BRALISON’S

FOOD SAFETY
MANUAL
For effective implementation of ISO 22000 Standard

BRA/ISO 22000/FSMS MANUAL/2025

 Table of Contents
FOOD SAFETY MANUAL................................................................................................................................. 1
For effective implementation of ISO 22000 Standard...........................................................................................1
1. INTRODUCTION......................................................................................................................................... 4
2. FOOD SAFETY STANDARDS..................................................................................................................... 5
3. TERMS AND DEFINITIONS..................................................................................................................... 18
4. UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT...........................................................17
a. Understanding the needs& Expectations of interested parties...................................................................18
b. Scope of food safety management System (refer Form 4)........................................................................19
c. Food Safety Management system............................................................................................................ 19
5. Leadership................................................................................................................................................... 20
5.1. Leadership and Commitment................................................................................................................... 20
5.2. Policy...................................................................................................................................................... 20
5.2.1. Establishing food safety policy............................................................................................................ 20
5.2.2. Communicating the Food Safety Policy...............................................................................................20
5.3. Organizational Roles, Responsibilities and Authorities............................................................................21
5.3.1. Roles of Food Safety Team Leader...................................................................................................... 21
6. PLANNING................................................................................................................................................. 21
6.1. Actions to Address Risks and Opportunities............................................................................................ 21
6.1.1. Actions to address risks and opportunities........................................................................................... 21
6.2. Objectives of the food safety management system and planning to achieve them.....................................22
6.2.1. Establishment of food safety objectives...............................................................................................22
6.3. Planning of Changes................................................................................................................................ 22
7. SUPPORTS................................................................................................................................................. 22
7.1. Resources................................................................................................................................................ 22
7.1.1. General............................................................................................................................................... 22
7.1.2. People................................................................................................................................................. 23
7.1.3. Infrastructure....................................................................................................................................... 23
7.1.4. Work Environment.............................................................................................................................. 23
7.1.5. Externally developed elements of the food safety management system................................................23
7.1.6. Control of externally provided processes, Products or services............................................................23
7.2. Competence............................................................................................................................................ 24
7.3. Awareness............................................................................................................................................... 24
7.4. Communication....................................................................................................................................... 25
7.4.1. External Communication..................................................................................................................... 25
7.4.2. Internal communication....................................................................................................................... 26
7.5. Documented information......................................................................................................................... 26
7.5.1. Creating and updating......................................................................................................................... 26
7.5.2. Control of Documented Information.................................................................................................... 26
8. OPERATIONS............................................................................................................................................ 27
8.1. Operation Planning and control............................................................................................................... 27
8.2. Prerequisite Programs (PRPs).................................................................................................................. 27
8.3. Traceability System................................................................................................................................. 28
8.4. Emergency Preparedness and response.................................................................................................... 28
8.4.1. General............................................................................................................................................... 28
8.4.2. Handling of emergencies and incidents................................................................................................ 28
8.5. Hazard Control........................................................................................................................................ 29
8.5.1. Preliminary steps to enable hazard analysis.........................................................................................29
8.5.1.1. General............................................................................................................................................... 29
8.5.1.2. Characteristics of raw materials, ingredients and product contact materials.........................................29
8.5.1.3. Characteristic of end products............................................................................................................. 29

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 8.5.1.4. Intended use........................................................................................................................................ 30
8.5.1.5. Flow Diagram and description of process............................................................................................ 30
8.5.1.5.1. Preparation of the flow diagrams..................................................................................................... 30
8.5.1.5.2. On site confirmation of the flow diagrams.......................................................................................30
8.5.1.5.3. Description of process and process environment..............................................................................30
8.5.2. Hazard analysis................................................................................................................................... 17
8.6. Updating the information specifying the PRPs and hazard control plan....................................................17
8.7. Control of monitoring and measuring...................................................................................................... 17
8.8. Verification related to PRPs and hazard control plan...............................................................................18
8.8.1. Verification......................................................................................................................................... 18
8.8.2. Analysis of results of verification activities.........................................................................................18
8.9. Control of Product and Process nonconformities......................................................................................17
8.9.1. General............................................................................................................................................... 17
8.9.2. Corrections.......................................................................................................................................... 17
8.9.2.1.................................................................................................................................................................. 17
8.9.2.2.................................................................................................................................................................. 17
8.9.2.3.................................................................................................................................................................. 17
8.9.2.4.................................................................................................................................................................. 17
8.9.3. Corrective actions............................................................................................................................... 17
8.9.4. Handling potentially unsafe products................................................................................................... 17
8.9.4.1. General............................................................................................................................................... 17
8.9.4.2. Evaluation for release.......................................................................................................................... 18
8.9.4.3. Disposition of nonconforming products............................................................................................... 18
8.9.5. Withdrawal/ recall............................................................................................................................... 18
9. Performance evaluation............................................................................................................................... 19
9.1. Monitoring, Measurement, Analysis and Evaluation................................................................................19
9.1.1. General............................................................................................................................................... 19
9.1.2. Analysis and evaluation....................................................................................................................... 19
9.2. Internal Audit.......................................................................................................................................... 19
9.2.1.................................................................................................................................................................... 19
9.2.2.................................................................................................................................................................... 20
9.3. Management Review (how often?).......................................................................................................... 20
9.3.1. Management Review output................................................................................................................ 21
10. Improvement........................................................................................................................................... 21
10.1.1. Nonconformity and corrective action plan........................................................................................... 21
10.1.2................................................................................................................................................................... 21
10.2. Continual improvement........................................................................................................................... 21
10.3. Update of the food safety management system........................................................................................22
Process Flow Diagram (UNI-DIRECTIONAL PROCESS)...............................................................................23

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 1. INTRODUCTION
This document
 Summarizes Bralisoninvest Company EPZ Limited’s Food Safety policy,
 Defines the scope of the food safety system
 Outlines our management system
 Details our key objectives and
 Key principles for managing food safety.

