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Alignment of FSSC 22000 with Code of Federal Regulations (CFR- part 117), “Current Good Manufa

FSSC 22000 is a voluntary 3rd party private certification scheme which is based on the ISO 22000 Food safety management fram
Certification to FSSC 22000 (Food manufacturing) provides evidence that a facility meets the requirememnts as set out in
ISO 22000; 2005
ISO/TS 22002-1; 2009
and FSSC 22000 Certification Scheme 41. (see www.fssc22000.com)

An initial gap analysis shows that FSSC 22000( Food Manufacturing) is very closely aligned with the requirements of the PC rule
FSMA, like FSSC 22000, is based on an ISO foundation and both FSSC 22000 and FSMA share the common goal of achieving foo

To further confirm these results and to be of greater help to our stake holders we commissioned a second more in depth analy
This document includes this in depth comparison for reference.
For the most part the requirements of the PCHF are reflected in the requirements of FSSC 22000, either in ISO 22000 which ou
In some sections however, the line by line comparison identifies some “differences” where FSMA demands a more prescriptive
These differences are identified both in this the document and in an FSSC 22000 supplementary document that can be used by
7), “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human F

00 Food safety management framework, with scope specific operational pre requisite programs. It is benchmarked by the GFSI and govern
equirememnts as set out in

h the requirements of the PC rules and CFR117’s.


he common goal of achieving food safety through preventive controls (PRPs) and a flexible management system approach.

ed a second more in depth analysis in which we could map the individual requirements of the PC rule against those of FSSC 22000.

00, either in ISO 22000 which outlines the requirements for managenement system, or in ISO 22002-1 which describes the requirements fo
MA demands a more prescriptive level of detail than is provided in the more interpretive FSSC 22000.
y document that can be used by certified facilities in conjunction with this document, to bridge the gap between the FSSC 22000 requirem
1
tive Controls for Human Food.”

hmarked by the GFSI and governed by an independent, non profit foundation

stem approach.

nst those of FSSC 22000.

ch describes the requirements for the PRPs or in the additional FSSC 22000 requirements.

etween the FSSC 22000 requirements and those of FSMA.


Terms and Definitions used by the FDA as defined in their Guidance1

Acid foods or Acidified foods: Foods that have an equilibrium pH of 4.6 or below.
Adequate: That which is needed to accomplish the intended purpose in keeping with good public health practice.
Allergen cross-contact: The unintentional incorporation of a food allergen into a food.

Cleaning: The removal of soil, food residue, dirt, grease or other objectionable matter.

Clean in place (CIP): A system used to clean process piping, bins, tanks, mixing equipment, or larger pieces of equipment witho
soil can be readily washed away by the flow of the cleaning solution.

Clean out of place (COP): A system (e.g. cleaning tanks) used to clean equipment parts, piping, etc. after disassembly.

Control, Control measure: See Preventive controls.

Correction: An action to identify and correct a problem that occurred during the production of food, without other actions ass
the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering comme

Corrective action: An action to identify and correct a problem that occurred during the production of food, including actions as
reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering

Control point (CP): Any step at which biological, physical, or chemical factors can be controlled.

Critical control point (CCP): A point, step, or procedure in a food process at which control can be applied and is essential to pre
acceptable level.

Critical limit (CL): A maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled
occurrence of a food-safety hazard.

Deviation: Failure to meet a critical limit.

End-Point Internal Product Temperature (EPIPT): A measurement of the internal temperature of the product at the end of the
Environmental pathogen: A pathogen capable of surviving and persisting with the manufacturing processing, packing, or holdi
in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen. Example
Salmonella spp. but do not include the spores of pathogenic sporeforming bacteria.
Environmental sample: A sample that is collected from a surface or area of the plant for the purpose of testing the surface or a
pathogens.
Facility: A domestic facility or foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosm
subpart H. Food: Includes (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used fo
ingredients.

Food allergen: A major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act (e.g., any of the
shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. (2) A food
paragraph (1), except any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such
Food safety plan: A set of written documents that is based upon food safety principles and incorporates hazard analysis, preve
verification procedures to be followed, including a recall plan.
Food Safety System: The result of the implementation of the Food Safety Plan.
Food-contact surfaces: Those surfaces that contact human food and those surfaces from which drainage, or other transfer, ont
during the normal course of operation. “Food contact surfaces” includes utensils and food-contact surfaces of equipment.
HACCP (Hazard Analysis and Critical Control Point): A system which identifies, evaluates, and controls hazards that are significa

Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence to d

Hazard requiring a preventive control: A known or reasonably foreseeable hazard for which a person knowledgeable about the
based on the outcome of a hazard analysis (which includes the severity of the illness or injury if the hazard were to occur and t
controls) establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to
corrective actions, verification and records) as appropriate to the food, the facility and the nature of the preventive control and
foreseeable hazard: A potential biological, chemical (including radiological), or physical hazard that is known to be, or has the p

Hazard: Any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.

Microorganisms: Yeast, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens.
microorganisms that are pathogens, that subject food to decomposition, that indicate that food is contaminated with filth, or t
Operating limits: Criteria that may be more stringent than critical limits and are established for reasons other than food safety.
Pest: Any objectionable animals or insects including birds, rodents, flies, and larvae.

Monitor: To conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure i
verification.

Pathogen: A microorganism of public health significance.


PCHF: The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Regulati

Prerequisite programs: Procedures, including Current Good Manufacturing Practices (CGMPs), that provide the basic environm
Plan.

Preventive controls qualified individual (PCQI): A qualified individual who has successfully completed training in the developm
equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through j
Preventive controls: Those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeab
food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent wit
processing, packaging, or holding at the time of the analysis.
Qualified individual: A person who has the education, training, or experience (or a combination thereof) necessary to manufac
individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.
RTE (Ready-to-eat) food: Any food that is normally eaten in its raw state or any other food, including a processed food, for whi
further processing that would significantly minimize biological hazards.

Sanitize: To adequately treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens, and in s
but without adversely affecting the product or its safety for the consumer.

Severity: The seriousness of the effects of a hazard.


Significantly minimize: To reduce to an acceptable level, including to eliminate.
Validation: Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measure
capable of effectively controlling the identified hazards.
Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whe
been operating as intended and to establish the validity of the food safety plan.

1
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM517417.pdf

2
ISO 22000:2005 Food safety management systems — Requirements for any organization in the food chain
https://www.iso.org/obp/ui/#iso:std:iso:22000:ed-1:v1:en

3
ISO/TS 22002-1: 2009 Prerequisite programmes on food safety -- Part 1: Food manufacturing
ISO/TS 22002-1:2009 Preview
ISO Terms and definitions2 ,3

Definitions used in ISO 22000:2005 identified in blue


Definitions used in ISO/TS 22002-1:2009 identified in red

certificate of
analysis ( COA )
cleaning

cleaning in place
(CIP)

cleaning out of
place (COP)

contaminant
contamination

control measure

correction

corrective action

critical control
point (CCP)

critical limit

disinfection

end product
establishment

first expired first


out ( FEFO )
first in first out
(FIFO)
flow diagram

(product) contact

food chain

food grade

hazard / food safety


hazard

food safety

food safety policy


label

material
specification /
product
specification

materials

monitoring

operational PRP

product recall

PRP prerequisite
programme

sanitation

sanitizing

updating
validation

verification

zoning
ms and definitions2 ,3

ns used in ISO 22000:2005 identified in blue


ns used in ISO/TS 22002-1:2009 identified in red

〈food safety〉 document provided by the supplier which indicates results of specific tests or analysis,
including test methodology, performed on a defined lot of the supplier’s product
〈food safety〉 removal of soil, food residue, dirt, grease or other objectionable matter

cleaning (3.5) of equipment by impingement or circulation of flowing chemical solutions, cleaning


liquids and water rinses into, on to and over surfaces in equipment or systems without dismantling and
designed for the purpose
system where equipment is disassembled and cleaned in a tank or in an automatic washer by circulating
a cleaning solution and maintaining a minimum temperature throughout the cleaning cycle
〈food safety〉 any biological or chemical agent, foreign matter or other substances not intentionally
added to food which may compromise food safety or suitability
〈food safety〉 introduction or occurrence of a contaminant (3.2) in food or food environment

〈food safety〉 action or activity that can be used to prevent or eliminate a food safety hazard (3.3) or
reduce it to an acceptable level
action to eliminate a detected nonconformity NOTE 2 A correction may be, for example, reprocessing,
further processing, and/or elimination of the adverse consequences of the nonconformity (such as
disposal for other use or specific labelling).
action to eliminate the cause of a detected nonconformity or other undesirable situation NOTE 1 There
can be more than one cause for a nonconformity.NOTE 2 Corrective action includes cause analysis and
is taken to prevent recurrence.

〈food safety〉 step at which control can be applied and is essential to prevent or eliminate a food safety
hazard (3.3) or reduce it to an acceptable level
criterion which separates acceptability from unacceptability NOTE 2 Critical limits are established to
determine whether a CCP (3.10) remains in control. If a critical limit is exceeded or violated, the
products affected are deemed to be potentially unsafe.

〈food safety〉 reduction, by means of chemical agents and/or physical methods, of the number of
microorganisms in the environment, to a level that does not compromise food safety or suitability

product that will undergo no further processing or transformation by the organization NOTE A product
that undergoes further processing or transformation by another organization is an end product in the
context of the first organization and a raw material or an ingredient in the context of the second
organization.
〈food safety〉 any building or area in which food is handled and the surroundings under the control of
the same management

stock rotation based on the principle of despatching earliest expiration dates first

〈food safety〉 stock rotation based on the principle of despatching earliest received products first
schematic and systematic presentation of the sequence and interactions of steps

all surfaces that are in contact with the product or the primary package during normal operation

sequence of the stages and operations involved in the production, processing, distribution, storage and
handling of a food and its ingredients, from primary production to consumption NOTE 1 This includes
the production of feed for food-producing animals and for animals intended for food production. NOTE
2 The food chain also includes the production of materials intended to come into contact with food or
raw materials.

lubricants and heat transfer fluids formulated to be suitable for use in food processes where there may
be incidental contact between the lubricant and the food

biological, chemical or physical agent in food, or condition of food, with the potential to cause an
adverse health effect
NOTE Food safety hazards include allergens.
NOTE In the context of feed and feed ingredients, relevant food safety hazards are those
that may be present be present in and/or on feed and feed ingredients and that may subsequently be
transferred to food through animal consumption of feed and may thus have the potential to cause an
adverse human health effect.
In the context of operations other than those directly handling feed and food (e.g. producers of
packaging materials, cleaning agents, etc.), relevant food safety hazards are those hazards that can be
directly or indirectly transferred to food because of the intended use of the provided products and/or
services and thus can have the potential to cause an adverse human health effect.

concept that food will not cause harm to the consumer when it is prepared and/or eaten according to
its intended use NOTE Food safety is related to the occurrence of food safety hazards (3.3) and does
not include other human health aspects related to, for example, malnutrition.

overall intentions and direction of an organization related to food safety (3.1) as formally expressed by
top management
〈food safety〉 printed matter that is part of the finished product package conveying specific information
about the contents of the package, the food ingredients and any storage and preparation requirements
EXAMPLE The term covers, but is not limited to: a) the package itself, printed matter attached to the
package, or a sticker used for over-labelling; b) multi-packs which have an inner label on the individual
product and an outer combined label for the whole contents.

