GMP AND HACCP

GMP AND HACCP

A Handbook for
Small and Medium Scale Food Processing Enterprises

published by

The Ceylon Chamber of Commerce in collaboration with

the Sri Lanka Food Processors Association

written by

Eresha Mendis, PhD and Niranjan Rajapakse, PhD

on behalf of

Ind-Expo Certification (Pvt) Ltd

Funded by the European Commission and the Processed Food

Development Initiative

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 GMP AND HACCP

This book has been published by The Ceylon Chamber of Commerce

(CCC), No. 50 Nawam Mawathe, Colombo 2, Sri Lanka
Tel : 0094-11-5588800 Fax : 0094-11-2449352 E-Mail: info@chamber.lk

First Edition: 2009

The copyright of this book belongs to The Ceylon Chamber Of Commerce

(CCC). This book or parts thereof, may not be reproduced, translated, or
transmitted in any form without prior written permission from CCC.

ISBN 978-955-604-037-1

written by,
Eresha Mendis, PhD and Niranjan Rajapakse, PhD

on behalf of,
Ind-Expo Certification (Pvt) Ltd.

Ind-Expo Certification (Pvt) Limited is a joint project of the Ceylon National Chamber of Industries
(CNCI) and National Chamber of Exporters (NCE) under the project, "Strengthening international
certification capacity in Sri Lanka with particular reference to Social Accountability Standard (SA 8000)
and Food Safety (HACCP/ISO 22000) Standard” supported by the United Nations Industrial
Development Organization (UNIDO ) IP Program in Sri Lanka implemented with the Ministry of Industrial
Development and funded by the Royal Norwegian Government.

cover page designed by,

Janaka Delpachithra

printed by,
Cybergate Services (Pvt) Ltd.
Tel : 011-2801283 / 0777-730889

Disclaimer:
The information contained in this book is solely for guidance purpose.
CCC disclaims all and any liability to any persons using the information in
this book as a basis for making or taking an action.

While all efforts have been made to make the information contained in the
book accurate, CCC seeks your understanding for any errors or omission.

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 GMP AND HACCP

WITH GRATITUDE WE ACKNOWLEDGE

FINANCIAL ASSISTANCE PROVIDED FOR THE
PRODUCTION OF THIS BOOK, BY THE
EUROPEAN COMMISSION UNDER THE SOUTH
EUROPE MEETS SOUTH ASIS PROJECT
IMPLEMENTED BY THE CEYLON CHAMBER OF
COMMERCE

APPRECIATION TO OTHER COOPERATE SPONSORS,

THE SRI LANKA FOOD PROCESSORS ASSOCIATION
(SLFPA), IND-EXPO CERTIFICATION (PVT) LTD AND
NATIONAL AGRIBUSINESS COUNCIL (NAC) FOR THE
SUPPORT IN MAKING THIS PUBLICATION

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Foreword

Trade liberalization has opened up market opportunities of the developing

countries. Yet, many small and medium scale food processing sector
enterprises (SMEs), specially in the developing countries have difficulties
and barriers in effectively exploiting these opportunities due to their inability
to demonstrate acceptable conformity to voluntary and mandatory technical
requirements in potential export markets.

Having realized the problems faced by the food processing sector, the
Ceylon Chamber of Commerce in consultation with its constituent members,
the National Agribusiness Council and the Sri Lanka Food Processors
Association has taken steps to publish this user friendly Handbook,
particularly focusing on the SME sector with funding from the European
Commission under the Asia Invest Project „South Europe Meets South Asia‟
(SEMSA).

The export industry in the food processing sector depends largely on the
supply chain, which comprises a large number of SMEs. Although these
industries have the resources and the know how to comply with Food
Safety Management Certification Systems such as HACCP and ISO 22000,
SMEs have much less access to information and know how to initiate
actions to install the foundations for HACCP and Good Manufacturing
Practices (GMPs).

It is the hope of the Ceylon Chamber of Commerce, their partners and

members that this Handbook will facilitate a large number of food
processing sector SMEs in Sri Lanka to implement GMP, HACCP and Food
Safety Management Systems in their organizations and meet stringent
quality standards in the international markets.

Harin Malwatte
Secretary General/CEO
The Ceylon Chamber of Commerce

26th of February 2009

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Acknowledgements

This publication is an outcome of a South Europe Meets South Asia Project

under the Asia Invest Project funded by EC. CCC would like to express its
gratitude to everyone who supported to publish this handbook.

The book has been written and proof read by Dr. Eresha Mendis and Dr.
Niranjan Rajapakse on behalf of Ind-Expo Certification (Pvt) Ltd .We
express our gratitude to Ind-Expo and the writers for taking up the challenge
of preparing this handbook within a very short period of time.

Mr. A. K. Ratnarajah, Chairman and Mr. Nihal Cooray, Technical Manager,

Ind-Expo Certification (Pvt) Ltd and Ms. Roshini Gunaratne, National Project
Coordinator, United Nations Industrial Development Organization (UNIDO)
for effective management and guidance provided to complete the
publication.

Our deepest gratitude extends to Prof. Upali Samarajeewa, National Expert

in Food Safety and Inspection, United Nations Industrial Development
Organization and Senior Professor, Food Science & Technology, University
of Peradeniya for providing suggestions and directions to improve the
content and giving encouragement and guidance to the writers.

Appreciation goes to our partners, National Agribusiness Council (NAC) and

the Sri Lanka Food Processors Association coordinated the development of
this handbook and provided valuable support, guidance and encouragement
in completing on time. Special thanks to Mr. Mario De Alwis, Chairman,
Process Food Development Initiative, Past President of Sri Lanka Food
Processors Association (SLFPA) and National Agribusiness Council (NAC),
Mr. Dhammika Gunasekara, President, Sri Lanka Food Processors
Association and Mr. Asoka Gopallawa, Chairman, National Agribusiness
Council (NAC) for their valuable inputs to improve this handbook.

Mr. Chandrarathna D. Vithanage, Senior Assistant Secretary General of the

Ceylon Chamber of Commerce provided invaluable assistance in several
ways in the production of this handbook. Our grateful thanks are due to him.

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Contents
Foreword iv

Acknowledgements v

Contents vi

Definitions and explanation of terms ix

Preamble xi

Chapter One
1. Introduction 1

2. GMPs and HACCP Prerequisite Programs 2

2.1 Identification of HACCP prerequisite programs 2

2.2 Key areas covered by GMPs and HACCP
prerequisite programs 4
2.3 Activities covered by GMPs and HACCP
prerequisite programs 5

2.3.1 Establishment: premises and facilities 5

2.3.2 Establishment: personnel training,
hygiene and practices 12
2.3.3 Establishment: cleaning and sanitation 14
2.3.4 Pest control 16
2.3.5 Equipment 17
2.3.6 Transportation, receiving, storage,
delivery and shipping 20
2.3.7 Customer complaints, traceability and recall 23
2.3.8 Raw material control and control of
manufacturing 25

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Chapter Two
Checklist 28

1. Premises and facilities 28

2. Personnel hygiene and practices 29
3. Sanitation 29
4. Pest control 31
5. Equipment conditions 31
6. Supplier quality management 31
7. Raw materials 32
8. Process controls 32
9. Quality assurance 33
10. Security 33
11. Storage, delivery and shipping areas 33
12. Finished products 34
13. Warehousing and distribution 34

Chapter Three
HACCP System 35

1. The Seven HACCP Principles 36

2. Structure of the HACCP System 37
3. Establishment of the HACCP System 38

Step 1: Assemble the HACCP team 39

Step 2: Describe the product 39
Step 3: Identify the intended use of the food product 40
Step 4: Construct a flow diagram of the process 41
Step 5: On-site verification of the process flow diagram 42
Step 6: Analyze hazard (HACCP principle 1). 42

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Step 7: Determine CCPs (HACCP principle 2) 43

Step 8: Establish limits for CCPs (HACCP principle 3) 45
Step 9: Establish a system to monitor control of CCPs
(HACCP principle 4) 45
Step 10: Establish corrective action procedures
(HACCP principle 5) 46
Step 11: Establish verification procedures
(HACCP principle 6) 47
Step 12: Establish a recordkeeping procedure
(HACCP principle 7) 48

4. HACCP Plan Summary 51

Appendices

Appendix 1. Recommended international code of hygienic

practice for desiccated coconut 52

Appendix 2. Recommended international code of hygienic

practice for spices and dried aromatic plants 57

Appendix 3. Recommended international code of hygienic

practice for fresh fruits and vegetables 60

Appendix 4. Recommended international code of hygienic

practice for the prevention and reduction of
mycotoxin contamination in cereals 62

References 64

Sources of information 66

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Definitions and explanation of terms

Allergy
Implies an abnormal sensitivity to certain substances and foods and
represents some response of the body‟s immune system. Typical allergic
responses include development of redness, heat, swelling, pain and itchy
feeling in the body.

Cleaning
Removal of soil, dust, food residue, dirt, grease, or other objectionable
matter from utensils, food processing equipment, and structures (Codex
Alimentarius, 1997b).

Codex Alimentarius Commission

A joint, subsidiary body of the Food and Agricultural Organization (FAO) of
the United Nations and the World Health Organization (WHO). Its role is to
develop, promote, and harmonize standards for food in order to facilitate
international trade. It has developed numerous internationally recognized
food standards as well as an internationally recognized HACCP system.

Codex Alimentarius
A set of internationally recognized food standards developed by the Codex
Alimentarius Commission.

Contaminant
Any extraneous or unwanted physical, chemical or biological substance, or
object, encountered in food, which may compromise food safety or food
suitability.

Critical control point (CCP)

These are stages in HACCP at which operators of food preparation
processes should exercise controls directed at preventing or minimizing the
risk of food hazards. The processing stages whose loss of control would
result in an unacceptable food safety risk.

Critical limit
In HACCP, a dividing line between what is safe and unsafe with respect to
food preparation. A maximum or minimum value to which a biological,
chemical, or physical parameter must be controlled at a CCP to prevent,
eliminate, or reduce to an acceptable level, the occurrence of a food safety
hazard.

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Cross-contamination
The transfer of contaminant from one food to another; common means of
cross-contamination include personnel, utensils and equipment.

Food hygiene
All conditions and measures necessary to ensure the safety and suitability
of food at all stages of the food chain (Codex Alimentarius, 1997b).

Food safety
The assurance that food will not cause harm to the consumer when it is
prepared and/or eaten according to its intended use (Codex Alimentarius,
1997b).

Foodborne illnesses
Diseases, usually either infectious or toxic in nature, caused by agents that
enter the body through the ingestion of food. (World Health Organization).

Hazard analysis and critical control point (HACCP) system

A system that identifies, evaluates, and controls hazards that are significant
for food safety (Codex Alimentarius, 1997b). HACCP, which is recognized
for its science-based approach, consists of a set of seven principles that
have been adopted internationally through the work of the Codex
Alimentarius Commission.

Hazard
A biological, chemical, or physical agent in, or condition of, food with the
potential to cause an adverse health effect (Codex Alimentarius, 1997b).

Pest
Any living creature, such as, rodents, crawling and flying insects, and birds,
capable of contaminating food by direct or indirect contact.

Prerequisite programs
Procedures, including good manufacturing practices that address
operational conditions providing the foundation for the HACCP system.

Sanitizing
Killing of microorganisms present on equipment, utensils and structures
using a chemical agent or a specific technique.

Utensils
Include knives, spoons, whisks and other items used by hand in food
manufacture and catering processes.

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Preamble
The food industry

The food system is a complex, concentrated, and dynamic chain of activities

that begins with the production of raw agricultural commodities on farms,
estates, fields and gardens and moves to value-added processed and
manufactured products and then to retail food stores and foodservice
establishments (restaurants and institutions) where they are merchandised,
prepared, and sold to consumers. Each sector of the food system is unique
in size, scope, and diversity and has evolved and adapted to changes in
demographics and lifestyles, science and technology, and consumer
demands. As the food industry has become larger, and more concentrated
and diversified food safety and sanitary practices have taken on a new
importance in protecting public health. Customers have ever higher
expectations of quality and safety of processed food products and hence
the food industry faces an unprecedented level of scrutiny. In the current
era of emphasis on food safety and security, high-volume food processing
and preparation operations have increased the need for improved sanitary
practices from processing to consumption. To more fully comprehend the
role of sanitation and food safety in the food industry, it is important to
understand how food can become unsafe or contaminated (Figure 1).

