Self-Assessment Catering and Food Service

FSSC DEVELOPMENT
PROGRAM
SELF-ASSESSMENT
CATERING AND FOOD-SERVICE (E)

[Link]
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SELF-ASSESSMENT: FSSC DEVELOPMENT PROGRAM - CATERING AND FOOD SERVICE

(CATEGORY E)

Clause Requirement Yes/No Objective Evidence/Comments

no.

1. Food Safety System Requirements

1.1 Leadership and commitment

1.1.1 Evidence shall be available to demonstrate that management is committed

to providing sufficient and necessary resources to develop, implement and
maintain their food safety program to comply with customer and legal
requirements.

1.1.2 Senior management shall ensure that employees are aware of their
responsibilities related to food safety including the importance of the food
safety program.

1.1.3 The organization shall maintain the appropriate legal registration for a
catering establishment, when required by legislation.

1.2 Organizational roles, responsibilities and authorities

1.2.1 The organization shall establish a clear organizational chart outlining the
organizations’ structure.
1.2.2 Documented roles, responsibilities and authorities related to food safety
and legality shall be defined, implemented, communicated and
understood in a manner to ensure product safety.

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1.3 Externally developed elements of the food safety system

1.3.1 Externally developed elements of the food safety system shall be verified
to ensure they cover and are suitable for the activities of the organization.
The responsibility for the operation of the food safety system still belongs
to the organization.
Note: externally developed elements may include PRPs, the hazard
analysis and the hazard control plan.

1.4 Competence

1.4.1 The organization shall ensure that all people are adequately trained in food
safety and practices according to their job responsibilities. Training records
shall be maintained.

1.4.2 All new personnel (including maintenance personnel) shall be effectively

trained on hygiene requirements, allergen awareness, cleaning, and pest
control awareness.

1.4.3 A HACCP training program shall be in place, for the HACCP/food safety
team and those responsible for the operation of the hazard control plan.

1.4.4 A refresher training program shall be documented and implemented.

All relevant personnel shall receive refresher training, to ensure personnel
remain aware of all procedures necessary to maintain the food safety of
the products produced.

1.4.5 A documented training program shall be in place and effectively

implemented for all personnel whose work can impact food safety.

1.4.6 Food defense awareness training shall be in place.

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1.5 Communication

1.5.1 External communication

[Link] Food safety requirements or technical guidance, from statutory and

regulatory authorities, customers and industry organizations, shall be
available and kept up to date.

[Link] Effective arrangements for communicating with external stakeholders

(suppliers and contractors, customers, statutory and regulatory
authorities, and industry organizations) shall be established, implemented
and maintained. A designated and responsible person shall be identified
to manage these communications.

[Link] Organizations shall inform their Conformity Assessment Body within three
(3) working days of the commencement of the events or situations listed
below:
• Serious events that impact the food safety system, legality and/or
the integrity of the conformity statement, as a result of a Force
majeure, natural or man-made disasters (e.g., war, strike,
terrorism, crime, flood, earthquake, malicious computer hacking,
etc.);
• Serious situations where the integrity of the conformity statement
is at risk and/or where the Foundation can be brought into
disrepute. These include, but are not limited to (1) recalls, (2)
actions imposed by regulatory authorities as a result of a food
safety issue(s), where additional monitoring or forced shutdown of
the site/facility is required, (3) legal proceedings, prosecutions,
malpractice, and negligence; and (4) fraudulent activities and
corruption.

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[Link] Records of communication with suppliers, contractors, customers,

statutory and regulatory authorities, and industry organization, shall be
maintained.

1.5.2 Internal communication

[Link] Senior management shall ensure effective internal communication within

its organization on all relevant information related to food safety and
legality, including when changes relevant to the food safety system occur.

1.6 Specifications including product release

1.6.1 Specifications shall be accurate and available for all product inputs (raw
materials, ingredients, packaging materials, rework), intermediate and
finished products.

1.6.2 Specifications shall be compliant with relevant safety, legislative and

customer requirements.

