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Food Industry Guide to Implement GMP/GHP Requirements

Edible Vegetable
Oils & Fats

Based on Part II of Schedule 4 of Food Safety & Standards (Licensing &

Registration of Food Businesses) Regulation, 2011
First Edition October 2017
Online available at www.fssai.gov.in

Disclaimer
It is to be noted that this guidance document does not intend to replace any legal provision
of Food Safety & Standard Act, 2006 & regulations thereunder. Further, wherever the
provision of this document conflicts with Part II of Schedule 4 of Food Safety &Standards
(Licensing and Registration of Food Businesses) Regulation, 2011 or any other regulation
under Food Safety & Standard Act, 2006 for that matter, the provision given in the
regulations shall prevail.

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 PREFACE

This Guidance Document on Food Safety Management System (FSMS) is prepared with the
intent to provide implementation guidance to food businesses (especially the small and
medium businesses) involved in manufacturing, packing, storage and transportation of
edible vegetable oils & fats, to ensure that critical food safety related aspects are addressed
throughout the supply chain.

This document contains practical approaches which a business should adopt to ensure food
safety; however, manufacturers may adopt higher or stringent levels, depending on the
needs & complexity of operation. The use of this guidance is voluntary and food business
operators may comply with the requirement of the regulation according to other
established best practices.

It is important that food handlers involved in the edible vegetable oils & fats supply chain
are trained appropriately to implement the good manufacturing practices and good hygiene
practices to ensure food safety.

We acknowledge the contribution of the experts from the technical panel of FSSAI along
with CHIFSS (CII-HUL Initiative for Food sciences) team for developing this document.

Pawan Agarwal – CEO, FSSAI

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 SCOPE
This document is applicable for food businesses involved in the entire or any part of the
edible oil supply chain. The major activities in the edible vegetable oils & fats supply chain
comprise of the following:

a) Pre-processing (Seed Storage /Crushing / Expeller oil /Solvent extracted crude oil)
b) Manufacturing & Packing of Edible vegetable oils & fats & Fats
c) Storage/Warehousing & Transportation of Packed/Bulk edible vegetable oils & fats &
Fats

All the above activities may or may not be carried by the same facility. For example,
crushing and extraction of crude oil; refining/ processing of crude oil, and the transportation
of oil to its destination may be carried by different businesses. Accordingly the raw materials
for these businesses would also be different like oil seeds (directly from farm), or crude oil
(post crushing by the supplier), or unpacked processed oil (for Bulk/retail packing only).
Hence, based on their position in the oil supply chain and the activities carried out, an oil
industry could use the guidance document accordingly as per the operations applicable to
them. The various types of Edible vegetable oils & fats covered under the document are:

a) Raw/ Crude edible vegetable oils

b) Refined edible Vegetable oils
c) Blended edible Vegetable oils
d) Hydrogenated Vegetable fats
e) Bakery fats & Margarines

The document is divided into five main sections. The first section gives an overview of the
edible vegetable oils & fats industry in India along with the rising need for food safety in the
sector. The second section contains guidance for implementation of good manufacturing
practices and good hygiene practices as outlined in Part II of Schedule 4 of Food Safety &
Standard (Licensing & Registration of Food Businesses) Regulation, 2011. The document has
specified requirements where compliance is essential and obligatory for food businesses
and in such cases the word “shall” is used. In addition certain good practices are also
strongly advised for food safety operation & in such case “should” is used.

The third section of this document is recommendatory in nature and provides the basic
knowledge and criteria for implementation of Hazard Analysis and Critical Control Point
(HACCP) system by the food businesses. This section includes the manufacturing flow chart
& two tables: Hazard Analysis and HACCP Plans. Tables of Hazard Analysis is expected to
help the industry to identify the food safety risks related to each processing step, to identify
the Critical Control Points (CCPs) along with recommended corrective actions and other
related information. Sample HACCP Plans have been taken from some established practising
edible vegetable oils & fats industries. These plans could be used as reference by the
industry and modified or altered based on their operations.

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 CONTENTS
A. Overview of edible vegetable oils & fats industry in India...................................................7

B. Implementation Guidelines ...............................................................................................9

1. Establishment – Design and Facilities ……………………………………………………….…….………………10

1.1 Location and Surroundings
1.2 Premises & Rooms
1.3 Equipments, containers and food contact surfaces
1.4 Facilities/Utilities

2. Control of Operation………………………………………….……………………………………………………………16
2.1 Food Receipt
2.2 Storage – Raw materials & packaging materials
2.3 Food processing including pre-processing
2.4 Food packaging
2.5 Rework & control of non-conforming products
2.6 Food transportation, warehousing and distribution
2.7 Food Traceability & Recall
2.8 Quality Control

3. Establishment – Maintenance & Sanitation…………………………….……………………………………….25

3.1 Cleaning and sanitation
3.2 Maintenance
3.3 Pest Control Systems
3.4 Waste disposal management

4. Establishment – Personal Hygiene…………………..……………………………………………………………..28

4.1 Health status of food handlers
4.2 Illness & injury
4.3 Personal Cleanliness
4.4 Personal behavior
4.5 Visitors

5. Product information and consumer awareness ………………………………….………………………….30

5.1 Product information &Labeling
5.2 Consumer awareness and Complaint handling

6. Training & management………………………………………………………………………………………………...31

6.1 Awareness and responsibilities
6.2 Training programmes
6.3 Instruction and supervision
6.4 Refresher training
6.5 Management & supervision

7. Audit, Documentation & Records ……………………………………….…………………………………………33

7.1 Self evaluation & review
7.2 Documentation & Records

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C. HACCP Implementation ....................................................................................................34

I. Introduction to HACCP ………………………………………………………………………………………..………..35

II. Application of HACCP System …………………………………………………………………………………..…..38

1. HACCP Implementation Steps
2. HACCP Plan for Kachi Ghani Mustard Oil
3. HACCP Plan for Refined Vegetable Oil
4. HACCP Plan for Hydrogenated Vegetable Fat

D. Inspection Checklist .........................................................................................................55

E. Proformas ............................................. ..........................................................................59

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A. OVERVIEW OF EDIBLE VEGETABLE
OILS & FATS & FATS INDUSTRY IN
INDIA

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 A. OVERVIEW OF EDIBLE VEGETABLE OILS & FATS INDUSTRY IN INDIA

Edible vegetable oils & fats form an essential part of the modern diet. These oils & fats play
a role as an energy source, and provide the diet with many beneficial micronutrients.

The demand for edible vegetable oils & fats in India has shown a compounded growth of
4.5% over the last 10 years and is estimated at 21 million tonnes for Oil Year (OY) 2016-17/
India plays an important role in the global edible oil market, accounting for approx. 10.2%
share of consumption; 7% share of oilseed production; 5% share of edible oil production and
16% share of world edible oil imports for OY 2015-16. As per USDA estimates, India is the
third largest consumer of edible vegetable oils & fats (after China and the EU-27 countries);
and will account for 11% of global edible oil demand and 16% of global imports.

India’s annual per capita consumption has shown a steadily increasing trend from 4 kg in the
1970s to 10.2 kg in the late 1990s to current levels of 17 kgs. However, it still ranks well
below the world average of around 24 kg (per capita figures including consumption of bio-
energy), thereby signifying the high growth potential of the industry. Thus the Oil industry is
sun shine sector for India. Large sections of farmers are dependent on this sector and; Oil
industry is impacting positively on wealth creation for India.

Role of Oils and Fats in Human Diet

Oil and fats are important parts of the human diet and more than 90% of the world’s
production from vegetables, animals and marine sources is used as food or as an ingredient
in food products. Oils and fats are a rich source of dietary energy and contain more than
twice the calorific value equivalent to the amount of Carbohydrates. Their functional and
textural features contribute to the flavour and palatability of natural and prepared foods.

Fats and oils are constructed of building blocks called “triglycerides” resulting from the
combination of one unit of glycerol and three units of fatty acids. They are insoluble in
water but soluble in most organic solvents. They have lower densities than water, and may
have consistencies at ambient temperature of solid, semisolid, or clear liquid. When they
are solid-appearing at normal room temperature, they are referred to as “fats,” and when
they are liquid at that temperature, they are called “oils.” Fats and oils are classified as
“lipids” which is a category that embraces a broad variety of chemical substances. In
addition to triglycerides, it also includes mono- and diglycerides, phosphatides,
cerebrosides, sterols, terpenes, fatty alcohols, fatty acids, fat-soluble vitamins, and other
substances.

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B. IMPLEMENTATION GUIDELINES

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1. ESTABLISHMENT – DESIGN AND FACILITIES
1.1 Location and Surroundings
The selection of the right location for the food facility is important to minimize any food
safety risk and to ensure that neighboring industries and activities do not became a
contamination source due to transferring hazards by air or water or increasing the risk of
pest infestation.

a) The food establishment shall be located away from any polluting industry or
adequate measures shall be taken to enclose and protect the manufacturing
premises from any possible environmental hazards.
b) The site boundaries shall be clearly identified with appropriate access control to
prevent any chances of theft and sabotage. Dogs, cats or other pet animals should
not be allowed to enter the premises.
c) The site shall be maintained in good order. Where buildings are surrounded by
grassed or planted areas, a clear space should be provided between the grassed
planted areas and the building. Such grassed/planted areas should be regularly
tended and maintained. The roads, yards and parking areas should be maintained
(for example, free from accumulated garbage, pest activity).There should not be any
stagnant water surrounding the facility.
d) If the building is used for residential purpose also, then there shall not have any
direct access to the food premises. The activities should be compartmentalized if
feasible to prevent cross contamination.
e) The manufacturing premises shall be located away from flood prone area. Where the
premises are located in areas prone to flooding, it is recommended that height of
the manufacturing area should be suitably elevated to prevent the risks due to
flooding.

1.2 Premises and Rooms

1.2.1 Construction, design and layout

Plant internal layout should be designed, constructed and maintained in such a way to
facilitate good hygiene and manufacturing practices.

a) The building shall provide adequate space with a logical flow of materials, products,
personnel, layout of equipment and to the extent that is practicable physical
separation of raw from processed areas.
b) The plant layout should have a proper space for inward and outward vehicle
movement. Conveyors and openings intending for transfer of materials shall be
designed to minimize any cross contamination from foreign matter, pests, etc.

