Nutty
Texture
Crunchy Crunchy Crunchy
Defects:
Insect parts:
Foreign material:
production of soy biscuits
Process step Hazard Critical Observation procedures Responsible Monitoring Corrective actions
Control of Frequency
description control limit procedures
CCP
Receiving of soy Confirm the Soy flour Control of Per lot QAM Control of Rejection of lot or
flour& wheat quality MC-10% specifications specifications change supplier.
flour (CCP-1) attributes Protein-38- per lot/visual and quality
40% control certificates
Wheat flour from
MC-10% suppliers
Protein-11- required.
12% Evaluation of
Starch-70- suppliers.
75%
Receiving of Contaminants No Control of
packaging from packaging contaminants specifications “ “ “ “
materials (CCP- materials(C) per lot
2)
Receiving of Contaminants
secondary from the Food grade “ “ “ “ “
materials (CCP- secondary
3) materials(C).
Receiving of Presence of Absence In agreement
butter, milk foreign with the “ “ “ “
powder, sugar, materials (P) Codex of
additives etc and Food.
(CCP-4) chemicals(C).
Storage of flours Growth of <107 cfu/g Laboratory Per lot “ Air Direct use of the
in sacks of poly micro organisms <106 cfu/g control of the conditioning flours or rejection if
propylene (CCP- (B) when RH product. of the silos. microorganisms
5) <16% Control of exist in greater
t=20 days. temperature numbers.
and humidity
according to
storage time.
Baking (CCP-6) Destruction of Baking at Thermometer Per annum Production Precautionary Interrupt
the pathogenic 180oC for of the oven Manager maintenance functioning and
microorganisms 45-50 should be of the oven repair of the oven or
and control of minutes, checked. and the air A.C. Rejecting the
development of cooling at conditioning doubtful lot.
pathogenic 18-20oC. of the unit.
microorganisms.
Water Total number of In agree Quality Monthly QAM Chlorination New source of water
Coli forms(B) ment with control of of water
the water
community
legislation
80/778 for
potable
water (B)
Fasces Coli “
forms (B) “ “ “ “ “
Streptococcal (B) “
Sulphur reducing “ “ “ “ “
Clostridium (B)
Presence of “
undesirable & “ “ “ “ “
toxic substances
in water namely
heavy metals,
ammonia,
hydrocarbons,
parasites,
NO3&NO2,
excessive
chlorine)
“
“ “ “ “ “
Presence of
foreign materials
(P)
Mixing Growth of micro Clean Visual After QAM Application Repeat cleaning of
(CCP-7) organisms (B) equipment control, usage of of cleaning equipment.
with cleaning equipment schedules
remains of schedule.
dough/
Cooling Destruction of Cooling at Control of Per lot Production Preventive Interrupt functioning and
(CCP-8) pathogenic micro room cooling rate Manager maintenance repair of AC or rejection
organisms (B) temperatur of AC. of doubtful lot.
e
Packaging Contamination Hermetic Visual Every half Packing Preventive Interrupt functioning and
(CCP-9) by pathogenic sealing & control of an hour. Unit maintenance repair the damage or
microorganisms upright effective up Manager of package rejection of doubtful lot.
or packaging. right machinery. Rejection of lot and / or
microorganisms packaging. change of the supplier.
which cause No Control of Per lot QAM Observation
deterioration. migration the of the
Materials specifications specifications
migrated from per lot. & supply
packaging quality
materials certificates Rejection of lot and / or
from the change of the supplier
supplier.
Absence of Visual Every half Packaging Evaluation of
foreign control of an hour. Unit suppliers.
materials, effective Manager Preventive
Contamination insects & upright maintenance
with foreign rodents. packaging. of packaging
materials, insects machinery
& rodents
Soy bread:
Preparation of soy based white bread loaf is based on wheat flour, soy flour, water and
yeast. It comprises the following process namely kneading, fermenting, proofing and
baking. However, the ingredients role and importance of various steps differ considerably
per process. The quality of flours affects the final quality of the bread. In general
FFSF/MFSF/DFSF may be used for making breads depending up on the protein
requirement at maximum level of 5% incorporation in the standard bakers’ formula. A
typical dough system for yeast is prepared by blending flours with water. Gluten is
formed from the two wheat flour proteins namely glidin and glutenin in the presence of
water mixing. Attaining a satisfactory bread texture depends up on the uniform
distribution of adequately hydrated and aerated nuclei to a certain extent. The
fermentation plays an important role in the development of typical bread products. The
released CO2 will initiate expansion of the cells developed during kneading and mixing. It
imparts odor and flavor to the bread.
1. Product name Soy bread

2. Important product characteristics of end Aw < 0.5; FFA < 1%; Total microbial counts
product < 50000/g, protein-min 30%. Fat-min 1%,
carbohydrates-min 35%.
3. How the product is to be used It is consumed directly at any time either
with tea or alone.
microns)/laminated packages.
5. Shelf-life 3-4 days normal retail shelf temperatures.
give all the nutritional information.
o
conditions of temperature (<25 C and RH
<13%)

FFSF/MFSF/DFSF B, C, P Polythene bags/laminated Greasing agents,
packages B, C, P disinfectants, C, P
Other
Soy flours Packaging materials Secondary materials Water

8. Dough B P 9.Inspecting B P 10. Dumping
11. Pasteurization B P
12. Baking B C 13. Chlorinating
17.Filling C P
18.Weighing B
20.Inspecting B P
21. Labeling B
22. Storing B
23.TransportB
P=physical; B=biological: C=chemical
Soy bread
Baking Area Dry Processing Area

Preparatory Area
Coolers/Dryers
Silos/Storage Bins
Dough Making
Sifting of flours
(Wheat/Soy
flours)
Weighing
Patternizing
Flour mixing
Filling
Baking
Sealing
Transport
- could contain air borne pathogenic organisms, yeasts or moulds.
Secondary materials
Water
Packaging materials
Processing steps
Flour mixing
Dough making/patternization
Baking
Cooling/Drying
Weighing
Transport
product.
Water
Processing steps

Flour storage
microorganisms.

Soy flour/ wheat flour

Secondary materials
Flour receiving

contamination.

contamination.
Description of manufacturing process, implementation of HACCP:
Receiving flours (CCP-1): Soy flour and wheat flour must be purchased from approved
suppliers. Their receipt should be accompanied with certificates of quality control and
microbial analysis. The certificates should report the humidity of the flours, presence of
any pieces of metals, pieces of hair from rodents, microorganisms and their number and
comparison with the upper approved standards of BIS/ISO. Visual control of the flours
must be conducted with reference to the color, high humidity and odor.
The most important quality is the strength of gluten. Not more than 5% soy flour is
incorporated; otherwise the loaf characteristics will be changed considerably. When
wheat flour and soy flour are mixed with water, a protein nexus is formed due to the
precipitation of two proteins, glutenin and glidinin. The glutinin poly merises forming an
elastic nexus, while the glidinin is incorporated in to sticky extensible mass entering in to
the nexus of gluten so that the dough becomes more extensible and flexible. The strong
flours absorb the CO2 produced during the ripening of the dough, thus resulting in even
more inflated bread.
Receiving of secondary and packaging materials (CCP-2& 3): These materials must
be purchased from approved suppliers. During their receipt, they must be accompanied
along with the quality certificates. These materials must be suitable for being employed
by the food industry. No substances are allowed to migrate from the packaging materials
to the food product. If the packaging materials do not comply with the specifications of
the BIS/ISO, they must be returned to the supplier. A new order should be placed on
another supplier.
Storage of flours in polypropylene sacks (CCP-4): The temperature and RH during the
storage must be kept at low preferably 20oC and 65% respectively. They should be
continuously recorded and corrective actions must be undertaken when ever the forgoing
presuppositions are not met. When the flour is stored for a long period, microbiological
analysis is imperative.
Storage of secondary materials (CCP 5): The storage temperature must be <20oC and
the RH must be < 65%. The place should be air-conditioned. The temperature and relative
humidity should be continuously monitored. Corrective actions should be undertaken
when forgoing circumstances are not met.
Weighing& mixing of flours and other ingredients (CCP-6): Wheat flour, soy flour,
water and yeasts are weighed accurately and mixed to a homogenous mixture. At this
stage, the personnel should comply with Good Manufacturing Processes (GMPs) and
personnel hygiene as desired in the Good Food Hygiene Practices (GFHPs).
Kneading (CCP-7): During mixing of flours, a fine dispersion of bubble air cell must be
formed with in the volume of dough. It must contain active yeasts and adequate nutrients
for the yeasts and production of CO2 during fermentation, so that the bubbles can be
inflated. The kneading is done in a mixer (11 wh/kg) for 2-5 minutes. In this way heat is
produced during mixing, resulting in a final temperature of 30oC. The materials before
mixing should be at low temperature.
Cutting the dough, first molding& first inflation at 30oC for 10 minutes and second
molding followed by placing in matrices:
After kneading, the dough is cut, patternized and finally molded. The first inflation takes
place at 30oCfor 10 minutes. After the inflation, the dough is molded again and placed in
the forms for baking.
Final swelling: It takes place at 50oC for 60 minutes and RH .85%.
Baking at 165oC for 40-50 minutes (CCP-8): During the baking the starch under goes
the following changes:
• Dilution of gluten in the right proportion.
• Provision of sugar to yeasts.
• Formation of a suitable surface for gluten adhesion.
• Flexibility enhancement, so that the bread gets more inflated.
• Water absorption from gluten during the baking, leading to lower flexibility of
gluten.
Cooling (CCP 9): After baking, the cooling takes place at ambient temperature for 90
minutes. Faults that may occur are:
• Over fermented dough will result in bread with a pale crust color and the crust
may be weak and crumbly.
• If the yeast has fermented all the available flours, the bread will lack volume and
springiness.
• Under fermentation results in bread with high crust color, small volume and dense
firm crumb of poor color.
Packaging and labeling (CCP 10): During the packaging process, the bread can be
easily contaminated with the pathogenic and other micro and macro organisms. This can
be avoided by hermetic sealing in conjunction with up right position of the packaging
materials. Packaging items must be suitable for food items. Further contamination can
occur from the foreign materials, insects and rodents that happened to be packed with the
product. The personnel should comply with GMPs.
Storage of packed bread (CCP11): The storage temperature must be < 20oC and the
relative humidity must be less than 65%. The place should be air-conditioned. The
temperature and RH should be recorded and corrective measures must be taken when
deviation occurs.
Table 28.Ingredients used in making wheat and soy bread
Ingredient Soy bread Wheat bread

%(w/w) %(w/w)
Water 45.0 38.0
Soy milk powder 6.6 0
Soy flour 20.0 0
Wheat flour 17.5 54.0
Pure gluten 2.5 0
Dough conditioner 0.2 0
Sugar 4.5 4.0
Yeast 1.0 1.0
Salt 0.9 1.0
Shortening 1.7 2.1
Table 29.Proximate composition of wheat and soy breads
Composition, % Wheat bread Soy bread

Moisture 37 44
Carbohydrates 81 40
Fat 2 2
Protein 14 14

Composition:
Protein: a minimum of % 30
Fat: a minimum of % 1.5
Carbohydrates a maximum of % 40
Crude Fiber: a maximum of % 4
Ash: a maximum of % 6.5
Moisture: a maximum of % 40
Microbiology:
Mold: 100/10g max.
Sensory parameters:
Odor: Less beany
Taste: Nutty
Texture: Soft
Defects:
Table 31. Quality assessment of the Soy Bread

Composition:
Protein:
a minimum of 30% 30 32
Fat:
a minimum of 1.5% 1.0 2.1
Crude Fiber:
a maximum of 4% 5.1% 4.3
Ash:
a maximum of 6.5% 5.9% 5.0
Carbohydrates
a maximum of 40% 38 40
Moisture:
Microbiology:
Total plate count:
20,000/g max 45,000/g 10,000/g
Total coli forms:
100/10g max 105/10g Nil
Salmonella:
E.coli:
Staphylococcus:
Yeast:
Mold:
100/10g max.
TI: 117/10g Nil
less than 75% of original.
Urease activity: <50% <80%
Nil
Available lysine: Nil Nil
Min 5.5g/6g N
Sensory parameters: 5.2g/6gN 6.0g/6gN
Color:
Creamy to yellow
Odor: Yellow Creamy
Less beany
Taste: Beany Less beany
Nutty
Texture Nutty Nutty
Soft
Defects: Soft More soft
Insect parts:
Foreign material:
Soy baked products

Table 32.Synoptical presentation of hazards, critical control limits, observation procedures, monitoring and corrective actions
for the production of soy bread
Process step Hazard Critical Control limit Observation Responsib Monitoring Correctiv
description Procedures le procedures e actions
Control of Frequen
CCP cy
Receiving of Presence of 5% Control of Per lot Quality Control of Rejection
flours (CCP-1) foreign the assurance specificatio of lot or
materials in certification Manager n and change
the per lot. provide the
flours(whea Visual quality suppliers.
t/soy control certification
bean)(P) from the
suppliers.
Evaluation
of suppliers.
Growth of Absence
micro
organisms
(B)
Out of five samples two of them
Fungi 102-104 cfu/g, Humidity<13%
Proteins:
12%(wheat)&38%(soybean)
Other chemical characters
(strength of gluten/amylase
activity)
Receiving of Low No migration Control of Per lot QAM Control of Rejection
packaging molecular certification specificatio of lot or
materials (CCP- weight s per lot ns and change
2) compounds provide suppliers.
migrating quality
from the certificates
packaging from the
materials(C) suppliers.
Evaluation
of suppliers.
Receiving of Chemical Materials suitable for food Control of Per lot QAM Control of Rejection
secondary substances handling. specification specificatio of lot or
materials (CCP- migrated s per lot. ns and change
3) from the provide suppliers.
secondary quality
materials(C) certificates
from the
suppliers.
Evaluation
of suppliers.
7
Storage of the Growth of <10 cfu/g Laboratory Per lot Lab Air Rejection
flours in sacks of micro <106 cfu/g when RH <16%, testing of Technician conditionin of the lot
propylene (CCP- organisms time: 20 days. the flours g of the silo if the
4) (B) for the microorga
quality. nisms
exist in
great
QAM numbers.
Control of Per lot Mixing of Rejection
the the of the lot
temperature materials. if the
and RH with micro
the advent organisms
of time of exist in
storage. great
numbers
Cross Contaminati No contamination. Cleaning Per lot QAM Cleaning Rejection
contamination of on of dough schedules and anti of the lot
dough with micro should be insect if the
organisms applied in schedules microorga
(B). the should be nisms
equipment. applied in exist in
The the great
personnel equipment numbers.
should places. The Rejection
comply with personnel of the lot
GMPs. should if the
comply micro
with the organisms
GMPs. exist in
great
numbers
Baking (CCP-5) Destruction Baking at 250oC for 40-45 The Monthly Production Precautiona Rejection
of minutes. thermometer Manager ry of the
pathogenic of the oven maintenanc doubtful
micro should be e of the lot.
organisms checked. oven.
and control
of spore
forming
bacteria(Ba
cillus
cereus)
Cooling (CCP 6) Control of Cooling at room temperature The Every Production Precautiona Rejection
the loaf (18oC) for 90 minutes. temperature half an Manager. ry of the
characteristi of the room hour. maintenanc doubtful
cs must be e of air lot.
monitored conditionin
regularly. g unit.
The air
conditioning
unit must be
checked for
it’s
functioning.
o
Storage of bread Control of Temperature < 20 C Temperature Every Production Precautiona Rejection
(CCP-7) temperature RH < 65% and RH half an Manager ry of the
and RH should be hour. maintenanc doubtful
regularly e of air lot.
tested. AC conditionin
unit must be g unit.
checked
regularly for
it’s
functioning.
Transportation of GMP.GFHP Vehicle for food transport. Use anti Per lot Production Precautiona Rejection
the bread. insect Manager ry of the lot
methods and maintenanc if not
disinfection e of the maintains
of the vehicle. the
vehicle quality as
regularly for required
maintaining by the
GFHPs. food
laws.
Receiving of flours
Receiving of packaging
materials
Receiving of
secondary
materials
Storage
Mixing in a mixer Weighing/mixing Storage at 20oC&RH65%

for 2-4 minutes flours.
Cutting Kneading for 3 h
Patternization Cutting dough
Mechanical molding 1st mechanical

molding
Molding
1st swelling 30oc 1st swelling 30oC

for 10 minutes for 10 minutes.
2nd mechanical molding/ 2nd mechanical molding/

place in the form. Place in the form.
Final swelling at Final swelling at

43oC, RH > 85% 43oC, RH > 85%
Baking at Baking at
210oc for 30 min 210oc for 30 min
Cooling
Packaging
Transport
109
Distribution
Soymilk (plain)/flavored milk

Strictly speaking soymilk is a water extract of whole soybeans. It is an off white
emulsion/suspension containing the water-soluble proteins and carbohydrates and most of
the oil of the soybeans. Plain: Bean to water ratio 1:5 contains 4% protein. Dairy type
soymilk: Bean to water ratio 1:7 and contains 3.5% protein. Slightly sweetened and
contains oil, salt and imitation flavors. Soy beverages: Bean to water ratio 1:20 and
contains 1% protein. Cultured products: Any of the above after lactic acid fermentation or
acidification with lactic acid. Blends: Mixtures of soymilk and other vegetable or dairy
milks.
Soybean types required for making soymilk
Large seeded soybeans. (larger than 20 g/100) with a yellow seed coat, yellow
cotyledons, clear hilum and thin but strong seed coat.
• Moderately high in protein content with improved ratio of 7S/11S.
• Lack of lipoxygenase and lower oil content.
• High NSI, high water uptake, low calcium and high germination rate.
• A high protein/ oil ratio provides a higher tofu yield and firmer texture.
• Taste is closely related to soluble carbohydrates content in seeds. High total
carbohydrates, high sucrose, low raffinose and low stachyose, are highly
desirable.
110
Soy milk (Plain)
Table 33.Product description:
1. Product name Soy milk (plain/flavored)
2. Important product characteristics of end product Aw < 0.5; FFA < 1%; Total microbial counts <
50000/g. The soymilk may consist of pure water,
soybean extract, sugar and salt. It has 3-4% protein,
1.5-2.0% fat and 8-10% carbohydrates. Flavored
soymilk may consist of pure water, soybean extract,
sugar, salt, and flavors and permitted food colors.
3. How the product is to be used Plain/flavored milk is ready to drink and applicable
to all sections of people suffering from lactose
intolerance. (Infants/youth/old/pregnant etc).
4. Packaging Plain soy milk is packed in 200/500 ml polythene

bags/ glass bottles/tetra packs,
5. Shelf-life The soymilk has shelf life of six months when

packed in tetra packs or else for few weeks under
refrigerated conditions. It has to be stored and
distributed at ambient temperature.
6. Where the product will be sold Retail, institutions and food service. Could be
consumed as a health food.

111
The identified biological, chemical and physical hazards related to the production of
soymilk are given as under.
Table 34.Product ingredients and incoming material (P=physical; B=biological;

C=chemical)

Other

11. De hulling P
12. Soaking B C 13. Chlorinating
14. Wet grinding B C
15.Filteration B P C
16. Homogenization
BPC 17.Filling C P
18.Weighing B
20.Inspecting B P
21. Labeling B
22. Storing B
23.TransportB
B= biological; C=chemical; P=physical
112
Table 36.The details of all identified hazards are enumerated as under.
Biological Hazards Chemical Hazards Physical Hazard

Ingredients / Materials
Soybeans could contain soil could contain could be contaminated
borne/ air borne pesticide residues with harmful
pathogenic organisms, could contain extraneous materials
yeasts or moulds mycotoxins. namely glass, metal,
plastic, wool etc.
Dry could contain could be contaminated
ingredients microbial with harmful
contaminants. extraneous materials
could contain rodent
excrements
Soybeans inadequate protection
Receiving against harmful
extraneous material
could result in
contamination
Dry could be contaminated
Ingredient with non food
Storage chemicals as a result
of improper storage
Dry in adequate protection
Ingredient against harmful
Receiving extraneous material
could result in
contamination
Water could contain could be contaminated
microorganisms with toxic substances
Packaging could contain defects
Material which could result in
leakage
Processing Steps
Dehulling could be contaminated
with microorganisms
Soaking could contain
microorganisms
Grinding could contain heat cleaning chemical
resistant spores residues could
contaminate the
beans.
if live steam is used,
113
boiled water additives
could carry over and
contaminate the
product
Filtration could be contaminated
with microorganisms
Weighing overfilling may lead to
leakage and prone to
contamination
Transport physical damage to
packages results in
leakage and
contamination of
product
Soy milk (Plain)
114
The next step is identification of Critical Control Points (CCPs). The CCP determination
is shown below.
Instructions:
question 1.
not CCP.
Process step/incoming Category and Q1 Q2 Q3 Q4

materials identified hazard
Soybeans B=Pathogens Yes Yes Yes Yes, thermal processing
C=Pesticides No
(farmers/growers
C= heat stable level-GPP)
toxins No No
(farmers/growers Yes Yes
P= harmful level-GPP)
extraneous material Yes (visual
foreign object
removal)
Packaging materials B=pathogens Yes Yes Yes Yes, sterilization
Dry ingredients as B= bacterial spores Yes N/a Yes Yes, thermal processing
delivered B=rodent excretes
(GMP)
P=HEM (GMP)
Water at intake B= GMP
C= heavy metals &
other toxins (GMP)
Cleaning and grading P=GMP
of soybeans
Dehulling of soybeans B Yes Yes Yes No
115
Soaking of soy splits Water (GMP)
Sodium bi
carbonates (0.5%)
Grinding/cooking in B Yes Yes Yes No
water C
Filtration B Yes Yes Yes No

C
Filling P (GMP)
Weighing P (GMP)
Packaging and sealing B Yes Yes Yes No
116
Some of the unaddressed hazards connected to this process are presented in the preceding
text.
Table 38.Unaddressed Hazards

hazard
growers.
analysis reports.
117
The detailed HACCP plans are shown as under.
Table 39.HACCP Plan

Process Hazard Critical Monitori Deviation procedures
step description limits ng
procedur
e
De Inefficient de Less than On line Line operator to adjust the clearance of the de huller drums
hulling hulling may 0.1% check of
cause the the
contamination sample.
of the product
with the
microorganisms
.
Blanchi In adequate heatCook the Check the Operator should adjust the time and temperature as per the
ng treatment splits as quality of authorized contingency plan and to inform the QC.
/cooking specified in splits for
the scheduled urease test
process
(under
pressure/open
vessel
boiling)
Drying Improper drying The moisture Check the If moisture content is greater the splits may be dried again a
(Sun/me content moisture inform QC
chanical should be less content as
) than 8%-10%. per the
guidelines
.
Packagi Over filling, Max fill On line Line operator to adjust the settings.
ng and improper gauge weight as check to
sealing polythene and specified in reject over
improper the scheduled and under
sealing process. filled bags
Proper sealing and
leaving improperl
recommended y sealed
space. bags.
118

Raw material Liaison with the farmers for Specifications of grain quality are
harvest unit operations like required. Rejection of under sized
harvesting, threshing and seeds.
winnowing.
Raw material Transport in sacks to drying Correct sacking and handling.
transport area.
Raw material Sampling and routine Correct sampling methods, training
inspection inspection. and inspection methods.
Preparation of Cleaning, grading, dehulling, Training operators for equipment,
seeds conditioning and blending. preventing insect infestations,
check for moisture content.
Packaging Filling in to containers and Establish specifications for labels
sealing. and fill weights.
119
Description of soymilk manufacturing process: Implementation of HACCP.
soy flour will be most likely unsafe for the consumption. Soybean variety may play an
important role. Bold seeded varieties are preferred.
120
Steeping (CCP-7): As per the quality standards of water prescribed by the GFHP and
food grade chemicals. The duration of soaking depends on the season. In winter long
durations are required as compared with summer. In general 4-8 hours soaking may be
opted .The moisture content of the soaked beans may be about 45%(wb).
Grinding (CCP-8): Type of grinders used is very critical. In general
burr/colloidal/hammer mills are in vogue. The grinding may be done in two stages. Hot
water may be used while grinding for inactivation of lipoxygenase, which may improve
the flavor. The bean to water ratio depends on the type of milk to be prepared. In general
1:8 (w/v) is preferred for plain milks and for beverages still higher dilution factor may be
considered. For paneer making 1:6 may be used.
Cooking (CCP-9) Pressure-cooking at 1.2kg.cm2& temperature 121oC for 40 minutes is
preferred to inactivate all the anti nutritional factors.
Filtration (CCP-10): Use decanter centrifuge/rotating drum filter/batch type filters.
Speed of the centrifuge or drums should be adjusted to get maximum residue separated.
Homogenization (CCP-11): Thorough mixing of the oil/emulsifier as per the required
quantity before homogenization. Homogenize at 3500 psi for 30 minutes. Standardization
of soymilk base by adding ingredients like sugar syrup, water, flavors (flavored milk)
may also be done during this process.
UHT/pasteurization (CCP-11): Treatment of soymilk in UHT plant or direct
pasteurization.
121
Application of pressure for texturization in case of paneer:
• For soft paneer the pressures recommended are 2-4 g/cm2 for five minutes and
then increased to 5-10 g/cm2 for 10-15 minutes or until the whey stops draining
out.
• For firmer paneer the pressure required is 20-100 g/cm2 for 20-30 minutes.
Packaging (CCP-12): During packaging the milk can possibly be contaminated with the
packed with the milk. The personnel should comply with the (Good Manufacturing
Process).
Containers:
Food Processor:
• Reliable supply of packaging material.
• Low fixed cost per unit.
• Low energy consumption.
• Packaging should keep product quality.
• Service and spare parts availability.
• Space saving in storage/ minimum refrigeration.
Distributor:
• Light weight.
• Effective space utilization.
• Minimum refrigeration.
• Labour saving transport packaging.
122
• Withstand rough handling.
Retailer:
• Minimum refrigeration space.
• Attractive packaging with sales appeal.
• Minimized handling of empties and transport packaging.
Containers:
• Convenient size.
• Safe, easy to handle, drink and pour from.
• Retain product quality.
• Easy to dispose off.
• Have high image/ novelty.
• Product identification.
Kinds of packages:
• Returnable: usually for refrigerated distribution with in limited area.
• One-way: used for refrigerated (pasteurized) products distribution with in a
limited area/ non refrigerated (UHT/sterilized) products for short and long
distance distribution.
Choice of container depends on the following factors:
• Desired retail price of the product.
• Product quality protection practices.
• Desired image.
• Refrigerated or non-refrigerated distribution.
• Type of distribution vehicle.
• Type of transport container available.
123
• Service of filling machine.
• Packaging size.
• Means of opening package.