Machinery and
Storage and
utensils
transportation
Air

Raw material
and Water, ice
ingredients and steam
Food
Food
Contamination Packaging
handling materials

Employees Plant
and visitors structure and
Pests environment

Figure 1. Sources of food contamination

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Classification of sources of food contamination

The sources of food contamination can be broadly categorized into three

main groups.

 Microbial (microorganisms, resulting in food spoilage and food

poisoning Eg. Pseudomonas spp., Lysteria monocytogenes)
 Chemical (Eg. pesticide residues, cleaning agents)
 Physical (Eg. glass fragments, metal particles)

Food contaminants become hazards if they pose risk to the human health or
cause injuries or illnesses.

Pathogenic microorganisms are a major safety concern for the food

industry. The vast majority of outbreaks of food-related illness are due to
pathogenic microorganisms, rather than to chemical or physical
contaminants. As they are generally undetectable by the unaided human
senses and they are capable of rapid growth under favorable storage
conditions, much time and effort are spent in controlling and/or eliminating
them. Even if the microorganisms in a food are ultimately destroyed by
cooking, they may have already produced toxins, making it vital to prevent
contamination through the use of appropriate hygienic practices. Like
microbial pathogens, spoilage organisms can either be present naturally on
food or gain access to food. Food spoilage microorganisms are
microorganisms upon growth in a food, produce undesirable flavor (odor),
texture and appearance, and make food unsuitable for human consumption.
Although not a direct food safety concern, increased levels of spoilage
organisms will usually mean a reduction in the length of time that the food
remains fit to eat. This can affect product quality and thus influence the
consumer's perception of the product.

Growth of microorganisms depends on a number of factors, such as

temperature, humidity/water activity, pH, availability of nutrients, presence
or absence of oxygen and inhibitory compounds such as preservatives.
Manipulation of these factors provides the basis for the control of
microorganisms during food processing operations. Prevention of
microorganisms to the food chain through early actions such as addressing
the microbiological quality of water and maintaining the storage and
transport systems clean pay much in the long term for the food industry.

The chemicals may enter the food chain as residues of pesticides,

antibiotics, preservatives, and chemicals used for cleaning and sanitization
of the food processing plants or even as intentional additives used with
profit as main motivation. The use of chemicals in the food industry are
governed by food regulations and good practices, which when ignored could

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end up in food safety problems such as recent incidence of melamine in

milk products.

The physical entities that can impair the safety of foods include solid
particles of material from soil, glass, metals etc entering food from the
environment and process equipment. Attention to prevent the entry of these
materials during handling practices forms the key to ensure food safety from
physical factors.

A good food manufacturing system need to establish adequate checks and

measures to prevent the problems arising due to entry of microbial,
chemical and physical contaminants right along the food chain.

What is sanitation and why it becomes important

In general, cleaning activities cover the removal of dust, dirt, debris,

accumulated raw materials, ingredients or product, and any chemical
residue from utensils, food processing equipment, and structures. Sanitizing
activities cover the use of a chemical agent or a specific technique to kill
microorganisms present on equipment, utensils and structures. As a whole
sanitation is the application of a science to provide wholesome food
processed, prepared, merchandised, and sold in a clean environment by
healthy workers; to prevent contamination with microorganisms that cause
foodborne illness; and to minimize the proliferation of food spoilage
microorganisms. Effective sanitation refers to all the procedures that help
accomplish these goals. The food plants are hygienically designed;
nevertheless, foods can be contaminated with spoilage microorganisms or
those that cause foodborne illness if sanitary practices are not followed.
However, hygienic and safe foods can be produced with adherence to
sanitary practices, even in older food processing plants giving low attention
to easy cleaning and sanitizing practices.

Food regulation and quality control

Food manufactures have both legal and ethical responsibilities to provide

the consuming public with foods that are safe and wholesome. A variety of
regulations, standards and approaches are applied today in the food sector
to guide food safety. Production of foods that are safe for consumption and
meet consumer expectations for quality and palatability also makes good
business sense as it will encourage consumers to patronize those products
repeatedly over time. Food manufacturers have responded to this need by
developing systems to measure, manage and improve product quality and
safety more effectively. Basically, these systems address preliminary food
safety requirements (prerequisite programs) and controlled processing

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operations through identification, monitoring and eliminating hazards

(Hazard Analysis and Critical Point (HACCP) system).

Good manufacturing practices (GMPs) are the minimum sanitary and

processing requirements necessary to ensure the production of wholesome
food. The prerequisite programs provide more comprehensive coverage of
the requirements relating to conditions and activities in a food plant. Many of
the GMPs and other prerequisite programs are directed at ensuring to
establish necessary conditions for the prevention of potential contamination
and cross-contamination of food.

This document provides guidance to small and medium scale food

enterprises (SMEs) on how to manufacture safe, quality food products
consistently by adherence to the principles of GMP and prerequisite
programs within a wide range of processes. This book further guide SMEs
on how to be prepared to establish HACCP system following completion of
implementing basic requirements addressed in prerequisite programs.

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Chapter One
1. Introduction
Food processing establishments worldwide are directly or indirectly
governed by national food laws and regulations to maintain good sanitary
conditions in the process and to implement food safety practices assuring a
safe food for the consumer. With globalization of the food trade, the national
standards are developed in line with Codex food standards developed by
the joint Codex Alimentarius Commission of the World Health organization
(WHO) and the Food and Agriculture Organization (FAO). Many food safety
and sanitary practices are regarded as good manufacturing practices
(GMPs) that eliminate health hazards from foods or avoid unacceptable
levels of hazards. In addition to the GMPs governed by national food laws
and regulations, food processing and handling establishments need to
develop and implement their own programs of GMPs to address specific
food safety requirements. Traditionally the food processing sector has relied
on practicing GMPs in its efforts to ensure the safety of processed foods.

At a later stage, introduction of the Hazard Analysis and Critical Control

Point (HACCP) system addressed safety in food processing sector in a
more comprehensive manner. However, to implement an effective HACCP
system, there should be some basic requirements or prerequisites to satisfy
the framework of HACCP system. GMPs that address all food safety and
sanitary practices but not included as a part of the HACCP plan along with
some other additional requirements, are now regarded as prerequisite
programs for the implementation of a HACCP system. Therefore, food
processing industries planning to establish HACCP systems need to identify
particular additional requirements, considering the GMPs that are currently
in practice. The activities for GMPs or the HACCP prerequisite programs
that are developed at food processing plants are needed to document as
standard operational practices or procedures (SOPs). These SOPs help to
identify the HACCP prerequisites need to be developed further, by
analyzing the gaps between effectiveness of current GMPs and their
expected levels. Gap analysis check lists developed for HACCP
prerequisites are commonly used in identifying the gaps to be met in
ensuring food safety and developing required GMPs.

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2. GMPs and HACCP Prerequisite Programs

Most of the GMPs and HACCP prerequisite activities are carried out to
address food safety considerations that are not included as a part of the
HACCP plan/s. In addition, control of unsanitary and undesirable but
nonhazardous contaminants is also a major consideration addressed by
them ensuring the prevention of potential contaminations. Even though, a
clearly identified framework exists for HACCP system, a generalized
framework for HACCP prerequisite programs cannot be identified for the
entire food sector as practices vary depending on the raw materials, end
products and the processing techniques, with due considerations given to
scales of operation. The actual framework needed for designing HACCP
prerequisite programs for a given food processing plant can vary from
another and also from one country to another based on the local field
conditions. Yet, the activities addressed by GMPs and HACCP prerequisite
programs for most food processing plants are essentially similar regardless
of the nature of their end products.

2.1 Identification of HACCP prerequisite

programs
In identifying HACCP prerequisite programs for food plants, a careful study
needs to be carried out on the following (Figure 2),

 Mandatory food safety practices required by national and/or

international regulations
 Food safety practices required by the establishment to ensure high
level of consumer protection and consumer confidence on the
products
 GMPs currently in practice and their effectiveness
 Additional GMPs need to be in place addressing basic food safety
and sanitary practices not covered by current GMPs

Mandatory practices required by the national regulations can vary

depending on the nature of the food product and processing or handling
practices. These practices basically address food safety and sanitary
management practices. However, there is no clear-cut boundary to classify
the activities that address safety and hygiene of food, under the
management practices of food safety and food sanitation. Because,

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outcomes of most of activities directly or indirectly fulfill the requirements of

food safety and sanitary management practices. International guidelines to
ensure food safety envisage harmonizing of practices to the extent possible
so that they become acceptable for cross border trade.

The food processing establishments with no HACCP systems in place but

operating with quality management standards, apply some basic GMPs as
regulatory requirements. Food industries with vision for competitiveness
move beyond the basic GMPs and implement companywide voluntary food
quality and safety management practices with a view to seek certification for
HACCP and ISO 22000.

Mandatory Food safety

practices required management practices
by government/
international Food sanitary
regulations and/or management practices
by customers (Good hygiene
Current GMPs practices/ GHP)
(documented as
SOPs)
Optional Food quality
(recommended/ management practices
advisory) practices
required by a
particular food Companywide
HACCP HACCP voluntary food quality
prerequisites processing
system management practices
establishment

Requirements not
satisfied by
current GMPs

Figure 2. A schematic diagram to illustrate the relationship among GMPs,

HACCP prerequisites and the HACCP system

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2.2 Key areas covered by GMPs and HACCP

prerequisite programs
Since the activities required as GMPs or HACCP prerequisite programs by
most food processing plants are similar, it is possible to compile a generic
list of basic food safety controls.

A generic list of basic food safety controls

 Plant environment and facilities
 Production equipment and machinery
 Raw materials and ingredients
 Quality assurance
 Storage and delivery
 Employee training and personal hygiene
 Cleaning and sanitation
 Pest control
 Recordkeeping and traceability

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2.3 Activities covered by GMPs and HACCP

prerequisite programs
The prerequisite programs that are described in the following sections
include the GMP activities required by food industry, and should, therefore,
be applicable to food plants that operate without HACCP systems.

2.3.1 Establishment: premises and facilities

Area covered

This prerequisite program addresses the

requirements directed at,

 The location, design, construction, and

maintenance of buildings that are used
for food processing

Importance

The primary considerations

ensure that the building, its
grounds, structures, and
facilities are not a source of
contamination or cross-
contamination of food, there
is protection from entry of
pests into the building, and
clean and sanitary conditions
can be maintained. These are
mainly implemented during
the design and construction
stages of a food processing
plant.

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 GMP AND HACCP

Location and surrounding

The processing factory and the building premises in which food is

stored need to be located away from environmentally polluted or
from areas having industrial, agricultural or other activities which are
potential sources of food contamination.
Area to dispose waste is specified and it is located away from the
factory premises.
If any of these undesirable conditions exist, there should be
adequate safeguard to protect against any potential contamination
or pest infestation.

Grounds

Floors should be adequately sloped and drained to prevent stagnant

water.
Free of litter and waste, be controlled for dust, and be adequately
maintained to protect against becoming a source of contamination or
pest infestation.
A clear perimeter which is free from grass, lawns, hedges, shrubs,
trees need to be maintained around the factory to prevent breeding
or attraction of pests.
Roads, yards, and parking lots need to be maintained so that they
do not constitute a source of contamination in areas where food is
exposed.

Building exterior

The design and maintenance of exterior walls and roofs of buildings

need to prevent the entry of sources of contamination and pests,
and leakage of water into the building.
Exterior walls need to be free of cracks that could be breeding sites
for pests.
Openings for exhaust fans and air intake ducts, and exterior
drainpipes need to be adequately screened and protected to prevent
entry of pests.
The loading and unloading areas of the building, and all exterior
doors and windows need to be adequately protected to prevent entry
of pests.
The location of exterior lighting should not attract insects into the
building.

