ISO 22000 FSMS Policies, Procedures, and Forms Bizmanualz.

com

Food Safety Manual

The Food Safety Manual establishes and states the policies governing the
Company’s Food Safety Management System (FSMS). These policies
define management’s arrangements for managing operations and activities
in accordance with ISO 22000:2005. These top-level policies represent the
plans or protocols for achieving food safety, quality assurance and
customer satisfaction.

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<Company Logo>

<Our Company, Inc.>

FOOD
SAFETY
MANUAL
30 January 2006

Revision #: _______________________________ Effective Date: ____________

Approved by: _____________________________________ Date: ____________

President/CEO

This manual is intended for the sole use of Our Company, Inc., and is
provided to customers for informational purposes only.
© 2006 Our Company, Inc.
The contents of this manual may not be reproduced or reprinted in
whole or in part without the express written permission of Our Company, Inc.

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The following document contains a sample food safety manual covering the
requirements of ISO 22000:2005. This sample is intended only to provide an
example of wording that might be used in a food safety manual.

This sample wording can be helpful in generating ideas for developing a manual
for your own company. However, food safety policies should be drafted as
appropriate and as necessary to accurately reflect your company’s food safety
management system.

While this manual generally follows the section numbering used in the ISO
standard for clarity, it is not necessary for your food safety manual to do the same.
The numbering scheme that is most useful and meaningful to you should be
selected.

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FOOD SAFETY MANUAL

Table of Contents

1.0 Purpose...............................................................................................................1
2.0 Scope..................................................................................................................1
3.0 Relation to ISO 22000:2005..............................................................................1
4.0 Our Company's Food Safety Management System...........................................1
4.1 General Requirements..................................................................................1
4.2 Documentation requirements.......................................................................3
5.0 Management Responsibility...............................................................................4
5.1 Management Commitment...........................................................................4
5.2 Food Safety Policy.......................................................................................4
5.3 FSMS Planning............................................................................................5
5.4 Responsibility and Authority.......................................................................5
5.5 Food Safety Team Leader............................................................................5
5.6 Communication............................................................................................6
5.7 Emergency Preparedness And Response.....................................................7
5.8 Management Review...................................................................................7
6.0 Resource Management.......................................................................................8
6.1 Provision of Resources................................................................................8
6.2 Human Resources........................................................................................9
6.3 Infrastructure................................................................................................9
6.4 Work Environment.......................................................................................9
7.0 Planning and Realization of Safe Products........................................................9
7.1 General.........................................................................................................9
7.2. Prerequisite Programs................................................................................10
7.3 Hazard Analysis Preparation......................................................................12
7.4 Hazard Analysis.........................................................................................14
7.5 Managing the HACCP Plan.......................................................................16
7.6 Updating the FSMS....................................................................................17
7.7 Verification Planning.................................................................................18
7.8 Traceability................................................................................................18
7.9 Control of Nonconformity.........................................................................19
8.0 Validation, Verification, and Improvement of the Food Safety Management
System..............................................................................................................22
8.1 General.......................................................................................................22
8.2 Validation of Control Measure Combinations...........................................22
8.3 Control of Monitoring and Measuring.......................................................23
8.4 Food Safety Management System Verification.........................................23
8.5 Continual Improvement.............................................................................25
FSMS Glossary............................................................................................................27

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List of Referenced Procedures

FS1000 – Document Control
FS1010 – Food Safety Records
FS1020 – Management Responsibility
FS1030 – Competence, Awareness, and Training
FS1040 – Job Descriptions
FS1050 – Prerequisite Programs
FS1060 – Hazard Analysis Preparation
FS1070 – Hazard Analysis
FS1080 – HACCP Plan Management
FS1090 – Purchasing
FS1100 – Supplier Evaluation
FS1110 – Receiving and Inspection
FS1120 – Manufacturing
FS1130 – Identification, Labeling, and Traceability
FS1140 – Control of Monitoring and Measuring
FS1150 – Control of Nonconforming Product
FS1160 – Internal Audit and System Validation
FS1170 – Corrective Action
FS1180 – Continuous Improvement
FS1190 – Product Recall
FS1200 – Emergency Preparedness and Response

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1.0 PURPOSE

The purpose of this food safety manual is to establish and state the general
policies governing Our Company’s Food Safety Management System. These
policies define management’s intended arrangements for managing Company
operations and activities in accordance with the framework established by ISO
22000:2005. These are the top-level policies representing the company's plans or
protocol for achieving food safety, quality assurance, and customer satisfaction.
All departmental or functional policies and procedures written must conform and
parallel these policies. All changes to policies and procedures are required to be
reviewed to ensure that there are no conflicts with the policies stated in this Food
Safety Manual (FSM).

2.0 SCOPE

The policies stated in this manual apply to all operations and activities at all
Company sites (locations). The scope of our food safety system may be stated as
in the following example:
"The processing and distribution of seafood products."
It is the responsibility of all department managers to help define, implement, and
maintain the procedures required by this manual and to ensure that all internal
processes related to food safety conform to these requirements. It is the
responsibility of all employees to follow procedures that implement these policies
and to help strive for continuous improvement in all activities and processes of
Our Company.
EXCLUSIONS
 None

3.0 RELATION TO ISO 22000:2005

For ease of reference, the sections of this manual are generally aligned with the
equivalent sections of the ISO 22000:2005 standard by section number.

4.0 OUR COMPANY'S FOOD SAFETY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS

Through this manual and its associated procedures and documents, Our Company
has established, documented, implemented, and will maintain a Food Safety
Management System conforming to the requirements of ISO 22000:2005. The
system is designed to ensure continual improvement of the effectiveness of Our
Company in the operation of the Food Safety Management System and in our
ability to satisfy our customers’ requirements.

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Maintenance of this system is the responsibility of the ISO Management

Representative in conjunction with all Department Managers.
This Food Safety Manual, along with the associated procedures, identifies the
processes needed for the Food Safety Management System at Our Company
(Figure 1).

Figure 1 – General Process Sequence Flow Chart

The Food Safety Team Leader maintains a document that identifies the sequence
of these processes and, in conjunction with the appropriate department managers,
defines the interactions of the processes within the procedures defining these
processes. Processes for management activities, provision of resources, product
realization, and measurement are included. Procedures shall include the methods
needed to ensure the effective operation and control of processes. These
processes will be managed in accordance with requirements of ISO 22000:2005.
Top Management will ensure the availability of resources to support the operation
and monitoring of processes through regular interaction with department
managers and through review activities at Management Review meetings.
Department Managers and the Management Rep will monitor, measure, and
analyze processes and implement any actions necessary to achieve intended
results and continual improvement of the processes. These results will also be
monitored at Management Review meetings.
Any outsourced processes that may affect our product’s safety and conformity to
requirements shall be controlled. The Food Safety Team Leader and appropriate

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department manager(s) are responsible for defining the methods to control

outsourced processes in procedures.
4.2 DOCUMENTATION REQUIREMENTS
4.2.1 General
This Food Safety Manual and the associated procedures are intended to satisfy the
ISO 22000:2005 documentation requirements for a food safety manual and food
safety objectives. Records required by the ISO 22000 standard are identified in
the appropriate procedures and/or the Food Safety Records procedure (FS1010).
Department managers and supervisors are responsible for identifying any
additional documents needed to ensure effective planning, operation, and control
of processes.
Procedures may vary in detail, based on the size of the department or organization
involved, the nature of its business, and the particular type of activity performed.
Procedure developers shall consider this, as well as the complexity of the
processes, their interactions, and the competence of the personnel involved.
Where competence is used to minimize the content in procedures, records must
support the decision (see FSM section 6.2.2 – Competence, Awareness, and
Training).
Documents may be in any medium, including software programs, electronic files
(".doc", ".html", ".pdf", and other formats), and hardcopy documents.
4.2.2 Control of Documents
All documents required by the Food Safety Management System shall be
controlled. Controls will ensure that all proposed changes are reviewed prior to
implementation to determine their effects on food safety and their impact on the
FSMS. The document control procedure will be established to define the controls
needed to:
a) Approve documents for adequacy prior to issue;
b) Review and update, as necessary, and approve document revisions;
c) Ensure that changes and the current revision status of documents are
identified;
d) Ensure that relevant versions of applicable documents are available at points
of use;
e) Ensure that documents remain legible and readily identifiable;
f) Ensure that relevant documents of external origin are identified and their
distribution controlled; and
g) Prevent unintended use of obsolete documents and apply suitable
identification to them if they are retained for any purpose.
4.2.3 Control of Records
Procedures define appropriate records to be established and maintained in order to
provide evidence of conformity to requirements and of the effective operation of
the Food Safety Management System. Records shall remain legible, readily
identifiable, and retrievable.

