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CONFIDENTIAL

The information contained in this manual is strictly confidential and

intended for the sole use of the recipients. Any copying,
dissemination, or distribution of this information is prohibited.

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FOOD SAFETY MANAGEMENT SYSTEM MANUAL

FSSC 22000 v 6

PREPARED BY:

EFFECTIVE FROM:

APPROVED BY:

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DECLARATION

<company name> brings out this Food Safety Management System Manual as part of the food
safety system under the authority of the Food Safety Team Leader. This Manual is the original
and authenticated one and the activities detailed in this Manual are true and correct. This FSMS
Manual follows the international standard, FSSC 22000 6 which it is based on. The criteria
outlined in this manual are mandatory and shall be complied with by all the staff, management,
and other stakeholders. Any changes or modifications to be incorporated in this manual shall be
made only upon authorization by the Director and the details of the modifications by the food
safety team leader will be indicated in the record of Amendments.

Date:

Signed by:

Signature:

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MANUAL CONTROL

Distribution List of the Manual – Refer document retained – EP/MR/0.. Document Issue and
Acknowledgment Register.

The Food Safety Team Leader holds the “Master Copy” of the FSMS Manual.

AMENDMENT LIST

Date of Reason for

S. No. Document Name Document No. Authorization
Amendment Change
1
2
3
4
5
6
7
8
9
10

2. Normative References

We have developed an FSSC 22000 V6 based Food Safety Management System which assures
the safety of food products manufactured and packed at <company name> premises. Process
control plans developed and operated for all aspects that are applicable to the safety of products
are described/referenced in the appropriate FSSC 22000 V6 Food Safety System documentation.

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3. Definitions, Vocabulary & Abbreviations

3.1 Food Chain: Sequence of the stages and operations involved in the production,
processing, distribution, storages, and handling of food and its ingredients, from primary
production to consumption.

3.2 FOOD SAFETY: Assurance that food will not cause an adverse health effect for the
consumer when it is prepared and /or consumed in accordance with its intended use

3.3 Food Safety Hazards: Biological, chemical or physical agent in food or condition of
food with potential to cause adverse health effect.

3.4 Food Safety Policy: Overall intention and direction of an organization related to food
safety as formally expressed by top management.

3.5 End Product: Product that will undergo no further processing or transformation by the
organization.

3.6 Flow Diagram: Schematic and systematic presentation of the sequence and interaction of
steps in the process.

3.7 Control Measures: Action or activity that is essential to prevent a significant food safety
hazard or reduce it to an acceptable level.

3.8 Prerequisite Program (Food Safety): Basic conditions and activities that are necessary
to maintain a hygienic environment throughout the food chain suitable for production,
handling and provision of safe end products and safe food for human consumption.

3.9 Operational PRP (Operational Prerequisite program): Control measure or combination

of control measures applied to prevent or reduce a significant food safety hazard to an
acceptable level, and where action criterion and measurement or observation enable effective
control of the process and/or product.

3.10 CCP Critical Control Point: Step in the process at which control measure(s) is (are)
applied to prevent or reduce a significant food safety hazard to an acceptable level, and
defined critical limit(s) and measurement enable the application of corrections.

3.11 Critical Limit: Measurable value which separates acceptability from unacceptability.

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3.12 Monitoring: To conduct a planned sequence of observations or measurements to assess

whether a CCP is under control and to produce an accurate record for future use in
verification.

3.13 Correction: Action to eliminate a detected nonconformity (ISO 9001:2000 definition

3.6.6).

3.14 Corrective Action: Action to eliminate the cause of a detected nonconformity or other
undesirable situation and to prevent recurrence

3.15 Validation (Food safety): obtaining evidence that a control measure (or combination of
control measures) will be capable of effectively controlling the significant food safety
hazard.

3.16 Verification: Confirmation, through the provision of objective evidence that specified
requirements have been fulfilled.

3.17 Updating: Immediate and or planned activity to ensure application of the most recent
information.

3.18 Action criterion: Measurable or observable specification for the monitoring of an OPRP

3.19 Documented information: Information required to be controlled and maintained by an

organization and the medium on which it is contained.

3.20 Traceability: Ability to follow the history, application, movement and location of an
object through specified stage(s) of production, processing and distribution.

Vocabulary and Abbreviations

FSMS: Food Safety Management System (FSSC 22000 V6)

Cl. No.: Clause number

Company: <company name>

FSTL: Food Safety Team Leader

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Company Profile

About <company>

Establishment:

<company name> is well-established and has been in existence for the last ___ years, The
Company is marketing its product under the Brand name “Earthistic Produce”.

Location with Infrastructure Facilities

Unit is situated ………………., Bangalore, Karnataka, India. The Industrial area has proximity
to Rail, Road and Air transport. The unit has a few transport vehicles for the transportation of
products to different retail locations. The unit has ____ KVA of power supply from the State
Electricity Board. We are located on the 2nd floor a building.

Food safety is one of the most important responsibilities of each person involved with production
and handling, and this manual has been produced to assist food handlers and managers in the
safe receiving, storage, and handling or raw materials and packaging materials, production,
fermenting, bottling, and delivery of products. Products manufactured at the facility are Sprouts,
Microgreen and Tofu. These products are packed and sold B2B customers in India. We accept
the orders as per the customer (B2B) and then plan the production accordingly.

This manual is prepared to ensure that the health and well-being of consumers are not
compromised by the end product. The <company name> is committed to ensuring that high
standards of food safety and hygiene, above and beyond the minimum requirements for
compliance with the appropriate legislation are realized and furthermore encourages progressive
improvement to ensure that food provided to consumers is free from contamination and safe to
eat/ consume.

For food production facility refer the following Annexures: EP/ANX/ (Plant Layout)

At <company name> we are committed to making constant improvements to the quality and
hygiene standards of the products manufactured. The company has a aim to produce healthier
and safe products to the customers.
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In regard to cleanliness and hygiene, the premises are cleaned round the clock and maintained to
the highest hygienic standards.

Our Vision

Our vision is to produce safe and quality products to satisfy the customers.< company name>, is
primarily in to preparing, processing, packing and dispatch of Sprouts, Microgreen and Tofu that
can be widely used by all range of customers. <add details> _______________________

4. Context of the organization

4.1 Understanding the organization and its context:

The organization has determined the external and internal issues that are relevant to its
purpose and that affect its ability to achieve the intended result(s) of its FSMS. The
organization has identified, reviewed, and updated the information related to these external
and internal issues by considering external and internal issues including, but not limited to
legal, technological, competitive, market, culture, social and economic environments, cyber
security and food fraud, food defense and intentional contamination, knowledge and
performance of the organization, whether international, national, regional or local.