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Building interior

(A) Design and layout

All machinery and equipment need to be located in such a way to
allow easy cleaning and maintenance.
The layout and the location of all structures, equipment, services,
and facilities provide sufficient space for movement of personnel and
equipment, flow of air, materials and products, movement of waste
and garbage, and storage of materials and products, to prevent
contamination and cross-contamination of materials and products.
There should be physically separate areas that are designated for
processing, for packaging, for raw materials storage and
preparation, and for finished product storage to avoid cross-
contamination.
Processing activities that could become potential sources of cross-
contamination need to be located in areas that are separated from
other processing activities and movement between high and low risk
areas of the factory is minimized with controlled corridors.
The personnel facilities, laboratory and other service areas need to
be included in the design with proper specifications.

(B) Floors
Floors should be rigid and free of cracks for easy cleaning and
maintenance.
Floors should be even but appropriate slopes need to be designed
towards exterior to allow easy draining of waste-water to outlets.

(C) Windows and doors

All doors and windows facing exterior need to be kept tightly closed.
Those required to be opened for ventilation need to be screened
with a suitable mesh to prevent entry of insects.
The doors which are used frequently in the processing area should
be self-closing and with rubber-strip curtaining to prevent entry of
rodents and other animals.

(D) Corners and joints

Corners need to be designed to prevent accumulation of
contaminants and to facilitate easy cleaning.
Joints in walls, floors, ceilings and in all structures should be sealed
and should be easily cleanable.

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(E) Structures
The design and construction of floors, walls, ceilings, overhead
structures, windows, doors, and stairs, and all utilities and service
structures such as ducts, pipes and drains should meet all basic
requirements for easy cleaning and safety.
The materials used for construction and finishing of these structures
should be durable, impervious, smooth and easily cleaned and
maintained.
The materials used for construction of walls and floors need to
withstand the rigorousness of the production processes such as
heat, vibrations and the routine cleaning and sanitizing conditions.
.
(F) Glass
Glass or glass-like materials such as breakable plastic should not be
used in items such as clocks, lights, and gauges that are placed in
processing areas where there is a likelihood of breakage that will
result in contamination of food product.

(G) Pipes and hoses

Water taps and hose connections placed inside processing area
should be free of leaks and water drips to discourage microbial
growth.
Water pipes should be free of condensation and mould growth.

(H) Drainage and sewage systems

Separate drainage and sewage lines should be placed with
appropriate slopes to ensure no accumulation and backflow into the
building even with rain water or during heavy cleaning operations.
Drains should permit access to regular cleaning and monitoring.
Drainage entry and exit points into the building need to be pest
proofed. Fumigation of drains needs to be practiced as an additional
precaution to discourage pests.

(I) Air quality and ventilation

Adequate exhaust fans should be installed to ensure adequate
ventilation and air exchange throughout the building removing the
condensates and smells reducing the humidity.
The direction of air-flow should not result in contamination or cross-
contamination of foods.
There should be adequate measures to control temperature,
humidity, smoke, aerosol, fumes and dust accumulation in the
processing and storage areas.

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(J) Lighting
In areas where processing, handling, storage, testing, inspection
and cleaning activities take place, adequate natural daylight or
adequate amount of lighting with day light type bulbs and intensity of
about 750 lux needs to be facilitated to permit employees to carry
out their designated tasks.
Adequate lighting facilities need to be provided in hand-washing
areas, change-rooms, locker rooms and toilet rooms.
Bulbs should be covered to prevent bulbs from breaking on raw
materials and into the product.

Access to premises

Food processing plant employees should use designated entrances

where sanitary standards are maintained.
Separate openings for receiving and delivery/shipping operations
should be in place to avoid possible contaminations. These locations
should not be used by employees as entrances or exits.
The entrances and exists of the food processing plants should be
controlled to allow only authorized personnel and access to visitors
should be controlled.

Employee facilities

(A) Hand-washing
Adequate and accessible hand-washing stations need to be placed
at the appropriate locations, with clean running water, soap or other
hand-cleaning and sanitizing materials and need to provide hand-
drying facilities or disposable paper towels.
Hand-washing facilities are suitably trapped and plumbed directly to
drains.
Notices need to be placed with easily understandable signs
reminding the necessity to wash hands.

(B) Washrooms and toilet rooms

Toilet and wash room openings should not face directly into storage,
processing or food handling areas to reduce the chances of
contamination.
All toilets need to be adequately lit and ventilated and separated
from production areas.

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Toilet areas are of good hygienic design and the floors, walls, ceiling
and sanitary equipment need to be clean and in good decorative
order.
The numbers and capacities of the facilities need to be established
according to the total number of employees and the scope of
production.
Sign boards messaging safety precautions need to be placed to
serve as reminders to employees.

(C) Change-rooms
All food handling operators and persons need to be provided with
designated changing areas at the entry to processing premises.
Adequate lockers need to be provided for all personnel for the safe
storage of personnel effects such as outdoor clothing, bags, etc.

(D) Lunchrooms and break-rooms

A separate canteen and rest room areas be provided for operators
to take their meals and breaks.
Lunchrooms should be facilitated with appropriate appliances
including food storage facilities and with covered garbage
receptacles.

Cleaning and sanitizing facilities

Cleaning and sanitizing facilities such as, potable running water,

sanitizing agents, a detergent dosing system for soaking, cleaning
and rinsing need to be adequately supplied.
All cleaning and disinfection agents should be stored safely in a
designated, secure area, off the production floor and clearly
identified with the appropriate health and safety symbols and full
product descriptions.
Cleaned utensils need to be stored in a clean and dry place with
good drainage condition to dry them quickly.

Storage facilities

Storage facilities should be designed to facilitate warehouse, storage

rooms, silos, tanks, vats, bins, or other containers, for the storage of
raw materials, ingredients, packaging materials, products to be
reworked or recycled, semi-finished products, finished products,
cleaning materials and nonfood chemicals avoiding use of floor for
storage of raw materials and processed products.

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Waste collection and storage facilities

Sufficient and designated waste containers should be provided to

dispose food debris, packaging waste and other rubbish, at strategic
points throughout the process.
Closed and pedal operated waste collecting bins should be
separately placed inside and outside of the building. Those placed
inside need to be removed every hour like and those placed outside
need to be removed at the end of day. (In large factories continuous
removal systems can be practiced)
There should be no leakage from waste containers and should be
maintained in sanitary condition.

Water

(A) Water supply

Clean and sufficient water supply need to be ensured to facilitate for
processing, cooling or pre-cleaning, and for rinsing of equipment.
Facilities need to be placed to ensure that temperature and pressure
requirements for water can be achieved.

(B) Water quality

The water quality need to be weekly checked to confirm its quality
based on microbiological, chemical, and physical specifications of
applicable government agencies.
Only approved chemicals should be used for treatment of water
used in food plants. Where chlorination is necessary contact time
and free chlorine levels should be routinely monitored.
Clear and documented programs for inspection and monitoring of
water treatment need to be set and the records of water quality test
results should be maintained.
Overhead tanks need to be inspected on a weekly basis.

Ice and steam

Ice used in food plant operations should be made from potable water
and should be handled and stored in a way to protect from
contamination.
Steam coming into contact with food during processing should be
generated from potable water and only approved chemicals should
be used in boilers which generate steam for these purposes.

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2.3.2 Establishment: personnel training, hygiene and

practices

Area covered

This prerequisite program addresses the activities

directed at,

 The requirements and sanitary behavior of

employees in food plants

Importance

Employees in a food plant

play a critical role in ensuring
the safety of foods produced
at the plant by accomplishing
designated tasks. It is
essential that the employees
should not contribute to or be
a source of contamination or
cross-contamination of foods.
Considerations under this
program ensure that both
temporary and permanent
employees have the required
education and training, are
adequately supervised, and
follow their required work-
related tasks, personal
hygiene requirements and
acceptable personnel
practices during their work.

Personnel training

(A) Food safety training

Periodic assessment of food safety training needs of employees in
food processing plants need to be carried out and records of
requirement assessments and training details should be maintained.

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All personnel need to be appropriately trained in food hygiene

disciplines covering hygienic food handling practices, personal
hygiene management and should be informed the danger
associated with poor personal hygiene and unsanitary practices.
Personnel involved in monitoring of food safety practices should be
trained to identify food hazards and situations that have the potential
to lead to contamination of foods.

(B) Technical training

Relevant to the job task that comprises operation, maintenance,
cleaning of food processing equipment, and sanitation and cleaning
activities, employees need to be provided with the relevant technical
training and records need to be maintained.
Additionally „on the job‟ training and evaluation need to be carried
out to ensure they fully understand their responsibilities to meet all
food safety requirements.

Personnel practices

(A) Personal hygiene

Personnel working in direct contact with food, food contact surfaces,
and food-packaging materials are required to maintain satisfactory
cleanliness of clothing and body, including hair and fingernails.
Personnel need to practice good personal hygiene habits and refrain
from eating, chewing, smoking, spitting, coughing and sneezing
during food handling operations.

(B) Hand-washing
Employees should wash, sanitize and dry their hands before they
start work, when re-entering the processing area, after a visit to the
toilet and at any other time when the hands may have become
contaminated.

(C) Garments and work-wear

Employees should wear outer garments suitable to the operation in
a manner that protects against the contamination of food, food-
contact surfaces or food-packaging materials.
Working personnel should wear effective hair restraints and beard
covers to cover hair and beard.
(D) Personal items
Food processing plant personnel should remove all jewelry,
materials in front pockets and other personal wear that might fall into
food, equipment or containers.

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Illness and injuries

Measures need to be taken to identify food processing plant

employees who are suffering from infectious diseases such as
diarrhea, jaundice, vomiting, fever, sore throat, discharges from the
ear, eye or nose, open or infected skin lesions or any disease that
can be transmitted through food and avoid them from handling of
food.
The employees should be encouraged to bring to notice of
management such situations and the employers need to identify
reasons behind absenteeism of employees as a means of
understanding potential threats.
Regular medical checkups need to be carried out to ensure
employees are fit for designated tasks (Bi-annual medical checkups
would be preferred).

2.3.3 Establishment: cleaning and sanitation

Area covered
This prerequisite program addresses all ongoing
and periodic activities and operations that are
directed at,

 maintaining the environment, facilities,

structures, and equipment in a food plant
under sanitary conditions

Importance

The maintenance of sanitary

conditions in a food plant,
including clean and sanitary
environment, structures,
facilities, and equipment is
essential to ensure that food is
produced under sanitary
conditions, to prevent
contamination from these
sources and to prevent breeding
of pests.

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Sanitation and cleaning programs

Written cleaning and sanitizing procedures and schedules should be

available for structures, facilities, and equipment in the food
processing plant to avoid mistakes.
These procedures should be clear, legible, with adequate details on
cleaning and sanitizing chemicals and their concentrations or
dilutions, the cleaning tools to be used, the frequency of cleaning
and sanitizing, and the personnel responsible for cleaning specific
food contact surfaces, equipment or structures.
Checklists should be available for each department to ensure that
every single piece of equipment in use has been appropriately
cleaned. The checklist needs to be signed by the supervisor.
The effectiveness of the cleaning and sanitizing activities for removal
of contamination should be verified and the records need to be
maintained.

Sanitizing chemicals and cleaning tools

All cleaning and disinfecting agents used in food establishments,

and on food-contact surfaces need to be “approved” food grade
materials and not perfumed.
An up-to-date list should be available for all cleaning and disinfecting
agents used on the premises and all operatives and first aid
providers need to be aware of their chemical content in the event of
an accident.
Tools used to clean food processing, storage and handling
equipment should not be used for other cleaning activities, should
not be stored on the floor, and should be identified and stored
separately from tools used for other cleaning activities.

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2.3.4 Pest control

Area covered

This prerequisite program addresses the activities

directed at,

 Controlling, preventing and excluding the

occurrence of pests
 Certain preventive measures for pest
control in relation to the building
structures, as well as the internal
environment and the external surroundings

Importance

Pests act as sources of

food contamination or
cross-contamination. Pest
control programs ensure
that food is produced
under controlled
conditions to prevent
contamination from
pests.

Pest control program

The industry needs to contract the services of an approved pest

control organization, or designate trained personnel to perform pest
control operations.
Procedures and schedules of pest control program should be
maintained for the establishment detailing all of the preventive
measures, pest-control devices and pest-control chemicals, the
monitoring of pest and compliance with regulations on use of
pesticides and pest control devices.