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The food safety records procedure is established to define the controls needed for
the correction, identification, storage, protection, retrieval, retention time, and
disposition of records.
4.2.4 Referenced Procedures
 FS1000 – DOCUMENT CONTROL
 FS1010 – FOOD SAFETY RECORDS

5.0 MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT

Top Management at Our Company shows its commitment to developing and
implementing the Food Safety Management System – and its continued
improvement – by showing that food safety is supported by the Company's
business objectives. Additionally, management commitment is demonstrated by
establishing food safety policy, conducting management review meetings, and
providing the resources required to meet our objectives for continually improving
the effectiveness of our operations and our Food Safety Management System.
Top Management, consisting of the Company President and all department
managers, is chartered with communicating to the entire organization the
importance of meeting ISO 22000 requirements, as well as statutory and
regulatory requirements and our customers' requirements related to food safety.
5.2 FOOD SAFETY POLICY
Our Company has established and implemented a food safety policy that is
appropriate to the organization and meets requirements set forth in ISO
22000:2005. The food safety policy is communicated by Top Management
throughout the Company. Department managers and supervisors are responsible
for ensuring all employees understand the policy. To ensure our policy remains
suitable, appropriate and timely, it shall be reviewed at least annually by Top
Management.
The <Our Company> Food Safety Policy:
 It is the policy of Our Company to develop and provide products and services
that are safe for consumption, as well as meet or exceed customer
requirements and comply with all statutory and regulatory requirements. We
accomplish this by adhering to our Food Safety Management System and
operational methods that recognize food safety and customer satisfaction as
our primary goals.
 We strive to continually improve the effectiveness of our Food Safety
Management System and our commitment to customer satisfaction by
monitoring our performance against our established objectives and through
leadership that promotes employee involvement. This concept represents Our
Company’s commitment to provide safe food products and to continually
improve in order to better serve our growing and demanding customer base.

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5.3 FSMS PLANNING

5.3.1 Food Safety Objectives
Top Management shall establish food safety objectives on an annual basis. These
objectives shall be measurable and consistent with the Company's food safety
policy. Food safety objectives shall also be reviewed at least annually by Top
Management.
5.3.2 Food Safety Management System Planning
As part of annual strategic planning meetings, Top Management establishes
strategic objectives for improving the Company's products, processes, and
customer satisfaction. These objectives are supported by specific measures that
track performance against those objectives. Department managers, in turn, set
departmental objectives with specific performance measures and targets that
support the company objectives.
As situations that demand changes to the Food Safety Management System arise –
either to meet objectives or because of changing business conditions – all changes
will be reviewed by Top Management, to ensure that the integrity of the Food
Safety Management System is maintained.
5.4 RESPONSIBILITY AND AUTHORITY
5.4.1 Responsibility and Authority
Responsibilities and authorities at Our Company are defined in each Job
Description, as well as in the Management Responsibility procedure, to ensure
effective operation and maintenance of the FSMS. Job Descriptions are also used
as a basis for annual performance reviews and are posted on the Company
intranet, in addition to being available through Human Resources.
5.4.2 Referenced Procedures
 FS1020 – MANAGEMENT RESPONSIBILITY
 FS1030 – JOB DESCRIPTIONS
5.5 FOOD SAFETY TEAM LEADER
5.5.1 The Company President shall appoint a Food Safety Team Leader. Irrespective of
his/her other responsibilities, the Food Safety Team Leader shall have
responsibility and authority to:
a) Manage a Food Safety Team (see 7.3.2) and organize its work;
b) Ensure relevant training and education for Food Safety Team members (see
6.2.1);
c) Ensure that the Food Safety Management System is established, implemented,
maintained, and updated; and
d) Report to Top Management on the suitability and effectiveness of the FSMS.

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5.5.2 The Food Safety Team Leader may additionally be the Company's liaison with
external parties on matters relating to the FSMS.
5.5.3 Referenced Procedures
 FS1060 – HAZARD ANALYSIS PREPARATION
 FS1030 – COMPETENCE, AWARENESS, AND TRAINING
5.6 COMMUNICATION
5.6.1 External communication
To ensure that sufficient information on issues concerning food safety is available
throughout the food supply chain, the Company shall establish, implement, and
maintain effective arrangements for communicating with:
a) Suppliers and contractors;
b) Customers or consumers, particularly with regard to product information
(including instructions regarding intended use, specific storage requirements
and, as appropriate, shelf life); enquiries; contracts or order handling,
including amendments; and customer feedback, including customer
complaints;
c) Statutory and regulatory authorities; and
d) Other organizations that have an impact on – or will be affected by – the
effectiveness or updating of the Company's Food Safety Management System.
Such communication shall provide information on food safety aspects of the
Company's products that may be relevant to other organizations in the food
supply chain. This applies especially to known food safety hazards that need to
be controlled by other organizations in the food chain. Records of external
communications shall be maintained (see 4.2.3).

Food safety requirements from statutory and regulatory authorities and customers
shall be available.

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Designated personnel shall have defined responsibility and authority to externally

communicate any information concerning food safety. Information obtained
through external communication shall be included as input to system updating
(see 8.5) and management review (see 5.8).
5.6.2 Internal communication
The Company shall establish, implement, and maintain effective arrangements for
communicating with all personnel on issues potentially having an impact on food
safety. To maintain the effectiveness of the Food Safety Management System, the
Company shall ensure that the Food Safety Team is informed in a timely manner
of changes, including – but not necessarily limited to – the following:
a) Existing or new products;
b) Raw materials, ingredients, and services;
c) Production systems and equipment;
d) Production premises, location of equipment, and surrounding environment;
e) Cleaning and sanitation programs;
f) Packaging, storage, and distribution systems;
g) Personnel qualification levels and/or allocation of responsibilities and
authorizations;
h) Statutory and regulatory requirements;
i) Knowledge regarding food safety hazards and control measures;
j) Customer, sector and other requirements that the organization observes;
k) Relevant enquiries from external interested parties;
l) Complaints indicating food safety hazards associated with the product; and
m) Other conditions that may have an impact on food safety.
The Food Safety Team shall ensure that this information is included in the
updating of the Food Safety Management System (see 8.5). Top Management
shall ensure that relevant information is included as input to the Management
Review (see 5.8).
5.6.3 Referenced Procedures
 FS1010 – FOOD SAFETY RECORDS
 FS1020 – MANAGEMENT RESPONSIBILITY
 FS1180 – CONTINUOUS IMPROVEMENT
5.7 EMERGENCY PREPAREDNESS AND RESPONSE
Top Management shall establish, implement, and maintain procedures to manage
potential emergency situations and accidents that can impact food safety and
which are relevant to the role of the Company in the food supply chain.
5.8 MANAGEMENT REVIEW
5.8.1 General
Top Management shall review the Company’s Food Safety Management System
at least annually (more frequently, if needed) to ensure its continuing suitability,
adequacy, and effectiveness. This review shall include assessing opportunities for