4.2 Understanding the needs and expectations of interested parties:

The organization manufactures, packing and dispatch of ____ products to its B2B customers. A
strict food safety culture is always adhered to in the receiving, storage, handling, manufacturing,
packing and transporting at <company name>. To combat these issues, basic food safety and
hygiene practices have been adopted by all food handlers staff, such as handwashing, cross-
contamination control, regular cleaning and maintenance amongst others.

4.3 Scope

Scope of this implementation includes receipt of raw materials, packaging materials, storage,
production process, packaging and dispatch of products under mentioned brand names (Earthistic
Produce) and pack sizes.

<company name> has defined the scope as "Receipt of raw materials, packing materials,
processing, storage and dispatch of all Sprouts, Tofu and Microgreen"

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The company’s FSMS is built upon the firm foundation of current Food Safety Programs such as
Good Manufacturing Practices and Sanitary Standard Operating Procedures.

The FSMS Program is consistent with the principles of and guidelines laid down by Food Safety
Management System FSSC 22000 V 6, TS 22002-1:2009, and the Joint FAO/WHO Codex
Alimentarius Commission HACCP System Guidance for its application Annex to CAC/RCP 1-
1969 Rev. 4 2020.

We at <company name> outsource the following support services and controls in a defined
mechanism:

 Maintenance
 Expert consulting
 Pest control
 Waste disposal
 External calibration
 External laboratory analysis
 Laundry
 Preventive maintenance for equipment and plant
 …..<add details>

4.4 Food Safety Management System

The Food Safety Management System or FSMS is the adoption of GMPs (Good Manufacturing
Practices), GHPs (Good Hygiene Practices), HACCP principles, Management Systems, Statutory
& Regulatory requirements, customer specifications and other policies to ensure food safety. The
organization is committed to following the best hygiene and food safety practices in the FSMS to
ensure a safe and hygienic environment for food production.

5. Leadership

5.1 Leadership and Commitment

The <company name> has always strived to provide the best products for its consumers and
develop a sustainable model of business by developing a line of enduring task force who live the
vision of the organization. The company is committed towards the health and safety of all its
employees, consumers and interested parties. The commitment also involves all the necessary
processes to provide safe and wholesome food to all the associated people of the organization.
We will achieve it by implementing, maintaining and continually improving a strong food safety
management system in our premises. We are also committed to comply with the necessary
regulatory and legal requirements for the process.
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The top management commits to provide adequate and timely resources for the establishment of
the system and conduct Management Reviews as required assessing the effectiveness of the food
safety management system.

Customer satisfaction is an essential part of the Food Safety Policy and the top management will
ensure that the needs and expectations of the customers, including unstated legal and regulatory
requirements will be determined, converted to process requirements and fulfilled to achieve
customer satisfaction.

5.2 Food Safety policy

5.2.1 Establishing Food Safety Policy

We at <company name> are devoted, dedicated and motivated workforce trained to ensure safe,
hygienic and quality products that conforms to legal requirements to achieve highest level of
customer satisfaction. This will be achieved by effective communication of food safety and
quality issues to employees, contractors and service providers in the procurement, cleaning,
production, packaging, storage and transport by continuous monitoring, reviewing and upgrading
procedures and processes, applying state of the art technology and quality and food safety
management system.

The organization is committed to provide safe, hygienic and nutritious food to consumers by:

 Maintaining food safety to the highest standard throughout receiving, manufacturing,

packaging, storage and delivery.
 Ensuring compliance to FSSC 22000 V 6 principles and regulations laid down by FSSAI.
 Providing comprehensive training plan for the food handler and service staff.
 Reviewing systems and procedures to enable continuous improvements.

5.2.2 Communication of Food Safety Policy

The food safety policy crafted by the food safety team and approved by Plant Head at the
<company name> is communicated, understood and applied at all levels within the company by
the in-house food safety team through training and display boards. As evidence of the same, it is
maintained as documented information and will be made available to relevant interested parties,
as appropriate.

5.3 Organizational Roles, Responsibilities and Authorities

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The top management of the <company name> ensures that responsibilities and authorities are
defined and communicated within the company to ensure the effective operation and
maintenance of the food safety management system.

The organization has appointed a food safety team, led by a Food Safety Team Leader, whose
members have a combination of multi-disciplinary knowledge and experience in developing and
implementing the FSMS. All personnel has the responsibility to report problems with the food
safety management system to identified person i.e., the food safety team leader or team
members.

Minimum qualification criteria, including required expertise, are defined and documented for all
members of the Food Safety Team is maintained with the Food Safety Team Leader. This is
reviewed and updated periodically. The assignment (including tasks, responsibilities and
authorities) is documented for the team members of the Food Safety Team as a part of the
Responsibility and Authority document maintained with the Food safety Team Leader. (Refer
Doc.: EP/ANX/03 Roles, responsibilities and authorities)

The Food Safety Team Leader (FSTL) ensures the implementation & maintenance of Food
Safety Management System in compliance with FSSC 22000 V6 Standard.

The responsibilities of FSTL include the following besides any other routine jobs:

 Reports on the performance of the Food Safety Management System for review as a basis
for improvement.
 Organizes scheduled as well as unscheduled Management Review meeting.
 Promoting awareness of customer requirements throughout the organization.
 Reviews with the Department Heads the Food Safety Management System in their
departments every 6 months.
 Establishes, implements, maintains and update the Documents and Record control
system.
 Establishes the Internal Food Safety Audit Plan and coordinates Internal and External
Audits.
 Initiates Follow-Up Audit activities to verify Audits and record the implementation and
effectiveness of the Corrections & Corrective Actions.
 Reports the results of Internal and External audits to the Top Management and the
Production Manager Estate & Facility in the Management Review Meetings.
 Verify the Food Safety Manual and Procedures for adequacy.
 Approves the process flow chart and HACCP plan.
 Manages and organizes the work of food safety team.
 Ensures relevant training and competencies for the food safety team.

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A qualified and experienced person is appointed as Food Safety Team Leader (Refer Doc.:
EP/ANX/04 Competency Matrix)

6. Planning

6.1 Actions to address risks and opportunities:

6.1.1 The food safety team at <company name> has determined the risks and opportunities
regarding food safety and hygiene that may occur on the premises to ensure that the FSMS can
achieve its intended results. (Refer Doc.: EP/NX/14) SWOT, Risks and Opportunities)

The development of the FSMS was done in to set up a system that helps prevent, or reduce,
undesired effects and achieve continual improvement.

6.1.2 The food safety team at <company name> has done a complete evaluation of all possible
risks and opportunities regarding food safety and hygiene and a plan to combat these risks have
been set in place. Implementation and addressal of these actions are also determined by the food
safety team and must be effectively communicated to all staff whose activities have an impact on
food safety and hygiene.