Bralison’s Food Safety priority is based on its stakeholder’s belief and experience that
commercial success and good food safety practice and performance are long-term compatible
goals. The intent of the policy is to provide a framework for employees to effectively manage
the food safety management system. We employ a systematic approach to plan, implement and
review our processes to ensure Food Safety.
This manual is for Bralisoninvest Company EPZ Limited’s Warehouse in Athi River.
Bralisoninvest Company EPZ Limited operates a food safety management system based on ISO
22000:2018 standard and is designed to control all hazards identified in its processes.
Bralisoninvest Company EPZ Limited has the responsibility of assuring compliance with
appropriate/applicable regulatory laws, guidelines, standards and codes of conduct. These
responsibilities have been assigned to various staffs at different levels within the organization
(See organogram). The managing director ensures that all employees are aware of their
responsibilities and mechanisms are in place to monitor the effectiveness of their operations.
Bralison will ensure, through induction and training, that all staff are aware of the food safety
management system. Bralison will also ensure that all food handlers receive appropriate training.
The company food safety policy statement will be placed in a suitably visible position and
communicated to all staff during their induction training.

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 2. FOOD SAFETY STANDARDS
Our company recognizes the importance of ensuring that its produce brands are not placed at
risk, either during processing, distribution or while in its warehouses.
A positive food safety culture is encouraged within the organization and is actively supported by
senior management. The is committed to conducting its business taking all responsible
precautions and ensuring due diligence is exercised to protect and preserve the human food chain
at all stages of involvement. The stages of involvement and therefore the scope of the
BRALISON’S Food Safety Management System are outlined in Figure 1: Process Flow
Diagram (appendixes)
The company’s approach to food safety is based on the internationally recognized Hazard
Analysis Critical Control Point (HACCP), system, which involves the identification of hazards,
determination of critical control points and identification, and implementation, of effective
control and monitoring measures.

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 1. Hazard analysis

7. Documentation 2. Critical
control Points

HACCP 3 Critical Limits

PLAN
6. Verification

5. Corrective
Actions 4. Monitoring

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 3. TERMS AND DEFINITIONS

Term Definition
Food Safety Concept that food will not cause harm to the consumer when it is prepared
and/or eaten according to its intended use.
Food Chain Sequence of the stages and operations involved in the production, processing,
distribution, storage and handling of a food and its ingredients, from primary
production to consumption.
Food Safety Biological, chemical or physical agent in food, with the potential to cause an
Hazard adverse health effect.
Control Measure Food safety action or activity that can be used to prevent or eliminate a food
safety hazard or reduce it to an acceptable level
End Product Product that will undergo no further processing or transformation by the
organization.
PRP – Prerequisite Food safety basic conditions and activities that are necessary to maintain a
Program hygienic environment throughout the food chain suitable for the production,
handling and provision of safe end products and safe food for human
consumption. Examples of PRP would include Good Hygiene Practice (GHP)
and Good Distribution Practice (GDP).
CCP – Critical Food safety step at which control can be applied and is essential to prevent or
Control Point eliminate a food safety hazard or reduce it to an acceptable level.

Critical Limit Criterion, which separates acceptability from unacceptability. Critical limits are
established to determine whether a CCP remains in control.
HACCP – Hazard A system, which identifies, evaluates and controls hazards which are significant
Analysis Critical for food safety.
Control Point
HACCP Plan A document prepared in accordance with the principles of HACCP to ensure
control of hazards which are significant for food safety in the segment of the
food chain under consideration
Hazard Analysis The process of collecting and evaluating information on hazards and conditions
leading to their presence to decide which are significant for Food Safety and
therefore should be addressed in the HACCP plan.
Validation Obtaining evidence that the control measures managed by the HACCP plan and
by the operational PRP’s are capable of being effective.

Verification Confirmation, through the provision of objective evidence, that specified

requirements have been fulfilled. The application of methods, procedures, tests
and other evaluations, in addition to monitoring to determine compliance with
the HACCP plan

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 4. UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT

Our company has determined external and internal issues that are relevant to its
purpose and that affect its ability to achieve the intended results of Food Safety
management system. It shall monitor and review and update information relating to
these external and internal issues.

Internal Issues
 The workflow of the organization, including roles and duties assigned to employees.
 The state of working conditions.
 Availability and utilization of resources.
 Rules, regulations, and policies governing the achievement of objectives.
 Client availability.
 The culture of food safety in the organization and the relationship between it and the
employees.
 The linkage between the company and its locations, period or activity.
 The competence of the labor force.
 Knowledge management and succession planning.

External Issues
 The actual surroundings in which a business operates such as politics, social and
cultural factors, laws and regulations and natural surroundings.
 Entities responsible for a successful business cycle including suppliers, contractors,
partners and competitors.
 Laws both at state and international levels.
 The presence of external product or service providers.
 Consumption trends and patterns.
 Industry trends.
 The influence played by the company’s products or services on the safety of food.

Through the strategic and operational planning process, our company identified external and
internal issues that are relevant to the purpose and direction of the organization and how
they affect the ability to achieve intended results.
The Organizational Context involves:
 Understanding the company’s core products and services;
 Identifying “interested parties” (stakeholders) - those who receive our products, or
may be impacted by them, or those parties who may otherwise have a significant
interest in the organization;
 Identifying and understanding the needs and expectations of interested parties;

 Determining the scope of the food safety management system.

The company has identified interested parties as follows:

 Customers/end users
 Share holders
 Employees
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  Suppliers
 Government
 Community
 Competitors
 Certification bodies

a. Understanding the needs& Expectations of interested parties.