1.6.3 Specifications shall be kept up to date, unambiguous and available to

relevant personnel.

1.6.4 Changes to specifications shall be clearly communicated both internally

and externally as applicable. Evidence of this shall be available.

1.6.5 A documented product release procedure shall be in place and

implemented to ensure that the final product meets the specification.
1.6.6 A designated person with responsibility for controlling specifications shall
be appointed.

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1.7 Documented information

1.7.1 Records shall be available to demonstrate that the organization complies

with the food safety system, including all applicable regulatory and
customer food safety requirements.

1.7.2 Records shall be:

• genuine and maintained in good condition, to preserve legibility.
• securely stored and accessible.
• protected from unintended alterations, and alterations or
corrections to completed records shall be approved and
justification for this maintained.
Electronic records shall be secured and backed up to prevent loss.

1.7.3 The organization shall set timescales for record retention which comply
with regulatory or customer requirements. Where there are no regulatory
or customer requirements, records shall be kept covering the shelf life of
the product as a minimum.

1.8 Procedures

1.8.1 Procedures shall be documented, implemented and maintained for all

processes and operations that affect food safety.

1.8.2 Procedures shall be clearly communicated to relevant personnel.

1.9 Traceability System

1.9.1 The traceability system shall be implemented and maintained to uniquely

identify incoming material from suppliers, through all stages of the
catering operation and to the dates they were utilized to produce the end
product served to the consumer.

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1.9.2 The traceability system shall be fully operational and effective and shall
consider as a minimum the lots/batches of raw materials and ingredients
received, and intermediate products produced, to the dates these items
were utilized to produce the end product served to the consumer.
The organization shall ensure that applicable statutory, regulatory and
customer requirements are met.

1.9.3 The traceability process shall incorporate all relevant records of:
• receipt and use of raw materials and ingredients
• production of intermediate products
1.9.4 There shall be clear labelling procedures that ensure continuous
identification of the materials/product through all stages of production.
Where raw materials and ingredients are transferred from their original
packages, this shall be done in an appropriate manner, so they remain
protected and with the original label of the product intact.
Where this is not possible and information is transcribed to another label
or via another method, a system shall be in place to ensure that traceability
is maintained.

1.9.5 The effectiveness of the traceability system shall be verified and tested
(backwards – to when inputs were received and their supplier, and
forwards – to the dates these inputs were used in the catering operation)
at least annually.
Note: It is not required to trace the end product to the exact customer, but
at a minimum to the date the raw material/ingredient was utilized.

1.9.6 The system shall be documented, updated as necessary and records shall
be maintained.

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1.10 Food safety incident management

1.10.1 Withdrawal/recall

[Link] The organization shall have an effective incident management procedure

for all products including incident reporting, communicating with
interested parties, and management of product withdrawal and recall.

[Link] This shall include having systems in place to ensure that products failing to
meet requirements are identified, located and removed from all necessary
points of the supply chain.

[Link] A designated responsible person shall be identified to provide information

to customers, consumers and regulatory authorities.
[Link] The incident management system shall be reviewed, tested and verified at
least once a year and records thereof shall be maintained.

[Link] All incidents shall be recorded and assessed to establish their severity and
the risk to the consumer. Relevant actions shall be taken to address the
risks identified.

1.10.2 Emergency preparedness and response

[Link] Top Management shall ensure procedures are in place to respond to
potential emergency situations or incidents that can have an impact on
food safety which are relevant to the role of the organization in the food
chain.
Note: Emergency situations include natural disasters, environmental
accidents, bioterrorism, workplace accidents, public health emergencies
and other accidents, e.g. interruption of essential services such as water,
electricity or refrigeration supply.

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[Link] Documented information shall be established and maintained to manage

these situations and incidents.

1.11 Nonconformity and corrective Action

1.11.1 When a nonconformity occurs, the organization shall:

• react to the nonconformity and take appropriate correction to deal
with the immediate issue;
• undertake a root cause analysis to determine the cause of the
nonconformity;
• implement suitable and effective corrective action in a timely
manner to prevent recurrence, and
• maintain records there-of.
1.11.2 The organization shall have a documented procedure for nonconformity
management and corrective actions.