6.1.3 The actions taken by the food safety team to address risks and opportunities will be
analyzed and only actions deemed appropriate to the magnitude of impact on food safety
requirements, the conformity of food products and services to customers and the requirements of
interested parties in the food chain will be enforced.

6.2 Objectives of the Food safety Management System and planning to achieve them:

<company name> has established measurable objectives that are consistent with our ‘Food
Safety Policy’ and pursued at relevant levels and functions in the organization. (Refer Doc.:
EP/ANX/12 FSMS Planning and Objectives).

The measurable target for Food Safety Objectives is fixed at the beginning of the year and
reviewed in every Management Review Meeting.

6.3 Planning of Changes

In the event of a change or amendment to the FSMS, the proposed changes will be subjected to
evaluation by the food safety team at <company name> If approved, the changes (including
personnel changes) will be communicated to all concerned parties. (Refer Doc.: EP/SOP/22
Planning of Changes)

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For the approval of any change or amendment to the FSMS, the food safety team will consider
the following:

a) the purpose of the changes and their potential consequences

b) the continued integrity of the FSMS

c) the availability of resources to effectively implement the changes

d) the allocation or re-allocation of responsibilities and authorities

7. Support

7.1 Resources

7.1.1 General

<company name> has identified, and established resources required to implement and improve
the processes of the FSMS and to satisfy the requirements of the customer to achieve Food
Safety Objectives.

Adequacy of resources including Human, Material, Machine, Method, and Money are reviewed
periodically by the top management and food safety team during the Management Review
Meetings.

7.1.2 People

<company name> attaches critical importance to ensure that all personnel performing activities
affecting Food Safety are suitably qualified and trained. The company has set up and maintains
minimum qualification criteria for all the positions in the organization. All new personnel joining
the company are given induction/ Food Safety training which includes, introduction to
<company name> Food Safety Policy.

Production Manager will monitor employees while on the job, as he is also responsible for
ensuring that personnel assigned to manage, perform, and verify work affecting Food Safety are
competent based on relevant education, training, skills and experience. The procedure also
requires that annually, the Department Heads review the competency needs for the personnel
reporting to them.

Based on this assessment, suitable training if required, is imparted to relevant personnel and
records of training are maintained.
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The training ensures that the employees are aware of the relevance and importance of their
activities and how they contribute to the achievement of Food Safety Objectives.

7.1.3 Infrastructure

<company name> management has identified, provided and maintained necessary facilities to
achieve effective control of all operations as applicable. It has established and maintains facilities
and equipment maintenance, in order to assign responsibility and define the process for the
identification, maintenance and control of all facilities, machines and equipment, including
material handling equipment, used in support of product realization processes.

<company name> determines, provides and maintains the infrastructure needed to achieve
conformity to product requirements.

 Infrastructure at <company name> includes:

- Building, in and around facilities (driveways, etc.), workspaces and associated utilities like
UPS, generators, solar panels etc.

- Calibrated process equipment.

- Supporting services like telephones, fax machine, computers, etc.

- Appropriate design and maintenance of the work area, which has a major effect on food safety.
The maintenance of the equipment complies with the Good Manufacturing Practice (GMP).

 Infrastructure is maintained to ensure their suitability. Equipment and machine

maintenance are carried out as per schedule established.
 Top management is responsible to ensure that facilities are of suitable size, construction,
and location with adequate control systems to facilitate operations.
 Top management is responsible to ensure that facilities are maintained in a good state of
repair.
 Preventive Maintenance of essential facilities and equipment is planned, implemented
and documented.
 Department managers/supervisors are responsible for identifying the need and
requirements for new and/or modification or repair to existing infrastructure and
facilities. Requests for changes are submitted to the FSTL for review and approval.
 Maintenance of facilities and equipment is performed by internal personnel, where
specified, and by outside contracted services.

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The facilities are reviewed for adequacy and suitability for the existing and future requirements
in the Management Review Meetings. (Refer Doc. EP/PRP/01) Building and Infrastructure).

7.1.4 Working Environment:

<company name> has provided the resources for the establishment, management and
maintenance of the work environment needed to implement the requirements of FSSC 22000 V6.

7.1.5 Externally developed elements of the Food Safety Management System

The scope of the food safety management system includes "Receipt of raw materials, packing
materials, processing, storage and dispatch of all Tofu, Microgreen and Sprouts" at the
<company name>.

<company name> follow the sanitary and hygienic requirements and food safety measures as
mentioned in Schedule 4 Part -II of the FSSR (Licensing and registration of food business) 2011.

7.1.6 Control of externally provided processes, products or services:

The food safety team at <company name> has a system in place for the control of externally
provided processes/services. According to the scope of food management system, the controls
are extended to all vendors who provide products and/or services pertaining to this scope. The
following measures are undertaken by the food safety team to ensure the same:

a) Established criteria are applied for the evaluation, selection, monitoring of performance
and re- evaluation of external vendors

b) Adequate communication lines through e-mails, receipts etc. are maintained with external
vendors

c) Ensure that all vendors and their products and/or services consistently meet a pre-
determined set of requirements needed to maintain the FSMS

d) All communication with vendors is retained as documented information

(Refer Doc.: EP/PRP/10 Vendor Selection and Management of Suppliers, EP/PRP/11 Vendor
Selection and Management of Service Providers)

7.2 Competence

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The FSTL is responsible to ensure that personnel assigned to manage, perform, and verify work
affecting Food Safety are competent based on relevant education, training, skills and experience.
The company has appointed a food safety team whose members have a combination of multi-
disciplinary knowledge and experience in developing and implementing the FSMS.

Minimum qualification criteria, including required expertise, are defined and documented for all
members of the Food Safety Team is maintained with the Food Safety Team Leader. This is
reviewed and updated periodically. The assignment (including tasks, responsibilities and
authorities) are documented for the team members of the Food Safety Team as a part of the
Responsibility and Authority document maintained with the Food safety Team Leader.

The Organization also attaches critical importance to all other personnel performing activities
affecting Food Safety, ensuring that they are suitably qualified and trained. The company has set
up and maintained minimum qualification criteria for all the positions in the organization.
Employees will be monitored by the head of departments. Based on this assessment, suitable
training is imparted to relevant personnel, and documents of training are maintained. (Refer
Doc.: EP/ANX/04 Competency Matrix)

The training ensures that the employees are aware of the relevance and importance of their
activities and how they contribute to the achievement of Food Safety Objectives.

7.3 Awareness

Food Safety training is an integral step in ensuring all personnel working in organization are
aware of the food safety culture enforced in the premises. All new personnel are given
induction / Food Safety training which includes: Introduction to Organization, Food Safety
Policy, etc. Employees are provided with on-the-job training, which is a more hands-on approach
to learning the Food Safety Policy. Additionally, employees will be monitored by the head of the
departments. Protocol also requires that the Department Heads review the competency needs for
the personnel reporting to them annually. Based on this assessment, suitable training and
awareness is imparted to relevant personnel, and records of training are maintained.