Our company has identified the interested parties and their expectations as follows;

S.no Interested Party Expectation (s)

1 Consumers/end-users  Safe products, prepared in hygienic conditions
in the absence of all health hazards.
 True and legible information on packaging
about products

2 Employees  Safe working conditions that poses no

occupational infections or injuries.
 Foster professional development & growth
through benefits, rewards & training.
 Correct product handling instructions

3 Government  Safe products

 Correct labeling of products
 Adherence to food safety legislations, collective
health of the people & their longevity.
4 Community  Conducive environment around our operations.
 Improve human health

5 Suppliers  Clear specifications on food safety requirements

 Continuous orders
 Prompt payments
 Long working relationship
 Clear channels of communication
6 Competitors  Level playing field

7 Certification bodies  Effective Implementation of food safety

standards
8 shareholders  Stable dividends /profits
 Reliable and long term cooperation, minimal
risk of supply chain disruption and legal and
financial compliance as well as avoiding fines
and penalties while recording excellent
performance.

Bralison shall review and updated as appropriate information related to interested parties
and their requirements.

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 b. Scope of food safety management System (refer Form 4)
Receiving of raw materials and fresh produce (fruits and vegetables), first stage quality
checks to determine acceptability, processing by cleaning, grading, sorting, second quality
check, labelling, storage and dispatch of the processed fresh fruits and vegetables

Product Categories
Products are vegetables which include;
 Potatoes (Irish)
 Onions(red)
 Cabbage
 Carrots

Functions in the company

Activities and processes are in the following departments of the company:
 Technical and compliance
 Accounts
 Administration, procurement and human resource

This scope applies to BRALISONINVEST COMPANY EPZ LIMITED located at EPZ,

ATHI RIVER-B1, SME PARK, P.O BOX 6368-00200, NAIROBI

c. Food Safety Management system.

Bralison’s Food Safety Management System includes;

a. Food Safety Policy;

b. Food safety objectives;
c. Food safety manual;
d. Prerequisite program Manual;
e. Work instructions, process procedures and internal standards;
f. Applicable national, international, and industry standards;
g. Product technical specifications
h. Production and quality plans; and
i. Customer supplied documentation such as specifications, test procedures, work
instructions, inspection instructions, etc.

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 5. Leadership

5.1.Leadership and Commitment

Our company’s top management demonstrates leadership and commitment to the Food
Safety Management System by:
a. Ensuring Food safety policy and the objectives of FSMS are established and are
compatible to the strategic direction of the organization.
b. Ensuring the integration of FSMS requirements into the organization’s business
process
c. Availing resources needed for FSMS
d. Communicating the importance of effective FSMS and conforming to FSMS
requirements, applicable statutory and regulatory requirements and mutually agreed
customer requirements to food safety.
e. Ensuring the FSMS is evaluated and maintained to achieve intended results
f. Directing and supporting persons to contribute to effective FSMS. This is done
through trainings and assigning roles to different FSMS team members in the
organization.
g. Promoting continual improvement. Done through investment in new technology
and adopting emerging good manufacturing practices in order to enhance food
safety.
h. Supporting the relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility. Our top management participates in
management review where issues touching on their various sections/ departments
are addressed. They also guide FSMS team under them in order to promote safe
good practices in their departments.

5.2.Policy

5.2.1.Establishing food safety policy

The BRALISON’s Top Management has established, implemented and maintained the
Food Safety Policy ref: FORM 1 that:
a. Is appropriate for the purpose and context of the organization;
b. Provides a framework for setting and reviewing the objectives of FSMS
c. Includes a commitment to satisfy applicable food safety requirements including
statutory and regulatory requirements and mutually agreed customer requirements
related to food safety.
d. Addresses internal and external communication
e. Includes a commitment to continual improvement
f. Addresses the need to ensure competencies related to food safety.
The food safety policy is annexed to this document.

5.2.2.Communicating the Food Safety Policy

BRALISON’s food safety policy has been;
a. Availed and maintained as documented information
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 b. Communicated, understood and applied at all levels of the organization. It has been
communicated through notice boards, intranet and also during produce hour.
c. Availed to our relevant interested parties such as suppliers and contractors

5.3.Organizational Roles, Responsibilities and Authorities

BRALISON’s top management has ensured that the responsibilities and authorities for
relevant roles are assigned, communicated and understood within the organization. Top
management shall assign the responsibility and authority for:
a. Ensuring the FSMS conforms to the requirements of ISO 22000:2018 standard
b. Reporting the performance of FSMS to top management. This is done by the food
safety team leader.
c. Appointing the food safety team and food safety team leader. BRALISON has
appointed the multi-disciplinary food safety team. A food safety team leader has also
been appointed.
d. Persons with authority and responsibility to initiate and document actions have been
designated.

5.3.1. Roles of Food Safety Team Leader

BRALISON’s food safety team leader shall be;
a. To ensure FSMS is established, implemented, maintained and updated
b. To manage and organize the work of food safety team.
c. To ensure relevant training and competencies for the food safety TEAM.
d. To report to top management on effectiveness and suitability of FSMS.

BRALISON encourages everyone across the board to report problems with regards to
FSMS to food safety TEAM member(s), food safety TEAM leader or supervisors.

6. PLANNING

6.1.Actions to Address Risks and Opportunities

During planning of FSMS, BRALISON considered the organization and its context and
needs and expectations of interested parties. The risks and opportunities have been
identified for the organization in order to;
a. Give assurance that FSMS can achieve intended results
b. Prevent or reduce undesired effects
c. Achieve continual improvement

6.1.1.Actions to address risks and opportunities

BRALISON has planned to address risks and opportunities relating to food safety as
contained in the food safety risk register. The food safety risk /opportunity register is
annexed to this document

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 6.2.Objectives of the food safety management system and planning to
achieve them.

