Revision No. 0

REVISION NO.
0
Company Name: Doc. No: HACCP /01
BIOTAN GROUP LIMITED

Revision No: 0
Date: AUGUST18, 2022
Title: HACCP MANAGEMENT SYSTEM MANUAL
Page No. : Page 43 of 43
Revision History Cover Sheet
Revision Date
Change Description
0 AUGUST18,2022 Initial Release

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HACCP MANAGMENT MANUAL APPROVAL
Document Name : HACCP Management System Manual

Revision Date : AUGUST 18, 2022
Revision No. : 0
This is a controlled document and not to be copied without authorization from

BIOTAN GROUP LTD. Uncontrolled copies could be delivered to clients upon
their request.
PREPARED BY:
Position: QUALITY CONTROLLER
Name: BAINOMUGISHA NSIBU
Sign:
APPROVED BY:
Position: MANAGING DIRECTOR
Name: PAUL SCHREILECHNER
Sign:

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TABLE OF CONTENTS
Subject Page Revision
Cover Page 0
Revision History 1 0
HACCP Manual Approval 2 0
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Table of Contents
1.0 Scope 5 0
2.0 Normative References 2 0
3.0 Terms and Definitions 6 0
4.0 Documentation Requirement for implementation of HACCP system 9 0
5.0 Management Responsibility 10 0
6.0 Requiremets for the implementation of HACCP system

17 0
7.0 Development & Application of the HACCP plan 25 0
Appendix A: List of Standard Operating Procedures 43

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GENERAL.
Introduction
Biotan Group Limited recognizes its responsibility as a provider of safe processed cashew
nuts. To this end, BIOTAN Company has developed and documented a HACCP Management
System to better satisfy the needs of its customers and to improve management of the
business. The company HACCP System focus is to comply with the International HACCP
Standard.
This manual has been prepared to define the Food Safety (HACCP) system, establish
responsibilities of the personnel affected by the system, and to provide general procedures for
all activities comprising the HACCP- Food Safety System. In addition, this manual is utilized
for the purpose of informing our customers of the Food Safety System and what specific
controls are implemented to assure the safety of our product.
This manual will be revised as necessary to reflect the HACCP System currently in use. It is
issued on a controlled copy basis to all internal functions affected by the safety system and on
an uncontrolled copy basis to customers and suppliers, although it can be issued to customers
on a controlled copy basis upon customer request.
The objective of this manual is to demonstrate the company’s HACCP- Food Safety
Management System that operated according to HACCP Standard requirements. The system
will instruct and guide employees whose actions will affect the product safety and states the
level of implemented controls to assure the acceptable product safety and quality. It is also to
inform the company’s clients about the level of implemented controls to assure the safety of
all operations.

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1.0 SCOPE
The company is focusing to apply all items of HACCP-Food safety without any exclusion to
all of its operations that include raw material receipt transportation, storage, processing and
dispatching of product to customers.
2.0 NORMATIVE REFERENCES

TBS HACCP TZS 1770:2016 Standard.
3.0 TERMS AND DEFINITIONS.

3.1 Continual improvement, the term continual improvement refers to an ongoing need to
improve the effectiveness of HACCP management system.
3.2 Control measures are actions or activities that are used to manage and control food safety
hazards.
3.3 Correction is any action that is taken to eliminate nonconformity.
3.4 Corrective actions are steps that are taken to eliminate the causes of an existing
nonconformity.
3.5 Critical control point (CCP) is the point (or step) at which a control measure must be
applied. It is a point that is critical or essential to safety.
3.6 Critical limit is a criterion or boundary that is used to distinguish between what is
acceptable (safe) and what is unacceptable (unsafe).
3.7 Food chain consists of the entire sequence of stages and operations involved in the
creation and consumption of food products.
3.8 Food safety hazard is an agent or condition that could potentially cause an adverse
human health effect.
3.9 Food safety hazard analysis is done in order to determine which hazards need to be
controlled, how much control is needed, and which combination of control measures should
be used in order to make sure that food is safe.
3.10 Hazard Analysis Critical Control Points (HACCP) is an internationally recognized
method of identifying and managing food safety related risk and, when central to an active
food safety program, can provide your customers, the public, and regulatory agencies
assurance that a food safety program is well managed.
3.11 Food safety policy statement formally defines an organization's commitment to food
safety. It expresses, in general terms, what top management intends to do about food safety
and describes the direction the organization wishes to take.

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3.12 Food safety record is a document that contains objective evidence which shows how
well food safety activities are being performed or what kind of results are being achieved. It
always documents what has happened in the past.
3.13 HACCP stands for Hazard Analysis and Critical Control Point. HACCP is a
methodology and a management system. It is used to identify, prevent, and control food
safety hazards
3.14 HACCP plan is a written document that describes how you plan to manage and control
your organization’s food safety hazards.
3.15 Audit is a systematic evidence gathering process that is carried out in order to determine
how well a HACCP management meets a set of expectations.
3.15 prerequisite programme (PRP)
specified procedures or instructions, specific to the nature and size of the operation, that
enhance or maintain operational conditions to enable more effective control of food safety
hazards, or that control the likelihood of introducing food safety hazards and their
contamination or proliferation in the products and product-processing environment
3.16 Update is an immediate or planned activity. Its purpose is to ensure that the most recent
information is being applied.
3.17 Validation is a process that is used to ensure that food safety control measures are
capable of being effective.
3.18 Verification is a process that uses objective evidence to confirm that specified
requirements have been met. Or application of methods, procedures, tests and other
evaluations, in addition to monitoring, to determine compliance with the HACCP system
3.19. non-conformity is a non-fulfilment of a specified requirement
3.20 record document that provides objective evidence of actions undertaken or results
achieved
3.21 decision tree sequence of questions applied to each step in the food handling process
relating to an identified food safety hazard to determine which steps are CCPs
3.22 deviation failure to meet a set requirement

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3.22 effectiveness extent to which planned activities are realized and planned results achieved
3.23 flow diagram systematic representation of the sequence of steps associated with the food
handling process in the segment of the food chain under consideration
3.24 food article or substance ordinarily eaten or drunk by man or purporting to be suitable, or
manufactured or sold, for human consumption, and includes any part or ingredient of any
such article or substance, or any substance used or intended or destined to be used as a part or
ingredient of any such article or substance
3.25 food handling organization: which during its operations, processes, manufactures, stores,
transports, distributes or sells foodstuffs or is engaged in any activity which may impact on
the safety of such foodstuffs
3.26. Control: to take all the actions necessary to ensure and maintain compliance with the
criteria and/or requirements established in the HACCP plan.
3.27. Decision tree: sequence of questions applied to each other step in the food handling
process relating to an identified food safety hazard to determine which steps are CCPs.
3.28. Document: a written, drawn, presented or recorded evidence of intention of activities to
be and/or performed.
3.29. HACCP team: a group of individuals (mult-disciplinary) who develop,implement and
maintain a HACCP system.
3.30. Monitor: the act of conducting a planned sequence of observations or measurements of
control parameters to assess whether a CCP is under control.
3.31. Shall: must expression of obligation and compulsory.