1.12 Complaint Handling

1.12.1 A documented complaint management program shall be in place and

effectively implemented for the management of customer and consumer
complaints relating to food safety (not quality), including analysis of trends.

1.12.2 Records of all customer and consumer complaints, including investigations

and corrective actions for food safety issues, shall be maintained.

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2. Pre-Requisite Programs

2.1 Construction and layout of buildings

2.1.1 The facility shall be of suitable size and located, designed, constructed and
maintained so as to reduce the risk of contamination and enable the
production of safe and legal products.

2.1.2 The facility shall be effectively maintained, cleaned and disinfected (where
appropriate) to prevent physical, chemical and microbiological product
contamination.

2.1.3 The grounds and surrounding areas of the facility shall be maintained and
kept free of waste and accumulated debris. Vegetation surrounding the
facility shall be tended or removed and not attract and harbor pests. Any
potential harborage, such as decommissioned equipment, should be
removed.

2.1.4 Buildings shall be provided with adequate ventilation.

2.1.5 Buildings shall be protected from pest entry.

2.1.6 Where outside space is used for storage, stored items shall be protected
from weather or pest damage.

2.2 Layout of premises and workspace

2.2.1 The organization's premises and workspace shall be designed and

maintained to reduce the risk of contamination and enable the production
of safe and legal products.

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2.2.2 Structures, surfaces and materials that come in contact with food shall be
easy to maintain, cleanable and where appropriate allow for disinfection.
Materials of construction shall be resistant to the cleaning system applied.

2.2.3 Adequate drainage and waste disposal systems and facilities shall be
provided and well maintained. They shall be designed and constructed so
that the likelihood of contaminating food or the water supply is avoided.

2.2.4 Internal structures and fittings

The organization shall design and maintain:
• floors, walls, doors, openings, ceilings and overhead fixtures to a
degree of hygiene appropriate to the operation;
• In wet process areas, floors shall be sealed and drained. Drains
shall be trapped and covered.
• ceilings and overhead fixtures that are constructed and finished
to minimize the build-up of products, foreign matter, dirt and
condensation, and the shedding of particles;
• external openings (e.g. doors, windows) to prevent entry of
foreign matter, including pests, appropriate to the operation;
• floors and joints to avoid stagnant water;
• drains to prevent entry of foreign matter and pests and to be
appropriate to the operation, to be cleanable and repairable;
2.2.5 The lighting shall be of the appropriate intensity and design to ensure that
food safety practice is effective. Light fixtures shall be protected to ensure
that materials, product or equipment are not contaminated in the case of
breakages.

2.2.6 The movement patterns of materials, products and people, and the layout
of equipment, shall be designed to protect against potential contamination
sources.

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2.3 Utilities

2.3.1 The organization's utilities shall be designed and maintained to reduce the
risk of contamination and enable the production of safe and legal
products.

2.3.2 Processes shall be in place to ensure that the quality of water, steam and
ice does not compromise the food safety of the finished product. The
facility shall be equipped with clean or potable water inlets appropriate to
the intended use.

2.3.3 Potable and non-potable water pipes shall be identified, and a system shall
be in place to prevent the cross-contamination of potable water by non-
potable water.

2.3.4 Suitable and sufficient ventilation shall be provided to remove excess or

unwanted steam, dust and odors, and air shall not flow from contaminated
areas to clean areas.

2.3.5 Controls shall be in place for compressed air and other gas systems, where
there is a direct or indirect food safety risk.

2.4 Waste disposal

2.4.1 The organization shall have a program in place for the collection and
disposal of waste material.

2.4.2 Suitable provisions shall be in place for the storage and removal of waste,
which prevents product contamination.

2.4.3 Containers designated for inedible products, waste or by-products shall be

clearly marked and properly utilized linked to their intended purpose and
use.