6.2.1.Establishment of food safety objectives

BRALISON has established food safety objectives refer form 2 at relevant levels in the
organization. The objectives are;
a. Consistent with food safety policy
b. Measurable where applicable
c. Takes into account applicable food safety requirements, including statutory,
regulatory and customer requirements.
d. Monitored and verified
e. Communicated. The objectives are communicated to the relevant members of staff.
f. Maintained and updated as appropriate.

BRALISON has determined;

a. What will be done
b. What resources will be required
c. Who will be responsible
d. When it will be completed (where appropriate)
e. How the results will be evaluated.

6.3.Planning of Changes
When BRALISON determines the need for changes FSMS, including personnel changes,
the change shall be carried out and communicated in a planned manner. BRALISON will
consider;

a. The purpose for the changes and the potential consequences;

b. The continued integrity of FSMS
c. The availability of resources to effectively implement the changes
d. The allocation or re-allocation of responsibilities and authorities.

7. SUPPORTS

7.1.Resources

7.1.1.General
BRALISON has determined and provided the resources needed for it to establish,
implement, maintain, update and continual improvement of the FSMS. The company has
considered;
a. Capacity of, and any constraints on, existing internal resources
b. The need for external resources.

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 7.1.2.People
BRALISON has ensured that persons necessary to operate and maintain an effective FSMS
are competent. Where the company will seek the assistance of external experts in the
development, implementation, operation or assessment of FSMS, evidence of agreement or
contracts defining the competency, responsibility and authority of external experts shall be
retained as documented information.

7.1.3. Infrastructure
BRALISON has provided the resources for the determination, establishment and
maintenance of infrastructure necessary to achieve conformity with requirements of FSMS.
The Infrastructure includes:
a. Land, Buildings, workspace and associated utilities;
b. Equipment, including both hardware and software;
c. Supporting services like transportation resources; and
d. Communication and information technology.

7.1.4.Work Environment
BRALISON has determined, provide and maintained the resources for the establishment,
management and maintenance of work environment necessary to achieve conformity with
requirements of FSMS. Suitable work environment has been provided and this include
a. Social(non-discriminatory, cam, non-confrontational-proper manner on handling
issues to deal with wedding rings, hair e.tc)
b. Psychological (stress reducing e.g. wellness program being run by the company)
c. Physical. Enough lighting is provided in the working areas and also there is natural
flow of air. The workplace is also maintained in a hygienic state and restrooms are
provided.

7.1.5.Externally developed elements of the food safety management

system.
BRALISON has not used any external resource in FSMS development. Elements of this
clause will be implemented should function be outsourced in future.

7.1.6.Control of externally provided processes, Products or services.

BRALISON has established and applied a criterion for evaluation, selection, monitoring of
performance and re-evaluation of external providers of processes, products and services.
This is documented in Purchasing Standard Operating Procedure. The procedure is;
a. Ensures that the relevant information to FSMS is communicated to external
providers. This done through material specification sheets which are sent out to the
suppliers. The external provided resources are also checked against the
specifications once they are received and this ensures that only conforming inputs
are used in realization of safe products.
b. The specifications are retained as documented information and records of analysis of
the externally provided resources are retained.

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 7.2. Competence

BRALISON has
a. Determine the necessary competence of persons doing work under its control which
affects food safety performance. This is contained in individual position job
descriptions.
b. Ensured that persons including food safety TEAM and those responsible for the
operation of hazard control plan are competent on the basis of appropriate training,
education or experience.
c. Ensured that the food safety TEAM is multi-disciplinary in terms of knowledge and
experience in developing and implementing the FSMS of the organization.
d. Has provided training to persons doing work in FSMS and evaluation is done for
the same to make sure the gaps which were there been closed.
e. Retained documented information as evidence.

7.3. Awareness
BRALISON ensured that all persons doing FSMS related work and who are under its
control are aware of;
a. Food safety policy. The food safety policy is communicated to staff through the
notice boards, intranet. The policy has is also and explained to the staff during the
monthly produce hour.
b. The FSMS objectives are also communicated to staff through the notice boards and
also during allocation of duties. This is done in order to have a buy in from staff.
c. Individual contribution. Staff are made of their individual contribution in attaining
the FSMS objectives and the overall performance of FSMS. The benefits of FSMS
are cascaded downwards to all staff.
d. The implications of not conforming to FSMS. Staff are told of consequences of not
conforming to FSMS. Such implications include: illnesses, legal costs, loss of
customer confidence which damages the organization reputation. All these could
result in job losses.

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 7.4. Communication
BRALISON has determined relevant FSMS communications both internal and external.
These include;
What To When To Whom How Who
Communicat
e
Food safety When Staff Verbally team leader
policy necessary Notice boards FSMS team
Audit team

supplier Availing copies

Food safety Allocation Staff Memos FSMS team leader
objectives Departmental employees Individual
meeting supervisor
Specification LPO issuance suppliers By mail. Avail copies via mail PSC
s
bi annual Statutory Verbal and emails CEO
Public medical and
health check ./pre- regulatory
matters employmen authorities:
/staff t medical
medica check
l check

Other Thru will be done by

Information When there is interested letters/mails/telephone/contracts the head of the
on the an impact on, parties section which
effectiveness or will be consultants, receives it
or updating affected by, training services/ products
of food safety food safety providers
management management and many
system. system other
advisory
bodies

7.4.1. External Communication

BRALISON has ensured that sufficient information is communicated externally and is

available to interested parties in the food chain. The company maintains an effective
communication with external provider’s and contractors, customers/ consumers. The
company communicates with external providers through local purchase orders, emails. We
communicate with customers/ consumers through product literature on the packaging,
emails flyers and mass media. Produce sale agreements are also entered into with produce
suppliers where the requirements of this clause are considered.