〈food safety〉 detailed documented description or enumeration of parameters, including permissible


variations and tolerances, which are required to achieve a defined level of acceptability or quality
〈food safety〉 general term used to indicate raw materials, packaging materials, ingredients, process
aids, cleaning materials and lubricants
conducting a planned sequence of observations or measurements to assess whether control measures
(3.7) are operating as intended
operational prerequisite programme PRP (3.8) identified by the hazard analysis as essential in order to
control the likelihood of introducing food safety hazards (3.3) to and/or the contamination or
proliferation of food safety hazards in the product(s) or in the processing environment
removal of a non-conforming product from the market, trade and warehouses, distribution centres
and/or customer warehouses because it does not meet specified standards

〈food safety〉 basic conditions and activities that are necessary to maintain a hygienic environment
throughout the food chain suitable for the production, handling and provision of safe end products
and safe food for human consumption NOTE The PRPs needed depend on the segment of the food
chain in which the organization operates and the type of organization. Examples of equivalent terms
are: Good Agricultural Practice (GAP), Good Veterinarian Practice (GVP), Good Manufacturing Practice
(GMP), Good Hygienic Practice (GHP), Good Production Practice (GPP), Good Distribution Practice (GDP)
and Good Trading Practice (GTP).

all actions dealing with cleaning or maintaining hygienic conditions in an establishment, ranging from
cleaning and/or sanitizing of specific equipment to periodic cleaning activities throughout the
establishment (including building, structural, and grounds cleaning activities)

〈food safety〉 process of cleaning, followed by disinfection

immediate and/or planned activity to ensure application of the most recent information
〈food safety〉 obtaining evidence that the control measures (3.7) managed by the HACCP plan and by
the operational PRPs (3.9) are capable of being effective
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled

〈food safety〉 demarcation of an area within an establishment where specific operating, hygiene or
other practices may be applied to minimize the potential for microbiological cross-contamination NOTE
Examples of practices include: clothing change on entry or exit, positive air pressure, modified traffic
flow patterns.
Preventive Controls for
Human Food (PCHF) Rule FSMA Requirement
SUBPART B—CURRENT
GOOD MANUFACTURING
PRACTICE
Has the management of the establishment taken
§117.10 Personnel reasonable measures and precautions to ensure
the following:
Disease control

Cleanliness

Allowing wearing of outer garments suitable to the


operation in a manner that protects against
allergen cross-contact and against the
contamination of food, food-contact surfaces, or
food-packaging materials

Maintaining adequate personal cleanliness

Washing hands thoroughly (and sanitizing if


necessary to protect against contamination with
undesirable microorganisms) in an adequate hand-
washing facility before starting work, after each
absence from the work station, and at any other
time when the hands may have become soiled or
contaminated

Removing all unsecured jewelry and other objects


that might fall into food, equipment, or containers,
and removing hand jewelry that cannot be
adequately sanitized during periods in which food
is manipulated by hand.

Maintaining gloves, if they are used in food


handling, in an intact, clean, and sanitary
condition.
Wearing, where appropriate, in an effective
manner, hairnets, headbands, caps, beard covers,
or other effective hair restraints.

Storing clothing or other personal belongings in


areas other than where food is exposed or where
equipment or utensils are washed.

Confining the following to areas other than where


food may be exposed or where equipment or
utensils are washed: eating food, chewing gum,
drinking
Taking any
beverages,
other necessary
or usingprecautions
tobacco. to protect
against allergen cross-contact and against
contamination of food, food-contact surfaces, or
food-packaging materials with microorganisms or
foreign substances (including perspiration, hair,
Have the grounds
cosmetics, tobacco,been addressed.
chemicals, and The grounds
medicines
about
applieda to
food
theplant
skin).under the control of the
§117.20 Plant and operator must be kept in a condition that will
grounds. protect against the contamination of food. The
methods for adequate maintenance of grounds
must include:
Are you properly storing equipment, removing
litter and waste, and cutting weeds or grass within
the immediate vicinity of the plant that may
constitute an attractant, breeding place, or
harborage for pests.

Are you maintaining roads, yards, and parking lots


so that they do not constitute a source of
contamination in areas where food is exposed.

Are you adequately draining areas that may


contribute contamination to food by seepage, foot-
borne filth, or providing a breeding place for pests.
Are you operating systems for waste treatment and
disposal in an adequate manner so that they do
not constitute a source of contamination in areas
where food is exposed.

If the plant grounds are bordered by grounds not


under the operator's control and not maintained in
the manner described above, are you taking care
of the plant by inspection, extermination, or other
means to exclude pests, dirt, and filth that may be
a source of food contamination.

Has the plant construction and design been


addressed. The plant must be suitable in size,
construction, and design to facilitate maintenance
and sanitary operations for food-production
purposes (i.e., manufacturing, processing, packing,
and holding). Is the plant doing the required:

Are you providing adequate space for such


placement of equipment and storage of materials
as is necessary for maintenance, sanitary
operations, and the production of safe food.
Are you permitting the taking of adequate
precautions to reduce the potential for allergen
cross-contact and for contamination of food, food-
contact surfaces, or food-packaging materials with
microorganisms, chemicals, filth, and other
extraneous material. The potential for allergen
cross-contact and for contamination may be
reduced by adequate food safety controls and
operating practices or effective design, including
the separation of operations in which allergen
cross-contact and contamination are likely to occur,
by one or more of the following means: location,
time, partition, air flow systems, dust control
systems, enclosed systems, or other effective
means.
Are you permitting the taking of adequate
precautions to protect food in installed outdoor
bulk vessels by any effective means, including:

Are you using protective coverings.

Are you controlling areas over and around the


vessels to eliminate harborages for pests.
Are you checking on a regular basis for pests and
pest infestation.

Are you skimming fermentation vessels, as


necessary.

Is the plant constructed in such a manner that


floors, walls, and ceilings may be adequately
cleaned and kept clean and kept in good repair;
that drip or condensate from fixtures, ducts and
pipes does not contaminate food, food-contact
surfaces, or food-packaging materials; and that
aisles or working spaces are provided between
equipment and walls and are adequately
unobstructed and of adequate width to permit
employees to perform their duties and to protect
against contaminating food, food-contact surfaces,
or food-packaging materials with clothing or
personal contact.

Is the plant providing adequate lighting in hand-


washing areas, dressing and locker rooms, and
toilet rooms and in all areas where food is
examined, manufactured, processed, packed, or
held and where equipment or utensils are cleaned;
and provide shatter-resistant light bulbs, fixtures,
skylights, or other glass suspended over exposed
food in any step of preparation or otherwise
protect against food contamination in case of glass
breakage.
Is the plant providing adequate ventilation or
control equipment to minimize dust, odors and
vapors (including steam and noxious fumes) in
areas where they may cause allergen cross-contact
or contaminate food; and locate and operate fans
and other air-blowing equipment in a manner that
minimizes the potential for allergen cross-contact
and for contaminating food, food-packaging
materials, and food-contact surfaces

Is the plant providing, where necessary, adequate


screening or other protection against pests

Has general maintenance been addressed.


Buildings, fixtures, and other physical facilities of
the plant must be maintained in a clean and
sanitary condition and must be kept in repair
§117.35 Sanitary adequate to prevent food from becoming
operations. adulterated. Cleaning and sanitizing of utensils and
equipment must be conducted in a manner that
protects against allergen cross-contact and against
contamination of food, food-contact surfaces, or
food-packaging materials.
Substances used in cleaning and sanitizing; storage
of toxic materials.

Are you ensuring that the cleaning compounds and


sanitizing agents used in cleaning and sanitizing
procedures must be free from undesirable
microorganisms and must be safe and adequate
under the conditions of use. Compliance with this
requirement must be verified by any effective
means, including purchase of these substances
under a letter of guarantee or certification or
examination of these substances for
contamination. Only the following toxic materials
may be used or stored in a plant where food is
processed or exposed:

Are you using those required to maintain clean and


sanitary conditions

Are you using those necessary for use in laboratory


testing procedures

Are you using those necessary for plant and


equipment maintenance and operation

Are the toxic cleaning compounds, sanitizing


agents, and pesticide chemicals being identified,
held, and stored in a manner that protects against
contamination of food, food-contact surfaces, or
food-packaging materials.
Are you addressing pest control. Pests must not be
allowed in any area of a food plant. Guard, guide,
or pest-detecting dogs may be allowed in some
areas of a plant if the presence of the dogs is
unlikely to result in contamination of food, food-
contact surfaces, or food-packaging materials.
Effective measures must be taken to exclude pests
from the manufacturing, processing, packing, and
holding areas and to protect against the
contamination of food on the premises by pests.
The use of pesticides to control pests in the plant is
permitted only under precautions and restrictions
that will protect against the contamination of food,
food-contact surfaces, and food-packaging
materials.

Are you addressing sanitation of food-contact


surfaces. All food-contact surfaces, including
utensils and food-contact surfaces of equipment,
must be cleaned as frequently as necessary to
protect against allergen cross-contact and against
contamination of food.

Are you addressing food-contact surfaces used for


manufacturing/processing, packing, or holding low-
moisture food must be in a clean, dry, sanitary
condition before use. When the surfaces are wet-
cleaned, they must, when necessary, be sanitized
and thoroughly dried before subsequent use.
Are you addressing wet processing, when cleaning
is necessary to protect against allergen cross-
contact or the introduction of microorganisms into
food, all food-contact surfaces must be cleaned
and sanitized before use and after any interruption
during which the food-contact surfaces may have
become contaminated. Where equipment and
utensils are used in a continuous production
operation, the utensils and food-contact surfaces
of the equipment must be cleaned and sanitized as
necessary.

Are single-service articles (such as utensils


intended for one-time use, paper cups, and paper
towels) being stored, handled, and disposed of in a
manner that protects against allergen cross-contact
and against contamination of food, food-contact
surfaces, or food-packaging materials.

Are you addressing sanitation of non-food-contact


surfaces. Non-food-contact surfaces of equipment
used in the operation of a food plant must be
cleaned in a manner and as frequently as
necessary to protect against allergen cross-contact
and against contamination of food, food-contact
surfaces, and food-packaging materials.

Are you addressing storage and handling of


cleaned portable equipment and utensils. Cleaned
and sanitized portable equipment with food-
contact surfaces and utensils must be stored in a
location and manner that protects food-contact
surfaces from allergen cross-contact and from
contamination.

§117.37 Sanitary facilities Is your plant equipped with adequate sanitary


and controls. facilities and accommodations including:
Have you addressed the water supply. The water
supply must be adequate for the operations
intended and must be derived from an adequate
source. Any water that contacts food, food-contact
surfaces, or food-packaging materials must be safe
and of adequate sanitary quality. Running water at
a suitable temperature, and under pressure as
needed, must be provided in all areas where
required for the processing of food, for the
cleaning of equipment, utensils, and food-
packaging materials, or for employee sanitary
facilities

Have you addressed plumbing. Plumbing must be


of adequate size and design and adequately
installed and maintained to:
Does it carry adequate quantities of water to
required locations throughout the plant
Does it properly convey sewage and liquid
disposable waste from the plant.

Does it avoid constituting a source of


contamination to food, water supplies, equipment,
or utensils or creating an unsanitary condition.

Does it provide adequate floor drainage in all areas


where floors are subject to flooding-type cleaning
or where normal operations release or discharge
water or other liquid waste on the floor

Does it provide that there is not backflow from, or


cross-connection between, piping systems that
discharge waste water or sewage and piping
systems that carry water for food or food
manufacturing
Have you addressed sewage disposal. Sewage must
be disposed of into an adequate sewerage system
or disposed of through other adequate means.

Have you addressed toilet facilities. Each plant


must provide employees with adequate, readily
accessible toilet facilities. Toilet facilities must be
kept clean and must not be a potential source of
contamination of food, food-contact surfaces, or
food-packaging materials.

Have you addressed hand-washing facilities. Each


plant must provide hand-washing facilities
designed to ensure that an employee's hands are
not a source of contamination of food, food-
contact surfaces, or food-packaging materials, by
providing facilities that are adequate, convenient,
and furnish running water at a suitable
temperature
Have you addressed rubbish and offal disposal.
Rubbish and any offal must be so conveyed, stored,
and disposed of as to minimize the development of
odor, minimize the potential for the waste
becoming an attractant and harborage or breeding
place for pests, and protect against contamination
of food, food-contact surfaces, food-packaging
materials, water supplies, and ground surfaces

Are all plant equipment and utensils used in


manufacturing, processing, packing, or holding
food so designed and of such material and
workmanship as to be adequately cleanable, and
be adequately maintained to protect against
allergen cross-contact and contamination.

Are equipment and utensils designed, constructed,


and used appropriately to avoid the adulteration of
food with lubricants, fuel, metal fragments,
contaminated water, or any other contaminants.

Is equipment installed so as to facilitate the


cleaning and maintenance of the equipment and of
adjacent spaces.