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2.4.4 The organization shall have in place a documented waste management

program including the identification of waste; waste collection; and
containment, removal and disposal of waste.

2.4.5 Labelled materials, products or printed packaging designated as waste

shall be disfigured or destroyed to ensure that trademarks cannot be
reused.

2.5 Equipment suitability, cleaning and maintenance

2.5.1 Equipment, containers and surfaces in direct or indirect contact with water
and food shall not be a source of food contamination.
2.5.2 Equipment, containers and surfaces in direct contact with food shall:
• be designed and constructed to ensure that they can be cleaned,
disinfected, drained, inspected and maintained.
• be smooth, accessible and have cleanable surfaces.
• be made from material compatible with the intended products
and cleaning chemicals/methods.
• not be penetrated by holes, nuts and/or bolts on its framework.
• have piping and ductwork (where relevant) which is cleanable,
drainable and with no dead ends.
• have product contact surfaces which are impermeable and rust or
corrosion free.

2.5.3 Forklifts and other driven transport trolleys shall be clean, well maintained
and of suitable type to avoid contamination through emissions.

2.5.4 Manufacturer’s instructions shall be followed to install, use and maintain

equipment which may affect food safety.

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2.5.5 Maintenance
[Link] The organization shall establish and implement a documented program/
system of planned, preventive and corrective maintenance to ensure an
adequate level of food safety in the facility.

[Link] A documented hygiene and clearance procedure shall be in place and

effectively implemented for all maintenance activities.

[Link] Equipment failure, and defects to premises, which are essential to food
safety shall be identified, assessed and documented to enable prompt
actions and improvement of the maintenance program.

2.6 Management of purchased materials

2.6.1 The organization shall control purchasing processes to ensure that all
externally sourced materials (raw materials, ingredients, additives,
packaging materials, processing aids, etc.) and services conform to
specifications and contractual agreements, to ensure product safety.

2.6.2 Purchased materials that have an impact on food safety shall be sourced
from approved suppliers that are identified, evaluated, and monitored.

2.6.3 Purchased products shall be inspected upon delivery.

2.6.4 Records shall be kept of purchased products with the identification of the
supplier and documented information relevant to food safety.

2.6.5 Testing results or a COA or COC shall be available to verify conformity with
specified requirements prior to acceptance or use.

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2.6.6 Delivery vehicles shall be checked prior to, and during unloading to verify
the quality and safety of the material has been maintained during transit
(e.g. integrity of seals, free from infestation, temperature records where
applicable).
Delivery vehicles and deliveries that do not conform with specifications
shall be refused or their access limited to a controlled area until the
product has been disposed of or returned to the supplier.

2.6.7 Results of evaluation, inspection and monitoring of suppliers and

purchased products, investigations, analyses and follow up actions shall be
recorded.

2.6.8 Outsourced activities which have an impact on food safety shall be sourced
from approved contractors that are identified, evaluated, and monitored.

2.6.9 Outsourced activities which have an impact on food safety shall be

recorded with the identification of contractors.
2.6.10 Procedures shall be available and implemented for the approval and
monitoring of all suppliers whose products or services affect product
safety.
The results of the evaluations and follow-up actions shall be recorded.

2.7 Measures for prevention of cross-contamination

2.7.1 The organization shall ensure that appropriate facilities (e.g., physical
barriers) and effective measures and procedures are in place to minimize
the risk of any potential physical, chemical or microbiological
contamination of the product.

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2.7.2 Physical contamination control
[Link] Measures shall be in place to prevent, control or detect potential physical
contamination, with consideration for the following:
• restriction on use of staples, paperclips and drawing pins;
• adequate covers over equipment or containers for exposed
materials or products.
Note: Potential physical contamination sources include wooden pallets
and tools, rubber seals, and personal protective clothing and equipment,
etc.

[Link] Where brittle materials are used, periodic inspection requirements and
defined procedures in the case of breakage shall be put in place. Brittle
materials, such as glass and hard plastic components in equipment, should
be avoided where possible.
Records for monitoring of brittle materials (glass and hard plastic) shall be
in place, including in the case of breakage.