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 GMP AND HACCP

All production and ambient storage areas should be protected by

electrical insect “knock-down” devices, each should be fitted with a
suitable catch tray which should be regularly inspected and emptied.
An accurate site map showing where bait stations are located are
compiled and held in the report book.
Detailed records of the pest control operations and inspections need
to be maintained.

2.3.5 Equipment

Area covered

This prerequisite program addresses the activities

directed at,
 Design, construction, installation,
performance, maintenance, and use of
equipment in a food plant

Importance

In this prerequisite program,

the primary considerations
are to ensure that the
equipment are capable of
processing products that meet
the safety and quality
requirements, while at the
same time the equipment
must not be a source of
contamination of the product.

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Processing equipment

(A) Design and construction

Design and construction of equipment that coming into contact with
food should ensure that the specific requirements of the process can
be achieved and the required maintenance, inspection, and cleaning
can be readily undertaken.
Equipment used to cook, heat treat, cool, store or freeze of foods
need to facilitate easy control and monitoring of physical
parameters.
It should be ensured that no contamination of product occurs from
the equipment itself, and there should be no unacceptable
accumulation of any material that is likely to be a source of
contamination.

(B) Food-contact surfaces

All food-contact surfaces, including utensils and food-contact
surfaces of equipment should withstand frequent cleaning to protect
against contamination of food.
The food-contact surfaces of equipment should be made out of
nontoxic material and should not be corroded or damaged during
processing operations.
Seams on food contact surfaces should be smooth to prevent
accumulation of product and to facilitate cleaning.

(C) Installation
All equipment used for food processing operations should be
installed in a manner to facilitate its operation, and the cleaning and
maintenance.

(D) Maintenance
A program should be developed specifying the routine maintenance
such as cleaning, inspection, servicing and lubrication, repairs in the
case of equipment break-down during regular operations and
scheduled and planned preventive maintenance.

Handling equipment

Equipment used to handle or move materials and products at a food

plant should be maintained in good condition to prevent damage to
or contamination of foods.

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 GMP AND HACCP

Storage equipment

Proper functioning of storage equipment such as freezers,

refrigerators and storage tanks should be maintained to prevent
decomposition or contamination of food products.
These equipment need to be fitted with an indicating thermometer,
temperature-measuring device, or temperature-recording device to
monitor the temperature fluctuations.
Regular cleaning schedules for storage equipment need to be
established and practiced to prevent food contaminations arising
from accumulating contaminants.

Monitoring and measuring equipment

All measuring equipment which has a direct effect on the production

process, safety and quality of the products should be regularly
calibrated against a national standard and records need to be
maintained.
Approved standard operating procedures should be used to perform
equipment calibration.
Clear procedures should be available to handle affected products if
the measurements show non-conformities and records need to be
maintained.
Intermediate checks need to be introduced to ensure that the
measuring equipment perform as expected between the calibrations.

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2.3.6 Transportation, receiving, storage, delivery and

shipping

Area covered

This prerequisite program addresses the activities

directed at,

 Transportation and receiving of all

materials to be used in the processing and
packaging operations
 Storage and warehousing of all materials
and products at the food establishment
 Shipping and transportation of all foods to
the point of delivery

Importance

Controlled functioning of these

procedures ensures the
prevention of contamination,
cross-contamination and
deterioration of products by
(a) control of incoming raw
materials, ingredients,
packaging materials, and
processing aids, their
subsequent inspection,
acceptance and storage until
they are utilized, and (b)
control of the storage of semi-
finished and finished products
from the time they are
produced, their subsequent
move to designated storage
areas or containers, their
shipment, delivery, and
distribution to their point of
use or sale.

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 GMP AND HACCP

Transportation and receiving

(A) Receiving location

A location which is well separated from food processing areas
should be used for receiving raw materials, ingredients, packaging
materials, and nonfood materials.
Operations conducted in these areas should be limited to sampling
and inspection to avoid contaminations.
Where possible cleaning and removal of unwanted parts of raw
materials should be done prior to transport to the processing
factories.
Receiving materials should not be kept long at the receiving location
and should soon be transferred to designated storage areas.

(B) Transport vehicles

Vehicles employed in delivering raw materials, ingredients, and
packaging materials to a food plant should be monitored to ensure
the sanitary conditions are maintained during the delivery.

(C) Verification of received materials

The quality and safety of raw materials, ingredients and packaging
materials should be verified against agreed specifications to
determine that they are suitable for their intended use.
Records of verification of received materials should be maintained.

Handling and storage

(A) Storage conditions

Clearly labeled storage areas for different materials (Eg. dry
products, chemicals, packaging and raw materials and finished
products) need to be demarcated.
During unloading of incoming materials such as raw materials,
ingredients, and packaging materials should be transferred to
designate storage areas ensuring no damage or contamination.
Properly designed store with good stacking system need to be
demarcated to prevent and protect from damage, deterioration,
contamination, and cross-contamination or pest infestation during
storage.
In and out areas and walking areas need to be clearly demarcated
within the store.
Proper ventilation and temperature control system need to be
facilitated in the store.

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 GMP AND HACCP

Incompatible materials should be completely segregated (Eg.

aromatic products, cleaning materials, incoming and finished
products) to prevent the risks of cross-contamination.

(B) Stock rotation

The release of raw materials and ingredients, and the shipment of
finished products should be controlled following first-in first-out
system to prevent extended storage of materials and products that
can result in deterioration and pest infestation.

Transportation/shipping

(A) Finished products

Food safety requirements such as product safety, specifications,
labeling and packaging of finished products need to be clearly
confirmed.

(B) Transport vehicle

All product transportation vehicles need to be inspected for
cleanliness and sanitary conditions before product is loaded for
delivery.
Inspection records of cleaning and sanitation requirements need to
be maintained.

(C) Delivery
Precautions need to be taken to ensure no damage, deterioration, or
contamination would occur to products during transportation.
During transportation temperature requirements of particular
products need to be taken into consideration.

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2.3.7 Customer complaints, traceability and recall

Area covered

This prerequisite program addresses the activities

directed at,

 Handling customer complaints

 The procedures to be followed for
conducting a recall of a food that has
reached the marketplace
 Identifying and tracing all raw materials,
ingredients, and products

Importance

Analysis and reviewing of customer complaints related

to defective products ensures the identification of trends
or indication of a need for a product recall or of any
specific problem requiring attention. Inevitably rejection
of product will be necessary from time to time to protect
the public, to comply with appropriate legislative or local
authority requirements, to protect the company or brand
name and to secure the cost recovery. The accurate
recorded identification of the usage and movement of
raw materials, ingredients, and products, including
recycled or reworked products, at all stages of
processing, handling, storage, and distribution of a food,
are essential the trace the correct lots that have been
affected.

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 GMP AND HACCP

Handling of customer complaints

Ensure the company has a written procedure to handle customer

complaints. This procedure should include receiving of complaints,
recording, investigation and management involvement to implement
corrective actions to prevent its recurrence and responsibilities need
to be clearly documented.

Identification

All raw materials and ingredients used for the production and
products at any stage, including intermediate, semi-finished, pre-
finished, finished, recycled, reworked, pre-packaged, and packaged
should be identified and the identification need to be recorded.
The identification should include the item number, possibly the
customers and the manufacturers, a description of the product, an
ingredient statement, analytical parameters, packaging and
palletizing requirements, shipping, storage, and shelf life information.

Traceability

A procedure need to be developed to enable the identification of

processing history of products produced from the plant at any stage
to get details of raw materials, ingredients, processing aids,
packaging materials, and the processing and storage equipment
used for the production of a particular food.

Recall procedure

Ensure the company has a written product recall procedure in

operation. The recall procedure needs to provide the precise method
of notifying all distribution networks and retailers involved, including
contact names and telephone numbers. The procedure needs to
specify halting the transit of products at any stage in the distribution
chain.
All recalled material at whatever stage of the distribution chain,
should be quarantined, clearly labeled and held pending decision is
made as to its destiny.

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2.3.8 Raw material control and control of

manufacturing

Area covered

This prerequisite program addresses the activities

directed at,

 Control of incoming raw materials and

other ingredients
 Control of food manufacturing operations
essential to produce a safe food

Importance

Proper functioning of controlled

purchasing ensures that
purchased are conforming to
specified requirements. All
reasonable precautions are
taken to ensure that production
procedures do not contribute
contamination from any source
by careful monitoring of
physical factors such as time,
temperature, humidity,
moisture, pH, pressure and
manufacturing operations such
as freezing, dehydration, heat
processing, acidification, and
refrigeration to ensure that
mechanical breakdowns, time
delays, temperature
fluctuations, and other factors
do not contribute to the
decomposition or
contamination of food.

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 GMP AND HACCP

Raw material control

(A) Incoming raw material and ingredient inspection

Raw materials and other ingredients should be inspected and
segregated or carryout necessary handling to ensure they are clean
and suitable for processing.
Adequate number of representative samples of raw materials should
be drawn to perform necessary assessments.
Containers and carriers of raw materials should also be inspected on
receipt to ensure that they do not contribute to contamination or
deterioration.

(B) Preparation
Raw material washing need to be performed where necessary to
remove pests, undesirable microorganisms, or extraneous material
using running water. Regular testing needs to be carried to ensure
sanitary quality of water used for these operations.

(C) Supplier control

Suppliers need to be communicated to inform material
specifications, quality requirements and other expected attributes.
Compliance with these requirements needs to be verified by
purchasing the materials with supplier's guarantee or certification.
Schemes to obtain supplier certification of raw materials need to be
established.

(D) Storage
Raw materials and ingredients should be stored under appropriate
temperature and relative humidity conditions to protect against
contamination and to minimize deterioration.

Control of manufacturing operations

(A) Control of contaminants

Filling, assembling, packaging, and other food operations should be
performed in a clean environment by providing physical protection
from contamination, using sanitary handling procedures and using
suitable packaging materials to avoid particularly airborne
contamination.
Manufacturing steps such as washing, peeling, trimming, cutting,
sorting, mashing, dewatering, cooling, shredding, extruding, drying,
whipping, defatting, and forming should be performed in a protective
environment provided with sanitized food contact surfaces, and by
using time and temperature controls at each manufacturing step.

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 GMP AND HACCP

Contamination of batters, breading, sauces, gravies, dressings, and

other similar preparations should be avoided by using ingredients
free of contamination, using adequate time and temperature controls
and providing adequate physical protection of components from
contaminants.
Effective measures should be taken to protect against the inclusion
of metal or other extraneous material in food by using sieves, traps,
magnets, electronic metal detectors, or other suitable effective
means.
Equipment, containers, and utensils used to convey, hold, or store
raw materials, work-in-process, rework, or food should be designed,
handled, and maintained in a manner that protects against
contamination.
Handling of finished food should be done separately to avoid mixing
of raw materials, other ingredients, or refuse that could result in
contaminated food.

(B) Temperature control

Food that supports the rapid growth of undesirable microorganisms
should be kept under appropriate temperature conditions such as
under refrigerated conditions, frozen state or heated to 60 °C or
above.

(C) Moisture control

Food such as dry mixes, nuts, intermediate moisture food, and
dehydrated food that requires control of moisture for preventing the
growth of undesirable microorganisms should be processed to and
maintained at a safe moisture level by use of a moisture barrier or by
other means.

(D) Control of pH
Food that required control of pH such as acid and acidified food for
preventing the growth of undesirable microorganisms need to be
monitored and maintained at a pH of 4.6 or below.

(E) Control of operation

Areas and equipment used for manufacturing human food should be
well separated from the manufacture of nonhuman food-grade
animal feed or inedible products.

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Chapter Two
Check list
This is a list to perform a self assessment of good practices in a food
manufacturing enterprise prepared based on areas covered by HACCP
prerequisite programs. You need to improve or take measures to correct the
situations for each question answered „No‟. You may mark N/A (not
applicable) in one of the columns, where the questions are not applicable to
your enterprise.