• How to drink from or pour from container.
• Place of consumption.
• Fixed cost of equipment.
• Labeling possibilities.
• Novelty factor.
The pasteurized product (75oC for 15 sec) can be filled in cartons, plastic bags, glass or
plastic bottles. The product should be stored under refrigeration and has then a shelf life
of approximately one week. The UHT treated product (1400Cfor 4 sec) should be
aseptically packed in cartons, plastic bags or plastic bottle. The shelf life is up to several
months in ambient temperature. No preservatives are involved. It provides adequate shelf
life and a product with good flavour and nutritional value. In bottle/can, sterilized soy
milk (120oC for 20 min) has the longest shelf life but is also a less nutritious product.
Taste and appearance are also affected.
Crate/outer box/transport container: The outer container in which the individual packages
or bottles are stored and transported should be considered early on in the planning of a
suitable packaging system.
Some factors to keep in mind are:
• Returnable or one-way container.
• Degree of automation.
• Degree of protection against physical impact, dust, rain, sunlight, theft and
stacking height.
• Ease of handling in plant, storage, trucks and shops.
• Bulkiness/weight.
• Cost per volume of soymilk transported.
124
• Durability.
• Desirability of non-authorized uses.
• Function as sales unit in shops.

Table 41.Types of containers and what they are suitable for
Returnable One way For For UHT For
Pasteurized treated sterilized
product aseptic product
packed
product
Primary Container
Glass bottle * * * * *
Plastic bottle * * * *
Plastic bag * * * *
Carton * * *
Can * *
Transport Container
Wooden *
grate
Plastic crate *
Cardboard *
box
Cardboard *
tray/shrink
film
Wrap around *
box
125
Storage of soy milk (CCP-14): The storage temperature and relative humidity must be
below 20oC and 65% respectively. The place should be air-conditioned. Both the
temperature and relative humidity must be recorded regularly and corrective actions must
be undertaken whenever deviation occurs.
126
Table 42.Expected quality (Soy milk)
Nutritional values per 100 g
Protein: a maximum of 4.0g
Fat: a maximum of 2.0g
Carbohydrates: a minimum of 3.0g
KJ: 204
Kcal: 49
Cholesterol: 0
Lactose: 0
SF: 15%
PUFA: 63.5%
MUFA: 1.5%
Microbiology:
Mold: 100/10g max.
127
Sensory parameters:
Odor: Less beany
Taste: Nutty
Defects:
Table 43. Quality assessment of the Soymilk
Composition:
Protein:
Fat:
Carbohydrates
A maximum of 3% 2.2% 3.0%
Crude Fiber:
Ash:
a maximum of 6.5% 4.4% 3.3%
Moisture:
Microbiology:
Total plate count:
20,000/g max 30,000/g 6,000/g
Total coli forms:
100/10g max 130/10g Nil
Salmonella:
128
E.coli:
Staphylococcus:
Yeast:
Mold:
100/10g max. 112/10g Nil
TI:
Urease activity:
Nil Nil Nil
Available lysine:
Min 5.5g/6g N 5.2g/6gN g/6gN
Sensory parameters:
Color:
Creamy to yellow Yellow Creamy
Odor:
Taste:
Nutty Nutty Nutty
Defects:
Insect parts:
Foreign material:
129
Table 44.Expected quality (Soy paneer)
Nutritional values per 100 g
Protein: a minimum of 5.0g
Fat: a minimum of 3.0g
Carbohydrates: a minimum of 2.0g
Calcium: 1.0 mg
Iron: 1.8 mg
Phosphorus: 0.95 mg
Vitamin B1: 0.05 mg
Vitamin B2: 0.04 mg
Nicotinic acid: 0.5 mg
Microbiology:
Mold: 100/10g max.
Sensory parameters:
Odor: Less beany
130
Taste: Nutty
Defects:
131
Table 45. Quality assessment of the Soy Paneer (Tofu)
Composition:
Protein:
a minimum of 5% 4.5% 8.0%
Fat:
Carbohydrates
Crude Fiber:
Ash:
a maximum of 6.5% 7.0% 6.0%
Moisture:
Microbiology:
Total plate count:
20,000/g max 50,000/g 10,000/g
Total coli forms:
100/10g max 120/10g Nil
Salmonella:
E.coli:
Staphylococcus:
Yeast:
132
Mold:
100/10g max. 123/10g Nil
TI:
Urease activity:
Nil Nil Nil
Available lysine:
Min 5.5g/6g N 4.2g/6gN 6.2g/6gN
Sensory parameters:
Color:
Creamy to yellow Yellow Creamy
Odor:
Taste:
Nutty Nutty Nutty
Defects:
Insect parts:
Foreign material:
133
Table 46.Hazard analysis worksheet of soymilk manufacturing:
Ingredient/pro Identifying potential Are any Justificati What Is this step
cess step hazards potential food on preventive CCP (Yes.
introduced/controlled/enh safety hazards measures no)
anced at. significant can be
(yes/no) applied to
prevent the
significant
hazards?
Soybean Biological-dead Yes Associate Removal Yes
cleaning insects/worms d with through
outbreaks mechanical
of food and manual
borne cleaning.
illness.
Chemical-chemical
residues Yes Rejection of
(pesticides/insecticides) lot.
Physical extraneous Yes Removal

matter through
mechanical
and manual
cleaning.
Soybean Physical-Dust/dirt/foreign Yes Cannot Removal Yes
washing matter. be through
removed repeated
at later washing
stage. steps.
Soybean Physical-moisture content No Quality No
soaking parameter
s not
associate
d with
safety.
134
135
Table 47.Synoptical presentation of hazards, CC limits, observation procedures, monitoring and corrective measures for
production of soymilk.
Process step Hazard Critical limit Observation procedures Responsibl Monitoring Corrective
Control CCP Frequency
description e procedures actions
Receiving of Presence of 5% Visual control Per lot QAM Control of Rejection
soybeans (CCP-1) foreign matter of specifications of lot and
in soybean (P) sample/control and provide or change
of the quality the
certification per certificates suppliers.
lot. from
suppliers.
Growth of Absence
micro
organisms (B)
Insects
Fungi Out of five Control of the
samples two certification.
of them 102-
136
104 cfu/g,
Humidity
<13%
Protein: 38-
40%
Other quality
parameters as
per standards.
Receiving of Chemical Materials Control of the Per lot QAM Control of Rejection
secondary materials substances suitable for certification. specifications of lot and
(greasing agent, migrating from food contact. and provide or change
detergents, secondary quality the
insecticides, materials. certificates suppliers.
pesticides, sacks etc from
(CCP-2) suppliers.
Receiving of Low molecular No migration. Control of Per lot. QAM Observations Rejection
packaging materials weight specifications. of the of the lot
(CCP-3) compounds specifications and/or
migrating from and supply change of
packaging quality the
materials. certifications supplier.
137
from the
suppliers.
Evaluation of
the suppliers.
Water Total coli forms In agreement Lab control of Monthly. QAM “ “
(B) with the water quality.
community
legislation
80/778 for
potable water.
Faeces Coli
forms (B) “ “ “ “ “ “
Faeces
Streptococcus “ “ “ “ “ “
(B)
Sulphur
reducing “ “ “ “ “ “
Clostridium (B) “ “ “ “ “ “
Presence of
138
undesirable and
toxic substances
in water (eg.
Heavy metals,
ammonia,
hydrocarbons,
parasites,
nitrate).
Excessive
quantity of
residual
chlorine©,
Presence of
foreign
materials (P).
Storage of soybeans Growth of Absence Quality control Per lot QAM Control of Rejection
in silos (CCP 4) micro specifications. of lot
organisms (B) unsuitable.
& insects.
Fungi (B) In five sample Monitoring and Daily QAM “ “
139
two of them recording the
102-104 cfu/g. humidity and
Humidity < temperature.
13%
Temp: < 25oC
Air
Conditioning.
Steeping (CCP-5) Quality of water As per the Inspection of Per lot Production Control of Rejection
& chemicals quality the quality Manager specifications. of lot
used. standards of certifications unsuitable.
water
prescribed by
the GFHP and
food grade
chemicals.
Set them as Recording of Per lot Production Control of Repair and
Steeping time described in temperature Manager conditions as maintenanc
and temperature the process. and timings. per the e of the
of the water season. equipment
and
rejection of
140
lot if not
properly
steeped.
Grinding (CCP-6) Type of grinder: Highly Inspection of Per lot Quality As per the Adjustment
burr/colloidal/ efficient the quality of Testing prescribed s of the
hammer mills grinding the mash and personnel standards. grinding
systems and determine the systems to
Addition of hot in two stages. TSS. get the
water if desired
required. particle size
prior to
operation,
otherwise
replace the
units.
Cooking (CCP-7) Pressure Precise Inspection of Per batch Production Control of Maintenanc
cooking at control of the cooking Manager conditions. e of the
1.2kg.cm2& pressure, systems and systems
temperature temperature recording the prior to use
141
121oC for 40 and holding parameters. and repair
minutes time. in case
required,
otherwise
replace
them.
Filtration and Use decanter Speed of the Inspection of Every run Production Control of Maintenanc
deodorization (CCP- centrifuge/rotati centrifuge or the units. Manager conditions. e of the
8) ng drum drums should systems
filter/batch type be adjusted to prior to use
filters. get maximum and repair
residue in case
separated. required,
Monitoring otherwise
the vacuum Control the Per lot Production Control of replace
Deodorization and inspection vacuum and Manager conditions them.
under vacuum of the quality recording the
of the extract. data.
Addition of additives Standardization All the dry Control of Per batch QAM Observations Rejection
(CCP-9) of soymilk base ingredients quality of the of lot and
142
by adding must be of specifications specifications or change
ingredients like food grade. of the and supply the
sugar syrup, ingredients and quality suppliers.
water, flavors concentrations certifications
(flavored milk). to be used for from the
standardization. suppliers.
The exact Evaluation of
composition of the suppliers
the product
must be
controlled.
Homogenization Use of good Thorough Control of Per lot Production Observations Prior
(CCP-10) quality mixing of the specifications. Manager of the maintenanc
vegetable oil/emulsifier specifications e of the
oil/emulsifier. as per the and supply system
required quality
quantity certifications
before from the
homogenizati suppliers.
on. Evaluation of
Homogenize the suppliers.
143
at 3500 psi for Recording the
30 minutes. pressure of
the
homogenizer
and time of
holding.
UHT/Pasteurization Treatment of Control of Good quality Per lot Production Evaluation of Maintenanc
(CCP-11) soymilk in UHT steam and instruments Manager the units e of the
plant or direct temperature. fitted with the regularly. units.
pasteurization. systems for
recording
Weighing Correct Control of Weighing Per batch Production Evaluation of Maintenanc
weighing weights. scales or Manager the units e of the
measures as automatic regularly. units.
required weighing and
filling units
must be
inspected for
their accurate
weights.
Aseptic filling Filling in Quality The quality Per Batch QAM Observations Rejection
(CCP-12) aseptic containers must be of the of lot and
144
containers. meeting the verified. specifications or change
specifications. and supply the
quality suppliers.
certifications
from the
suppliers.
Evaluation of
the suppliers
Storage (CCP-13) Control of Temperature Temperature Every half Production Precautionary Rejection
temperature and < 20oC and RH should an hour. Manager maintenance of the
RH RH < 65% be regularly of air doubtful
tested. AC unit conditioning lot.
must be unit.
checked
regularly for
it’s functioning.
Transportation GMP.GFHP Vehicle for Use anti insect Per lot Production Precautionary Rejection
food methods and Manager maintenance of the lot if
transport. disinfection of of the vehicle. not
the vehicle maintains
regularly for the quality
145
maintaining as required
GFHPs. by the food
laws.
Cleaning in Place Automatic/man CIP plant Use the set Must be of
ual cleaning of must be SS practices like: best SS and
pipe lines, tanks and consists Pre rinse with other
etc. of tanks for water, rinsing equipment
water, lye & with lye,70oC, from reputed
acid, flushing with Dealers
centrifugal water and
pump, SS air finally
operated disinfection
valves and with
steam heating disinfectant.
system.
146
147
Soymilk Processing Line
Weighing Unit Precleaner Steamer Dehuller Cleaner Bagging unit
Enzyme inactivator grinder Plate heat exchanger Decanter Deodorizer
Mixing Tanks Sugar/flavor Oil storage Homogenizer

solution tanks
Storage tanks
Direct method sterilizer
Aseptic homogenizer
Aseptic filling
148
Soymilk Plant Layout
Soybean Store Shelling/Dehulling
Raw materials Soymilk Processing Utilities

Store (Base/standardization/CIP plant)
Packaging material store Aseptic Filling and Packaging QC Lab
Product store
149
150
production of Soypaneer.
Receiving of soybeans Presence of 5% Visual control Per lot QAM Control of Rejection
(CCP-1) foreign matter of specifications of lot and
in soybean (P) sample/control and provide or change
of the quality the
lot. from
suppliers.
Growth of Absence
micro
organisms (B)
Insects
Fungi Out of five Control of the
samples two certification.
of them 102-
151
104 cfu/g,
Humidity
<13%
Protein: 38-
40%
Other quality
parameters as
per standards.
Receiving of secondary Chemical Materials Control of the Per lot QAM Control of Rejection
materials (greasing agent, substances suitable for certification. specifications of lot and
detergents, insecticides, migrating from food contact. and provide or change
pesticides, sacks etc (CCP- secondary quality the
2) materials. certificates suppliers.
from
suppliers.
Receiving of packaging Low molecular No migration. Control of Per lot. QAM Observations Rejection
materials (CCP-3) weight specifications. of the of the lot
compounds specifications and/or
152
from the
suppliers.
Evaluation of
the suppliers.
community
legislation
80/778 for
potable water.
Faeces Coli
forms (B) “ “ “ “ “ “
Faeces
(B)
Sulphur
reducing “ “ “ “ “ “
Clostridium (B)
Presence of “ “ “ “ “ “
153
undesirable and
toxic substances
in water (eg.
Heavy metals,
ammonia,
hydrocarbons,
parasites,
nitrate).
Excessive
quantity of
residual
chlorine.
Presence of
foreign
materials (P).
Storage of soybeans in Growth of Absence Quality control Per lot QAM Control of Rejection
silos (CCP-4) micro specifications. of lot
& insects.
154
13%
Temp: < 25oC
Air
Conditioning.
Steeping (CCP-5) Quality of water As per the Inspection of Per lot Production Control of Rejection
& chemicals quality the quality Manager specifications. of lot
used. standards of certifications unsuitable.
water
prescribed by
the GFHP and
food grade
chemicals.
Set them as Recording of Per lot Production Control of Repair and
Steeping time described in temperature Manager conditions as maintenanc
and temperature the process. and timings. per the e of the
of the water season. equipment
and
rejection of
155
lot if not
properly
steeped.
Grinding (CCP-6) Type of grinder: Highly Inspection of Per lot Quality As per the Adjustment
burr/colloidal/ efficient the quality of Testing prescribed s of the
hammer mills grinding the mash and personnel standards. grinding
systems and determine the systems to
Addition of hot in two stages. TSS. get the
water if desired
required. particle size
prior to
operation,
otherwise
replace the
units.
Cooking (CCP-7) Pressure Precise Inspection of Per batch Production Control of Maintenanc
cooking at control of the cooking Manager conditions. e of the
1.2kg.cm2& pressure, systems and systems
temperature temperature recording the prior to use
156
121oC for 40 and holding parameters. and repair
minutes time. in case
required,
otherwise
replace
them.
Filtration and Use decanter Speed of the Inspection of Every run Production Control of Maintenanc
deodorization (CCP-8) centrifuge/rotati centrifuge or the units. Manager conditions. e of the
ng drum drums should systems
filter/batch type be adjusted to prior to use
filters. get maximum and repair
residue in case
separated. required,
Monitoring Control the Per lot Production Control of otherwise
the vacuum vacuum and Manager conditions replace
Deodorization and inspection recording the them.
under vacuum of the quality data.
of the extract.
Coagulation (CCP-9) Type of salt Nigari type Select the salt Per lot “ Selection of
used and the This is based on the salt
concentration. produced type of tofu
157
from the required.
seawater
during salt
manufacture
and contains
magnesium
sulphate,
magnesium
chloride, and
calcium
chloride. It is
used at 3% by
weight of dry
beans and
coagulates at
78-85oC.
Sulphates
Calcium
sulphate or
gypsum and
magnesium
158
sulphate or
Epson salt are
both used at
2.2% of dry
beans at 70-
75oC.
Gypsum
coagulates
more slowly
than other
coagulants to
give the
smoothest
texture and
maximum
precipitation.
The hydrated
form is heated
and then
ground to fine
particles
159
before use.
Acids
Citrus juice,
citric acid,
lactic acid or
4% vinegar is
used. Lemon
juice is used
at 21% and
vinegar at
16%. of dry
beans at 80-
90oC.
Lactone
Glucono delta
lactone is
mixed with
soymilk at
0.6% and
heated to 85-
90oC for 30-
160
50 minutes.
The
coagulation is
important and
requires care.
If the curd has
a crumbly
texture, it is
likely to have
been caused
by adding too
much
coagulant too
fast and at too
high
temperature,
causing the
paneer to
form too
quickly.
Insufficient
161
coagulant will
give a low
yield.
Different
coagulants are
used either
singly or as a
mixture.
Heating and coagulation Mode of adding The soymilk Careful Per lot Production
(CCP-10) the salt is boiled. addition Manager
A small
amount of
coagulant is
162
placed into a
wooden or
metal
container and
the hot milk is
added.
Finally the
reminder of
the coagulant
is added and
the mixture is
left for 15-20
minutes to
coagulate.
Filtration of the coagulum Mode of Unbleached “ “ “ “ “

(CCP-11) filtration cheesecloth is
used to line a
wooden
container/met
al perforated
163
box into
which the
coagulated
milk is pored
carefully.
The reminder
of the cloth is
folded on top
and a
wooden/metal
lid is fitted.
Pressure applied (CCP-12) Type of paneer For soft “ “ “ “ “

to be made paneer the
pressures
recommended
are 2-4 g/cm2
164
for five
minutes and
then increased
to 5-10 g/cm2
for 10-15
minutes or
until the whey
stops draining
out.
For firmer
paneer the
pressure
required is 20-
100 g/cm2 for
20-30
minutes.
Cooling (CCP-13) Temperature The final “ “ “ “ “

and the quality product may
of water be cooled in
water at 5oC
165
for 60-90
minutes
before being
packaged and
refrigerated or
sold directly.
Storage (CCP-14) Control of Temperature Temperature Every half Production Precautionary Rejection
must be unit.
checked
regularly for
it’s functioning.
166
GFHPs. by the food
laws.
water, lye & with lye,70oC, from reputed
valves and with
system.
167
168
Tofu fingers
169
Isolated Soy proteins (ISP)
• Concentrated form of commercially available soy protein products.
• They contain > 90% protein on a moisture free basis.
• The basic process involves solubilization of proteins in water. The solution is
separated from the solid residue and finally precipitated, separated and dried.
• Free from objectionable odors, flavors, color, antinutritional factors and
flatulances.
• ISP can be further modified and processed in to spun fibres as an ingredient for
muscle food analogs, proteinates and enzyme modified ISP.
Definition:
Association of American Feed Control Officials (AAFCO) defines, as “SPI is the major
proteinaceous fraction of soybeans prepared from dehulled soy beans by removing the
majority of non protein components and must contain not less than 90% protein on a
moisture free basis”.
Conventional Procedure:
• Protein solubilization at neutral or slightly alkaline pH.
• Precipitation by acidification to the isoelectric pH 4.5.
• The isoelectric ISP has low solubility in water and limited functional properties.
• Resuspending isoelectric ISP in water neutralizing with different bases and spray
drying the resulting solution or suspension can produce different proteinates.
i. Sodium
ii. Potassium
iii. Ammonium
iv. Calcium
The first three are highly soluble in water, high viscosity solutions, foaming,
emulsification, gel forming etc. The later one is used for high level of incorporation
without excessive viscosity.
170
• Available in fine powders, granules, spun fibres and other fibrous forms.
Table 49 Product descriptions:
1. Product name Isolated Soy Protein
2. Important product characteristics of end Aw < 0.5; FFA < 1%; Total microbial
product
counts < 50000/g. The soy isolated protein
may contain Protein: > 90%, Fat: max
0.5%, Ash: max 4.5% and Total
carbohydrates: max 0.3%.
3. How the product is to be used The protein may be used in all food
formulations and health foods for enriching
with protein and also for different
functional properties as required.
4. Packaging Packed in hermetically sealed

glass/polythene/laminated packaging
systems.200-500 g packets are available.
5. Shelf-life The isolated soy protein has shelf life of 12

months at room temperature. It has to be
stored and distributed at ambient
temperature.

171
Soy protein isolate
The identified biological, chemical and physical hazards related to the production of soy
protein isolates are given as under.
Table 50.Product ingredients and incoming material (P=physical; B=biological;

C=chemical)

Other

11. De hulling P
12 De fatting B C 13. Chlorinating
14. Alkali solubilization B C
15.Acid precipitation B C
16.Spray Drying B, C 17.Filling C P
18.Weighing B
20.Inspecting B P
21. Labeling B
22. Storing B
23.TransportB
B= biological; C=chemical; P=physical
The details of all the hazards are enumerated as under.
172
Soybeans
moulds.
Dry ingredients
Water
Packaging materials
Processing steps:
Cleaning
De hulling
Weighing
Transport
-physical damage to packages results in leakage and contamination of
product.
Soybeans
Water
Processing steps:
173
storage.
De fatting
Alkali solubilization
- excess alkali may affect the quality.
Acid precipitation
- excess acid may affect the quality.

Soybeans
Dry ingredients
Soybean receiving

contamination.
-in adequate protection against harmful extraneous material could result in

contamination.
text.
hazard
growers.
analysis reports.
174
Description of soy protein isolates manufacturing process: Implementation of
HACCP.
175
Defatting the beans and preparation of flakes (CCP 7): Care must be taken while
defatting the beans and making white flakes. These flakes permit easier separation after
extraction. The flakes must have the highest protein solubility for maximum recovery.
The heat treatment of the flakes may be monitored in terms of the NSI values. The initial
NSI values must be very high.
Extraction Medium and Conditions (CCP 8): Flakes are mixed with extraction
medium, in agitation (rpm?) and heated vessels (time/temp). Extraction medium in water
to which an alkali (NaOH, Ca (OH) 2, NH4 or tribasic sodium phosphate) has been added
(quality/conc?). pH to neutral or slightly alkaline. More proteins can be extracted at
higher pH. However the proteins may undergo chemical modifications/ denaturation/
maillard reaction and formation of dark pigments and in loss of nutritive value. pH 7.5 -
pH 9.0 are most commonly preferred. Loss of cysteine-dehydroalanine and loss of lysine-
lysinoalanine may occur. Under these conditions, majority of the proteins go in to
solution. The sugars and other soluble substances are also dissolved. Extraction time may
30 minutes-60 minutes. Temperature is up to 80oC. The solid/liquid ratio is2.5 times the
weight of solid. Larger volumes of liquid mean larger extraction vessels, centrifuges and
a larger volume of whey for disposal. Industrial level is in between 1:10 and
1:20Agitation; agitation (rpm?) increases the rate of protein solubilization. One-hour
extraction time with moderate agitation is preferred. Strong agitation causes flakes
disintegration.
Solid-liquid separation after extraction (CCP 9): Extract clarification process in two
steps. Screening (vibrating screen/ rotary screen) to separate the solids followed by
centrifugal clarification or in one step by using the decanter centrifuges.
176
Extract treatment (CCP 10): The clarified extract can be treated to remove the
impurities further ion exchanges to remove phytates/ash contents; activated carbon to
remove the phonetic compounds; UF to concentrate and remove low MW components
etc; use of membrane processes for extract purification.
Precipitation (CCP 11): Isoelectric pH(type of acid/temp?).
Separation and washing of the curds (CCP 12): Curd is separated from the whey by
filtration or centrifugation (Desludger/decanted centrifuges). Curd must be washed to
remove residues of whey soluble thorough washing is most important.
Drying (CCP 13): Spray drying is mostly used.
Packaging (CCP-14): During packaging the protein isolates can possibly be
contaminated with the microorganisms causing quality deterioration. Hermetic sealing
and upright position of the packaging material can avoid this. There should not be any
migration of the low molecular weight substances from the packages. Further more
contamination can take place from foreign materials like insects and rodents that
accidentally happen to be packed with the protein isolates. The personnel should comply
with the GMPs.
Storage of protein isolates (CCP-15): Both the temperature and relative humidity must
be below 20oC and 65% respectively. They should be recorded and corrective actions
must be taken when deviating. When the flour is stored for a long period, microbiological
Problems in conventional processing:
Process losses:
i. Okara: 40% of the solids in the raw material and carries away 15% of the
protein entering the process.
177
ii. Whey: 25% of the dry matter and 10% of its nitrogen are found in this
fraction.
iii. Curd: Contains 75% of the protein of starting material.
Quality: Impurities like phytates and phenols.