2.7.3 Chemical contamination control

[Link] Measures shall be in place to prevent contamination of foods or food
contact materials by chemicals (e.g. cleaning agents, disinfectants,
lubricants, pesticides, etc.)

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[Link] The organization shall ensure the chemicals used:

• have been approved by competent authorities for its intended
use, where applicable;
• are applied according to the manufacturers/product instructions
(concentrations, temperature, mechanical action/method of
application, waiting time before rinsing, if any, etc.);
• are applied by competent personnel;
• are labelled;
• are stored separately from food and food contact materials, in a
locked or secured area; and
• lubricants coming into contact with food and water shall be
approved for food contact purpose.

2.8 Allergen management

2.8.1 A documented program shall be in place to control allergens and prevent

cross-contamination of product through all stages of operation.

2.8.2 Regulations and appropriate customer requirements shall be addressed in

the development of the allergen control program.

2.8.3 Potential causes of cross-contamination shall be identified and procedures

established for the handling of raw materials, intermediate and finished
products to avoid cross contamination.

2.8.4 Where catering organizations offer special meal requests, a process shall
be in place to address allergen control in meal preparations.

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2.8.5 Procedures for control shall consider:

• cleaning
• segregation;
• additional protective clothing; and
• use of dedicated tools/equipment.

2.9 Cleaning and Disinfection

2.9.1 Documented cleaning and disinfection procedures shall be in place and

effective, including monitoring and verification activities, to ensure the
cleanliness of the facility and equipment. Records of monitoring and
verification shall be maintained.

2.9.2 Operating procedures shall specify:

• The premises and equipment subjected to cleaning and
disinfection,
• A description of the process or method of cleaning,
• Frequency of cleaning,
• Responsibility for cleaning,
• Cleaning agents and tools,
• Source of water, and
• Monitoring and verification arrangements for the effectiveness of
cleaning, including frequency of these activities.

2.9.3 Cleaning equipment and chemicals shall be clearly marked, stored in a

segregated area away from product, equipment, packaging and suitable
for intended use.

2.9.4 Cleaning equipment shall be fit for purpose and utilized in accordance with
the manufacturer's instructions and in such a way that cleaning and/or
disinfection is effective.

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2.9.5 Where CIP (cleaning in place) systems are used, these shall be separated
from active product lines, and the parameters for CIP shall be defined and
monitored (including type, concentration, contact time and temperature of
any chemicals used).

2.9.6 The cleaning and disinfection program shall be validated.

2.10 Pest Control

2.10.1 An effective pest control program shall be in place to reduce or eliminate

the risk of pest infestation, which shall:
• be appropriate to the raw material, product, process and facility;
• have identified and designated a competent person(s) to manage
the program and related activities;
• identify target pests (e.g., rodents, insects and birds), relevant to
the organization and operation;
• have documented plans, methods, schedules and control
procedures; and
• include documentation of the chemicals used.
2.10.2 Pest-monitoring programs shall include the placing of detectors and traps
in key locations to identify pest activity. A map of detectors and traps shall
be maintained. Detectors and traps shall be sufficient in number, designed
for purpose, placed in appropriate positions and located to prevent
potential contamination of materials, products or facilities.

2.10.3 The inspection program shall be undertaken by a competent person at an

appropriate frequency and findings shall be addressed.

2.10.4 Pest control inspections and resulting actions shall be documented/

recorded, including the monitoring and implementation of actions.

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2.10.5 Any infestation shall be documented and appropriate control measures

taken in a timely manner.

2.10.6 The cause of infestation shall be identified, and corrective action taken to
prevent reoccurrence. Records shall be kept of infestation, monitoring and
eradication.