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 7.4.2. Internal communication
BRALISON establishes, implements and maintains an effective system of communicating
issues having an impact on food safety. The food safety TEAM is informed in a timely
manner of changes in the following;
a. Products or new products
b. Raw materials, ingredients and services
c. Production systems and equipment
d. Production premises, location of equipment and authorizations
e. Cleaning and sanitization programs
f. Packaging, storage and distribution systems
g. Competencies and or allocation of responsibilities or authorizations
h. Applicable statutory and regulatory requirements
i. Knowledge regarding food safety hazards and control measures
j. Customer, sector and other requirements that BRALISON observes
k. Relevant enquiries and communication from external interested parties
l. Complaints and alerts indicating food safety hazards associated with the end product
m. Other communication that has an impact on food safety.
All these requirements will be included during the updating of the FSMS and relevant
information will be included as input during management review.

7.5. Documented information

BRALISON’s FSMS shall include;

a. Documented information required by ISO 22000:2018 standard. This will include
but not limited to; PRP manual, food safety policy.
b. Documented information as determined by BRALISON as necessary for
effectiveness of FSMS such as food safety manual, quality plans etc.
c. Documented information required by statutory, regulatory authorities and
customers. Such documents include customer specifications, standards and legal
notices.

7.5.1.Creating and updating

When creating and updating documented information BRALISON will ensure appropriate;
a. Identification and description (e.g. a title, date, author or referent number)
b. Format e.g. language, software version, graphics) and media (e.g. paper, electronic)
c. Review and approval for suitability and adequacy.

7.5.2.Control of Documented Information

All documented information required by FSMS shall be controlled to ensure;

a. Is available and suitable for use, where and when needed. Documented information
will be availed to the users through the intranet.

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 b. It’s adequately protected. The documents availed through the intranet will be
protected from interference in that the users will not be allowed to edit/ print the
documents.
Control of documented information is covered under Control of Documents and SOP.

8. OPERATIONS

8.1.Operation Planning and control

BRALISON has planned, implemented, controlled, maintained and updated the processes
needed to meet the requirements for the realization of safe products and to implement the
action determined in clause 6.1 by;
a. Establishing the criteria for the processes. The layout of production environment
was considered during zoning of the different processes involved in order to avoid
reflux of products/ ingredients thus avoiding cross contamination. There is a
separate entrance for personnel and raw materials. There is sanitation station for use
by personnel before entering the production sites. Ablution block is also situated
outside the production environment. Interrelated activities were put together while
departments were being created in for smooth flow of activities and tasks. There is
also sequential flow of activities where raw materials (loose produce are stored at
the upper floor) while packaging is done at the lower floor.
b. Implementing control of processes in accordance to criteria. The process controls
have been implemented as designed to make sure that outputs which goes to the next
stage as input meets the set criteria before release. Produce received from source
factories are tested in line with set criteria before being accepted into the system.
The same is done during blending where the produces have to achieve the
determined density before being released for packaging. The same criterion is also
applied for packaging materials during receipt as they have to be analyzed against
the set criteria before acceptance/ rejection.
c. Keeping documented information to extent necessary to have confidence to
demonstrate that processes have been carried out as planned. Documented
information is retained as evidence on the performance of various processes in the
operation.
BRALISON controls planned changes and reviews the consequences of unintended changes
taking action to mitigate any adverse effects as necessary.

8.2. Prerequisite Programs (PRPs)

BRALISON has established, implemented, maintained and keeps updating the PRPs to
facilitate prevention and/ or reduction of contaminants (including food safety hazards) in the
products, production processing and work environment.
BRALISON has documented the PRPs as contained in the PRP Manual.

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 8.3. Traceability System
Traceability system procedure (refer FORM 8) in place in the company which uniquely
identifies incoming raw materials from suppliers and first stage of receiving of the product.
Each supplier’s are given unique product identification code which are recorded in the
traceability record.
The traceability records provides the information as follows;
 Farm location
 Block number
 Crop ID
 Year
 Order number
Reworking of the produce after recalling can easily be done after withdrawing the product

8.4.Emergency Preparedness and response

8.4.1.General
BRALISON’s management has ensured procedures are in place to respond to potential
emergency situations or incidents that can have an impact on food safety which are relevant
to our role in the food chain.
The company has developed and Emergency response procedure which specifies how to
respond to emergency situations.

8.4.2. Handling of emergencies and incidents

BRALISON shall respond to emergency situations by following the set procedure ref
FORM 3 by
 Ensuring applicable statutory and regulatory requirements are identified.
a) The applicable regulatory requirements identified are, Public health act cap
254 and the standards act cap 486.
b) BRALISON will communicate internally about the emergency situations to
food safety TEAM and relevant staff in order to find ways of mitigating the
emergency.
c) Communicating externally. The company will communicate externally to
suppliers of affected raw materials; customers about the affected lot and
appropriate authorities about the emergency. The media will also be
informed about the situation depending on the scale of the emergency.
 Take action to reduce the consequences of the emergency situation, appropriate to
the magnitude of the emergency or incident and the potential food safety impact.
Mitigation measures shall be put in place in order to reduce consequences of
emergency situations. This will include but not limited to; isolation and disposal of
the affected lot.
 Mock recall shall be conducted periodically to test the effectiveness of procedures.
 Review and where necessary, update the emergency preparedness procedure after
occurrence of any incident, emergency situations or tests. A post review will be done
and any shortcomings in the procedures will addressed by reviewing the emergency
preparedness procedures.

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 8.5. Hazard Control

8.5.1.Preliminary steps to enable hazard analysis

8.5.1.1. General
Bralison has collected, maintained and updated all information needed to conduct hazards
analysis. Records, which pertain to this, are contained in the hazards analysis plan refer
FORM 5 (HCCP PLAN)). Some of the documented information includes
a. Applicable statutory, regulatory and customer requirements. Some of such records
include product standards, public health act.
b. The company’s products, processes and equipment. Material safety data sheets and
machine manuals formed part of the documented information used.
c. Food safety hazards relevant to the FSMS. Known food safety hazards associated
with produce was taken into account during HACCP study.