7.4 Communication

7.4.1 General

The food safety team at <company name> has determined the internal and external
communications relevant to the FSMS, including:

a) on what it will communicate

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b) when to communicate

c) with whom to communicate

d) how to communicate

e) who communicates

The company will ensure that all staff whose activities have an impact on food safety understand
the importance of effective communication. (Refer Doc.: EP/SOP/03 Communication)

7.4.2 External Communication

External communication includes the requirements of FSMS and other system procedures with
the external parties like suppliers, contractors, subcontractors, customers and statutory/
regulatory agencies.

Customers including employees and consumers are communicated in relation to product

information, food safety requirement like allergens, complaints, feedbacks, suggestions for
changes and overall quality scores.

Statutory and regulatory authorities are communicated regarding the notifications and changes in
the food laws and compliances thereof.

The company gives adequate importance to identification of customer’s requirements, which

includes product requirements, specified or unspecified by the customers/employees, but
required for intended use, requirements about availability, delivery and support and legal and
regulatory requirements.

Partner and marketing team are authorities who interact with customers for:

 Products requirement
 Allergen requirement,
 Attending customer complaints, receiving and corrective action upon customer Feedback
 Evaluating customer preferences and feedbacks.

7.4.3 Internal communication

<company name> has established, implemented and maintained effective arrangements for
communicating with personnel on issues having on impact on food safety. The issues shall be
communicated through emails, notice boards and memos.
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Food safety team is informed in timely manner of changes, including but not limited to the
following:

- Products or new products

- Production plans

- Raw material, ingredients

- Production system and equipment

- Production premises, location of equipment, surrounding environment

- Cleaning and sanitation program

- Packaging, storage and distribution system

- Personnel qualification levels and or allocation of responsibilities and authorities

- Statutory and regulatory requirements

- Knowledge regarding food safety hazards and control measures

- Customer, sector and other requirements that organization observed

- Relevant enquiries from customer or other interested parties

- Complaints indicating food safety hazards associated with the product

- Other conditions that have impact on food safety

7.5 Documented Information

7.5.1 General

The FSMS documentation includes the Food Safety Manuals, Food Safety System Procedures,
Work instructions, Plans, Specifications, Records, & Forms to ensure effective operation and
control of the processes.

Hierarchy of Food Safety Management System

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Food
Safety
Policies

Food Safety Systems

and Procedures,
FSMS Manual

Plans, Specifications, Work

Instructions, GMPs, PRPs

Records

7.5.2. Creating and Updating:

<company name> maintains the document related to Food safety management system to ensure
that right information is being communicated to the right people.

The procedure ensures that:

 All documents are reviewed and approved prior to issue

 The pertinent issues of appropriate documents are available at the appropriate location
 All changes to documents are in writing, should be reviewed and approved by the same
functions as the original documents
 The master list of all applicable documents is maintained
 The document control procedure provides for identifying and establishing current
revision status of all documents
 Obsolete documents are removed from points of use
 Where practical nature of change is highlighted in the document
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 Documents are legible, readily identifiable and retrievable

Food Safety Records are maintained in accordance with the above procedures to ensure that the
requirements of the Food Safety Management System as well as customer’s requirements are
met.

Regarding effective communication of these protocols, the organization has established a

procedure for identification, collection, indexing, access, filing, storage, retrieval, protection and
disposition of Records necessary to demonstrate that requirements for Food Safety are met and
that the Food Safety Management System is effective.

External communication includes the requirements of FSMS and other system procedures with
the external parties like suppliers, contractors, subcontractors, customers and statutory/regulatory
agencies.

Customers including employees and consumers are conveyed information in relation to product
information, food safety requirements i.e., hazards, complaints, feedbacks, suggestions for
changes and overall quality scores.

Communication regarding statutory and regulatory authorities regarding the notifications and
changes in the food laws and compliances thereof.

<company name> gives adequate importance to identification of customer’s requirements, which

includes product requirements, specified or unspecified by the customers/employees, but
required for intended use, requirements about availability, delivery and support and legal and
regulatory requirements.

7.5.3 Control of Documented Information

The company has established a procedure for identification, collection, indexing, access, filing,
storage, retrieval, protection and disposition of Document necessary to demonstrate that
requirements for Food Safety are met and that the Food Safety Management System is effective.

The documentation system set up by the company have specific protocols that ensure that
documents related to the Food Safety Management System is maintained by and communicated
to the to the right people. (Refer Doc,: EP/SOP/01 Control of Documents Maintained,
EP/SOP/02 Control of Documents Retained)

The protocol mentioned above ensures that:

 All documents are reviewed and approved prior to issue

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 The pertinent issues of appropriate documents are available at the appropriate location
 All changes to documents are in writing, should be reviewed and approved by the same
functions as the original documents
 The master list of all applicable documents is maintained
 The document control procedure provides for identifying and establishing current
revision status of all documents
 Obsolete documents are removed from points of use
 Where practical nature of change is highlighted in the document
 Documents are legible, readily identifiable and retrievable

8.0 Operations

8.1 Operational Planning and Control

<company name> has planned and developed the processes needed for the realization of safe
products. It implements, operates and ensures the effectiveness of planned activities and any
changes to those activities.

8.2 Prerequisite Programs (PRPs)

The company has made available a complete and actual description of the pre-requisite program
(PRP). The procedures belonging to the PRP are well established (specified and documented),
fully operational and integrated in the food safety management system and verified. Their
verification is addressed as a part of the Internal Audit cum Verification procedure.

The Codex General Principles of Food Hygiene lay a firm foundation for ensuring food safety
and suitability. The food hygiene principles, good manufacturing practices and food legislation
are included into its PRP. These are addressed in the various PRP related documents (such as
HACCP manual) which detail how we address each (relevant and applicable) part of the PRP.

PRPs are based on various factors like probable hazards in product through environment, which
includes biological, chemical and physical contamination of product(s), and food safety hazard
levels in the product and product processing environment.

The PRP(s) are:

 Appropriate to the need of the company about food safety.

 Appropriate to the size and type of operation and nature of the products processed /served
and /or handled.
 Implemented across entire operation either general or specific.
 Approved by the food safety team.
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When selecting and establishing PRP(s), appropriate information was considered and utilized
(e.g., statutory and regulatory requirements, customer requirements, recognized guidelines,
codex alimentary commission (codex) principles and codes of practices, national or international
or sector standards.

The food safety team has considered the following while establishing PRP(s):

 Construction and layout of building and associated facilities.