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improvement and the need for change to the Food Safety Management System,
including the food safety policy and objectives.
The Food Safety Team Leader shall be responsible for maintaining Management
Review records (see 4.2.3).
5.8.2 Review Input
The input to Management Review shall include, but not necessarily be limited to,
information on:
a) Follow-up actions from previous Management Reviews;
b) Analysis of results of verification activities (see 8.4);
c) Changing circumstances that can affect food safety (see 5.6.2);
d) Emergency situations, accidents (see 5.7), and product recalls1 (see 7.9.4);
e) Reviewing results of system updating activities (see 8.4.2);
f) Review of communication activities, including customer feedback (see 5.6.1);
and
g) External audits or inspections.
This information shall be presented in a manner that enables Top Management to
relate the information to the stated objectives of the Food Safety Management
System.
5.8.3 Review Output
The output from the Management Review shall include decisions and actions
related to:
a) Assurance of food safety (see 4.1);
b) Improvement of the effectiveness of the Food Safety Management System
(see 8.5);
c) Resource needs (see 6.1); and
d) Revisions of the organization's food safety policy and related objectives (see
5.2).
5.8.4 Referenced Procedures
 FS1020 – MANAGEMENT RESPONSIBILITY
 FS1040 – JOB DESCRIPTIONS

6.0 RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURCES

During planning and budgeting processes – and as needed throughout the year –
Top Management shall determine and ensure the availability of resources
appropriate to establishing, implementing, maintaining, and updating the Food
Safety Management System.

1
The term "recall" also refers to withdrawal.

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6.2 HUMAN RESOURCES

6.2.1 General
The Food Safety Team – as well as any other personnel carrying out activities that
have an impact on food safety – shall be competent and have appropriate
education, training, skills, and experience. Where the assistance of external
experts is required for development, implementation, operation, or assessment of
the Food Safety Management System, records of agreement or contracts defining
the responsibility and authority of external experts shall be available.
6.2.2 Competence, Awareness, and Training
The Company shall:
a) Identify the necessary competencies for personnel whose activities have an
impact on food safety;
b) Provide training or take other action to ensure personnel possess the necessary
competencies;
c) Ensure that personnel responsible for monitoring, corrections, and corrective
actions of the Food Safety Management System are trained;
d) Evaluate the implementation and effectiveness of a), b), and c);
e) Ensure that all personnel are aware of the relevance and importance of their
individual activities in contributing to food safety; and
f) Ensure that the requirement for effective communication (see 5.6) is
understood by all personnel whose activities have an impact on food safety.
Human Resources shall maintain appropriate records of training and actions
described in b) and c).
6.2.3 Referenced Procedures
 FS1030 – COMPETENCE, AWARENESS, AND TRAINING
 FS1040 – JOB DESCRIPTIONS
6.3 INFRASTRUCTURE
Our Company shall provide adequate resources for establishment and
maintenance of the infrastructure necessary to implement the requirements of the
ISO 22000:2005 standard.
6.4 WORK ENVIRONMENT
The Company shall provide adequate resources for establishment, management,
and maintenance of the work environment necessary to implement the
requirements of the ISO 22000:2005 standard.

7.0 PLANNING AND REALIZATION OF SAFE PRODUCTS

7.1 GENERAL
The Company shall plan and develop processes needed for the realization
(production) of safe products. The Company shall implement, operate, and ensure
the effectiveness of planned activities, as well as any changes to those activities.

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This includes prerequisite programs (PRPs, or Good Practices – see 7.2), as well
as operational PRPs and/or the Company HACCP Plan.
7.2. PREREQUISITE PROGRAMS
7.2.1 Purpose of Prerequisite Programs (PRP)
Top Management will be responsible (or will assign responsibility) for the
establishment, implementation, and maintenance of Company PRPs – also known
as “Good Practices” or “Standard Operating Procedures” – to assist in controlling:
a) The likelihood of introducing food safety hazards to products through the
work environment;
b) Biological, chemical, and physical contamination of products, including
cross-contamination between products; and
c) Food safety hazard levels in the product and product processing environment.
7.2.2 PRP Requirements
The PRP shall:
a) Be appropriate to the Company's needs with regard to food safety;
b) Be appropriate to the size and type of the operation and the nature of the
products manufactured and/or handled by the Company;
c) Be implemented across the entire production system, either as programs
applicable in general or to particular products or operational lines; and
d) Be approved by the Food Safety Team.
The Company's authorized legal representative (or its Legal department) shall
identify statutory and regulatory requirements pertaining to prerequisite programs,
good practices, and/or SOPs.
7.2.3 Establishing and Maintaining PRPs
When selecting and/or establishing PRPs, Top Management or its
representative(s) shall consider and utilize appropriate information (e.g., statutory
and regulatory requirements, customer requirements, recognized guidelines,
Codex Alimentarius Commission (or Codex) principles and codes of practices2,
and national, international, or sector standards).
The Company shall consider the following when establishing its prerequisite
program(s):
a) Construction and layout of buildings and associated utilities;
b) Layout of premises, including workspace and employee facilities;
c) Supplies of air, water, energy, and other utilities;
d) Supporting services, including waste and sewage disposal;
e) Suitability of equipment and its accessibility for cleaning, maintenance, and
preventive maintenance;
f) Management of purchased materials (e.g., raw materials, ingredients,
chemicals and packaging), supplies (e.g., water, air, steam and ice), disposals

2
See "annex C" of the ISO 22000:2005 standard, which lists Codex references and guidelines.

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(e.g., waste and sewage) and handling of products (e.g., storage and
transportation);
g) Measures for the prevention of cross-contamination;
h) Cleaning and sanitizing;
i) Pest control;
j) Personnel hygiene; and
k) Other aspects, as appropriate.
Verification of PRPs shall be planned (see 7.7) and PRPs shall be modified as
necessary (see 7.6). Records of verifications and modifications shall be
maintained.
Documents should specify how activities included in the Company PRPs are
managed.
7.2.4 Establishing Operational Prerequisite Programs
Prerequisite programs are generally well-established and accepted operating
guidelines or "Good Practice". PRPs are established prior to any hazard analysis
(see 7.3 and 7.4). In performing the hazard analysis, a Food Safety Team will
identify certain PRPs as operational PRPs – PRPs essential to controlling the
likelihood of:
 Introducing food safety hazards to;
 Contaminating; and/or
 Allowing food safety hazards to proliferate in
the Company's product(s) or processing environment(s).
The Food Safety Team will document operational PRPs, including the following
information in each program:
 Food safety hazard(s) to be controlled by the program (see 7.4.4);
 Control measure(s) (see 7.4.4);
 Monitoring procedures that demonstrate that the operational PRPs are in
place;
 Corrections and corrective actions to be taken if monitoring shows that the
operational PRPs are not in control (see 7.9.1 and 7.9.2, respectively);
 Responsibilities and authorities; and
 Record(s) of monitoring.
7.2.5 Referenced Procedures
 FS1050 – PREREQUISITE PROGRAMS
 FS1150 – CONTROL OF NONCONFORMING PRODUCT
 FS1160 – INTERNAL AUDIT AND SYSTEM VALIDATION
 FS1170 – CORRECTIVE ACTION

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7.3 HAZARD ANALYSIS PREPARATION