1 Premises and facilities

YES NO
1. The processing factory and the building premises are
located away from environmentally polluted areas.
2. The building perimeter is free of grass, lawns, hedges,
shrubs, or trees.
3. The surrounding premises are adequately sloped and
free of standing water.
4. Exterior walls are free of cracks and do not provide
breeding sites for pests.
5. There are no signs of tunneling or other rodent activity.
6. Scrap, pallets, or any equipment are not stored along
the building walls.
7. The surrounding area is clean and free of paper, trash,
and litter.
8. Areas for processing, packaging, raw materials storage
and finished product storage are clearly demarcated to
avoid cross-contamination.
9. Windows and doors that are required to keep open are
fitted with screens in good condition.
10. All doors are tight fitting to preclude pest entry.
11. The outside waste compactor is clean and properly
maintained.
12. Adequate exhaust fans are in place in the plant to
ensure adequate ventilation.
13. There is a system to control temperature, humidity,
smoke, aerosol, fumes and dust accumulation inside
the plant.

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 GMP AND HACCP

2 Personnel hygiene and practices

YES NO
14. All the personnel are examined for signs of infectious
diseases daily before start work.
15. All the personnel are provided with basic food safety
knowledge.
16. Restrooms are on a daily cleaning schedule.
17. There are signs in restrooms to remind people to wash
hands before returning to work.
18. There are adequate hand-washing/sanitizing stations
around the operation to ensure effective use.
19. Employees sanitize hands and/or gloves properly when
handling product directly.
20. Employees have uniforms that are clean, without
buttons on their shirts or items in shirt pockets.
21. Jewelry (earrings, watches, bracelets, necklaces, rings,
etc.) is not worn in production areas.
22. Effective hair and beard restraints are worn to prevent
contamination of the product.
23. If bandages are worn, they are blue in color or metal-
detectable and covered when possible.
24. Eating, drinking, smoking, etc., is limited to designated
areas away from production.

3 Sanitation
YES NO
25. Written cleaning and sanitizing procedures and
schedules are available for all the structures, facilities,
and equipment. Records are kept of all cleanings.
26. Sanitation inspections/Audits are done at least monthly
by the Quality Control Department.
27. Entry into the processing/packaging areas is controlled
and measures are taken to reduce the potential to
transfer microorganisms into the plant, utilizing
footbaths/hand sanitizing stations.
28. All sanitizers are approved to use in food plants.
29. Floor/wall junctions in production areas are sealed and
designed ensuring easy cleaning.
30. All walkways over product lines or stored product are
clearly demarcated and have solid bases.

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 GMP AND HACCP

31. Waste containers are maintained and emptied

regularly.
32. Overhead lines, ceilings, and walls are cleaned
regularly to remove dust, cobwebs, food, and debris.
33. All walls are smooth and easily cleanable, free of
cracks and holes.
34. All electrical boxes are mounted flush to the wall,
maintained in good repair, and free of rust and flaking
paint.
35. All ceilings are constructed of a smooth and easily
cleanable material.
36. Insulation line material is in good repair. No string,
rope, wire, or tape is used as pipe or support.
37. Floors are well drained, smooth, and clean with no
cracks.
38. All the machineries are placed allowing easy cleaning
and maintenance.
39. Equipment which has undergone repairs or
maintenance is cleaned and sanitized before using.
40. The water quality is regularly checked to confirm
microbial, chemical and physical specifications.
41. Adequate supply of potable running water is provided
for soaking, cleaning and rinsing.
42. Separate drainage and sewage lines are placed with
appropriate slopes.
43. Drains permit access to regular cleaning and
monitoring
44. Drainage entry and exit points into the building are pest
proofed.

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 GMP AND HACCP

4 Pest control
YES NO
45. There is a program in place for controlling and
monitoring pests.
46. Pest control stations are examined regularly by
designated personnel.
47. Insectocutors have catch pans which are emptied
regularly and bulbs are changed yearly.
48. Pest control stations are placed around all doors.
49. A site map is maintained indicating the location of all
pest control locations.
50. All pesticides are kept under lock and key.
51. Records of all pesticide applications and pest
inspections are kept on file.

5 Equipment conditions
YES NO
52. Lighting has covers to prevent bulbs from breaking on
raw materials and into the product.
53. There is adequate lighting in the plant to perform
scheduled tasks.
54. All equipment which comes in direct contact with the
product is made of smooth and non-corrosive material.
55. All equipment is constructed for easy cleaning.
56. Brooms, squeegees, and mops have hangers and are
kept off the floor.
57. Idle and obsolete equipment is removed from the
processing area.

6 Supplier quality management

YES NO
58. An approved supplier list is used and supplier audits
are maintained.
59. Suppliers are communicated to provide information on
required quality specifications.

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7 Raw materials
YES NO
60. All raw materials are checked upon receipt to ensure
that they comply with specifications and required
safety.
61. All raw materials are segregated and are dated upon
receipt.
62. All ingredients are tracked through production by
recording lot numbers.
63. There is a program to ensure damaged raw materials
are properly handled upon receipt.
64. All bagged ingredients are cleaned and/or outer layers
stripped before using.
65. All raw materials that are identified not to be in
specification are properly quarantined.

8 Process controls
YES NO
66. Appropriate line covers are provided to protect the
product from contamination.
67. Current and accurate formulas, together with
processing parameters (mix times, temperatures, etc.)
are documented and maintained.
68. All rework can be traced and identified.
69. All meters and scales are routinely calibrated with the
weights or measuring equipment of known accuracy.
70. All thermometers and temperature recording devices
are calibrated with a thermometer of known accuracy.
71. Records of these calibrations are maintained on file for
review.
72. Plant has an effective program to identify, monitor, and
control potential product/ingredient quality deviations
during processing.
73. Plant takes samples throughout processing in sufficient
quantities and frequency to effectively monitor and
control all in-process specifications.
74. All food containers are kept off the floor.

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9 Quality assurance
YES NO
75. Training of employees is carried out based on
requirement analysis and records are maintained.
76. Procedures exist to identify and trace material and then
how to dispose them. This consists of quarantine,
corrective action, and record retention.
77. There is a written recall program that is up to date and
is tested at least annually for finished goods and raw
material.
78. There is complete lot traceability.
79. There is a plan in place for customer complaint follow-
up.

10 Security
YES NO
80. The points of entry locations are limited, secured, and
locked after normal business hours and on weekends.
81. Water reservoirs, storage tanks, and unloading lines
are secured, capped, and locked.
82. The facility has visitor procedures that include badges
and escorts.
83. All boxes, cases, drums, and bulk tanks kept closed,
tied, or sealed and have tamper-evident closures.

11 Storage, delivery and shipping areas

YES NO
84. All stock is stored at least four inches off the floor (six
inches if on racks).
85. All stock is stored in a clean and dry environment.
86. All coolers and freezers have recording thermometers
with a program for monitoring.
87. Finished products, raw materials, and quarantined
damaged goods are stored separately.

33
 GMP AND HACCP

88. All stock is stored in an orderly manner and properly

stacked to prevent damage.
89. All pallets, racks, and shelving are clean, in good repair,
located 18″ away from the wall.
90. All damaged finished products are disposed in a timely
manner.
91. All stock is rotated on a first in first out basis.
92. Finished product, packaging material, equipment, or
ingredients are not stored in close proximity to any
chemical, cleaning compounds, pesticides, or odorous
material.
93. All carriers are inspected before loading for cleanliness
and odor. This is documented.

12 Finished products
YES NO
94. Finished products are checked according to the defined
procedures.
95. Plant maintains a statistically sound sampling program,
which ensures that all finished products either meet or
exceed specifications.
96. All finished products are properly coded. This code is
complete and legible.
97. All finished products are coded on the outside of the
container.

13 Warehousing and distribution

YES NO

98. Warehouses that are used to store product are well

separated from the production line.
99. An outside inspection service conducts periodic
product safety/ sanitation audits of those facilities.
100. Product transportation vehicles are inspected for
cleanliness and sanitary conditions before product is
loaded for delivery.

34
 GMP AND HACCP

Chapter Three
HACCP System
This chapter overviews principles and practices of hazard analysis critical
control point (HACCP) system. HACCP is an industry-wide effort approved
by the scientific, as well as by the regulatory and industry communities,
designed to focus on food safety and is being successfully applied in food
processing plants, retail food stores, and food service operations around the
world. HACCP prerequisite programs discussed in chapter 1 are essential
for the development and implementation of successful HACCP programs.
These prerequisite programs provide the environment and conditions
necessary for the production of safe, wholesome food. The existence and
effectiveness of these prerequisites should be assessed during the design
and implementation of an HACCP program using a checklist containing
complete set of requirements. Following enforcement of these practices,
development of effective HACCP programs should be appropriately
implemented in each manufacturing stage of the food industry under
consideration. Following key points overview the HACCP system.

Key points

 HACCP is an acronym for the Hazard Analysis and Critical Control Point
system.
 It is a product safety management system that identifies and monitors
specific foodborne hazards (biological, chemical or physical) that can
adversely affect the safety of the food product.
 Hazard analysis serves as the basis for establishing critical control points
(CCPs) or steps in the process that must be controlled to ensure the safety
of the food.
 HACCP programs involve primarily the application of good common sense
and preventive considerations to address situations before they become
problems.
 HACCP practice is recognized internationally as the most effective way to
produce safe food through a logical and common sense approach to
control food.
 The application of HACCP is possible throughout the food supply chain
from primary production (farmers, growers) to the consumer.
 The major thrusts of HACCP are to determine how and where food safety
hazards may exist and how to prevent their occurrence that helps to
demonstrate due diligence.

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 GMP AND HACCP

1. The Seven HACCP Principles

The HACCP system consists of seven principles which outline how to
establish, implement and maintain a HACCP plan for a particular food
processing operation (Figure 3). The HACCP plan systematically and
comprehensively addresses the activities required in producing safe foods
free from microbiological, chemical, physical, and allergenic contaminants
identifying potential critical control points (CCPs) in the process and
appropriate controlling measures. Generally, the HACCP system of a
company comprises with different HACCP plans for different products
produced using different raw materials and ingredients, different processes
and process parameters, and different processing equipment. However, a
single HACCP plan can be practiced when a company produces only a
single product or family of products with great similarities to the above
considerations.
2. Determine CCPs
1. Analyze hazard
Deciding which of
Looking at how the
these controls are
product is made
absolutely critical to
identifying possible
food safety
hazards posed to the
safety of food

SAFE 3. Establish limits

7. Establish a recordkeeping for CCPs
procedure FOOD
Setting limits for
Documenting the safety operation of
requirements and recording the critical controls
all findings as the products
are produced

4. Establish a system
6. Establish verification to monitor control
procedures of CCPs
Ensure that the HACCP Assuring that the food
system functioning 5. Establish corrective meets limits set for
properly action procedures CCPs
Identifying the likely
corrective action to be
taken when a particular
CCP is not under control

Figure 3. Seven principles that are used for the development of an HACCP
plan

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 GMP AND HACCP

2. Structure of the HACCP System

The structure of HACCP system includes implementation of pre-planned
prerequisite programs, preparation and planning procedure for a HACCP
study to identify the gaps, all HACCP principles to develop HACCP plan(s)
and routine evaluation of HACCP plan(s) by recordkeeping and monitoring
procedures (Figure 4).

Preparation and
planning

HACCP
awareness and
understanding the
concept
Principle 7: Establish
recordkeeping
Principle 1: Analyze hazards and documentation
GMPs and Identification and
training of the Principle 2: Determine CCPs procedures
HACCP
HACCP team
prerequisites Principle 3: Establish limits
for CCPs
Baseline audit of Principle 4: Establish a Process flow charts
support systems system to monitor
and gap analysis control of CCPs Hazard analysis charts
HACCP control charts
Principle 5: Establish HACCP PLAN
corrective action HACCP team list
Planning for the
HACCP procedures Product descriptions
study project

Principle 6: Establish
verification Monitoring records
procedures to confirm HACCP CCP record reviews
RECORDS
that the HACCP system Audit
To control is working effectively Training
food safety
requirements
at the To control production process related hazards
establishment

Figure 4. The complete structure of the HACCP system

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 GMP AND HACCP

3. Establishment of the HACCP System

A model consisting of a sequence of twelve steps for developing and
implementing a HACCP plan for a particular food product has been
developed by the Codex Alimentarius and this logic sequence clearly
specifies the necessary tasks need to be accomplished for a successful
application of the HACCP system in a food processing establishment.
These steps include five preparatory steps that provide guidance and which
are also considered necessary preliminary steps, followed by seven steps
that address the seven principles of HACCP. The twelve steps in the
process are as follows:

Codex Alimentarius Logic Sequence

Step 1. Assemble the HACCP team

Step 2. Describe food product
Step 3. Identify the intended use of the food product
Step 4. Construct a flow diagram of the process
Step 5. On-site verification of the process flow diagram
Step 6. Analyze hazard (HACCP principle 1)
Step 7. Determine CCPs (HACCP principle 2)
Step 8. Establish limits for CCPs (HACCP principle 3)
Step 9. Establish a system to monitor control of CCPs (HACCP
principle 4)
Step 10. Establish corrective action procedures (HACCP principle 5)
Step 11. Establish verification procedures (HACCP principle 6)
Step 12. Establish a recordkeeping procedure (HACCP principle 7)

38
 GMP AND HACCP

Step 1: Assemble the HACCP team

The HACCP team is a group of a food company‟s employees who should

be assembled and given the responsibility to develop and implement an
HACCP system. The HACCP team need be composed of individuals with
specific knowledge of the product characteristics and expertise appropriate
to its manufacturing process, and its variability, including individuals from
relevant areas such as engineering, production, sanitation, quality
assurance, analytical/food microbiology, and personnel involved in the
manufacturing operation itself.