1.2.2 Internal structures

This requirement applies to areas used for oil handling, cleaning, sanitizing & personal
hygiene

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a) Walls and partitions shall
 be provided where necessary to protect food from contamination
 have a smooth surface, impervious and preferably plastered
 be easily cleanable
 be sealed to prevent the entry of dirt, dust and pests;
 be free from flaking paint or plaster, finished and maintained to prevent the
accumulation of dust, minimise condensation, and shedding of particles
Wall floor joints should be curved in processing and packaging areas to facilitate cleaning

b) Ceilings shall
 be sealed to prevent the entry of dirt, dust and pests;
 be free from flaking paint or plaster, finished and maintained to minimize the
accumulation of dust, condensation, mould growth, and shedding of particles
The overhead fixtures shall be suitably protected so that they do not act as contaminants in
case of breakage.

c) Floors shall be
 be non-slippery, sloped appropriately, to allow adequate drainage.
 be maintained in good repair with no cracks and crevices
 be made of materials that are durable and easy to clean such as Epoxy coated floors or
kota stone flooring or any other suitable flooring.

d) Windows
 shall be constructed to minimize the accumulation of dirt
 windows, roof vents or exhaust fans that open to the external environment shall be
fitted with removable and cleanable insect-proof screens;
 where open windows would result in contamination, windows must remain closed and
fixed during operations.
 The ends should be secured to prevent the entry of pests.
 If window panes made of glass, it should be laminated.

e) Doors
 shall have smooth, non-absorbent surfaces
 Shall be easy to clean
 shall be close-fitting and with suitable precautions to prevent entry of pests
 Gaps if any between the door and the floor should be closed with suitable material like
rubber strips, polyurethane etc to avoid pest entry.
 Entry/exit points should be suitably protected with such as strip PVC/air curtains/ wire
mesh doors/ doors with self closing devices etc. To ensure dust, insects, birds and
animals are kept out.

1.3 Equipments, containers and food contact surfaces

a) Equipment and containers that come in direct contact with food (including food contact
surfaces) and used for food handling, storage, processing, packing shall be:

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- made of impervious, corrosion free material which do not impart any toxicity to the food
material and shall be easy to clean.
- located, designed and fabricated so that it permits necessary maintenance and periodic
cleaning.
- kept in good order, repair and condition as to minimize any risk of contamination. These
include free from cracks, crevices, open seams etc.

- shall be placed to achieve easy and effective cleaning of adjacent areas like floors, walls,
ceilings and other surfaces.
b) All openings such as manholes, inlets, outlets, draining out of points, etc. should
be made such that they can be locked and/or effectively sealed.

c) The use of metal vessel, metal container or other equipment made up of metal, which is
likely to cause metallic contamination and is injurious to health, should not be used in
the preparation, packing or storage of food products. E.g. Copper, copper alloys, iron
etc. should be avoided as they have catalytic effects for oxidation.

d) They shall be located, designed and fabricated so that it permits necessary maintenance
and periodic cleaning. For e.g. The preferred design of tanks should be:

- Tall, narrow tanks to minimize contact surface area of oil and tank. This will avoid air
and oxygen contact, if any.

- Suitable shape is vertical circular cross section tank with self-supporting fixed roof.

- Tank bottoms should be conical or sloped (with a sump) to facilitate draining.

Tank construction material and for ancillary equipment (including heating facilities):
 Should be inert to oils and fats; and should be food contact in nature.
 Stainless steel – is the most preferred metal and is recommended for storage
and transportation of “fully” refined oils and fats.
 Mild steel is acceptable for “crude” and “semi-refined” oils; and can be used
with coating of an inert material inside. (E.g. phenolic epoxy resin, or zinc
silicate)
*The suitability for contact with oils and fats and the method of cleaning should be
obtained from coating manufacturer

1.4 Facilities/Utilities
1.4.1 Water supply

a) Adequate supply of potable water shall be available to meet operational and clean-up
needs.
b) Water including steam used as a product ingredient or in contact with food of food
contact surfaces or used for equipment and plant cleaning shall be potable.

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c) Potable water quality shall be as specified in the latest edition of BIS standard on
drinking water (IS 10500). Potable water shall be analysed at least semi-annually to
confirm that it meets the requirements of this standard.
d) Where it is necessary to store water, storage facilities including the storage tanks and
water pipes shall be adequately designed, made of material that is non-toxic, corrosion
resistant material and periodic cleaned and maintained to prevent contamination and
records of the same should be maintained. The tanks shall be covered to prevent access
by animals, birds, pests and other extraneous matter.
e) Where water filters are used, they shallbe regularly changed or effectively maintained.
f) Recycled/condensate water used in processing or as an ingredient shall not present risk
of contamination. It shall be of the same standard as potable water.
g) Non potable water (for use in, for example, steam production, firefighting&
refrigeration equipment and other similar purposes where it will not contaminate food)
shall have a separate system. Non-potable water systems shall be identified and shall
not connect with, or allow reflux into, potable water systems.
h) Colour coding of separate pipelines for potable water and non-potable water is
recommended.

1.4.2 Drainage and waste disposal

a) Adequate drainage and waste disposal systems and facilities shall be designed and
constructed so that the risk of contaminating food or potable water supply is avoided.

b) Drains shall be designed to meet expected flow loads, constructed so as to prevent

accumulation or back flow of waste water. Drains should be located so that they can be
easily and effectively cleaned and inspected.
c) Drains shall be equipped with appropriate traps to effectively capture contaminants.
d) Containers for holding waste should be of adequate size, made of impervious material,
leak-proof, clearly identified, easy to clean, and where necessary to disinfect shall be
provided in the premises for collection of waste material. These shall be kept closed,
preferably foot operated or arrangements shall be made to prevent cross
contamination.
e) Wherever existing, refuse stores are to be designed and managed in such a way as to
enable them to be kept clean and free form animals and pests.
f) Waste disposal shall be done in accordance with specific requirement of Factory
Act/state pollution control board.

1.4.3 Personnel Hygiene Facilities

Personnel hygiene facilities shall be available to ensure that an appropriate degree of
personal hygiene can be maintained to avoid any cross contamination. Such facilities shall
be suitably located & designated.
a) Hand washing facility –
 Appropriate hand washing facility shall be available at the production and packaging
entrance.

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b) Toilets –
 Adequate number of toilets facility shall be provided. Arrangements should be made for
separate toilets for males and females.
 They should not directly open in food handling areas.
c) Rest & refreshment room –
 Appropriate facility should be provided for employees.
 It shall not directly open to manufacturing/processing/packaging areas.
d) Change room facility shall be provided for direct food handlers with locker facility.
e) Waiting room is recommended to have an appropriate facility for waiting room and
toilets for transporters.
A display board mentioning’ Dos’ and ‘Don’ts’ for workers shall be posted in a prominent
place inside the premises, in English and local language, for all to understand. This will help
all the employees to maintain their alertness on good hygiene practices.

1.4.4 Lighting
a) Adequate natural or artificial lighting shall be provided to enable the personnel to
operate in a hygienic manner.
b) The intensity of light should be adequate to the nature of the operation. Recommended
interior light intensities (in lux ) for food processing plants is as under:

Functional Area Lux

Product inspection 1180-1400

Processing areas 590-700

Packaging 750-860

Maintenance areas 750-860

Bulk ingredient storage 320-430

Ingredient warehouse 215-320

Finished product warehouse 215-323

Raw material receiving 215-320

Administrative offices 645-970

Cafeteria 430-540

Locker and rest rooms 320-540

c) Lighting fixtures shall be protected to ensure that food is not contaminated in case of
breakages.

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1.4.5 Storage facilities
The food storage facilities shall be designed and constructed to:
a) provide protection from dust, condensation, waste, pest access and harbourage and
other sources of contamination.
b) be easy to maintain and clean. All materials and products shall be stored off the floor
and away from walls with sufficient space to allow cleaning and facilitate pest control
activities.
c) have separate storage facilities for food, ingredients, packing material, non-food
chemicals and hazardous material.
d) have separate storage facility for storing rework, returned, recalled or non-conforming
product.

1.4.6 Air circulation and ventilation

a) Food premises shall have adequate natural and/or mechanical ventilation including air
filters, exhaust fans, should be provided.

b) The air shall not flow from contaminated to clean areas.

c) It is recommended to have adequate ventilation in sanitary conveniences.

1.4.7 Compressed Air and Other Gases

a) Compressed air, nitrogen, ammonia and other gas systems wherever required used in
manufacturing and/or filling shall be constructed and maintained so as to prevent
contamination.

1.4.8 Boiler/ Water treatment chemicals

a) The source of boiler / water treatment chemicals which comes in direct contact with the
food materials during processing should be of food grade.
b) Boiler/ water treatment chemicals should be appropriate for the intended use and
should be used in accordance with the manufacturer’s instructions.

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2. ESTABLISHMENT – CONTROL OF OPERATIONS
Control of operation is necessary to produce safe food which is fit for human consumption
and is free from contamination and/or cross contamination by:
i. Developed and validated methods of manufacturing and handling of food items
throughout procurement, storage, processing, packaging, warehousing, and
ii. Designing, implementing, monitoring and reviewing effective control systems.

2.1 Food Receipt

a) All raw material e.g. seeds/oils/process aids/ food additives consignments should be
procured from approved suppliers and wherever applicable FSSAI licensed/registered
FBO. An approved supplier is the one which is evaluated as per the quality supplied and
other relevant factors.
b) No raw material or ingredient thereof shall be accepted by an establishment if it is
known to contain chemical, physical or microbiological contaminants including
adulterants, which would not bereduced to an acceptable level by normal sorting
and/or processing.
c) All raw materials, food additives and Process aids, wherever applicable, should be
inspected and sorted before processing. The FBO shall have procedures in place to
confirm that the incoming materials meet the documented specifications through
certificate of analysis, visual inspection, laboratory testing, review of label for allergens
etc.
d) Records of raw materials or ingredients orany other material used in processing as well
their source of procurements shall be maintained for traceability.
e) It is recommended to have food grade certificates for applicable food ingredients
/processing aids from suppliers
f) All packaged raw materials shall be checked for ‘expiry date’/’best before’/’use by
date’, packaging integrity and storage conditions.
g) All bulk tankers/ containers receipt shall be checked for seal integrity / previous cargo /
fitness checklist at the time of receipt.

h) Plant should have a separate area for receiving Crude oil or Oil seeds. Raw materials (oil
seeds/ crude oil) are received according to the storage and processing capacity of the
oil processing plant.

i) All bulk tankers/ containers receipt shall be checked for seal integrity / previous cargo /
fitness checklist at the time of receipt.

j) The incoming vehicles that bring the oil seeds should be checked for cleanliness and
hygiene i.e. the trucks are clean, with no pests or dirt, with no strong odour other than
that of the raw material.