Are food-contact surfaces corrosion-resistant when


in contact with food

Are food-contact surfaces made of nontoxic


materials and designed to withstand the
environment of their intended use and the action
of food, and, if applicable, cleaning compounds,
sanitizing agents, and cleaning procedures

Are food-contact surfaces maintained to protect


food from allergen cross-contact and from being
contaminated by any source, including unlawful
indirect food additives
Are seams on food-contact surfaces smoothly
bonded or maintained so as to minimize
accumulation of food particles, dirt, and organic
matter and thus minimize the opportunity for
growth of microorganisms and allergen cross-
contact

Is equipment that is in areas where food is


manufactured, processed, packed, or held and that
does not come into contact with food so
constructed that it can be kept in a clean and
sanitary condition

Are the holding, conveying, and manufacturing


systems, including gravimetric, pneumatic, closed,
and automated systems, of a design and
construction that enables them to be maintained
in an appropriate clean and sanitary condition.

Are each freezer and cold storage compartment


used to store and hold food capable of supporting
growth of microorganisms fitted with an indicating
thermometer, temperature-measuring device, or
temperature-recording device so installed as to
show the temperature accurately within the
compartment.

Are instruments and controls used for measuring,


regulating, or recording temperatures, pH, acidity,
water activity, or other conditions that control or
prevent the growth of undesirable microorganisms
in food accurate and precise and adequately
maintained, and adequate in number for their
designated uses
Are compressed air or other gases mechanically
introduced into food or used to clean food-contact
surfaces or equipment treated in such a way that
food is not contaminated with unlawful indirect
food additives

In general, are all operations in the manufacturing,


§117.80 Processes and processing, packing, and holding of food (including
operations directed to receiving, inspecting,
controls. transporting, and segregating) conducted in
accordance with adequate sanitation principles.

Is there appropriate quality control operations


employed to ensure that food is suitable for human
consumption and that food-packaging materials
are safe and suitable
Is the overall sanitation of the plant under the
supervision of one or more competent individuals
assigned responsibility for this function.

Have adequate precautions been taken to ensure


that production procedures do not contribute to
allergen cross-contact and to contamination from
any source

Are chemical, microbial, or extraneous-material


testing procedures used where necessary to
identify sanitation failures or possible allergen
cross-contact and food contamination

Do you reject food that has become contaminated


to the extent that it is adulterated, or if
appropriate, treated or processed to eliminate the
contamination
Have you addressed raw materials and other
ingredients. Raw materials and other ingredients
must be inspected and segregated or otherwise
handled as necessary to ascertain that they are
clean and suitable for processing into food and
must be stored under conditions that will protect
against allergen cross-contact and against
contamination and minimize deterioration. Raw
materials must be washed or cleaned as necessary
to remove soil or other contamination. Water used
for washing, rinsing, or conveying food must be
safe and of adequate sanitary quality. Water may
be reused for washing, rinsing, or conveying food if
it does not cause allergen cross-contact or increase
the level of contamination of the food.

Have you addressed raw materials and other


ingredients must either not contain levels of
microorganisms that may render the food injurious
to the health of humans, or they must be
pasteurized or otherwise treated during
manufacturing operations so that they no longer
contain levels that would cause the product to be
adulterated.
Have you addressed raw materials and other
ingredients susceptible to contamination with
aflatoxin or other natural toxins that must comply
with FDA regulations for poisonous or deleterious
substances before these raw materials or other
ingredients are incorporated into finished food

Have you addressed raw materials, other


ingredients, and rework susceptible to
contamination with pests, undesirable
microorganisms, or extraneous material that must
comply with applicable FDA regulations for natural
or unavoidable defects if a manufacturer wishes to
use the materials in manufacturing food.

Have you addressed raw materials, other


ingredients, and rework that must be held in bulk,
or in containers designed and constructed so as to
protect against allergen cross-contact and against
contamination and must be held at such
temperature and relative humidity and in such a
manner as to prevent the food from becoming
adulterated. Material scheduled for rework must
be identified as such.
Have you addressed frozen raw materials and other
ingredients that must be kept frozen. If thawing is
required prior to use, it must be done in a manner
that prevents the raw materials and other
ingredients from becoming adulterated.

Have you addressed liquid or dry raw materials and


other ingredients received and stored in bulk form
that must be held in a manner that protects against
allergen cross-contact and against contamination

Have you addressed raw materials and other


ingredients that are food allergens, and rework
that contains food allergens, that must be
identified and held in a manner that prevents
allergen cross-contact

Have you addressed manufacturing operations.


Equipment and utensils and food containers must
be maintained in an adequate condition through
appropriate cleaning and sanitizing, as necessary.
Insofar as necessary, equipment must be taken
apart for thorough cleaning.

Has the food manufacturing, processing, packing,


and holding conducted under such conditions and
controls as are necessary to minimize the potential
for the growth of microorganisms, allergen cross-
contact, contamination of food, and deterioration
of food

Has the food that can support the rapid growth of


undesirable microorganisms held at temperatures
that will prevent the food from becoming
adulterated during manufacturing, processing,
packing, and holding
Have any measures such as sterilizing, irradiating,
pasteurizing, cooking, freezing, refrigerating,
controlling pH, or controlling aw that been taken to
destroy or prevent the growth of undesirable
microorganisms that must be adequate under the
conditions of manufacture, handling, and
distribution to prevent food from being adulterated

Has any work-in-process and rework been handled


in a manner that protects against allergen cross-
contact, contamination, and growth of undesirable
microorganisms

Have any effective measures been taken to protect


finished food from allergen cross-contact and from
contamination by raw materials, other ingredients,
or refuse. When raw materials, other ingredients,
or refuse are unprotected, they must not be
handled simultaneously in a receiving, loading, or
shipping area if that handling could result in
allergen cross-contact or contaminated food. Food
transported by conveyor must be protected against
allergen cross-contact and against contamination
as necessary

Does any equipment, containers, and utensils used


to convey, hold, or store raw materials and other
ingredients, work-in-process, rework, or other food
been constructed, handled, and maintained during
manufacturing, processing, packing, and holding in
a manner that protects against allergen cross-
contact and against contamination
Have adequate measures been taken to protect
against the inclusion of metal or other extraneous
material in food.

For any food, raw materials, and other ingredients


that are adulterated are they disposed of in a
manner that protects against the contamination of
other food

Or, if the adulterated food is capable of being


reconditioned, can it be reconditioned (if
appropriate) using a method that has been proven
to be effective

And if reconditioned (if appropriate) and


reexamined has it been subsequently found not to
be adulterated within the meaning of the Federal
Food, Drug, and Cosmetic Act before being
incorporated into other food
Have any steps such as washing, peeling, trimming,
cutting, sorting and inspecting, mashing,
dewatering, cooling, shredding, extruding, drying,
whipping, defatting, and forming been performed
so as to protect food against allergen cross-contact
and against
Has any heatcontamination.
blanching, when Food must be
required in the
protected from contaminants that may drip, drain,
preparation of food capable of supporting
or be drawn
microbial into the
growth, been food.
effected by heating the
food to the required temperature, holding it at this
temperature for the required time, and then either
rapidly cooling the food or passing it to subsequent
manufacturing without delay. Growth and
contamination by thermophilic microorganisms in
blanchers
Have you, must
for anybebatters,
minimized by thesauces,
breading, use of
adequate
gravies, operatingdipping
dressings, temperatures and
solutions, by other
and periodic
cleaning and sanitizing
similar preparations asare
that necessary
held and used
repeatedly over time been treated or maintained in
such a manner that they are protected against
allergen cross-contact and against contamination,
and
Haveminimizing
you, for anythe potential
filling, for the growth
assembling, of
packaging,
undesirable microorganisms
and other operations been performed in such a
way that the food is protected against allergen
cross-contact, contamination and growth of
undesirable microorganisms
Have you, for any food, such as dry mixes, nuts,
intermediate moisture food, and dehydrated food,
that relies principally on the control of aw for
preventing the growth of undesirable
microorganisms been processed to and maintained
at a safe moisture level
Have you, for any food, such as acid and acidified
food, that relies principally on the control of pH for
preventing the growth of undesirable
microorganisms been monitored and maintained at
a pH of 4.6 or below
Have you, for when any ice is used in contact with
food, been made from water that is safe and of
adequate sanitary quality in accordance with
§117.37(a), and been used only if it has been
manufactured in accordance with current good
manufacturing practice as outlined in this part
Is the storage and transportation of food under
conditions that will protect against allergen cross-
§117.93 Warehousing and contact and against biological, chemical (including
distribution radiological), and physical contamination of food,
as well as against deterioration of the food and the
container.

Are the human food by-products held for


§117.95 Holding and distribution as animal food without additional
distribution of human food manufacturing or processing by the human food
by-products for use as processor, as identified in §507.12 of this chapter,
animal food held under conditions that will protect against
contamination, including the following:

Are the containers and equipment used to convey


or hold human food by-products for use as animal
food before distribution designed, constructed of
appropriate material, cleaned as necessary, and
maintained to protect against the contamination of
human food by-products for use as animal food

Are the human food by-products for use as animal


food held for distribution held in a way to protect
against contamination from sources such as trash
When during holding, are the human food by-
products for use as animal food accurately
identified

Is the labeling that identifies the by-product by the


common or usual name affixed to or accompany
human food by-products for use as animal food
when distributed

Are the shipping containers (e.g., totes, drums, and


tubs) and bulk vehicles used to distribute human
food by-products for use as animal food examined
prior to use to protect against contamination of the
human food by-products for use as animal food
from the container or vehicle when the facility is
responsible for transporting the human food by-
products for use as animal food itself or arranges
with a third party to transport the human food by-
products for use as animal food

Does the manufacturer, processor, packer, and


117.110 Defect action holder of food at all times utilize quality control
levels. operations that reduce natural or unavoidable
defects to the lowest level currently feasible
Have you ensured the mixing of a food containing
defects at levels that render that food adulterated
with another lot of food is not permitted and
renders the final food adulterated, regardless of
the defect level of the final food

Subpart C—HAZARD
ANALYSIS AND RISK-BASED
PREVENTIVE CONTROLS

§ 117.126 Food safety plan. Requirement for a Food Safety Plan (FSP)
General overview

Have you considered the different types of food


each of which will need a FSP
Is your FSP written

Is your FSP prepared by or overseen by a


preventive control qualified individual

Have you conducted a written hazard analysis


Have you identified your preventive controls

Do you have a written supply-chain program


Do you have a written recall plan

Do you have written procedures for monitoring


your preventive controls
Do you have written corrective actions

Do you have written verification activities


Have you developed a program to capture and
retain all pertinent records

Have you conducted a hazard analysis to identify


and evaluate known or reasonably foreseeable
hazards for each type of food manufactured,
§ 117.130 Hazard analysis. processed, packed, or held at your facility to
determine whether there are any hazards requiring
a preventive control
Is your hazard analysis written

Did you consider biological hazards such as


parasites, environmental pathogens and other
pathogens
Did you consider chemical hazards including
radiological hazards, pesticides, drug resides,
natural toxins, decomposition, unapproved food or
color additives, and food allergens

Did you consider Physical hazards (such as stones,


glass, and metal fragments)

Did you consider hazards that may occur naturally

Did you consider hazards that may be introduced


unintentionally

Did you consider hazards that may be intentionally


introduced for purposes of economic gain

Did you include in your hazard analysis a


consideration of the severity of illness for each
hazard

Did you include in your hazard analysis a


consideration of the probability that the hazard will
occur in the absence of a preventive control
Do you have a ready to eat food that is exposed to
the environment prior to packaging and the
packaged food does not receive a treatment or
otherwise include a control measure that would
significantly minimize the pathogen. If you
answered YES did you include an evaluation of
environmental pathogens as a hazard

Did you consider the effect of the formulation of


the food in your hazard analysis

Did you consider the condition, function and


design of the facility and equipment in your hazard
analysis

Did you consider the raw materials and other


ingredients in your hazard analysis
Did you consider transportation practices in your
hazard analysis

Did you consider manufacturing and processing


procedures in your hazard analysis

Did you consider packaging activities in your hazard


analysis

Did you consider labeling activities in your hazard


analysis

Did you consider storage and distribution in your


hazard analysis
Did you consider intended or reasonably
foreseeable use of the food in your hazard analysis

Did you consider sanitation in your hazard analysis

Did you consider employee hygiene in your hazard


analysis

Did you consider if there were any other factors


that should be taken into account in your hazard
analysis
§ 117.135 Preventive Have you identified all necessary preventive
controls. controls

Have you implemented all necessary preventive


controls

Are all your CCPs identified as preventive controls


Are your preventive controls written

For each of your preventive controls have you


considered your process controls such as heat
processing, acidifying, irradiating and refrigeration
etc.