2.11 Personal hygiene and employee facilities

2.11.1 The organization shall ensure the implementation and adherence to

appropriate hygiene practices for all personnel, visitors and contractors,
including requirements on:
• handwashing;
• protective clothing / workwear;
• restrictions on smoking, eating, drinking, spitting, personal items,
nail polish / false nails, jewelry, etc.; and
• illness and injury.
These requirements shall be compliant with legislation (if applicable) and
be available in a form that is easily understood.

2.11.2 Personnel, visitors and contractors shall wear suitable protective clothing
and footwear that is cleaned and changed regularly. Hair shall be protected
/ fully enclosed.

2.11.3 Personnel, visitors and contractors shall wash hands frequently, sanitize
where necessary, and cover injuries on hands or forearms with suitable
waterproof dressings. Controls shall be in place for the issue and use of
gloves to prevent contamination.

2.11.4 Personnel, visitors and contractors shall leave personal belongings in a

dedicated place.

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2.11.5 Personnel, visitors and contractors, known to be infected with, or carrying

a disease or illness transmissible through food or people, shall be
prevented from contact with foods and with materials which come in
contact with food.

2.11.6 Personnel hygiene facilities and toilets

[Link] The organization shall ensure that staff facilities are designed, located and
operated to prevent contamination.

[Link] Suitable changing rooms shall be provided for personnel.

[Link] Toilets shall be provided, operational, accessible and adequately segre-

gated from processing and food handling areas.

[Link] Suitable and sufficient hand-washing and drying facilities shall be provided
and accessible, including the supply of water at a suitable temperature,
soap and, where relevant, sanitizer. Taps and waste bins should be hands-
free.

[Link] Separate eating facilities shall be provided away from production,

packaging and storage areas.

2.12 Warehousing

2.12.1 The organization shall ensure that all raw materials (including packaging),
ingredients, intermediate and finished product are stored and transported
(where applicable) under conditions that protect product integrity.

2.12.2 All vehicles, including contracted vehicles used for the transportation shall
be suitable for the purpose, maintained in good repair and be clean.

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2.12.3 There shall be adequate facilities for the storage of raw materials,
ingredients, packaging materials, intermediate and finished products,
including:
• Storage off the floor and with sufficient space between the material
and the walls to allow inspection and pest control activities to be
carried out.
• Storage in clean, dry, well-ventilated spaces protected from dust,
condensation, fumes, odors or other sources of contamination.

2.12.4 The storage facilities shall be properly constructed / organized to protect

materials (raw materials, ingredients, packaging materials, intermediate,
and finished products, etc.) and avoid cross-contamination.

2.12.5 Storage and transport shall be appropriate to minimize the deterioration

of the raw materials, ingredients, intermediate and finished products (e.g.,
by temperature and humidity control).

2.12.6 Maintenance and hygiene processes shall be effectively implemented for

vehicles and equipment used for loading and unloading.

2.12.7 A product transport procedure shall be in place and effectively

implemented.

2.13 Management of analysis/testing services

2.13.1 The organization shall implement a program to ensure that analysis of

products and ingredients is systematically undertaken for issues that are
identified as being critical to food safety and legal requirements, as well as
customer specifications.

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2.13.2 Where out of specification results are obtained, the organization shall
handle the affected lot(s) of product as nonconforming products and apply
appropriate correction and corrective actions.

2.13.3 Appropriate methods, relevant for food safety, shall be used to provide
valid results (e.g. by procedures set forth in ISO 17025 and/or industry
recognized methods).

2.13.4 Analysis procedures shall be in place to ensure that all specified product
requirements are met, including legal requirements and customer
specifications.

2.14 Product Information and consumer awareness

2.14.1 Organizations shall, where requested, make relevant ingredient and

allergen information available to the consumer to make an informed
decision about the food.
This shall meet legislative and customer requirements.

2.15 Labelling

2.15.1 The organization shall ensure that (pre)packaged finished products are
labelled according to applicable statutory and regulatory requirements in
the country of intended sale, including allergen and customer specific
requirements.

2.16 Logo Use

2.16.1 Conforming organizations shall use the FSSC 22000 Development Program
logo only for marketing activities such as the organization’s printed matter,
website, and other promotional material.