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 2.2 Storage – Raw materials & packaging materials
a) A food business shall store food and packaging materials in appropriate dry and
ventilated areas for effective protection from dust, condensation, drains, waste and
other sources of contamination duringstorage.Packaging material storage room for
storing of Laminates, PET bottles and Jars etc should be closed from all sides to restrict
entry of flies, rodents, birds, insects/pests etc.
b) The packed food materials/ ingredients/packaging material shall be stored on racks/
pallets such that they are stored off the floor on pallets and off the walls to ensure easy
and adequate cleaning and prevent harbouring of any insects, pests or rodents.
c) All raw materials, food additives and ingredients shall be stored in separate areas from
packaging materials, stationery, hardware and cleaning materials.
d) The storage of raw materials, ingredients, work-in-progress and finished packed
products shall be subjected to FIFO (First in First out),FEFO (First expire First out).
e) If any ingredients contain allergens, the same should be clearly identified and stored to
prevent cross-contamination.
f) All non-confirming rework / rejected / recalled stocks need to be stored separately with
proper labelling.

g) Storage tank of seed silos /crude oils/ refined oils should be hygienic in design & should
be properly sealed covered either with a proper fitting cover/lid to protect the oil
completely from dust, dirt and flies and other insects or any kind of contamination.

h) Proper labelling of the storage tanks of crude oils/ in process oils /refined oils should be
done to avoid cross contamination of different types of oils, if different types are used.

i) Storage tank of seed silos /crude oils/ refined oils should be hygienic in design & should
be properly sealed covered either with a proper fitting cover/lid to protect the oil
completely from dust, dirt and flies and other insects or any kind of contamination.
They should not be rusted and in case of MS or other alloy tanks, tanks surfaces should
be coated with food grade coating or inert coating.

Moisture content of oil seeds and nuts effects the quality of raw materials. High moisture
in oilseeds reduces oil content, decrease protein, and increase the colour and the
refining loss during extraction of oil. High moisture also increases microbial growth and
therefore spoil the food material.
Seeds shall be stored at Moisture Content less than 10%. If the seed moisture content is
over 10% then it should be dried prior to storage. Moisture can be lowered by:
 Steaming/ boiling along with sun-drying.
 Adequate ventilation or aeration of the seeds or nuts during storage.
 During very humid conditions, the perishable raw materials such as
coconut, etc. shall be processed as soon as possible after harvesting.

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2.3 Food processing including pre-processing

a) Food processing operations flow diagram and standard operating procedures shall be
documented, implemented and for should be displayed at particular operations site.Also,
standard operating procedures for process changeover from one kind of product to
another such as from one kind of oil to another shall also be maintained and
implemented.
b) Food processing daily process critical parameters like temperature / vacuum etc records
shall be maintained with appropriate coding for traceability.
c) Intermediate in-process samples should be taken and tested for critical parameters and
test results records should be maintained.
d) Personnel should be required to put on clean protective clothing including footwear and
wash their hands before entering .
e) Cleaning schedule for equipments in the food processing sections should be maintained
to ensure entire operations are carried out in hygienic conditions.
f) Systems shall be in place to prevent contamination of foods by foreign bodies such as
glass, metal shards from machinery and dust. In manufacturing and processing, suitable
detection or screening devices should be used where necessary.

g) Procedures should be in place to be followed by food handlers in the case of breakage.

Equally systems shall be in place to prevent contamination of foods by harmful
chemicals.

h) Access to processing area by outsiders should be restricted or controlled. Where risks are
particularly high, access to processing areas shall be only via a changing facility.
i) Presence of any allergens must be identified in food ingredients and products and
controls shall be put in place to prevent their presence in foods where they are not
labelled. Where cross-contact cannot be guaranteed, consumers shall be informed.

List of various check points during oil processing are as under:

STEP ACTIVITY QA/QC CHECK POINTS

Seed harvest and Liaison with farmers, harvesting *Specifications of oilseed required.
procuring *Time of harvest
*Training of workers to separate seed and
avoid contamination of oil
*Use of sacks
*Rejection of damaged/mouldy oil seeds

Cleaning and Removal of Physical waste. *Correct sampling methods for inspection of
Conditioning seeds
*Training of staff in inspection procedures

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Extraction Pressing of Oil seeds *Checking of incoming Seeds
Mechanically/ With use of *Handling of equipment
Solvent to Extract Oil.
Refining Degumming, Neutralization, *Volume and concentrations of chemicals
Bleaching and Deodorization of used
Crude Extracted Oil. *Training of personnel to operate equipment
*Control of time and temperature.
*Record maintenance of batches

Packaging Filling into Containers and *Specifications for product quality

Sealing. *Specifications for labels
*Inspection and recording procedure

Storage Storage of Oil before Dispatch. *Control of store room temperature

*Implementing cleaning schedules
*tock rotation procedure supervision
*Recording procedures

Transport Transport of oil for distribution Correct handling to minimize loses

Distribution Dispatch of products in required *Establishing inspection procedures for

amounts to consumers and receipt of correct specified product.
retailers *Establishing pecording procedures

Retail Selling of Individual Packs Checking for physical appearance of

container/package
* Checking for vital stats like shelf life and date
of manufacure

2.4 Food Packaging

a) The packaging design and materials shall provide protection forproducts in order to
prevent contamination, damage and accommodate required labelling as laid down
under the FSS Act &Regulations there under. Only Food grade packaging materials shall
be used. Packaging materials like aluminium, tin and plastic shall conform to BIS
standards as mentioned under the FSS Regulations.
b) The food packaging materials shall be inspected before use to prevent using damaged,
defective or contaminated packaging, which may lead to contamination of the product.
The foodbusiness operator shall have effective procedures in place to confirm that
contaminated,damagedor defective reusable containers are properly cleaned and
sanitized, repaired orreplaced, as appropriate, before re-use.
c) The packaging materials or gases where used, shall be non-toxic and shall not pose
threat to the safety and suitability of food under the specified conditions of storage and
use.
d) Packaging section shall always be considered high care zone and access to packaging
section shall be restricted and controlled via changing facility Personnel need to be
required to put onclean protective clothing and footwear before entry .

e) The filling and packaging area should be closed from all sides to restrict entry of flies,
rodents, birds and pests and any other foreign material like dust / water etc

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f) To prevent any physical hazard, it is a good practice to have a 1 or 5 micron filter
installed before packing or bulk loading of oils , fats and their co-products .
g) All packaging equipments like weighing scale shall be calibrated on daily basis against
certified standards & their records should be maintained.

h) To prevent any physical hazard, it is a good practice to have a 1 or 5-micron filter

installed before packing or bulk loading of oils, fats and their co-products.

i) All packaging equipment like weighing scale shall be calibrated on daily basis against
certified standards & their records should be maintained.

j) Filling and packaging shall be under hygienic environment in a separate designated area
that should be closed from all sides to restrict entry of flies, rodents, birds and pests.

2.5 Rework & control of non-conforming products

a) All rework material shall be labeled, stored, handled and used in such a way that
product safety, quality, traceability and regulatory compliance are maintained. All
traceability records for rework shall be maintained.

b) Stored rework material shall be protected from exposure to microbiological, chemical

or extraneous matter contamination.
c) Where rework is incorporated into a product as an “in-process” step, the acceptable
quantity, the process step and method of addition, including any necessary pre-
processing stages, shall be defined.

d) Where ever rework activities involves product decantation from filled packages
adequate controls shall be put in place to ensure removal and segregation of packaging
materials and to avoid contamination of the product with extraneous matter.
e) Standard operating procedure should be defined and documented for handling any
rework or non-confirming products.

2.6 Food transportation, warehousing and distribution

a) Vehicles of only FSSAI registered transporters shall be used for transportation of edible
vegetable oils & fats and fats
b) The dispatches of finished goods must follow FIFO or FEFO (First Expiry First Out)
system.
c) Conveyances and/or containers or tankers used for transporting edible vegetable oils
& fats and fats shall be kept clean and maintained in good repair and condition. Where
direct contact with oils can occur such as during bulk transportation, the materials used
in carrier construction should be suitable for food contact.
d) Tankers/containers / rail wagons/ trucks used to transport crude/refined oils & fats/
packed products shall be inspected for proper servicing & cleaning based on the risk
evaluation of previous cargo & next product cargo loading. The documents of the
vehicle inspection checklist should be maintained.

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e) For bulk transportation of oils, the tankers / containers / rail wagons shall be reserved
for that purpose only and such containers shall be marked in a clearly visible and
indelible manner to show that they are used for transporting of oils and fats only. These
shall not be used for transporting chemicals or petroleum products.
f) All edible vegetable oils & fats & fats transportation in tankers / containers / wagons
shall be carried out under intact unbreakable sealed conditions. It is preferable that
seals have marking or numbers to avoid any chances cross contamination or sabotage.
g) Its recommended to follow best practices for warehousing all packed goods should be
stored 18” away from walls preferably stocks to be kept on pellets and should not be
get stored directly on floor.
h) The warehouses should be kept clean and hygienic condition to avoid pest infestation,
dirt, dust, smell.

i) Tankers/containers / rail wagons/ trucks used to transport crude/refined oils & fats/
packed products shall be inspected for proper servicing & cleaning based on the risk
evaluation of previous cargo & next product cargo loading. The documents of the
vehicle inspection checklist should be maintained.

j) For bulk transportation of oils, the tankers / containers / rail wagons shall be reserved
for that purpose only and such containers shall be marked in a clearly visible and legible
manner to show that they are used for transporting of oils and fats only. These shall not
be used for transporting chemicals or petroleum products.

k) The mode of transportation shall be under the reduced amount of air contact and with
reduced temperature, as both accelerate the rate of oxidation.

l) All edible vegetable oils & fats & fats transportation in tankers / containers / wagons
shall be carried out under intact unbreakable sealed conditions. It is preferable that
seals have marking or numbers to avoid any chances cross contamination or sabotage.

m) To minimize the food spoilage during transportation, all critical links should be identified
and taken care of.
 If the vehicle is open from the top and/or sides, cover the transport vehicle from all
the sides with preferably a water proof material like tarpaulin sheet to protect the
finished goods.
 Cushion the vehicles with dry grass before loading the retail packages to avoid
physical damage which can cause leakage during transportation and distribution.

n) The transportation of oil is done in designated oil tanks (if loose in bulk), designated
containers (if bulk and retail packs), followed by various distribution points and retail
chains.

Loading and Unloading

a) Before the transfer of solid, semi-solid and high viscosity oils and fats in storage tanks,
shore tanks, ship tanks and road and rail tanks; the oils should be brought to transfer
temperature by slow heating, so that the liquid is completely homogeneous.

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b) As best practice; heating should not exceed the maximum rate of 5°C over a 24 hour
period and if steam is used, the steam pressure should not exceed 150 kPa (1.5 bars)
gauge, to prevent localized over-heating.

c) The temperature is chosen according to oil and fat type and also to minimize damage to
the oil or fat.

d) Soft oils transfer temperature:

i. Long term storage of all soft oils should be at ambient temperature and no heating
should be there.
ii. If the oils become solid during storage, extreme care should be taken during initial
heating, ensuring no overheating.

e) Temperature at loading and unloading should refer to the average of top, middle and
bottom temperature readings. Readings should be taken not less than 30 cms away
from the heating coils.

f) Different oil grades/types should be kept separate.

g) Pumping ‘new’ oil into ‘old’ oil should be avoided for oxidative quality reasons.

h) The order of loading and discharge should be carefully chosen to minimize adulteration.
Following principles should be observed:
 Fully refined oils before partly refined oils
 Partly refined oils before crude oils
 Edible vegetable oils & fats before technical grades
 Fatty acids or acid oils should be pumped last
 Special care should be taken to prevent adulteration between lauric oils and non-
lauric oils.

i) The first few pumping of each grade should be collected where possible in a separate
tank for quality checks.