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4. DOCUMENTATION REQUIREMENT FOR IMPLEMENTATION OF HACCP

SYSTEM
4.1 The HACCP Manual

BIOTAN GROUP LIMITED has established and maintained HACCP manual that defines scope of
the system, PRPs procedures or reference to them and documented procedures for the system.
4.2 Control Of Documents
HACCP team shall ensure that documents are identified and controlled as required by the HACCP
management system according to the Documents Control Procedure. Head of Department shall ensure
that documents:
 are reviewed and approved for adequacy prior to issue;
 are updated, reviewed, and approved for re-issue as necessary;
 are identified with their current revision status;
 are available at point of use;
 are legible, readily identifiable, and retrievable;
 of external origin are identified and their distribution is managed;
 After the action is taken on normal external origin document, the copy is kept in respective
file at registry.
 Obsolete documents and / or invalid documents are promptly removed from locations of issue
or use and are destroyed or correctly identified (those retained for legal and / or knowledge
preservation) to avoid unintended use.
4.2.1 Document Approval and Issue
The documents are reviewed and approved for adequacy by authorized personnel prior to issue. A
master list identifying the current revision status of documents is
furnished and readily available in the Documents Control Section to preclude the use of invalid and /
or obsolete documents. Managers of the related departments that use the documents are responsible
for preparing and reviewing them. HACCP Management System documents are controlled through the
document number, revision, approval and the document distribution record.
4.2.2 Document Changes

Changes of documents are reviewed and approved by the same function that has reviewed and
approved the original one. The nature of the change in a document is identified, in accordance with
document control procedure

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4.3 Control of Records

BIOTAN maintains HACCP Food Safety records in order to demonstrate conformance to specified
requirements and the effective operation of the HACCP management system. The company makes
sure that all HACCP Management records are legible, stored and retained in such a way that they are
readily retrievable, in a suitable environment to prevent damage or deterioration and loss. Each
Department head is responsible for identifying, collecting, accessing, organizing, maintaining and
disposing its HACCP Management system records in accordance with Record Control Procedure.
When specified contractually, HACCP Management system records are to be accessible for evaluation
by the customer or his representative for an agreed period. Retention times of HACCP Management
system records are established and recorded, as in Record Control Procedure. Records are established
and maintained to provide evidence of conformity to requirements and effective operation of HACCP
Management System.
5.0 MANAGEMENT RESPONSIBILITIES.
5.1. Top Management Commitment.
Top Management provides evidence of its commitment to the development, implementation, and
continual improvement of the HACCP Management System. The responsibility for, and commitment
to, a food safety system and policy rests with the Managing Director and shall include but not be
limited to commitment to the implementation of the HACCP system, participation in continual
improvement of the HACCP system, review of the HACCP system for continued adequacy, suitability
and effectiveness, communication and understanding of the HACCP system within the organization,
establishing a forum for resolving conflict and Ensuring the availability of resources.
5.1.1 Authorities and responsibilities

Authorities and responsibilities reside with Managing Director and are delegated to functions and/or
individual members of staff within their control as appropriate. All personnel who
manage, perform and/or verify work are responsible for the safety of products produced by the
company. All such personnel are authorized to identify and record problem relating to products,
process, and the food safety management system as a whole. All staff and personnel have the
responsibility to comply with documented procedures and the direction of management. All personnel
have the responsibility to assure that processes in which they are working are in a state of control and
that the tasks are completed in a responsible manner. All personnel are also responsible for identifying
nonconforming product, marking such product as being nonconforming, notifying management, and
controlling further processing until the problem has been corrected. To prevent nonconformities, they
may also initiate, recommend, or provide solutions through designated channel, such as the Corrective
and Preventive Action system.

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5.1.2 Board of Directors
The strategic planning body; the board is responsible for strategic planning and is the source of broad
managerial directives. The board meets regularly and as needed to address active issues.
5.1.3 Managing Director
He is in-charge of all business and activities of the company. Is responsible to ensure that all products
of prescribed quality and safety are manufactured in the most economical manner, marketed and
delivered in the required quantity and on time. Define the Food Safety policy and objectives. Ensure
the communication and understanding of the Food Safety Policy and Objectives throughout BIOTAN.
Review the HACCP management system
5.1.4 Administrative Officer

Responsible for all human resource provision and in-charge of Administration Department.
Responsible for coordinating the trainings and manpower planning, health, transport, security and
remuneration scheme. Ensure that qualified, skilled, and trained personnel and other resources are
available to the HACCP Management System. Ensure that personnel comply with applicable
standards, regulations, specifications, and documented procedures.
5.1.5 Quality Controller

He/she is an In-charge of Quality Control Department. Responsible for planning and coordinating
sampling and coordinating quality & safety issues along the production line and final products.
Implement Food Safety and HACCP System in relation to the role of Quality Controller. Ensure that
qualified, skilled, and trained personnel and other resources are available to the HACCP Safety
Management System. Ensure that the services satisfy customer requirements.
Ensure that personnel comply with applicable standards, regulations, specifications, and documented
procedures. Initiate actions to prevent the occurrence of any non-conformity. Responsible for timely
completion of corrective actions in his/her area of responsibility and verify its effectiveness.
Responsible for attending customers’ complaints. The problems related to food safety are reported to
Quality Controller and shall he/she have responsibility and authority to initiate and record actions.
5.1.6 Factory Engineer

He/she is responsible for maintenance and repair and installation of all company equipment
machinery, buildings. Prepares maintenance program and organize a team for maintenance
program to ensure smooth and constant operation and availability of machine and equipment for
production.
Keeps preventive maintenance charts and avails the required parts in for all productions. Ensure that
the services satisfy customer requirements. Ensure that personnel comply with applicable standards,
regulations, specifications, and documented procedures. Initiate actions to prevent the occurrence of
any non-conformity.
Responsible for timely completion of corrective actions in his/her area of responsibility and verify its
effectiveness.

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5.1.7 Production Supervisors

Coordinate and control all the production activities in the Factory. Check processing and
packaging operations as well as the respective materials handling so as to ensure that all
products of prescribed safety and quality are manufactured in accordance to HACCP
Management System requirements. Ensure that the services satisfy customer requirements.
Ensure that personnel comply with applicable standards, regulations, specifications, and
documented procedures. Initiate actions to prevent the occurrence of any non-conformity.
Responsible for timely completion of corrective actions in his/her area of responsibility and
verify its effectiveness.
5.1.8 HACCP Management System Team
Document and maintain the Food Safety Policy and Objectives. Ensure that the HACCP
system is established, implemented and maintained. Reports regularly the suitability and
effectiveness of the HACCP management system. Coordinate improvements to the HACCP
management system.
5.1.9 All Personnel

Operate in conformance with the requirements of the HACCP Management System. Make
appropriate notifications when unsafe conditions exist or requirements are not being met.

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5.1.10 HACCP system Policy

The company Top Management has defined, documented and communicates its Food Safety
Policy as follows:
BIOTAN GROUP LTD recognizes its responsibility towards providing

only safe products to consumers by ensuring the Safety of Food product
throughout all stages of the production, including the supply chain and
delivery process. The management and staff at BIOTAN are committed to
take all necessary measures to ensure the Safety of the products sold to
customers.
Our Food Safety Policy is based on openness, credibility, transparency,

and emphasizes the importance of high level of Food Safety measures. It
also emphasizes open communication with suppliers, consumers and with
food industry, and an efficient and preventive surveillance system. All staff
are obliged to abide by this policy, HACCP Manual, Work Instructions,
and all Procedures laid down by the management. The company expects all
suppliers to also have food safety philosophy.
The company is also committed to follows all the relevant National

Standards as well as applicable regulatory and regal requirements. With
customers’ safety at the center of our focus, we shall continually improve our
processing skills and capabilities to guarantee safe products to our
customers.
To achieve the safe products, the company is committed to implement,

certify and maintain the certified HACCP Management System through
complying with all HACCP Management System Standard Requirements.
Food Safety Policy is declared to ensure it is understood implemented and maintained at all
levels of the company.