Alternative processes:
i. Solubilization of the soy proteins in the salt solutions (salting-in) followed by
precipitation with water.
ii. Precipitation from the extract at near boiling using calcium salts. (Tofu).
iii. UF of the extract to remove low molecular weight components & filtration
through ion exchange / activated carbons.
iv. Physical separation of the intact protein bodies from very finely ground soy
flour by density fractionation.
Table 53.Expected quality of soy protein isolates (100g)
Calories: 384
Total fat: max 0.5g
Total carbohydrates: 1 g
Protein: minimum 90g
Sodium: 1.1g
Ash: max 5g
Calcium: 200 mg
Potassium: 92 mg
Phosphorus: 880 mg
Folate: 200 mcg
Isoflavones: 112 mg.
178
Proce
ss flow chart:
White Flakes
Water (GMP) Extraction Alkali (CCP)
Pulp Separation (CCP) Extract
Washing
Separation
Residue
Acid (CCP) Precipitation
Curd
Separation
Washing
Separation Whey
Alkali Washed curd
Neutralization Re suspension Water
179
Spray Drying Spray Drying
Proteinate Iso electric ISP
180
production of ISP
Receiving of Presence of 5% Visual control Per lot QAM Control of Rejection
soybeans/defatted foreign matter of specifications of lot and
soy flakes (CCP-1) in soybean (P) sample/control and provide or change
of the quality the
lot. from
suppliers.
Growth of Absence Control of the “ “ Evaluation of “
micro certification. the supplier.
organisms (B)
Insects (B) Absence
Fungi Out of five
samples two
of them 102-
181
104 cfu/g,
Humidity
<13%
Protein: 38-
40%
Other quality
parameters as
per standards.
Receiving of Chemical Materials Control of the Per lot QAM Control of Rejection
secondary materials substances suitable for certification. specifications of lot and
(greasing agent, migrating from food contact. and provide or change
detergents, secondary quality the
insecticides, materials. certificates suppliers.
pesticides, sacks etc from
(CCP-2) suppliers.
Receiving of Low molecular No migration. Control of Per lot. QAM Observations Rejection
packaging materials weight specifications. of the of the lot
(CCP-3) compounds specifications and/or
182
from the
suppliers.
Evaluation of
the suppliers.
community
legislation
80/778 for
potable water.
Faeces Coli
forms (B) “ “ “ “ “ “
Faeces
(B)
Sulphur “ “ “ “ “ “
reducing
Clostridium (B) “ “ “ “ “ “
Presence of
183
undesirable and “ “ “ “ “ “
toxic substances
in water (eg.
Heavy metals,
ammonia,
hydrocarbons,
parasites,
nitrate).
Excessive “ “ “ “ “ “
quantity of
residual
chlorine.
Presence of “ “ “ “ “ “
foreign
materials (P).
Storage of soybeans Growth of Absence Quality control Per lot QAM Control of Rejection
in silos (CCP 4) micro specifications. of lot
& insects.
184
13%
Temp: < 25oC
Air
Conditioning.
Extraction (CCP 5) Agitation (rpm) As per the Monitoring the Per batch Production Observe the If deviating
scheduled speed while Manager conditions may be put
limit. grinding. and record. in to order,
otherwise
replace the
system.
Heated vessels “ Monitoring the “ “ “ “
(temp&time) temperature
and time
schedules.
Extraction
medium As per the Evaluation of Every Production Observe the Reject the
(quantity and standards the quality and batch. Manager certification lot and
quality of the prescribed for concentration of the supplier change the
185
salts like isolation. before run. for quality. supplier.
NaOH, Ca (OH)
2.NH4 or tribasic
sodium
phosphate.
pH pH 7.5-9.0 Observe and Every run QAM Verification of In case
(neutral/slightly record the pH. the results. faulty
alkaline). results,
replace the
equipment.
30-60
Extraction time minutes.
80oC max.
Extraction
temperature 1:10/1:20
Solid/liquid
Solid/liquid ratio
separation (CCP 6) Screening using
vibratory/rotary
screens.
186
Centrifugal
clarifications.
Decanter
centrifuge.
Extract treatment Use ion Remove Quality check Per batch QAM Laboratory If deviating
(CCP 7) exchange/activa phytates/poly of the product assessment of repeat the
ted phenols/ash/lo the extract process for
carbon/UF/mem w mw after negative
brane components treatment. results.
technology.
Precipitation (CCP Iso electric pH pH 4.0-4.5 All the Every run Product Quality Adjust the
8) parameters Manager control report parameters
should be and
monitored. maintain
the quality.
Otherwise
repeat the
process.
“
Type of acid HCl/H2SO4 Quality must be Every Product Quality Check “
187
used RT to 80oC tested. batch Manager Quality
Temperature of Regulation of Per lot QAM assessment
precipitation. temperature. and
monitoring
the results.
Separation & Filtration/centri All the Quality Every run. QAM “ “
washing of the curds fugation residues of assessment.
(CCP 9) (desludger.deca whey soluble
nter centrifuge) should be
removed.
Drying (CCP 10) Spray drying Optimized Quality “ “ “ “
conditions as assessment of
per scheduled. the product.
Weighing (CCP 11) Correct Control of Weighing Per batch Production Evaluation of Maintenanc
weighing weights. scales or Manager the units e of the
measures as automatic regularly. units.
required weighing and
filling units
must be
inspected for
their accurate
weights.
188
Aseptic filling (CCP Filling in Quality The quality Per Batch QAM Observations Rejection
12) aseptic containers must be of the of lot and
containers. meeting the verified. specifications or change
specifications. and supply the
quality suppliers.
certifications
from the
suppliers.
Evaluation of
the suppliers
Storage (CCP 13) Control of Temperature Temperature Every half Production Precautionary Rejection
must be unit.
checked
regularly for
it’s functioning.
189
GFHPs. by the food
laws.
water, lye & with lye70oC, from reputed
valves and with
system.
190
191
Wet Processing Area Dry Processing Area
Preparatory Area
Dryers
Silos/Storage Bins
Soaking in vats
Cleaners
Extractors
Blanching
Dehuller
Separators
Flakers/flaking
Precipitators
Separators
Whey neutralizers/ washers
Spray dryers
Storage rooms/Transportation
192
Production of Soy sauce
Soybeans/DFSF 50% Wheat 50% Salt
Cooked Roasted & crushed
Mixed Seed mold (Aspergillus.oryzae)
Koji-Murami Incubated
Koji Brine
Moromi Mash
Lactic acid bacteria/yeast
Brine fermentation Fermented
Pressed Cake
Raw soy sauce
Refining process
Pasteurized
Koikuchi-Shoyu
193
Soy sauce:
Today soy sauce is made by two methods: the traditional brewing method, or
fermentation, and the non-brewed method, or chemical-hydrolyzation. The fermentation
method takes up to six months to complete and results in a transparent, delicately colored
broth with balanced flavor and aroma. The non-brewed sauces take only two days to
make and are often opaque with a harsh flavor and chemical aroma. Soy sauce has been
used to enhance the flavor profiles of many types of food, including chicken and beef
entrees, soups, pasta, and vegetable entrees. It’s sweet, sour, salty, and bitter tastes add
interest to flat-tasting processed foods. The flavor enhancing properties, or umami, of the
soy extract are recognized to help blend and balance taste. The condiment also has
functional preservative aspects in that its acid, alcohol, and salt content help prevent the
spoilage of foods.
Raw materials:
• Soybeans-The soybeans used in soy sauce are mashed prior to mixing them with
other ingredients.
• Wheat-In many traditional brewed recipes, wheat are blended in equal parts with
the soybeans. Pulverized wheat is made part of the mash along with crushed
soybeans. The non-brewed variety does not generally use wheat.
194
• Salt- Salt, or sodium chloride, is added at the beginning of fermentation at
approximately 12-18% of the finished product weight. The salt is not just added
for flavor; it also helps establish the proper chemical environment for the lactic
acid bacteria and yeast to ferment properly. The high salt concentration is also
necessary to help protect the finished product from spoilage.
• Fermenting agents-The wheat-soy mixture is exposed to specific strains of mold
called Aspergillus oryzae or Aspergillus soyae, which break down the proteins in
the mash. Further fermentation occurs through addition of specific bacteria
(lactobaccillus) and yeasts which enzymatically react with the protein residues to
produce a number of amino acids and peptides, including glutamic and aspartic
acid, lysine, alanine, glycine, and tryptophane. These protein derivatives all
contribute flavor to the end product.
• Preservatives and other additives-Sodium benzoate or benzoic acid is added to
help inhibit microbial growth in finished soy sauce. The non-brewed process
requires addition of extra color and flavor agents.
The Manufacturing Process
Traditional brewed method

Brewing, the traditional method of making soy sauce consists of three steps: koji-making,
brine fermentation, and refinement.
Koji-making
Soybeans/defatted soy meal mixed with roasted and coarsely broken wheat are cooked in
continuous pressure cookers with adequate amounts of water until the grains are
thoroughly cooked and softened... The mash, as it is known, is allowed to cool to about
27°C before a proprietary seed mold (Aspergillus) is added .The mass is inoculated with a
mould, Aspergillus oryzae (A.sojae) and incubated in shallow vats with perforated
bottoms. Air is forced through the molds. After three days of incubation under controlled
195
Conditions of temperature and moisture the mould growth cover the entire mass, which
turns greenish as a result of sporulation. The mass is called Koji, essential ingredient of
most of the oriental fermentations. It is concentrated source of amylolytic and proteolytic
enzymes necessary for the decomposition of the carbohydrates and proteins. The koji is
Koji
mixed with brine containing 22-25% salt (w/v) and transferred to deep fermentation
tanks. The high concentration of salt inhibits the growth of wild microorganisms.
Brine fermentation
The koji is transferred to fermentation tanks, where it is mixed with water and salt to
produce a mash called moromi. Lactic acid bacteria and osmophillic yeasts cultures are
added and the slurry (called moromi-mash) is allowed to ferment at controlled
temperature and occasional aeration. The starch is transformed to sugars, which are
fermented to lactic acid and alcohol. pH drops from near neutral to 4.7-4.8. The moromi
is held in the fermentation tanks for 6-8 months. The fermented mash is pressed to
separate the sauce from the solid residue. The sauce is filtered, clarified and heated to 70-
80oC. Heating is necessary to pasteurize the sauce and to develop characteristic color and
aroma. After final clarification the sauce is bottled. The use of defatted soybean meal
instead of whole soybeans is justified, since most of the oil is lost in the residue. Soy
sauce is popular in SE Asia. It contains much lower proportion of wheat and therefore
less alcohol in the final product. It contains 28% soluble solids (18% salt& 7% protein).
The moromi must ferment for several months, during which time the soy and wheat paste
turns into a semi-liquid, reddish-brown "mature mash." This fermentation process creates
over 200 different flavor compounds.
196
Soy sauce
Refinement
After approximately six months of moromi fermentation, the raw soy sauce is
separated from the cake of wheat and soy residue by pressing it through layers of
filtration cloth. The liquid that emerges is then pasteurized. The pasteurization
process serves two purposes. It helps prolong the shelf life of the finished product,
and it forms additional aromatic and flavor compounds. Finally, the liquid is bottled
as soy sauce.
Non-brewed method (chemical hydrolysis)
Instead of fermenting, many modern manufactures artificially break down the soy
proteins by a chemical process known as hydrolysis because it is much faster. (Hydrolysis
takes a few days as compared to several months for brewing.)
197
1. In this method, soybeans are boiled in hydrochloric acid for 15-20 hours to
remove the amino acids. When the maximum amount has been removed, the
mixture is cooled to stop the hydrolytic reaction.
2. The amino acid liquid is neutralized with sodium carbonate, pressed through a
filter, mixed with active carbon, and purified through filtration. This solution is
known as hydrolyzed vegetable protein.
3. Caramel color, corn syrup, and salt are added to this protein mixture to obtain the
appropriate color and flavor. The mixture is then refined and packaged.
Sauces produced by the chemical method are harsher and do not have as desirable a taste
profile as those produced in the traditional brewed manner. The difference in taste occurs
because the acid hydrolysis used in the non-brewed method tends to be more complete
than its fermentation counterpart. This means that almost all the proteins in the non-
brewed soy sauce are converted into amino acids; while in the brewed product more of
the amino acids stay together as peptides, providing a different flavor. The brewed
product also has alcohols, esters, and other compounds that contribute a different aroma
and feel in the mouth.
In addition to the brewed method and the non-brewed method, there is also a semi-
brewed method; in which hydrolyzed soy proteins are partially fermented with a wheat
mixture. This method is said to produce higher quality sauces than can be produced from
straight hydrolysis.
198
Quality Control
Numerous analytical tests are conducted to ensure the finished sauce meets minimum
quality requirements. For example, in brewed sauces, there are several recommended
specifications. Total salt should be 13-16% of the final product; the pH level should be
4.6-5.2; and the total sugar content should be 6%. For the non-brewed type, there is 42%
minimum of hydrolyzed protein; corn syrup should be less than 10%; and carmel color 1-
3%. The fermented sauce must be made from fermented mash, salt brine, and
preservatives (either sodium benzoate or benzoic acid). This specification also states that
the final product should be a clear, reddish brown liquid that is essentially free from
sediment. The non-fermented sauce is defined as a formulated product consisting of
hydrolyzed vegetable protein, corn syrup, salt, caramel color, water, and a preservative. It
should be a dark brown, clear liquid. The Japanese are more specific in grading the
quality of their soy sauces. They have five types of soy sauce: koikuchi-shoyu (regular
soy sauce), usukuchi-shoyu (light colored soy sauce), tamari-shoyu, saishikomi-shoyu,
and shiro-shoyu. These types are classified into three grades, Special, Upper, and
Standard, depending upon sensory characteristics such as taste, odor, and feel in the
mouth, as well as analytical values for nitrogen content, alcohol level, and soluble solids.
Byproducts/Waste
The fermentation process produces many "byproducts" that are actually useful flavor
compounds. For example, the various sugars are derived from the vegetable starches by
action of the moromi enzymes. These help subdue the saltiness of the finished product.
Also, yeast acting on sugars forms alcohols. Ethanol is the most common of these
alcohols, and it imparts both flavor and odor. Acids are generated from the alcohols and
sugars, which round out the flavor and provide tartness. Finally, aromatic esters
(chemicals that contribute flavor and aroma) are formed when ethanol combines with
organic acids.
199
Chemical hydrolyzation also leads to byproducts, but these are generally considered
undesirable. The byproducts are a result of secondary reactions that create objectionable
flavoring components such as furfural, dimethyl sulfide, hydrogen sulfide, levulinic acid,
and formic acid. Some of these chemicals contribute off odors and flavors to the finished
product.
Table 55.Nutritional values of soy sauce (per 100g):
Water 71.0 g
Energy 53 Kcal
Energy 221 KJ
Protein 5.2 g
Fat (total lipid) 0.08 g
Fatty acids, saturated 0.01 g
Fatty acids, mono-unsaturated 0.01 g
Fatty acids, poly-unsaturated 0.04 g
Carbohydrates 8.5 g
Fiber 0.8 g
Ash 15.1 g
Isoflavones 1.6 mg
Calcium, Ca 17.0 mg
Iron, Fe 2.0 mg
Magnesium, Mg 34 mg
Phosphorus, P 110 mg
Potassium, K 180 mg
Sodium, Na 5715 mg
Zinc, Zn 0.37 mg
Copper, Cu 0.11 mg
Manganese, Mn 0.42 mg
Selenium, Se 0.8 µg
Vitamin C (ascorbic acid) 0.0 mg
200
Thiamin (vitamin B1) 0.05 mg
Riboflavin (vitamin B2) 0.13 mg
Niacin (vitamin B3) 3.36 mg
Panthotenic acid (vitamin B5) 0.32 mg
Vitamin B6 0.17 mg
Folic acid 16 µg
Vitamin B12 0.0 µg
Vitamin A 0 IU
Vitamin E 0.00 mg
201
Soy sprouts:
The soybeans for sprouting must be having the following characteristics:
• Medium seed size (10-12 g /100).
• High germination rate.
• High protein, high isoflavone, high sugars and lipoxygenase free.
1. Product name Soy sprouts

product < 50000/g
3. How the product is to be used Normally taken as such in salads or mixed
along with other sprouted legumes.
4. Packaging Sealed polythene bags or in loose.
5. Shelf-life 2-4 weeks under refrigerated conditions.
202
The plant schematic/floor plan is given as under.
Wet Processing Area Sprouting Area

Preparatory Area
Germinators
Silos/Storage Bins
Soaking in vats in cool

water (15-20oC) (2-3
times) for 2-12 hours.
Cleaners
Rinse and
drain for 8-
12 hours. (4
times)
Draining
Cleaned soybeans
Soysprouts, 1/4-
inch length
roots. Harvest.
Rinsing with
cool water.
Transport
203
The identified biological, chemical and physical hazards and flow diagram related to the
production of soy sprouts are given below.
Table 57. Product ingredients and incoming material

Soybeans B, C, P Polythene bags B, C, P Silica B, C, P
Other

11. Soaking B C
12. Draining B C 14. Chlorinating
13.Rinsing B P C
15. Sprouting B P C
16.Harvesting B P 17.Filling C P
18.Weighing B
20.Inspecting B P
21. Labeling B
22. Storing B
23.TransportB
P=Physical; B=Biological, C=Chemical

Soybeans
moulds.
Dry ingredients
204
Water
Packaging materials
Processing steps:
Cleaning
Soaking
Rinsing
Sprouting
Weighing
Transport
product.
Soybeans
Water
Processing steps:

storage.
Rinsing
205
Soybeans
Dry ingredients
Soybean receiving
- Inadequate protection against harmful extraneous material could result in

contamination.

contamination.
The next step is identification of CCPs. The CCP determination is shown below.

step/incoming and
hazard
thermal
processing
C=Pesticides No
(farmers/growers
C= heat level-GPP)
stable toxins No
(farmers/growers
extraneous
foreign object
removal)
B=rodent
206
excretes
(GMP)
P=HEM
(GMP)
Water at B= GMP
intake C= heavy
metals &
other toxins
(GMP)

step/incoming and
hazard
Cleaning and P=GMP
grading of
soybeans
Soaking of Water
soy beans (GMP)
Draining Water, GMP

Rinsing
Filling P (GMP)
Weighing P (GMP)
sealing (Proper
gauge and
sealing
clearance)
Instructions:
question 1.
levels, if no, not CCP. If yes Proceed to Q4
207
not CCP.
text.

hazard
growers.
analysis reports.

unit operations likequality are required.
winnowing. seeds.
area. handling.
methods.
Preparation of seeds Cleaning, grading, de Training operators for
hulling, conditioning and equipment, preventing
moisture content.
208
Description of soy sprouts manufacturing process: Implementation of HACCP.
209
Weighing: The soybeans are weighed and passed through a magnetic system so that the
Soaking of the beans (CCP-7): Add 2-3 times as much cool (15-20oC) water. Mix seeds
to assure even water content for all. Allow seeds to soak for 2-12 hours. Prefer to soak for
a shorter time. Check after 2 hours for softening. If they are still hard, let them keep
soaking until they are all soft (up to 12 hours). Normally 4 hours is usually the right soak
duration. If over soak they will fall apart, so will sprout poorly or even rot.
Draining& rinsing (CCP-8): Drain off the soak water. Rinse thoroughly with cool water
(15-20oC). Soy soak water is starchier than most other seeds, so rinse and rinse until the
water that is drained off runs clear. Drain thoroughly. Set the sprouts away from the direct
sunlight and at room temperature. Rinse and drain again 8-12 hours. And once more rinse
and drain again for 8-12 hours. And perhaps once more rinse and drain again for 8-12
hours. And conceivably once more rinse and drain for 8-12 hours.
Sprouting (CCP-9): Soy will sprout better with more frequent rinses and drains every 4-
8 hours. With personal preferences, it may be rinsed and drained again at 4-8 hours. Stop
here, many like the sprouts small. The rinsing and draining may be continued again at 8-
12 hours interval up to 6 days. These sprouts have only i/4 inch roots, which is typically
after just 3 rinses and drain cycles. Grow them as long as people like (continue rinse and
drain schedules) and find out when they are most delicious. When rinsed, try not to
disturb the seeds/sprouts. Let them stay where they are. On the 3rd day, soak the sprouts in
cool water for 10-20 minutes. Rinse well after this soaking. Allow the sprouts to grow for
24 hours with out water. They will generate more heat (which all sprouts do as they grow
out every stage) than usual and gain mass during this period. However, there is a slight
danger in this- that the sprouts will generate too much heat and will start to slow cook,
but it is a rare problem.
Harvest (CCP-10): The sprouts are done 8-12(or 24 h) hours after the final rinse. Be
sure to drain them as thoroughly as possible after the final rinse. The goal during the final
210
8-12 hours is to minimize the surface moisture of sprouts. They will store best in
refrigerator if they are dry to the touch. Transfer the sprouts to a plastic bag or the sealed
container of choice/ glass and put them in the refrigerator.
Yield: 2:1
Packaging (CCP-11): During packaging the sprouts can possibly be contaminated with
the microorganisms causing quality deterioration. Hermetic sealing and upright position
of the packaging material can avoid this. There should not be any migration of the low
packed with the sprouts. The personnel should comply with the (Good Manufacturing
Process).
Storage of sprouts (CCP-12): Both the temperature and relative humidity must be below
20oC and 65% respectively. They should be recorded and corrective actions must be taken
when deviating. When the sprouts are stored for a long period, microbiological analysis is
required.
211
The synoptical presentation of HACCP is shown as under.
212
213
production of Soy sprouts
Processing step Hazard description CClimit Observation procedures Responsible Monitoring Corrective actions
(CCP) procedures
CCP
Receiving of soybean Presence of foreign material 5% Visual Per lot QAM Control of Rejection of lot or
(CCP-1) in soybean (P) control of specifications and change supplier
sample/contr procure quality
ol of the certificates from
certification suppliers
s per lot
Growth of micro organism
(B)/insects Absence “ “ “ “ “
Fungi (B) Out of five Control of “ “ Evaluation of “

samples two the supplier
2
of them 10 - certificates
104 cfu/g, per lot
Humidity
<13%
Protein
214
content 38-
40%
Other macro
and micro
nutrients
sacs etc (CCP-2)
Water Total Coli forms (B) In Lab control Monthly QAM New drilling at New water source
agreement of water greater depths,
with the quality chlorination of water
community
legislation
80/778 for
potable
water (B)
Clostridium (B)
215
(eg. Heavy metals,
chlorine(C)

in water (P) “ “ “ “ “ “
Storage of soybeans Growth of micro organisms Absence Immediate Per lot QAM Control specifications Use them
in silos (CCP-3) (B)/insects control immediately
Fungi In five Notices of Daily

samples two the results of
4
10 cfu/g,
Humidity
<13%
Temperature
<25oC
Air
conditioning
216
Application of anti Residues of the used Tolerant Measuring Per application QAM Control of the “
insect methods at chemicals levels as the amount indication of the
soybean (CCP-4) prescribed of chemical weighing machine.
by BIS/ISO
Presence of physical Residues of substances of Absence Control of Daily QAM Monitoring Repetition of
contaminants (CCP-5) physical origin in soybean. equipment maintenance of the produces.
for equipments calibration of
appropriate equipment.
functioning
Magnet (CCP-6) Metal residues Absence Control of Every hour QAM “ Repairing of the
equipment equipment
of pipe lines, tanks etc. must be SS practices
and consists like:
of tanks for Pre rinse
water, lye & with water,
acid, rinsing with
disinfectant lye, 70oC,
dosing flushing
system, SS with water,
centrifugal rinsing with
pump, SS air acid 70oC,
operated flushing
valves and with water
steam and finally
217
heating disinfection
system. with
disinfectant.
Soaking in water Water quality, operational Good Quality Every run Production Quality assessment of Repetition of the
(CCP-6) parameters quality of check and Manager the ingredients and testing results and
water. observation recording of incase of deviation
Dry of scheduled temperature and time rejection of lot.
ingredients parameters. schedules.
of food
quality
Time/temp
of soaking
Rinsing with water GMP
(CCP-7)
Draining the water SOP
(CCP-8)
Sprouting the beans GMP
(CCP-9)
Harvesting the GMP
sprouts (CCP-10)
Packaging (CCP-11) No migration of low Food grade QC Every lot QAM Regular monitoring Replace the lot
molecular weight film
compounds.
Transportation of GMP/GFHP Vehicle for Use anti
products food insect
transport. methods and
218
disinfection
of the
vehicle
regularly for
maintaining
GFHPs.
Storage of products Control of temperature and Temperature Temperature
(CCP-12) RH < 20oC and RH
RH < 65% should be
regularly
tested. AC
unit must be
checked
regularly for
it’s
functioning.
219
The quality of the product so prepared with and with out HACCP is shown below.
Table 63.Quality assessment of the soy sprouts
Composition:
Protein:
a minimum of 12% 10% 13.1%
Fat:
a minimum of 6% 5% 6.7%
Crude Fiber:
Ash:
a maximum of 1.0% 1.4% 1.0%
Content mg/100g
Vitamin A, 11 8 11.5
Vitamin B 0.340 0.250 0.358
Vitamin C 28.1 22.0 30.1
Calcium 67 52 72
Iron 3.0 2.1 3.3
Magnesium 70 60 75
Phosphorus 160 156 161
Potassium 480 450 490
Moisture:
Microbiology:
Total plate count:
20,000/g max 50,000/g 10,000/g
220
Total coli forms:
100/10g max 120/10g Nil
Salmonella:
E.coli:
Staphylococcus:
Yeast:
Mold:
100/10g max. 123/10g Nil
Defects:
Insect parts:
Foreign material:
221
222
Soy nuts
Roasted soy nuts are whole soybeans that have been soaked in water and then baked until
browned. Soy nuts can be found in a variety of flavors, including chocolate covered.
High in protein and isoflavones, soy nuts are similar in texture and flavor to peanuts.
1. Product name Soy nuts

product < 50000/g
3. How the product is to be used Normally taken as such. They are available
in different flavors like salted and paprika.
They are also covered with a layer of
chocolate.
4. Packaging Sealed polythene bags or in hermetically
sealed metal containers.
5. Shelf-life 8 weeks under normal room conditions.
223
The plant schematic/floor plan is given below.
Wet Processing Area Baking/cooking area
Preparatory Area
Spread in single layer on a
oiled cookie sheet and roast at
190oC for 30-50 minutes,
stirring often until well
browned
Or
Spread on a large
microwavable dish and
microwave on high for 10-15
minutes, mixing the nuts to
avoid burning
Silos/Storage Bins
Soaking in vats in cool

water (15-20oC) (2-3
times) for 6-8 hours.
Cleaners
Garnish with
salt/paprika/herbs
Draining
Cleaned soybeans
Rinsing with cool

water.
224
Transport
nuts are given along with the flow diagram below.