 Layout of premises, including workspace and employee facilities.
 Supplies of air, water, energy and other utilities.
 Supporting services including waste and sewage disposal
 Suitability of equipment’s and its accessibility for cleaning, maintenance and preventive
maintenance.
 Management of purchased materials (e.g., raw materials, ingredients, chemicals,
packaging) supplies (water, air, steam, gas, and ice), and handling products (e.g., storage
and transportation)
 Measure for prevention of cross contamination.
 Cleaning and sanitizing
 Pest control
 Personnel hygiene
 Food Storage
 Food defense, threat and vulnerability
 Other aspects as appropriate

8.3 Traceability System

<company name> has established and applied the traceability system that enables the
identification of product lots and their relation to batches of raw material, processing and
delivery records.

Traceability records are maintained for a period of one year for system assessment to enable the
handling of potentially unsafe products and in the event of product withdrawal. (Refer Doc.:
EP/SOP/07 Traceability System)

8.4 Emergency Preparedness and Response

We, <company name> has established, implemented and maintained procedures to manage
potential emergency and accidents that can impact food safety, and which are relevant to the role
of organization in the food chain. (Refer Doc.: EP/SOP/10 Emergency Handling procedures,
EP/ANX/05 Emergency Preparedness Plan)

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8.4.1 General

The procedures at the organization which are established to manage potential emergency
situations and accidents that can impact food safety and hygiene are an important part of the food
safety culture at the company and is highly relevant to the role of organization in the food chain.

8.4.2 Handling emergency situations and incidents

In the advent of emergency situations and/or incidents, the food safety team at the organization
will:

 Ensure applicable statutory and regulatory requirements are identified

 Ensure that details of the emergency are communicated internally to all personnel
working within the premises
 Ensure that any communication regarding the emergency is relayed effectively to all
external vendors and personnel (e.g., suppliers, customers, appropriate authorities, media)
 Act to reduce the consequences of the emergency, appropriate to the magnitude of the
emergency or incident and the potential food safety impact
 Periodically test procedures where practical
 Review and, where necessary, update the documented information

8.5 Hazard Control

Hazards are defined as biological, chemical, physical agents and allergens in food or condition of
food with potential to cause adverse health effect. Hazards in food can cause food poisoning and
injury, amongst other. Hazard Control is the process by which measures are introduced to
eliminate or maintain hazards at an acceptable level where they will not cause harm. The
organization has adequate hazard control measures in place to ensure the highest level of food
safety and hygiene for consumers. Food fraud is also taken into consideration while conducting
hazard analysis.

8.5.1 Preliminary steps to enable hazard analysis:

8.5.1.1 General

The Food safety team has recorded all relevant information documents for conducting hazard
analysis. These records of information are regularly updated for relevance.

8.5.1.2 Characteristics of raw materials, ingredients and product contact materials

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The Products are specified and documented in its Product Information document. The
description of the safety of the Products encompasses the food chain, ranging from raw materials
used to the distribution of the finished products. This is further documented through the Flow
Diagrams and Hazard Identification & Risk Analysis for the Product.

All raw materials, ingredients and product contact materials are described in documents in details
under the following heads:

 Biological, physical and chemical characteristics

 Composition of formulated ingredients
 Origin
 Method of production
 Packaging and delivery method
 Storage condition and shelf life
 Preparation and or handling before use or processing
 Food safety related acceptance criteria or specification of purchased materials and
ingredients as appropriate to their intended uses
 Statutory and regulatory requirements are followed when selecting the raw materials

(Refer Doc.: EP/ANX/15 Raw Material Specifications, EP/ANX/16 Packaging Material

Specifications)

8.5.1.3 Characteristics of end-products

Characteristics of the end-products have been described in Finished Good specifications form to
the extend needed to conduct hazard analysis including information on the following:

 Product name or similar identification

 Composition
 Biological, physical and chemical characteristics related to food safety
 Intended shelf life and storage conditions
 Packaging (Wherever applicable)
 Labeling related to food safety and or instructions for handling, preparation and usage.
 Method of distribution

8.5.1.4 Intended use

The intended use of the products is continually reviewed. The intended use, the reasonably
expected handling of the end-product, and any unintended but reasonably expected mishandling
and misuse of the end-product shall be considered and described in documents to the extend

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needed to conduct the hazard analysis. (Refer Doc.: EP/ANX/17 Finished Product
Specifications)

8.5.1.5 Flow diagrams and description of processes

8.5.1.5.1 Preparation of flow diagrams

Flow diagrams provide a graphic representation of the processes occurring inside the premises
and is used when conducting the hazard analysis. It is used as a basis for evaluating the possible
occurrence, increase, decrease or introduction of food safety hazards. The food safety team has
maintained an updated flow diagram as documented information for the products and processes
occurring in the premises. (Refer Doc.: EP/ANX/18 Process Flowchart)

8.5.1.5.2 Onsite confirmation of flow diagrams

The food safety team at the company confirms the accuracy of the flow diagrams on-site. Flow
diagrams are also reviewed for any updates on a regular basis.

8.5.1.5.3 Description of processes and process environment

The existing control measures, process parameters and or the rigorousness with which they are
applied or procedure that may influence food safety shall be described to the extent needed to
conduct hazard analysis.

8.5.2 Hazard Analysis

8.5.2.1 General

The food safety Team has identified and registered all potential (biological, chemical and
physical) hazards that can have an adverse effect on the safety of the products. The identification
includes all aspects of the operation within the scope of the FSMS. Potential hazards have been
documented in the Hazard analysis plan for each process step for the identified product cluster.

8.5.2.2 Hazard identification and determination of acceptable level

Identification of food safety hazards is based on:

- The primary information and data collected

- Experience

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- External information including to the extent possible, epidemiological, another historical

data

- Information from food chain on food safety hazards

8.5.2.3 Hazard Assessment

The company has conducted hazard assessment of each food safety hazard identified.

Food safety hazards are evaluated according to the possible severity of adverse health effects and
likelihood of their occurrence.

Probability (Likelihood of
Severity Risk
occurrence)
Unlikely Little Damage Low

1 1 1–4
Likely Very Serious Damage Medium

2 2 6
Certain Disaster High

3 3 9

The severity of the hazard’s adverse health effects, evaluated quantitatively, in terms of critical,
major or minor impact severity, as follows:

The risk rating, in quantitative terms (arrived at by multiplying the probability of occurrence
with the severity of impact), and the classification of the identified hazard into significant or non-
significant category based on the risk-rating factor. A risk rating of 4 or below indicates that the
risk is insignificant and a risk rating of 6 or 9 indicates that the control measure is required to
control the identified hazard.

Risk Assessment Matrix

Probability
1 2 3
Severity
2 4 6
3 6 9
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Risk Level = Likelihood x Severity

A critical aspect of Hazard analysis is identification of CCPs, or Critical Control Points; CCPs
are identified as per criteria laid down for CCP determination. Critical Limit describes the limits
beyond which this hazard is considered existent and it ensures the identified acceptable levels of
food safety hazard in the end-product not exceeded.