Have you considered the parameters associated


with control of each hazard such as maximum or
minimum value to which each parameters must be
controlled

Have you considered allergen controls to ensure


protection of food from allergen cross contact
during storage, handling and use
Have you considered labeling of the finished food
to ensure it is not misbranded

Have you considered sanitation controls to ensure


the facility is maintained in a sanitary condition to
prevent or significantly minimize hazards from
environmental pathogens

Have you considered sanitation controls to ensure


the facility is maintained in a sanitary condition to
prevent or significantly minimize hazards from
biological hazards due to employee handling
Have you considered sanitation controls to ensure
the facility is maintained in a sanitary condition to
prevent or significantly minimize hazards from
allergen hazards

In your sanitation controls have you considered


cleanliness of food contact surfaces including
utensils and equipment
In your sanitation controls have you considered
food contact surfaces of utensils and equipment
In your sanitation controls have you considered
prevention of allergen cross contact from insanitary
objects and from personnel to food and food
packaging

In your sanitation controls have you considered


contamination from raw product to processed
product
Have you considered supply chain control (see
below)

Do you have a recall plan (see below)


Have you considered other important preventive
controls to control hazards that require a
preventive control such as cGMPs and hygiene
training

§ 117.136 Circumstances in
which the owner, operator,
or agent in charge of a Have you considered if some of your hazards do
manufacturing/processing not require a preventive control by following the
facility is not required to steps below.
implement a preventive
control.

Have you determined and documented that the


type of food could not be consumed without
application of an appropriate control – if so you do
not need the preventive control in your FSP

Is your customer subject to the requirements of


the preventive control rules in subpart C (food
safety plan) AND are both you and they are doing
the following
You are relying on your customer (as noted above)
to control the hazard
You are disclosing in documents accompanying the
food that the food is “not processed to control the
identified hazard”

That you are obtaining a written assurance from


your customer at least annually that the customer
has established and is following procedures that
will significantly minimize or control the hazard

Is your customer not subject to the requirements


of risk based preventive controls in subpart C? If so
are you doing the following

Requiring your customer to provide assurance it is


manufacturing, processing or preparing the food in
accordance with applicable food safety
requirements

PLUS You are disclosing in documents


accompanying the food that the food is “not
processed to control the identified hazard

PLUS You are obtaining a written assurance from


your customer at least annually that the customer
has established and is following procedures that
will significantly minimize or control the hazard

Are you relying on your customer to provide


assurance that the food will be processed to
4 control the identified hazard by an entity in the
distribution chain subsequent to the customer. If
so have you done the following

Disclose in documents accompanying the food that


i the food is “not processed to control the identified
hazard

Annually obtain and assurance from your customer


ii that they will do the following

Disclose in documents accompanying the food, in


accordance with the practice of the trade, that the
A food is ‘‘not processed to control [identified
hazard]’’ and

Will only sell to an entity that agrees in writing to


B do the following
Follow procedures (identified in a written
assurance) that will significantly minimize or
prevent the identified hazard (if the entity is
subject to the requirements for hazard analysis and
risk-based preventive controls in this subpart) or
1 manufacture, process, or prepare the food in
accordance with applicable food safety
requirements (if the entity is not subject to the
requirements for hazard analysis and risk-based
preventive controls in this subpart); or

Obtain a similar written assurance from the entity’s


2 customer, subject to the requirements of §
117.137, as appropriate; or

Have you established, documented, and


implemented a system that ensures control, at a
5 subsequent distribution step, of the hazards in the
food product you distribute and you document the
implementation of that system

Did you document any circumstance, specified in


b above paragraph that applies to you, including:

A determination that the type of food could not be


1 consumed without application of an appropriate
control;

Obtain the annual written assurance from your


customer for the above controls; and

Document in your system that ensures control, at a


subsequent distribution step, of the hazards in the
food product you distribute.

§ 117.137 Provision of
Are you a facility that provides a written Assurance
assurances required under as above in § 117.136. If not, you must
§ 117.136

Act consistently with the assurance and document


its actions taken to satisfy the written assurance

Do you produce a food with a hazard requiring a


§ 117.139 Recall plan preventive control. If so, you must …
Establish a written recall plan for the food.

Does the written recall plan include procedures


that describe the steps to be taken, and assign
responsibility for taking those steps, to perform the
following actions as appropriate to the facility:

Do you have a way to directly notify your direct


1 consignees of the food being recalled, including
how to return or dispose of the affected food

Do you have a way to notify the public about any


2 hazard presented by the food when appropriate to
protect public health

Do you have a way to conduct effectiveness checks


3 to verify that the recall is carried out

Do you have a way to appropriately dispose of


recalled food—e.g., through reprocessing,
4 reworking, diverting to a use that does not present
a safety concern, or by destroying the food.

Do you have the preventive controls required


under § 117.135 which are subject to the following
§ 117.140 Preventive preventive control management components as
control management appropriate to ensure the effectiveness of the
components. preventive controls, taking into account the nature
of the preventive control and its role in the facility’s
food safety system:
Have you established monitoring in accordance
a1 with § 117.145 - see below for more details

Have you established corrective actions and


a2 corrections in accordance with § 117.150 - see
below for more details

Have you established Verification in accordance


a3 with § 117.155 - see below for more details.

When establishing your supply chain control


program did you take into account corrective
b1 actions and corrections taking into account any
supply non-conformance
When establishing your supply chain control
b2 program did you take into account Review of
records in accordance with § 117.165

When establishing your supply chain control


b3 program Reanalysis in accordance with § 117.170.

Did you include written procedures for monitoring


§ 117.145 Monitoring. in your food safety plan to include frequency of
monitoring

Do you have a system in place to monitor the


preventive controls with adequate frequency to
b provide assurance that they are consistently
performed
Do you have a procedure to document the
C1 monitoring

Are you using exception records e.g. of


refrigeration temperature during storage of food
C2 and if so do you have a system to adequately
capture the exceptions
§ 117.150 Corrective Do you have a written corrective action plan that
actions and corrections. considers in various possible corrective actions

Did you establish and implement written corrective


action procedures that must be taken if preventive
controls are not properly implemented, including
procedures to address, as appropriate the
following:

Does your corrective action procedure include


managing the presence of a pathogen or
A1i appropriate indicator organism in a ready-to-eat
product detected as a result of product testing
conducted in accordance with § 117.165
Does your corrective action procedure include
managing the presence of an environmental
ii pathogen or appropriate indicator organism
detected through the environmental monitoring
conducted in accordance with § 117.165

Does your corrective action procedure include key


2 steps that have to be taken in each situation:

Do your steps describe appropriate action to take


i to identify and correct a problem that has occurred
with implementation of a preventive control

Do your steps describe appropriate action to take


ii when necessary, to reduce the likelihood that the
problem will recur
Does your corrective action describe how you will
iii evaluate all the affected food for safety

Does your corrective action describe how you will


prevent all affected food from entering into
commerce to ensure no food enters commerce
Iv that is adulterated under section 402 of the
Federal Food, Drug, and Cosmetic Act or
misbranded under section 403(w) of

the Federal Food, Drug, and Cosmetic Act.

Did you consider corrective action in the event of


b an unanticipated food safety problem if any of the
following circumstances apply:

A preventive control is not properly implemented


i and a corrective action procedure has not been
established

A preventive control, combination of preventive


ii controls, or the food safety plan as a whole is
found to be ineffective
A review of records in accordance with § 117.165
finds that the records are not complete, the
iii activities conducted did not occur in accordance
with the food safety plan, or appropriate decisions
were not made about corrective actions.

Did you consider that if any of the circumstances


2 listed immediately above of this section apply, you
must:

Take corrective action to identify and correct the


problem, reduce the likelihood that the problem
will recur, evaluate all affected food for safety, and,
2i as necessary, prevent affected food from entering
commerce as would be done following a corrective
action procedure of this section

When appropriate, reanalyze the food safety plan


in accordance with § 117.170 to determine
2ii whether modification of the food safety plan is
required.

For all corrections, did you consider that you do


c not need to comply with the requirements of this
section if:
You take action, in a timely manner, to identify and
correct conditions and practices that are not
1 consistent with the sanitation controls in § 117.135
or

You take action, in a timely manner, to identify and


2 correct a minor and isolated problem that does not
directly impact product safety.

Do you have a process in place to ensure that you


document all corrective actions (and where
appropriate, corrections). Note: these records are
d subject to verification in accordance with §
117.155 and records review in accordance with §
117.165.

Have you established a written process to ensure


that you will complete all verification activities
§ 117.155 Verification. which must include, as appropriate to the nature of
the preventive control and its role in the facility’s
food safety system the following:

A1 Validation in accordance with§ 117.160


Verification that monitoring is being conducted as
A2 required by § 117.140 (and in accordance with §
117.145)

Verification that appropriate decisions about


A3 corrective actions are being made as required by §
117.140 (and in accordance with § 117.150)

Verification of implementation and effectiveness in


A4 accordance with § 117.165
Reanalysis in accordance with § 117.170.

A5
Do you have a process in place to ensure that you
B document all verification activities conducted in
accordance with this section

Did you validate that the preventive controls


identified and implemented in accordance with §
§ 117.160 Validation. 117.135 are adequate to control the hazard as
appropriate to the nature of the preventive control
and its role in the facility’s food safety system

Was the validation of the preventive controls


B1 performed (or overseen) by a preventive controls
qualified individual:
Did the timing of all your validations meet the
requirements of the Rule by doing one of the
following:

Conducting the validation prior to implementation


B1iA of the food safety plan; or

Within 90 calendar days after production of the


B1iB1 applicable food first begins; or

Within a reasonable timeframe, provided that the


preventive controls qualified individual prepares
(or oversees the preparation of) a written
2 justification for a timeframe that exceeds 90
calendar days after production of the applicable
food first begins;
Do you have a procedure in place to ensure that
changes which could impact whether the control
ii measure or combination of control measures,
when properly implemented, will effectively
control the hazards are still validated

Do you have a procedure in place to ensure that if


a reanalysis of the food safety plan reveals the
iii need for change that the preventive controls are
still validated

Do your procedures in relation to the above make


you consider obtaining and evaluating scientific
and technical evidence (or, when such evidence is
2 not available or is inadequate, conducting studies)
to determine whether the preventive controls,
when properly implemented, will effectively
control the hazards

Did you consider you do not need to validate the


C1 food allergen controls in § 117.135

The sanitation controls in § 117.135(c)(3)


2

3 The recall plan in § 117.139

4 The supply-chain program in this part


Other preventive controls, if the preventive
controls qualified individual prepares (or oversees
the preparation of) a written justification that
5 validation is not applicable based on factors such
as the nature of the hazard, and the nature of the
preventive control and its role in the facility’s food
safety system.