Other

11. Soaking B C
13.Rinsing B P C
15. Baking B P C
16.Garnishing BC 17.Filling C P
18.Weighing B
20.Inspecting B P
21. Labeling B
22. Storing B
23.TransportB
225

Soybeans
moulds.
Dry ingredients
Water
Packaging materials
Processing steps:
Cleaning
Soaking
Rinsing
Baking
Weighing
Transport
product.
Soybeans
226
Water
Processing steps:

storage.
Rinsing

Soybeans
Dry ingredients
Soybean receiving

contamination.

contamination.
The next step is identification of CCPs. The CCP determination is shown in Table 3.
227

step/incoming and
hazard
thermal
processing
C=Pesticides No
(farmers/growers
C= heat level-GPP)
stable toxins No
(farmers/growers
extraneous
foreign object
removal)
B=rodent
excretes
(GMP)
P=HEM
(GMP)
Water at B= GMP
intake C= heavy
metals &
other toxins
(GMP)

step/incoming and
hazard
Cleaning and P=GMP
grading of
228
soybeans
Soaking of Water
soy beans (GMP)
Draining Water, GMP

Rinsing Water, GMP
Filling P (GMP)
Weighing P (GMP)
sealing (Proper
gauge and
sealing
clearance)
Instructions:
question 1.
• Q2: Is this operation specifically designed to eliminate, if no proceed to Q3. If yes
not CCP.
229

hazard
growers.
analysis reports.
230

winnowing. seeds.
area. handling.
methods.
moisture content.
Description of soy nuts manufacturing process: Implementation of HACCP.

231
Storage of secondary materials (CCP 4): The temperature and relative humidity during
Weighing: The soybeans are weighed and passed through a magnetic system so that the
Soaking of the beans (CCP 7): Prepare the soy before soaking. It will remove the
starchy material from the water. Over sprouting and do not drain well enough causes
discoloration and un pleasant odors. Add 2-3 times as much cool (15-20oC) water. Mix
seeds to assure even water content for all. Allow seeds to soak for 2-12 hours. Prefer to
soak for a shorter time. Check after 2 hours for softening. If they are still hard, let them
keep soaking until they are all soft (up to 12 hours). Normally 4 hours is usually the right
soak duration. If over soak they will fall apart.
232
Draining& rinsing (CCP 8): Drain off the soak water. Rinse thoroughly with cool water
(15-20oC). Soy soak water is starchier than most other seeds, so rinse and rinse until the
water that is drained off runs clear. Drain thoroughly.
Baking/deep frying in oil (CCP 9): Spread the soybeans in one layer on a well-oiled
cookie sheet. Roast at 190oC for 30-50 minutes, stirring often until well browned. Or
alternately deep-fry the soaked beans in oil till golden brown color.
Microwave cooking (CCP 9): First soak 100 g soybeans in water at room temperature
for 6-8 hours. Dry them with a cloth or paper. Spread them on a large microwavable dish
and microwave on high for 10-15 minutes, until the beans are crispy and golden brown. It
is important to mix the soy nuts regularly to avoid burning especially at the end of the
process. Flavor the nuts with salt and herbs.
Garnishing (CCP 10): Salt the nuts to taste or may be garnished with other flavors or
may be enrobed with other spices. The concentration of the salts and ingredients are very
important.
Packaging (CCP-10): During packaging the nuts can possibly be contaminated with the
packed with the nuts. The personnel should comply with the GMPs.
Storage of soy nuts (CCP-11): Both the temperature and relative humidity must be
be taken when deviating. When the nuts are stored for a long period, microbiological
233
The synoptical presentation of HACCP is shown in below.
234
235
production of Soy nuts.
Processing step Hazard description Critical Observation procedures Responsible Monitoring Corrective actions
Control procedures
CCP
Limit
Receiving of soybean Presence of foreign material 5% Visual Per lot QAM Control of Rejection of lot or
(CCP-1) in soybean (P) control of specifications and change supplier
sample/contr procure quality
ol of the certificates from
certification suppliers
s per lot
Growth of micro organism
(B)/insects Absence “ “ “ “ “
Fungi (B) Out of five Control of “ “ Evaluation of “

samples two the supplier
of them 102- certificates
4
10 cfu/g. per lot
Humidity
<13%
Protein
236
content 38-
40%
Other macro
and micro
nutrients
sacs etc (CCP-2)
Water Total Coli forms (B) In Lab control Monthly QAM New drilling at New water source
agreement of water greater depths,
with the quality chlorination of water
community
legislation
80/778 for
potable
water (B)
Clostridium (B)
237
(eg. Heavy metals,
chlorine(C)

in water (P) “ “ “ “ “ “
Storage of soybeans Growth of micro organisms Absence Immediate Per lot QAM Control specifications Use them
in silos (CCP-3) (B)/insects control immediately
Fungi In five Notices of Daily

samples two the results of
4
10 cfu/g,
Humidity
<13%
Temperature
<25oC
Air
conditioning
238
Application of anti Residues of the used Tolerant Measuring Per application QAM Control of the “
insect methods at chemicals levels as the amount indication of the
soybean (CCP-4) prescribed of chemical weighing machine.
by BIS/ISO
Presence of physical Residues of substances of Absence Control of Daily QAM Monitoring Repetition of
contaminants (CCP-5)) physical origin in soybean. equipment maintenance of the produces
for equipments .calibration of
appropriate equipment.
functioning
Magnet (CCP-6) Metal residues Absence Control of Every hour QAM “ Repairing of the
equipment equipment
of pipe lines, tanks etc. must be SS practices
and consists like:
of tanks for Pre rinse
water, lye & with water,
acid, rinsing with
disinfectant lye,70oC,
dosing flushing
system, SS with water,
centrifugal rinsing with
pump, SS air acid 70oC,
operated flushing
valves and with water
steam and finally
239
heating disinfection
system. with
disinfectant.
Soaking in water Water quality, operational Good Quality Every run Production Quality assessment of Repetition of the
(CCP-7) parameters quality of check and Manager the ingredients and testing results and
water. observation recording of incase of deviation
Dry of scheduled temperature and time rejection of lot.
ingredients parameters. schedules.
of food
quality
Time/temp
of soaking
Rinsing with water GMP
Draining the water GMP
Baking the beans Temperature of the oven 190oC for Quality Every run Quality Quality assessment In case of deviation
(CCP-8) 30-50 check and Manager reject the lot.
minutes observation
of scheduled
parameters
Garnishing the nuts GMP
Packaging (CCP-9) No migration of low Food grade QC Every lot QAM Regular monitoring Replace the lot
molecular weight film
compounds.
Transportation of GMP/GFHP Vehicle for Use anti
products food insect
transport. methods and
disinfection
240
of the
vehicle
regularly for
maintaining
GFHPs.
Storage of products Control of temperature and Temperature Temperature
(CCP-10) RH < 20oC and RH
RH < 65% should be
regularly
tested. AC
unit must be
checked
regularly for
it’s
functioning.
241
Table 71.Standard nutritive values to be maintained in the product: (100 g salted)
Water 2g
Energy 471 kcal/1972 kj
Protein 35.2g
Fat (total) 25.4g
Fatty acids, Saturated 3.7g
MUFA 5.6g
PUFA 14.3g
Carbohydrates 33.6g
Fiber 17.7g
Ash 3.9g
Isoflavones 200mg
Ca 138mg
Fe 3.9mg
Mg 145mg
P 363mg
K 1470mg
Na 163mg
Zn 3.14mg
Cu 0.8mg
Mn 2.2mg
Se 19.1mcg
Vitamin C 2.2mg
Vitamin B1 0.1mg
Vitamin B2 0.145mg
Vitamin B3 1.41mg
Vitamin B5 0.45mg
Vitamin B6 0.21mg
242
Folic acid 211 mcg
Vitamin A 200 IU
Vitamin E 0.91mg
243
Tempeh
Tempeh is a cake of soybeans that is made by removing the hulls of cooked soybeans,
mixing with a culture of tempeh starter and ageing for a day or two. The culture helps
hold the soybeans together in a cake form. It is common to tempeh made with added
ingredients such as vegetables, grains or other beans. During tempeh production the
soybeans are acidified to prevent the growth of spoilage bacteria. Tempeh has a tender
chewy consistency that makes it an excellent addition to variety of foods. The easiest way
to prepare tempeh is bake the sliced tempeh in a pan with a lot of oil until it becomes
crisp.
1. Product name Tempeh

product < 50000/g
3. How the product is to be used Normally taken as such after baking in oil.
It is also added as an ingredient with
vegetables, grains and beans.
4. Packaging Sealed polythene bags.
5. Shelf-life 3 days under refrigerated conditions.
244
nuts are given along with the flow diagram below.

Other

11. Soaking B C
13.Rinsing B P C
15. Dehulling B P C
16.Cooking B, P, C
16.Inoculation B
17Incubation B 18.Filling C P
19.Weighing B
21.Inspecting B P
22. Labeling B
23. Storing B
24.TransportB

hazard
Soybeans could contain pesticide residues Up stream( farm level) programs such as
growers.
analysis reports.
245

winnowing. seeds.
area. handling.
methods.
moisture content.
Description of tempeh manufacturing process: Implementation of HACCP.

246
Storage of secondary materials (CCP 4): The temperature and relative humidity during
Ingredients: Besides whole soy beans, acidulant (vinegar), and tempeh starter are
required to make the tempeh. Tempeh starter contains spores of Rhizopus oligosporus or
Rhyzopus oryzae. They should be of superior quality and free of contamination.
Soaking and dehulling of soybeans (CCP- 7): Whole soybeans can be dehulled by
soaking the beans for 8 - 14 hours in water and then removing the hulls by hand. In doing
so, the beans are split into two halves and the seed coats are discarded.
Cooking the dehulled beans (CCP-8): The dehulled beans are cooked for 15-20 min.
Drain and remove the cooked beans onto towels to drain off the excess water and to cool
the beans, which are now swollen and soft. It's important that the beans become very dry.
247
Otherwise undesirable bacteria can grow which will create off-flavours.
Inoculation of the beans (CCP- 9): Put the cool and dry beans in a clean container and
sprinkle them with 1 teaspoon of tempeh starter (can be ordered at tempeh.com) and mix
thoroughly.
Incubating the beans (CCP-10): Take 2 plastic bags 18 x 28 cm and perforate them with
holes at a distance of about 1 cm by a thick but sharp needle. Divide the soybeans in the
two bags and seal them. Press them flat, making sure that the total thickness of the beans
is about 3 cm. Place the packed beans in an incubator at 30°C or at a warm place for
about 24- 48 hours or until the container is filled completely with white mycelium and
the entire contents can be lifted out as a whole piece. A simple incubator can be made
with putting a light bulb in an old fridge. Depending on the room temperature bulbs with
different wattage (15W, 25W,) can be used, but remember that the tempeh will also
produce some heat on its own.
Packaging (CCP-11): During packaging the tempeh can possibly be contaminated with
other microorganisms causing quality deterioration. Hermetic sealing and upright
position of the packaging material can avoid this. There should not be any migration of
the low molecular weight substances from the packages. Further more contamination can
take place from foreign materials like insects and rodents that accidentally happen to be
packed with the nuts. The personnel should comply with the GMPs.
Storage of tempeh (CCP-12): The fresh tempeh will feel warm and will have a pleasant
mushroom flavor. The finished tempeh can be stored in refrigerator for 3 days.
248
Before inoculation After growth of fungus
Nutritional values of tempeh

Since tempeh is made from whole soybeans, it is rich in fiber and soy isoflavones. It is
also a generous source of many nutrients such as calcium, B-vitamins and iron. As
opposed to other soy products, tempeh can contain a small amount of vitamin B12, which
is coming from the bacteria, which do grow with the tempeh cultures.
249
Table 77.Nutritional values of tempeh (per 100g)
Water 54.9 g
Energy 199 Kcal
Energy 833 KJ
Protein 19.0 g
Fat (total lipid) 7.7 g
Fatty acids, saturated 1.11 g
Fatty acids, mono-unsaturated 1.7 g
Fatty acids, poly-unsaturated 4.3 g
Carbohydrates 17.0 g
Fiber 4.8 g
Ash 1.4 g
Isoflavones 53 mg
Calcium, Ca 93.0 mg
Iron, Fe 2.3 mg
Magnesium, Mg 70.0 mg
Phosphorus, Mg 206 mg
Potassium, K 367 mg
Sodium, Na 6.0 mg
Zinc, Zn 1.81 mg
Copper, Cu 0.67 mg
Manganese, Mn 1.43 mg
Selenium, Se 8.8 µg
Vitamin C (ascorbic acid) 0.0 mg
Thiamin (vitamin B1) 0.131 mg
Riboflavin (vitamin B2) 0.111 mg
Niacin (vitamin B3) 4.63 mg
Panthotenic acid (vitamin B5) 0.355 mg
Vitamin B6 0.299 mg
Folic acid 52.0 µg
Vitamin B12 1.0 µg
Vitamin A 69 µg
250
15. Approximate expenditure incurred in the project (Rs):
i. Salary of Scientific staff: 3, 00,000
ii. Salary of Technical staff: -
iii. Salary of Supporting staff: -
iv. Miscellaneous /contingencies: 10,000
Cost of laboratory equipment/chemicals/glassware: -
Total: 3, 10,000
16. Conclusions and Recommendations

16.1 Conclusions
251
HACCP procedures were developed for making Soy based foods with utmost quality and
safe for use.
16.2 Recommendations
The HACCP procedures developed may be used for the production of different soy based
foods with Good Manufacturing Processes and Good Food Hygiene Practices
recommended by the codex Alimanatarius Commission/FAO for maintaining the safety
and quality of the products. It improves the utilization of soy-based foods domestically.
These products will also have great export potential as per the International standards.
17.(a) Papers Published
i. Gandhi, A.P. (2008) Development of HACCP procedure for the production

of Full fat Soy Flour, International Food Research Journal 15(2), 141-154.
ii. Gandhi, A.P. (2008). Production of Soy Nuts using the Hazard Analysis
Critical Control Point (HACCP) procedure. Asian Food Journal 1 (3),p
iii. Gandhi, A.P. (2009). Quality of Soybean and its food products-a review.
International Food Research Journal.16 (1).
(b) Papers presented

i. Gandhi, A.P (2008) Development of HACCP protocols for the production
of soy milk, presented in the ISPUC, held at CIAE, Bhopal, December 10-
14,2008.
18. Details of field/laboratory books and final materials and their location: The data
registers are with the Project Leader and the reports are available in the center.
19 Acknowledgments:
252
Gratefully acknowledges the cooperation received from the Director, CIAE; Project
Director and staff of SPUCenter in accomplishing the project.
20 References:
253
Bernard, D.1998. Developing and implementing HACCP in USA. Food Control, 9(2-3):
91-95.
254
Burges, K.J. (1994) An overview of Good Manufacturing Process, International Dairy
Federation, 271:12-19.
CMSF. (1988). HACCP in microbiological safety and quality. Blackwell Science:

London
Codex (1993). Principles for the establishment and application of Microbiological

Criteria for Foods, Codex Alimentarius Commission Procedural Manual, 8th Edition,
1993; 109-116.
EC-ASEAN Economic Cooperation Programme on standards, quality and conformity

assessment (2005). Guidelines on HACCP, GMP and GHP for ASEAN Food SMES.
FAO (1995). The use of hazard analysis critical control point (HACCP) principles in food
control, FAO Food and Nutrition paper 58.
FAO (1998). Food Quality and safety systems-a training manual on food hygiene and the
Hazard Analysis and Critical Control Point (HACCP) system.
FAO (1999). Understanding the Codex Alimentarius.
FAO (2001). Food Hygiene Basic Texts. Codex Alimentarius.
FAO (2003). Recommended International Code of Practice- General Principles of food

Hygiene.
FAO/WHO (2004) Guidance to governments on the application of HACCP in small

and/or less developed food business, FAO Food and Nutrition Paper 86.
Food Quality and Safety Systems (1998). A training manual on food hygiene and the
hazard analysis and critical control point (HACCP) system.
FPI (1993). Establishing Hazard analysis Critical Control Point Programs, a workshop
Manual. The food processors’ Institute, Washington, D.C.
Gandhi, A.P. (2006) General Principles of Food Sanitation and Hygiene, Beverage and
Food world, 33(11), p 40-42.
255
Gandhi, A.P. (2006) Soybean-the greater bean, World Grain (USA), February issue, p 59-
62.
Gandhi, A.P. (2008) Development of HACCP procedure for the production of Full Fat
Soy Flour, International Food Research Journal, 15,141-154.
Gandhi, A.P. (2008). Production of Soy Nuts using the Hazard Analysis Critical Control
Point (HACCP) procedure. Asian Food Journal 1 (3),p
Gandhi, A.P.2009. Quality of Soybean and its food products-a review. International Food
Research Journal.16 (1).
Ioannis S. Arvanitoyannis and Athena Traikou (2005) A comprehensive review of the

implementation of HACCP to the products of flour and flour based food products,
Critical Reviews in Food Science and Nutrition, 45:327-370.
Mauropoulas, AA and Arvanitoyannis, I.S. (2000). Application of HACCP system to feta

cheese and manouni production line, Food Control, 10:213-219.
Mc Swane, Rue, N and Linton, R. (2000). Essentials of Food Safety and Sanitation, 2nd
Edition, Prentice Hall Inc; NJ, USA.
Mortimore, S. and Wallace, C. (1994). HACCP: A practical approach. Chapman and

Hall: London, USA.
National Advisory Committee on Microbiological Criteria for Foods (NACMCF) (1997).

Hazard Analysis and Critical Control Point Principles and Application Guidelines.
Oakland (1993). Total Quality Management, pp 3-35, Butterworth Heinemann, Oxford,

UK.
Pierson, M. D. and Corset, D.A. (1992). HACCP. Principles and Applications. Chapman
and Hall, New York.
Sandron, D.K. and Arvanitoyannis, I. (1999). Implementation of HACCP system to meat

and poultry industry: A review. Food Rev.Int.15 (3): 265-308.
Sandron, D.K. and Arvanitoyannis, I. (2000). Implementation of HACCP system to the

dairy industry: A review .Food Rev.Int.16 (1): 77-112.
Sandron, D.K. and Arvanitoyannis, I. (2000). Implementation of HACCP system to the

cheese making industry: A review. Food Rev.Int.16 (3): 327-369.
256
Sperber, WH (1998) Auditing and verification of food safety and HACCP. Food Control,
9(2-30,157-162.
United States Department of Agriculture (USDA). (1997). Guide Book for the
preparation of HACCP Plans. USDA: Washington, USA.
USDHH/FDA/Centre for Food Safety and Applied Nutrition (2006). Managing Food
Safety-a Manual for the voluntary use of HACCP principles for operations of foods
service and retail establishments.
USDHH/FDA/Centre for food Safety and Applied Nutrition (2006). Managing Food
Safety-a Manual for applying HACCP principles to risk based retail and food service
21. Signatures and name of the Investigator:
(A.P.Gandhi)
22. Signature of Project Director:
(S.D.Kulkarni)
23. Signature of the Director (with comments if any)
(MMPandey)
257
258
ANNEXURES
259
Annexure-1
Forms /Register to be maintained by the manufacturer
Form Description Location Issue Status CCP Approval
No monitoring date
1 Soybean Purchase Log Office
2 Soybean Processing Chart
3 Soybean Processing Chart
2 (Yield Estimation &
Processing Results)
4 Factory Quality Checks
5 Corrective Action Log
6 Calibration Records
7 Periodic Sanitation
Control Record
8 Factory Schematic. Floor
Plan
9 Chemicals, cleaners and
sanitizers
10 Product Testing Chart
11 Customer Complaints
12 Employee Health
13 Daily Sanitation Control
Record
14 End of day clean up/
sanitation Inspection
Form
15 Cold Room Temperature
Chart
260
261
Annexure-2
Soybean Processing Chart
Date Batch No
Date unloaded
Quality assessment Reject if does not confirm to the standards.
Stored in silos at controlled temperature
and RH
Date removed from the silos
Product Description
Temperature of Processing Room
Unit Operations (Step wise)
Yield % of product
Aw of final product
Quality assessment of the product
Storage of the product at standard RH and
temperature.
Destination and date transported
Production problems
Action(s) Taken
Factory Supervisor
262
263
Annexure-3
Assessment of the implementation of pre-requisites
Inspection (audit) number ……………………
HACCP Audit Grid (number 1/4) sa = satisfactory
ac = acceptable
ns = non satisfactory
ab = absence
na= not applicable
Control of Contamination sources
Considered criteria Documents associated to these criteria
1 Buildings Plan of the establishment (1/500 to 1/1000) showing:

1.1 Conformity of the premises: general organization: - drinking water supply
- Conformity of the establishment immediate surroundings........................ - waste water drain off
- compliance with the onward flow principle ............................................. Plan of the establishment (1/100 to 1/300)showing:
- separation of clean sector and unclean sector .......................................... - identification of rooms.............................................................................
- no crisscross of the production lines ......................................................... - position of workstations and the equipment
- separation of hot zone and cold zone ....................................................... - position of cloakroom and toilets.............................................................
- location of inputs/outputs of flows (staff, products,) ..........................
- flowchart of flows (staff, products, raw materials, waste,)..................
1.2 Conformity of the premises: construction : Explanatory leaflet of materials used and techniques of constructions
- wall coverings: smooth, light colored, washable, resistant...................... employed
- floor covering: smooth, light colored, washable, resistant ...................... ..............................................................................................................................
- floor and walls joined by round gorge assemblages ..................................
- floor grids and U-bends to collect waste water .........................................
- ventilation devices ensuring steam and smoke elimination ……………...
- lighting bright and neutral in color ……………………………………...
264
HACCP Grid 1
1.4 Lawful or normative conformity..……………………………. Documents attesting of:

national approval……………………………………………...............................
foreign country importation approval………………………................................
certification of voluntary setting in conformity with specific food safety
standards…………………………………………
1.5 Maintenance of buildings and equipment………………………… Daybook of technical mending of buildings and
equipment.................................
2 Supplies Contracts past with suppliers

2.1 Contractual relationship with the suppliers ……………………… criteria of acceptance of batches
planed corrective actions for any case of loss of control......................................
2.2 Raw materials specifications. Cards of specifications of raw materials. ............................................................

Composition .........................................................................................................
Microbiological standards ....................................................................................
Residues limit content ..........................................................................................
conditioning (type, volume, weight…) ................................................................
Preserving conditions ...........................................................................................
lifespan .................................................................................................................
Organization of stock turnover ...........................................................................
2.3 Checking of deliveries …………………………………………… Recording cards of control of deliveries ..............................................................

temperature of delivered products .......................................................................
intact conditionings...............................................................................................
compliance with consumption deadlines...............................................................
labeling compliance with official food safety marking rules...............................
265
cleanliness of the delivery vehicle ........................................................................
2.4 Water portability…………………………………………………. Analysis or certificate of water potability

3 Implementation of a system of traceability ............................................................
3.1 System of upstream
traceability........................................................................ Specimen of simulation test of upstream traceability
Recordings relating to upstream traceability: .....................................................
delivery control cards ...........................................................................................
3.2 System of downstream listing of raw materials stock ..............................................................................
traceability..................................................................
Specimen of simulation test of downstream traceability
Recordings relating to downstream traceability ..................................................
customers purchase orders ...................................................................................
listing of finished product stocks ..........................................................................
customers invoices ...............................................................................................
4 Pest control
4.1 Implementation of a pest control Pest control plan…………………………………………………………………
plan.............................................................. Insect control plan……………………………………………………………
- management of the outdoor dustbins, absence of waste on the ground.............. …..
- management of materials and equipment outdoor storage ................................. Intervention forms of the pest control company (department)...
5 Control of staff originated contaminations

5.1 Medical follow-up of the staff members Individual health certificates of food handling ability
5.2 Plan of staff training Time table and contents of training activities
5.3 Clothing hygiene: Staff members vocational training certificate

standard work clothing supplied by the company washing of clothing by the In house management procedure of clothing , or washing supplier contract
company or under its responsibility management of clean and dirty clothing
lockers with 2 compartments
boots/shoes washstands in conformity with standards
5.4 Compliance with GHP and GMP Specific approved GHP and GMP guide of the production sector or ..................
in house manual of the GHP and GMP of the company
6 Hands and premises cleaning
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6.1 Hands Posting of washing hands instruction near the washstands
washstands in conformity with standards or regulations
washing hands procedures
6.2 Premises Sum of written cleaning procedures comprised in "cleaning plan"
enforcement of a cleaning plan Check-grids of good execution of cleaning tasks
microbiological Control of effectiveness of cleaning Weekly check-grid of visual cleanliness of equipment surfaces
Reports of microbiological controls of surfaces
Assessment of the phase of preliminary HACCP study

Assessment carried out following the chronological continuation of the method tasks
Task number 1
1.1 Management engagement Management engagement declaration letter
1.2 HACCP team founding Organisation chart of the HACCP team ...............................................................
members of the staff involved in the HACCP team Individual post sheets ...........................................................................................
assignment of technical tasks and responsibilities Individual vocational training certificates ............................................................
training of the team to HACCP method
calling in external experts
1.3 Means put at the disposal (computer, photocopy, Listing of the HACCP team functioning means....................................................
budget…)............................
1.4 Activities management Planning of activities.............................................................................................