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5.1.11 Food Safety Objectives:
The HACCP system policy is upheld by the application of the measurable overall objective
and specific objectives covering both the HACCP Management System and the products.
These objectives are established documented, and regularly review by the management in
order to ensure continuing suitability:
The Company overall objective is to implement and maintain a certified HACCP

Management System. To archive the overall objective the company has documented both
long term and short-term specific objectives.
5.1.12 External Communication

The Company Managing Director serves as the primary liaison to external parties such as
suppliers and contractors, customers or consumers, statutory and regulatory authorities, and
other organizations that have an impact on, or will be affected by, the effectiveness or
updating of the HACCP Management System. Information obtained through external
communication are included as input to system updating and Management Review Meetings.
The Managing Director ensures that employees are aware of the importance of meeting
customer requirements and expectations and how those requirements relate to their work
activities.
5.1.13 Internal Communication
Although informal communication is an effective method of transmitting information relating to

products and processes, formal mechanisms are in place to document and facilitate such
communication. The effectiveness of internal communications and any further formalization of such
communications are considered during Management Review Meetings.
The effectiveness of the HACCP Management System process are communicated to the various levels
and functions through the use of the HACCP Management System documentation, training, internal
audits and subsequent reporting, document control, corrective and preventive action systems, and
Management Review Meetings. Further communication regarding such production processes and their
effectiveness is achieved through staff meetings, memos, information on notice boards etc.

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5.2 Appointment of the management representative

A management representative shall be appointed by the Company Managing Director and
shall, irrespective of other responsibilities and duties, act as the management representative of
the HACCP system and shall have the responsibility and authority to
a) ensure that the HACCP system is established, implemented, maintained and continually
improved in accordance with the requirements of this standard,
b) report on the performance of the HACCP system to management and any need for
improving the system,
c) ensure management’s commitment is visible, and
d) ensure a clear route for communication, up, down and sideways.
5.3 Resources management.
5.3.1 Appointment of HACCP Team Leader.
BIOTAN Group Limited’s Top Management has appointed a HACCP Team leader whose,
irrespective of other responsibilities, shall have the responsibility and authority to manage a HACCP
team and organize its work, to ensure relevant training and education of the team members, to ensure
that the HACCP management system is established, implemented, maintained and updated, and to
report to the organization’s Top management on the effectiveness and suitability of the HACCP
Management system.
5.3.2 Provision of Resources
Biotan Group Limited shall provide adequate resources for the establishment, implementation,
maintenance and updating of the HACCP Management System.
5.3.3 Competence, Awareness and Training
The Top management shall ensure that employees undergo HACCP Management Internal Awareness
Training, where the company’s commitment to and policy for Food Safety is communicated, as is the
importance of meeting customer requirements, the importance of their respective positions, and how
they contribute to the achievement of the Food Safety Objectives. Internal Awareness Training is
provided to new employees during orientation.
Top management ensures that staffing and skills levels within the organization are appropriate to
ensure the optimal efficiency and effectiveness of our operations.
As part of Food Safety planning, attendees of Management Review Meetings identify company-wide
training need in light of any new business developments or new technologies to be incorporated.

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5.3.4 Infrastructure
The Factory Engineer ensures that our facilities are maintained appropriately to achieve conformity of
the product, including workspaces, equipment and any supporting services related to facilities
maintenance. Such considerations are discussed during Management Review Meetings.
Each equipment is described and records for each are documented and kept by the Factory Engineer.
Floor plans are available for the arrangement of the equipment.
5.3.4 Work Environment
Management ensures that the appropriate human and physical factors of the work environment are
considered and provided. Consideration of such factors includes health and safety conditions, work
methods, handling methods, appropriate equipment and ambient working conditions. Such
considerations are also included during Management Review Meetings.
5.3.5 Training Needs
HACCP team shall establish training needs for all personnel involved in the establishment,
implementation and maintenance of the HACCP system. Training records shall be maintained.
5.4 Management Review
5.4.1 General
The Top Management Reviews the HACCP system to assess and evaluate the HACCP Management
System to ensure its continued effectiveness and suitability in satisfying the requirements of HACCP
system and our stated Food Safety policy and objectives. Reviews are carried out according to the
Management Review Procedure (Doc. No. OP/ADM/001) as frequently as necessary, but at least
twice annually.
Topics discussed during the meeting and resulting action plans are recorded in Management Review
Agenda and Minutes, which are maintained as HACCP Management System records in accordance
with the Records Control Procedure (Doc. No.OP/QCD/011).
5.4.2 Review Input
During management review meetings, the management reviews current performance and improvement
opportunities arising from the results of internal audits, customer feedback, process performance/
trends, product conformance, the status of corrective and preventive actions, accidents and
withdrawals, and follow-up actions from previous meetings.

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The HACCP Policy and Objectives are also reviewed for their continuing suitability. Data gathered
through measurement and monitoring activities is analyzed to determine the effectiveness of the
HACCP Management System.
Analysis is also applied to data relating to customer satisfaction, conformance to customer

requirements, supplier, and any other relevant sources. Also, communication methodology is
reviewed. The company plans to continually improve the Food Safety Management System. This
improvement is facilitated not only by management review, but also by establishing and reviewing the
HACCP Policy and Objectives, internal audit results, the analysis of data and corrective and
preventive actions, as well as any other recommendations for improvement. All such process is
managed to achieve improvement.
In addition, the Management Review Meetings serve as a vehicle whereby we may evaluate potential
problems and take actions to prevent their occurrences.
6 REQUIREMENTS FOR THE IMPLEMENTATION OF HACCP SYSTEM.
6.1 Principles of the HACCP system.
HACCP is a systematic approach to the identification, evaluation and control of food safety hazards
based on the following seven principles;
Principle 1: List the food safety hazards and measures to control the hazards (hazard analysis)
Principle 2: Determine critical control points (CCPs) (decision tree).
Principle 3: Establish critical limits for each CCP.
Principle 4: Establish a monitoring system for each CCP.
Principle 5: Establish corrective action plans.
Principle 6: Establish validation, verification and review procedures.
Principle 7: Establish record keeping and documentation.

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6.2 APPLICATION OF THE HACCP SYSTEM.
Prior to application of HACCP system, BIOTAN Group Limited have established in place prerequisite
programmes such as good hygiene practices according to TZS 109, the appropriate codes of practice
and appropriate food safety requirements.
6.3 Application of Prerequisite Programmes (PRPs)
6.3.1 The company has established, implemented and maintained PRP (s) to assist in controlling the
likelihood of introducing food safety hazards to the product through the work environment, biological,
chemical and physical contamination of the product(s), including cross contamination between
products, and food safety hazard levels in the product and product processing environment. The
prerequisite programs established, implemented and maintained by the company as per this
requirement includes Premises, Distribution and Transportation, Receiving and Storage, Equipment,
Water supply, Personnel hygiene, Sanitation and Pest Control, Control of Hazardous and Inedible
Substances and Recall.
6.3.2 The prerequisite programs established, implemented and maintained by the company as
per this requirement includes external areas to the facility;building structure, ablution
facilities, production, distribution and storage facilities; staff and product flow; construction
of equipment; maintenance programme; cleaning and disinfection programme; pest control
programme; refuse or waste control programme; services needed for production, for example,
air, water; personnel hygiene programme; product recall and traceability programme; control
of suppliers; m) relevant training programmes; and relevant records.
Premises
Building and surroundings are designed, constructed and maintained in a manner to prevent
conditions that may result in the contamination of food.
"Premises" includes all elements in the building and building surroundings: the outside
property, roadways, drainage, building design and construction, product flow, sanitary
facilities, and water/steam quality and supply.
Building Exterior
Outside Property and Building
Land is free of debris and refuses and is not close to environmental contaminants (e.g.
objectionable odors, smoke, dust or other contaminants).
Roadways are properly graded, compacted, and drained. Premises, shipping and receiving
areas provide or permit good drainage.
Buildings are of sound construction, are maintained in good repair, and do not present any
chemical, biological or physical hazards to the food. Each building is designed to:

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 provide suitable environmental conditions;

 allow adequate cleaning and sanitation;
 minimize contamination by extraneous materials;
 prevent access by pests; and
 provide adequate space for conducting all operations.
Building Interior
Design, Construction and Maintenance
Floors, walls and ceiling materials (as well as various coating and joint sealants) are of
accepted construction materials in relation to food handling.
Where required or appropriate, areas of the establishment are provided with conveniently
located hand wash stations. Waste pipes connected to hand wash stations are adequately
trapped. Sanitizers are available, where appropriate.
Windows are sealed or equipped with close-fitting screens. Where it is possible that glass
windows might break and glass particles might contaminate the food, windows are
constructed of alternate materials or are adequately protected.
Hygienic operations are promoted throughout the facilities by means of a regulated flow in
the process, from the arrival of raw material to the final product. Physical or operational
separations occur to prevent contamination of food via employee traffic patterns, product
flow and equipment. The traffic pattern of personnel and visitors prevents cross-
contamination of food products. Incompatible operations are physically and operationally
separated to prevent cross-contamination of food.
Lighting
Lighting is appropriate, permits the intended production or inspection activity to be conducted
effectively, and does not alter food colour. Lux requirements meet the respective program
standards.
Ventilation
Ventilation prevents build-up of heat, steam, condensation or dust and removes contaminated
air. Ventilation openings are equipped with tight-fitting screens or are otherwise protected
with non-corrodible material. Air intakes are located to prevent the entry of contaminated air.

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Waste Disposal
Drainage and sewage systems are equipped with appropriate traps and vents. The
establishment is designed and constructed to prevent cross-connection between the effluent of
human wastes and any other wastes in the establishment. No drainage pipes pass directly over
or through production areas, unless they are controlled to prevent contamination.
Facilities are provided for the storage of waste and inedible material prior to their removal
from the establishment. These facilities are designed to prevent contamination. Containers
used for waste are clearly identified and are leak proof.
Sanitary Facilities-Employee Facilities

Washrooms with self-closing doors are provided. Washrooms, staff canteen and change
rooms are adequately ventilated and maintained. They are separate from and do not lead
directly into food processing areas. Washrooms have hand wash facilities with a sufficient
number of maintained sinks that are properly trapped to drains.
Handwash facilities are adequately maintained and have cold running potable water, soap,
sanitary hand-drying supplies or devices, and, where required, a cleanable waste receptacle.
Hand wash stations are maintained in all applicable areas of the facility. Notices to wash
hands are posted at all handwash stations.
Equipment Cleaning and Sanitizing Facilities

Equipment cleaning and sanitizing facilities are constructed of corrosion-resistant materials
that can be cleaned easily. Equipment cleaning and sanitizing facilities are adequately
separated from food storage, processing and packaging areas to prevent contamination of
food.
Transportation, Receiving and Storage

The company ensures that incoming material (raw material, packaging material, returned
finished product, and non-food chemicals) are transported, received, stored and handled in a
manner to prevent chemical, physical or microbiological contamination of raw cashew nuts
and its products. Effective measures are taken by the company to prevent contamination of
raw materials, and packaging materials. The company does not accept incoming materials if
they are known to be contaminated with the following:
 undesirable microorganisms, pesticides, toxic substances and decomposed or
extraneous matter

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Transportation - Food Carriers

The company verifies that carriers are suitable for transporting food. Upon receiving goods or
prior to loading goods for shipment, the company inspects carriers to ensure that they are free
from contamination and suitable for transporting food. The inspection responsibility is under
quality control division.
Where appropriate, materials used in carrier construction are suitable for contact with food.
Carriers are loaded, arranged and unloaded in a manner that prevents damage to and
contamination of products. Finished products are transported under conditions that prevent
biological, physical and chemical contamination of food.
Incoming materials are received in an area separate from processing area(s).
Ref. Transportation Policy and Procedure
Receiving and Storage

Incoming Material Receiving and Storage
This section covers incoming raw material, finished products and non-food products.
The company keeps on file all letters of supplier guarantee required to certify that incoming
materials meet its purchasing specifications.
Raw materials are inspected at receiving, where possible, to confirm that they meet
purchasing specifications. Incoming materials are handled and stored in a manner to prevent
damage and/or contamination. Refer to Materials Receiving and Issuing Procedure.
Finished Product Storage

Finished products are stored and handled under conditions that prevent deterioration. Since
final products are sensitive to humidity, are stored under appropriate conditions to prevent
deterioration. Finished products are stored and handled in a manner that prevents damage.
Equipment
Equipment and containers used in the company are designed and constructed so as to ensure
that they can be adequately cleaned, disinfected and maintained to avoid the contamination of
food.

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General Equipment
Equipment Design and Installation
Equipment and/or utensils are designed, constructed and installed so as to ensure that they
are:
 capable of delivering the requirements of the process and
 accessible for cleaning, sanitizing, maintenance and inspection.
Adequate space is provided within and around equipment to prevent contamination of food
products during operations.
Equipment is designed so that all food contact surfaces are smooth, non-corrosive, non-
absorbent, non-toxic, and free from pitting, cracks and crevices.
All lubricants used on equipment that comes into contact with food are of acceptable
standards. Equipment and utensils used to handle inedible material are not used to handle
edible material.
Equipment Maintenance
Any equipment that has an impact on food safety functions as intended and does not
introduce hazards to the operation. The company's preventive maintenance program ensures
that equipment functions properly.
Personnel
The personnel program ensures that employees follow safe food handling practices. The
program:
 sets out how the company trains personnel; and
 Verifies the effectiveness of that training.
Training
General Food Hygiene Training
The company trains employees in appropriate personal hygiene and hygienic handling of
food. Training in food hygiene is provided at the beginning of employment and is reinforced
and updated at appropriate intervals.

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Technical Training
The company provides technical training appropriate for the complexity of the manufacturing
process and the tasks assigned. For example, personnel learn:
 the importance of CCPs for which they are responsible;
 applicable critical limits;
 procedures for monitoring the program;
 action to be taken if critical limits are not met; and
 Procedures for completing records.
 Developing HACCP documents
 Implementing prerequisite programs & HACCP Plans
 Understanding HACCP and food safety Requirements
Personnel and supervisors responsible for the sanitation program are trained to understand the
principles governing and the methods required for effective cleaning and sanitizing.
The company keeps its employees' knowledge up-to-date through additional training in
process technology and new equipment operation as appropriate.
Person Hygiene-Cleanliness and Conduct

The company has and enforces a policy to ensure good personal hygiene and hygienic
behavior and habits that prevent the contamination of food products. The policy includes
procedures for hand washing and/or sanitizing, protective clothing and personal hygiene.
All employees who work in food handling areas must maintain personal cleanliness.
Whenever employees enter a food production area, they must wash their hands thoroughly
with soap under running potable water. Hands are always washed after handling contaminated
materials and after using toilet facilities and use disinfectant. Protective clothing and gloves
applicable to the operation are worn and maintained in a sanitary manner.
Before any employees enter a food handling area, they remove from their person any objects
that may fall into or otherwise contaminate food. Jewelers is not worn or carried into food
handling areas. Tobacco, gum and food are not permitted in food handling areas. Access of
personnel and visitors is controlled to prevent food contamination. The company has
established Employees Personal Hygiene Instructions and the hygiene monitoring record form
that shall daily be filled before the start of shift by the shift supervisor and the packing
supervisor and reviewed by Quality Controller who shall also keep the personal hygiene
records