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2.16.2 The confirming organization is not allowed to use the FSSC 22000
Development Program logo, any statement or refer to its conforming
status on:
• a product; its labelling; its packaging (primary, secondary or any
other form);
• certificates of analysis or certificates of conformance (CoA’s or
CoC’s);
• in any other manner that implies FSSC approves a product,
process, or service and
• where exclusions to the scope apply.

2.16.3 Where the FSSC 22000 Development logo is being used, it shall comply
with the design specifications included within the Program document.

2.17 Food Defense

2.17.1 The threats to the product because of intentional product tampering or

intentional contamination shall be assessed.
2.17.2 The points in the process which are vulnerable to intentional product
tampering/intentional contamination shall be identified and subjected to
additional control.

2.17.3 Measures shall be in place to address what to do with the product, if

prohibited access took place and the product may have been tampered
with or intentionally contaminated.

2.18 Food Fraud Mitigation

2.18.1 The organization shall conduct a food fraud vulnerability assessment

identifying potential vulnerabilities in raw materials, ingredients, packaging
materials and outsourced processes.

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2.18.2 For each vulnerability identified, the organization shall establish and
implement appropriate mitigation measures.

2.18.3 Document the above mentioned within a food fraud mitigation plan, which
shall be kept up to date and reviewed annually.

2.19 PRP Verification

2.19.1 The organization shall establish, implement, and maintain routine (e.g.,
monthly) site inspections/PRP checks to verify that the site (internal and
external), production/preparation environment and processing equipment
are maintained in a suitable condition to ensure food safety. The frequency
and content of the site inspections/PRP checks shall be based on risk with
defined sampling criteria.

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3. HACCP Control

3.1 Preliminary steps to enable hazard analysis

3.1.1 The organization shall identify and comply with relevant regulatory and
customer requirements related to the product and product categories.

3.1.2 Task 1: Establish a multi-disciplinary food safety team.

A multi-disciplinary team with different responsibilities for food safety shall
have undertaken the tasks described in this section of the checklist (Tasks
2-5).
Note: The team should comprise of personnel with the knowledge and
experience in the organization’s products, processes, equipment and food
safety hazards.

3.1.3 Task 2: A complete product description shall be available of the

product/product category including all ingredients, raw materials,
packaging, intermediate and finished product, and the conditions for
storage and distribution.
The product description shall include product characteristics (biological,
chemical and physical), composition, source, place of origin, method of
production, packaging, storage and delivery conditions and shelf life, and
preparation and/or handling before use or processing.

3.1.4 Task 3: The intended use of the product shall be described and the target
consumer identified, including vulnerable consumer groups.

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3.1.5 Task 4: All the process steps taken to produce the product shall be
documented in a process flow diagram.
Flow diagrams shall be clear, accurate and sufficiently detailed to the
extent needed to conduct the hazard analysis. It shall include the following
as appropriate:
• sequence and interaction of the steps;
• any outsourced processes;
• where raw materials, ingredients, processing aids, utilities and
intermediate products enter the flow;
• where end products, intermediate products, by-products and
waste are released or removed.

3.1.6 Task 5: Onsite verification of the process flow diagram(s) shall take place
at least annually, or more often when changes occur, to ensure it
accurately reflects the production process.

Hazard analysis
3.2 The approach for analysis and control of hazards shall be in line with the
seven (7) HACCP principles and 12 steps of the CODEX Alimentarius.

3.2.1 The organization shall conduct a hazard analysis of their food

manufacturing process, based on the preliminary information, to
determine if there are any food safety hazards associated with the
production of their food products that might cause a food safety risk.

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3.2.2 Principle 1: A hazard analysis shall be conducted for each process step in
the manufacturing of the food item.
• identify and document all food safety hazards that are reasonably
expected to occur;
• determine the acceptable level in the end product for each food
safety hazard identified; and
• conduct a hazard assessment for each food safety hazard
identified (likelihood of occurrence versus severity of its adverse
health effects)

3.2.3 The hazard analysis shall be conducted by a competent multi-disciplinary

team.