organization, programming Timetable, deadlines file .....................................................................................
dissemination, updating of successive versions of HACCP documents Working sessions reports ......................................................................................
field of study and compiling of specific data Flow chart of dissemination of HACCP documents
Bibliographical collection: technical and lawful data relating to the sector of
production and the type of analyzed
hazards.........................................................
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Task number 2
2.1 Description of the product Descriptive file of the product..............................................................................
composition, volume, conditioning
raw materials specifications: composition, proportion in the finished product,
physicochemical parameters, lifespan, preservation, pre
treatment........................
Task number 3
3.1 Identification of the expected use User instructions manual.......................................................................................
lifespan Labelling
expected groups of consumers Mandatory ...................................................................................................
conditions of use Informative ..................................................................................................
foreseeable deviations of use
Task number 4
4.1 Draft of the flow diagram
...............................................................................................................................
...............................................................................................................................
Task number 5
5.1 Verify the flow diagram Flow diagram(s)
flow diagram in accordance with real field conditions for each product or each family of products ........................................................
........................................... or by current elementary operations usually associated to carry out the products
taking into account of all the productions rates (high and (cookery)...............................................................................................................
low).............................. or by work periods ................................................................................................
contents of the diagram: nature of the stages, inputs, contacts, physicochemical
parameters (T°, time, Aw, pH)
Task number 6
6.1 Hazards analysis List of identified hazards......................................................................................
analysis of the considered field hazards (biological, physical, chemical) based Transposition of the identified hazards on the flow diagram then on a table
on the related to the stages of production
flow diagram Risks assessment report (calculation of index of criticality)................................
risk assessment by calculation of index of criticality Identification and collection of the preventive measures relating to each risk...
................................................ ..............................................................................................................................
..............................................................................................................................
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Operational procedures of implementation of these measures..............................
6.2 Preventive measures
drafting...............................................................................
List of CCPs
Task number 7
7.1 Determination of CCPs
by the use of the Codex decision tree
or by the intuitive method
plus identification of a related quantifiable and manageable parameter(s)
Task number 8 List of the selected criteria and their required justifications
8.1 Determination of critical limits for each CCP
selected criteria
required justifications
bibliographical data on the microbial flora
results of ageing
lawful obligations
Evaluation of implemented HACCP plan

Assessment carried out following the chronological continuation of the method steps
Task number 9
9.1Implementation of a monitoring system for each CCP Manual of operational procedures.........................................................................
Models of recording documents of the measured values, used within the
framework of the monitoring procedures..............................................................
Duration.......................................................................................................
Temperature.................................................................................................
pH................................................................................................................
Aw...............................................................................................................
measurement of quantities: volume, weight, and formulation ...........................
Measuring instruments calibration Plan of calibration of the measuring instruments..................................................
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Task number 10
10.1 Draft of corrective actions to implement in the event of loss of control Table of correspondence between the observed deviations and the corrective
(deviation of the monitored values) action type that must be implemented...................................................................
Operational procedures manual of corrective actions ..........................................
10.2 Ensure the follow-up of the batches subjected to corrective actions Model of monitoring sheet of batches subjected to corrective action
(traceability of
these batches)
Task number 11 Plan of analysis of products (raw materials, in production or finished products):
11.1 Establish verification procedures ..............................................................................................................................
microbiological analysis of the finished sampling plan (number and frequency of samples)...............................................
products................................................... types and standards of the microbial flora of the products....................................
simulations of deviations or losses of report of bacteriological analysis of products
control......................................................... .......................................................
recordings audit Microbiological analysis plan of equipment surfaces
...................................................................................................... ...........................................
checking of compliance with the implemented corrective actions sampling plan (number and frequency of samples)...............................................
......................... types and standards of equipment surfaces microbial flora..................................
validation of good cleaning practices report of bacteriological analysis of equipment surfaces
..................................................................... ......................................
Audit reports (in house or external) ......................................................................
11 .2 Define practical methods of
checking............................................................
Task number 12
12.1 Establish documentation and records keeping
The whole of the documents taken into account at the preceding steps................
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Annexure-4
Routine evaluation of the real and effective implementation of an HACCP plan in the company
This fourth part is a documentary review. The documents relating to the good practices of hygiene are examined first. Then those relating to HACCP method are
examined (in particular those which refer to the control of the CCP)
13 Implementation of GHP and GMP: real and effective Raw material delivery checklists correctly and immediately kept........................
13.1 Supplies Satisfactory water analyses reports
monitoring........................................................................................
13.2 Cleaning plan validation Checklists of cleaning tasks execution correctly and immediately completed...
..............................................................................................................................
Satisfactory results of microbiological analysis of surfaces..................................
13.3 Pests control Intervention forms of pest control service correctly filled ...................................
plan............................................................................................
Staff medical certificates correctly updated
13.4 Medical follow-up of the staff
Individual staff training certificates
13.5 Staff training Maintenance daybook correctly kept
13.6 Maintenance of buildings and equipment

13.7 Upholding of the conformity and provisioning of the washstands
(observation
in the course of visit)
13.8 Upholding of the conformity and provisioning of the boots/shoe
washstands
(observation in the course of visit)
14 HACCP plan , CCPs control

14.1 CCP Recording relating to CCPs monitoring :
monitoring.............................................................................................. temperature recordings of the cold stores .............................................................
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records of inventory control (respect of consumption deadlines) ........................
records of heat treatment couple "duration / temperature", schedules of
sterilization, pasteurization, cooking
.....................................................................
measurement records of pH (dairy products, dry salted meats)
............................
measurement records of water activity (Aw) ........................................................
measurement records of weights, volumes, formulation rates ..........................
reports of calibration (in house or official way) of measuring instruments
(scales,
Monitoring sheets of corrective actions correctly and progressively filled until
the
departure of concerned batches............................................................................
Analysis reports of raw materials or in production or finished products .............

14.2 Corrective action follow- ..............................................................................................................................
up............................................................................ Simulations of upstream and downstream traceability realized randomly at the
14.3 Finished products conformity time of the visit .....................................................................................................
14.4 Recordings of simulations of incidents / or simulation of incident during the

Traceability..................................................................................................... audit
session...................................................................................................................
14.5 Simulations of incidents

.................................................................................
thermometers…) ...................................................................................................
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Annexure-5
Audit Report Template
Name of the Establishment: Industry:

Address: Staff member
met:
Phone number: Number of
employees:
Fax Number: Volume
production:
e-mail:
Inspection note number:

Page number:
Grid reference Observation Document Short Possible

comings solutions
Conclusions:
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Annexure-6
Hazards
(Hazard Examples)
Chemical Hazards:
Raw Materials During Process
Pesticides Cleaning agents
Growth regulators incorrect ingredient concentrations
Antibiotics Hydrocarbon lubricants
Heavy metals Refrigerants
Natural toxins Pest control agents
Microbial toxins Allergens
Allergens Fumes/dust
Packaging
Plasticizers
Ink/adhesive
Metals
Physical hazrads
The list is endless, including foreign objects of all kinds. The food industry tends to take
special care over some types that easily cause damage if eaten by people, such as glass9
prerequisite- a glass management policy and management system) and metals
(prerequisite – good maintenance management). However, in this latter case, metal
detection also in use and is normally treated as a CCP. This of course, means that the
correct term is metal rejection- simply to detect metal is clearly not the object of the
activity.
Microbiological Hazards
Pathogenic bacteria Presence
Parasites and protozoa contamination
Viruses and algae survival
Moulds growth
- the organism or its toxic products.
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Annexure-7
Calibration
Measuring equipment used to monitor Critical Control points (CCPs) (and also product
legality factors, such as fill volumes or average weights) shall be calibrated and where
possible, traceable to a recognized national standard. Where a national standard is not
applicable, the nature of the basis of the calibration shall be described.
All too often, companies establish calibration methods involving routine use of
subcontractors, or regular internal systems whereby instruments are calibrated very
frequently with a very accurate method. This is not always necessary- calibration is
required to keep systems in control, but this can be maintained with simpler methods that
are referred back to a national standard on a less frequent basis. What matters is that the
frequency and the accuracy of calibration is appropriate to ensure that instrument
variations are identified before they take the instrument out of allowed tolerance. Weight
scales, for example can be calibrated against a reference set of brass weights preserved by
the company in a good condition, (perhaps normally locked away in the Quality
managers’ office). This reference set need calibration to national standards only, for
example, every five years or so, unless damaged.
Thermocouple probe thermometers are notorious for going out of calibration. A frequent
rapid method of checking is required to maintain good measurement systems, coupled
with a less frequent reference back to a national standard.
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Annexure-8
HACCP Certification
HACCP Certification- Warnings
A frequently defined objective for developing an HACCP system is to obtain recognition

by an expert body in the form of certification from a third party audit (perhaps required
due to customer pressure). This practice has value in providing extra verification of
validity and effectiveness of the system, but it does present a risk. The award of
certification does not mean that the system is faultless. No auditor is perfect- the illusion
of excellence provided by a certificate can lead to situations where a business may
believe that it operates a flawless HACCP system. It may well then not maintain
effectiveness of its own certification (auditing) processes. Companies should beware of
HACCP certification that is offered as a route to enable a company to export into other
countries. In all cases the authorization for exports will be delivered only by the National
Competent Authority, which approves the food establishments, involved. Demonstration
of good practice with an HACCP certificate will only provide part of any evidence
required and is a good route to demonstrating committed management, but other
approvals are also needed at national level, such as use of accredited laboratories.
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Annexure-9
Correlation with other standards
ISO 22000: 2005- Food safety management systems-requirements
As its title suggests this standard sets out a systematic approach to food safety, combining
two approaches into an effective tool for management. These approaches are:
• the management system approach, as normally understood in ISO 9001:2000
except that ISO 22000 looks at the customer requirement of food safety ONLY
and not at all the other requirements that are expressed as customer requirements.
For companies that use management systems, this means that an ISO 22000
approach can fit food safety very easily into this pattern.
• ISO 22000 is almost exclusively based on HACCP, with less attention to GHP,
GMP or other prerequisites (which it terms as supportive safety measures). With
this attention to HACCP, it provides a flow diagram demonstrating linkages
between the twelve tasks of HACCP and its own sections.
The Global Food Safety initiative (GFSI)

This is a comprehensive private initiative for food safety resulting from cooperation
between major European food retail super and hypermarket chains. Because of their need
to demonstrate due diligence the protocol is comprehensive. Its specifications go beyond,
but include those of this GHP, GMP, and HACCP guide. It is much more prescriptive in
setting its requirements.
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Annexure-10
Food chain steps
There are different steps in the food chain Every step must be covered by specific
standards to ensure a high level of food safety. The whole food chain must be monitored.
This includes also the environment as there is no seafood in a poisoned sea and there are
no crops in a dead landscape. The aim is to link failed productions with their causes so
auditing can find failures of the existing food safety systems and avoid harm.
The different steps in the food chain are:

Agrarian origin,
Transportation,
Storage
Industrial processing,
handling by the consumer.
Food safety depends on:

1. Basic knowledge in farming, industrial know-how, transport and storage.
2. Ethical behaviour
3. Controls: HACCP, ISO 9001:2000, GMP, HALAL
What to take care of in order to ensure food safety
a - Biological hazards: Bacterial infections (Salmonella, Shigella, Campylobacter,

Aspergillus), virus infections (Hepatitis, Creuzfeld-Jacobs-Disease) b - Parasites:
Such as nematodes in herring and other relevant worms.
c - Chemical contaminants: Herbicides, pest control substances and other

chemicals such as mercury in Japan.
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d - Bacterial poisoning: Natural toxins can harm people even after the
agent has been removed or killed. (Staphyloccocine, botulism and other
poisons)
e - Physical hazards: Ground Glass, metal or plastic fragments.
f - Radioactive contaminants: Radioactive fall-out of nuclear tests such as

Brazil nuts with Strontium 90 due to fall-out of nuclear tests coming down
in the rain forest of the Amazon region, or fall-out from the catastrophe of
Tschernobyl.
g - Wrong industrial food processing and bad kitchen habits: High

Temperature on backing and frying. Just to mention acrylamid in french
fries, crisp bread and breakfast cereals.
h - Wrong nutritional habits: Under- or oversupply of vitamins and
trace elements, insufficient supply of dietary fiber.
History of HACCP
The HACCP concept had its origin in the USA and stands for "Hazard Analysis Critical
Control Point".
Chronology of its development:
1958- Foundation of the NASA (National Aeronautics and Space Administration)
1959- Development of the HACCP concept to assure one hundred percent safety of food
to be used in space.
1971- The HACCP system was published and documented in the USA.
1985- The National Academy of Science (NAS) recommended the use of the system.
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Worldwide the system became used and the FAO/WHO Codex Alimentarius (Food and
Agriculture Organisation/World Health Organisation) cited the system in the Codex.
1993- The European regulation 93/43 EG from 14.7.93 provides the use of the system for
the production of food.
1998- With coming into force on the august the 8th of 1998 the Hygiene Verordnung
(German hygiene Rule) demands the use of the HACCP system in Germany.
The HACCP-concept
The European hygiene rule defined in the paper 94/356/EG demands for an HACCP-
concept which can be integrated in a quality management system
This HACCP concept has to be developed for all products of every factory. The five basic
ideas of HACCP-concept are:
1. Make a hazard analysis

2. Determine the critical points (CPs) which might be of hazard in the production of
the food.
3. Determine the CPs which may be CCPs being of high importance to the safety of
the food and which may be controlled safely using simple checks named
"Controlling".
For the controlling define the specifications of the product.
4. Define a control system of the critical points, using tests which can be carried out
during production in order to interfere in case of wrong production. "Monitoring".
Introduce a documentation in order to record every happening.

Define the corrections to be made in case of critical point being out of control.
5. Define the way of verification to confirm that the HACCP-system
works."Verification”.
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Timetable to install an HACCP System
1. The head of the enterprise names the QS Manager who is responsible for the
installation of the HACCP System
2. The QS Manager names the members of the team which shall work out the
HACCP system. The team should be composed of members of the production
line, members of the bacteriological control, members of the quality control,
members of the development. There should be persons with knowledge of food
bacteriology, food hygiene, food technology. If there are not such persons in the
factory, external aid should be taken in the phase of installing the system.
3. The team determines what products can be handled together "Valid for.."
4. Come together of the team to make a "Description of the Products".
It should contain:
A short description of the product.
List of regulations and laws which regulate the food.
The list of the ingredients .
Important specifications of the product such as chemical and bacteriological limits
Temperatures, Packaging of glass, tin can, PP, PE, paper or aluminium wrapping
Shelf life ,Instructions of use and storage conditions.
5. Come together of the team to make the "Flow Diagrams of the Products".
6. The team checks all documents to make corrections of possible errors.
7. The team marks all CPs on the flow diagrams.
CPs are all points were a hazard for health of the consumer might occur.
8. The team identifies and marks all CCPs on the flow diagrams, trying to have a
low number of critical control points. CCP is a Critical Point were the hazard can
be avoided, eliminated or reduced to an acceptable level.
How to identify a CCP ?
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At any point of the production line ask the question:
- Is this point a hazard to the health of the consumer ?
9. IF NO go to the next point. IT IS NOT A CP

IF YES . The hazard is put under control at this point and it is reduced to an
insignificant tolerable danger with the correct activity or it is totally eliminated.It
IS A CCP and is put under control
- Are the control activities sufficient to avoid, eliminate or reduce the danger to an
acceptable level?
NO, the technology of the production should be changed. YES, the CCP is
marked in the flow diagram. and the controls are enumerated how often they have
to be done and what specifications have to be observed.
10. For every CCP there should be made a list containing the following informations:
The place were the CCCP is situated (heater, packing line, Storage), What kind of
controls should be made ( chemical bacteriological), What kind of instruments are
necessary (thermometers, culture agar, microscope) ,Instructions how to handle
the instruments and detailed description of the laboratory methods ,How often
shall the controls be made? Who makes the controls ? (Name the personal and the
substitutes who have to make the controls)
11. The team determines the tests to be made at the CCPs (temperature, pH, acidity,
filter, metal detector etc. The team marks the intervals between these tests.
12. The team determines the corrections to be made in case of fail production. The
team determines who is responsible to execute the corrections
13. The team determines the methods used to control the CPs
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14. The QS Manager verifies if the system works or not and if the internal audits are
made in time HACCP is a living system. After installing the system it should be
rechecked periodic. The work on the basic documents will never end.
Don't forget to answer in your documents the following questions:

Who controls? When? How the controls are made? Where the controls are made? Make a
drawing of the building enumerating the rooms
1. Make a drawing of the machines enumerating them

2. Make a diagram of the production line with including the material flow
3. Make a drawing of the rooms containing all water tabs, enumerating them
4. Make a drawing of the way the personal has to walk, starting from the entrance to
the room where they may change clothes, the way to their working place, the way
they have to go during work and the way back to change clothes.
5. Make a drawing of the sewage system
6. Make a plan of progressive education of the personal. This plan should include
informations about new machines, new products, hand washing and disinfection,
informations about shelf life of the products.
Fingernail colours make an inspection of clean nails difficult. Therefore it should
not be allowed.
7. Make a cleaning and disinfection plan
8. Make a plan to control the cleaning and disinfection
9. Plan of the controls of water used in production
10. Plan of pest control
Industrial hygiene is teamwork. Everyone engaged in production of food must cooperate.

There must be a detailed description of every work. The procedural rules should be
available at the place where work takes place. The quality and the safety of the end
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product depends on interventions at all stages of agricultural production or harvesting
through manufacture, processing,storage and transport to the final consumer.
The main concern is to avoid contaminations originated from:
• Biological factors :
• Bacteria, such as Salmonella, pathogen Escherichia coli, Clostridium botulinum,

• Viral infections or BSE.
The biological factors can be avoided through cleaning and disinfection activities.
They must be supervised by a controlling person making periodic surface contact

cultures and cultures from different points of the production line.Bioluminescence
ATP tests are also performed with good results.
On market there are test stripes which indicate after some minutes the presence of
proteins signalising bad cleaning.
• Introduce a documentation in order to record every happening.

• The Hygiene rule 93/43/EWG demands also for a hygiene training of the staff.
• Chemical factors:
• Residues of cleaning agents, insecticides and other chemicals. Very important is to
make sure that all residues of cleaning and disinfection agents are eliminated
before product processing starts. This is done with rinsing with clean drinking
water. There should be a daily cleaning and disinfection plan.
• Physical factors:
• Splinters of metal, glass, bones, wood, stones and other materials.
System to avoid the risk of physical factors are filters, X-ray scanners and metal
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detectors are widely used. Other materials can hardly be detected. So every effort
should be undertaken to avoid splinters of glass, wood and plastics into the food.
The bottles should be turned overhead and blown out with a flush of compressed
air before filling. All the way to the filling should be covered, so splinters cannot
get into the glass. Start a "Glass damage book" where damage of Glass is
registered telling the name of the product, the filling machine, the name of the
operator, date and the time of damage.
All handling and controlling of the production of food should be conform to the system
of "Good Manufacturing Practice ( GMP ).
Risks which might endanger the health of consumer

The health of the consumer may be endangered by following factors:
• Contamination and recontamination of food by pathogen bacteria

• Parasites or chemical substances
• Survival of heat processing of pathogen bacteria, her later multiplication under
favourable conditions and formation of undesired chemical reactions
• Formation or undesired, toxic substances and formation of bacterial toxins
Hazard Analysis and Critical Control Point (HACCP)
The HACCP - Concept is now introduced by the Hygiene Rules 93/43/EWG in the
production line of food in Europe. It bears the main ideas from the worldwide accepted
HACCP-System of the FAO/WHO Codex Alimentarius. The HACCP is a system
demanded by the EG Hygiene Directives and avoids the hazards to the health of the
consumer. Everything which is not a hazard to the health of the consumer is not covered
by the system.
Hazard
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With hazard every risk of the health of the consumer are meant.
Excluded are all events which are not related to health. This is the difference of the
Quality Management of ISO 9.000 which covers every events of quality.
Critical Point
It is every point in the production of Food where risks of the health of the consumer can
be present.
Critical Control Point
A Critical Control Point ( "CCP" ) is a point in the production line where a risk of
hygiene may be put under control or eliminated.
With appropriate measures at that point the risk can be:
• avoided
• eliminated
• or reduced to an acceptable level
Examples of critical control Points (CCPs) are:
• Income of raw materials

• Storage and cooling of food
• Recipes, handling and processing of food
• Defrost, heating, warm hold phase and cooling

• Distribution of food in restaurant, fast-food
• pH of food
• Correct separation between clean and unclean sectors
• Cleaning and disinfection
• Hygiene of the surroundings and hygiene of the stuff
In case of deviations of the specifications it is proceeded as follows:
• The product is given to rework

• The product is mixed with another charge in order to bring the analytic to
acceptable values
• The customer is informed about the deviation and accepts the product
• When no rework is possible and the customer does not agree with the deviation a
selling to other customers at reduced price is to be considered
• When above procedures are not indicated the product must be rejected
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Planing HACCP
To plan HACCP proceed as follow: Prepare the following tables:
Detailed description of every product

A detailed schematic description for every product should contain:
• Definitions: Explain used terminologies and abbreviations

• Cite the different foods which belong to the described group
• Characteristics: like flavour, smell, consistency, etc
• Ingredients: All ingredients should be listed
• Chemical and physical properties: Important analytical values such as pH, acidity,
viscosity should be established as specification. Maximum and minimum of the
deviations should be included in this table
• Purchasing department
• Processing: such as pasteurisation,sterilisation etc should be mentioned.
• Packing:glass ,tin can ,PP , PE etc
• Storage:Specification of the storage temperature,moisture etc.
• Shelf life.
• Indication for consumer for final preparation of the food before eating.
• Special informations for specific consumer groups such as diabetics.
Description of processing
Prepare a table with a complete information about the production containing:
• Incoming of raw materials.

• Description of the processing.
• Temperatures,heating time, pressures.
• Temperature maximum time for storage.
The description of processing must be completed with a process flow diagram of the
whole proceeding with the marked CCPs, the target values and tolerances and the
corrective action should the product fall out of specification.
Static hygiene conditions:

Building
The building where food is being handled according to hygiene rules must be in a
condition to avoid negative influence during processing. Cleaning and disinfection of the
288
rooms must be possible. Necessary temperatures for handling,processing and storage
must be available. The building must be clean and the maintenance must have been done.
The floor must be easy to clean and to disinfect. It should be watertight. The walls are to
be covered with watertight material, easy to clean and to disinfect. The ceiling should be
covered wit watertight material avoiding condensation water, dirt and molds. There must
be a sufficient number of hand washers with spender of liquid soap and disinfection
based on alcohol. There must be a sufficient natural and artificial illumination of all
rooms. There must be a facility for the personal to change cloth. Windows must have fly
screens. The rooms are not to be used for other activities. The surface of tables and other
surfaces which come in contact with food must be easy to clean and to disinfection. To
wipe there should be used only one-way towels ,not using it more then a day. Buckets and
other cleaning utensils should be of different colour in order do avoid cross
contamination from one place to another. Machines and other utensils for processing of
food : All surfaces must be easy to clean and to disinfect. Everything should be of
stainless steel. Plastic parts should be made of polyester heat resistant to 130 C .
The wire used to hold brushes together should be of stainless steel.Brushes should be
made of polyester. They should be of different colour in order to avoid toilet brushes or
highly contaminated places be used in the kitchen. All parts and utensils should be free of
cadmium.
Toilets:
There must be a sufficient number of toilets with water flushing. Toilets should not have a
direct communication with the processing rooms. The hand washers in the toilet room
should provide liquid soap an disinfection based on alcohol being operated automatically
or by arm, (not by hand !) One way paper towels should be used. There must be cold and
warm water. The toilet room must have an air exhauster .
Dynamic hygiene conditions:
Cleaning, disinfection and maintenance of the building,hygienic handling of food. The

building must be cleaned and disinfected properly. Maintenance of the building includes
painting of walls and ceilings to avoid molds. Change broken coverings of walls and
close all unnecessary holes. Control the handling through all phases of the production,
from income control, from production to storage and transportation.
Incoming control: Raw products and ingredients should not be accepted when there is
evidence for the presence of pest,pathogen microorganism or there is evidence that the
products are spoiled. If necessary the products must be changed to adequate containers,
or changed from wood pallets over to plastic pallets.
All products should be labelled with:
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Name of the producer.
Date of delivery.
Expiration date.
Storage and handling of raw materials:
Raw materials must be stored and handled under well defined conditions.
Production, improve the technical processing:

Use good manufacturing practice principles handling food during processing.Make a
separation of "dirty" and "clean" areas making sure that the routes of transportation of
"dirty" and "clean" material does not cross each other (For example: keeping cooked
meat and uncooked meat together in one refrigerator or one cooling room. this must be
avoided)Avoid crossing unpacked food with already packed food. Avoid people working
in "dirty areas" to get to "clean areas". This can be controlled by different hair coverings:
Red for dirty areas and green or white for clean areas. Wood utilities should be avoided
as they bear pathogen moulds, bacteria and virus.This includes Tables, doors and
environment:
Health condition or the staff which comes in contact with food

Medical inspection of all people handling food is to be periodic repeated and
documented. This includes clinical inspection, bacteriological examination of faeces with
regard to Salmonella bacteria, daily control of the personal to avoid purulent wounds,
persons with diarrhoea and other problems to come in contact with food. These persons
should be engaged in areas were they cannot come in contact with open unpacked food.
Diseases which are spread by food. Persons with the diseases mentioned below should
not come in contact with unpacked food. Cholera, Enteritis infectiosa, paratyphoid,
dysentery, tuberculosis, dermatosis, salmonellosis and shigellosis.
Pest control
The rules related to hygiene in handling with food demands to avoid any negative
affecting of food.
Pest and their excrement affects food in this way. The measures to control the affecting
should be integrated in the HACCP system.
Hazard analysis of pest control

Possible Pest in a food factory
• Insects: cockroaches, moths, ants, beetles, flies, wasps,mites and spiders

• Rodents: rats, mice.
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Dissemination of pest
Dissemination of pest can happen through:
• Dissemination with the product itself- such as banana spiders.