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Communicable Diseases and Injuries

The company requires employees to advice management when they are suffering from a
communicable disease likely to be transmitted through food. No person is permitted to work
in a food handling area when he or she is known to be suffering from or be a carrier of a
disease likely to be transmitted through food.
Employees who exhibit infected wounds, skin infections or sores or who suffer from diarrhea
are not permitted to work in food handling areas where contamination of food may occur.
Employees who have open cuts or wounds do not handle food or food contact surfaces unless
the injury is completely covered.
Medical examination to all staff is conducted twice a year and documented AND records are
kept by Quality Controller.
Sanitation and Pest Control

The objective of the sanitation and pest control program is to ensure that the facilities and
equipment are clean and that pests are excluded from the establishment.
The written sanitation program specifies the following:
1. The area(s) and equipment to be cleaned, the frequency and the person responsible for
each
2. Instructions for cleaning the specified equipment and areas
3. The cleaning equipment to be used and the instructions for its proper operation (e.g.
pressure, volume, etc.)
4. The detergents and sanitizers to be used
The company monitors and verifies the effectiveness of its sanitation program by conducting:
 routine sensory inspections of areas and equipment; and
 direct, on-site observation of cleaning procedures.
The sanitation program is adjusted as necessary to incorporate new cleaning procedures (e.g.
new equipment, Operations begin only after all sanitation requirements have been met (e.g.
pre-operation inspection).

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Pest Control
Pest Control Program
The company has a written and effective pest control program. Birds and animals are
prevented from entering the establishment.
The written pest control program includes the following:
 The contact persons for pest control at the company are factory nurse who is
responsible to supervise the pest control activities and one staff have been trained at
(Tropical Pesticide Research Institute) on the programme.
 The name of the pest control company, where applicable, or the name of the person
responsible for the program
 A list of chemicals and methods of application used
 A map of pest control devices and/or bait stations
 The frequency of inspection
 A survey of pests and control information.
Refer to the Pest Control Procedure
6.3.3Additional to the PRPs, the following shall be done before the HACCP study is
attempted: a) a complete investigation to determine the suitability of the facility and the
equipment with regards to design, construction and maintenance; b) identification of
shortfalls that might complicate the implementation of the HACCP plan. Suitable food
handling equipment and facilities shall be available to handle the intended product safely; and
c) evidence of progress made with the correction of the shortfalls identified during the
investigation. Responsibilities and appropriate time limits shall be set for the completion of
the intended
6.3.4 BIOTAN Group Limited shall make sure that the established PRPs are fully operational
and that they are verified in order to facilitate the successful application and implementation
of the HACCP system.
6.5 BIOTAN operations shall always focus on the intent of the HACCP system which is to
control the CCPs. Review and re-designing of the operation shall be considered hazard which
must be controlled is identified but no CCPs are found.
6.6 During hazard identification, evaluation and subsequent operations in designing and
applying HACCP system, consideration shall be given to the impact of raw materials,food
processing practice and role of manufacturing processes to control hazards.

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7. DEVELOPMENT AND APPLICATION OF THE HACCP PLAN
General
BIOTAN HACCP team has developed the HACCP Plan document in accordance with the principles
of HACCP as stipulated in clause 6.1 of this manual.
7.1 Stage 1: Assemble the HACCP Team
The company Managing Director has assembled the HACCP Team by ensuring the establishment of
criteria for the selection of HACCP team members to assist with the plan, establishment,
implementation, maintenance and continual improvement of the HACCP system. Every team member
has accepted, in writing, his/her assignment and commitment to the HACCP team.
7.1.2 The HACCP team is comprised of multi-disciplinary members that possess the required
knowledge and experience in developing and implementing the Food Safety Management System.
The team members include the Administration Officer, Factory Engineer, Quality Controller, ICS
Manager and Production Supervisors.
7.1.3 The assembled team shall establish defined and documented scope of the HACCP plan and the
team activities. The defined scope describes the segment of the food chain involved and the general
food safety hazard to be addressed.
7.2 Stage 2: Description of the Product
The HACCP team have described BIOTAN product in terms;
Product Aspect Product Information

Composition The products include cashew kernel
Origin of Ingredients Tanzania organic group of cashew growers
Physical or chemical Product moisture content ranges between 4.5°C to 5.0°C
properties that impact
food safety
Treatment or processing Sorting, steaming, shelling, drying and peeling and packaging
Packaging System -Vacuum plastic bags in boxes
- Packed in vacuum plastic bag to a slab
- Each slab has 11.34kg (net weight)
-Then, two slabs are packed in a corrugated box to weigh 22.68kg
-Packaging materials safety is based on supplier assurance that plastic
polythene bags are suitable to be in contact with food product
Target safe shelf life Variable according to product and customer requirements but all above 12
under prescribed storage month
and usage conditions
Instructions for Use Eaten when roasted, blended, etc.
Intended Consumers All groups
Labeling instructions To indicate manufactured date, expiry date and LOT number.
Storage At dry and cool place (ambient, in consumers’ home)

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7.3 Stage 3: Identify intended use of the product.
Normally eaten when roasted but can be blended. Our product can also be used to make juice when
ground. All societies can use this product.
7.4 Stage 4: Flow Diagrams and Process Steps.
7.4.1. Description of the processes.

I. Purchasing &receiving raw cashew nuts.
To ensure that the Company receives the correct quality of raw materials, the Quality Controller
takes sample and check raw cashew nuts for the following criteria: foreign matter, the moisture
content, any visual damage, and the presence of any earthy mould smell. This is done to
determine if the deliveries match to the original supplier’s sample and the quality declaration
indicated on the documents (Material Receiving and Issuing Procedure Doc. No. WI/PRD/002;
and Raw Material Quality Inspection Report (OF/QCD/020)
II. Storage and Handling

After quality control inspection and approval, the procedures for receiving, this includes
offloading and staking in the store follows. During offloading and further transportation coffee
has to be well protected from moisture and other contaminations. Coffee bags are stored in the
warehouse on the dry pallets away from the walls and roof, and by leaving enough space
between the stacks for proper ventilation. For traceability purpose, the lots are marked with the
identification tag.
III. Raw Grading (Sizing) Cleaning

Prior to usage raw cashew nuts graded but also this process involves cleaning to remove dusts,
stones, and other impurities. Cleaning residues are held separate from sound raw cashew nuts
and they are disposed properly and kept out of the human food chain. The weighing of cleaning
residues is done in order to evaluate the cleaning losses per LOT.
IV. Steam cooking

Steam cooking is achieved by injecting steam into a rotating cylinder containing the raw cashew
nuts for twenty-five minutes. Each grade is steamed separately to avoid mixing of grades. After
25 minutes, steamed raw cashew nuts are discharged and put on the clean floor for cooling
purpose. For effective cooling, the cooked raw cashew nut is left to cool for three days.
V. Shelling
This includes machine shelling, manual shelling and scooping. Cooled steam cooked raw cashew
is then issued to the production line for shelling. During shelling, shells and rotten kennels are
separated off and disposed properly out of the food chain.
VI. Drying of shelled kennels.