Practical advice

 It is important to select team members who are fully

committed to develop and maintain an effective HACCP
system in the organization.

 The company’s senior management must demonstrate

its commitment to the development, implementation,
and maintenance of the HACCP system.

 Number of people in the team will be dependent upon

the type of operation and number of controls which
need to be monitored.

 Due to the technical nature of the information required

for hazard analysis, it may also be necessary that
outside experts are consulted to verify the
completeness of the hazard analysis and the HACCP
program.

Step 2: Describe the product

The HACCP team must be able to describe the important characteristics

relating to the safety of the food product. This information will be used by
the team in the identification and analysis of all hazards. This description
includes a general characterization of the product, its ingredients, and the
processing and manufacturing methods. The method of the product
distribution should also be described, along with information on whether the

39
 GMP AND HACCP

food is to be distributed frozen, refrigerated, or at ambient temperature, as

well as the storage requirements.

Information need to be collected to provide a complete description

 General characteristics (Eg. name of the product, the composition of
the product, volume, structure etc.)
 Process technologies (Eg. heating, cooling, freezing, fermentation,
irradiation)
 Physical or chemical properties (Eg. pH, preservatives, presence of
allergenic ingredients)
 The packaging information of the product including the package unit
(Eg. can, bag, case), the packaging material (Eg. foil, plastic, paper),
and packaging conditions (Eg. modified atmosphere packaging)
 The shelf-life of the product
 Conditions required for a proper storage (Eg. refrigerated, frozen)
and humidity conditions
 The labeling instructions that provide information to the consumer on
handling, storage (Eg. refrigerated, frozen) and use (Eg. cooking
time and temperature) of the product
 Any special conditions required for the distribution of the product
(Eg. refrigeration or freezing during shipping)

Step 3: Identify the intended use of the food product

In this step it needs to establish where and by whom the product will be
used. The HACCP team needs to identify and describe the normal or
expected use of the food product and intended target groups of consumers.

Practical advice

 Certain vulnerable groups of the population who are at

higher risk to certain hazards (Eg. elderly persons,
pregnant women, infants) need to be clearly
determined.

40
 GMP AND HACCP

Step 4: Construct a flow diagram of the process

The process flow diagram is a simple but logical stepwise sequence of

events through the whole process, giving a clear and simple description of
how the end product is made. The process flow diagram is extremely useful
for conducting the hazard analysis and for the critical control point
determination.
Information need to be included in constructing the process flow diagram
 Receiving of raw materials and ingredients
 Handling, sorting, preparation and storage of raw materials and
ingredients
 Processing treatments
 Temperature and time profiles
 Details of any product reworking or recycling loops
 Transfers within and between production areas
 Packaging, labeling, storage and shipping

Raw material Raw material

procurement preparation

Bowl chopping

Vacuum filling

Cooking

Smoking

Peeling

Packaging & Frozen

labeling delivery

Frozen storage

Figure 5. A flow diagram for the manufacture of sausages

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 GMP AND HACCP

Step 5: On-site verification of the process flow diagram

Once the previous tasks have been completed, the HACCP team with
assistance from personnel who actually operate the process should perform
an on-site review of the manufacturing operation to verify the flow diagram
accurately represents the actual activities and operations used to prepare
the product.

Practical advice

 This can be performed by observing each step of the

process, from receiving of raw materials to shipping
of finished product.

 The omission of a processing step means that the

step is not subjected to the required scientific
analysis for biological, chemical, and physical
hazards. Therefore, if a necessary step for
preparation of the product is not in place, it is
necessary to include this step into the process to
ensure the successful development of the HACCP
plan.

Step 6: Analyze hazard (HACCP principle 1)

Hazard is a biological, chemical, or physical property which may cause a

food to be unsafe for human consumption. Hazard analysis is the process
where the team members systematically analyze each raw material and
step of the process and identify and analyze all potential hazards and their
control measures. Control measures are specific for each hazard and
following are some examples.

Control measures for biological hazards

Testing for presence of pathogens
Use of preservatives: prevent pathogens
Sterilization: eliminate pathogens
Low temperature storage: prevent pathogens

Control measures for chemical hazards

Testing for presence of known pesticides, allergens, toxicants
Separate storage for cleaning chemicals: prevent contamination
Labeling of chemicals: avoid contamination

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 GMP AND HACCP

Control measures for physical hazards

Use of detection methods: metal detectors, X-ray detectors,
scanning, visual observation
Use of removal methods: filters, sieves

Practical advice
 When conducting a hazard analysis, safety concerns
must be clearly differentiated from quality concerns.

 The hazard analysis is carried out in two stages; hazard

identification (identification of known potential
hazards that are likely to be present in food) and
hazard evaluation (determine which of the hazards
identified are significant, and their control measures
be addressed in the HACCP plan).

 Assessment of the likelihood of occurrence and

severity of hazards is an essential part of hazard
analysis and it should employ all sources of
information available.

 In assessing the likely occurrence of a hazard, the

HACCP team needs to examine published information
and data, and previous experiences on occurrence of
the hazard in the product.

 In assessing the severity of the risk presented by a

hazard, the HACCP team must address the severity of
health consequences to consumers of the product, if
the identified hazard is not controlled.

 If hazards can be controlled by prerequisite programs

these will not be subjected to HACCP control.

Step 7: Determine CCPs (HACCP principle 2)

A CCP is defined as a point, step, or procedure in a food manufacturing

process at which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce it to an acceptable level.

43
 GMP AND HACCP

Examples of CCPs include

 Raw materials receiving, testing ingredients for chemical residues or
other contaminants/adulterants, mixing ingredients, other food
handling operations
 Batching, thawing, product formulation (ingredient weight/volume,
pH, homogenicity), thermal processing, reprocessing, hot-holding
steps, cooling, metal detection
 Refrigeration, refrigerated-storage, packaging, handling of
refrigerated foods and ingredients

General procedure for determining CCPs is use of decision tree which

consist of three or four questions, asked in a logical sequence for each
identified hazard (Figure 6) so that the point of control of that hazard within
the HACCP plan can be determined. Depending on the answer to the first
question („Yes‟ or „No”) the path will be determined for the next question
until identifying it as a CCP or not.

Modify steps in
the product or Start
process

Y
Q1a. Do preventive
Q1b. Is control at this N control measures
step necessary Q1b Q1a exist ?
for safety ?

N Y

Q2. Is this step specifically

designed to eliminate or
Y
Q3. Could contamination with Q2 reduce the hazard to an
the identified hazard(s) at acceptable level ?
this step, occur in excess
of acceptable level(s) or N
could these hazards
increase to unacceptable
level(s) ? N
Q3
CCP
Stop Y
(not a CCP)

Q4. Will a subsequent step

Y : Yes eliminate the identified
Q4 hazard(s) or reduce the
N : No Y N key occurrence to
acceptable level(s) ?
Figure 6. An example of a decision tree for process steps (adapted from
Codex Alimentarius, 1997b)

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 GMP AND HACCP

Step 8: Establish limits for CCPs (HACCP principle 3)

A critical limit is defined as a maximum and/or minimum value to which a

biological, chemical, or physical parameter must be controlled at a CCP to
prevent, eliminate, or reduce to an acceptable level, the occurrence of a
food safety hazard. A critical limit is used to distinguish between safe and
unsafe operating conditions at a CCP. If the critical limits at a CCP are not
respected, the product obtained at the CCP will not be acceptable.

Practical advice

 Critical limits and criteria for food safety may be

derived from sources such as regulatory standards and
guidelines, literature surveys, experimental results,
and expert recommendations.

 They are measurable parameters that can be

determined and monitored through testing and
observation.

 Operational limits are often set at more stringent levels

to provide a buffer or action zone for process
management.

Step 9: Establish a system to monitor control of CCPs

(HACCP principle 4)

The HACCP team needs to establish the monitoring procedures which will
be a planned sequence of observations or measurements of control
parameters to assess whether a CCP is under control. Successful
establishment of the monitor control system provides an early warning that
the process is loosing control and pinpoints the cause of problem.

Few examples of monitoring procedures

 Raw materials sampling and inspection
 Checking and documenting process control specifications
(time/temperature)
 Checking and inspection of dry storage room temperature and
humidity
 Checking the cold room storage temperature
 Checking the amounts of additives/ingredients used for each
batch/lot and documenting

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 GMP AND HACCP

Practical advice

 Continuous monitoring requires carefully calibrated

equipment to ensure the accuracy.

 The monitoring procedures must be specific and

designed to monitor each CCP identified.

 It is necessary to establish a reliable monitoring

frequency and procedure to indicate that the CCP is
under control.

 All personnel responsible for monitoring must be

trained and have a clear understanding of their role.

Step 10: Establish corrective action procedures

(HACCP principle 5)

This HACCP principle recognizes that in spite of the fact that a CCP is
operating in a process, it is possible that there could be loss of control at the
CCP and this loss of control will be detected during the monitoring
procedure. Accordingly, corrective actions are defined as actions to be
taken when the results of monitoring at the CCPs indicate a loss of control.

Few examples of corrective actions

 Rejection of raw materials and ingredients that do not meet
specifications
 Adjusting a cooler‟s thermostat to obtain the proper temperature
 Extending cooking time
 Reprocessing or reheating a product to the proper temperature
 Modifying food-handling procedures
 Rejecting a batch

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 GMP AND HACCP

Practical advice

 To address a problem correctly, the manufacturer needs

to identify the hazards and their causes.

 Long-term corrections are valuable because they address

the underlying cause and are expected to solve a problem
permanently.

 Corrective actions must be documented and recorded to

assist in the identification of problems and to determine
if the HACCP plan requires modification.

Step 11: Establish verification procedures (HACCP principle 6)

Since the HACCP plan is not intended to be static once developed and
implemented, it must be reviewed periodically to ensure that it remains
current and effective. The verification of the initial HACCP plan involves
validation to ensure that the critical limits, the monitoring procedures and
the corrective action established at each CCP are indeed capable of
controlling CCPs effectively.

Few examples of verification activities for CCPs

CCP Verification activities

Pasteurization Review of pasteurization records,
microbiological testing of product periodically

Acidification Review of pH measurement records,

microbiological testing of product periodically
to ensure the required pH is maintained

Receiving of raw material Review of certificates of analysis provided by

suppliers, periodic sampling and testing of raw
material to ensure raw material meet
specifications

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 GMP AND HACCP

Practical advice

 Verification is carried out through auditing, product

testing and reviewing records, procedures and
practices where necessary.

 It is possible to involve individuals within a company,

third-party experts, and regulatory agencies to carry
out verification activities.

 It is important that individuals doing verification have

appropriate technical expertise and knowledge to
perform this function and establish the effectiveness of
the plan in protecting the product.

 Each individual control point is evaluated to ensure

that it is operating and that the limits for its operation
are correct.

Step 12: Establish a recordkeeping procedure

(HACCP principle 7)

There should be a proper documentation and record keeping practice

providing factual evidence that an activities specified in the HACCP plan
have been performed in a timely manner in accordance with established
procedures. This procedure needs to cover all documents and records
come under each HACCP principle and helps in analyzing trends, to
improve the system.