Warehousing of final oil product

a) Its recommended to follow best practices for warehousing all packed goods should be
stored 18” away from walls preferably stocks to be kept on pellets and should not be
get stored directly on floor.

b) The warehouses should be kept clean, ventilated and under hygienic condition to avoid
pest infestation, dirt, dust, smell.

c) Where specified for a particular oil(s), temperature and humidity control systems
should be introduced and must be carried out with calibrated recording equipment with
appropriate maintenance of records.

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The storage conditions during oil transportation are: -

a) There must be clear markings and identification for all pipelines and storage tanks.
b) Tanks for solid, semi-solid and high viscosity oils and fats:
- Heating coils should be of stainless steel
- Means of heating: bare hot pipes, bare steam pipes, external heat exchangers
- All heating media employed should be properly evaluated and safely used.
c) Storage tanks, tankers and containers should be preferably should be insulated and
impervious to oils and fats. They are preferably designed as per standard specification
and design. Calibration and certification of tanks are kept.
d) All ships and storage tanks with heating facilities should be equipped with temperature
sensors and control devices to prevent overheating of oils in the tank and associated
lines.

2.7 Food Traceability and recall

a) FBOs shall have a traceability system for assigning codes or lot numbers to incoming
materials, packaging materials and finished products, etc. This will help to identify
products backward & forward complete traceability.
b) The FBO shall have a documented and effective product recall plan in place in
accordance with the Food Safety & Standards Recall Regulations, 2017. Such a plan shall
allow the FBO to effectively locate all affected food products that may cause a potential
threat to public health and enable the complete, rapid recall of the implicated lot of the
product from the market.
c) Where a product has been recalled because of an immediate health hazard, other
products which are produced under similar conditions which may also present a hazard
to public health shall be evaluated for safety and may need to be recalled
d) Recalled products shall be held under supervision until they are destroyed, used for
purposes other than human consumption, determined to be safe for human
consumption, or reprocessed/reworked in a manner to ensure their safety
e) Product recall procedure should be internally tested and documented through mock
recalls at least once in year by facility recall team.

2.8 Quality Control

a) The FBO shall have a quality control programme in place to include inspection and
testing of incoming oil, in process and finished edible oil.

b) A laboratory facility and trained and competent testing personnel should be available
for food testing. If there is no in-house laboratory present, then all the regular testing
shall be done through an accredited external laboratory/laboratory notified by FSSAI. In
case of complaints or feedback on the product, the FB shall carry out the testing either

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 though their in-house/ external accredited labs/ lab notified by FSSAI to ensure product
compliance to standards.

c) All incoming crude oils / Bulk chemicals / Ingredients test records or COA shall be
maintained. Defined adulteration tests under FSS regulations standards should be
performed with each lot
d) In-process and finished product samples should be tested and records should be
maintained. Each category or type of finished oils & fats shall be tested as per FSS
standards & regulations 2011 atleast once in six month from FSSAI approved labs.It is
recommended to retain the control samples, till the end of shelf life. Further, it should be
disposed off. Testing records shall be maintained.

e) Calibration of laboratory equipments shall be done periodically.

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3. ESTABLISHMENT - MAINTENANCE AND SANITATION
3.1 Cleaning and sanitation

a) Cleaning and sanitizing programmes shall be established at facility to ensure that the
food-processing equipment and environment are maintained in a hygienic condition to
prevent contamination of food, such as from metal shards, flaking plaster, food debris
and chemicals and records of the same shall be maintained. The programme should
ensure that all parts of the establishment are appropriately clean, and shall include the
cleaning of cleaning equipment.
b) Master sanitation schedule shall be maintained for overall facility through checklists
which includes
 Description of areas & equipment’s to be cleaned
 Frequency of cleaning
 Type of cleaning procedure & methods wet or dry
 Type of cleaning chemicals to be used
 Person responsible for cleaning
 Persons responsible for monitoring & verification of effectiveness of cleaning
 In case of any deviation what correction & corrective actions being taken
 Where ever chances of microbial risk with product air count & swab test being
recommended
c) Cleaning and disinfection chemicals shall be food grade wherever chances of it may
come in direct or indirect contact through equipment’s or plant surfaces , handled and
used carefully and in accordance with manufacturers’ instructions, for example, using
the correct dilutions and stored, where necessary, separated from food, in clearly
identified containers to avoid the risk of contaminating food.
d) Cleaning shall remove food residues and dirt and it can be carried out by the separate or
the combined use of physical methods, such as heat, scrubbing, turbulent flow and
vacuum cleaning or other methods that avoid the use of water, and chemical methods
using detergents, alkalis or acids.

e) Cleaning procedure should generally involve-

 Removing gross visible debris from surfaces.
 Applying a detergent solution to loosen soil and bacterial film (cleaning)
 Rinsing with water (hot water where possible to remove loosened soil and residues
of detergent.
 Dry cleaning or other appropriate methods for removing and collecting residues and
debris and
 Where necessary , cleaning should be followed by disinfection with subsequent
rinsing.
f) Designated area with lock & key provision should be allocated for cleaning equipment’s
& chemicals.
h) Where ever necessary & applicable CIP procedure should be defined for equipment’s
cleaning.

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3.2 Maintenance
a) Preventive maintenance of equipment and machinery shall be carried out regularly as
per the instructions of the manufacturer.
b) A preventive maintenance programme must include all devices used to monitor and/or
control food safety hazards and cover the maintenance procedure, frequency and
identification of the person (and/ or external agency) responsible for maintenance
activity.
c) Internal & External calibration schedule for critical food safety equipment’s should be
maintained.
d) Corrective maintenance shall be carried out in such a way that production on
adjoining lines or equipment is not at risk of contamination and post maintenance
verification to be get verified .
e) Temporary fixes when used shall not put product safety at risk and should be removed
/ permanently fixed in a timely manner.
f) Lubricants, heat transfer fluids or any other similar material used shall be food grade
where there is a risk of direct or indirect contact with the product.
g) It is recommended as best practice to maintain plant equipment’s breakdown records.

h) Loose items control policy (Nut &bolts , Nails broken pieces or smaller parts of
machines ) should be followed to prevent any contamination with product or
packaging material .

3.3 Pest Control Systems

a) Buildings shall be kept in good repair and condition to prevent pest access and to
eliminate potential breeding sites. Holes, drains and other places where pests are
likely to gain access shall be kept sealed. Wire mesh screens, for example on open
windows, doors and ventilators, will reduce the problem of pest entry. Animals, birds
and pets shall be excluded from the food premises.
b) Establishment should have a nominated person to manage pest control activities,
and/or with the help of an external appointed contractors. Major pest activities for
rodent, lizard, cockroaches, flies, rats, mice and vermin, insects; to exclude from the
establishments and processing areas .
c) A valid and legal contract with the third party/ pest control service providers should be
available in the premises which include type of pest services and their frequencies.
d) List of approved pest chemicals their concentration for uses with their MSDS records
shall be available at site. Treatment of chemicals, with appropriate limits, shall be
carried out by trained operatives without posing a threat to the safety or suitability of
food.
e) If any pest treatment chemicals / tools stored inside plant facility shall always be kept
under lock & key.
f) Pest control devices like bait stations / Pesto flash lay out map should be maintained.

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g) Detectors and traps shall/be designed and located so as to prevent potential
contamination of materials, products and facilities such as having poisonous baits
outside premises and glue traps inside processing area.
h) Pest control services reports shall be maintained and verified.Pest control program
effectiveness could be measured through pest agency monthly audit and trend analysis
report and relevant actions for improvements taken.
i) Food or any other material (like in case of termites in wood) found to be infested shallbe
handled in such a way to prevent contamination of other food materials, products or
the establishment.
i) Pest control 4 D method

3.4 Waste disposal management

a) Accumulation of food waste, non-edible by products and other refuse shall not be
allowed in food handling or storage areas. Removal frequencies shall be managed to
avoid accumulation and overflow in food handling, food storage, and other working
areas and the adjoining environment except so far as is unavoidable for the proper
functioning of the business, with a minimum daily removal
b) Waste stores and dust bins must be kept appropriately clean, free of pestsand in closed
conditions and shall be disposed as per local rules and regulations including those for
plastic and other non- environment friendly materials.
c) The disposal of sewage and effluents (solid, liquid and gas) shall be in conformity with
standards laid down under Environment Protection Act, 1986
d) Waste disposal SOP should be defined & Hazardous waste disposal records to be
maintained.
e) Its recommended as best practice to store bio degradable & non degradable waste
separately.

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4. Establishment – Personal Hygiene
4.1 Health status of food handlers
a) Food handlers of the establishment shall undergo a medical examination by a
registered medical practitioner annually to ensure that they are free from any
infectious and other communicable diseases. A record of these examinations shall be
maintained. However, apart from the said frequency, medical examination of a food
handler shall be carried out, if clinically or epidemiologically indicated.

b) The employees in the food premises shall be inoculated against the enteric group of
diseases as per recommended schedule of the vaccine and a record shall be
maintained.

4.2 Illness & Injury

a) Food handlers shall not have illnesses, injuries or conditions such as:
 Jaundice
 Diarrhoea
 Tuberculosis
 Vomiting
 Fever
 Sore throat with fever
 Visibly infected skin lesions (boils, cuts, etc.)
 Discharges from ear, eye or nose.

In case of such illnesses, injuries or conditions, these shall be reported the

management so that any need for medical examination and/or possible exclusion from
food handling is considered.
b) In food-handling areas, personnel with open cuts, wounds or burns shall be required to
cover them with suitable water-proof dressings before starting operations. Any lost
dressing must be reported to supervision immediately. The dressings should preferably
be brightly coloured and metal detectable

4.3 Personal cleanliness

a) Food handlers shall maintain a high degree of personal cleanliness and shall wear work
clothing, head covering, and footwear that is fit for purpose, clean and in good
condition (eg. free from tears, rips or fraying material). Workwear shall provide
adequate coverage to ensure that hair, beards, moustaches, perspiration, etc. cannot
contaminate the product.
b) Where gloves are used for product contact, they shall be clean and in good condition.
c) Protective clothing mandated for food processing areas or hygiene purposes shall not
be used for any other purposes.
d) All people entering food processing, storage, distribution and handling areas shall wash
their hands with soap and potable water, followed by drying and sanitizing, where
required -

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  before starting work;
 after handling chemicals;
 after handling contaminated materials;
 after breaks;
 after coughing or sneezing or blowing their nose; and
 after using toilet facilities.
 after using telephone / cell phones,
 after smoking in designated areas etc.