The good kennels are weighed then subjected to the drier at a temperature above 75°C and
above for ten hours. Any further biological hazard is killed at this stage. After ten hours, dried
kennels are removed and subjected to the cooling chamber.

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VII. Cooling/Humidification
From drier, the dried LOT is then subjected to the cooling chamber for about six hours for
humidification. Humidification loosens the kennel testa for easy peeling.
VIII. Peeling
Cooled LOT is then weighed and peeled. At this stage testa separated off and disposed properly
out of the food processed chain. Peeled kennels are then weighed and issued to Sorting &
Grading section.
IX. Product Sorting and Grading.

At this section, peeled products are manually sorted. The sorted LOT is then graded in to several
grades which include W180, W210, W320, SSW, SW, LWP, SWP, SPLITS, B-BITTS, SPS,
P2L, BP & FW.
X. Re- Drying
After grading, all grades are returned back to the drier for re-drying purpose. This stage apart
from importance it is essential in maintaining the range of expected moisture which should be
within 4.5°C to 5.0°C.
XI. Product Packing.

From drier, the re-dried kennels are immediately packed in a vacuum plastic bag each to weigh
11.34kg net weight. Each grade is packed separately to avoid mixing of grades. All operational
prerequisite programme like checking the bags before use is adhered to.
XII. Product Storage.

After packing, the packed slabs are then taken to the product store. Slabs are staked on the
pallets according to grades.
XIII. Dispatch, Loading & Stuffing.

Products are dispatched according to client order. Before loading, the carrier is inspected for
quality environment. This is another PRP. Also, before stuffing, the container is inspected for
quality environment.

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Organic Cashew nuts Processing Flow Diagram

RECEIVING
RAW CASHEW NUTS (CCP)
RAW STORAGE
STEAM BOILER RAW

GRADING and CLEANING Foreigner Matters such
dusts & stones separated off
HEAT EXCHANGER steam STEAM COOKING Bacteria and other small

organisms killed.
Hot hair above75ºC) COOLING

(for three days)
SHELLING (machine shelling,manual Rotten kennels and

shelling and scooping) shells given out as
impurities.
WEIGHING
For re-drying DRYING (CCP) To packing section

At above 75ºC for ten hours.
COOLING
For five hours
WEIGHING
MACHINE PEELING Testa given
WEIGHING THEN
To drier for re-drying TRANSFERING TO SORTING &
GRADING SECTION.
VACUUM PACKING (CCP)

PACKING MATERIALS
(Vacuum bags)
PRODUCT STORAGE Dispatch to stuffing

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7.5: Stage 5: Confirmation of the flow diagram.

The HACCP team having sufficient knowledge of the processing operation has made on-site visit and
confirmed processing operation against the flow diagram at all stages and concluded that there is
accurate representation of the operation.
7.6: Stage 6: Hazard analysis
The HACCP Management Team has conducted the hazard analysis to determine the hazards needed to
be controlled, the degree of control required to ensure food safety, and which combination of control
measures is required.
Food safety hazards that are reasonably expected to occur in relation to the cashew nuts type of
processing and actual processing facilities were identified and recorded based on preliminary
information gathered from process flow diagram, experience, literature and any other information on
food safety as follows

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Hazard analysis
Processing Type Of POTENTIAL Acceptance level Control Measures Significant
Step Hazard Hazards introduced, risk
increased, or (Yes/No)
controlled at this
step
Physical Stones, Metal Pieces, 7mm to 25mm magnets, Air blower, No
Stalk , Dirt, Insects, sharp,pointed objects Screen are installed in the
Glass Pieces, Jute considered as hazard process.
Strings From Agri as per TFDA
Fields
Biological pathogenic micro Salmonella-Absent in high temperature used in No
organisms (fungi and 25g, Y & M- 10 the process destroy
bacteria )/ 6 micro-organism
contamination from CFU/g
unclean carts, trollies
Sizing/Sorting
and trucks.
Chemical Heavy Metals and As per • Training is provided to No
pesticide residues TFDAregulations farmers regarding the use
and organic of pesticides.
standards • Final product is tested
(contaminants and for heavy metals &
toxins regulations) pesticide residues once in
a year
• Food Grade Oil &
grease used.
Physical Contamination from 7mm to 25mm PRP-Pest control, PRP- No
dirty water, Stones, sharp,pointed objects Warehousing, GMP,
Metal Pieces, Stalk , considered as hazard Hygiene, Purchase
Dirt, Insects, Glass as per TFDA material from approved
Pieces, Jute Strings supplier
From Agri Fields
Biological Survival of pathogens Salmonella-Absent in • hourly monitoring of Yes
due to low 25g, Y & M- 10 6 steam temperature
STEAMING temperature of Steam CFU/g • Schedule preventive
maintenance.
•Caliberation of
temperature gauze
Chemical Rust from old tanks As per TFDA No
and pipes regulations and
organic standards
(contaminants and
toxins regulations)
Physical Contamination by 7mm to 25mm PRP-foreign body No
foreign bodies from sharp,pointed objects control,
broken shaking, tools considered as hazard
and shells particles, as per FDA
SHELLING Stones, Metal Pieces,
Stalk , Dirt, Insects,
Glass Pieces, Jute
Strings From Agri
Fields

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Biological Fungal and Bacterial Salmonella-Absent in • containers are No

growth due to not 25g, Y & M- 10 inspected before Loading
properly cleaned tools 6 • only foodgrade and
and parts of shelling CFU/g Clean and dry container
facility is used
Chemical Chemical residues of as per TFDA/Codex • Clean and sanitized No
cleaning susbstances food grade Containers
are used
• inspection of cleaning
is done
Physical Nut- bolts, Scrap from 7mm to 25mm magnets and seives are No
equipment, Stones sharp,pointed objects installed in the process
from previous considered as hazard for removal of foreigen
material, brush as per TFDA material in additiona to
physical checks and
DRYING vibrators
Biological pathogenic micro Salmonella-Absent in High temperature steam No
organisms (fungi and 25g, Y & M- 10 is used to reduce
bacteria )/ 6 microbial contamination
contamination from CFU/g
unclean trays
7.7 Determination of critical control points (CCPs)

Critical Control Point being a step at which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce it to an acceptable level. The CCP decision tree and expert
knowledge were used at each process step identified as a significant hazard to identify the CCP that
should be controlled by the HACCP plan. For each CCP identified its control measure was identified.
Below is the sample CCP Decision tree table that was done for each process step/significant hazard to
ascertain whether it is a CCP or not.
CCP Decision Tree Table for Production

Process Step/Hazard CCP Decision Tree Questions
Step 1: Receiving of Raw cashew nuts Q1 Q2 Q3 Q4 CCP
Biological hazards: Bacteriological Pathogens Yes No Yes Yes No

Chemical Hazards: aflatoxin Yes Yes - - Yes
Physical Hazards: Foreign Matter Yes No Yes Yes No

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Identified Critical Control Points (CCPs) and its Corresponding Control Measures
Food Safety Hazard to be Control Measures Critical Control Point(CCPs)