7.3.1 General
All relevant information needed to conduct hazard analyses shall be collected,
maintained, updated, and documented. Records of all hazard analyses shall be
maintained.
7.3.2 Food Safety Team
A Food Safety Team will be appointed for each hazard analysis. This Team shall
have a combination of multidisciplinary knowledge and experience in developing
and implementing the Company's FSMS. Knowledge and experience shall
include, but need not be limited to, the Company's products, processes,
equipment, and food safety hazards within the scope of the FSMS.
Human Resources will maintain records demonstrating that the Food Safety Team
has the requisite knowledge and experience (see 6.2.2).
7.3.3 Product Characteristics
7.3.3.1 Raw materials, ingredients, and product contact materials
All raw materials, ingredients, and product contact materials shall be documented
to the extent necessary to conduct hazard analyses (see 7.4). Documentation shall
include the following (where appropriate):
a) Biological, chemical and physical characteristics;
b) Composition of formulated ingredients, including additives and processing
aids;
c) Origin;
d) Method of production;
e) Packaging and delivery methods;
f) Storage conditions and shelf life;
g) Preparation and/or handling prior to use or processing; and
h) Food-safety-related acceptance criteria or specifications of purchased
materials and ingredients appropriate to their intended uses.
The Company shall have appropriate legal counsel identify statutory/regulatory
food safety requirements pertinent to the above.
Descriptions of raw materials, ingredients, and product contact materials shall be
kept up-to-date (see 7.6).
7.3.3.2 End Product Characteristics
Characteristics of end products shall be documented to the extent necessary to
conduct hazard analyses (see 7.4). Documentation shall include information on
the following (where appropriate):
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;

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e) Packaging;
f) Labeling relating to food safety and/or instructions for handling, preparation,
and usage; and
g) Method(s) of distribution.
The Company shall have appropriate legal counsel identify statutory/regulatory
food safety requirements pertinent to the above.
Descriptions of end products shall be kept up-to-date (see 7.6).
7.3.4 Intended Use
The intended use, reasonably expected handling of the end product, and any
unintended (but reasonably expected) mishandling and misuse of the end product
shall be considered and documented to the extent necessary to conduct hazard
analyses (see 7.4).
Groups of users and – where appropriate – groups of consumers shall be
identified for each product and consumer groups known to be especially
vulnerable to specific food safety hazards (e.g., food allergies) shall be
considered.
Such intended-use descriptions shall be kept up-to-date (see 7.6).
7.3.5 Flow Diagrams, Process Steps, and Control Measures
7.3.5.1 Flow Diagrams
Flow diagrams shall be prepared for products or process categories covered by the
FSMS. Flow diagrams provide a basis for evaluating the possible occurrence,
increase, or introduction of food safety hazards into the Company's processes and
products.
Flow diagrams shall be clear, accurate and sufficiently detailed. Flow diagrams
shall include, but need not be limited to, the following (where appropriate):
a) Sequence and interaction of all steps in a given operation;
b) Outsourced processes and subcontracted work;
c) Where raw materials, ingredients, and intermediate products enter the process;
d) Where reworking and recycling take place; and
e) Where end products, intermediate products, by-products, and waste are
released or removed.
In accordance with verification planning (see 7.7), the Food Safety Team will
verify the accuracy of flow diagrams by process walkthroughs and on-site
checking. The Food Safety Team shall maintain verified flow diagrams as
records (see 4.2.3).
7.3.5.2 Description of Process Steps and Control Measures
Existing control measures, process parameters (and/or the rigor with which they
are applied), or procedures that may influence food safety shall be described to
the extent necessary to conduct hazard analyses (see 7.4).

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External requirements (e.g. from regulatory authorities or customers) that may

impact the choice and the rigorousness of the control measures shall also be
described.
Descriptions of process steps and control measures shall be kept up-to-date (see
7.6).
7.3.6 Referenced Procedures
 FS1010 – FOOD SAFETY RECORDS
 FS1030 – COMPETENCE, AWARENESS, AND TRAINING
 FS1060 – HAZARD ANALYSIS PREPARATION
 FS1070 – HAZARD ANALYSIS
 FS1080 – HACCP PLAN MANAGEMENT
 FS1160 – INTERNAL AUDIT AND SYSTEM VALIDATION
7.4 HAZARD ANALYSIS
7.4.1 General
The Food Safety Team will conduct hazard analyses to determine which hazards
need to be controlled, the degree of control needed to ensure food safety in each
case, and which combination of control measures is required for the hazard(s) in
question.
7.4.2 Hazard Identification and Determination of Acceptable Levels
7.4.2.1 The Food Safety Team will identify and record all food safety hazards reasonably
expected to occur pertaining to the type of product, type of process, and nature
and makeup of processing facilities. Hazard identification will be based on:
a) The preliminary information and data collected, according to 7.3;
b) Experience;
c) External information including, to the extent possible, epidemiological and
other historical data; and
d) Information from the food chain on food safety hazards that may be of
relevance for the safety of the end products, intermediate products, and the
food at consumption.
The Food Safety Team will indicate the step(s) at which each food safety hazard
may be introduced.
7.4.2.2 When identifying food safety hazards, the Food Safety Team will consider:
a) The steps preceding and following the specified operation;
b) The process equipment, utilities/services, and surroundings; and
c) The preceding and following links (the Company's suppliers and customers)
in the food supply chain.
7.4.2.3 For each food safety hazard identified, the Food Safety Team will, whenever
possible, determine an "acceptable level" of each food safety hazard in the end

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product. In doing so, the FST will take into account established statutory/
regulatory requirements, customer food safety requirements, the intended use of
the product by the customer (see 7.3.4), and other relevant data. The FST will
record the justification for, as well as the result of, the determination.
7.4.3 Hazard Assessment
For each food safety hazard identified by the FST (see 7.4.2), a hazard assessment
will be conducted to determine:
a) If eliminating the hazard or reducing it to acceptable levels is essential to the
production of safe food; and
b) If control of the hazard is needed to meet the defined acceptable levels.
The FST will evaluate each food safety hazard according to the possible severity
of adverse health effects and the likelihood of its occurrence (see "food safety
hazard" and "risk" in the FSMS Glossary). The FST will describe its evaluation
methodology for each hazard and record the results of each hazard assessment.
7.4.4 Selection and Assessment of Control Measures
Based on the food safety hazard assessment (7.4.3), the Food Safety Team will
identify and select an appropriate combination of control measures, capable of
preventing, eliminating, or reducing the food safety hazard(s) to defined
acceptable levels.
Each control measure (as described in 7.3.5.2) will be reviewed with respect to its
effectiveness against identified food safety hazards.
Each selected control measure will be managed (a) through operational PRP(s) or
(b) according to the Company's HACCP Plan, using a logical approach that
includes assessments regarding:
a) The control measure's effect on identified food safety hazards, relative to the
strictness applied;
b) Feasibility of monitoring (i.e., ability to monitor the control measure in a
timely manner, to enable immediate corrective action);
c) Its place in the system, relative to other control measures;
d) The likelihood of a control measure failing or exhibiting significant process
variability;
e) The severity of the consequences, in the case of control measure failure;
f) Whether the control measure is specifically established and applied to
eliminate or significantly reduce the level of food safety hazards; and
g) Synergistic effects (i.e., interaction between control measures that results in
their combined effect being greater than the sum of their individual effects).
Control measures categorized as part of the Company HACCP Plan shall be
implemented in accordance with 7.5. Other control measures shall be
implemented as operational PRPs, in accordance with 7.2. The QA department