Did you have a written procedure to verify that the


preventive controls are consistently implemented
and are effectively and significantly minimizing or
§ 117.165 Verification of preventing the hazards. To do so you must
implementation and determine which are applicable to you and conduct
effectiveness. activities that include the following, as appropriate
to the facility, the food, and the nature of the
preventive control and its role in the facility’s food
safety system:

Calibration of process monitoring instruments and


A1 verification instruments (or checking them for
accuracy)
Product testing, for a pathogen (or appropriate
A2 indicator organism) or other hazard

Environmental monitoring, for an environmental


pathogen or for an appropriate indicator organism,
if contamination of a ready-to-eat food with an
A3 environmental pathogen is a hazard requiring a
preventive control, by collecting and testing
environmental samples

Do you have a written procedure in place to review


the following records within the specified
timeframes, by (or under the oversight of) a
preventive controls qualified individual, to ensure
A4 that the records are complete, the activities
reflected in the records occurred in accordance
with the food safety plan, the preventive controls
are effective, and appropriate decisions were made
about corrective actions:

Do you have a written procedure in place to review


records of monitoring and corrective action within
7 working days after the records are created or
within a reasonable timeframe, provided that the
A4i preventive controls qualified individual prepares
(or oversees the preparation of) a written
justification for a timeframe that exceeds 7 working
days
Do you have a written procedure in place to review
records of calibration, testing (e.g., product testing,
environmental monitoring), supplier and supply-
A4ii chain verification activities, and other verification
activities within a reasonable time after the records
are created

Do you have written procedures as appropriate to


the facility, the food, the nature of the preventive
A5b control, and the role of the preventive control in
the facility’s food safety system for the following
activities:

The method and frequency of calibrating process


monitoring instruments and verification
instruments (or checking them for accuracy) as
required by this section
A5b1
Are you doing product testing as part of your
preventive controls in your food safety plan and if
so are you compliant with all the following in the
form of written procedures and documentation:
A5b2
Are your product testing program and procedures
scientifically valid

I
Are you identifying the test microorganism(s) or
Ii other analyte(s)
Are you specifying the procedures for identifying
Iii samples, including their relationship to specific lots
of product
Are you including the procedures for sampling,
Iv including the number of samples and the sampling
frequency
Are you identifying the test(s) conducted, including
V the analytical method(s) used

Are you identifying the laboratory conducting the


Vi testing

Are you including the corrective action procedures


Vii required by § 117.150
Are you doing environmental monitoring as part of
your preventive controls and as required by this
A5b3 section, and if so, do you have written procedures
that include the following:

i Is your procedure scientifically valid; and

Ii Are you identifying the test microorganism(s); and

Are you identifying the locations from which


samples will be collected and the number of sites
to be tested during routine environmental
iii monitoring in an adequate way. The number and
location of sampling sites must be adequate to
determine whether preventive controls are
effective; and

Are you identifying the timing and frequency for


collecting and testing samples in an effective way.
The timing and frequency for collecting and testing
samples must be adequate to determine whether
preventive controls are effective; and

Iv

Are you identifying the test(s) conducted, including


v the analytical method(s) used; and

Are you identifying the laboratory conducting the


testing; and
Vi

Are you including the corrective action procedures


Vii required by § 117.150
Do you have a written procedure in place to ensure
§ 117.170 Reanalysis. you conduct a reanalysis of the food safety plan as
a whole at least once every 3 years;

Do you have a written procedure in place to


conduct a reanalysis of the food safety plan as a
B whole, or the applicable portion of the food safety
plan according to the following:

Whenever a significant change in the activities


conducted at your facility creates a reasonable
B1 potential for a new hazard or creates a significant
increase in a previously identified hazard; or

Whenever you become aware of new information


B2 about potential hazards associated with the food;
or

Whenever appropriate after an unanticipated food


B3 safety problem in accordance with § 117.150(b); or
Whenever you find that a preventive control,
B4 combination of preventive controls, or the food
safety plan as a whole is ineffective.

Do you have a written procedure to make sure that


you complete the reanalysis required of this
section and validate, as appropriate to the nature
C of the preventive control and its role in the facility’s
food safety system, any additional preventive
controls needed to address the hazard identified
that meet the following timelines:

Before any change in activities (including any


C1 change in preventive control) at the facility is
operative; or

When necessary to demonstrate the control


measures can be implemented as designed within
C2i 90 calendar days after production of the applicable
food first begins; or
Within a reasonable timeframe, provided that the
C2ii preventive controls qualified individual prepares
(or

oversees the preparation of) a written justification


for a timeframe that exceeds 90-calendar days
after production of the applicable food first begins.

Do you have a written procedure in place to revise


the written food safety plan if a significant change
in the activities conducted at your facility creates a
D reasonable potential for a new hazard or a
significant increase in a previously identified hazard
or document the basis for the conclusion that no
revisions are needed.

Do you have a written procedure in place to make


E sure you have a preventive controls qualified
individual perform (or oversee) the reanalysis.
Do you have a written procedure in place to
conduct a reanalysis of the food safety plan when
F FDA determines it is necessary to respond to new
hazards and developments in scientific
understanding.

§ 117.180 Requirements
applicable to a preventive Do you have a written procedure in place to make
controls qualified sure that one or more preventive controls qualified
individual and a qualified individuals (PCQI) oversee the following:
auditor.
A1 Preparation of the food safety plan;(117.126)

A2 Validation of the preventive controls; (117.160)

Written justification for validation to be performed


A3 in a timeframe that exceeds the first 90 calendar
days of production of the applicable food;

Determination that validation is not required:


A4 (117.160 c )

A5 Review of records; (117.165 (a) )


Written justification for review of records of
A6 monitoring and corrective actions within a
timeframe that exceeds 7 working days;
Reanalysis of the food safety plan;(117.170 (d) )
A7 and

Make a determination that reanalysis can be


completed, and additional preventive controls
validated, as appropriate to the nature of the
A8 preventive control and its role in the facility’s food
safety system, in a timeframe that exceeds the first
90 calendar days of production of the applicable
food.
Do you have a qualified auditor to conduct an
B onsite audit see (§ 117.435(a)).

Has your preventive controls qualified individual,


successfully completed training in the development
and application of risk-based preventive controls at
least equivalent to that received under a
standardized curriculum recognized as adequate by
FDA or be otherwise qualified through job
experience to develop and apply a food safety
C1 system. (Job experience may qualify an individual
to perform these functions if such experience has
provided an individual with knowledge at least
equivalent to that provided through the
standardized curriculum. This individual may be,
but is not required to be, an employee of the
facility.)

Is your qualified auditor, a qualified individual who


has technical expertise obtained through
C2 education, training, or experience (or a
combination thereof) necessary to perform the
auditing function.
Do you have a written procedure to document that
all applicable training in the development and
application of risk based preventive controls is
d documented in records, including the date of the
training, the type of training, and the person(s)
trained.

§ 117.190 Implementation You must establish and maintain the following


records documenting implementation of the food
records required safety plan:

Do you have documentation, as required by §


117.136 of the basis for not establishing a
1 preventive control in accordance with § 117.136;
and

Records that document the monitoring of


2 preventive controls; and
3 Records that document corrective actions; and

Records that document verification, including, as


4 applicable, those related to the following:

4i Validation; and

4ii Verification of monitoring; and

4iii Verification of corrective actions; and

Calibration of process monitoring and verification


4iv instruments; and

4v Product testing; and

4vi Environmental monitoring; and

4vii Records review; and


4viii Reanalysis;

Records that document the supply chain program;


5 and

Records that document applicable training for the


6 preventive controls qualified individual and the
qualified auditor.

A your records established in a way that meet the


B requirements of Subpart F
Subpart D—MODIFIED
REQUIREMENTS
§ 117.206 Modified Are you a facility that is solely engaged in the
requirements that apply to storage of unexposed packaged food stores AND
you store refrigerated packaged food that requires
a facility solely engaged in time/temperature control to significantly minimize
the storage of unexposed or prevent the growth of, or toxin production by
packaged food pathogens; If so,

Did your facility establish and implement


temperature controls adequate to significantly
I doA1 minimize or prevent the growth of, or toxin
production by, pathogens

Does your facility monitor the temperature


controls with adequate frequency to provide
A2 assurance that the temperature controls are
consistently performed

Does your facility have a procedure to take the


A3 following corrective actions if there is a loss of
temperature control
Correct the problem and reduce the likelihood that
A3i the problem will recur
A3ii Evaluate all affected food for safety
Prevent the food from entering commerce, if you
cannot ensure the affected food is not adulterated
A3iii under section 402 of the Federal Food, Drug, and
Cosmetic Act
Does your facility verify that temperature controls
A4 are consistently implemented by doing the
following:
Calibrating temperature monitoring and recording
A4i devices (or checking them for accuracy)
Reviewing records of calibration within a
A4ii reasonable time after the records are created

Reviewing records of monitoring and corrective


actions taken to correct a problem with the control
of temperature within 7 working days after the
records are created OR within a reasonable
A4iii timeframe, provided that the preventive controls
qualified individual prepares (or oversees the
preparation of) a written justification for a
timeframe that exceeds 7 working days

Did your facility establish and maintain the


A5 following records:

Records (whether affirmative records


demonstrating temperature is controlled or
exception records demonstrating loss of
A5i temperature control) that document the
monitoring of temperature controls for any such
refrigerated packaged food; and

Records of corrective actions taken when there is a


A5ii loss of temperature control that may impact the
safety of any such refrigerated packaged food
Are all your records compliant with the
B requirements of subpart F (see below)

SUBPART F—
REQUIREMENTS APPLYING
TO RECORDS THAT MUST
BE ESTABLISHED AND
MAINTAINED

§ 117.301 Records subject


to the requirements of this
subpart.
Your records must be kept as original records, or
§ 117.305 General true copies (such as photocopies, pictures,
requirements applying to scanned copies, microfilm, microfiche, or other
records. accurate reproductions of the original records), or
electronic records
a
Your records must contain the actual values and
b observations obtained during monitoring and, as
appropriate, during verification activities
c Are your records accurate, indelible, and legible
Your records must be created concurrently with
d performance of the activity documented
Your records must be as detailed as necessary to
e provide history of work performed; and include the
following:
Information adequate to identify the plant or
F1 facility (e.g., the name, and when necessary, the
location of the plant or facility)
The date and, when appropriate, the time of the
F2 activity documented
The signature or initials of the person performing
F3 the activity
Where appropriate, the identity of the product and
F4 the lot code, if any

Did you consider that records that are established


or maintained to satisfy the requirements of this
part and that meet the definition of electronic
records in § 11.3 of this chapter are exempt from
g the requirements of part 11 of this chapter.
Records that satisfy the requirements of this part,
but that also are required under other applicable
statutory provisions or regulations, remain subject
to part 11 of this chapter
§ 117.310 Additional Has the owner, operator, or agent in charge of the
requirements applying to facility signed and dated the food safety plan upon
the food safety plan. initial completion and upon any modification

§ 117.315 Requirements Do you have a procedure for retaining all relevant


records at the plant or facility for at least 2 years
for record retention. after the date they were prepared

A1

If you are a qualified facility (see Subpart D


117,201) did you consider all records that a facility
relies on during the 3-year period preceding the
applicable calendar year to support its status as a
A2 qualified facility must be retained at the facility as
long as necessary to support the status of a facility
as a qualified facility during the applicable calendar
year
Did you consider all records that relate to the
general adequacy of the equipment or processes
being used by a facility, including the results of
scientific studies and evaluations, must be retained
by the facility for at least 2 years after their use is
discontinued (e.g., because the facility has updated
the written food safety plan (§ 117.126) or records
that document validation of the written food safety
plan (§ 117.155)

Did you consider, except for the food safety plan,


offsite storage of records is permitted if such
records can be retrieved and provided onsite
within 24 hours of request for official review

Did you consider the food safety plan must remain


onsite, and electronic records are considered to be
onsite if they are accessible from an onsite location

Did you consider if the plant or facility is closed for


a prolonged period, the food safety plan may be
transferred to some other reasonably accessible
location but must be returned to the plant or
facility within 24 hours for official review upon
request

Did you consider all records required by this part


§ 117.320 Requirements must be made promptly available to a duly
authorized representative of the Secretary of
for official review. Health and Human Services for official review and
copying upon oral or written request

Did you consider records obtained by FDA in


§ 117.325 Public accordance with this part are subject to the
disclosure. disclosure requirements under part 20 of this
chapter

Did you consider existing records (e.g., records that


are kept to comply with other Federal, State, or
local regulations, or for any other reason) do not
§ 117.330 Use of existing need to be duplicated if they contain all of the
required information and satisfy the requirements
records. of this subpart. Existing records may be
supplemented as necessary to include all of the
required information and satisfy the requirements
of this subpart.

Did you consider the information required by this


part does not need to be kept in one set of records,
and if existing records contain some of the required
information, any new information required by this
part may be kept either separately or combined
with the existing records
§ 117.335 Special
Did you consider any written assurance required by
requirements applicable to this part must contain the following elements
a written assurance.

Did you document the effective date

Did you document the printed names and


signatures of

authorized officials

Did you document the applicable assurance under:

Section 117.136(a)(2);

Section 117.136(a)(3);

Section 117.136(a)(4);

Section 117.430(c)(2);

Section 117.430(d)(2); or
Section 117.430(e)(2);

If you have a written assurance required under §


117.136 you must include:

Acknowledgement that the facility that provides


the written assurance assumes legal responsibility
to act consistently with the assurance and
document its actions taken to satisfy the written
assurance

Provision that if the assurance is terminated in


writing by either entity, responsibility for
compliance with the applicable provisions of this
part reverts to the manufacturer/processor as of
the date of termination

SUBPART G SUPPLY
-CHAIN PROGRAM

§117.405 Requirement to
establish and implement a
supply-chain program.