Hand washing notices shall be posted at appropriate places.

e.) Fingernails shall be kept clean, trimmed and without nail polish.

4.4 Personal behavior

a) The FBO shall implement an effective personal hygiene programme that identifies
hygienic behaviour and habits to be followed by personnel to prevent contamination of
food.
b) Any behaviour or unhygienic practices which could result in contamination of food shall
be prohibited in food processing, distribution, storage and handling areas. This includes
smoking, chewing or eating, sneezing or coughing over unprotected food, spitting etc.
c) Personal effects such as jewellery, watches, pins or other items should not be worn or
brought into food handling areas if they pose a threat to the safety and suitability of
food
d) Food contact tools and equipments shall not be kept in personal lockers

4.5 Visitor control

a) Food Business Operator should implement and display visitor control policy
b) The Food Business shall ensure that visitors to its food manufacturing, processing or
handling areas must wherever appropriate, wear protective clothing, footwear and
adhere to the all the personal hygiene provisions required for personnel required in the
food business.
c) Visitor identity cards provisions should be in place to maintain control on visitors access
into restricted areas.
d) Visitors do & don’ts rules shouldbe displayed at prominent areas.

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5. Product information and consumer awareness
5.1 Product information & Labeling
a) All incoming, in-process and finished products shall be suitably identified for product
identification, stage of processing, inspection and test status etc. so as to avoid their
inadvertent use. Lot identification shall be done to facilitate traceability, product recall,
effective stock rotation etc.

b) All packaged food products shall be labelled with requisite information as per provisions
of Food Safety and Standards Act, 2006 and Regulations made there under so as to
ensure that adequate and accessible information is available to next person in the food
chain to enable them to handle, transport store, process, prepare, display or use the
food products safely and correctly and that the lot or batch can be easily traced and
recalled if necessary. This should also include information that identifies food allergens
in the product as ingredients or where cross contamination cannot be excluded as per
FSS (Packaging & Labelling) Regulations, 2011, if applicable.

5.2 Consumer awareness and Complaint handling

a) Information shall be presented to consumers in such a way so as to enable them to
understand its importance and make informed choices. Information may be provided by
labelling or other means, such as company websites, education programmes and
advertisements, and may include storage, preparation and serving instructions
applicable to the product

b) The Food Business shall have a system to handle product complaints with identified
person or people responsible for receiving, evaluating, categorizing, investigating and
addressing complaints. Complaints shall be accurately categorized according to safety
concerns and other regulatory concerns, such as labelling and shall be investigated by
appropriately-trained technical personnel

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6. TRAINING & MANAGEMENT
6.1 Awareness and responsibilities
a) All personnel shouldbe aware of their role and responsibility in protecting food from
contamination or deterioration. Food handlers shall have the necessary knowledge and
skills to enable them to handle food hygienically.
b) Those handling strong chemicals or potentially hazardous substances shall be trained in
safe handling procedures and techniques

6.2 Training programmes

a) Suitable trainings shall be given to all personnel handling food to enable them to have
the required knowledge and skills in GHP and GMP for specific tasks along with personal
hygiene requirements commensurate with their work activities, the nature of food, its
handling, processing, preparation, packaging, storage, service and distribution.

b) These training programmes shall be delivered by qualified and trained personnel.

Records of training shall be kept.

6.3 Instruction and supervision

a) Periodic assessments of the effectiveness of training, instructions programmes as well
as routine supervision and checks should be made to ensure that food hygiene and food
safety procedures are being implemented correctly and effectively by all personnel.

b) Managers and supervisors of food processes should have the necessary knowledge and
skills in food hygiene (GHP and GMP) principles and practices to be able to judge
potential risks and take necessary action to remedy deficiencies.

6.4 Refresher training

a) Training programmes shall be routinely reviewed and updated wherever necessary.
Systems should be in place to ensure that food handlers remain aware of all procedures
necessary to maintain the safety and suitability of food.

6.5 Management & supervision

a) The FBO management shall lead establishment of Food safety management systems in
their premises.

b) The FBO management shall ensure providing necessary trainings & resources to their
employees to develop food safety culture at plant site.

c) FBO shall appoint trained & competent managers and supervisors for management and
supervision of food safety systems.

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d) The FBO management shall provide and maintain documented standard operating
procedure for FSMS systems compliance and its supervision at site through records
/checklists on routine basis to control any possible hazards throughout supply chain .

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7. AUDIT AND DOCUMENTATION
7.1 Self-evaluation and review
a) The FBO shall conduct a self-evaluation process to review the effectiveness of the
implemented food safety system at periodic intervals though internal and external
audits or other mechanisms, but atleastonce in a year. Necessary corrective actions
based on self evaluation results shall be taken.

b) FBO should also undertake a complete review of the systems including self- evaluation
results, customer feedback, complaints, new technologies and regulatory updates at
periodic intervals, but atleast once in a year for continual improvement.

7.2 Documentation and records

a) Appropriate documentation & records of processing, production and distributions
shall be maintained in a legible manner, retained in good condition for a period of one
year or the shelf-life of the product, whichever is more.

b) Following records shall be maintained by the FBO:

 incoming materials checks – raw materials, ingredients, packaging materials. Etc.
 Inspection and testing
 Operational controls such as temperature, pressure, time etc.
 Product recall and traceability
 Storage
 Cleaning and sanitation
 Pest control
 medical examination and health status
 Training
 Calibration
 Complaints and customer feedback
 Corrective and preventive actions
 Self-evaluation results

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C. HACCP IMPLEMENTATION

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I. INTRODUCTION TO HACCP
Implementing Hazard Analysis and Critical Control Point (HACCP) is crucial for any food
manufacturing process. A HACCP plan covers the total supply chain, from inbound logistics,
through storage, processing, sanitation and maintenance to the final use by the consumer.
Across the operations, it must be ensured that procedures are available for internal logistics,
processing specifications, working instructions, hygiene procedures and preventive
maintenance plans. These procedures must cover start-ups, shutdown and unexpected
stoppages during processing.

Hazard Analysis Critical Control Point (HACCP) is essential to carry out to identify the
weakness of the production line and to suggest critical limits in compliance with legislation
and therefore the preventive and corrective measures.

Though HACCP system was designed to aim zero defect products, yet it is not feasible to
achieve 100% defect free products. However, it sets a goal to minimize the associated risks
during production and subsequently reduce unacceptable unsafe products.

During implementation of HACCP, it is imperative to set controls at each point of the

production line at which safety problems (physical, chemical and microbiological) are likely
to occur.

A HACCP plan is required to be in place before initiating the HACCP system. A HACCP plan
consists of 5 initial steps and 7 major HACCP principles.

The requirements for Sanitation Standard Operating Procedures (SSOPs) along with Good
Manufacturing Practices (GMPs) & Good Hygiene Practices should be considered as Pre-
Requisite for HACCP.

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Risk assessment is a critical step in a HACCP plan. Below is a template to determine what
severity and probability a processing step is involved with and therefore what level of
criticality is holds in the processing line.

Consequence/ Severity

How severe could the outcome be if the risk event occurs?

Severe Major Significant Minor Insignificant

What's the chance of the risk occuring?

Frequent Extreme Extreme Very High High Medium
Probability/ Likelihood

Likely Extreme Very High High Medium Medium

Occasional Very High High Medium Medium Low

Seldom High Medium Medium Low Very Low

Unlikely Medium Medium Low Very Low Very Low

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Introduction to Decision Tree
Hazard Analysis and Critical Control Point (HACCP) decision trees are tools that can be used
to help you decide whether a hazard control point is a critical control point (CCP) or not. A
CCP is a step at which control can be applied. However, it is not always possible to eliminate
or prevent a food safety hazard, so this allows you to reduce it to an acceptable level.

The purpose of a decision tree is to support the judgement of the team and help you to
confirm whether the hazard needs more food safety controls. Decision trees are not
mandatory elements of HACCP but they can be useful in helping you determine whether a
particular step is a CCP.

It is vital that you determine the correct CCPs to ensure that food is managed effectively and
safely. The number of CCPs in a process will depend on how complex the process is and how
many hazards are present.

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II. APPLICATION OF HACCP SYSTEM
1. HACCP Implementation steps
1.1 Assemble HACCP team
The food operation shall ensure that the appropriate product specific knowledge and expertise is
available for the development and implementation of an effective HACCP plan. A multidisciplinary
team shall be assembled either in-house or if such expertise is not available on-site , expert advice
shall be obtained from other sources, such as trade and industry associations, independent experts,
regulatory authorities, HACCP plan shall be identified and shall describe which segment of the food
chain is involved and the general classes of hazards to be addressed (all or selected classes).

1.2 Describe product

A full description of the product shall be drawn up, including relevant safety information such as
composition (including raw materials ingredients, allergens), origin,physical/chemical properties that
impact food safety (including Aw, pH, etc.),microbial/static treatments (heat treatment, freezing,
brining, smoking etc.), packing, labelling, durability and storage conditions and method of
distribution. Within businesses with multiple product for example, catering operations with similar
characteristics or processing steps may be grouped for the purpose of development of the HACCP
plan.

1.3 Identify intended use

The intended use of the product shall be defined based on the expected uses of the product by the
end user or customer. The suitability of the product for vulnerable groups of the population such as
pregnant women, infants, elderly should be considered, as necessary.

1.4 Construct flow diagram

The flow diagram shall be prepared to cover all steps in the operation for each specific product or
product category. When applying HACCP to a given operation, consideration shall be given to steps
preceding and following the specified operation.

1.5 On-site confirmation of flow diagram

Steps shall be taken to confirm the proceeding operation against the flow diagram during all stages
and hours of operation and amend the flow diagram where appropriate. The confirmation of the
flow diagram should be performed by a competent person or persons. On-site verification activities
shall be carried out whenever there are any changes in the process.

1.6 List of all potential hazards associated with each step, conduct a hazard
analysis, and consider any measures to control identified hazards (SEE
PRNCILPLE 1)
The HACCP team should list all potential hazards (physical, chemical, biological) that may be
reasonably expected to occur at each step according to the scope. It should then 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 safe food.

In conducting the hazard analysis, the following should be included as appropriate:

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  The likely occurrence of hazard and severity of their adverse health effects;
 The qualitative and/ or quantitative evaluation of the presence of hazards;
 Survival or multiplication of micro-organisms of concern;
 Production of persistence of foods of toxins, chemicals or physical agents; and
 Conditions leading to the above.

For selection of control measures, consideration shall be given to what control measures, if any, can
be applied to each hazard.

More than one control measure may be required to control a specific hazard and more than one
hazard may be controlled by a specified control, measure. Where elimination of hazard is not
practical, justification for acceptable levels of the hazard in the finished product shall be determined
and documented.