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will document the methodology and parameters used for this categorization and
record the results of the assessment.
7.4.5 Referenced Procedures
 FS1060 – HAZARD ANALYSIS PREPARATION
 FS1070 – HAZARD ANALYSIS
 FS1080 – HACCP PLAN MANAGEMENT
7.5 MANAGING THE HACCP PLAN
7.5.1 The HACCP Plan
The HACCP Team will document each HACCP Plan the Company requires for
the realization of its product(s). Each HACCP Plan will include the following
information for every critical control point (CCP):
a) Food safety hazard(s) to be controlled at the CCP (see 7.4.4);
b) Control measure(s) (see 7.4.4);
c) Critical limit(s) (see 7.5.3);
d) Monitoring procedure(s) (see 7.6.4);
e) Corrections and corrective action(s) to be taken if critical limits are exceeded
(see 7.5.5);
f) Responsibilities and authorities; and
g) Record(s) of monitoring.
7.5.2 Identification of Critical Control Points
For each food safety hazard to be controlled by the HACCP plan, the HACCP
Team will identify CCPs for identified control measures (see 7.4.4).
7.5.3 Establishment of Critical Limits
The HACCP Team will determine critical limits for the monitoring established for
each CCP. Critical limits will be established to ensure that the identified
acceptable levels of food safety hazards in the end product (see 7.4.2) are not
exceeded. Critical limits shall be measurable. The HACCP Team will document
the rationale for each critical limit chosen.
Critical limits based on subjective data (e.g., visual inspection) shall be supported
by instructions or specifications and/or education and training.
7.5.4 System for Monitoring Critical Control Points
The HACCP Team will establish a monitoring system (if one does not exist) for
each CCP to demonstrate that the CCP is in control. The monitoring system will
include all scheduled measurements or observations relative to critical limits.
The monitoring system will consist of relevant procedures, instructions, and
records that cover the following:
a) Measurements or observations that provide results within an adequate time
frame;
b) Monitoring devices used;

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c) Applicable calibration methods (see 8.3);

d) Monitoring frequency;
e) Responsibility and authority related to monitoring and evaluation of
monitoring results; and
f) Record requirements and methods.
Monitoring methods and frequency must be capable of determining when critical
limits have been exceeded in time for the monitored product to be isolated before
it is used or consumed.
7.5.5 When Monitoring Results Exceed Critical Limits
Planned corrections and corrective actions to be taken when critical limits are
exceeded are specified in the Company's HACCP Plan(s). Such actions are
designed to ensure that:
a) The cause of nonconformity is identified;
b) The parameter(s) controlled at the CCP is (are) brought back under control;
and
c) Recurrence is prevented (see 7.9.2).
Documented procedures shall be established and maintained for the appropriate
handling of potentially unsafe products to ensure that they are not released until
they have been evaluated (see 7.9.3).
7.5.6 Referenced Procedures
 FS1050 – PREREQUISITE PROGRAMS
 FS1080 – HACCP PLAN MANAGEMENT
 FS1140 – CONTROL OF MONITORING AND MEASURING
 FS1150 – CONTROL OF NONCONFORMING PRODUCT
 FS1170 – CORRECTIVE ACTION
7.6 UPDATING THE FSMS
7.6.1 Updating FSMS Information
Following the establishment of operational PRPs and/or the Company's HACCP
plan(s), the Food Safety Team Leader will ensure that the following information
is updated, if necessary:
a) Product characteristics;
b) Intended use;
c) Flow diagrams;
d) Process steps; and/or
e) Control measures.
See section 7.3, "Hazard Analysis Preparation", for clarification.
The Food Safety Team Leader will amend the Company HACCP Plan(s) and
procedures and instructions specifying prerequisite programs, if needed.

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7.6.2 Referenced Procedures

 FS1000 – DOCUMENT CONTROL
 FS1050 – PREREQUISITE PROGRAMS
 FS1060 – HAZARD ANALYSIS PREPARATION
 FS1080 – HACCP PLAN MANAGEMENT
7.7 VERIFICATION PLANNING
7.7.4 Purpose
Verification planning shall define the purpose, methods, frequencies, and
responsibilities for verification activities. Verification activities shall confirm
that:
a) Prerequisite programs are implemented;
b) Hazard analysis inputs are continually updated;
c) Operational PRPs and elements of the Company HACCP plan(s) are
implemented and effective;
d) Hazard levels fall within identified acceptable levels; and
e) Other procedures required by the organization are implemented and effective.
The output of this planning shall be in a form suitable for the Company's
method(s) of operations.
7.7.2 Verification Results
Quality Assurance (or a third-party auditor) will record verification results and
communicate them to the food safety team. Verification results shall be provided
to enable the analysis of the results of the verification activities (see 8.4.3).
7.7.3 Product Control
If system verification is based on testing of end product samples and where such
test samples show lack of conformity with the acceptable level(s) of the food
safety hazard (see 7.4.2), the affected lots of product shall be handled as
potentially unsafe in accordance with 7.9.3.
7.7.4 Referenced Procedures
 FS1070 – HAZARD ANALYSIS
 FS1150 – CONTROL OF NONCONFORMING PRODUCT
 FS1160 – INTERNAL AUDIT AND SYSTEM VALIDATION
7.8 TRACEABILITY
7.8.1 Traceability System
The Company will develop and implement a traceability system that enables the
identification of product lots and their relationships to batches of raw materials,
processing, and delivery records. This traceability system will enable the

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Company to identify incoming material from its immediate suppliers and identify
the initial distribution route of the end product.
7.8.2 Traceability Records
Quality Assurance and/or the Food Safety Team Leader will maintain traceability
records for a defined period for the purpose of system assessment: (a) to enable
the appropriate handling of potentially unsafe products; and (b) in the event of a
product recall (withdrawal). Records shall be in accordance with statutory and
regulatory requirements and customer requirements and may, for example, be
based on the end product lot identification.
7.8.3 Referenced Procedures
 FS1010 – FOOD SAFETY RECORDS
 FS1130 – IDENTIFICATION, LABELING, AND TRACEABILITY
 FS1150 – CONTROL OF NONCONFORMING PRODUCTS
7.9 CONTROL OF NONCONFORMITY
7.9.1 Corrections
The Company will ensure that when critical limits for CCP(s) are exceeded or
there is a loss of control of operational PRPs, the affected end products are
identified and controlled with regard to their use and release.
A documented procedure shall be established and maintained defining:
a) Identification and assessment of affected end products, to determine their
proper handling; and
b) Review of the corrective actions.
Products manufactured under conditions where critical limits have been exceeded
are potentially unsafe products and shall be handled in accordance with 7.9.3.
Products manufactured under conditions that do not conform to operational PRPs
shall be evaluated with respect to cause(s) of nonconformity and possible food
safety consequences and such evaluation will be recorded. Any product made
under such conditions will be handled in accordance with 7.9.3, if necessary.
All corrections will be recorded by the party performing such activity and will
include information on the nature of the nonconformity, its cause(s) and
consequence(s), and information needed for traceability purposes related to the
nonconforming lots. Corrections will be approved by Quality Assurance.
7.9.2 Corrective Actions
Data derived from the monitoring of operational PRPs and CCPs shall be
evaluated by designated person(s) who possess sufficient knowledge and
authority to initiate corrective actions. Corrective actions may be initiated by any
employee when he/she observes:
a) Critical limits are being exceeded; or
b) The process is not conforming to operational PRPs.