The company has determined the critical limit of each identified CCP and recorded and
monitoring the same. (Refer Doc.: EP/ANX/19 Hazard Analysis and Plan)

Critical limits based on subjective data (e.g., visual inspection, handling, process etc.) are
supported by instruction or specification or observation related to critical limits.

8.5.2.4 Selection and Categorization of control measures

Control measures are defined as actions and/or activities that are taken to prevent, eliminate or
reduce the occurrence of a hazard. The existing control measures, process parameters and or the
rigorousness with which they are applied or procedure that may influence food safety shall be
described to the extent needed to conduct hazard analysis.

Control measures have been selected after its effectiveness against the food safety hazards was
identified.

Selected control measures have been categorized as to whether they need to be managing
through operational PRP (s) or by the HACCP plan.

Selection of control measures are carried out using logical approach that includes assessment
with regards to the following questions on which the decision tree is based.

Its effect on identified food safety hazards relative to strictness applied.

Is there a significant No Apply PRPs as appropriate.
(likelihood x severity)
STOP, proceed to next step in the
hazard at this step?
process.

Ye
s
In all cases, a control measure in a subsequent
Is it necessary to apply No step in the process or in the food chain will
control measures at this reduce the hazard to an acceptable level. Apply
step? PRPs as appropriate.
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Implement control measures (a) by modifying

Ye your own process, or
s
(b) have control measures in the process of the
Are control measure already supplier of your raw materials.
in place? No

If (a) and (b) are not feasible:

inform your customer about the possible
presence of the hazard.

Ye
s

Categorize the control measure as an OPRP.

Is there any failure of the control 1. Establish action criteria.
measure with a high risk (likelihood 2. Monitor (measure or observe) to detect
x severity) for the safety of the failure.
product? The method and frequency shall be
Include the following: proportionate.
to likelihood and severity of failure.
- The effect on the hazard. No 3. In case of failure, assess the causes and
consequences of the failure.
- Control measure specifically
and when necessary manage effected product
applied to reduce to acceptable level
as potentially unsafe (correction).
- Any subsequent control measures? STOP, proceed to next step in the process.

- Single control measure or

Categorize the control measure as an OPRP.
1. Establish action criteria.
2. Monitor (measure or observe) to detect failure.
The method and frequency shall be proportionate to likelihood
and severity of failure.
3. In case of failure, assess the causes and consequences of the
failure and when necessary manage effected product as
Ye
s potentially unsafe (correction).
No 4. When possible, redesign the product, process or control
Is it feasible to establish measures.
measurable critical limits and 5. Inform customers and/or consumers about the risk.
monitoring that enable timely 6. Take action to reduce the likelihood and severity of failure.
detection and correction of all STOP, proceed to next step in the process.
failure?
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Ye
s

Categorize the control measure as a

CCP.
1. Establish measurable critical
limits.
2. Monitor (measurement) to detect
any failure to meet critical limits.
3. In case of failure, manage effected
products as potentially unsafe.

8.5.3 Validation of control measure (s) and combination(s) of control measure(s)

The company has produced safe food for many years before the introduction of the HACCP
system / FSMS. Therefore, historical results from on-line quality control monitoring and end-
product testing, customer or consumer complaints have been used as evidence for validation of
control measures.

The Control measures that are effective and capable of in combination, ensuring control of
identified food safety hazard(s) to obtain end products that meet the defined acceptable levels.

If the result of the validation shows that one or both above elements cannot be confirmed, the
control measures are reassessed.

Modification includes changes in control measures (i.e., process parameters, rigorousness and or
their combination) and or changes in raw material, manufacturing technologies, and end-product
characteristics, methods of distribution and or intended use of the end products. (Refer Doc.:
EP/SOP/28 Validation)

8.5.4 Hazard control plan (HACCP / OPRP plan)

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8.5.4.1 General

The Hazard Analysis and Critical Control Point Plan, or HACCP Plan, has been documented by
the food safety team and includes the following information:

 Food safety hazard(s) are controlled at CCP

 Control measures (GMP, SSOP, other cleaning procedures etc.)
 Critical limits and action criterions (Time, concentration of chemicals, temperature etc.)
 Monitoring procedures
 Corrections and corrective actions to be taken if critical limits are exceeded
 Responsibilities and authorities
 Record Monitoring

Another important aspect of the HACCP plan are the Operational PRPs (OPRP), defined as a
PRP or Pre-requisite program that has a control measure that controls a significant hazard in the
production process. The operational PRP(s) for the processes at organization have been
documented and shall include the following information for each program.

 Food safety hazard(s) is controlled by program

 Control measures
 Correction and corrective action to be taken if monitoring shows that the operational
PRPs are not in control
 Responsibilities and authorities
 Record of monitoring

8.5.4.2 Determination of critical limits and action criteria

Critical Limit is the limit beyond which a hazard is considered a danger to the production
system. Identification of critical limits for hazards ensures that danger level of hazards within the
system can be identified and brought to an acceptable level, which in turn ensures food safety.

The food safety team has determined the critical limit of each identified CCP; recording and
monitoring of the same is done.

Critical limits based on subjective data (e.g., visual inspection, handling, process etc.) are
supported by instruction or specification or observation related to critical limits.

8.5.4.3 Monitoring systems at CCP and for OPRPs

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The food safety team has established monitoring system for each CCP and OPRP; records of the
same are maintained in the form of training record, internal audit report, cleaning and sanitizing
report etc.

The monitoring system consist of relevant procedures, instructions and records that cover the
following:

- Measurement or observations that provide results within an adequate time frame

- Monitoring device used

- Applicable calibration methods

- Monitoring frequency

- Responsibility and authority related to monitoring and evaluation of monitoring results

8.5.4.4 Actions when critical limits or action criteria are not met:

Any product resulting from the process while the critical limit has been exceeded is treated as
non-conforming product.

The corrective actions with respect to product might include:

 Actions like product recall.

 Temporary hold of product.
 Identification of the non-conforming products.
 Rework of the product.
 Disposal / destruction of the product.

The corrective actions with respect to process might include:

 Adjusting the process.

 Adjusting or correcting or restoring the process conditions.
 Documented procedure is established for appropriate handling of potentially unsafe
product to ensure that they are not released until they have been evaluated.

8.5.4.5 Implementation of the hazard control plan

The organization’s food safety team have implemented and maintained the hazard control plan
using documented information, such as checklists maintained by trained people. All documents
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related to monitoring and enforcement of control measures for the HACCP plan are retained as
evidence of the implementation of the HACCP plan.