Has the facility established and implemented a


written, risk-based supply-chain program for those
a1 products or ingredients where a supply-chain
preventive control has been identified?
Have you considered if the receiving facility that is
an importer, is in compliance with the foreign
supplier verification program requirements under
part 1, subpart L of this chapter, and has
documentation of verification activities conducted
a2 under §1.506(e) of this chapter (which provides
assurance that the hazards requiring a supply-
chain-applied control for the raw material or other
ingredient have been significantly minimized or
prevented) need not conduct supplier verification
activities for that raw material or other ingredient.

Have you considered the requirements in this


a3 subpart do not apply to food that is supplied for
research or evaluation use, provided that such food

Is not intended for retail sale and is not sold or


a3i distributed to the public

Is labeled with the statement “Food for research or


a3ii evaluation use

Is supplied in a small quantity that is consistent


with a research, analysis, or quality assurance
a3iii purpose, the food is used only for this purpose,
and any unused quantity is properly disposed of

Is accompanied with documents, in accordance


with the practice of the trade, stating that the food
a3iv will be used for research or evaluation purposes
and cannot be sold or distributed to the public

b Is the supply-chain program written

Have you considered when a supply-chain-applied


control is applied by an entity other than the
receiving facility's supplier (e.g., when a non-
supplier applies controls to certain produce (i.e.,
c produce covered by part 112 of this chapter),
because growing, harvesting, and packing activities
are under different management), the receiving
facility must
Have you verified the supply-chain-applied control;
c1 or

Obtain documentation of an appropriate


verification activity from another entity, review and
c2 assess the entity's applicable documentation, and
document that review and assessment

§117.410 General
Does the supply-chain program include all of the
requirements applicable to following
a supply-chain program
a
a1 Using approved suppliers as required by §117.420
Determining appropriate supplier verification
a2 activities (including determining the frequency of
conducting the activity) as required by §117.425
Conducting supplier verification activities as
a3 required by §§117.430 and 117.435
Documenting supplier verification activities as
a4 required by §117.475; and

When applicable, verifying a supply-chain-applied


control applied by an entity other than the
receiving facility's supplier and documenting that
verification as required by §117.475, or obtaining
a5 documentation of an appropriate verification
activity from another entity, reviewing and
assessing that documentation, and documenting
the review and assessment as required by
§117.475

Have you considered the following as appropriate


b supplier verification activities for raw materials and
other ingredients
b1 Onsite audits
Sampling and testing of the raw material or other
b2 ingredient
Review of the supplier's relevant food safety
b3 records; and
Other appropriate supplier verification activities
based on supplier performance and the risk
b4 associated with the raw material or other
ingredient
Have you considered the supply-chain program
must provide assurance that a hazard requiring a
c supply-chain-applied control has been significantly
minimized or prevented

Have you considered except as provided by


paragraph (d)(2) of this section, in approving
d1 suppliers and determining the appropriate supplier
verification activities and the frequency with which
they are conducted, the following

Have you considered the hazard analysis of the


food, including the nature of the hazard controlled
d1i before receipt of the raw material or other
ingredient, applicable to the raw material and
other ingredients

Have you considered the entity or entities that will


d1ii be applying controls for the hazards requiring a
supply-chain-applied control

Have you considered the supplier performance,


d1iii including
Have you considered the supplier's procedures,
d1iiiA processes, and practices related to the safety of
the raw material and other ingredients

Have you considered the applicable FDA food


safety regulations and information relevant to the
supplier's compliance with those regulations,
including an FDA warning letter or import alert
relating to the safety of food and other FDA
compliance actions related to food safety (or, when
applicable, relevant laws and regulations of a
country whose food safety system FDA has
officially recognized as comparable or has
determined to be equivalent to that of the United
States, and information relevant to the supplier's
compliance with those laws and regulations); and
d1iiiB

Have you considered the supplier's food safety


history relevant to the raw materials or other
ingredients that the receiving facility receives from
the supplier, including available information about
results from testing raw materials or other
ingredients for hazards, audit results relating to the
safety of the food, and responsiveness of the
supplier in correcting problems; and
d1iiiC
Have you considered the any other factors as
d1iv appropriate and necessary, such as storage and
transportation practices.
Are you considering supplier performance which
can be limited to the supplier's compliance history
d2 as required by paragraph (d)(1)(iii)(B) of this
section, if the supplier is

d2i A qualified facility as defined by §117.3

A farm that grows produce and is not a covered


farm under part 112 of this chapter in accordance
d2ii with §112.4(a), or in accordance with §§112.4(b)
and 112.5; or

A shell egg producer that is not subject to the


d2iii requirements of part 118 of this chapter because it
has less than 3,000 laying hens

Have you considered that if the owner, operator, or


agent in charge of a receiving facility determines
through auditing, verification testing, document
review, relevant consumer, customer or other
complaints, or otherwise that the supplier is not
controlling hazards that the receiving facility has
identified as requiring a supply-chain-applied
control, the receiving facility must take and
e document prompt action in accordance with
§117.150 to ensure that raw materials or other
ingredients from the supplier do not cause food
that is manufactured or processed by the receiving
facility to be adulterated under section 402 of the
Federal Food, Drug, and Cosmetic Act or
misbranded under section 403(w) of the Federal
Food, Drug, and Cosmetic Act

§117.415 Responsibilities Has the receiving facility approved the suppliers


of the receiving facility

a1
Except as provided by paragraphs (a)(3) and (4) of
this section, has the receiving facility determined
a2 and conducted appropriate supplier verification
activities, and satisfied all documentation
requirements of this subpart.

Has the entity other than the receiving facility


done any of the following, provided that the
a3 receiving facility reviews and assesses the entity's
applicable documentation, and documents that
review and assessment:
Have they established written procedures for
a3i receiving raw materials and other ingredients by
the entity
Is there documentation that written procedures for
a3ii receiving raw materials and other ingredients are
being followed by the entity; and
Did you determine, conduct, or both determine
a3iii and conduct the appropriate supplier verification
activities, with appropriate documentation

Did the supplier conduct and document sampling


and testing of raw materials and other ingredients,
for the hazard controlled by the supplier, as a
supplier verification activity for a particular lot of
a4 product and provide such documentation to the
receiving facility, provided that the receiving facility
reviews and assesses that documentation, and
documents that review and assessment.

Did you consider for the purposes of this subpart, a


b receiving facility may not accept any of the
following as a supplier verification activity:

Did you deny a determination by its supplier of the


b1 appropriate supplier verification activities for that
supplier

b2 Did you deny an audit conducted by its supplier;

Did you deny a review by its supplier of that


b3 supplier's own relevant food safety records; or

Did you consider the conduct by its supplier of


other appropriate supplier verification activities for
b4 that supplier within the meaning of §117.410(b)
(4).

Did you conduct approval of suppliers. The


receiving facility must approve suppliers in
§117.420 Using approved accordance with the requirements of §117.410(d),
suppliers and document that approval, before receiving raw
materials and other ingredients received from
those suppliers;

a
Are there written procedures for receiving raw
b materials and other ingredients.

Have written procedures for receiving raw


b1 materials and other ingredients been established
and followed;

Are there written procedures for receiving raw


materials and other ingredients that must ensure
that raw materials and other ingredients are
received only from approved suppliers (or, when
b2 necessary and appropriate, on a temporary basis
from unapproved suppliers whose raw materials or
other ingredients are subjected to adequate
verification activities before acceptance for use);
and

Has the use of the written procedures for receiving


b3 raw materials and other ingredients been
documented.

§117.425 Determining
appropriate supplier Has the appropriate supplier verification activities
verification activities (including the frequency of conducting the activity)
(including determining the been determined in accordance with the
frequency of conducting requirements of §117.410(d).
the activity)

Except as provided by paragraph (c), (d), or (e) of


§117.430 Conducting this section, has one or more of the supplier
supplier verification verification activities specified in §117.410(b), as
determined under §117.410(d), been conducted
activities for raw materials for each supplier before using the raw material or
and other ingredients. other ingredient from that supplier and periodically
thereafter.

Have you considered, except as provided by


paragraph (b)(2) of this section, when a hazard in a
raw material or other ingredient will be controlled
b1 by the supplier and is one for which there is a
reasonable probability that exposure to the hazard
will result in serious adverse health consequences
or death to humans:

Have you determined if the appropriate supplier


b1i verification activity is an onsite audit of the
supplier; and
Have you determined if the audit must be
conducted before using the raw material or other
b1ii ingredient from the supplier and at least annually
thereafter.

Have you determined if the requirements of


paragraph (b)(1) of this section do not apply if
there is a written determination that other
b2 verification activities and/or less frequent onsite
auditing of the supplier provide adequate
assurance that the hazards are controlled.

Have you determined if a supplier is a qualified


facility as defined by §117.3, the receiving facility
c does not need to comply with paragraphs (a) and
(b) of this section if the receiving facility:

Have you obtained a written assurance that the


c1 supplier is a qualified facility as defined by §117.3:

Before first approving the supplier for an applicable


c1i calendar year; and

On an annual basis thereafter, by December 31 of


c1ii each calendar year, for the following calendar year;
and

Have you obtained written assurance, at least


every 2 years, that the supplier is producing the
raw material or other ingredient in compliance
with applicable FDA food safety regulations (or,
c2 when applicable, relevant laws and regulations of a
country whose food safety system FDA has
officially recognized as comparable or has
determined to be equivalent to that of the United
States). Does the written assurance include either:

A brief description of the preventive controls that


c2i the supplier is implementing to control the
applicable hazard in the food; or

A statement that the facility is in compliance with


State, local, county, tribal, or other applicable non-
c2ii Federal food safety law, including relevant laws and
regulations of foreign countries.
Have you considered if a supplier is a farm that
grows produce and is not a covered farm under
part 112 of this chapter in accordance with
§112.4(a), or in accordance with §§112.4(b) and
d 112.5, the receiving facility does not need to
comply with paragraphs (a) and (b) of this section
for produce that the receiving facility receives from
the farm as a raw material or other ingredient if
the receiving facility:

Has obtained written assurance that the raw


material or other ingredient provided by the
d1 supplier is not subject to part 112 of this chapter in
accordance with §112.4(a), or in accordance with
§§112.4(b) and 112.5:

Have you conducted this before first approving the


d1i supplier for an applicable calendar year; and
Do you conduct on an annual basis thereafter, by
d1ii December 31 of each calendar year, for the
following calendar year; and

Have you obtained written assurance, at least


every 2 years, that the farm acknowledges that its
food is subject to section 402 of the Federal Food,
Drug, and Cosmetic Act (or, when applicable, that
d2 its food is subject to relevant laws and regulations
of a country whose food safety system FDA has
officially recognized as comparable or has
determined to be equivalent to that of the United
States).

Did you consider if a supplier is a shell egg


producer that is not subject to the requirements of
part 118 of this chapter because it has less than
E 3,000 laying hens, the receiving facility does not
need to comply with paragraphs (a) and (b) of this
section if the receiving facility:

Has obtained written assurance that the shell eggs


produced by the supplier are not subject to part
e1 118 because the shell egg producer has less than
3,000 laying hens:

Has determined before first approving the supplier


e1i for an applicable calendar year; and

Has determined on an annual basis thereafter, by


e1ii December 31 of each calendar year, for the
following calendar year; and
Has obtained written assurance, at least every 2
years, that the shell egg producer acknowledges
that its food is subject to section 402 of the Federal
Food, Drug, and Cosmetic Act (or, when applicable,
e2 that its food is subject to relevant laws and
regulations of a country whose food safety system
FDA has officially recognized as comparable or has
determined to be equivalent to that of the United
States).

Have you established that there must not be any


financial conflicts of interests that influence the
F results of the verification activities listed in
§117.410(b) and payment must not be related to
the results of the activity.

Has an onsite audit of a supplier been performed


§117.435 Onsite audit by a qualified auditor.