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The Company will establish and maintain documented procedures that specify
appropriate actions to:
a) Identify and eliminate the cause of detected nonconformities;
b) Prevent recurrence of those nonconformities; and
c) Bring the process into control after nonconformities are encountered.
Appropriate actions may include, but are not necessarily limited to:
a) Reviewing nonconformities (including customer complaints);
b) Reviewing trends in monitoring results that may indicate development
towards loss of control;
c) Determining the cause(s) of nonconformities;
d) Evaluating the need for action to ensure that nonconformities do not recur;
e) Determining and implementing the actions needed;
f) Recording the results of corrective actions taken; and
g) Reviewing corrective actions taken, to ensure their effectiveness.
Corrective actions will be recorded and such records maintained for a period to be
determined by statutory/regulatory, Company, and/or customer requirements.
7.9.3 Handling of Potentially Unsafe Products
7.9.3.1 The Company will prevent nonconforming products from entering the food
supply chain, unless it is possible to ensure that:
a) The food safety hazard in question has been reduced to the defined acceptable
levels;
b) The food safety hazard of concern will be reduced to identified acceptable
levels prior to releasing the product; or
c) The product meets defined acceptable levels of the food safety hazard of
concern, in spite of the nonconformity.
All lots of product(s) that may have been affected by a nonconforming situation
will be held under the Company's control until after their evaluation.
If products are determined to be unsafe after they have left the Company's control,
the Company will notify relevant interested parties and initiate a recall
(withdrawal).
The Company will document the controls and related responses and authorization
for dealing with potentially unsafe products.
7.9.3.2 Evaluating For Release
Each lot of product affected by a nonconformity will be considered "safe" and
released to the customer(s) only when one or more of the following conditions
applies:
a) Evidence other than that produced by the monitoring system(s) shows control
measures have been effective;
b) Evidence exists to show that the combined effect of the control measures for
that particular product complies with the performance intended (e.g.,
identified acceptable levels); and/or

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c) Results of sampling, analysis, and/or other verification activities show the

affected product lot complies with identified acceptable levels for the food
safety hazard(s) concerned.
7.9.3.3 Disposing of Nonconforming Product
Following evaluation, if the lot of product is not acceptable for release, it shall be
handled by one of the following activities:
a) Reprocessing or further processing within or outside the Company, to ensure
that the food safety hazard is eliminated or reduced to acceptable levels; or
b) Destruction of the product and/or disposal as waste.
7.9.4 Recalls (Withdrawals)
7.9.4.1 To enable and facilitate a timely and complete withdrawal of lots of end products
identified as unsafe, Top Management will appoint personnel with the authority to
initiate withdrawals and will appoint personnel responsible for executing
withdrawals.
7.9.4.2 The Company will establish and maintain a documented procedure for:
a) Notifying relevant interested parties (statutory/regulatory authorities,
customers, and/or consumers);
b) Handling recalled (withdrawn) products, as well as affected product lots still
within the Company's control (i.e., in stock); and
c) The sequence of actions to be taken in the event of a recall.
Withdrawn products shall be secured or held under supervision until they are
destroyed, used for purposes other than originally intended, determined to be safe
for the same (or other) intended use, or reprocessed in a manner to ensure they
become safe.
7.9.4.3 Cause, scope, and results of product recalls will be recorded and reported to Top
Management, for input to Management Reviews (see 5.8).
7.9.4.4 The Food Safety Team and Quality Assurance will periodically verify and record
the effectiveness of the Company's product recall program by using appropriate
methods (e.g., challenge tests, mock withdrawals, or practice withdrawals).
7.9.5 Referenced Procedures
 FS1000 – DOCUMENT CONTROL
 FS1010 – FOOD SAFETY RECORDS
 FS1030 – COMPETENCE, AWARENESS, AND TRAINING
 FS1070 – HAZARD ANALYSIS
 FS1080 – HACCP PLAN MANAGEMENT
 FS1140 – CONTROL OF MONITORING AND MEASURING
 FS1150 – CONTROL OF NONCONFORMING PRODUCTS
 FS1170 – CORRECTIVE ACTION

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 FS1190 – PRODUCT RECALL

8.0 VALIDATION, VERIFICATION, AND IMPROVEMENT OF THE FOOD

SAFETY MANAGEMENT SYSTEM

8.1 GENERAL
The Food Safety Team will plan and implement the processes needed to validate
control measures and/or control measure combinations and to verify and improve
the Food Safety Management System.
8.2 VALIDATION OF CONTROL MEASURE COMBINATIONS
8.2.1 Validation
Prior to implementing control measures to be included in operational PRPs and
HACCP Plan(s), and after any change (see 8.5), Quality Assurance will verify
that:
a) Selected control measures are capable of achieving the intended control of the
food safety hazard(s) for which they are designed; and
b) Control measures are effective and are, in combination, capable of ensuring
control of identified food safety hazards to enable the Company to make end
products that meet defined acceptable levels.
8.2.2 Reevaluation
If the result of a validation shows that one or both of the above elements cannot
be confirmed, the control measure and/or combination of measures shall be
modified and reevaluated (see 7.4.4).
Modifications may include changes in control measures (i.e., process parameters,
rigorousness, and/or their combination) and/or:
a) Change(s) in raw materials;
b) Manufacturing technologies;
c) End product characteristics;
d) Distribution methods; and/or
e) Intended use(s) of end product(s).
8.2.3 Referenced Procedures
 FS1070 – HAZARD ANALYSIS
 FS1140 – CONTROL OF MONITORING AND MEASURING
 FS1160 – INTERNAL AUDIT AND SYSTEM VALIDATION
 FS1170 – CORRECTIVE ACTION
 FS1180 – CONTINUOUS IMPROVEMENT

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8.3 CONTROL OF MONITORING AND MEASURING

8.3.1 Monitoring Equipment and Methods
The Company will provide evidence that the specified monitoring and measuring
methods and equipment are adequate to ensure the performance of the monitoring
and measuring procedures. Where necessary to ensure valid results, measuring
equipment and methods used will be:
a) Calibrated or verified at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement
standards; where no such standards exist, the basis used for calibration or
verification shall be recorded;
b) Adjusted and readjusted, as necessary;
c) Identified to enable the calibration status to be determined;
d) Safeguarded from adjustments that would invalidate measurement results; and
e) Protected from damage and deterioration.
Quality Assurance will maintain records of calibration and verification results.
In addition, QA will assess the validity of the previous measurement results when
the equipment or process is found not to conform to requirements. If the
measuring equipment does not conform, the Company will take action appropriate
for the equipment and any product affected.
QA will maintain records of such assessments and resulting actions.
8.3.2 Monitoring Software
When computer software is used to monitor and measure specified requirements,
the ability of that software to satisfy the intended application(s) shall be
confirmed. Such testing/confirmation will be performed prior to the initial use of
such software and software will be retested/reconfirmed as necessary.
8.3.3 Referenced Procedures
 FS1140 – CONTROL OF MONITORING AND MEASURING
 FS1150 – CONTROL OF NONCONFORMING PRODUCT
8.4 FOOD SAFETY MANAGEMENT SYSTEM VERIFICATION
8.4.1 Internal Audit
The Company will conduct a periodic internal audit of its Food Safety
Management System, to determine if the FSMS:
a) Conforms to the planned arrangements, to the FSMS requirements established
by the Company, and to the requirements of the ISO 22000:2005 standard;
and
b) Is being effectively implemented, managed, and updated.
The audit program will be planned to consider the importance of the processes
and areas to be audited, as well as any updates resulting from previous audits (see
8.5 and 5.8). Audit criteria, scope, frequency, and methods shall be defined.