8.5.1.2.Characteristics of raw materials, ingredients and product

contact materials.
Bralison has ensured all applicable statutory and regulatory food safety requirements were
identified for all raw materials, ingredients and product contact materials. Documented
information concerning all raw materials, ingredients and product contact materials to the
extent needed to conduct a hazard analysis including the following as appropriate;
a. Biological, chemical and physical characteristics
b. Composition of formulated ingredients, including additives and processing aids
c. source
d. Place of origin
e. Method of production
f. Method of packaging and delivery
g. Storage conditions and shelf life
h. Preparation and or handling before use or processing
i. Acceptance criteria related to food safety or specifications of purchased materials
and ingredients appropriate to their intended use.

8.5.1.3.Characteristic of end products

Bralison has ensured that all applicable statutory and regulatory food safety requirements
are identified for all the end products intended to be produced. Documented information to
the extent necessary for hazard analysis concerning characteristics of end products including
the following
a. Product name or similar identification
b. Composition
c. Biological, chemical and physical characteristics relevant to food safety
d. Intended shelf life and storage conditions
e. Packaging
f. Labelling relating to food safety and/ or instructions relating to handling,
preparation and intended use
g. Distribution and delivery method
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 8.5.1.4.Intended use
The intended use including reasonably expected handling of the end product and any
unintended use but reasonably expected mishandling and misuse of the end product will
be considered and will be maintained as documented information to the extent necessary
for the company to conduct the hazard analysis. Group of consumers/users will be
identified for each of products. Our company shall identify groups of consumers/ users
known to be especially vulnerable to food safety hazards being controlled.

8.5.1.5. Flow Diagram and description of process.

8.5.1.5.1. Preparation of the flow diagrams

Food safety TEAM has established, maintained and updated the flow diagrams as
documented information for the products/ product categories and processes covered by
FSMS. The flow diagrams were used when conducting hazard analysis as a basis for
evaluating the possible occurrence, increase, decrease or introduction of food safety
hazards. Flow diagrams includes the following where appropriate;
a. The sequence and interaction of the steps in the process
b. Outsourced services
c. Raw materials, ingredients, processing aids, packaging materials, utilities and
intermediate products enter the flow
d. Where reworking and recycling takes place
e. Where the end products, intermediate products, by products and waste are
released or removed.

8.5.1.5.2.On site confirmation of the flow diagrams

Bralison’s food safety TEAM carried out on site confirmation of the flow diagrams. The flow
diagrams were updated as appropriate and retained as documented information.

8.5.1.5.3.Description of process and process environment.

Food safety TEAM has described to the extent needed to conduct a hazard analysis;
a. The layout of premises, including food and non-food handling areas
b. Process equipment and contact materials, processing aids and flow of materials
c. Existing PRPs, process parameters, control measure or the strictness with which they
are applied, or procedures that can influence food safety.
d. External requirements (statutory and regulatory or customer requirements) that can
impact the choice and strictness of the control measures.
Variations resulting from expected seasonal changes or shift patterns shall be included as
appropriate. The description of process and process environment has been documented in
the PRP manual ref FORM 6

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 8.5.2. Hazard analysis

Bralison’s food safety TEAM has conducted hazard analysis based on preliminary
information, to determine the hazards that need to be controlled. The degree of control
ensured food safety. The hazard analysis & assessment document is appendixes to this
manual.

8.6. Updating the information specifying the PRPs and hazard control
plan

The following information shall be updated where necessary;

a. Characteristics of raw materials, ingredients and product- contact materials
b. Characteristics of end products
c. Intended use
d. Flow diagrams and descriptions of process and process environment
Bralison shall ensure that hazard control plan and PRPs are up to date.

8.7.Control of monitoring and measuring

Bralison uses specified monitoring and measuring methods and equipment which are
adequate for monitoring and measuring PRP activities and hazard control plan. The
monitoring and measuring equipment used shall be;
a. Calibrated at specified intervals prior to use. The equipment in use for monitoring/
measurement are calibrated on an annual basis as per control of monitoring and
measuring equipment SOP FORM NO 9
b. Adjusted or re-adjusted as necessary
c. Identified to enable calibration status to be determined. Each calibrated equipment
shall have a sticker affixed to it showing the calibrate date, due date and equipment
serial number where applicable.
d. Safeguarded from adjustments that would invalidate the measurement results. The
equipment is protected from unauthorized access and calibrations as equipment
manuals which detailed calibration procedure are kept away by authorized only.
e. Protected from damage and deterioration
Calibration and verification certificates shall be provided by the body undertaking the
same. All calibrations shall be traceable to international/ national standards and where no
standards exist the basis used for calibration or verification shall be retained as documented
information.
Bralison shall assess the validity of the previous measurements results when the equipment
or process environment is found not to conform to requirements. Appropriate action in
relation to the equipment or process environment and any product affected by the non-
conformance.
The assessment and resulting action shall be maintained as documented information.
The software used in monitoring and measurement within FSMS shall be validated by the
Bralison, software supplier or third party prior to use and information on validation
activities shall be documented and maintained. Software shall be updated as when required.

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 Whenever there are changes, including software configuration/ modifications to
commercial off- the –shelf software, they shall be authorized, documented and validated
before implementation.

8.8.Verification related to PRPs and hazard control plan

8.8.1.Verification
Bralison has established, implemented and maintained verification activities. The
verification planning shall define purpose, methods, frequencies and responsibilities for
verification activities. Verification activities shall confirm that;
a. The PRPs are implemented and effective
b. The hazard control plan is implemented and effective
c. Hazard levels are within identified acceptable levels
d. Input to hazard analysis is updated
e. Other actions determined are implemented and effective.
Verification activities shall not be carried out by the persons responsible for monitoring the
same activities. Documented information on verification activities shall be retained and
communicated.
Where verification activities is based on testing the end product samples or direct process
samples and were such tests samples show nonconformity with acceptable level of food
safety hazard, the company shall handle the affected lots as potentially unsafe and apply
corrective actions as per Handling potentially unsafe products procedure ref FORM 10

8.8.2.Analysis of results of verification activities

Bralison’s food safety TEAM shall conduct an analysis of the results of verification that shall
be used as input to the performance evaluation of FSMS.