3.2.4 Principle 2: Determining Critical Control Points (CCPs) and Operational

Prerequisite Programs (OPRPs)
Where the hazard analysis indicates any significant hazards not minimized
or eliminated by PRPs, and based on the outcome of the decision tree, then
OPRPs and/or CCPs shall be identified for their control and properly
categorized.

3.2.5 If these hazards are identified within the process/operation, the

organization shall have effective control measures that ensure the
elimination of the hazards or to reduce them to acceptable levels. The
organization shall implement specific controls for all relevant steps not
identified as CCPs or OPRPs e.g., effective implementation and
management of PRPs.

3.2.6 Principle 3: Critical Limits shall be established for each CCP and action
criteria for OPRPs. Critical limits at CCPs shall be measurable. Action
criteria for OPRPs shall be measurable or observable.

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3.2.7 Critical limits and action criteria shall be validated, and the validation shall
be documented.

3.2.8 Principle 4: Monitoring procedures shall be established for each CCP and
OPRP and undertaken by competent personnel to ensure that CCPs and
OPRP's are effectively implemented.
It shall consist of:
• monitoring methods or devices used;
• monitoring frequency;
• monitoring results;
• responsibility and authority related to monitoring; and
• responsibility and authority related to evaluation of monitoring
results.
Deputies shall be identified, trained and available in case of the absence of
the person responsible for monitoring.

3.2.9 Principle 5: Corrections and/or corrective actions shall be established for

each CCP and OPRP in the event that critical limits or action criteria are not
met. It shall ensure that:
• the potentially unsafe products are not released;
• the cause of nonconformity is identified;
• the parameter(s) controlled at the CCP or by the OPRP is (are)
returned within the critical limits or action criteria; and
• recurrence is prevented.

3.2.10 Principle 6: Verification procedures shall be established and effectively

implemented for PRPs, OPRPs and CCPs.

3.2.11 Principle 7: Record keeping and documentation for HACCP procedures

shall be established and effectively implemented.

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3.2.12 The organization shall establish, implement and maintain a documented

hazard control plan which shall include the following for each CCP or OPRP:
• food safety hazard(s) to be controlled at the CCP or by the OPRP;
• critical limit(s) at CCP or action criteria for OPRP;
• monitoring procedure(s);
• correction(s) to be made if critical limits or action criteria are not
met;
• responsibilities and authorities; and
• records of monitoring.
3.2.13 In the event of changes to raw materials, packaging materials, processes,
infrastructure, equipment, etc., the hazard control plan (HACCP / OPRP
Plan) shall be reviewed and updated if needed.

3.3 Control of monitoring and measuring

3.3.1 Measuring and monitoring devices critical to food safety and regulatory
requirements shall be appropriate to the intended use, reliable, accurate,
and function properly.
They shall be well maintained and, where appropriate, calibrated.

3.3.2 Measuring and monitoring devices critical to food safety shall be identified,
calibrated on a regular basis, traceable to recognized national or
international standards, and be effectively controlled.

3.3.3 Actions shall be taken and recorded when measuring and monitoring
devices are found to be outside of specified limits.

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3.4 Handling of potentially unsafe products

3.4.1 The organization shall ensure that potentially unsafe product is clearly
identified and controlled to prevent unintended use or delivery.
It shall be reprocessed or further processed within or outside the
organization to ensure that food safety hazards are eliminated or reduced
to acceptable levels or destroyed and/or disposed of as waste.

3.4.2 Products affected by a nonconforming situation shall be held under control

until they have been evaluated.

3.4.3 The organization shall be able to take measures for the reporting,
containment, reprocessing, withdrawal or recall when products are
potentially unsafe.

3.4.4 The control of non-conforming product shall be managed by competent

and sufficiently trained personnel.

3.4.5 A documented procedure shall be in place to identify and manage all non-
conforming raw materials, product inputs, semi-finished and finished
products, processing equipment and packaging materials.

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