Have you determined if the raw material or other


ingredient at the supplier is subject to one or more
FDA food safety regulations, an onsite audit must
consider such regulations and include a review of
the supplier's written plan (e.g., Hazard Analysis
and Critical Control Point (HACCP) plan or other
food safety plan), if any, and its implementation,
for the hazard being controlled (or, when
applicable, an onsite audit may consider relevant
laws and regulations of a country whose food
safety system FDA has officially recognized as
comparable or has determined to be equivalent to
that of the United States).
B
Have you considered that the following may be
substituted for an onsite audit, provided that the
c1 inspection was conducted within 1 year of the date
that the onsite audit would have been required to
be conducted:
Are the written results of an appropriate inspection
of the supplier for compliance with applicable FDA
food safety regulations by FDA, by representatives
c1i of other Federal Agencies (such as the United
States Department of Agriculture), or by
representatives of State, local, tribal, or territorial
agencies; or

Have you considered that for a foreign supplier, the


written results of an inspection by FDA or the food
safety authority of a country whose food safety
c1ii system FDA has officially recognized as comparable
or has determined to be equivalent to that of the
United States.

Have you considered that for inspections


conducted by the food safety authority of a
country whose food safety system FDA has
officially recognized as comparable or determined
c2 to be equivalent, the food that is the subject of the
onsite audit must be within the scope of the
official recognition or equivalence determination,
and the foreign supplier must be in, and under the
regulatory oversight of, such country

Have you considered that if the onsite audit is


solely conducted to meet the requirements of this
subpart by an audit agent of a certification body
Asd that is accredited in accordance with regulations in
part 1, subpart M of this chapter, the audit is not
subject to the requirements in those regulations.

§117.475 Records The records documenting the supply-chain


documenting the supply- program are subject to the requirements of
chain program subpart F of this part.

Has the receiving facility reviewed the records


b listed in paragraph (c) of this section in accordance
with §117.165(a)(4).
Does the receiving facility document the following
c in records as applicable to its supply-chain
program:
c1 Is there a written supply-chain program

Is there documentation that a receiving facility that


is an importer is in compliance with the foreign
supplier verification program requirements under
c2 part 1, subpart L of this chapter, including
documentation of verification activities conducted
under §1.506(e) of this chapter;

Is there documentation of the approval of a


c3 supplier;
Are there written procedures for receiving raw
c4 materials and other ingredients;
Is there documentation demonstrating use of the
c5 written procedures for receiving raw materials and
other ingredients;
Is there documentation of the determination of the
c6 appropriate supplier verification activities for raw
materials and other ingredients;
Is there documentation of the conduct of an onsite
c7 audit. This documentation must include:
Does it have the name of the supplier subject to
c7i the onsite audit;
Does it have the documentation of audit
c7ii procedures;
c7iii Does it have the dates the audit was conducted;
c7iv Does it have the conclusions of the audit;
Were corrective actions taken in response to
c7v significant deficiencies identified during the audit;
and
Is there documentation that the audit was
c7vi conducted by a qualified auditor;
Is there documentation of sampling and testing
c8 conducted as a supplier verification activity. This
documentation must include:
Does it include identification of the raw material or
c8i other ingredient tested (including lot number, as
appropriate) and the number of samples tested;

Does it include identification of the test(s)


c8ii conducted, including the analytical method(s)
used;

Does it include the date(s) on which the test(s)


c8iii were conducted and the date of the report;

c8iv Does it include the results of the testing;

Does it include corrective actions taken in response


c8v to detection of hazards; and

Does it include information identifying the


c8vi laboratory conducting the testing;

Have you considered documentation of the review


c9 of the supplier's relevant food safety records. This
documentation must include:

Does it include the name of the supplier whose


c9i records were reviewed;

c9ii Does it include the date(s) of review;

Does it include the general nature of the records


c9iii reviewed;
c9iv Does it include the conclusions of the review; and

Does it include the corrective actions taken in


c9v response to significant deficiencies identified
during the review;

Have you considered documentation of other


appropriate supplier verification activities based on
c10 the supplier performance and the risk associated
with the raw material or other ingredient;

Have you considered documentation of any


determination that verification activities other than
an onsite audit, and/or less frequent onsite
auditing of a supplier, provide adequate assurance
that the hazards are controlled when a hazard in a
c11 raw material or other ingredient will be controlled
by the supplier and is one for which there is a
reasonable probability that exposure to the hazard
will result in serious adverse health consequences
or death to humans;

Have you considered the following documentation


c12 of an alternative verification activity for a supplier
that is a qualified facility:

Have you determined there is the written


assurance that the supplier is a qualified facility as
c12i defined by §117.3, before approving the supplier
and on an annual basis thereafter; and

Have you determined there is the written


assurance that the supplier is producing the raw
material or other ingredient in compliance with
applicable FDA food safety regulations (or, when
c12ii applicable, relevant laws and regulations of a
country whose food safety system FDA has
officially recognized as comparable or has
determined to be equivalent to that of the United
States);

Is there any of the following documentation of an


alternative verification activity for a supplier that is
c13 a farm that supplies a raw material or other
ingredient and is not a covered farm under part
112 of this chapter:

Is there any written assurance that supplier is not a


covered farm under part 112 of this chapter in
c13i accordance with §112.4(a), or in accordance with
§§112.4(b) and 112.5, before approving the
supplier and on an annual basis thereafter; and
Is there any written assurance that the farm
acknowledges that its food is subject to section
402 of the Federal Food, Drug, and Cosmetic Act
(or, when applicable, that its food is subject to
c13ii relevant laws and regulations of a country whose
food safety system FDA has officially recognized as
comparable or has determined to be equivalent to
that of the United States);

Is there any of the following documentation of an


alternative verification activity for a supplier that is
c14 a shell egg producer that is not subject to the
requirements established in part 118 of this
chapter because it has less than 3,000 laying hens:

Is there any written assurance that the shell eggs


provided by the supplier are not subject to part
c14i 118 of this chapter because the supplier has less
than 3,000 laying hens, before approving the
supplier and on an annual basis thereafter; and

Is there any written assurance that the shell egg


producer acknowledges that its food is subject to
section 402 of the Federal Food, Drug, and
Cosmetic Act (or, when applicable, that its food is
c14ii subject to relevant laws and regulations of a
country whose safety system FDA has officially
recognized as comparable or has determined to be
equivalent to that of the United States);

Is there any written results of an appropriate


inspection of the supplier for compliance with
applicable FDA food safety regulations by FDA, by
representatives of other Federal Agencies (such as
c15 the United States Department of Agriculture), or by
representatives from State, local, tribal, or
territorial agencies, or the food safety authority of
another country when the results of such an
inspection is substituted for an onsite audit;

Is there any documentation of actions taken with


c16 respect to supplier non-conformance;

Is there any documentation of verification of a


c17 supply-chain-applied control applied by an entity
other than the receiving facility's supplier; and
Have you considered, when applicable,
c18 documentation of the receiving facility's review
and assessment of:
Is there any applicable documentation from an
entity other than the receiving facility that written
c18i procedures for receiving raw materials and other
ingredients are being followed;

Is there any applicable documentation, from an


entity other than the receiving facility, of the
c18ii determination of the appropriate supplier
verification activities for raw materials and other
ingredients;

Is there any applicable documentation, from an


entity other than the receiving facility, of
c18iii conducting the appropriate supplier verification
activities for raw materials and other ingredients;

Is there any applicable documentation, from its


c18iv supplier, of:

Is there any results of sampling and testing


c18ivA conducted by the supplier; or

Is there any results of an audit conducted by a


c18ivB third-party qualified auditor in accordance with
§§117.430(f) and 117.435; and

Is there any applicable documentation, from an


entity other than the receiving facility, of
c18iv verification activities when a supply-chain-applied
control is applied by an entity other than the
receiving facility's supplier.
Clause Reference ISO/TS
FSSC22000 Clauses FSSC vs. PCHF 22002-1; 2009

ISO/TS 22002-1: 13.5 & 13.6 Comparable

ISO/TS 22002-1: 13.7 Comparable


ISO 22000 6.2 & 7.2 .1

ISO/TS 22002-1: 13.4 Comparable

ISO/TS 22002-1: 13.7 Comparable

ISO/TS 22002-1: 13.7 Comparable

ISO/TS 22002-1: 13.8 Comparable


13 Personnel hygiene and employee
facilities

ISO/TS 22002-1: 13.4 Comparable


ISO/TS 22002-1: 13.4 Comparable

ISO/TS 22002-1: 13.7 Comparable

ISO/TS 22002-1: 13.8 Comparable

ISO/TS 22002-1: 13.7 Comparable

4 Construction and layout of buildings


ISO/TS 22002-1: 4 Comparable

4 Construction and layout of buildings


ISO/TS 22002-1: 4 and 5.4 Comparable 5 Layout
or Premises and Workspace

4 Construction and layout of buildings


ISO/TS 22002-1: 4 Comparable

4 Construction and layout of buildings


5 Layout
or Premises and Workspace
ISO/TS 22002-1: 4.2, 4.3, 5.4 and 12 Comparable

12 Pest control;
ISO/TS 22002-1: 7 Exceeds 7 Waste disposal

4 Construction and layout of buildings


ISO/TS 22002-1: 4.2, 4.3, Comparable

5 Layout or Premises and Workspace


ISO/TS 22002-1: 5 Comparable

ISO/TS 22002-1: 5.4 Comparable 5.4 Location of equipment


5 Layout or Premises and Workspace
6 Utilities -
ISO/TS 22002-1: 5.1, 5.7, 6.4, & 10 Exceeds Air, Water and Energy
10 Measures for Prevention of Cross
Contamination
5 Layout of premises and Works
Space
9 Management of Purchased
ISO/TS 22002-1:5.7, 9.3, 12.4, 14.3 Materials
Comparable
and 16.3 12 Pest Control
14 Re Work
16
Warehousing

ISO/TS 22002-1: 5.7 and 12.4 comparable

ISO/TS 22002-1: 5.7 and 12.4 Comparable


5.7 Storage of food, packaging
materials, ingredients and non-food
ISO/TS 22002-1: 5.7 and 12 Comparable chemicals
12 Pest control

Different – not specified 5.4 Location of equipment


ISO/TS 22002-1: 5.4 in FSSC22000

ISO/TS 22002-1: 5 Comparable 5 Layout of premises and workspace

ISO/TS 22002-1: 6.6 Comparable 6 Utilities- Air, Water, Energy


5 Layout of Premises and and
Workspace
ISO/TS 22002-1: 5.7, 6.4 and 16.1 Exceeds 6 Utlities-Air, Water, Energy
16 Warehousing

5 Layout of Premises and Workspace


ISO/TS 22002-1: 5.3, 12 Exceeds 12 Pest
Control

5 Layout of Premises and Workspace


ISO/TS 22002-1: 5.1, 11 Comparable 11 Cleaning
and Sanitizing
ISO/TS 22002-1: 11.2, 16.2 Comparable
– although
microbial quality and 11 Cleaning and Sanitizing
adequacy of cleaning 16 Warehousing
and sanitizing
compounds not
specifically itemised

ISO/TS 22002-1: 11.2

ISO/TS 22002-1: 6.5, 8.5 and 8.6 Comparable 6 Utilities- Air, Water, Energy
8 Equipment Suitability,
Cleaning and Maintenance

ISO/TS 22002-1: 6.5, 8.5 and 8.6 Comparable

5 Layout of Premises and Workspace


ISO/TS 22002-1: 5.7 and 16.2 Comparable 16
Warehousing
ISO/TS 22002-1: 12 Comparable 12 Pest Control

8 Equipment Suitability, Cleaning and


ISO/TS 22002-1: 8.5 and 11 Comparable Maintenance
11 Cleaning and Sanitizing

6 Utilities- Air, Water, Energy


8 Equipment Suitability,
ISO/TS 22002-1: 6.4, 8.1 and 11 Comparable Cleaning and Maintenance
11 Cleaning
and Sanitizing
8 Equipment Suitability, Cleaning and
ISO/TS 22002-1: 8.5 and 11.2 Comparable Maintenance
11 Cleaning and Sanitizing

Different – addressed in
FSSC2000 as food, 5 Layout of Premises and Workspace
ISO/TS 22002-1: 5.7 and 7 packaging materials, 7 Waste
ingredients and non- disposal
food chemicals

Comparable- although 8 Equipment Suitability, Cleaning and


non-food-contact surfaces Maintenance
ISO/TS 22002-1: 8.5 and 11 not specifically called out in 11 Cleaning and Sanitizing
FSSC22000

5 Layout of Premises and Workspace


8 Equipment
ISO/TS 22002-1: 5.7 and 8.5 Comparable Suitability, Cleaning and Maintenance
6 Utlilities-air, water, energy
ISO/TS 22002-1: 6.2 and 13.2 Comparable 13 Personal hygiene
and employee facilities