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 GMP AND HACCP

Practical advice

 Each record should be identified by a unique reference

number to track information.

 Records must be kept for a length of time defined by

legislation and the shelf-life of the product.

 Records should be available to each food processing

plant manager, who should be familiar with their
content.

 Records should cover

HACCP plan (process flow diagrams, HACCP control
chart, HACCP team details)
CCP monitoring records
Hold/trace/recall records
Training records
Audit records
Customer complain records
Calibration records

Examples of records required during operation of the HACCP

program

(1) Ingredients
Supplier certification documenting compliance of an ingredient with
the manufacturer‟s specifications and critical limits
The manufacturing plant audit records verifying supplier compliance
Storage temperature record for temperature-sensitive ingredients,
when ingredient storage is a CCP
Storage time records of limited shelf-life ingredients, when ingredient
storage is a CCP

(2) Preparation
Records from all monitored CCPs
Records verifying the continued adequacy of the food preparation
procedures

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 GMP AND HACCP

(3) Packaging
Records indicating compliance with specifications of packaging
materials
Records indicating compliance with sealing specifications

(4) Finished products

Sufficient data and records to establish the efficacy of barriers in
maintaining product safety
Sufficient data and records establishing the safe shelf life of the
product if age of product can affect safety
Documentation of the adequacy of the HACCP procedures from an
authority knowledgeable of the hazards involved and necessary
controls

(5) Storage and distribution

Storage temperature records
Refrigerated shipment records
Records showing no product shipped after shelf-life date

(6) Deviation and corrective action

Validation records and modification to the HACCP program
indicating approved revisions and changes in ingredients,
formulations, preparation, packaging, and distribution control, as
needed

(7) Employee training

Records of employee training programs
Records indicating that food employees responsible for
implementation of the HACCP program understand the hazards,
controls, and procedures

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 GMP AND HACCP

4. HACCP Plan Summary

Table 1. A format for an HACCP plan summary provided with an example

Process Hazard Type Critical Monitoring

CCP*
Step (M/C/P) Limit
What & How Frequency
Raw material Microbial: Supplier pre- Supplier meets Approve supplier Before season
receiving Pathogens certification requirements for
(fresh salad from field sanitation, Examine Each lot
leaves in field water & potable water, and incoming lot for,
pouches) workers employee hygiene - Proper tag
- Approved
Supplier monitors supplier
with microbiology - No damage
test program to
verify compliance

continued …

Corrective Actions Records & Verification Persons

Persons
& Person(s) Person(s) Procedure Responsible for
Responsible
Responsible Responsible and Frequency Verification
QA manager Discontinue Daily incoming Compare records for HACCP team
supply or reject inspection compliance to HACCP (Internal HACCP
Receiving lot(s) records plan. verification)
warehouse
person QA supervisor QA supervisor Use company HACCP HACCP
verification procedure team from
another
Audit every two weeks food processing
plant or a
consultant

Note:
* A selected CCP from an HACCP plan tabulated for a refrigerated fresh
vegetable salad

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 GMP AND HACCP

Appendices
Appendix 1

Recommended international code of hygienic practice for

desiccated coconut – Specific requirements other than the
practices discussed in chapter 1.

Adapted from Codex Alimentarius Commission -To obtain complete list of

requirements refer to CAC/RCP 4-1971

Definitions
Coconut meat - white solid layer of the kernel.
Dehusking - the removal of the husk, leaving the shell intact.
Hatcheting - the removal of the shell.
Paring - the removal of the brown skin around the kernel.

(1) Protection of product from contamination

After harvesting, clean and sanitary methods should be observed to
protect against contamination of the nuts during the process of
ripening and dehusking. Following dehusking, special precautions
are necessary to ensure that contamination does not occur.

(2) Handling procedures

All handling procedures should be such as will prevent the product
from being contaminated. Extreme care should be taken in
transporting dehusked coconuts to prevent spoilage or deterioration.

(3 ) Location, size and sanitary design

Special precautions should be taken in the shredding, desiccating,
and packing sections to protect against the entry of birds, insects
and vermin and for this purpose all openings should be covered with
perforated metal gauze or other suitable protective covering.

Separate and adequate space should be provided for the storage of

nuts awaiting manufacture, shell awaiting disposal, rejected nuts,
firewood, etc.

Floors should be constructed of material which is not capable of

supporting microbial growth, and should be hard surfaced. They
should be designed and so drained as to facilitate effective cleaning.

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 GMP AND HACCP

(4) Sanitary facilities and controls

(a) Separation of processes

The husk, if it is not removed in the growing area, should be
removed in a place separate from the factory. Dehusked nuts should
be received into the factory buildings, and the processes of
hatcheting, paring, and washing of the coconut meat should be
carried out in a separate section from the subsequent processes.
There should be no direct access from the hatcheting, paring, and
washing sections to the other sections.
The sections should be so arranged that the coconut passes from
the hatcheting, paring, and washing sections through to the packing
room without retracing its path or passing through an area used for
ancillary activities. Precautions should be taken to prevent
contamination of shredding, desiccating, and packing sections of the
factory with dust.
Separate rooms or compartments should be provided for the storage
of inedible materials such as fuel and lubricants. The food handling
area should be completely separated from any of the premises used
as living quarters.

(b) Water supply

No husk pit for the retting of husks should be located within 100
meters (300 feet) of any well from which water is drawn for use in
the factory.

(c) Lighting and ventilation.

Premises should be well lit and ventilated. Special attention should
be given to the venting of areas and equipment producing excessive
heat, steam, obnoxious fumes or vapors, or contaminating aerosols.
Good ventilation is important to prevent both condensation (which
may drip into the product) and mould growth in overhead structures
– which growth may fall into the food.

(5) Materials
All food contact surfaces should be smooth; free from pits, crevices
and loose scale; nontoxic; unaffected by coconut meat and milk

(6) Equipment and utensils

Equipment and utensils used for inedible or contaminating materials
should be so identified and should be used only for handling such
products. Suitable containers should be provided for the collection of
coconut shell and parings, and for rejected kernels.
Desiccators used for the coconut meat must not under any
circumstances be used for the drying of coconut parings.

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 GMP AND HACCP

(7) Sanitary maintenance of plant, facilities and premises

All equipment in the shredding, desiccating, and packing sections
coming into direct contact with the coconut should be cleaned,
washed, and disinfected after each period of work and at least twice
daily by means approved by the official agency.

(8) Vermin control

Effective measures should be taken to protect against the entrance
of insects, rodents, birds or other vermin into the plant, and
especially into the shredding, desiccating, packing and storage
sections, and against the harborage of these pests on the premises.

(9) Raw material handling

(a) Acceptance criteria

The raw material should not be accepted by the plant if known to
contain decomposed, toxic or extraneous substances which will not
be removed to acceptable levels by normal plant procedures of
sorting or preparation.

(b) Storage
Coconuts stored on the plant premises should be maintained under
conditions that will protect against contamination and infestation and
minimize deterioration.

(10) Inspection and sorting

At the paring and washing stage, all kernels should be inspected
and any unfit, including germinated kernels, rejected. Such
operations should be carried out in a clean and sanitary manner.
Only clean, sound coconut meat should be permitted for further
processing.

(11) Washing
Water used for washing the kernels should be clean and of potable
quality. It should be so frequently changed that the possibility of
contamination is kept to a minimum and the water should not be
recirculated unless suitably treated, for example by filtration and
chlorination, to maintain it in a condition as will not constitute a
public health hazard.

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(12) Preparation and processing

(a) Preparatory operations

Preparatory operations leading to the finished product and the
packaging operations should be so timed as to permit expeditious
handling of consecutive units in production under conditions which
would prevent contamination, deterioration, spoilage, or the
development of infectious or toxigenic microorganisms.

(b) Processing
After washing and before shredding, the coconut meat should be
subjected to an effective process to eliminate pathogenic organisms
from the surface of the meat, such as immersion in an adequate
quantity of boiling water for a period of not less than one and a half
minutes.

(c) Handling
After this process, the coconut meat should not be manually handled
in any way, but mechanical devices, or containers and scoops or
rakes or other implements constructed of impervious materials,
should be used to prevent contamination. Such implements should
be cleaned, washed, and disinfected after each period of work and
at least twice daily.

(d) Desiccating
Shredded coconut should be dried in a current of clean hot air free
from chemical contamination until the moisture content reaches a
safe level for storage. There should be thin layering of shredded
coconut on the desiccator trays, and effective methods for the
breaking up of the mat should be used. After drying, the desiccated
coconut should be cooled before packaging.

(e) Bulk Storage

If desiccated coconut is not packed at the factory into the containers
in which it will be shipped, it should be transported to the packing
plant in non-absorbent containers capable of being cleaned and
which are disinfected before filling at the factory. The same hygienic
precautions should be taken in the packing plant as are appropriate
to the packing section of the factory.

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(13) Packaging of finished product

(a) Materials
The packaging material should be approved by the official agency
and, for example, may comprise multi-wall paper sacks with
appropriate fat- and moisture-resistant layers of aluminum lined
cases.

(b) Techniques
Packaging should be done in a separate clean room. Precautions
such as the use of magnets or metal detectors should be taken to
eliminate any metallic contamination. Packaging should be done
under conditions that preclude the introduction of contamination into
the product, and mechanical rams or vibrators should be used so as
to eliminate manual handling of the desiccated coconut.

(14) Laboratory control procedures

Regular and frequent samples of desiccated coconut should be
taken from the packing section and examined for,

Contamination with any objectionable matter

Microorganisms
Fat content and free fatty acids
Moisture content

(15) End-product specifications

Appropriate methods should be used for sampling, analysis, and
determination to meet the following specifications.

To the extent possible in good manufacturing practice the product

should be free from objectionable matter.
The product should not contain pathogenic microorganisms such as
salmonellae or any toxic substance originating from microorganisms.
The product should be such that the acidity of the oil extracted by
the solvent process should not exceed 0.3% m/m of free fatty acids
calculated as Lauric acid.
The moisture content of the product should not exceed 3% m/m.

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Appendix 2

Recommended international code of hygienic practice for

spices and dried aromatic plants – Specific requirements other
than the practices discussed in chapter 1.

Adapted from Codex Alimentarius Commission -To obtain complete list of

requirements refer to CAC/RCP 42 – 1995

Definitions
Spice Blends -Spice blends are obtained by mixing and grinding, cleaned,
dried and sound selected spices.

(1) Drying (Curing)

Plants or parts of plants used for the preparation of spices may be
dried naturally or artificially, provided adequate measures are taken
to prevent contamination or alteration of the raw material during the
process. To prevent the growth of microorganisms, especially
mycotoxin producing mould, a safe moisture level should be
achieved.
If dried naturally, plants or part of plants should not be in direct
contact with the soil. They should be placed on raised platforms or
on a floor made of a suitable material.
New concrete floors should be used for drying only when it is
absolutely certain that the new concrete is well-cured and free of
excess water. It is safer to use an approved plastic cover spread
over the entire new concrete floor as a moisture barrier prior to use
for spices.
Excessive heating/drying of material should be avoided in order to
retain its aromatic principles. Suitable precautions should be taken
to protect the spices from contamination by domestic animals,
rodents, birds, mites and other arthropods or other objectionable
substances during drying, handling and storage.

(2) Packaging
Packaging should protect the clean, dried spices from contamination
and the entry of water or excess moisture. In particular, the
reabsorption of ambient moisture in humid tropical climates should
be prevented. Contamination from mineral oils used for processing
natural fiber bags should be prevented by the use of liners where
appropriate. Reusable containers should be properly cleaned and
disinfested before reuse.

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(3) Raw material requirements

Spices should not be accepted by the plant if they are known to
contain parasites, microorganisms, decomposed, toxic, or
extraneous substances which will not be reduced to acceptable
levels by normal plant procedures, sorting or preparation. Particular
care should be taken to avoid contamination.
Plants, parts of plants or spices suspected of being contaminated
with animal or human fecal material should be rejected for human
consumption. Special precautions must be taken to reject spices
showing signs of insect damage or mould growth because of the
danger of their containing mycotoxins such as aflatoxins.