1.7 Determine Critical Control Points (SEE PRINCIPLE 2)

For each hazard that requires control, control measures shall be identified. The control measures
shall be reviewed to identify those that need to be addressed through the HACCP plan and for which
CCPs shall be identified. There may be more than one CCP at which control is applied to address the
same hazard or there may be cases where there is no CCP identified. The CCP in the HACCP system
shall be determined and this may be facilitated by a logic reasoning approach such as the application
of a decision tree (see dia 2). The application of a decision tree should be flexible. This example of a
decision tree may not be applicable to all situations and alternative approaches may be used.

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.

1.8 Establish Critical Limits for each CCP (SEEPRINCIPLE 3)

Critical Limits shall be specified and validated for each CCP. In some cases more than one critical
limit may be elaborated at a particular step.

These critical limits shall be measurable, Critical Limits based on subjective data (such as visual
inspection of product, process, handling) shall be supported by instructions or specifications and / or
education and training.

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

A monitoring system shall be established for each CCP to demonstrate that the CCP is under control.
The monitoring shall be able to detect loss of control at the CCP and in time to make adjustments to
regain control of the process and prevent violation of the critical limits. Where possible, process
adjustments should be made when the results of monitoring indicate a trend towards loss of control
at a CCP. The adjustment should be taken before a deviation occurs.

Data derived from monitoring shall be evaluated by a designated person with knowledge and
authority to carry out corrective actions when indicated. If monitoring is not continuous, then the
amount or frequency of monitoring shall be sufficient to ensure that the CCP is under control. The
monitoring system shall cover the following:

a) Measurements or observations that provide results within an adequate time frame;

b) Monitoring device used;
c) Applicable calibration method;
d) Monitoring frequency;
e) Responsibility and authority related to monitoring and evaluation of monitoring results; and
f) Records.

39 | P a g e
All records and documents associated with monitoring CCPs shall be signed by the person(s) doing
the monitoring and by the responsible reviewing official(s) of the company.

The monitoring methods and frequency shall be capable of determining when the critical limits have
been exceeded in time for the product to be isolated before it is used or consumed.

1.10 Establish corrective actions (SEE PRINCIPLE 5)

Specific planned corrective actions shall be developed for each CCP in the HACCP system in order to
deal with deviations when they occur and to prevent their recurrence. This may require
identification of the causes of deviation.

The action shall ensure that the CCP has been brought under control. Actions taken shall also include
proper disposition of the affected product. Deviation and product disposition procedures shall be
documented. Records of deviations and disposition shall be maintained.

1.11 Establish Verification Procedures (SEE PRINCIPLE 6)

The verification procedures consist of two activities, verification activities and validation activities.

The food business operator shall have in place a system to verify the HACCP plan at a set frequency.
Procedures for verification shall be established. The frequency of verification should be sufficient to
confirm that the HACCP system is working effectively.

Verification should be carried out by someone other than the person who is responsible for
performing the monitoring and corrective actions. Where certain verification activities cannot be
performed in-house, verification should be performed on behalf of the business by external experts
or qualified third parties.

The HACCP system, including the HACCP plan, shall be reviewed (atleast once in a year) and
necessary changes made when any modification is made in the product, process, or any step.

Verification activities shall include:

 Self-evaluation;
 Review of the HACCP system and plan and its records;
 Review of deviation and product dispositions; and
 Confirmation that CCPs are kept under control.

The results of verification shall be maintained and communicated to the HACCP team/ relevant staff.

The food business operator shall periodically validate the HACCP plan and necessarily before its
implementation and after any changes are made. The objective of the validation process is to ensure
that identified hazards are complete, correct and effectively controlled under the HACCP plan.
Validation activities should include actions to confirm the efficacy of the HACCP system. Records of
validation shall be maintained. An annual review of the complete HACCP system shall be carried out.

Verification and validation activities are also important for maintenance of the system as well as
continual improvements.

1.12 Establish Documentation and Record Keeping (SEE PRINCIPLE 7)

HACCP procedures shall be documented. Documentation and record keeping shall be appropriate to
the nature and size of the operation and sufficient to assist the business to verify that the HACCP
controls are in place and being maintained.

Documentation shall include (as a minimum) the following:

40 | P a g e
  HACCP team composition;
 Product description;
 Intended use;
 Flow chart;
 Hazard analysis;
 CCP determination;
 Critical limit determination;
 Validation process; and
 HACCP plan

The HACCP plan shall include the following information for each identified CCP:

 Food safety hazard(s) to be controlled at the CCP;

 Control measure(s);
 Critical limit(s);
 Monitoring procedure(s);
 Corrections and corrective action(s) to be taken if critical limits are exceeded;
 Responsibilities and authorities for monitoring, corrective action and verification;
 Record(s) of monitoring.

Records to include

 CCP monitoring activities;

 Deviations and associated corrective actions;
 Disposition of non-conforming products;
 Verification procedures performed;
 Modifications to the HACCP plan;
 Validation record;
 Product release records; and
 Testing records.

41 | P a g e
2. HACCP Plan for Kachi Ghani Mustard oil

2.1 Process Flow Chart for Kachi Ghani Mustard oil

42 | P a g e
2.2 Hazard Analysis & Identification for Kachi Ghani Mustard oil
Hazard Preventive CCP Y/N
Process Step Potential hazard Likelihood Severity Risk Q1 Q2 Q2A Q3 Q4 Q5 Reason for decision
Type Measure
Foreign material , Sieve is present for Sieve is used to
scaling , metal , removing for remove foreign
feather pieces, foreign particles. particles & GMPs
Physical polymer , particles, M L ML Y N N - - - N are implemented to
wooden straws & reduce the load of
pieces foreign particles in
seed.
Argemone seed Y, This is the point
where argemone
CCP-1 seed (chemical
hazard) are
removed.
CCP-1(Sieve size
Mustard Seed 1.75 mm is in
sieving place(argemone Visual inspection of
seed size 1.6mm so sieve once in a day
Chemical M H MH argemone seed will Y Y Y - - - & seed checking
pass through it & twice a day. Online
gets separated) check of screened
seed before seed
tank are the control
measures. and
subsequent
argemone test of
oil is the final
control measure
Biological None - - - - - - - - - - - -
Kholu plant Dirt, foreign Proper control that
Plate press material, rust, PRP is in place to ensures correct type
filter Physical gaskets, metal L M LM control all physical Y Y - N N - N of filter cloth has
pieces, polymer, hazard being used. And
particles, insects subsequent step of

43 | P a g e
 CCP-2 packing filter
is control
measure.PRPs like
personal hygiene
and pest control is
in place.
Chemical None - - - NA - - - - - - -

Biological None - - - NA - - - - - -
Final stage- This is the point
KGMO oil where all physical
filtration hazards are
before issuing removed. Pressure
Polymerized
to packing drop and visual
material, scaling,
service. Tank inspection of filter
gaskets pieces,
bag are control
rust, Foreign
Physical H H HH CCP-2(1 mic PF) Y Y - Y - - Y, CCP-2 measures. Hence
material, hairs,
this is CCP-2.
insects,, plastic
Maintenance of
bags, stickers,
polish
threads.
filter(cartridge/bag
filter type for KGMO
care must be taken
while opening it
Chemical None - - - NA - - - - - - - -.
Biological None - - - NA - - - - - - -

44 | P a g e
 2.3 HACCP Implementation Plan for Kachi Ghani Mustard oil

Process Significant
CCP Critical limit Monitoring Corrective Action HACCP Record Verification Validation
Step Hazard
CCP2 Packaging Foreign Differential What If the differential pressure is more than Record Name What: Effectiveness of Requirement:
2
Polish matter pressure inlet vs. 0.8kg/cm . , close feed valve to filter.Check CCP-2 polish filter and its control 1.Documentation to
filter outlet Foreign matter filter condition if necessary, supervisor shall measure ensure compliance to
physical hazard check oil visually. If pressure diff. is less than Monitoring How: check log sheet for procedure
2
Critical Limits 0.2 kg/cm immediately oil to be rejected / sheet complete documentation 2.Presence of dirt not
2
0.2 kg/cm to How recirculated to before CCP point. Responsibility and specified frequency detected in final
2
1.2 kg/cm Pressure gauge Packaging check. Check record of product
supervisor filter bag change and How : As per SOP
Safe limits When Open filter and check for proper bag correct size being used.
differential 2 hourly/ while installation and damage to bag. Check Check that pressure
pressure at inlet oil transferring sample for any foreign matter. gauges are in good Frequency: Annually
Vs. Outlet min. working order.
0.2 to max. 0.8 Where Check correct installation
bar Packaging Hold the entire quantity of product that of filter bags. Job responsibility :
might have been affected during the When daily once by FS Packaging In charge &
Responsibility deviation period. Draw samples from these Coordinator/ pkg. in FS Coordinator
stock and check thoroughly for the presence charge
Packaging of foreign matter. Such quantity shall be
Supervisor released for dispatch only after, quality And monthly once by FS
clearance. In case foreign matter is noticed coordinator
the entire stock shall be rejected and
subsequently reprocessed. Responsibility

Packaging in charge and

Responsibility FS coordinator
Packaging supervisor.

45 | P a g e
3. HACCP Plan for Refined Vegetable Oil
3.1 Process Flow Chart for Refined Vegetable Oil

46 | P a g e
 3.2 Hazard Analysis & Identification for Refined Vegetable Oil

Hazard CCP
Process Step Potential Hazard LIK SEV RISK Preventive Measure Q1 Q2 Q3 Q4 Q5 Reason for decision
Type Y/N

Foreign material,
Subsequent process step is the control.
scaling, gaskets,
Physical M L ML NO- N N - - Strainer will control all physical
metal pieces, Y
hazards.
Crude Oil polymer. Particles
Storage Tank
N Subsequent process step Deodorizer is
Chemical Pesticide Residue L M LM NO Y N N - -
the control measure
Oil does not have sufficient moisture
for microbes growth &processing is
Biological None - - - NA - - - -
done at high temp. Hence not a
significant hazard (Kill Step)
Yes after process crude oil
Foreign material, storage tank & before taking oil
Subsequent process step is the control.
scaling, gaskets, for first stage of processing i.e.
Process Crude Physical M L ML Y Y - N N Strainer will control all physical
metal pieces, degumming there is Auto filter N
Oil Tank hazards.
polymer. Particles strainer which will control all
physical hazards.
Chemical Pesticide Residue L M LM NO Y N N - - Deodorizer is the control measure
Biological None - - - NA - - - - - -
This is the step where all physical
hazards are removed. The pressure
polymerized
drop is one control measure and
material, gaskets
Physical H H HH CCP-2 Y Y Y Y Y second is visual inspection of filter bag.
Pieces rust,
Hence there is CCP2. Maintenance of
Transfer to bleaching earth
polish filter - Care must be taken while
Pkg. Serv.
opening the filter as foreign
Tank through
CCP-2 PF 1 Chemical None _ _ _ NA _ _ _ _ _ _ _ _
mic filtration Biological None _ _ _ NA _ _ _ _ _ _ _ _
3.3 HACCP Implementation Plan for Refined Vegetable Oil