• Dissemination with the packing Such as bacteria and moulds on cardboard boxes
such as seen on a piece of cardboard on nutrient media:
• Dissemination with the transport devices, such as pallet giving places for mice
and rats to hide. Pallets can also transmit insects like wood spoilage :
• Dissemination from one place of the plant to another, such as the transport from
storage of raw material at open air facilities.
There are many ways of affecting food by pest:
• Transmission of bacteria.
• Damage of product and packing material.
• negative affecting of Taste and smell.
• Modification of appearance.
• Spoiling.
• Attack by secondary pest at the point of packing damage.
Determination of critical points in relation to Pest control (CCPS)

There should be made a flow diagram, of the product to be analysed and a diagram of the
building where the production and the storage of the raw material, packing material and
end product is taken place.In this diagram the CCPS should be marked.
Factors which can facilitate pest dissemination
• Possible food for pest like garbage,empty tin cans with rests of food, open
drainpipes etc.
• Temperature of the different surroundings:Warm rooms and hot places facilitate
the multiplication of pest.
• Humidity:High humidity intensifies not only yeasts and molds but also the
multiplication of pests
Neglected or abandoned rooms or environment can act as biotope for pests which can
migrate to other parts of the building used for the actual production.
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The whole building and his environment should be considered as one.
The best place is as good as the worst place is.
Categories of effects of pest attack,according to Voigt
• Catastrophic: When the health of the population is endangered

• Critical: When the food is not suitable or when it is spoiled
• Small: When consumption is restricted
• Insignificant: When the consumer does not notice the failure.
General considerations about pest control

Contamination caused by rodents and insects produces loss of material and is a way of
transmission of diseases. The Hygiene rules demand to keep food free of influence of pest
and pesticides and repulsive modifications as well all hazards for the health of the
consumer.
Rodents
Rats and mice
They generally live near garbage and drainpipes.As these animals live in places with high
contamination with bacteria they bear on the hairs of their coat dirt and pathogen bacteria
and contaminate the food with which they come in contact. Rats and mice feed
themselves with garbage and deteriorated food contaminating itself with bacteria which
are eliminated in their faeces and urine. When rats and mice die the fleas abandon the
corps an can attack human transmitting diseases or cause allergies. The teeth of rodents
grow continuously. In order to keep them short they have to gnaw hard objects such as
electrical wires, causing electrical shorts and fire. Rats and mice should therefor be
exterminated.
Extermination of rats and mice
Combat of rats and mice are made with anticoagulants. In the surroundings of food only
approved products of are allowed. As babies of rats and mice can feed by itself after 17
days of lactation it is necessary to proceed with the lay out of poison for at least 14 days
after the death of adult animals. The new generation can leave their nest in that time.
Rats and mice are reservoir of Borrelia, which is transmitted to humans by ticks.
Bacteria transmitted by rodents, according Hoffmann 1986
Bacteria transmitted by rodents according to Hoffmann 1986
• Salmonella, cause salmonllosis, paratyphi and salmonellosis of cattle

• Shigella, cause shigelosis
• Yersinia enterocolytica
• Yersinia pseudotuberculosis
• Francisella tularensis, cause tularemie
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• Listeria monocytogenes, cause listeriosis
• Pseudomonas pseudomallei, causes melioidosis
• Streptobacillus moniliformis, causes rat-bite fever and complications
• Clostridium botulinum
• Leptospira interrogans, it is pathogenicindexLeptospira interrogans
• Leptospira interrogans,serogroup Icterohaemorrhagiae, cause Weilsch disease
• Leptospira interrogans, serogroup Grippotyphosa, cause hay-fever
• Leptospira interrogans, serogroup Pomosa,causes pig breeders disease
• Leptospira interrogans, serogroup Canicola,cause dogs disease
• Spirillum minus, cause rat-bite fever and "Sodoku"
• Coxiella burnetii, cause Q fever
• Erysipelothrix rhusiopathiae cause pig epidemic
• Mycobacterium tuberculosis, cause tuberculosis
• Vibrio cholerae, cause cholera
• Borrelia sp., cause borreliosis
Viruses transmitted by rodents
• Pig pest
• Rabies
• Virus of encephalitis
Molds transmitted by rodents
• Tricophyton quinckeanum
• Trichophyton schoenleinii
Nematodes transmitted by rodents
• Trichinella spiralis
• Hymenolepis nana
• Hymenolepis diminuta
• Echinococcus multiocularis
Cockroaches
They like damp and hot places eating all kind of food, including spoiled garbage.They
make therefore the transport of bacteria. They contaminate food with their legs, faeces
and vomits.
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Bacteria transmitted by cockroaches.According to Hoffmann, 1985
• Salmonella
• Shigella
• Escherichia coli
• Proteus
• Klebsiella pneumoniae
• Enterobacter
• Serratia marcescens
• Vibrio cholerae
• Vibrio parahaemolyticus
• Yersinia pestis
• Pseodomonas aeruginosa
• Streptococcus sp
• Staphylococcus aureus
• Listeria monocytogenes
• Bacillus anthracis
• Chlostridium welchii type A

• Mycobacterium tuberculosis
• Mycobacterium leprae
Viruses transmitted by cockroaches. According to Hoffmann, 1985
• Hepatitis virus B
• Poliomielitis virus type1
• Cocksackie virus type B5 abd A12
• ECHO virus type 6
Yeast and molds transmitted by cockroaches. According to Hoffmann, 1985
• Candida albicans
• Aspergillus
• Trichophyton rubrum
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Protozoa and nematodes transmitted by cockroaches. According to Hoffmann,
1985
• Balantidium coli
• Entamoeba hystolytica
• Giardia intestinalis
• Toxoplasma gondii
• Taenia sp
• Ascaris and other nematodes
Flies
Flies like the house fly Musca domestica and Fannia canicularis make the transport of
bacteria like Salmonella.
Bluebeettle
The genus Calliphora sp. and Lucilia sp. inhabit contaminated places such as latrines
garbage etc.They enter buildings carrying diseases and putrefaction agents. Contact of
food with bluebottle can be avoided keeping food in refrigerator or covering food with a
covering bell or plastic coverings, the doors and windows should be closed with fly
lattice. Indoor electrical devices with blue light should be used which kill insects using
high voltage. Larvae should be killed with insecticides and keeping theenvironment clean
and free of garbage, deteriorated meat and carcases. Interior and surroundings of the
buildings should be free of garbage and carcases. Insecticides should not come in to drain
pipes as they may kill small animals which are part of the food chain for other animals.
Bacteria transmitted by flies. According to Hoffmann 1985,Steinbrink 1989
• Salmonella
• Shigella
• Escherichia coli
• Proteus vulgaris
• Vibrio cholerae
• Brucella abortus
• Brucella suis
• Streptococcus sp
• Staphylococcus aureus
• Erysiopelothrix rhusiopathiae
• Bacillus anthracis
• Clostridium botulinum
• Mycobacterium tuberculosis
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Bird control
Interior and surroundings of food storage, market halls and stores, food processing
buildings the presence of birds are not acceptable. Common bird which try to built their
nests in the interior of buildings are pigeons, starlings and sparrows.
Bird control should be done by removing their nests and avoid reinvasion.
Shooting is not always effective and should not collide with rules of animal protection.
Pest control tries to avoid pests, early detection and control.
Important are tight doors, smooth surface of walls and floors and good air conditioning.
Fumigation: Methyl bromide
Methyl bromide is being used as a method of fumigation for raw materials such as wheat,
semolina and flour to ensure effective eradication of insect pests. Chemical fumigation
however is banned. Natural solutions are therefore being searched, such as heat and
controlled humidity.
Phosphine
Phosphine is the most frequently used alternative to methyl bromide for durable
commodities. It is widely used to kill pests in cereals, legumes, dried fruits, nuts and
other commodities. Phosphine requires a long exposure period (5 to 15 days) and usually
temperatures of over 15oC to release phosphine from its tablet form, making its use not
practicable in cold climate. It can be used in transit. Phosphine gas is generated by the
reaction of metallic phosphide such as aluminium phosphide or magnesium phosphide
granules and tablets with atmospheric moisture. Other systems use compressed gas
cylinders mixed with carbon dioxide, or by reacting phosphide granules with water and
carbon dioxide (Horn Generator). Used on its own initial dosages of 900 to 1200 ppm and
final concentrations of 200 to 400 ppm for 36 to 48 hours.

Corrosion, however, should be kept in mind as it endangers electrical equipment.
Resistance of pests to phosphine develop under frequent use with poor sealing of
structures.
Heat, phosphine, Carbon dioxide treatment
Combination of heat(30 to 38oC), phosphine (150 to 500 ppm) and carbon dioxide (3 to
7%) increase respiration in insects, allowing reduced concentration of phosphine and
reduces the potential for corrosion. These values compare to temperatures over 50oC for a
heat treatment alone, or an initial dosage of phosphine of 900 ppm or more when used on
its own.
Irradiation
Irradiation can be used to disinfect packaged or bulk products. In Canada irradiation is
allowed only for wheat and wheat flower, spices, herbs and vegetable seasonings.
High-speed centrifugal impact
High-speed centrifugal impact machines (Entoleters) are useful to destroy any insects that
may be in flour. This procedure is less useful for semolina as it tends to break up the
larger particles.
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Diatomaceous earth (DE)
The fossilized diatoms are amorphous silicon dioxide which works as an insecticide by
adsorbing to the wax coatings on insect bodies, leading to death by drying. It is used on
grain, in grain storage and transport containers, and in food processing plants and flour
mills. It is primarily used in specific areas as a spot treatment or surface treatment of

containers. It can also be applied inside electrical and control panels and in dead spaces
behind walls before they are closed up.
Personnel items
A separate area should be provided for personal items such as coats, shoes and lunches
that are brought into the plant as they might be a root of pests.
Good Sanitation Practices
The importance of cleaning and sanitation must be emphasized to all staff. In particular,
cooperation among cleaning crews, quality control officials, and a pest control service
will be beneficial. In case of faulty food injured people have rights of recourse.If the
producer of the faulty food has a valid HACCP concept with written results of his
controls the injured person must provide the evidences that the failure was originated
during during handling and treatment of a specific producer. If the produce does not have
the written results of his controls or the frequency of the controls are not sufficient he has
to prove that the failure has not been originated under his responsibility.
The HACCP system is therefore a practical instrument of protection against unjustified
accusations. However if he fails to proof that the failure could not be originated during
his responsibility the producer has to assume the liability.
Waste control
There should be a document with informations about:
Type of waste.
Place where waste and garbage is collected.
How the waste is transported and to where it should go.
Date and signature.
Garbage and waste cannot be collected and stored in the store where food is being sold,
stored or handled.
Containers should have a lid and they should always be closed.
Pest control should avoid rats and insects to get to the garbage.
Own experiences with pipelines have shown leaking valves between product line and
pipes being cleaned in place, so that CIP solutions got into the product.
Don't underestimate the value of pipeline diagram. Engineers like to talk it down because
of the trouble to make the initial drawing and to keep it update.
Only with complete diagrams hazards like lealing valves placed between product and CIP
lines operated simultaneously can be made visible.
Total Quality Management

Total Quality Management TQM can be installed after ISO 9000. The system tries to
unite all the different phases of the activities of a company beginning from the financial
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control down to production and technical details. With growing international business
the enterprises have to integrate modifications in the basic structure concerning the rapid
changing international market. ISO 9000 is the basic activity which supports Total
Management.
Characteristics and ability of the Total Management staff
The staff according A.Borning should have:
• International communicability.
• The ability to create and guide international teams
• Intercultural sensibility
• Knowledge of the differences between the nations as basis of negotiations
In the past quality control and quality improvement was considered as being in the
responsibility of one department or a part of an enterprise. In Total Management Quality
has to concern every part of the enterprise. The whole personal staff is responsible for the
quality management of the enterprise. To coordinate internal processes and external
demands of customers Business Process Management BMP can be used. It is a structured,
methodical enterprise specific handling of the transaction. The relation from supplier to
customer is in BMP of great importance.
The different goals of the TQM should be:
• Continuous improvement of processes

• Information and coordination of the staff in case of innovations
• Complete basic activities before begin of an innovation
• Delegation through description of the position and jobs of every employee.
• Time Management
• Rules of meeting
• Education and training
• Target to be achieved
• Opinion poll
The integration of manager and the way of thinking of different continents and cultures
must be kept always in mind to solve international problems.Therefore are opinions and
conferences with a multinational staff extremely important.
The main question which rules all activities of Total Quality Management is:
What can be improved ?
The target of the Total Quality Management is:
The most important targets are:
High capital rentability
Team spirit, culture of the enterprise directed to Total Quality Management resulting in
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success on long terms.
Targets must be arranged according to their priority in order not to create conflict
situations between employees responsible for the execution of the different sections. In
case of necessary changes in the structure of the organisation the international manager
staff should have flexibility to overcome difficulties related to:
• Isolated business groups

• Market Oriented Profitcenter
• Joint Venture fusions
• Decentral Diversification Activities
• Outsourcing
• Horizontal Networklike Project Organisation like Matrixstructures
• Creation of Experimental Units
• Modifications resulting from Common Cost-Analysis
• Lean Management
Rotation of the Management between branches inland as well as branches from abroad
with the main head is very useful to create a common feeling and fortify the unit of the
enterprise.
Loyalty
The career of managers with many changes of jobs between enterprises should be
analysed very skeptical.They show little care about the flag they serve and the destiny of
the enterprises. Their goal is their own career. They have no identification with the
history and with the future of the enterprise. In bad times they go and take the know how
and company secrets to bargain with it for a new job.
Quality Management Manual

The Quality Management Manual contains all topics concerning Quality Management
QM having a description of all standards of the QM system.All other documents are
subordinated to the Quality Management Manual. When the whole enterprise is organised
according to the principles of ISO 9000 it is certified during a period of 3 years. During
this period the certifying company makes audits each year
External audits
The external audits are made by the company which had certified the enterprise. The
external audit controls the actual work to be accord to the established rule of the Quality
Management Manual.The duration of an external audit is approximately one day.The
external auditor may negate the certificate when serious faults are found.
ISO 22000: 200x Food Safety Management Standard
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ISO 22000 will be international and will define the requirements of a food safety
management system covering all organisations in the food chain from farmers to catering,
including packaging. In recent times there has been a worldwide proliferation of third
party HACCP and Food Safety Standards developed both by national standards
organisations and industry groups including the UK's own BRC. The idea of harmonising
the relevant national standards on the international level was initiated by the Danish
Standards Association (DS). ISO 22000 aims to harmonise all of these standards.
The standard has the following objectives:
1.Comply with the Codex HACCP principles.

2.Harmonise the voluntary international standards.
3.Provide an auditable standard that can be used either for internal audits, self-
certification or third-party certification.
4.The structure is aligned with ISO 9001:2000 and ISO 14001:1996.
5.Provide communication of HACCP concepts internationally.
The ISO 22000 gives definitions on related terms, describes a food management system
including:
1.General system requirements.
2.Definition of the management responsibility and commitment.
3.Documentation requirements.
4.Definition of responsibility and authority.
5.Calling for a food safety team, communication, contingency preparedness and response.
6.Gives a review on management, resource management, provision of resources, human
resources, realization of safe products, product and process data, hazard analysis, design
of the CCP plan, design of the SSM programmes, operation of the food safety
management system, control of monitoring and measuring devices, measurement,
analysis and updating of the FSM system.
7.System verification,validation and updating.
8.Correspondence between ISO 22000:200x and ISO 9001:2000.
ISO 9001:2000
The ISO 9000 series turnbed out to be the best international quality management system.
The ISO-9001:2000 can be used for internal application by organisations, certification, or
contractual purposes. The ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 family of
standards have been consolidated into a single revised ISO 9001:2000 which contains a
single quality management requirements standard that is applicable to all organisations,
products and services aiming to:
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Address customer satisfaction.
Meet customer and applicable regulatory requirements.
Enable internal and external parties to assess the organisation?s ability to meet these
requirements.
The ISO-9001:2000 quality system aims to enhance customer satisfaction. This includes
the processes for continual improvement of the quality system and the assurance of
conformity to the customer and applicable regulatory requirements.
In global business the certification according ISO 9000 turned out to be an imperative
duty. The HACCP concept should be integrated in the quality system fulfilling hygiene
regulations. The ISO 9000 was first released in 1987, a first revision was published in
1994 and in 2000 the modification to ISO 9001:2000 was released. Since then only three
main standards subsisted: ISO 9000:2000: Includes a description approach to quality
Management as well a revised vocabulary. ISO 9001:2000: Includes the quality
management system, requirements. ISO 9004:2000: Includes guidelines for performance
improvement moving toward Total Quality Management. It is not intended for
certification or contractual use.
They rely on the following eight principles:
1.Customer focused organisation
2.Leadership
3.Involvement of people
4.Process approach
5.System approach to management
6.Continual improvement
7.Factual approach to decision making
8.Mutually beneficial supplier relationship
Documentation of the system should include:
1.Quality Manual.
2.Specific statement regarding quality policy and quality objectives.
3.Documented procedures that describe the sequence of processes necessary to

ensure the conformity of the product.
4.Documented instructions to ensure the effective operation and control of the
processes.
5.Quality records.
Control of documents:
A procedure for the control of documents should include:
1.Controlled distribution of documents.

2.Approval of documents prior to issue.
3.Review and updating and re-approval of documents.
4.Identifying the current revision status of documents.
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5.Ensuring that only relevant versions of applicable documents are available at
points of use.
6.Insuring that documents remain legible, readily identifiable and retrievable.

7.Identifying, distributing and controlling documents from an external source.
8.Controlling obsolete documents.
Control of records should include:

Maintenance
1.Identification
2.Storage
3.Retrieval
4.Protection
5.Retention time
6.Disposition of all quality records.
Management commitment:
1.Conduct regular management reviews
2.Ensure the availability of necessary resources
3.Ensure that everyone is aware of the importance of meeting customer, regulatory and
legal requirements.
Customer focus:
1.Customer needs and expectations must be determined.
2.They must be converted into requirements
3.The requirements must be fulfilled.
Quality policy:
The quality policy of the organisation should be communicated and understood by
everyone. It should be capable of continual improvement and regularly reviewed.
Quality management system planning:
Quality planning should be documented including quality objectives and resource.

Responsibility, authority and communication:
The administration of the QMS covering the responsibilities and authorities, function,
relationship and the internal communication must be documented.
Review input from:

1.Earlier management reviews such as follow-up actions.
2.Previous internal and external audits.
3.Customer feedback.
4.Process performance.
5.Product conformance.
6.Preventive and corrective actions.
7.Changes that could affect the QMS and recommendations for improvement.
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Review output:
1.Improves the overall QMS and its process.
2.Improves the product.
3.Enhances customers satisfaction.
4.Confirmes the resources required.
Resource management includes:
1.Human resources on regard of competence, awareness and training.
2.Provision of resources.
3.Work environment.
4.Infrastructure.
Specifications
Specifications are essential technical requirements for items, material, or services,

including the procedures to be used to determine wether the requirements have been met.
Specifications may also include requirements for preservation, packaging, packing and
marking.
Without proper specifications it is impossible to expect a manufacturer or supplier to
produce an article, equipment or system that completely satisfies the customer.
Types of specifications
Three types of specifications can be used to settle product requirements:

1. General specifications: Are overall specifications of the product written by the
purchaser. It requires a detailed description of the article. Suitable, appropriate,
conventional harmless or healthy should not be used as they open loopholes in case of
complaints. It should contain the whole formula for food, ingredients and packaging.
2. Overall performance specifications: These Specifications have vague contents. They
leave everything up to the manufacturer. Later complaints are almost impossible.
3. Standard specification: Here a detailed description of every ingredient is given. Lists
of the National Standards Organisations NSOs of parts commonly used by manufacturers,

or The British Standards Institution (BSI) lists such as BS 9000, CENELEC and IECQ
and CECC as well as standards and regulations such as Codex Alimentarius and other
organisations can be used.
HACCP programmes:
1. Good practices: Assessment and Implementation of Prerequisites

• Compare the situation of the company with a scheme of Comprehensive Hygiene
Management for SMEs.
• Identify the items of the scheme which have not, or have only been partially satisfied
amongst those which have been fully implemented, by answering the following questions
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Item 1
o are the buildings and equipment in compliance with regulations and
standards?
o does a contractual relationship with raw material suppliers exist?
o does an effective pest control plan exist?
item 2
o is a policy of staff health control defined and applied?
item 3
o are the rules of hands washing and personal hygiene defined and
applied?
o does a cleaning plan of the buildings and equipment exist and is it
effectively applied?
item 4
o do control procedures of the different "time/temperature" couples
implemented in the company exist?
o is there a control of the products formulation constancy?
item 5
o does a sampling and analysis plan of the finish products exist?
training
o is staff training ensured and regularly updated?
2. First phase of the HACCP method (tasks 1 to 8)3: the HACCP Study
• HACCP method analysis, task-by-task, without being allowed to pass to the next task
until the preceding one is entirely carried out;
• Audit by the use of grid 2 /4 (relating to the preliminary analysis phase of HACCP
method) to check that each task carried out is completely and correctly fulfilled;
• With the help of the explanatory booklet, assurance that the criteria of audit grid 2/4 are
entirely fulfilled, before being allowed to proceed to implementation of HACCP method
second phase (devoted to HACCP plan design).
3. Second phase of the HACCP method (tasks 9 to 12): design of the HACCP plan
• HACCP method implementation, task-by-task, without being allowed to pass to the next
task until the preceding one is entirely carried out;
• Audit by the use of grid 3/4 (relating to HACCP plan design) to check that each task has
been carried out is completely and correctly fulfilled;
• With the help of the explanatory booklet, assurance that the criteria of audit grid 3/4 are
entirely fulfilled, before being allowed to start operating the HACCP plan.
Third phase: Routine evaluation of the operating HACCP plan
• With the help of the explanatory booklet, make sure that the criteria of the audit grid 4/4
(relating to the real and effective operation of the HACCP plan) are entirely fulfilled;
• If all of the criteria of audit grid 4/4 are not fulfilled, return to stages 3, 2 or even 1
(above).
Management scheme:
1 Building Standards, Suppliers Control, Pest Control Plan
2 Personnel Health Policy
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3 Hand Washing Rules & Cleaning Plan
4 Hot & Cold Technologies + Foodstuffs Formulation
5 Finish Products Analysis
Management scheme:
1 Building Standards, Suppliers Control, Pest Control Plan
2 Personnel Health Policy
3 Hand Washing Rules & Cleaning Plan
4 Hot & Cold Technologies + Foodstuffs Formulation
5 Finish Products Analysis
1.2. Building Standards, Suppliers Control, Pest Control Plan
Buildings and Environment Conformity
The design of new buildings, or the improvement of the existing buildings and
equipment, should respect the following principles:
General principles
• The plant should have at least four doors:
• one door for the entry of raw materials
• one door for the entry of production staff
• one door for the shipment of finished products
• one door for waste disposal
• The onward flow principle.
Successive production operations should ensure a forward progression of products,
without back return, from the lowest level of development towards the highest one, from
the least healthy condition towards the healthiest one, from the least susceptible condition
towards the most susceptible one. In order not to flout this rule, operators should not
move from place to place - they should maintain work at the station at which they are
placed.
• No production line criss-cross.
Two (or more) production lines should not crisscross. They can be connected (e.g.
assembly of composed products put into a previously washed package) or split (e.g.
manufacturing lines of by-products obtained during the preparation of the main product).
• Separation of cool and warm zones.

Zones where hot foodstuffs are treated shall be clearly differentiated from those where
old ones are treated in order to avoid their thermal pollution.
• Separation of clean and dirty areas.
Waste produced with each stage of manufacture should be removed in the most direct
way possible towards its treatment location(s) (e.g. dishwashing) or storage (e.g. waste
handling).
Construction Regulation and Standards
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• Floors shall be:
smooth and impermeable washable, non-skid not subject to rot, hardwearing
• Walls shall be:
smooth light colored, washable not subject to rot, ‘shock-resistant’ (up to 2 meters
high) bonded to the floor by semicircular joints, with no nooks or crannies, to allow easy
cleaning and drainage of wash and rinse water (see diagram below)
• Ceilings shall be:
light colored, washable, smooth
• Passive or mechanical ventilation devices must ensure the elimination of steam and
smoke
• Lighting shall be:
bright, neutral in color (so as not to modify the foodstuff colors)
Equipment conformity
• Equipment shall be:
smooth not subject to rot, stainless, washable (without nooks and crannies that are
inaccessible for cleaning).
Compliance with these rules prohibits the use of undressed wood, cardboard or
tapes for the manufacture of furniture (or their use in temporary repairs).
Equipment should not be placed adjacent to walls so as to allow for proper cleaning
and for proper pest and cleaning inspection.
• Materials used to manufacture tables shall be:
Smooth not subject to rot, light colored hardwearing, washable impermeable.
The compliance with these rules prohibits the use of undressed wood or cardboard,
and porous or rough materials like undressed concrete. The materials most often used are
stainless steel, plastics and glazed earthenware tiles.
• Tools shall be:
inalterable in all parts.
The compliance with this principle prohibits the use of wood even for the handles
of tools. The materials most often used are stainless steel, aluminum (which may not be
allowed by some food control authorities, in the US for example) and plastics.
• Machines shall be:

not subject to deterioration, preferably stainless, definitely non-corrosive.
easily dismantled.
washable (without nooks and crannies that are inaccessible for cleaning).
Pest Control Plan
Pests generally taken into account are rodents and insects (and, in S.E. Asia, some small
amphibians). In certain sectors (e.g. hypermarkets or other large spaces) birds may settle
in the superstructures of the buildings or cats (e.g. in slaughter-houses) can soil the
environment whilst attacking stored foodstuffs.
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Passive control, surroundings and outbuildings keeping
In order not to allow the settlement of pests on the plant surroundings, (i.e. not to provide
those places of refuge and feed resources) it is necessary to maintain a non-attractive
environment that includes:
• Isolated storage of unutilized materials, pallets and machines, without contact with the
walls of the buildings.
• Design and maintenance of external spaces, including:
- The elimination of holes and spaces in wasteland with high vegetation.
- The regular short shearing of grass lawns.
- The absence of rags, papers, plastic films and other detritus abandoned on the
ground (sources of materials for the construction of rodent nests).
• Keeping of interior surfaces (racks, tops of furniture pieces) clean so as not to leave
feed sources for rodents and insects.
• Tidying and cleaning of technical buildings (machine shop, boiler room) so as not to
support rodent settlement.
• Installation of mosquito nets at windows and suitable screens on access doors.
• Rigorous management of waste containers that shall include:
- Frequent washing so as not to attract insects.
- Storing on a clean and easily washable surface (water tap and floor drainage of
waste water).
- Kept closed (to prevent use as a feed source by all types of pests).
- Filling without overflowing (not to drop food waste on the ground).
Active control
Pest’s detection
• Insects:
- Search for dead insects.
- Search for alive insects in places of refuge (drawers).
- Search and careful removal of bodies in electric insects trap collectors.
• Rodents:
• Search for rodents dropping or traces of urine.
• Search for attacks on foodstuffs (biting traces) or attractive conditions (torn open
bags).
- Presence of traces of grease of rodents on the usual passing through points.
- Search for nests of rodents.
Rodents control plan
This plan is composed of a complete (set of) document(s), defining actions to be
implemented, and including:
• Technical cards of rodent poisons utilized.
• Procedure and time tabling of rodent control operations, including the checking and
renewal of distributed poison baits.
• Timetabling and procedure for identification, evaluation and elimination of possible
rodent infestation.
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• Implementation procedure of additional treatment in the event of a residual infestation.
• Factory plans on which the locations of poison baits are identified.
• Identification on walls of the premises in order to locate poison baits.
Insect control plan.
This plan is composed of a complete (set of) document(s), defining actions to be
implemented, and including:
• Technical cards of insecticides utilized.
• Time tabling and procedure of insect control operations (walls insecticides, paint
application and renewal, premise insecticide spraying).
• Factory plan on which are localized the poison baits devoted to crawling insects.
• Factory plan on which the locations of electric insect traps are identified.
• Timetabling and procedure for traps emptying and trapped insects monitoring in order
to evaluate infestation levels.
Contractual Relationship with Suppliers and Deliveries Control
Raw materials specification.
In order to have a sound basis for deliveries’ control, the characteristics of ordered raw
materials need to be specified precisely with suppliers. The conditions of acceptance /
rejection of batches also needs to be clearly defined. Raw materials specifications should
include:
• Cards of specification of raw materials.
• Formulation defining physico-chemical composition, presentation, particle or chunk
size and variability, constants (e.g. pH, Aw, salt or sugar concentration, viscosity of the
liquids).
• Condition defined by type, volume, and shape.
• Labeling (in particular with food safety official marks and elements of traceability).
• Bacteriological standards (lawful or contractual) (possibly including contractual access
to results of bacteriological control plans set up by suppliers).
• Purity criteria, including absence of, or allowed levels of, foreign bodies (plastic, glass,
metals) or residues (heavy metals, pesticides,).
• Condition for and responsibilities in case of inspection failure (removal, replacement