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 8.9. Control of Product and Process nonconformities

8.9.1.General
Bralison shall ensure that data received from monitoring of OPRPs and at PRPs are
evaluated by designated persons who are competent and have authority to initiate
corrections and corrective actions. Authorized persons in the company warehouse manager
and technical person.

8.9.2. Corrections

8.9.2.1.
Bralison ensures that when PRPs or action criteria for OPRPs are not met, the products
affected are identified and controlled in regard to their use and release. Bralison has
established, maintained and continue to update documented information that includes;
a. Method of identification, assessment and correction for affected products to ensure
their proper handling. The affected products are identified during implementation of
quality plans in place. The affected products will be assessed by re-subjecting to
existing quality plans.
b. Arrangements for review of corrections carried out. The products will be subjected
to fresh tests to check if they meet the set parameters. The products will only be
released if set parameters are met. The product might also be downgraded if it meets
the parameters of a lower product.

8.9.2.2.
When critical limits at PRPs are not met, affected products shall be identified and handled
as potentially unsafe products.

8.9.2.3.
Where action criterion for an OPRP are not met, the following shall be carried out;
a. Determination of consequences of that failure with respect to food safety
b. Determination of cause(s) of failure
c. Identification of affected products and handling in accordance to with disposition of
nonconforming products
Results of evaluation shall be retained as documented information.

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 8.9.2.4.
Documented information shall be retained to describe corrections made on nonconforming
products and processes including;
a. Nature of nonconformity
b. Cause of the failure
c. The consequences as a result of nonconformity

8.9.3. Corrective actions

Need for corrective action will be evaluated when PRPs or action criteria for OPRPs are not
met. Documented information that specifies appropriate actions to identify and eliminate the
cause of detected non conformities, to prevent recurrence and to return the process to
control after non conformity is identified have been established by the company under
corrections and corrective actions procedure FORM 11. These actions include;
a. Reviewing nonconformities identified by the customer or customer complaints or
regulatory inspections reports
b. Reviewing trends in monitoring results that can indicate loss of control
c. Determining the causes of nonconformities
d. Determining and implementing actions to ensure that nonconformities do not recur
e. Documenting the results of corrective actions taken
f. Verifying corrective actions taken to ensure that they are effective.
Documented information of all corrective actions will be retained by Bralison.

8.9.4.Handling potentially unsafe products

8.9.4.1.General
Bralison shall take actions to prevent potentially unsafe products from entering the food
chain unless;
a. The food safety hazards of concern are reduced to defined acceptable levels
b. The food safety hazards of concern will be reduced to identified acceptable levels
prior to entering the food chain
c. The product still meets the defined acceptable levels of the food safety hazard of
concern despite the nonconformity.
Products that have been identified as potentially unsafe under our control until they have
been evaluated and disposition determined. Where the products will have left the control of
warehouse are determined to be unsafe, the company shall notify relevant interested parties
and initiate a withdrawal as per Handling Potentially unsafe and withdrawals procedure ref
FORM 10. Controls and related responses from relevant interested parties and authorization
for dealing with potentially unsafe products shall be retained by company as documented
information.

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 8.9.4.2. Evaluation for release
Bralison shall evaluate products affected by nonconformity and products affected by failure
to remain within the critical limits at CCPs shall not be released but shall be handled in
accordance with disposition of nonconforming products. Products affected by failure to
meet action criterion for OPRPs shall only be released as safe when any of the following
conditions apply;
a. Evidence other than the monitoring system demonstrates that the control measures
have been effective
b. Evidence shows that the combined effect of the control measures for that particular
product conforms to the performance intended (identified acceptable levels)
c. The results of sampling, analysis and/ or other verification activities demonstrate
that the affected products conform to acceptable levels for the food safety hazard(s)
concerned.
Results of evaluation for release of products shall be retained as documented information.

8.9.4.3. Disposition of nonconforming products

Products that are not accepted for release shall be;
a. Reprocessed or further processing within or outside Bralison to ensure that the food
safety hazard is reduced to acceptable levels
b. Redirected for other use as long as food safety in the food chain is not affected
c. Destroyed or disposed as waste as per EMCA regulations of 2006
Documented information on the disposition of non-conforming products, including the
identification of the person(s) with approving authority shall be retained.
(How is it determined which option to take- a, b, or c)?

8.9.5. Withdrawal/ recall

Bralison shall ensure timely withdrawal/ recall of lots of end products that have been
identified as potentially unsafe, by appointing competent persons having authority to initiate
and carry out the withdrawal/ recall. The following offices holder’s/persons have been
appointed to product withdrawal committee;
1. Manager/ Fsms Team Leader
2. Technical Officer
3. Warehouse Manager
Bralison has established and maintained documented information under Handling
Potentially unsafe and withdrawals procedure ref FORM 10. The procedure details;
a. Notifying relevant interested parties (statutory and regulatory bodies, customers and
consumers)
b. Handling withdrawn/ recalled products as well as products still in stocks
c. Performing sequence of actions to be taken
Withdrawn/ recalled products and end products still in stock shall be secured/ held under
control of the company until they are managed in accordance to Handling Potentially unsafe
and withdrawals procedure ref FORM 10. The cause, extent and result of withdrawal/ recall
shall be retained as documented information and reported to top management as input for
management review. Bralison shall from time to time verify implementation and
effectiveness of withdrawals/ recall through use of appropriate techniques e.g. mock
withdrawal/ recall or practice actual withdrawal/ recall and retain documented information.