47 | P a g e
 Process Significant Critical
CCP Monitoring Corrective Action HACCP Record Verification Validation
Step Hazard limit
CCP2 Packaging Foreign Differential What If the diff. pressure is more than Record Name What: Effectiveness of Requirement:1.Documentation
2
Polish matter pressure 0.8kg/cm , close feed valve to CCP-2 polish filter and its control to ensure compliance to
filter inlet vs. Foreign matter filter.Check filter condition if measure, calibration of validation procedure to
outlet physical hazard necessary, supervisor shall Monitoring pressure gauge measure the accuracy of
check oil visually. If pressure sheet / shift log How: check log sheet for control measure .
2
Critical How diff. is less than 0.2 kg/cm book complete documentation
Limits Pressure gauge immediately oil to be rejected / Responsibility and specified frequency
2 How : As per SOP
0.2 kg/cm recirculated to before CCP step Packaging check. record of filter bag
to 1.2 When supervisor change and correct size
2
kg/cm Pressure being used.
reading every 2 Open filter and check for proper Check that pressure Frequency: Annually
Safe limits hour/ while oil bag installation, no damage to gauges are in good
differential under bag. Check sample for any working order.
foreign. Job responsibility : Packaging
pressure at transferring Check correct installation
In charge & FS Coordinator
inlet Vs. (minimum) of filter bags.
Outlet min. Where Hold the entire quantity of When daily once by FS
0.2 to max. Packaging tank product that might have got Coordinator/ packaging
0.8 bar farm filter affect during the deviation incharge
period. Draw samples from
Responsibility And monthly once by FS
these stock and check
coordinator
thoroughly for the presence of
Packaging foreign matter, such quantity
operator Responsibility
shall be released for dispatch
only after, quality clearance. In Packaging in charge and
case foreign matter is noticed FS coordinator
the entire stock shall be
Rejected and subsequently be
reprocessed.

Responsibility
Packaging supervisor.

48 | P a g e
4. HACCP Plan for Hydrogenated Vegetable Oil
4.1 Process Flow Chart for Hydrogenated Vegetable fat (Vanaspati)

49 | P a g e
 4.2 Hazard Analysis & Identification for Hydrogenated Vegetable fat (Vanaspati)

Sev
Hazard Potential Lik CCP Q2
Process Step erit Risk Preventive Measure Q1 Q2 Q3 Q4 Q5 Reason for decision
Type hazard e Y/N A
y
CPO Incoming Physical Polymerized M L ML PRP N Y Y N N N - Wire mesh of 10mm size is
tanker receiving material, placed while CPO unloading
scaling , gaskets and Subsequent process step
pieces, rain like QC check, belcher PLF etc
water are in place and PRP like
Personal Hygiene is in place.
Chemical Subsequent process step
Pesticide
- - - NA - - - - - - - Deodorizer is the control
Residue
measure
Biological None - - - NA - - - - - - - Oil does not have sufficient
moisture for microbiological
growth & oil is going series of
steps at high temp. Hence not
a significant hazard .
Deodorization Scaling,
Subsequent step is filter and
Physical polymer. M L ML Yes N Y N N -
controls the hazard
Particles
Temperature and vacuum
reading of the deodorizer is
Pesticide
M H MH CCP-1 Y Y Y - - checked and monitored every
Residue
2 hourly and recorded in the
Chemical log sheet. CCP1

None - - - NA - - - -
Biological
Nickel Catalyst Physical Polymerized M L ML Yes after bleaching step & N Y Y N N N -
addition in material, before taking oil for Subsequent step is filter and
Hydrogenation scaling , gaskets deodorization, there is controls the hazard

50 | P a g e
process pieces, rain polish filter which
water controls all physical
hazards.
Chemical Food grade phosphoric acid is
being used. COA for every load
of delivery is checked to verify
Heavy metals,
PRP is in place to control the content of ingredient &
Pesticide - - - - - - - - - -
all chemical hazard Deodorizer is the control
Residue, water
measure for pesticide. Potable
water is being used for
process.
Bilogical None - - - NA - - - - - - - NA.

Scaling,
Subsequent step is filter and
Physical polymer. M L ML Yes N Y N N -
controls the hazard
Particles
Temperature and vacuum
reading of the deodorizer is
Pesticide
M H MH CCP-1 Y Y Y - - checked and monitored every
Residue
2 hourly and recorded in the
Chemical log sheet. CCP1

Hydrogenation – None - - - NA - - - -
Auto Clave Biological
Till oil addition & Physical Polymerized M L ML PRP N Y Y N N N - Subsequent process step is the
Vitamin A&D material, control . all physical hazards
addition in VNS. scaling , gaskets will be controlled in
Blending tank pieces, rain subsequent polish filter of 1
water , micron ,SOP are in placed for
vitamin addition, Personal
hygiene is in placed.
Chemical No chemical is being used in
any steps. Still excess vitamin
None - - - NA - - - - - - - comes under chemical hazards.
SOP and quality check are in
placed for std qty of vitamin

51 | P a g e
 dosing as per FSSAI std
requirement

Biological None - - - NA - - - - - - - Biological hazard is not

considered.

This is the point where all

physical hazards are removed.
Polymerized
The pressure drop is one
material,
control measure and second is
scaling, gaskets
visual inspection of filter bag .
pieces, rust,
VNS filtration- Hence there is CCP-2 .
Physical Foreign H H HH CCP-2 Y Y Y - Y - -
transferring to maintenance of polish filter –
material, hairs, .
packaging care must be taken while
insects,, plastic
service tank opening the filter as foreign
bags, stickers,
through filtration matter may enter into inside
threads.
of filter and which may cause
physical hazard in product.
-.
Chemical None - - - NA - - - - - - -

Biological None - - - NA - - - - - - -
Buffer Tank for N Very rare chance of gasket
packing particles to come in products
Physical Gasket pieces. L L LL PM N - - - - -
and also food grade gaskets
are being used in all steps.
Chemical None - - - NA - - - - - - - -
Biological None - - - NA - - - - - - - -

52 | P a g e
 4.3 HACCP Implementation Plan for Hydrogenated Vegetable fat (Vanaspati)

Process Significant
CCP Critical limit Monitoring Corrective Action HACCP Record Verification Validation
Step Hazard
CCP2 Packaging Foreign Differential What If the diff. pressure is more Record Name CCP What calibration of What : Effectiveness
Polish matter pressure inlet than 0.8 bars. , close feed pressure gauge how of CCP- PF of 1 mic
filter vs. outlet Foreign matter valve to filter .Check filter Monitoring log check log sheet for for removing of
physical condition if necessary, sheet / shift log complete documentation Physical hazards like
Critical Limits hazard operator shall check oil book and specified frequency foreign matters,
0.2 bar to 1.2 visually. If pressure diff. is check. Check record of debris, cut pieces,
bar How less than 0.2 bar Responsibility filter bag change and etc.
Pressure gauge immediately oil to be QA/QC/Packaging correct size being used.
Safe limits rejected / recalculated to Check that pressure How
differential When before CCP point. gauges are in good As per CCP-2
pressure at Once in a shift working order. validation SOP
inlet Vs. Outlet (minimum) Open filter and check for Check correct installation When
min. 0.2 to proper bag installation, no of filter bags. When daily
max. 0.8 bar Where damage to bag. Check by packaging executive Annual basis
Packaging sample for any foreign. once in month by
Hold the entire quantity of packaging In charge Responsibility
Responsibility product that might have got
affect during the deviation Responsibility FS coordinator/QC in
Plant Shift period. Draw samples from charge
operator these stock and check Packaging in charge
Shift executive thoroughly for the presence
of foreign matter, such
quantity shall be released for
dispatch only after, quality
clearance. In case foreign
matter is noticed the entire
stock shall be Rejected and
subsequently be
reprocessed.

53 | P a g e
Responsibility
Pack. Shift supervisor

54 | P a g e
D. INSPECTION CHECKLIST

55 | P a g e
 Date FBO Name

Food Safety Officer FBO's representative

FBO License No. Address

Indicate the following – Compliance (C), Non Compliance (NC), Partial Compliance (PC) or Not Applicable (NA)

S. No. Audit Question Scoring

Food establishment has an updated FSSAI license and is displayed at a
1 2
prominent location.

I Design & facilities

The design of food premises provides adequate working space; permit
2 2
maintenance & cleaning to prevent the entry of dirt, dust & pests.

The internal structure & fittings are made of non-toxic and impermeable
3 2
material.

Walls, ceilings & doors are free from flaking paint or plaster, condensation &
4 2
shedding particles.

5 Floors are non-slippery & sloped appropriately. 2

Windows are kept closed & fitted with insect proof screen when opening to an
6 2
external environment.

7 Doors are close fitted to avoid entry of pests. 2

Equipment and containers are made of non-toxic, impervious, non- corrosive

8 2
material which is easy to clean & disinfect.

9 Premise has sufficient lighting. 2

10 Adequate ventilation is provided within the premises. 2

Adequate storage facility for food, packaging materials, chemicals, personnel

11 2
items etc available.

Personnel hygiene facilities are available. (Adequate number of hand washing

12 2
facilities, toilets, change rooms, rest & refreshment room etc).

Potable water (meeting standards of IS:10500) is used as a product ingredient

13* or in contact with food or food contact surface & tested for quality semi 4
annually. Check for records.

Food material is tested either through internal laboratory or through an

14 2
accredited lab. Check for records.

Food material is tested either through internal laboratory or through an

14 2
accredited lab. Check for records.

56 | P a g e
II Control of operation
Incoming material procured as per internally laid down specification &from an
15 approved vendors. Check for records (like specifications, name and address of 2
the supplier, batch no., quantity procured etc).

16 Raw materials is inspected at the time of receiving for food safety hazards. 2

Incoming material, semi or final products are stored according to their

17 temperature and humidity requirement, in a hygienic environment. FIFO & 2
FEFO is practised.

Requisite time and temperature is being achieved, maintained, monitored &

18* 4
recorded while manufacturing/processing. Check for records.

19 Food manufactured/processed is packed in a hygienic manner. 2

20 Packaging materials is food grade & in sound condition. 2

Cleaning chemicals & other hazardous substance are clearly identified &stored
21 2
separately from food.

22 Transporting vehicle for food use are kept clean and maintained in good repair. 2

Transporting vehicle are capable of meeting requisite temperature (where

23 2
applicable).

Recalled products are held under supervision & destroyed or

24 2
reprocessed/reworked in a manner to ensure their safety. Check for records.