etc).
Preferential choice of suppliers benefiting from:
• Certification (e.g. ISO 9001, ISO 22000),
• or of a national or international approval (e.g. EEC and USA approvals),
• or of other approvals (Halal, Kosher, vegetarian, GM free, retailer promoted assurance
schemes, etc),
• or of an accreditation or a referencing by a recognized customer.
Preferential choice of suppliers accepting customer visits of their production site.
Recording cards of deliveries check.
These cards shall allow for minimum control of the following criteria:
• Delivery temperature of the product (see Appendix – Calibration).
• Use-by date or deadline of optimal use.
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• Labeling conformity and, in particular, official food safety marks.
• Appending of batch identification marks necessary to operate any upstream and
downstream traceability system.
• Free from packaging damage.
• Cleanliness of delivery vehicles.
Details of parameters checked / inspected on deliveries may be recorded in a variety of
ways, perhaps either on check cards or by use of an inspection grid, printed from ink pad,
on the reverse of delivery orders.
Receiving (into storage) procedures for raw materials following delivery checks, and
any initial decontamination operations.
Some care must be taken during introduction of raw materials into storage:
• Maximum time duration following arrival of raw materials into temperature controlled
storage (chill rooms and cold rooms) shall be defined and respected.
• Soiled packaging (outer cardboard boxes, wooden pallets or supports, etc) shall be
eliminated before placing raw materials in clean stores.
• If fruits or vegetables undergo a decontamination treatment by steeping in disinfectant
solution (chlorination, ozonisation,) the concentration of disinfectant and process time
(max and / or min) shall be defined and controlled for each batch.
Rejection. Procedures.
The application of a rejection procedure must correspond to the clauses drawn up by
contract with the supplier. The following needs to be recorded on rejection cards:
• Reference(s) of the rejected batch (identification, constitution).
• The reason for rejection by reference to conditions defined in the supply contract.
• Signatures of the conveyer and the receiver.
1.3. Personnel Health Policy
Enforcement of staff (and management) health policy depends theoretically on food

factory occupational health care. It is nevertheless necessary to recommend the following
provisions:
• An annual medical consultation of every operator concerned in handling or
manufacturing of foodstuffs.
• The systematic monitoring of staff for lesions caused by staphylococcus through clinical
examinations of arms, hands, face, throat and other exposed skin, to be carried out by a
medical practitioner of appropriate food handling experience.
• The systematic monitoring of staff for potential Salmonella carriers (probably subject to
frequent bouts of diarrhea) by conversing with a medical practitioner from industrial
medicine.
• Enforcement of detection procedures for operators likely to carry Staphylococcus or
Salmonellas, by way of bacteriological analysis.
Medical treatment for those diagnosed positive with one of these two microorganisms
(without penalty so as to ensure staff confidence in the scheme).
Hand Washing Rules and Cleaning Plan
Hand Hygiene
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The hands, frequently in direct contact with foodstuffs, need to be considered as the first
operational tool. For this reason, detailed attention must be given to their cleanliness (just
as with any equipment placed at the operator’s disposal) and to their washing regime. It
should be noted that the hands, if not subjected to strict hygiene rules, constitute the first
vector of contamination of food stuffs, by germs (pathogens) passed on from the operator.
The implementation of training to demonstrate the proper technique for hand washing
and drying is recommended.
Hand wash sinks
Hand wash sinks shall conform to the following principles:
• Water flow shall not be operated by hand, but by foot or knee or by an automatic
presence detector.
• Liquid (or foam) soap shall be bactericidal but not a skin irritant (thereby excluding
toilet soaps without bactericidal effect).
• Soap dispensers shall be placed in a position adjacent to the wash sinks.
• A second dispenser reserved for a disinfecting solution (e.g. of alcohol solution) can be
associated with the liquid soap dispenser.
• The device devoted to hand drying must be of single use (paper towels being practically
the only possible solution).
• Nailbrushes complete the wash-stand equipment. They should be made entirely from
synthetic matter (handle and bristles) and need to be kept in a dilute clean disinfectant
solution, renewed for each work period.
Hand washing procedure
• Wetted, liquid soap-smeared hands must be rubbed for 20 seconds (the operator
counting: 101 . . . 102 . . . 103 . . . up to 120).
• The rinsing of hands, which are rubbed under running water, must last a minimum of 10
seconds (counting…).
• Wiping of the hands is not systematic, not being necessary for certain types of activities.
• If a disinfectant solution is used, it shall be allowed to dry naturally on the hands.
Hand washing frequency
With effective hand washing taking a long time, strict definition of the frequency and
circumstances of this procedure are needed. Hands must be effectively washed whenever
and wherever their contamination is practically certain. This washing, carried out
immediately after dirty operations, will restore hands to satisfactory cleanliness and will
prevent any points in contact with hands from gross contamination. If these contact points
are themselves grossly contaminated, hand hygiene is not possible because, as work
continues, they are immediately decontaminated.
Complete hand washing after dirty operations (or dirty situations)
(Practically the same in all branches of the food industry)
• Arrival at the workstation.
• Passing through and / or using toilets or changing rooms.
• After nose blowing.
• After dustbin handling.
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• After handling cardboard boxes from delivery (cardboard box bases are often very
dirty).
• After handling shell eggs (frequent contaminated by salmonellae).
• After handling non-cleaned vegetables direct from the soil.
• After handling game or poultry ‘in fur or feather’.
• while passing from raw food production areas to cooked food product areas (i.e. from
low risk to high risk areas).
• In this case materials used (cutting boards, knives, etc…) must similarly be changed or
correctly cleaned.
Quick hand washing before conducting clean operations
There is a multiplicity of clean operations, each specific to a branch of the food industry
(e.g. cooked meat cutting, assembly of pastry making...). Whilst remaining at work within
the confines of an appointed process, only a quick hand wash procedure is necessary, so
long as operators systematically care about washing their hands after previous dirty
operations and if contact point hygiene control is maintained.
Hands contact point’s hygiene
• Hands contact points shall be listed (handles of refrigerators or doors, kitchen utensil
handles, machines, electric switches, etc).
• These contact points must be the object of meticulous daily cleaning (or even a teach
restart at the workstation or with a change of operator).
Additional rules
• No smoking at the work station, in the work place or whenever wearing work clothes.
• No food tasting involving hand-to-mouth.
• No nail varnish (or perfume - this is not a hygiene concern, but is one of potential food
taint).
• Maintaining neat short finger nails.
• No rings, jewellery or watches to be worn (even if wearing work gloves).
• The washing of gloved hands must be carried out with the same régime as for bare
hands.
• No reuse of disposable gloves after removal.
Work Clothing Hygiene

In agro-food industries, clothing can be a major vector involved in food contamination.
Work clothing, when not clean, can be a source of contamination for hands, whenever it
is used to wipe them. In certain sectors, such as butchery, clothing is in direct contact
with handled carcasses, (e.g. in shouldering carcasses when loading delivery vehicles).
Work clothing management must respect some specific principles:
• It is of a standard type and is provided by the company.
• It is put in a locker (or a compartment of cupboard), physically separated from personal
clothing (the locker shall be maintained in a clean manner).
• Its color, or the color of one of its elements (cap, overall), may be specific to a work
station or a zone of assignment of operators.
• It includes a cap or net which covers all hair – this includes snoods for moustaches and
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beards (head covering may also be devoted to other purposes, such as shock proof
helmets).
• It includes shoes (crush proof and non-skid) which are only worn in the factory (foot
wear shall not contaminate work wear in a locker).
• It is laundered by the company or under its responsibility (e.g. by contract with an
industrial laundry – in this case the wash method shall be defined to ensure that laundry
is not cross contaminated from dirty clothing from other sources).
• It is:
- hard-wearing to mechanical actions (tear) and frequent washing,
- ignition proof.
• permanent devices (boots/shoes washstands) or movable ones (trays), containing a
disinfecting solution, must allow cleaning/disinfection of shoes or boots before getting
into the production zone.
Premise Hygiene – The Cleaning Plan
Good hygiene of buildings and equipment involves the enforcement of a cleaning plan.
There are at least two copies of the cleaning plan in the factory:
• A complete version of the document, held and updated by the department of quality
management, and to which technical cards of cleaning and disinfection products used are
attached, as well as directions for use of machines used in cleaning processes;
• A divided version, allowing each cleaning operative of the cleaning plan to have the
part(s), which relates to her/his duty.
• In the cleaning plan file, tasks checklists are included, as well as expected results of
surface bacteriological tests.
• The execution of cleaning tasks must be followed up by recorded checks by the

operative, immediately monitoring its effectiveness.
• Conducting microbiological analyses of surfaces makes it possible to check the
effectiveness of the cleaning plan.
IMPORTANT
The method known as ‘W.W.W.W.W.H.’ (mnemonic - five Wives and one Husband)
makes it possible to draft a suitable cleaning plan. These letters stand for six questions
(when? who? what? where? why? and how?) that direct the development of the plan.
The choice of the first question (asked from When? or Who? or What?) defines the
process of organizing tasks in the cleaning plan:
• ‘When?’ – cleaning tasks will be organized by day, by week, by month (by schedule)
• ‘Who?’ – cleaning tasks will be assigned by operator, by team…
• ‘What? – cleaning tasks will be organized according to building, department
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and equipment.
1.6. Finish Products Analysis – Bacteriological Tests
Products
Bacteriological testing carried out on finished products is generally characterized by a

relatively long response time. As a result, it is not possible to await the receipt of tests
results to affect production control, nor even to wait for them for product release.
Consequently, tests on finished products have an assessment function on GHP, as well as
on the operating HACCP plan. Unfavorable results do not make it possible to employ
corrective actions on finished product, but must lead to re-evaluation and improvement of
GHP implementation, as well as of the HACCP plan. Within the framework of risk
analysis, carried out in an HACCP study, bacteriological tests on product at different
production stages, makes it possible to evaluate the impact of each process activity/step,
in terms of risk reduction or increase. For analysis results to be interpretable, they must
be compliant with specific rules of coherence based on the relative weighting of total
bacterial populations and component populations.
Surfaces
Bacteriological tests carried out on tools or equipment surfaces are characterized by a
relatively long response time. As a result, it is not possible to await the receipt of tests
results to affect production control, nor even to wait for them for product release.
Consequently, tests on tool or equipment surfaces have an assessment function on GHP,
as well as on operating HACCP plan. Unfavorable results do not make it possible to
employ corrective actions on finished product, but must lead to re-evaluation and
improvement of the factory-cleaning plan.
Interpretation of the Flora
• Total aerobic mesophilic flora:
- is a reflection of total contamination;
- reaches high values in any case of failure of the hot or cold thermal
process chains (refrigeration, delayed hot distribution, cooling,)
- the return to normal values will be obtained by reinforcement of thermal storage chain
control.
• Total coli forms:
- is witness to a possible fæcal contamination?
- to correct such a variance, it is necessary to seek out and control the sources of fæcal
contamination (e.g. dirty operators' hands, animal gut contents, ground spread manure
contaminating green vegetables, egg shells…).
• Fæcal coli form:
- is witness to definite fæcal contamination?
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• Staphylococcus aureus:
- is responsible for food poisoning incidents;
- is particularly of human origin, often in partnership with fæcal coli forms;
- to correct such a variance, it is necessary to seek out and control the sources of human
origin contamination (e.g. dirty operators' hands…).
• Clostridium perfringens (anaerobic sulphite reducing bacteria):
- is responsible for food poisonings incidents;
- is of fæcal or ground origin and is frequently in spore form;
• Salmonellae:
- are responsible for serious food poisoning incidents;
- are of fæcal origin and most of the times associated to poultry/egg and related
products;
- to correct this anomaly it is necessary to seek and control the sources of fæcal
contamination (dirty operators' hands, animal gut contents, ground manure contaminating
green vegetables, egg shells…).
1.7. Staff Training
The following simple principles can be followed to plan, design and implement staff
training.
Sequence to be followed
• Analyze the training needs, taking into account the specific context of the enterprise and
the different public to be addressed.
• Establish a training plan with clearly defined objectives and indicators.
For example: “Train all the seasonal personnel in hygiene before they are sent to
production”. The indicator in this case is the number of persons who have followed
the session and the different skills to be acquired. Design and organize the session. This is
where the training tools and materials are prepared and the logistical
arrangements made.
• Carry-out the training.
• Assess the effects.

A few tips for trainers
• 2 weeks before the session: confirm the implementation conditions, i.e.: dates, list of•
participants, room…1 week before: is the equipment and material to be distributed
available?
• 1 day before:
- is the equipment in place?
- is the room ready to receive the trainees?
- is the material to be distributed ready ?
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• 15 minutes before the training: verify that the equipment is working and the materials
available for the trainees.
• In the beginning of the training:
- welcome the trainees;
- present the programme and schedule of the day.
• Every morning (if the session lasts several days): make a synthesis of the previous day,
answer questions, present the programme of the day.
• During the session: alternate the functions (producer, regulator, facilitator), explain
difficult points, have exercises done by the trainees, listen carefully to the trainees answer
all questions.
Assessment of the training
• Evaluate if the trainees have acquired the necessary skills and/or competences.
• Measure deviations using the indicators defined in the beginning.
CHAPTER 2: HACCP Study
2.1 Transition to HACCP
The version of the HACCP method to which this guide refers is the official version
published in the ‘Codex Alimentarius’6. In the following lines of this guide, HACCP
tasks are described in a summarized form, limited to some words or to short sentences. It
is accepted that use of this guide cannot be considered without reference to the Codex
version. Particular tasks will be studied from the practical point of view, in order to
facilitate the implementation of the method under field conditions.
Prerequisites
Enforcement of Good Hygiene Practice (GHP) and
Good Manufacturing Practice (GMP) constitute
essential prerequisites for the transition to the
implementation of HACCP methodology.
IMPORTANT
In order to make sure of real and effective implementation of these good practices, it is
necessary to refer to the audit grid 1/4 ‘Assessment of implementation of prerequisites’
attached to this document. (To use all audit grids, it is necessary to refer to the
explanatory booklet that is attached to them).
Success in implementing this HACCP process will depend on a thorough application of
each task in sequence and of the real and effective application of its requirements.
Jumping one or more task, or being satisfied with incomplete implementation, may well
lead to a situation of failure, with potential dangerous conditions within an apparently

safe system.
Procedures of implementation of HACCP – via each product or via manufacturing
operations
A HACCP scheme can be easily approached product by product in companies which
manufacture only one product or a restricted range of products. On the other hand, for
companies that offer a larger range of products (often-small firms in canning or in
delicatessen product manufacture), specific application of HACCP to each product will
constitute an insurmountable obstacle.
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It should be noted, in this second case, that the large variety of products is obtained by the
use of a limited number of basic technologies of manufacture (cooking, cooling, etc.),
always the same ones, but combined in different ways. Under these conditions, all that is
required is to choose a proper application of HACCP methodology to each one of these
basic operations. For any complete product, association of each basic operation involved,
properly managed by HACCP application, allows risk control to be established on the
production line.
2.2 The HACCP Method
• The HACCP process sets out two missions (two main processes to be carried out,
each with definable results).
• The HACCP method is the application of seven defined principles.
• The HACCP method defines twelve tasks for analysis, effective control
implementation and system review.
HACCP – The 2 missions
1. Hazard analysis (Objective – determination of CCPs – Critical Control Points).
2. Control of CCPs (Objective – effective implementation of food safety control at
CCPs).
HACCP – The 7 principles
1. Conduct a Hazard Analysis.
a - Identify the hazards associated with food production at all the stages of this
process.
b - Evaluate the probability of appearance of these hazards
c - Identify the necessary preventive measures
2. Determine the Critical Control Points (CCPs) of these hazards.
3. Establish critical limit(s). (Which must be met to ensure that each CCP is under?
control) Establish operational criteria (limiting values, target levels, tolerances).
4. Establish a system to monitor control of the CCPs.
Establish a monitoring system to affirm real and effective control of the CCPs
5. Establish the corrective action to be taken when monitoring indicates that a

particular CCP is not under control.
6. Establish procedures for verification to confirm that the HACCP system is
working effectively.
7. Establish documentation concerning all procedures and records appropriate to
these principles and their application.
2.3 The HACCP 12 Tasks7

Task 1: Select the HACCP Team
• Constitution of the team: internal and external competences, flow chart;
• Training of the team in HACCP;
• Organization of the team;
- Functional mode
- Organizer, secretary, team leader
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• Definition of the necessary resources;
- Office devices (computer, photocopier,)
- Budget
• Collection of information;
- Data: historical, causes of food borne disease, epidemiologic, clinical
- Normative and lawful data
- Technological data
• Planning of activities;
- Timetable and duration of team work sessions
- Programme of the implementation of successive HACCP stages
• Definition of the field of study (e.g. product, group of products, hazards under study,
full product process or part(s) of process, etc.) Full food safety control for any product
will only be complete when every process that goes towards its manufacture has been
included, but practical and time restraints frequently lead to a division into realistic
parts).
Task 2: Describe the Product
• Collect data on the finished product (and possibly in-process product)
- General characteristics: denomination, composition, volume, structure,
- Physical-chemical characteristics: pH, Aw, red ox potential (Eh), preservatives,
- Modified atmosphere,
- Packing,
- Labeling,
- Conditions of storage and lifespan,
- Storage and distribution network conditions.
• Collect data on raw materials
- Definitions,
- Presentation: volume, type of packaging,
- Formulation (% of each raw material used),
- Physicochemical characteristics: pH, Aw, Eh, viscosity,
- Concentration rate of the solutions and additives rate,
- Temperature of storage,
- Lifespan,
- Treatment, preparation, manufactured, use/purpose.
Task 3: Identify Intended Use
• Identification of the intended methods of use:
- Lifespan,
- Methods of preparation,
- Instructions of use,
- Foreseeable deviations,
- Storage,
- Intended target groups of consumers.
• Examination of the adequacy between product and its instructions of use.
Task 4: Construct a Flow Diagram
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• Identification of elementary operations/steps.
Collection of additional information on each elementary operation/step
- Nature, function,
- Process, method, parameters,
- Inputs (raw materials and packaging),
- Buildings, equipment, environment,
- Flow,
- Operators,
- GHP (cleaning, disinfection, maintenance),
- Instructions.
Task 5: On-Site Verification of the Flow Diagram
• On-site checking of flow diagram for different periods of production:
- Regular.
-High production rate.
- Low production rate.
- Different shifts.
• Modification of the flow diagram, or drafting of several versions of the diagram:
- according to real conditions observed on production site;
- or according to specific organization during different production rates.
Task 6: List all Potential Hazards Associated with Each Step, Conduct a Hazard
Analysis, and consider any Measures to Control Identified Hazards
• Analyze causes of hazards to each operation/step.
• List causes of hazards (physical, chemical, microbiological) (see Text Box below).
• for microbiological hazards, causes are of three types:
- contamination by germs of spoilage or pathogenic flora
- multiplication of the germs/pathogens
- survival of the germs/pathogens to a decontaminating treatment (heat,
ionization,)
• Qualitative and quantitative hazard evaluation: Calculation of hazard criticality,
subsequently used in risk evaluation, Hazard grading.
• Definition of the preventive measures.

• Formalize preventive measures (control means, procedures, instructions, and records).
Task 7: Determine Critical Control Points

DEFINITION Critical Control Point (CCPs):
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.
For each elementary operation, determine if it constitutes a CCP.
You can use 3 different approaches to do so:

1. by use of a decision tree, or
2. by the application of INTUITIVE REASONING (using common sense), or
3. by carrying out Hazard Analysis on the Flow Diagram by an alternative method.
Task 8: Establish Critical Limits for each CCP
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DEFINITION Critical Limit (CL):
A criterion (target value + tolerance) that separates acceptability from unacceptability.
• For any CCP, the critical limit represents the value beyond which the control of the
identified hazard is no longer guaranteed. It makes sense to bring the process back to
tight control before this value is reached or breached. Therefore, for safety (and
economic) reasons, a target value more rigorous than the critical limit needs to be
enforced.
• A target value needs a tolerance that ensures that, when intervention occurs, the critical
limit is not exceeded.
• Identification for each CPP, based of the identified hazards, leads to characteristics to be
controlled and appropriate preventive measures.
• For each characteristic, defined critical limits have to be respected in order to ensure
CCP control.
Task 9: Establish a Monitoring System for each CCP
DEFINITI
ON Monitoring:
A planned sequence of observations or measurements of CCP control measures. The
records of monitoring provide evidence for future use in verification that the CCP is
under control.
• Monitoring provision: plan, method, device necessary to carry out the observations,
tests or measurements employed to ensure that the critical limits of each CCP are
respected.
• Define the monitoring provisions for each CCP.
• Formalize the monitoring provisions (responsibilities, procedures, instructions,
records...).
Task 10: Establish Corrective Actions
DEFINITION Corrective Action:
Any action to be taken when the results of monitoring at the CCP indicates a loss of
control or trend towards loss of control.
Corrective actions include:
• provisions to ensure the return to CCP control, and

• the management of any affected products.
Task 11: Establish Verification Procedures
DEFINITION Verification:
The application of methods, procedures, tests and other evaluations, in addition to
monitoring, to determine compliance with the HACCP plan.
Definition of all provisions for confirming an effective HACCP operating plan is needed.
These provisions may include:
• Tests on products.
• Monitoring of target values.
• Implementation and concerned batches follow up.
• Simulation of incidents.
• Auditing of the HACCP system.
• Review of records – deviation review – trend analysis.
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All checking provisions shall be formalized into the HACCP system. It shall include
Verification of all parts of the HACCP system, including its records
Task 12: Establish Documentation and Record Keeping
Documentation:
Collection of documents which describes the provisions of the HACCP system, including
records that prove its real and effective implementation.
• Report of HACCP study (stages 1 to 8)
• Design of HACCP plan (stags 9 to 12)
- HACCP plan elements,
- Specifications,
- preventive measures,
- critical limits and CCP monitoring system,
- corrective actions,
- document management,
- verification methods,
- checks,
- reviews of the system,
- records.
GMP, GHP & HACCP AUDIT GUIDE
Presentation of the Audit Guide
The complete audit document consists of four evaluation grids.
The first one is devoted to pre-requisites and the following three to the HACCP method,
(preliminary study, HACCP plans implementation, validity and effectiveness of the plan).
Two columns in each grid are reserved for noting observations taken at the time of audit:
• as appropriate, the observation will give a satisfactory (sa), acceptable (ac) or not
satisfactory (ns) result;
• in other cases the observation makes it possible to note an absence (ab), good practice
not implemented or documentation not appearing in the file;
• finally, an audit grid item available for observation may not be applicable in the context
of the particular food process (na).
Assessment of the Implementation of Pre-requisites
Conformity of the buildings: general organization
Examination of the plans of premises makes it possible to examine matters of the
fundamental principles of organization, often better than on the field, such as •
observance of the ‘onward flow’ principle on production lines • separation of clean and
unclean sectors • no criss-cross of production lines • separation of hot and cold zones.
Immediate surroundings must contain no source of contamination, such as a garbage
dump or wet unhygienic zones. Passageways and parking areas must be paved or
cemented. Lawns must be cut regularly to avoid high vegetation constituting a refuge for
pests. The plans provided in the file shall make it possible to identify each room and to
locate each work station, each significant material, as well as water mains (or other
supplies) and hand washing points. Wastewater and clean water circulations are also to
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take into account. Finally, the plans make it possible to locate entrances and exits of
various flows (production, waste, operators . . .) as well as their circulation within the
physical plant.
Conformity of the buildings: construction and materials
The descriptive booklet, either within the framework of a project, or associated with
observations on the ground (at the time of the visit to the premises), makes it possible to
control the conformity of materials and methods implemented in building the plant. The
covering of the floor and the walls, the way in which they are joined, the devices used to
collect water for floor washing, (the principles of which are stated in #1.2 of the guide),
must conform to regulation. Passive or mechanical ventilation devices must ensure the
elimination of steam and smoke. Lighting must be bright and neutral in color (so as not to
modify the foodstuff colors)
Conformity of the premises: equipment, materials and furniture
The technical documentation of these elements, associated to ground observations carried
out at the time of the visit to the premises, make it possible to check their conformity with
the regulation.
Lawful or normative conformity
The elements of conformity of the buildings presented under the former points can be
controlled and confirmed within the framework of an official approval or a certification.
Upholding the condition of buildings, maintenance
Ageing and decay, by continued use of the establishments, can cause the loss of condition
of the buildings. The implementation of regular maintenance, together with appropriate
immediate remedial action for sudden breakage, confirmed by the keeping of a
maintenance daybook (register of requests with records of repair), helps uphold the
condition of buildings and equipment.
Supplies
Contractual relationship with suppliers
The criteria of acceptance for delivered consignments, with corrective actions required
according to the significance of any noted variance, must be defined in advance and
included in a contractual document drawn up between the producer and his suppliers.
Specification of raw materials
• of composition: this plays a significant role in the tendency of the product to deteriorate
(water content) or in its stability (sugar or salt content). Also it guarantees the accuracy of
the composition of the finished product as defined on final product labeling.
• of microbiological standards guarantees the safety of food by limiting the presence of
pathogenic germs and of toxic metabolites (microbial toxins, histamine . . .).
• of the maximum allowed content of residues, covering such substances as heavy metals,
antibiotics, pesticides.
• of packaging: ensuring by its characteristics protection of delivered raw material. By its

volume it influences parameters such as duration of defrosting time or the utilization
period after opening.
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• the condition of preservation is generally related to temperature and shelf life. These
two measurable parameters can be the subject to monitoring for each consignment and
are thus favorable to the introduction of CCPs.
• organization of stock turnover: it should comply with FIFO principles (First In / First
Out).
Control of deliveries
Inspection of delivery checklists makes it possible to control the conformity of certain
major specifications of raw materials. Observation of variations in these specifications
indicates a loss of hazards control and will result in the use of pre-established corrective
actions. Observations and measurements must be carried out at the time of delivery, and
the checklists must be checked at the same time. When a variance is noted, the
‘customer/supplier’ agreement must include the signature of a type-approval certificate or
a card of anomaly specifically drafted for this purpose, by the supplier or his
representative (delivery person). If immediate inspection is not possible, (such as for
large mixed palletized loads, or if a long term check is involved, such as for
microbiological counts), then the customer / supplier agreement must be clear on the
procedure adopted for inspection and on actions to be taken in the light of failure.
Potability of water
Water is a nutritious raw material and also a cleaning agent. Considering this double use,
confidence in its microbiological quality, as well as its chemical quality, is of prime
importance.
Analysis reports can be easily obtained from water suppliers. However, manufacturers
using private water sources (well, borehole.) will have to employ their own water quality
control plan.
Implementation of a system of traceability