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 9. Performance evaluation

9.1. Monitoring, Measurement, Analysis and Evaluation

9.1.1.General
Bralison has determined;
a. What needs to be monitored and measured? The following will be monitored and
measured; OPRPs, Verification plan, PRPs, food safety objectives, trainings
b. The method for monitoring, measurement, analysis and evaluation as applicable to
ensure valid results. This will be as per the verification plan.
c. When the monitoring an measurement will be performed
d. When the results from monitoring and measurement shall be analyzed and evaluated.
e. Who shall analyze and evaluate the results from monitoring and measurement
Details of the above are contained in the verification plan of FSMS. Documented
information will be retained by BRALISON.

9.1.2. Analysis and evaluation

Bralison shall analyze and evaluate appropriate data and information arising from
monitoring and measurement, including results of verification activities related to PRPs and
the hazard control plan, the internal and external audits. Analysis will be carried out;
a. To confirm the overall performance of the system meets the planned arrangements
and the FSMS requirements established by the company.
b. To identify the need for updating or improving the FSMS
c. To identify trends which indicate higher incidence of potentially unsafe products or
process failures
d. To establish information for planning of internal audit program related to the status
and importance of areas to be audited
e. To provide evidence that corrections and corrective actions are effective.
Results of the analysis and the resulting activities shall be retained by Bralison as
documented information and the results will be reported to top management as input during
management review. The results will also be used during updating of FSMS.

9.2. Internal Audit

9.2.1.
Bralison shall conduct internal audits semi-annually in a financial year to provide
information on whether the FSMS;
a. Conforms to Bralison’s own FSMS requirements; requirements of ISO 22000:2018
standard
b. Is effectively implemented and maintained.

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 9.2.2.
Bralison shall,
a. Plan, implement and maintain audit programs including the frequency, methods,
responsibilities, planning requirements and reporting, which shall take into account
the importance of the processes concerned, changes in the FSMS, and the results of
monitoring, measurement and previous audits
b. Define the audit criteria and scope of each audit
c. Select competent auditors and conduct audits to ensure objectivity and impartiality
of audit process
d. Ensure that the results of audits are reported to food safety TEAM and relevant
management
e. Retain documented information as evidence of the implementation of the audit
program and the audit results.
f. Make necessary correction and take necessary corrective actions within agreed time
frame
g. Determine the FSMS meets the intent of food safety policy and objectives of FSMS
Follow up activities by Bralison shall include the verification of the actions taken and
reporting of the verification results.

9.3. Management Review (semi-annually in a financial year)

Management review shall consider

a. Status of actions from previous management reviews
b. Change in external and internal issues that are relevant to food safety management
systems including changes in the organization and its context.
c. Information on the performance and effectiveness of FSMS including trends in
1 Results of system updating
2 Monitoring and measurement results
3 analysis of results of verification activities related to PRPs and hazard control plan
4 non conformities and corrective actions
5 audit results both internal and external
6 inspections (regulatory, customer)
7 the performance of external providers
8 review of risks and opportunities and effectiveness of actions taken address them
9 the extent to which objectives of FSMS have been met
d. The adequacy of resources
e. Any emergency situation, incident or withdrawal/ recall that occurred
f. Relevant information obtained through external and internal communication
including requests and complaints from interested parties.
g. Opportunities for continual improvement
The data for management review shall be presented in a manner that enables top
management to relate stated information to the stated objectives of FSMS.

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 9.3.1. Management Review output

Output from management review shall include:

a. Decisions and actions related to continual improvement opportunities
b. Any need for updates and changes to FSMS including resource needs and revision of
food safety policy and objectives of FSMS
Documented information shall be retained as evidence of management reviews.

10.Improvement

10.1.1. Nonconformity and corrective action plan

When nonconformity occurs, Bralison shall
a. React to nonconformity and as applicable
1 Take action to control and correct it
2 deal with consequences as per established procedures
b. Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order
that it does not recur or occur elsewhere by:
1 reviewing the nonconformity
2 determining the causes of nonconformity
3 determining if similar nonconformities exist or could potentially occur
c. Implement any action needed
d. Review the effectiveness of any corrective action taken
e. Make changes to FSMS if necessary
Bralison will ensure that corrective actions shall be appropriate to the effects of the
nonconformities encountered.

10.1.2.
Bralison shall retain documented information as evidence of:
a. The nature of nonconformities and any subsequent action taken
b. The results of any corrective action.

10.2. Continual improvement

We shall continually improve the suitability, adequacy and effectiveness of our FSMS. Top
management will ensure that Bralison continually improves the effectiveness of the FSMS
through use of communication, management reviews, internal audit, analysis of results of
verification activities, validation of control measures and combinations of control measures,
corrective actions and FSMS updating.

10.3. Update of the food safety management system

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 Bralison’s top management shall ensure that the FSMS is continually updated. The food
safety TEAM shall evaluate the FSMS at planned intervals. The TEAM will consider whether
to review the hazard analysis, the established hazard control plan and the established PRPs.
The updating activities will be based on:
a. Input from communication, external as well as internal
b. Input from other information concerning the suitability, adequacy and effectiveness
of FSMS
c. Output from analysis of results of verification activities
d. Output from management review
System updating activities shall be retained as documented information and reported as
input to the management review.

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 Process Flow Diagram (UNI-DIRECTIONAL PROCESS)

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 I ______________CATHERINE TOLOLWO___________ the current

(Position) __________CEO____________________ having read and confirmed

this document as adequate, approve its use within Bralisoninvest Company

(EPZ) Limited in Athi River with effect from _____25_________ of

___JAN___________ the year 2025.

MANAGING DIRECTOR
CATHERINE TOLOLWO

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