8.6 Updating the information specifying the PRPs and the Hazard control Plan:

As and when required, the company updates the following information:

 Product characteristics
 Intended use
 Flow diagrams
 Process steps
 Control measures

If necessary, the HACCP plan and instruction specifying the PRPs shall be amended.

8.7 Control of monitoring and measuring:

Monitoring and measuring methods and equipment are adequate to ensure the performance of the
monitoring and measuring procedures.

Wherever necessary to ensure valid results, the measuring equipment and methods used are
calibrated or verified prior to use against national and international measurement standards. They
adjusted or readjusted as necessary, identified to enable the calibration status to be determined,
and protected from damage and deterioration.

Records of the calibration and verification are maintained.

The validity of previous measurement results is assessed when the equipment or process is found
not to conform to requirements.

If the measuring equipment is non-conforming, appropriate action is taken for equipment and
any product affected and records are maintained for the same. (Refer Doc.: EP/ANX/17 Control
of Monitoring and Measuring Equipments)

8.8 Verification related to PRPs and the Hazard control plan:

8.8.1 Verification

Verification of FSMS is carried out at planned intervals and it defines the purpose, methods,
frequencies and responsibilities for the verification activities. (Refer Doc.: EP/SOP/13
Verification)
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It confirms that:

 PRPs are implemented.

 Input to the hazard analysis are continually updated
 The operational PRPs and the element in the HACCP plan are implemented and effective
 Hazards levels are within identified acceptable level
 Other procedures required by the organization are implemented and effective.
 Record of the verification results is communicated to the food safety team and
maintained in the form of internal audit records.

In addition to the above measures, the food safety team systematically evaluates the individual
results of planned verification. If verification does not demonstrate conformity with planned
arrangements, the organization acts to achieve the required conformity:

 existing procedures and communication channels

 the conclusion of hazard analysis, operational PRPs and the HACCP plan
 the effectiveness of human resource management and of training activities

HACCP plan will be reviewed by the food safety team at minimum annually or when any of the
following occur, but is not limited to:

 Change in ingredients and/or recipe.

 Change in processing conditions, process flow or equipment.
 Updated or new processing line for products
 Change in food contact packaging, storage or distribution conditions.
 Change in consumer use of finished product.
 Emergence of a new risk (e.g., known adulteration of an ingredient)
 Responding to customer complaint reviews to prevent reoccurrence.
 Following a recall/withdrawal.
 New developments within industry including scientific information associated with
ingredients, process or product.

8.8.2 Analysis of the results of verification activities

The food safety team analyzes the result of verification activities which are done at the set
frequencies, including the results of the internal audits and external audits. The analysis is carried
out to ensure that:

 The overall performance of the system meets the planned arrangements and the FSMS
requirements established by the company
 The need for updating or improving the FSMS are identified
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 Any corrections and corrective actions that have been taken are effective.
 The results of the analysis and the resulting activities is reported to top management as
input to management review

8.9 Control of product and process non-conformities

8.9.1 General

The food safety team has ensured that when critical limits for CCP(s) are exceeded or there is a
loss of control of operational PRP(s), the product affected are identified and controlled with
regards to their use and release. Corrective actions shall be initiated when critical limits are
exceeded, as mentioned previously, and/or when there is a lack of conformity with operational
PRPs. (Refer Doc.: EP/SOP/11 Control of Non-conformance)

8.9.2 Corrections

The food safety team has ensured that when critical limits for CCP(s) are exceeded or there is a
loss of control of operational PRP(s), the product affected are identified and controlled with
regards to their use and release.

This procedure clearly defined the identification and assessment of affected end products to
determine their proper handling and a review of correction carried out.

All corrections are approved by the Food Safety Team Leader and recorded together with
information on the nature of non-conformity, its cause(s) and consequences, including
information needed for traceability purposes and related to the non-conformity lot.

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

When action criteria for an OPRP are not met, the following shall be carried out:

 Determination of consequences of that failure with respect to food safety

 Determination of causes of failure
 Identification of the affected products and handling in accordance with the procedure

Results of evaluation as documented information shall be retained by the food safety team
leader.

Documented information shall retain to describe corrections made on non-conforming

products and processes including:
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 Nature of non-conformity
 Cause of failure
 Consequences as result of non-conformity.

8.9.3 Corrective Actions

Corrective actions shall be initiated by any non-conformity received through any internal or
external medium or when critical limits are exceeded or when there is a lack of conformity with
operational PRPs.

The company has established and maintained the documented procedure that specify appropriate
actions to identify and eliminate the causes of detected non-conformities, to prevent recurrence
and to bring the process or system back in to control after non-conformity is encountered. (Refer
Doc.: EP/SOP/06 Corrections and Corrective Actions)

These actions include:

 Reviewing non-conformities (including customer complaints)

 Reviewing trends in monitoring results that may indicate development towards loss of
control.
 Determining the causes of non-conformity
 Evaluating the need for action to ensure that non-conformities do not occur
 Determining and implementing the actions needed
 Recording the results of corrective actions taken and
 Reviewing corrective actions taken to ensure they are effective.

All corrective actions are recorded in Corrective action request form.

8.9.4 Handling of potentially unsafe products

(Refer Doc.: EP/SOP/14 Procedure for Handling Potentially Unsafe Products)

8.9.4.1 General

The organization handles non-conforming products by acting to prevent the non-conforming

product from entering the food chain unless it is possible to ensure that:

 The food safety hazard(s) of concern have been/will be reduced to the defined acceptable
level before entering in the food chain.
 The product still meets the defined acceptable level(s) of the food safety hazard(s) of
concern despite the non-conformity.
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All batches of products that may have been affected by a non-conforming situation shall be held
under control of us until they have been evaluated.

If products that have left the control of the organization are subsequently determined to be
unsafe, then we notify relevant parties and initiates a withdrawal.

The controls and related responses and authorization for dealing with potentially unsafe products
are documented.

8.9.4.2 Evaluation for release

(Refer Doc.: EP/SOP/18 Evaluation for Release)

Non-conforming products are released as safe when any of the following conditions apply:

 Evidence other than the monitoring system demonstrates that the control measures have
been effective.
 Results of sampling, analysis and/or other verification activities demonstrate that the
affected lot of product complies with the identified acceptable levels for food safety
hazard(s) concerned.

8.9.4.3 Disposition of non-conforming products

(Refer Doc.: EP/SOP/21 Disposition of non - conforming products)

One of the following activities shall be handled if the lot of product is not acceptable for release:

 Reprocessing or further processing within or outside the organization to ensure that the
food safety hazard is eliminated or reduced to acceptable level.
 Destruction and /or disposal as waste.

8.9.5 Withdrawal / Recall

(Refer Doc.: EP/SOP/09 Product Recall or Withdrawal)

To enable and facilitate the complete and timely withdrawal of lots of end products which have
been identified as unsafe, top management has appointed personnel having authority to initiate
withdrawal and personnel responsible for executing the withdrawal.