A system of traceability makes it possible to manage any food safety crisis by going back
to the origin of the products implicated. It also makes it possible to identify all the outlets
where they have been sold. A traceability system also allows, using the HACCP flow
charts, to find those production batches that will be subject to corrective action, i.e. all
batches that have been produced since CCP monitoring indicates the last time that the
system was known to be still in control. Frequently, (and particularly when computerized
systems of traceability are implemented by specialist providers), those responsible for
food product traceability do not know the configuration of the traceability system; they
are simply trained how to use it. Under these conditions, it is good practice to submit this
system to a simulation trial, rather than rely on a system audit. Simulation results allow
the auditor to judge the efficacy of the traceability system and the capability of staff in its
use.
System of upstream traceability

A simulation of upstream traceability needs to be able, for any real substance chosen
randomly from within raw materials stocks, to divulge all information on its source,
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origin, batch, and delivery date. The system of traceability must be able to provide an
answer to these questions. Examination of delivery checklists, supplier invoices and
records of raw material stocks can all help to understand the system of traceability.
System of downstream traceability

A simulation of downstream traceability needs to be able, for a product chosen randomly
in finished products stocks, to divulge all information on recipients of any other parts of
this batch, as well as batches of raw materials that were used for its manufacture. The
system of traceability must be able to provide an answer to these questions. The
examination of purchase orders, copies of clients’ invoices and registers of finished
product stocks, can also help understand the system of traceability.
Pest control
Implementation of a pest control plan
The presence of pests in a factory can be noted during a visit to the premises by the
presence of dead insects or droppings / urine of rodents. A plan of rodent extermination
must be implemented. The file must include a plan of the factory where the poison baits
are located, and the technical cards of rodent poisons being used. Storage outside the
buildings (equipments and materials) must not be placed next to the walls but kept as far
from them as possible and must allow a minimum space of at least two meters. This
arrangement makes it possible to avoid the settling of pests directly against the walls,
their penetration and their establishment inside the plant. Management of waste materials
must prevent their overflow and the presence of any food waste on the ground that could
attract pests. A plan of insects control must also be implemented. The file must include
the schedule of operations and technical information cards of insecticides.
The implementation of the programme of pests control operations must be recorded on
appropriate checklists.
Control of human sources of contamination
Medical monitoring of the operators
Monitoring is proven by the delivery of an annual medical certificate of fitness for
foodstuffs handling to each operator. In the event of a stoppage caused by a severe
infectious condition, or presenting a significant risk of transmission via food, such a

certificate may well be required for a return to work.
Staff training to the principles of hygiene and good manufacturing practices
The company must implement a plan of staff training. As with medical monitoring,
appropriate certificates of training shall be delivered for each successfully trained
member of staff.
Professional clothing hygiene
• The documents relating to the internal system of management of professional
clothing (clean or soiled) must makes it possible to check that it is provided and
cleaned by the company (or under its responsibility). Moreover each member of the
staff must use two cupboards in the cloakroom (or one single cupboard with two
compartments), to ensure the separate storage of working garments and everyday
wear. Permanent devices (boots/shoes washstands) or movable ones (trays),
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containing a disinfecting solution, must allow cleaning/disinfection of shoes or boots
before getting into the production zone
Respect of the good hygiene practices and good manufacturing practice
Due to training and to the provision of guides of good hygiene practices and guides of
good manufacturing practices, staff is able and is obliged to respect these good practices.
Hands cleaning and material cleaning

Hands
Visits to premises make it possible to check that conforming washstands (non-manual
taps, disinfectant liquid soap dispenser, disposable hands wiping system) are made
available to operators in sufficient numbers. These washstands must be located near
working stations, cloakrooms and toilets. Contamination by hands, regarded as the ‘first
tool of the operators’, is controlled by the training received and by the posting of hand-
washing instructions near the washstands.
Material and buildings
The control of contamination of equipment and buildings requires the introduction of a
cleaning plan, drafted by applying the problems resolution method known as ‘the
W.W.W.W.H.W method‘(Who? What? Where? When? How? Why?) Written
procedures of cleaning, together with technical cards of cleaning products, are gathered
in this cleaning plan. Each operator (production operator or member of the cleaning team)
has a copy of the part that corresponds to his cleaning tasks. The good execution of this
cleaning plan can be assured by checking with appropriate records.
• control of good execution of tasks using a check-grid completed as the work progresses
• control of visual cleanliness of surfaces using a weekly (or higher frequency) check-grid
• microbiological control plan of surfaces, valuable for validation of the cleaning plan,
and resulting in analysis reports for appropriate action.
Assessment of preliminary HACCP study step
After evaluation of the implementation of pre-requisites in the former grid, this second
grid approaches HACCP itself. This method is structured in twelve Tasks that are taken in
order, one after the other. Grid 2/4 takes into account steps 1 to 8 inclusive.
Task 1
Management commitment
This commitment testifies to the sincere resolve of the management to apply HACCP
methodology involves a letter addressed individually to each member of the staff of the
company.
Set up of the HACCP team
The HACCP team organization chart (organogram) should be the basis for specifying
functions and responsibilities for each member. These functions and responsibilities need
to be described on individual job specifications for the HACCP programme.
Resources
The resources available to the HACCP team (computer, photocopier, budget etc.) shall be
clearly defined and recorded in the HACCP file.
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HACCP team management
Organization is planned around the scheduling of activities, setting out the frequency and
duration of team working sessions. The plan defines time limits for the implementation of
HACCP stages. With objectives being predicted for completion by specific dates, any
delay needs to be justified.
Each working session starts with a statement of work completed since the former meeting
and ends in the allocation of the tasks to be realized for the following meeting. Each
working session must be recorded in a report.
Task 2
Description of the product
The product description file, completed by the execution of stage n° 2, collates all
relevant information on the product including (but not restricted to):
• composition (ingredients, nutrition)
• volume, nature, storage, packaging, labeling,
• raw materials specifications (composition, proportion in the product, physicochemical
characteristics, conservation, pre-processing, microbiological standards).
Task 3
Identification of expected use
This stage results in the drafting of documented instructions for use. The information
provided by labeling of the product (storage temperature, shelf life . . .) also depends on
the conclusions of this step. This study on expected use needs to take into account the
expected groups of consumers involved (e.g. children, older people). It also needs to
include a study on potential foreseeable deviations of use and on any dangers that could
result from these.
Task 4
Draft the flow diagram
Task 5
Verify the flow diagram
The flow diagram is the base for hazards analysis, so it must closely correspond to the
real field conditions for all products or all families of products (as appropriate to the
study), for all the production periods. In certain sectors of production (catering, pastry
baking), flow diagrams will relate to basic operations (oven cooking, fast cooling . . .).
Combinations of these flow diagrams then make it possible to carry out study of all types
of production schemes. When each one of these basic operations is controlled, the whole
of the production can then be regarded as controlled. It should be noted that the same
product can present conditions for more than one flow diagram if the conditions of
production change, for example between slack and busy periods. In this example, the
number of operators, and hence also work organization, may change. During inspection
or audit, some sequences of production need to be compared with the flow diagram
appearing in the file in order to assess its validity.
Task 6
Hazards analysis
Using the flow diagram and the list of potential hazards already in the file, the analyst
now needs to evaluate the significance of hazards:
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• by checking that no hazard has been overlooked;
• by checking that all hazards identified by using the flow diagram are collated in a
summary (table, list . . .);
• by checking that the calculation of the criticality index (specified on a separate
document) provides a valid evaluation and hence a correct rating of risks;
• by checking through the calculation of the criticality index, that identified risks are real
(and thus excluding any risks with a zero index value)
A list of preventive measures, each specific to each identified hazard as applied in the
particular establishment, with procedures for implementation, must appear in the file.
Task 7
Determine critical points
The use of the HACCP flow diagram, together with a CCP decision method (CODEX
decision tree, or the intuitive method), allows for identification of CCPs, which are
gathered into a summary (table, list, etc…).The identification of a parameter, indicating
maintained safety control or otherwise of each CCP, that can be monitored, allows
differentiation from standard production operation control. This measurement needs to be
timely so as to maintain production∗, and at low cost. Auditors need to verify that a
measurable parameter is associated with each identified CCP.
Task 8
Establish critical limits for each CCP
By examination of the file documents, the limits of the criteria, which separate
acceptability from non-acceptability, need to be the assessed. Each criterion, together
with its possible justifications, is evaluated using:
• limits of performances of the available equipment . . .
• quantified data (from data sources) on the microbial flora (temperature, pH and Aw,
growth limits . . .);
• results of ageing tests;
• lawful or normative obligations.
∗ if results take too long to come back, production will be held up awaiting them, or
expensive large stores of working- process or final product will be required
Assessment of the drafted HACCP plan

This third grid relates to the evaluation of the last four tasks of HACCP method. These
are devoted to the drafting of the hazard control plan.
Task 9
Establish a monitoring system for each CCP
Initially, the significance and appropriateness of all monitoring procedures need to be
evaluated. Then the framework of parameters for monitoring, (T°, Temps, Aw, pH,
weight, volumes) and their recording, needs to be established and validated to ensure that
any loss of control is immediately identified.
Calibration plan of measuring instruments
Any instruments involved in monitoring of CCPs need to be included in calibration plans
and the calibration plans need to be implemented.
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(If an instrument is found to be out of calibration, an action plan needs to be in place,
particularly indicating actions for all products that have been produced since the last
time that the instrument can be confirmed as being correctly calibrated).
Task 10
Establishment of corrective actions
The HACCP plan needs to define the corrective actions implemented in the event of loss
of control (i.e. observation of a deviation of values being monitored for control). To this
aim the documentary system must fulfill certain constraints:
• to establish appropriate levels of corrective action to be implemented corresponding to
the gravity of observed CCP deviation
• to define application of operational procedures of for the various corrective actions
selected
Ensuring the follow-up of batches of products for corrective action(s)
The company must set up a system of monitoring sheets, based on traceability, to follow
up the batches that need to be subject to corrective actions.
Task 11
Establish verification procedures
The inspector (or the auditor) controls the implementation of validation methods and
documents for HACCP plan or for the implementation of GHP and GMP. The details of
implementation means may include (but not be restricted to):
An analytical control plan (microbiological and chemical) of the finished product,
(defining the finished product standards) including:
• sampling plan (number, size, frequency of samples)
• microbiological standards for different (types, groups of) products
• residue standards for such as: growth factors, pesticides, antibiotics, and heavy metals
• standard analysis model report
• keys for interpretation of analyses
Analytical control plan of surface cleanliness:
• sampling plan (number and frequency of samples)
• microbiological standards for surfaces
• standard analysis model report
• keys for interpretation of analyses
Field verification
Confirmation of the verity rests on the execution of a documentary review or audits (by
external or internal people) of the risks control system (GHP/GMP and / or HACCP).
If this step does not allow for satisfactory observation of results, it will lead to revising
the set-up of the hazard control system.
Task 12
Establish documentation and record keeping
The inspector (or the auditor) needs to check that the HACCP system documentation
effectively includes all documents (commitment, objectives and system establishment,
procedures, analysis reports, outside technical data, checklists, etc . . .) as defined in the
eleven steps of the HACCP outlined above or in the Pre-requisites section (- and for the
control of this twelfth step)
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Routine evaluation of the real and effective implementation of an
HACCP plan in the company
This last grid is intended to be employed at the time of routine visits carried out in
companies whose complete HACCP system has already been inspected (or audited), and
has already received an official approval or a certification
Implementation of the GHP
Supplies control
The inspector (or the auditor) needs to confirm that raw material delivery checklists are
correctly kept. He needs to ensure, by examining preceding weeks’ checklists, that
corrective actions are actually implemented based on documented delivery controls, such
as:
• documented warnings to the suppliers
• rejection of raw materials batches
Available analysis reports also enable him to check that water used for production (as an
ingredient or as a cleaning medium) is potable.
Validation of the cleaning plan
The inspector (or the auditor) needs to confirm that checklists of task implementation are
correctly and immediately completed at the time of cleaning completion
He must also check the validity of results of microbiological cleanliness analyses for
equipment and surfaces. In the event of nonconformity of the results, he must make sure
that the company has taken appropriate action, such as bolstering its cleaning procedures
or changing its cleaning / disinfection products (if contaminating microbiological flora
have become resistant).
Validation of the pest control plan
The inspector (or the auditor) needs to confirm that any intervention forms of the pest
control company are correctly filled out for each visit.
During the visit of the premises, he must also seek out signs of pests:
• droppings and urine of rodents
• damage to foodstuffs bags (rice, pasta, beans…) caused by rodents
• Insect’s bodies
• droppings of birds nesting / nests in the superstructures of buildings
Medical follow-up of the staff
This medical follow-up is validated by the presence of a medical certificate of aptitude to

foodstuffs work, in the personal file of each operator employed by the company.
Staff training
The implementation of the continual training plan is confirmed by the presence of
certificates delivered for each training course, in the personal file of each staff
member. The inspector (or the auditor) can also have informal conversations, (without
breaking principles of hygiene), with operators posted on the lines of production, in order
to evaluate their level of awareness and competence.
Maintenance of buildings and equipment
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In addition to the visual observations that can be made during the visit to evaluate
premises maintenance, the inspector (or the auditor) must check on the upkeep of the
maintenance daybook
Upholding of the conformity and provisioning of the washstands

This part of the audit mainly depends on visual observations carried out during the visit
to the production premises.
Upholding of the conformity and provisioning of the boots/shoes washstands
This part of the audit mainly depends on visual observations carried out during the visit
to the production premises
HACCP plan, CCP monitoring
CCP monitoring
The implementation of this step (n° 9) of the method is validated by the records relating
to the CCP monitoring. Assurance in the discipline in their keeping and their use is an
essential point of the audit of any implemented HACCP plan. Without such rigor being
applied to the keeping and use of these records, no real and effective HACCP plan can be
implemented. Any loss of control indicated by a deviation of the measured values, needs
to be checked and coupled with necessary corrective action. Recordings need to be dated
and signed after reading and before archiving.
A (non exhaustive) list of records relating to the monitoring of CCPs
• records of cold store temperatures (chill and frozen) and of air-conditioned production
areas
• records of inventory control (in respect of deadlines for use)
• records of the heat treatment pair of parameters ‘duration / temperature’
• schedules of sterilization, pasteurization, cooking
• monitoring recordings of pH (dairy products, dry salted meats . . .)
• measurement recordings of water activity values (Aw)
• weighing, volume measurement of product ingredients, during recipe build
Follow-up of the corrective actions
The inspector (or the auditor) needs to confirm that monitoring sheets of corrective
actions are correctly and progressively filled, until the effective reworking, removal or
destruction of any affected batches
Conformity of the finished products
Conformity of finished products to microbiological and toxicological standards must be
validated by analysis reports held by the company. Any observation of analysis
report not in accordance with standards, must lead to reconsideration, and subsequently
to, improvement of the entire current system of hazard control. (GHP, GMP and HACCP
plan)
Traceability
The inspector (or the auditor) needs to check simulations of upstream and downstream
traceability at the time he is visiting the establishment – either on raw materials, or in
production, or finished products randomly taken.
Simulations of incidents
The simulation of incidents is a method which can be used to check the validity and
329
effectiveness of monitoring systems.
Warning lights signals losses of control or hooters (cold stores, metal detectors . . .) such
simulations of incidents can be periodic recorded events, which the auditor will be able to
reports to trace from records. They may also be carried out at the request of the inspector
(or the auditor) at the time of visit.
Sanitation and Hygiene Practices
of Employees in Food Safety
Human beings are involved at all stages of food chain i.e. production, harvesting,
packaging, transportation, loading, unloading, handling, etc. They are source of
contamination. Illnesses associated with foods are primarily those transmitted by the
faecal-oral route. Although raw produce can serve as a source of a variety of food borne
organisms, such as viruses, bacteria, protozoa, fungi, and parasitic worms, yet one should
be gravely concerned about the presence of pathogenic bacteria, such as E. coli 0157:H7.
Methods directed towards reducing food safety risks in food production,

harvesting and distribution operations must start with good sanitation and
hygiene practices. The application of a good sanitation and hygiene
programme should focus on the employees, environment, facilities, and transportation of
fresh foods.
Employees: Microbial Hazard
Worker's health and hygiene play a critical role in the controls for minimizing microbial
contamination of food. Faecal-oral diseases are the primary microbiological concerns that
have been associated with food. Workers during growing, harvesting, sorting, processing,
and packing food can spread these diseases. Infected food Industry workers/employees
have been implicated as the source of several food borne outbreaks of gastro-enteritis,
involving salads, cold food items, and ice.
Proper hand washing minimizes the spread of pathogenic bacteria and other microbial
hazards, limiting the potential for contamination of produce.
Control of Potential Hazards
Personal Health of Employees
•Good hygienic practices by all personnel (incl. Senior Managers) who are involved in
the harvesting, packing, and distribution of food are essential in the control of microbial
and other biological hazards. Any individual in the agricultural environment (farm,
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packing areas and transportation chain) who contacts food or equipment used in contact
with food in agricultural areas presents a potential contamination risk.
•All personnel, including those indirectly involved in food operations (such as, pest
control operators), must comply with established hygienic practices. Infectious diseases,
ill health accompanied by diarrhea, open lesions (including boils, sores, or infected
wounds), and other ailments are a source of microbial contamination that could
contaminate food, water supplies, and other workers.
•Some microbial pathogens that can be transmitted by food contaminated by infected

individuals include, but are not limited to, the following:
1. Salmonella species,
2. Shigella species,
3. Staphylococcus aureus,
4. Streptococcus pyrogenes,
5. E. coli,
6. Giardia lamblia,
7. Hepatitis A virus,
8. and many others.
Symptoms associated with infections by these pathogens may include diarrhea, fever,
vomiting, jaundice, and sore throat with fever. An employee suffering from any of these
symptoms presents an increased risk of transmitting food borne illness. Unfortunately
most of the food companies do not practice regular medical check-up of their employees
to prevent such incidences. It is suggested that:
•Operators train employees to report to the person in charge any information about their
health or activities as they relate to diseases that are transmissible through food. Because
of the high infectivity (ability to invade and multiply) and virulence (ability to produce
severe disease) of Salmonella typhi, Shigella species, E. coli 0157:H7, or hepatitis A
virus, any worker diagnosed with an active case of illness caused by any of these
pathogens should be restricted from work assignments that involves contact with food or
produce handling equipment.
•The supervisor, or the person in charge, should consider ways to monitor the health of
their employees and take steps to reduce the chance of food borne illness. For example,
disposable rubber or similar gloves, leak-proof band aids, or other corrective measures
for minor cuts should be provided for use as necessary to the personnel who may have
contact with produce.
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• More importantly, the person in charge should ensure that workers with diarrhea
disease are not working with food or any equipment used in the harvesting and
processing of food.
•Workers should be taught to report symptoms caused by illness, infection, or other

source that is associated with acute gastrointestinal illness such as: diarrhea, fever,
vomiting, jaundice, or sore throat with fever, a lesion containing pus such as a boil or
infected wound that is open or draining and that is located on parts of the body that might
have contact with food or produce harvesting and processing equipment.
Prevention is better
•Role and attitude of senior managers is very crucial. Many time senior managers ignore
the need of training and re-training of employees. Such shortsighted managers are doing
disservice to their companies because poor quality and unhygienic food is eroding their
companies' good will in market place.
• All employees, including supervisors, full time, part time and seasonal personnel
should be trained in good hygienic practices. Computer can be used to train people
either through animation films of video films.
•Processors or growers may want to consider establishing a training programme that

would include a system to monitor and evaluate compliance with established sanitary
practices. The operators should also consider follow-up training sessions to encourage
adherence to good hygienic practices.
•The biggest challenge is to change the mindset of employees and facilitate the learning
of new techniques.
Well Designed Programme
The focus of any training programme should include, but is not limited to, the following:
•The importance of good hygiene.
•All personnel should understand the impact of poor personal cleanliness and unsanitary
practices on food safety.
•Smoking or eating in areas where food is present can contaminate the produce because
of the potential that the hands and food-contact surfaces may become contaminated.
332
• Unsanitary personal practices such as scratching the head, placing the fingers in or
about the mouth or nose, and indiscriminate and uncovered sneezing or coughing may
contaminate food or any handling equipment. Within packinghouses, hair can be a
direct and indirect vehicle of contamination. Workers may contaminate their hands by
touching their hair. For enclosed facilities, operators may want to consider the use of
hair restraints to keep dislodged hair from ending up in food and to deter employees
from touching their hair.
•Thorough hand washing after each absence from the workstation, after using the
bathroom, before and after eating, and before commencing work is very important. Many
of the diseases that are transmissible through food may be harbored in the employee's
intestinal tract and shed in the faeces. Thorough washing of hands with soap and warm
water helps to stop the spread of germs. Employees should be taught proper hand
washing techniques that include: hand washing with warm water (if available); proper use
of soap; and thorough scrubbing (including cleaning under finger nails and between
fingers), rinsing, and drying of the hands.
•The importance of using sanitation facilities. All employees should be encouraged to use
on-site latrines and to avoid eliminating wastes outside of these facilities. The use of well
maintained sanitation facilities for waste elimination helps reduce the potential for cross
contaminating fields, produce, other workers, and water supplies, and increases the
likelihood that employees will wash their hands after using such facilities.
•Employee must feel proud and help colleagues in achieving sanitation and hygienic
standards.
Please remember, employees are not machines but more important than machine. Respect
their individuality and build on their strengths. In competitive business environment,
good knowledgeable employees are the most important assets. You take care of them they
will take care of your business interests.
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Project Report HACCP

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Project Report HACCP

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RPF-III

Development of HACCP procedures for the production of soy based

Project No: 583

Soybean Processing and Utilization Center

2. Institute Code No: CIAE/PHT/SPU/2007-6

3. ICAR Code No: PI-2007/6-IAE.Q00

4. Name and address of the Research Institute:

Central Institute of Agricultural Engineering, Bhopal.

5 Title of the project:

7. Name and designation of the leader: Dr. A.P. Gandhi

Sl. No Name Designation Time to Work to be done

Soybean Processing and Utilization Center, Central Institute of Agricultural

10. (a) Objectives:

(b). Practical utility

11. (a). Technical program

(b). Observations to be recorded:

12 Date of start April 2007

13. Date of completion March 2009

14 Final report of the Project

The HACCP system consists of the following seven principles:

Conduct a hazard analysis.

Determine the Critical Control Points (CCPs).

Establish critical limit(s).

Establish a system to monitor control of the CCP.

Establish documentation concerning all procedures and records appropriate to these

GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM

1. Assemble HACCP team

3. Identify intended use

5. On-site confirmation of flow diagram

7. Determine Critical Control Points (SEE PRINCIPLE 2)

8. Establish critical limits for each CCP (SEE PRINCIPLE 3)

9. Establish a monitoring system for each CCP (SEE PRINCIPLE 4)

Monitoring is the scheduled measurement or observation of a CCP relative to its critical

10. Establish corrective actions (SEE PRINCIPLE 5)

• Review of the HACCP system and its records;

12. Establish Documentation and Record Keeping (SEE PRINCIPLE 7)

Documentation examples are:

Record examples are:

• CCP monitoring activities;

Training of personnel in industry, government and academia in HACCP principles and

guidelines were used for the preparation of HACCP plans.

1. Product name Full Fat Soy flour

Full Fat Soy flour

Wet Processing Area Dry Processing Area

Bacteria (non spore forming) Protozoa and parasites

From packaging materials

Table 2.Product ingredients and incoming material

Raw material Packaging material Dry ingredients

Table 3.Flow diagram

Soybeans Packaging material Dry ingredients Water

P=physical; B=biological; C=chemical

Dry ingredients storage

HAZARD IDENTIFICATION: PHYSICAL HAZARDS

- inadequate protection against harmful extraneous material could result in

Dry ingredient receiving

- in adequate protection against harmful extraneous material could result in

Process Category Q1 Q2 Q3 Q4 CCP

Process Category Q1 Q2 Q3 Q4 CCP

Product name: Full Fat Soy Flour

Stage Activity Control activity

Process Flow Chart for making MFSF

Cleaning dirt, foreign matter

Hulls De hulling CCP-1