(4) Inspection and sorting

Raw materials should be inspected and sorted prior to processing
and where necessary, laboratory tests should be conducted. This
inspection may include,

Visual inspection for foreign matter

Organoleptic evaluation: odor, appearance, possibly taste
Testing for microbiological or mycotoxin contamination: systematic
monitoring for sensitive materials, periodic monitoring for less
sensitive materials.

(5) Storage
Raw materials stored in the plant premises should be maintained
under conditions that will protect them against contamination and
infestation and minimize deterioration. Spices not scheduled for
immediate use should be stored under conditions that prevent
infestation and mould growth.
Provision should be made in existing storage or at the design stage
in new storage for gas tightness to permit in situ fumigation of
spices.

(6) Storage of the end-product

Spices and their products should be stored at a moisture low enough
so that the product can be held under normal storage conditions
without development of mould or significant deterioration by
oxidative or enzymatic changes. An environment with a relative
humidity between 55 and 60 percent should be maintained to protect
quality and prevent mould growth. Where this is not practicable,
spices should be packed in waterproof and gas-proof containers and
stored in a proper warehouse.
Finished products may be packed in gas tight containers preferably
under inert gases like nitrogen, etc., or under vacuum in order to
protect quality and retard possible mould growth.

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All products should be stored in clean, dry buildings, protected from

insects, mites and other arthropods, rodents, birds, or other pests,
chemical or microbiological contaminants, debris and dust.

(7) Control of infestation by insects, mites and other

arthropods
Spices should be stored in such a manner that infestation can be
controlled by such methods as anaerobic or refrigerated storage or
fumigation prior to storage. Stored spices should be inspected
regularly and, if infested, fumigated by appropriate methods. If
necessary, affected spices may be removed for fumigation. In this
case, the storage areas should be cleaned and disinfected
separately.

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Appendix 3
Recommended international code of hygienic practice for
fresh fruits and vegetables – Specific requirements other than the
practices discussed in chapter 1.

Adapted from Codex Alimentarius Commission -To obtain complete list of

requirements refer to CAC/RCP 53 – 2003

Specific process steps

(1) Postharvest water use

Water quality management will vary throughout all operations. Packers
should follow GMPs to prevent or minimize the potential for the
introduction or spread of pathogens in processing water. The quality of
water used should be dependent on the stage of the operation. For
example, clean water could be used for initial washing stages, whereas
water used for final rinses should be of potable quality.

Post-harvest systems that use water should be designed in a

manner to minimize places where product lodges and dirt builds up.
Antimicrobial agents should only be used where absolutely
necessary to minimize cross-contamination during post-harvest and
where their use is in line with good hygienic practices. The levels of
antimicrobial agents should be monitored and controlled to ensure
that they are maintained at effective concentrations. Application of
antimicrobial agents, followed by a wash as necessary, should be
done to ensure that chemical residues do not exceed levels as
recommended by the Codex Alimentarius Commission.
Where appropriate, the temperature of the post-harvest water should
be controlled and monitored.
Recycled water should be treated and maintained in conditions that
do not constitute a risk to the safety of fresh fruits and vegetables.
The treatment process should be effectively monitored and
controlled.
Recycled water may be used with no further treatment provided its
use does not constitute a risk to the safety of fresh fruits and
vegetables (Eg. use of water recovered from the final wash for the
first wash).
Ice should be made from potable water. Ice should be produced,
handled and stored to protect it from contamination.

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(2) Chemical treatments

Packers should only use chemicals for post-harvest treatments (Eg.
waxes, fungicides) in accordance with the General Standards on
Food Additives or with the Codex Pesticide Guidelines. These
treatments should be carried out in accordance with the
manufacturer‟s instructions for the intended purpose.
Sprayers for post-harvest treatments should be calibrated regularly
to control the accuracy of the rate of application. They should be
thoroughly washed in safe areas when used with different chemicals
and on different fruits or vegetables to avoid contaminating the
produce.

(3) Cooling of fresh fruits and vegetables

Condensate and defrost water from evaporator type cooling systems
(Eg. vacuum cooling, cold rooms) should not drip onto fresh fruits
and vegetables. The inside of the cooling systems should be
maintained clean.
Potable water should be used in cooling systems where water or ice
is in direct contact with fresh fruits and vegetables (Eg. hydro
cooling, ice cooling). The water quality in these systems should be
controlled and maintained.
Forced-air cooling is the use of rapid movement of refrigerated air
over fresh fruits and vegetables in cold rooms. Air cooling systems
should be appropriately designed and maintained to avoid
contaminating fresh produce.

(4) Cold storage

When appropriate, fresh fruits and vegetables should be maintained
at low temperatures after cooling to minimize microbial growth. The
temperature of the cold storage should be controlled and monitored.
Condensate and defrost water from the cooling system in cold
storage areas should not drip on to fresh fruits and vegetables. The
inside of the cooling systems should be maintained in a clean and
sanitary condition.

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Appendix 4

Recommended international code of hygienic practice for

the prevention and reduction of mycotoxin contamination
in cereals – Specific requirements other than the practices
discussed in chapter 1.

Adapted from Codex Alimentarius Commission -To obtain complete list of

requirements refer to CAC/RCP 51-2003

Definitions
Mycotoxins –toxins produced by fungi

(1) Storage
Avoid piling or heaping wet, freshly harvested commodities for more
than a few hours prior to drying or threshing to lessen the risk of
fungal growth. Sun drying of some commodities in high humidity
may result in fungal infection. Aerate the commodities by forced air
circulation.
Make sure that the storage facilities include dry, well-vented
structures that provide protection from rain, drainage of ground
water, protection from entry of rodents and birds, and minimum
temperature fluctuations.
Crops to be stored should be dried to safe moisture levels and
cooled as quickly as possible after harvest. Minimize the amount of
foreign materials and damaged kernels in stored grains.
The mycotoxin level in in-bound and out-bound grain should be
monitored when warranted, using appropriate sampling and testing
programs.
For bagged commodities, ensure that bags are clean, dry and
stacked on pallets or incorporate a water impermeable layer
between the bags and the floor.
Where possible, aerate the grain by circulation of air through the
storage area to maintain proper and uniform temperature levels
throughout the storage area. Check moisture content and
temperature in the stored grain at regular intervals during the
storage period.
Measure the temperature of the stored grain at several fixed time
intervals during storage. A temperature rise of 2-3°C may indicate
microbial growth and/or insect infestation. Separate the apparently
infected portions of the grain and send samples for analysis. When
separated, lower the temperature in the remaining grain and aerate.
Avoid using infected grain for food or feed production.

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Use good housekeeping procedures to minimize the levels of insects

and fungi in storage facilities. This may include the use of suitable,
registered insecticides and fungicides or appropriate alternative
methods. Care should be taken to select only those chemicals that
will not interfere or cause harm based on the intended end use of
the grains and should be strictly limited.
The use of a suitable, approved preservative (Eg. organic acids such
as propionic acid) may be beneficial. These acids are effective in
killing various fungi and thus prevent the production of mycotoxins in
grains intended only for animal feed. The salts of the acids are
usually more effective for long-term storage. Care must be taken
because these compounds can negatively affect the taste and odor
of the grain.
Document the harvesting and storage procedures implemented each
season by making notes of measurements (Eg. temperature,
moisture, and humidity) and any deviation or changes from
traditional practices. This information may be very useful for
explaining the cause(s) of fungal growth and mycotoxin formation
during a particular crop year and help to avoid similar mistakes in
the future.

(2) Transport from storage

Transport containers should be dry and free of visible fungal growth,
insects and any contaminated material. As necessary, transport
containers should be cleaned and disinfected before use and re-use
and be suitable for the intended cargo. The use of registered
fumigants or insecticides may be useful. At unloading, the transport
container should be emptied of all cargo and cleaned as appropriate.
Shipments of grain should be protected from additional moisture by
using covered or airtight containers or tarpaulins. Avoid temperature
fluctuations and measures that may cause condensation to form on
the grain, which could lead to local moisture build-up and
consequent fungal growth and mycotoxin formation.
Avoid insect, bird and rodent infestation during transport by the use
of insect-and rodent proof containers or insect and rodent repellent
chemical treatments if they are approved for the intended end use of
the grain.

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References

Abington A. H., (2001). Auditing in the food industry, Woodhead Publishing

Limited, CRC Press, Taylor & Francis Group, London, UK

Alli I., (2004). Food quality assurance: Principles and practices, CRC Press,
Taylor & Francis Group, FL, USA

Clute M., (2009). Food industry quality control systems, CRC Press, Taylor
& Francis Group, FL, USA

Codex Alimentarius Commision, (1997a). Basic texts on food hygiene,

Codex Alimentarius Commission, Joint FAO/WHO Food Standards
Program, Rome

Codex Alimentarius Commission, (1997b). Recommended international

code of practice: General principles of food hygiene Joint FAO/WHO Food
Standards Programme, Rome, [online] available at
<www.codexalimentarius.net/>

Cormier R. J., Mallet M., Chiasson S., Magnússon H., and Valdimarsson G.,
(2007). Effectiveness and performance of HACCP-based programs, Food
Control, 18(6), 665-671

Cramer M. M., (2006). Food plant sanitation, CRC Press, FL, USA

Current good manufacturing practice in manufacturing, packing, or holding

human food: Codes of federal regulations, Title 21, Part 110, Office of the
Federal Register, National Archives and Records Administration.
Washington, D.C., [online] available at <www.access.gpo.gov/cgi-
bin/cfrassemble.cgi?title=200221>

Hazard analysis and critical control point systems: Code of federal

regulation, Title 21, Part 120, Office of the Federal Register, National
Archives and Records Administration, Washington, D.C., [online] available
at <www.access.gpo.gov/cgi-bin/ cfrassemble.cgi?title=200221>

Lelieveld H. L. M., Mostert M. A., and Holah J. (Eds.), (2005). Handbook of

hygiene control in the food industry, CRC Press Taylor & Francis Group, FL,
USA

Mortimore S. and Wallace C., (1994). HACCP: A practical approach,

Chapman & Hall, London, UK

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NACMCF, (1997). Hazard analysis and critical control point principles and
application guidelines, adopted in August 1997 by the National Advisory
Committee on Microbiological Criteria for Foods, Journal of Food Protection,
61(9), 1998, 1246–1259

Peter R., (2008). Total food chain safety: how good practices can
contribute?, Trends in Food Science & Technology, 19(8), 405-412

Sun Y. M., and Ockerman H. W., (2005). A review of the needs and current
applications of hazard analysis and critical control point (HACCP) system in
foodservice areas. Food Control, 16(4), 325-332

Trienekens J., and Zuurbier P., (2008). Quality and safety standards in the
food industry, developments and challenges. International Journal of
Production Economics, 113(1), 107-122

Vasconcellos J.A., (2004). Quality assurance for the food industry: A

practical approach, CRC Press, Taylor & Francis Group, FL, USA

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Sources of information

For any information regarding assistance to develop and install GMP/

HACCP/ ISO 22000 or any other food safety management systems,
certification, training programs, laboratory services and other related
assistance, you may contact any of the following organizations.

1. The Ceylon Chamber of Commerce

Foreign Trade Information Division
No 50, Nawam Mawatha
P.O. Box 274
Colombo 02
Sri Lanka
Tel. No: 0094-11-5588800, -2380157/8
Fax No: 0094-11-2449352, -2437477
E-Mail: info@chamber.lk

2. Sri Lanka Food Processors Association

No. 503, Sri Jayawardenapura Mawatha
Ethulkotte
Sri Lanka
Tel-0094-11-4920206, 4300996
Fax: 0094-11-2862335
E-mail info@slfpa.org

3. National Agribusiness Council

No. 503, Sri Jayawardenapura Mawatha
Ethulkotte
Sri Lanka
Tel-0094-11-4301408, 4301675, 4300767
Fax: 0094-11-2862335
E-mail nac@agrolanka.net

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4. Ind-Expo Certification (Pvt) Ltd

Registered Centre for Chartered Institute of Environmental Health (UK)
Apt. 20, 1st Floor
Galle Face Court 2
Colombo 03
Sri Lanka
Tel No: 0094-11-2423452
Fax No: 0094-11-2423453
E-Mail: indexpo@sltnet.lk

5. Department of Food Science & Technology

Faculty of Agriculture
University of Peradeniya
Peradeniya
Sri Lanka
Tel No: 0094-81-2395212
Fax No: 0094-81-2395212

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