Controlled by HACCP Plan
1b. Aflatoxin in raw materials i) Moisture contents determination CCP 1: Raw material receiving area
and final product. iv) Higher temperature processing (Inspection )
6. Ingress of contaminants and/or i) Control moisture content limit of CCP 2: Drying stage
growth of bacteria and moulds to final product at maximum 5.0% by (Control of Drying Parameters)
the final product when safe hot air drying
moisture content (max.5.0%) is ii) Maintaining temperature at
not attained at drying stage. drier at minimum of 75oC
7a. Ingress of contaminants i) Proper sealing of product CCP 3: Packing stage
and/or growth of bacteria and packaging.
moulds to the final product ii) Packing material inspection for
when the product reabsorb any leakages before being used.
moisture and moisture content iii) Re-drying of the products
is above 5.0% because of
improper sealing/leakages of
bulk pack.
7.8 Determination of critical limits for each control point
Critical limit is a predetermined value to be met for the safe product. Critical limits were determined
for the monitoring established for each control.
Critical Limits for Monitoring Established Critical Control Points
Critical Control Point(CCPs) Critical limits

CCP 1: Raw material receiving area i) Absence of any signs of moulds contaminations.
(Inspection ) ii)Acceptable moisture content of coffee beans max.12%
CCP 2: Drying
Absent in 25g, Y & M- 10 6 CFU/g
CCP 3: Packing i) Moisture content range 4.5% -5.0 %
ii) Absence of any air leakages to packed product


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7.9 System for the monitoring of critical control points
Monitoring is the act of conducting a planned sequence of observations. A monitoring system shall be
established for each CCP to demonstrate that the CCP is in control. The system shall include all schedules,
which enables the tests to be made for the needed requirement on particular control. This include: monitoring
device, applicable calibration method monitoring frequency, responsibility and authority.
Critical Control Points Monitoring System

(CCPs) Monitored Monitoring Calibration Monitoring Responsibility Records and
Parameter Devises Method Frequency Method
CCP 1: i)Signs of moulds i) Visual I) Test Sample i) ICS manager Raw Material
contaminations inspection ii) from every Receiving
ii) Insects Moisture meter i) Oven dry consignment Report:
damages method Received.
iii) Moisture
content % of the
raw materilas.
CCP 2: i) Moisture i) Oven dry i) Reference i) MC hourly i)QC Control Panel

content % Method Drying Record
ii) Inlet hot air ii) Supervisor Book
temp gauge.
CCP3 i) Moisture I) Oven i) Reference i) Every LOT i)QC Product Packing

Content Method to be packed Book
ii) Supervisor
The monitoring methods and frequencies shall be capable of determining when the critical limits have been
exceeded in time for the product to be isolated before it is used or consumed.
7.10 Actions when monitoring results exceed critical limits:
Table below shows the planned corrections and corrective actions to be taken when critical limits are exceeded.
The actions ensure that the cause of nonconformity is identified, that the parameters controlled at the CCPs are
brought back under control, and that recurrence is prevented.

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Actions When Monitoring Results Exceed Critical Limits

Actions When Monitoring Results Exceed Critical Limits
Critical Control Critical limits Corrections and Corrective Actions

Point(CCPs)
i) Absence of signs of moulds i) temperature above 12%, the supplier is advised
CCP 1: Raw material
contaminations. on further redrying
receiving area
(Inspection) ii) presence of signs of moulds contaminations, the
ii)Acceptable moisture consignment is rejected
content of max.12%
CCP 2: Drying stage i) MC of at maximum 5.0% i) The product with high moisture content is re-dried.
(Control of Drying
Parameters)
CCP3: Packing section i) Moisture contents ranges i) moisture content above 5.0 °C, re-dry
4.5°C-5.0°C before packing.
ii) improper sealing, re-seal
ii) Proper sealing
7.11: Stage 11: Verification Planning

The purpose of verification planning is to ensure that HACCP System is doing what is planned to do.
Verification is therefore a continual process similar to monitoring but normally with lower frequency
for observing the food system as a whole.
The verification shall confirm on PRP(s) implementation, oPRP(s), HACCP plan and other procedures
required by BIOTAN.
The output of this planning shall be in a form suitable for BIOTAN operations, indicating method,
purpose, frequency and responsibilities for the verification activities.The PRP(s), oPRP(s) and
HACCP plan to be listed for verification planning form are provided bellow;

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Verification plan table
Table: Verification plan

Verified Item & Verification
verification activities Method Frequency Responsible result records
Shelf life of packed
cashew nuts kennels
Microbiological, Heavy galab laboratories gmbh, MD

metal residual, am schleusengraben Once every six months. & Test reports
chemical and physical 7,21029 hamburg- January and July QC
properties of product germany
sample SHALL be sent to
Aflatoxin verification TBS, Government chemists Annually QC Test reports
activities or abroad for Aflatoxin
analysis
Inspection and Certification by the organic Once a year, ICS Manager Inspection
certification of organic accredited & report
production Body like -ECOCERT Director
Medical examination Municipal councils to Twice a year Feb. and Admin.Office

for staff provide the location and August r Employees
examination certificates
External Auditing and Once every year QC and

surveillance inspections System audit HACCP Audit and
Team Leader inspection
reports
Internal Auditing on Trained auditors within Depending on the status QC and Internal Audit
HACCP System BIOTAN staff as per but at least once every HACCP report
internal audit programme year. Team Leader
Testing traceability and Mock recall from Selected Once every year, in June QC Test reports
withdrawal of product and planned area as per
recall procedure
The recorded verification results shall be communicated to the HACCP team. Verification results shall
be provided to enable the analysis of the results of the verification activities
If system verification is based on testing of product samples, and where product samples show
nonconformity with the acceptable level of food safety hazard, the affected lots of products shall be
handled as potentially unsafe.
The HACCP team shall analyze the results of verification activities, including the results of the
internal audits and external audits. The analysis shall be carried out in order to confirm that the overall
performance of the system meets the planned arrangements and the HACCP requirements established
by BIOTAN, to identify the need for updating or improving the HACCP system, to identify trends
which indicate a higher incidence of potentially unsafe products, to establish information for planning

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of the internal audit programme concerning the status and importance of areas to be audited, and to
provide evidence that any corrections and corrective actions that have been taken are effective.
The results of the analysis and the resulting activities shall be recorded and shall be reported, in an
appropriate manner, to the management as input to the management review. It shall also be used as an
input for updating the food safety management system.
The HACCP team shall systematically evaluate the individual results of planned verification system.
If verification does not demonstrate conformity with planned arrangements, the company through
HACCP team and management review meeting shall take action to achieve the required conformity.
Such action shall include, but not limited to, review of existing procedures and communication
channels; the conclusions of the hazard analysis, the established operational PRP(s) and the HACCP
plan; the PRP(s), and the effectiveness of human resource management and training activities.
Validation is the process of obtaining evidence that the elements of food safety system are effective.
Prior to implementation of control measures of oPRP(s) and HACCP plan you have to ensure that the
end products meet the defined acceptable levels. If the validation results indicate abnormalities on
control measures, the amendments and reassessment are carried out.
Internal Audit
The company shall conduct periodic internal audits to determine whether or not the HACCP
management system conforms to the requirements, our internal procedures, and whether or not the
system has been effectively implemented and maintained. Such audits are in accordance with the
internal audit procedure. The procedure defines the requirements for internal auditors, for conducting
audits, and for recording the results and reporting them to management.
The HACCP Team Leader is responsible for scheduling and managing regular internal food safety
audits. Every area of the company that affects product safety and quality will be scheduled for internal
audits, according to the status and importance of the activities being audited taking into consideration
the results from previous audits.
Audits shall be performed by trained internal auditors who are independent of the area being audited.
Findings are reported on corrective action request forms, which are submitted to the HACCP Team
Leader. The HACCP Team Leader ensures that the management of the area being audited takes timely
corrective action to eliminate detected nonconformities and their causes. Once the action is completed,
the HACCP Team Leader, or designated representative, verifies the effective implementation of
corrective and preventive actions during subsequent audits or special follow-up audits. Audit findings
and results are reviewed at management review meetings.
7.12 Stage 11: Establish Documentation and record keeping

HACCP team shall establish documentation concerning all procedures and records appropriate to
these principles and their application.