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The company has established and maintained the documented procedure for notification to
relevant interested parties, handling of withdrawn products as well as affected lots of the
products still in stock and the sequence of action to be taken.

The cause and extent of withdrawal shall be recorded and reported to top management as input to
management review.

The company verifies and records the effectiveness of the withdrawal program through use of
appropriate techniques (e.g., mock withdrawal or practice withdrawal).

9. Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

The food safety team will determine the following after evaluation of the HACCP Plan:

a) what hazard controls need to be monitored and measured

b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure
valid results

c) when the monitoring and measuring of the concerned hazards shall be performed

d) when the results from monitoring and measurement shall be analyzed and evaluated

e) Which personnel from the food safety team shall analyze and evaluate said results from
monitoring and measurement. The company shall retain appropriate documented information as
evidence of the results (Refer Doc.: EP/SOP/23 Performance Evaluation)

9.1.2 Analysis and evaluation

The food safety team systematically evaluates the individual results of planned verification
including internal audits and external audits. If verification does not demonstrate conformity
with planned arrangements, the organization acts to achieve the required conformity with:

 existing procedures and communication channels

 the conclusion of hazard analysis, operational PRPs and the HACCP plan
 the effectiveness of human resource management and of training activities

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The analysis is carried out to ensure that:

 The overall performance of the system meets the planned arrangements and the FSMS
requirements established by the company
 The need for updating or improving the FSMS are identified
 Any corrections and corrective actions that have been taken are effective.
 The results of the analysis and the resulting activities is reported to top management as
input to management review

9.2 Internal audit

The company conducts internal audits at planned intervals to determine whether the FSMS
conforms to planned arrangements and if the FSMS requirements established is effectively
implemented and updated.

For the execution of an effective internal audit system, an audit program is planned, taking into
consideration the risks associated with each department, importance of the processes and areas to
be audited as well as any updating actions resulting from previous audits. Further, the audit
criteria, scope, frequency and methods are defined. Selection of auditors and the conduct of audit
ensure the objectivity and impartiality of audit process; Auditors do not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting
results and maintaining records is defined in a documented procedure.

The management responsible for the area being audited ensures that actions are taken without
undue delay to eliminate detected non-conformities and their causes. Follow up activities
includes the verification of the actions taken and the reporting of verification results. (Refer
Doc.: EP/SOP/05 Internal Audit)

9.3 Management review

Regular Management Review Meetings are conducted as minimum two times a year, to ensure
the continuing suitability and effectiveness of the Food Safety Management System to meet
Food Safety Objectives in satisfying the requirements of the Standard and to meet customer’s
requirements. The food safety or production related executive (subject to change according to the
management hierarchy of the company) may organize unscheduled Management Review
Meeting at any time. (Refer Doc.: EP/SOP/04 Management Review Meeting)

9.3.1 General

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Top management at the company along with the Food Safety team, shall review the
organization’s FSMS, at planned intervals, to ensure its continuing sustainability, adequacy and
effectiveness.

9.3.2 Management review inputs

The following topics as a minimum are reviewed during the meeting in addition to the agenda
proposed by the Food Safety Team Leader (FSTL):

- the status of actions from previous management reviews

- Results of system updating activities

- Monitoring and measurement results

- Changes of external and internal issues that are relevant to FSMS, including changes in the
organization and its context.

- Analysis of results of verification activities related to PRPs and the hazard control plan

- Results of Internal and External Audits.

- Non-Conformity Reports, Correction & Corrective Actions taken.

- Customer feedback including complaints and action taken.

- Adequacy of the existing Food Safety Management System.

- Adequacy of existing resources. Performance of external providers.

- Review of risk and opportunities and its effectiveness of actions taken to address them

- Training awareness and competency requirements.

- Facilities and work environment.

- Food Safety Planning for new projects.

- Changing circumstances that can affect food safety

- Emergency situations, accidents and withdrawals

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- Opportunities for continual improvement

- Date of next meeting

- Allergen plan review, trend on verification plan, environmental program review actions

- Objectives on FS and Quality culture with targets, timelines achieve status,

- Quality culture result verification update

9.3.3 Management review outputs

The FSTL records the minutes of the meeting. The minutes should include as a minimum action
related to:

- decisions and actions related to continual improvement opportunities

- any need for updates and changes to FSMS, including resource needs and revision of the
food safety policy and objectives of the FSMS

- Improvement of FSMS and its processes

- Improvement of deliverables and service as related to customer’s requirements

- Resource needs

- Revisions or updating of the organization's food safety policy and related objectives if any.

The issues discussed in the MRM will be closed out with proper action from the person allocated
with the responsibility to act on it. All open points in the MRM need to be followed up within the
target dates. In case any points remain open, then proper justification of the open points needs to
be submitted by the responsible person.

10. Improvement

10.1 Non-conformity and corrective action

10.1.1 When a nonconformity occurs, the Food safety team shall:

a) react to the nonconformity and, as applicable:

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 act to control and correct it

 deal with the consequences

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 reviewing the nonconformity, determining the causes of
the nonconformity and by determining if similar nonconformities exist, or could potentially
occur.

After identification of the non-conformity, necessary corrective actions are undertaken, and the
effectiveness of any corrective action taken is reviewed to determine whether it is appropriate for
the situation.

10.1.2 The organization shall continually improve on the suitability, adequacy and effectiveness
of FSMS. The food safety team shall retain documented information as evidence of the nature of
the non-conformities, any subsequent actions taken and the corrective actions undertaken to
combat them.

10.2 Continual improvement

The organization’s top management ensures that there is continual improvement of the
effectiveness of the FSMS by appropriate communication, management review, internal audit,
evaluation of individual verification results, analysis of result of verification activities, validation
of control measure combinations, corrective actions. The objective of validation is to ensure that
the hazards originally identified by the food safety team are complete and correct and that they
will be effectively controlled under the proposed plan. Validation is targeted at the assessment of
the scientific and technical inputs into the HACCP Plan and operational PRPs, to ensure that the
information supporting the HACCP Plan is correct.

10.3 Update of the food safety management system

The organization’s top management ensures that the FSMS is continually updated; to achieve
this, the food safety team evaluates the FSMS at planned intervals.

The said evaluation and updating activities are based on:

 Input from communication, external as well as internal

 Input from other information concerning the suitability, adequacy and effectiveness of the
FSMS.
 Output from the analysis of results of verification activities
 Output from management activities

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Term of Reference

This FSSC 22000 V 6 FSMS study consider biological, chemical, and physical hazards from
the receiving of the raw materials throughout the whole process until the distribution to the
customers. The priority of the study is the food safety issue.

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