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Auditors will be selected and audits conducted to ensure the objectivity and
impartiality of the audit process. Auditors cannot audit their own work.
Responsibilities and requirements for planning and conducting audits – and for
reporting results and maintaining records – will be defined and the audit
procedure documented.
Management responsible for areas being audited will ensure that actions to
eliminate detected nonconformities and their causes – corrective and preventive
actions – are taken without undue delay. Audit follow-up will include verification
of corrective/preventive actions taken and reporting of verification results.
8.4.2 Evaluating Individual Verification Results
The Food Safety Team will systematically evaluate individual results of planned
verification (see 7.7). If such verification does not demonstrate conformity with
the planned arrangements, the Company will take action to achieve the required
conformity. Such action shall include, but may not be limited to, review of:
a) Existing procedures and communication channels (see 5.6 and 7.6);
b) Conclusions of hazard analyses (see 7.4), established operational PRPs (see
7.2), and the Company's HACCP Plan(s) (see 7.5);
c) Prerequisite programs (see 7.2); and
d) The effectiveness of Human Resource management and of training activities
(see 6.2).
8.4.3 Analyzing Results of Verification Activities
The Food Safety Team will analyze results of verification activities, including
results of the internal audits (see 8.4.1) and external audits, in order to:
a) Confirm that the overall performance of the system meets the planned
arrangements and the Food Safety Management System requirements
established by the Company;
b) Identify the need for updating or improving the Company's Food Safety
Management System;
c) Identify trends that may indicate a higher incidence of potentially unsafe
products;
d) Establish information for planning of the internal audit program concerning
the status and importance of areas to be audited; and
e) Provide evidence that any corrections and corrective actions taken are
effective.
The Food Safety Team will ensure that results of the analysis and resulting
activities are recorded and reported in an appropriate manner to Top Management,
as input to the Management Review (see 5.8) and that such results will be used as
input for updating the FSMS (see 8.5).
8.4.4 Referenced Procedures
 FS1010 – FOOD SAFETY RECORDS
 FS1080 – HACCP PLAN MANAGEMENT

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 FS1140 – CONTROL OF MONITORING AND MEASURING

 FS1150 – CONTROL OF NONCONFORMING PRODUCT
 FS1160 – INTERNAL AUDIT AND SYSTEM VALIDATION
8.5 CONTINUAL IMPROVEMENT
8.5.1 Continual Improvement
Top Management shall ensure that the Company continually improves the
effectiveness of its FSMS through the use of:
a) Effective communication (see 5.6);
b) Management review (see 5.8);
c) Internal audits (see 8.4);
d) Evaluating individual verification results (see 8.4);
e) Analyzing results of verification activities (see 8.4);
f) Validating control measures or their combinations (see 8.2);
g) Corrective actions (see 7.9); and
h) FSMS updating (see 8.5.2).
8.5.2 Updating the FSMS
Top Management shall ensure that the Company FSMS is continually updated.
To achieve this, the Food Safety Team shall periodically evaluate the FSMS.
After evaluating the FSMS, the FST will consider the need to review hazard
analyses (see 7.4), established operational PRPs (see 7.2), and the Company's
HACCP Plans (see 7.5). Evaluation and update activities will be based on:
a) Input from internal and external communications (see 5.6);
b) Other information concerning the suitability, adequacy, and effectiveness of
the Food Safety Management System;
c) Output from analyzing results of verification activities (see 8.4); and
d) Output from Management Reviews (see 5.8).
FSMS updating activities shall be recorded and reported in an appropriate manner
as input to Management Reviews (see 5.8).
8.5.3 Referenced Procedures
 FS1020 – MANAGEMENT RESPONSIBILITY
 FS1170 – CORRECTIVE ACTION
 FS1180 – CONTINUOUS IMPROVEMENT

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Food Safety Manual - Revision History

Revision Date Description of changes Requested By

0.0 2/1/2006 Initial Release

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FSMS GLOSSARY

Term Definition
Acceptable level The level of a safety hazard considered to present a risk the consumer
would accept. The acceptable level of the hazard in the end product,
sometimes referred to as the "target level", should be stated in the
product description and set at or below statutory/regulatory limits.
An acceptable level for a hazard at an intermediate step in the
commodity (product) flow diagram may be set higher than that of the
final product, provided that the acceptable level in the final product is
achieved.
Active record Record currently in use or used in the context of ongoing business.
May also be referred to as a “production” record.
Calibration Comparison of a measurement standard or instrument of known
accuracy with another standard or instrument to detect, correlate,
report, or eliminate by adjustment any variation in the accuracy of the
item being compared.
Calibration Period during which a certified calibration is valid.
period
CCP See "critical control point".
CCP decision A sequence of questions to assist in determining whether a control
tree point is a CCP.
Competence State of having a combination of adequate training and experience to
perform a task or set of tasks.
Control measure An action or activity that can be used to prevent or eliminate a food
safety hazard (3.3) or reduce it to an acceptable level.
Control point Any step at which biological, chemical, or physical factors can be
controlled.
Controlled Document that provides information or direction for performance of
document work within the scope of a given procedure. Control characteristics
may include, but are not limited to, revision number/letter, revision
date, signatures indicating review and approval, and controlled
distribution.
Correction Action taken to eliminate a detected nonconformity.
1) For the purposes of ISO 22000, a correction relates to the
handling of potentially unsafe products and can, therefore, be
made in conjunction with a corrective action.
2) A correction may be, for example, reprocessing, further
processing, and/or elimination of the adverse consequences of the
nonconformity (such as disposal for other use or specific
labeling).

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Term Definition
Corrective action Action taken to eliminate the cause of a detected nonconformity or
other undesirable situation
1) A nonconformity may have more than one cause.
2) Corrective action includes cause analysis and is taken to prevent
recurrence.
See "preventive action".
Critical control A step at which control can be applied that is essential to prevention or
point (CCP) elimination of a food safety hazard or reduction of the hazard to an
acceptable level.
Critical limit Criterion that separates the acceptable from the unacceptable. Critical
limits are established to determine whether a CCP remains in control.
If a critical limit is exceeded or violated, the affected products are
deemed potentially unsafe.
Cross- The transfer of harmful bacteria from one food to another by way of a
contamination nonfood surface, such as a cutting board, countertop, utensils, or a
person’s hands.
Deviation Failure to meet a critical limit.
Document Information and its supporting medium. The medium may be paper,
magnetic, electronic, optical computer disc, photograph, or sample.
End product A product that will undergo no additional processing or transformation
within the organization. A product that undergoes further processing
or transformation by another organization is an end product within the
context of the first organization and a raw material or ingredient in the
context of the second organization.
External A document of external origin that provides information or direction
document for the performance of activities within the scope of the Food Safety
Management System. Examples include, but are not limited to,
customer drawings, industry standards, international standards, and
equipment manuals.
Farm-to-Table A multi-step journey that food travels before it is consumed. The steps
Continuum in the continuum are Farm, Processing, Transportation, Retail, and
Table.
Each sector along the farm-to-table continuum plays a role in ensuring
that the food supply is fresh, of high quality, and safe from hazards. If
a link in the continuum is broken, the safety and integrity of the food
supply can be threatened.
Flow diagram A schematic, systematic presentation of the sequence and interactions
of steps in a process. A flow diagram usually takes the form of a
flowchart, where all steps in a process and their inputs and outputs
(including byproducts and waste) are shown as boxes connected by
unidirectional arrows.
Flow diagrams may be referred to as "process maps".

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Term Definition
Food Code A 400-page reference guide published by the U.S. Food and Drug
(USA) Administration (FDA). The Food Code instructs retail outlets (such as
restaurants and grocery stores) and institutions (such as nursing homes
and schools) on how to prevent foodborne illness. It consists of model
requirements for safeguarding public health and ensuring that food is
unadulterated (free from impurities) and honestly presented to the
consumer. The FDA first published the Food Code in 1993 and
revised it every two years through 2001; at that time, it was agreed that
the Food Code would be revised every four years. The last revision
was in 2005.
Food safety The concept that food will not cause harm to the consumer when
prepared and/or eaten according to its intended use.
Food safety Biological, chemical, or physical agent in food or condition of food
hazard with the potential to cause an adverse health effect.
1) The term “hazard” is not to be confused with the term “risk”
which, in the context of food safety, means a function of the
probability of an adverse health effect (e.g. becoming diseased)
and the severity of that effect (death, hospitalization, absence
from work, etc.) when exposed to a specified hazard. Risk is
defined in ISO/IEC Guide 51 as the combination of the
probability of occurrence of harm and the severity of that harm.
2) Food safety hazards include allergens.
3) In the context of feed and feed ingredients, relevant food safety
hazards are those that may be present in and/or on feed and feed
ingredients and that may subsequently be transferred to food
through animal consumption of feed and may thus have the
potential to cause an adverse human health effect. In the context
of operations other than those directly handling feed and food
(e.g. producers of packaging materials, cleaning agents, etc.),
relevant food safety hazards are those hazards that can be directly
or indirectly transferred to food because of the intended use of the
provided products and/or services and thus can have the potential
to cause an adverse human health effect.
Food Safety An ordered, well-documented system that results in safe food. The
Management FSMS is designed to ensure consistency and improvement of work
System (FSMS) procedures and practices, including produced goods. These procedures
are based on standards or principles, such as ISO 22000 or HACCP,
that specify procedures for achieving effective management in the
safety of food production.
Food safety Overall intentions and direction of an organization related to food
policy safety, as formally expressed by top management
Food safety team Personnel responsible for testing, inspecting, and reporting on FSMS
procedures to ensure their conformance to applicable requirements.