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7.12.1 Control Of Documents
Food safety team Leader shall ensure that documents are identified and controlled as required by the
HACCP management system according to the Documents Control Procedure (Doc. No. OP/ QCD/
001). HACCP Team Leader shall ensure that documents:
 are reviewed and approved for adequacy prior to issue;
 are updated, reviewed, and approved for re-issue as necessary;
 are identified with their current revision status;
 are available at point of use;
 are legible, readily identifiable, and retrievable;
 of external origin are identified and their distribution is managed;
 After the action is taken on normal external origin document, the copy is kept in respective
file at registry.
 Obsolete documents and / or invalid documents are promptly removed from locations of issue
or use and are destroyed or correctly identified (those retained for legal and / or knowledge
preservation) to avoid unintended use.
7.12.1.2 HACCP Management System documentation
BIOTAN’s HACCP Management System documentation includes: Food Safety manual with HACCP
plan, Food Safety policy and related objectives, Operating Procedures (OP), Work Instructions (WI) ,
records’ Forms (OF) for implementing procedures, and other documents required by standard and the
company to ensure the effective development, implementation and updating of the Food Safety
Management System.
7.12.13 Documents Control Procedure

All HACCP related documents are controlled according to Documents Control Procedure (Doc. No.
OP/ QCD/ 001).

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7.12.2 Control of Records

BIOTAN maintains HACCP and food safety records in order to demonstrate conformance to specified
requirements and the effective operation of the food safety and HACCP management system. The
company makes sure that all HACCP Management system records are legible, stored and retained in
such a way that they are readily retrievable, in a suitable environment to prevent damage or
deterioration and loss. Each Department head is responsible for identifying, collecting, accessing,
organizing, maintaining and disposing its HACCP Management system records in accordance with
Record Control Procedure.
When specified contractually, HACCP Management system records are to be accessible for evaluation
for an agreed period. Retention times of HACCP Management system records are established and
recorded, as in Record Control Procedure. Records are established and maintained to provide evidence
of conformity to requirements and effective operation of Food Safety Management System.

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HACCP PLAN SAMPLE SHEET.

Company Name: Doc. No: HACCP/01
BIOTAN GROUP LIMITED Revision No: 0

7.6 Establishing the HACCP Plan
Date: AUGUST 18, 2022
7.6.1 HACCP Pla Page No. : Page 40 of 43
Table: HACCP Plan
CCPs Hazards to be Controlled Critical Limit(s) Control Measures Monitoring Procedures Corrections and Corrective Records of
at the CCP Action Monitoring
What? and How? When? Who?
CCP1: Aflatoxins contaminations 1.Moisture content i) Sample visual inspection i) Visual Inspection for any i) At receiving I) ICS Manager CCP1: Receiving of raw Raw
Receiving of in raw materials maximum 12% ii) Moisture contents sign of Mouldy smell, insects sample and cashew nut from purchasing
raw cashew 2.Absence of any determination damages, foreign matters. the ii) Quality farmers/before buying. Book.
nut from signs of moulds II)Determination of MC by consignment Controller
farmers/before using the Moisture Meter.
buying.
Steam temperature at min. 70 0

CCP 2: Salmonella Salmonella-Absent in I) Determination of moisture I) Hourly i) Boiler CCP 2: Steam cooking Drying Record
C.
25g, Y & M- 10 6 content by oven dry method operator Book
DRYING CFU/g in the Lab.
ii) Section
S/visor
i) Proper sealing (air tight) of

CCP3 Salmonella Salmonella-Absent in I)Visual check for proper I) After i) Drier CCP3 Packing
product packaging
25g, Y & M- 10 6 sealing sealing Operator Report Book
ii) Inspection of packing material
PACKING CFU/g ii) Visual inspection of every Drying
before being used
packing material prior filling ii) At ii) Supervisor.
product receiving
Company Name: Doc. No: HACCP/01
BIOTAN GROUP LIMITED Revision No: 0
Date: June 2009

Title: HACCP MANAGEMENT SYSTEM MANUAL Page No. : Page 42of 43
Appendix C: List of Standard Operating Procedures / Work instructions.
S/No. Document Title Document Number

1. HACCP Managrement System Document s Control Procedure Doc. No: OP/ QCD/001
2. HACCP Management System:Documents Writing Procedure Doc.No: OP/QCD/002
3. Complaints Handling Procedure Doc.No: OP/QCD/003
4. Products Transportation Safety Procedure Doc.No: OP/QCD/004
5. Corrective and Preventive Action (CAPA) Procedure Doc.No: OP/QCD/005
6.
7. Management Review Procedure Doc.No: OP/ADM/001
8. HACCPTraining Procedure Doc.No: OP/ADM/002
9. Internal Audit Procedure Doc.No.OP/ ADM/003
10. Withdrawal/ Recall Policy and Procedure Doc. No:OP/QCD/009
11. Pest Control Procedure Doc. No:OP/QCD/010
12. Material Receiving and Issuing Procedure Doc. No:WI/QCD/011
13. Equipment List, Maintenance Task Procedure Doc. No:OP/EGD/005
14.
15.
16.
17.
18. Packing Procedure Doc. No: WI/PRD/006
19. Records control procedure Doc. No:OP/QCD/011
20.
21.
22.
23.
24.
25.
26.

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Appendix D: Document Review Comments:

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Revision History Cover Sheet

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HACCP MANAGMENT MANUAL APPROVAL

Document Name : HACCP Management System Manual

This is a controlled document and not to be copied without authorization from

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5.0 Management Responsibility 10 0

6.0 Requiremets for the implementation of HACCP system

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2.0 NORMATIVE REFERENCES

3.0 TERMS AND DEFINITIONS.

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BIOTAN GROUP LIMITED

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4. DOCUMENTATION REQUIREMENT FOR IMPLEMENTATION OF HACCP

4.1 The HACCP Manual

 are reviewed and approved for adequacy prior to issue;

 are updated, reviewed, and approved for re-issue as necessary;

 are identified with their current revision status;

 are available at point of use;

 are legible, readily identifiable, and retrievable;

 of external origin are identified and their distribution is managed;

4.2.2 Document Changes

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4.3 Control of Records

5.0 MANAGEMENT RESPONSIBILITIES.

5.1. Top Management Commitment.

5.1.1 Authorities and responsibilities

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5.1.2 Board of Directors

5.1.4 Administrative Officer

5.1.5 Quality Controller

5.1.6 Factory Engineer

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5.1.7 Production Supervisors

5.1.8 HACCP Management System Team

5.1.9 All Personnel

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5.1.10 HACCP system Policy

BIOTAN GROUP LTD recognizes its responsibility towards providing

Our Food Safety Policy is based on openness, credibility, transparency,

The company is also committed to follows all the relevant National

To achieve the safe products, the company is committed to implement,

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5.1.11 Food Safety Objectives:

The Company overall objective is to implement and maintain a certified HACCP

5.1.12 External Communication

5.1.13 Internal Communication

Although informal communication is an effective method of transmitting information relating to

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5.2 Appointment of the management representative

5.3 Resources management.

5.3.1 Appointment of HACCP Team Leader.

5.3.2 Provision of Resources

5.3.3 Competence, Awareness and Training

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5.3.4 Work Environment

5.3.5 Training Needs

5.4 Management Review