III Maintenance & sanitation

Cleaning of equipment, food premises is done as per cleaning schedule &
25 2
cleaning programme.

Preventive maintenance of equipment and machinery are carried out regularly

26 2
as per the instructions of the manufacturer.

27 Measuring & monitoring devices are calibrated periodically. 2

Pest control program is available & pest control activities are carried out by
28* 4
trained and experienced personnel. Check for records.

29 No signs of pest activity or infestation in premises (eggs, larvae, faeces etc.) 2

Drains are designed to meet expected flow loads and equipped with traps to
30
capture contaminants.

Food waste and other refuse are removed periodically from food handling
31 2
areas to avoid accumulation.

Disposal of sewage and effluents is done in conformity with standards laid

32 2
down under Environment Protection Act, 1986.

IV Personal Hygiene 2

33 Annual medical examination & inoculation of food handlers against the enteric 2
group of diseases as per recommended schedule of the vaccine is done. Check

57 | P a g e
 for records.

No person suffering from a disease or illness or with open wounds or burns is

34 2
involved in handling of food or materials which come in contact with food.

Food handlers maintain personal cleanliness (clean clothes, trimmed nails

35* &water proof bandageetc) and personal behaviour (hand washing, no loose 4
jewellery, no smoking, no spitting etc).

Food handlers equipped with suitable aprons, gloves, headgear, shoe cover
36 2
etc; wherever necessary.

V Training & Complaint Handling

37 Internal / External audit of the system is done periodically. Check for records. 2

38 Food business has an effective consumer complaints redressal mechanism. 2

Food handlers have the necessary knowledge and skills & trained to handle
39 2
food safely. Check for training records.

Appropriate documentation & records are available and retained for a period of
40* 4
one year or the shelf-life of the product, whichever is more.

Total points ....../90

Asterisk mark (*) questions may significantly impact food safety & therefore must be addressed as a priority.
Failure in any of the asterisk mark (*) questions, will lead to Non-compliance
Grading –
+
A 85-90 Compliance – Exemplar
A 80-84 Compliance/Satisfactory
B 60-79 Needs Improvement
No grade <60 Non Compliance

58 | P a g e
E. PROFORMAS

59 | P a g e
1. Mandatory Proformas
1.1 Medical Fitness Certificate for Food handlers

60 | P a g e
1.2 Form E – Form of Guarantee

FORM E

Form of Guarantee

Date of sale Nature and quality Batch No. or Code Quantity Price
of article/brand No.
name, if any

1 2 3 4 5

Invoice No. _____ Place:______

From: ______ Date:_________

To: _________

I/We hereby certify that food/foods mentioned in this invoice is/are warranted to be of the nature and

quality which it/ these purports/purported to be.

Signature of the

Manufacturer/Distributor/Dealer

Name and address of

Manufacturer/Packer

(in case of packed article)

License No. (wherever applicable)

61 | P a g e
2. Recommendatory Proformas
2.1 Approved Supplier List

Primary Approved Supplier (Name & complete address) Secondary Approved Supplier (Name & complete
Item/Material Location
S.No. Complete Contact Contact Complete Contact Contact
Name of Use Email id Fax Email id Fax
Address Person No. Address Person No.

2.2 Incoming Vehicle Inspection Record

Date of Incoming Vehicle:

Vehicle Type:
Material in Vehicle received:
Number of Persons accompanying Driver:

PARAMETER EVALUATED REMARKS

Security lock
Type of carrier (full covered/ Open Roof)
Mode of covering products (in case of Open Roof)
Overall Hygiene in the interior
Overall Hygiene on the exterior
Any sharp edges / points in the interior of vehicle
Any pests detected
Any grease /oil detected

Authorized Singature

62 | P a g e
2.3 Incoming Material Inspection

Includes all type: Raw materials, Ingredients, Food addiitives, Processing aids,
Packaging materials, Cleaning and sanitation chemiclas, etc.

Material Name:
Supplier Name:
Identification/Location of Supplier:
Quanity received:
Pack size received:
Material Receipt Date:
Transport Mode:
Rejected (Yes/No):
Reason for Rejection:

PARAMETER EVALUATED STATUS/RESULTS Signature

Temperature (Degree Celsius)
Visual Inspection Condition (OK/Not OK)
Packaging & Labelling Condition (OK/Not OK)
Production Date/Shelf Life Date/Expiry Date
Vehicle Inspection Condition (OK/Not OK)
Quality Lab Results (If applicable)
Certificate Of Analysis (COA) received (Yes/No)

Remarks
Clearannce Date

Authorized Signatore

2.4 Operation Log Sheet (Template for Temperature Control)

Temp. Specification
Actual
S.No. Date Time Gauge / Range Remarks Sign
Result
Number allowed

63 | P a g e
 2.5 Product Release Record

Name of Product:
Date of Manufacturing:
Time of Manufacturing:
Batch/Lot No.:
Best Before/ Expiry Date:

Quality Acceptance
Anal yti cal
Mi crobi ol ogi cal
Sensory
Others, i f any

Quality Lab signature

2.6 Non-conforming Material/Product

HOLD: REJECT:

Material Type:
Finished Product Raw Material
In-Process Product Packaging Material

Material Name:
Date of Manufacturing/Receipt:
Quantity of Manufacturing/Receipt:
Lot/Batch No.
Quantity used:
Lot/Batch No.
Quantity Hold:
Lot/Batch No.
Quantity Rejected:
Lot/Batch No.

Reason for Hold:

Reason for Rejection:

Corrective Action:
Preventive Action:

Remarks:

Signature:
QC Executive Qualiity Manager Mfg. Manager

64 | P a g e
2.7 Rework Record

Batch Date Qty Material Source Time Finished Product

No

2.8 Outgoing Vehicle Inspection Record

Date of Outgoing Vehicle:

Vehicle Type:
Material in Vehicle to be dispatched:
Date of Manufacturing:
Time of Manufacturing:
Batch/Lot No.:
Number of Persons accompanying Driver:

PARAMETER EVALUATED REMARKS

Security lock
Type of carrier (full covered/ Open Roof)
Mode of covering products (in case of Open Roof)
Overall Hygiene in the interior
Overall Hygiene on the exterior
Any sharp edges / points in the interior of vehicle
Any pests detected
Any grease /oil detected

Authorized Singature

65 | P a g e
2.9 Product Recall record

Date of Nature of Results of Product / Batches & Mode of

S.No.
Complaint Complaint Investigation quantity recalled Disposal

66 | P a g e
2.10 Product Identification and Traceability

Traceability Detail Format

Product Description
Plant Name: Manufacturing Date:
Product Name: Manufacturing Time:
Pack Size: Batch/Lot no.:

Traceability Details
Investigation Date: InvestigationTime End:
InvestigationTime Start: Total Time Taken:

A. CIP Details
CIP Details
Equipment Name Date Time Person Remarks
responsible

B.Ingredient Details
Material Description
Remarks
Name Batch/Lot No.

C. Water Treatment Details

Chemical/Material Description
Remarks
Name Batch/Lot No.

D. Primary Packaging
Material Description
Remarks
Name Batch/Lot No.

E.Manufacturing Details
Date Shift Cases CCP Compliance Remarks
Manufactured

F. Analytical Details
Date Shift Analytical Product Remarks
compliance% blocked,if any

G.Dispatch Details
Invoice No. Date of Quanity Dispatch Remarks
Dispatch Dispatched= Destination
Total produced-
(Rejected+
Control samples+
Warehouse
retained)

67 | P a g e
2.11 List of Monitoring and Measuring Devices and Records of Calibration

S.No. Name of ID.No. Location Range Least Frequency In house In house Remarks Sign
Equipment Count of calibration calibration
Calibration Done On Due On

2.12 Preventive Maintenance Schedule

LIST OF MACHINERY AND EQUIPMENT FOR MAINTENANCE

Location of
Name of Code/
Specification place of the
S.No. Machine/ Identification Frequency of check Remarks
/Supplier Machine/
Equipment No.
Equipment
Daily Weekly Monthly Half Yearly Yearly

2.13 Preventive Maintenance Record

Machine/Equipment Name.:
Machine/Equipment No.:
Location:

S.No. Maintenance Check Point Frequency of check Signature Remarks

Daily Weekly Monthly Half Yearly Yearly

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2.14 Pest Management Plan

Type of Pest Mode of Control Station Number Frequency of Remarks

(locations) designated Monitoring
monitored

2.15 Pest monitoring record

Date Type of Mode of Station Number Frequency Clean Remarks Sign

Pest Control (locations) designated of (ok/Not ok)
monitored Monitoring

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2.16 Monitoring of Personnel hygiene
Date:

Hand
Infectiou Overall
wash, Clean
sDisease No Hygiene Action Re-
sanitize outer Clean
Clean & / Skin Tobacco/ Status needed examina
Employee Employee Area of (and No open No Covered garments Shoes/
S.No. trimmed infection Smoking upon on non- tion
Code name work Gloves Wounds Jewellery Hair / shoe
Nails / / examina complian status
where protectiv covers
Allergy, Chewing tion ce (Yes/No)
necessar e clothing
if any (Yes/No)
y)
1
2
3
4
5
6
7
8
9
10
11
12
13
14

Jewelllery:wrist watches, cufflinks, ear rings, glass bangles, stick bindis

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2.17 Customer/ Consumer Complaint Log

Complaint Number: _______________

Date: _______________ Time recorded: _______________ am pm

Quality related: Food safety related:

Customer Details
Customer Name: _______________
Phone: _______________
Address: _______________ City: _______________
State/Province: _______________ Zip code: _______________
Email: _______________

Product Consumed
Product name: _______________
Batch Code/Lot no.: _______________
Package size: _______________
Location purchased: _______________
Date of purchase: _______________ Date consumed: _______________
How was the product stored? __________________________________________________

Nature of Complaint
Foreign object Off/ Unsatisfactory Flavor Allergic
Packaging Illness Others

How many people consumed? __________________ Ages? _______________

Symptoms/Additional Problem Information:______________________________________________________________

Has the Customer

Seen a Doctor? Gone to Hospital?
Spoken to a public health? Contacted Regulatory Agency?

____________________________________________________________________________________________________
Comments & follow up action
Feedback from client- Status or date finalized

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2.18 Training Record

Date of Training:
Conducted By:
Subject of Training:
Brief summary of the subject:
Duration of Training:

S.No. Name of person trained Functional area Remarks Signature

1
2
3
4
5
6
7
8
9
10

2.19 Training Effectiveness record

Date of Training:
Subject of Training:
Brief summary of the subject:

S.No. Name of person Functional area Pre-evaluation Post-evaluation Effectiveness Comment on Signature of
trained result result status (Yes/No) effectiveness trainee
1
2
3
4
5
6
7
8
9
10

Effectivess can be based on: Improvement in quality of work, Improvement in work output, Behavioural change, Overall usefulness of training, etc.

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