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Term Definition
Food safety team Someone who has acquired the necessary competencies, training,
leader certifications, and managerial skills to lead a Food Safety Team.
Food supply A sequence of stages and operations involved in the production,
chain (or food processing, distribution, storage, and handling of food and/or its
chain) ingredients, from primary production to consumption.
1) This includes production of feed for food-producing animals and
for animals intended for food production.
2) The food (supply) chain also includes the production of materials
intended to come into contact with food or raw materials.)
Good practice A practice or set of practices designed to ensure that food products,
services, etc., are executed according to prescribed food safety
standards. Good Practice ensures that finished products have the
correct identity, strength, quality and purity characteristics they are
represented to have, and have not been altered during processing,
packaging, or handling.
Most "good practices" have been around for so long and are
commonly followed by good producers, etc., that standards and
regulations have grown up around them. Examples of "good
practices" include Good Manufacturing Practice, Good Veterinary
Practice, and Good Hygienic Practice.
HACCP A systematic approach to the identification, evaluation, and control of
food safety hazards.
HACCP plan The written document, based upon the principles of HACCP, which
delineates the food safety procedures to be followed by the Company.
HACCP system The result of implementing the HACCP Plan.
HACCP team People responsible for developing, implementing, and maintaining the
HACCP system.
Hazard analysis The process of collecting and evaluating information on hazards
associated with the food under consideration to decide which are
significant and must be addressed in the HACCP plan. Hazard
analysis consists of two steps, identification and evaluation.
High-risk food Food that supports the growth of bacteria and/or microbes, such as
meat, dairy, or eggs.
Hold Time period used for investigation after a food has been identified as
potentially unsafe. The "hold" process is unique to USDA commodity
foods.
Internal Document of internal origin (developed entirely by or completed by
document the Company) that provides information or direction for the
performance of activities within the scope of the Food Safety
Management System. Examples include, but are not limited to, the
procedures contained in the Company's FSMS manual.

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Term Definition
Management Consists of the Food Safety Team Leader, Department Managers, and
team the Company President, at a minimum.
MAP See "modified atmosphere packaging".
Material Safety A Material Safety Data Sheet is designed to provide workers and
Data Sheet emergency personnel with the proper procedure(s) for handling or
(MSDS) working with a particular substance. MSDSs include information such
as physical data (melting point, boiling point, flash point, etc.),
toxicity, health effects, first aid, reactivity, storage, disposal, protective
equipment, and spill/leak procedures that are of particular use if a spill
or other accident occurs.
An MSDS is designed for employees who may be occupationally
exposed to hazards at work, employers who need to know the proper
methods for storage, etc., and emergency responders (such as fire
fighters, hazardous material (HazMat) crews, emergency medical
technicians, and hospital emergency room personnel).
MSDSs are not designed for consumers – they reflect the hazards of
working with materials occupationally. For example, an MSDS for
paint does not apply to someone who uses a can of paint once a year
but does apply to someone who uses paint, especially in confined
spaces, 40 hours a week.
Modified Food packaging in which a mixture of gases replaces ordinary air in
atmosphere the food package. Carbon dioxide and nitrogen are commonly used in
packaging MAP to replace oxygen. Many foodborne pathogens cannot thrive in
(MAP) low-oxygen environments. A low-oxygen environment also inhibits
spoilage by preventing growth of molds and yeasts.
Monitoring Conducting a planned sequence of observations or measurements to
assess whether control measures are operating as intended; also, the
regular measurement or observation of a critical control point to make
sure the product does not go outside of its critical limits.
MSDS See "Material Safety Data Sheet".
Operational A PRP identified during a hazard analysis as essential to controlling:
prerequisite (a) the likelihood of introducing food safety hazards to; (b)
program contamination of; and/or (c) proliferation of food safety hazards in the
product(s) or processing environment(s). Also known as an
"operational PRP".
Prerequisite Basic conditions and activities necessary to maintain a hygienic
program environment throughout the food supply chain which is suitable for
production, handling, and provision of safe end products and safe food
for human consumption.
PRPs depend on the segment of the food chain in which the
organization operates and the type of organization (see ISO
22000:2005, Annex C). Examples of equivalent terms are Good
Agricultural Practice (GAP), Good Veterinarian Practice (GVP), Good
Manufacturing Practice (GMP), Good Hygienic Practice (GHP), Good

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Term Definition
Production Practice (GPP), Good Distribution Practice (GDP), and
Good Trading Practice (GTP).
Preventive action Long term cost / risk weighted action taken to prevent a problem from
occurring, based on an understanding of the product or process. See
"corrective action".
PRP Prerequisite program.
Product The act of bring a product (goods or services) into existence; making a
realization product.
Recall Remove a food product from the market because it may cause health
problems or possible death; withdraw.
Reference A standard of the highest order of accuracy in a calibration system,
standard establishing the basic accuracy values for that system. See "working
standard".
Risk A function of the probability of an adverse health effect (e.g., disease,
illness) and the severity of that effect (e.g., work absence,
hospitalization, death) when exposed to a specified hazard.
Safe food Food that is not harmful or injurious when consumed; food that does
not cause medical illness or pose a health hazard to the consumer.
Recently, food scientists, nutritionists, and various organizations have
pushed for a narrower definition of safe food, to include only foods
that provide a long-term nutritional benefit or promote health. It is
unlikely the narrower definition will ever have full force of law,
considering the economic impact it would have on producers, not to
mention the success of similar legislation (e.g., Prohibition, 1919-
1933, USA). Regardless, one must be mindful of the context in which
the term "safe food" is used.
Segregation Removal of product to an area of storage that spatially (physically)
isolates it from other foods.
Supplier Company/organization that directly supplies Our Company with food;
food ingredients; food processing, handling, and/or packaging
equipment; and/or other items directly or indirectly related to food
safety (e.g., cleaning/sanitation chemicals, labels, containers,
equipment maintenance services).
Target Standard which must be met to control a hazard.
Target level See "acceptable level".
Traceability The ability to relate individual measurement results to national
standards or nationally accepted measurement systems through an
unbroken chain of comparisons.

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Term Definition
Uncontrolled Document that was removed from – or never was a part of – the
document Company's controlled document system. Uncontrolled documents
may not be used to provide work direction or information necessary
for the performance of work. Uncontrolled copies of documents may
be used as training aids.
Updating Immediate and/or planned activity to ensure application of the most
recent information on a given topic.
Validation Obtaining evidence that the control measures managed by the HACCP
plan and by the operational PRPs are capable of being effective
Vendor See "supplier".
Verification Confirmation, by obtaining objective evidence, that specified
requirements have been fulfilled.
Withdraw See "recall".
Working Designated measuring equipment used in a calibration system as a
standard medium for transferring the basic value of reference standards to lower
echelon transfer standards or other measuring and test equipment. See
"reference standard".

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