ISO/TS 22002-1: 6.2 Comparable

ISO/TS 22002-1: 6.2 Comparable


6 Utilities - air, water, energy
ISO/TS 22002-1: 6.2 Comparable

ISO/TS 22002-1: 6.2 Comparable

5 Layout of Premises and and


ISO/TS 22002-1: 5.3 and 7.4 Comparable Workspace
7 Waste disposal

ISO/TS 22002-1: 6.2 Comparable 6 Utilities - air, water, energy


ISO 22002-1 : 7.3 & 7.4 Comparable 7 Waste disposal
ISO 22000: 7.2.3

13 Personal hygiene and employee


ISO/TS 22002-1: 13.2 Comparable facilities

ISO/TS 22002-1: 13.2 13 Personal hygiene and employee


Comparable
ISO 22000 6.2 facilities
Comparable (referred to 7 Waste disposal
ISO/TS 22002-1: 7 as inedible)

ISO/TS 22002-1: 8.2 Comparable

8 Equipment Suitability, Cleaning and


Maintenance

ISO/TS 22002-1: 8.2 Comparable

5 Layout of Premises and Workspace


ISO/TS 22002-1: 5.4 Comparable

ISO/TS 22002-1: 8.3 Comparable

8 Equipment Suitability, Cleaning and


Maintenance
ISO/TS 22002-1: 8.1 Comparable

8 Equipment Suitability, Cleaning and


Maintenance
ISO/TS 22002-1: 8.1 and 10.3 Comparable 10 Measures for
Prevention of Cross Contamination
ISO/TS 22002-1: 8.2 Comparable

8 Equipment Suitability, Cleaning and


Maintenance

ISO/TS 22002-1: 8.2 Comparable

ISO/TS 22002-1: 16.3 Comparable 16 Warehousing

5 Layout of Premises and Workspace


8 Equipment
ISO/TS 22002-1: 5.7, 8.4 and 16.2 Comparable Suitability, Cleaning and Maintenance

16 Warehousing

8 Equipment Suitability, Cleaning and


ISO 22000: 8.3, 8.4 and 8.6 Comparable Maintenance
ISO/TS 22002-1: 6.5 6 Utilities - air, water, energy
Comparable

ISO 22000: 7 and 4 22002-1


Comparable
ISO/TS 22002-1: ( All Paragraphs) Prerequisite programmes on food
safety — Part 1:
Food manufacturing

ISO 22000: 7.1 and 7.10


ISO 22002-1: 1 FSSC 22000
FSSC 22000 Comparable 22002-1 1 Scope
Part 2:Requirements for
Certification 1.1.4.1
ISO 22000: 5.4, 6.1 and 6,2 Comparable 11 Cleaning and Sanitizing
ISO/TS 22002-1: 11

10 Measures for Prevention of Cross


ISO/TS 22002-1: 10 Comparable Contamination

ISO/TS 22002-1: 11.5 and Comparable 11 Cleaning and Sanitizing


ISO 22000: 7.8 and 8

ISO 22000: 7.2.1 Comparable


5 Layout or Premises and Workspace
ISO 22000: 7.3.3.1, 7.10 6 Utilities -
and ISO/TS 22002-1: 5.7 6.2 : Air, Water and Energy
9.3 FSSC 22000 Part 2 Comparable 9 Management of purchased
Requirements for Certification:
2.1.4.1 ; and 2.1.4.4 materials

ISO 22000: 7.3.3.1 and 7.3.5.2


FSSC 22000 Part 2 Requirements for Comparable
Certification: 2.1.4.1 and 2.1.4.4
ISO 22000 7.3.3.1. and 7.4.1 Comparable
ISO 22000: Annex C

ISO 22000: 7.3.3.1 and 7.4 Comparable 14 Rework


ISO 22002-1: 14

5 Layout or Premises and Workspace


9
ISO/TS 22002-1: 5.7, 9.3, 14.3 and Management of purchased materials
Comparable
16.3 14 Rework

16 Warehousing
ISO 22000: 7.3.3.1 Comparable

5 Layout or Premises and Workspace


9
ISO/TS 22002-1: 5.7, 9.3 and 16.3 Comparable Management of purchased materials
16
Warehousing

5 Layout or Premises and Workspace


14 Rework
ISO/TS 22002-1: 5.7, 14.3 and 16.3 Comparable
16 Warehousing

8 Equipment Suitability, Cleaning and


ISO/TS 22002-1: 8.5 and 16.3 Comparable Maintenance
16 Warehousing

10 Measures for Prevention of Cross


ISO/TS 22002-1: 10 Comparable Contamination

5 Layout or Premises and Workspace


6 Utilities -
ISO/TS 22002-1: 5.7, 6.4, and 16 Comparable Air, Water and Energy 16
Warehousing
ISO 22000: 7.4 and 7.6.2 Comparable

5 Layout or Premises and Workspace


10 Measures
ISO/TS 22002-1: 5.7, 10.3 and 14 Comparable for Prevention of Cross Contamination
14
Rework

5 Layout or Premises and Workspace

9 Management of
purchased materials
ISO/TS 22002-1: 5.7, 9.3, 10 and 16 Comparable 10 Measures for Prevention
of Cross Contamination

16
Warehousing

8 Equipment Suitability, Cleaning and


Maintenance
ISO/TS 22002-1: 8.5, 8.6, 11 and 16 Comparable 11 Cleaning and sanitizing
16 Warehousing
10 Measures for Prevention of Cross
ISO/TS 22002-1: 10.4 Comparable Contamination

ISO 22000: 7.10 Comparable

ISO 22000: 7.10 Comparable

ISO 22000: 7.10 Comparable

10 Measures for Prevention of Cross


ISO/TS 22002-1: 10 Comparable Contamination

Comparable - although
ISO 22000: 7.6.2 and ISO/TS 22002- FSSC22000 does not
1: 10 address heat blanching
specifically

Comparable- although
ISO 22000: 7.6.2 and ISO/TS 22002- FSSC22000 does not
1: 10 address these
preparations specifically
10 Measures for Prevention of Cross
ISO 22000: 7.6.2 and ISO/TS 22002- Comparable Contamination
1: 10
10 Measures for Prevention of Cross
Contamination

Comparable- although
ISO 22000: 7.6.2 and ISO/TS 22002- FSSC22000 does not
1: 10 address moisture level
control specifically

Comparable although
ISO 22000: 7.6.2 and ISO/TS 22002- FSSC22000 does not
1: 10 address pH control
specifically

ISO/TS 22002-1: 6.2 Comparable 6 Utilities - Air, Water and Energy

ISO/TS 22002-1: 16 Comparable 16 Warehousing

ISO/TS 22002-1: 5.7 5 Layout or Premises and Workspace

Comparable – In FSSC
22000 food and food
by-products are treated
in the same way under
ISO/TS 22002 until they
reach the animal food
producer where ISO/TS
22002-6 will become the
applicable PRP alongside
ISO 22000 and FSSC
Additional Scheme
ISO/TS 22002-1: 16 Requirements. 16 Warehousing

ISO/TS 22002-1: 5.7 5 Layout or Premises and Workspace


ISO 22000: 7.3.3.2

Comparable –In FSSC


22000 food and food
by-products are treated
in the same way under
ISO/TS 22002 until they
reach the animal food
ISO 22000: 7.3.3.2 producer where ISO/TS
22002-6 will become the
applicable PRP alongside
ISO 22000 and FSSC
Additional Scheme
Requirements.

ISO/TS 22002-1: 16 16 Warehousing

Different – FSSC22000
does not specifically
ISO 22000: 7.10 address aiming for
lowest defect level
Different – FSSC22000
does not specifically
ISO 22000: 7.10 address defect levels or
mixing with adulterated
food

ISO 22000: 4.1 and 7.1 Comparable

ISO 22000: 4 Comparable


ISO 22000: 7.2-7.4
ISO 22000: 4.2.1 Comparable

Different –while
FSSC22000 requires a
responsible Food safety
Team Leader, it does not
ISO 22000: 5.5, 6.2 address the specific
training curriculum,
education or experience
required

ISO 22000: 7.4 and 7.6.1 Comparable


Comparable- ISO 22000
ISO 22000: 7.4.4, 7.5 and 7.6.2 describes oPRP's which
are similar to PC's

Different - While ISO


22002-1 has a
requirement for the
control of supplied
materials,
recommendations for a 9 Management of purchased
ISO/TS 22002-1: 9 materials
sepecific supply chain
control program will be
included in a
supplementary FSSC
22000 addendum.
Comparable- although
ISO/TS 22002-1: 15 and ISO 22000: there is a difference in 15 Product recall procedures
7.10.4 terminology; recall vs
withdrawal

ISO 22000: 7.5, 7.6.4 and 8.3 Comparable


ISO 22000: 7.6.5 and 7.10 Exceeds

ISO 22000: 7.8 and 8 Exceeds


ISO 22000: 4.1, 4.2, 7.7 and 8.5.2 Comparable

ISO 22000: 7.4 Comparable


ISO 22000: 7.4.2 and 7.6.1 Comparable

ISO 22000: 7.2 and 7.3.3 Comparable


Comparable, but does
not mention specific
chemical hazards which
ISO 22000: 7.3.3.1, 7.4.2 need to be considered
(e.g., radiological,
pesticides)

ISO 22000: 7.3.3.1, 7.4

ISO 22000: 7.3, 7.4 Comparable

ISO 22000: 7.4


FSSC 22000 Part 2; Requirements Comparable
for Certification 2.1.4.4

2.1.4.4 Food Fraud prevention

ISO 22000: 7.4


FSSC 22000 Part2 Requirements for Comparable
Certification 2.1.4.4

ISO 22000: 7.4.3 Comparable

ISO 22000: 7.4.3 Comparable


4 Construction and layout of buildings
10
ISO 22002-1: 4.2 and 10.1-10.2 Different – FSSC22000 Measures for Prevention of Cross
FSSC 22000 Part 2: Requirements does not call out RTE Contamination
for Certification 2.1.4.7 food specifically 2.1.4.7 Environmental monitoring

ISO 22000: 7.3.3 Comparable

5 Layout or Premises and Workspace


ISO 22000: 7.4.2.2 and ISO 22002-1: Exceeds 8 Equipment
5 and 8 Suitability, Cleaning and Maintenance

ISO 22000: 7.3.3.1 Comparable


ISO 22000: 7.3.3 and 7.3.5 Comparable

ISO 22000: 7.3.3 and 7.3.5 Comparable

ISO 22000: 7.3.3 and 7.3.5 Comparable

ISO 22000: 7.3.3.2


FSSC Part 2 Requirements for Comparable
Certification 2.1.4.6

ISO 22000: 7.3.3 and 7.3.5 Comparable


ISO 22000: 7.3.4 Comparable

Comparable - FSSC
22000 considers
ISO 22000: 7.2.3 sanitation when
establishing PRPs

Comparable –
FSSC22000 considers
ISO 22000: 7.2.3 employee hygiene when
establishing PRPs

ISO 22000: 7.4.2 Comparable


Comparable - However
FSSC 22000 does not
cover all the Supply
Chain PC's- This will be
ISO 22000: 7.5 and 7.6.2 included as a
recommenation for
consideration in an FSSC
22000 supplement.

ISO 22000:, 7.5, 7.6.2 and 7.8 Comparable

Comparable –
FSSC22000 refers to
control measures that
ISO 22000: 7.4.4 and 7.6.2 could be managed
either through
operational PRPs or
HACCP
ISO 22000: 7.2, 7.4.4, 7.5 and 7.6 Comparable

ISO 22000: 7.4.4 and 7.6.2 Comparable

ISO 22000: 7.6.3 Comparable

10 Measures for Prevention of Cross


ISO 22000: 3.3 and 7. Contamination
ISO 22002.1 10.3 and 14.2
FSSC 22000 Part 2 Requirements for Comparable 14 Rework
2.1.4.6
Certification 2.1.4.6 Management of allergens:
ISO 22000: 7.3.3.2
FSSC 22000 Part 2 Requirements for Comparable 2.1.4.2 Product labelling:
Certification 2.1.4.2

Comparable - however
careful consideration of
ISO 22000: 7.2.3 and ISO 22002-1: 11 sanitation as an oPRP
will be recommended in
an FSSC 22000
supplement

11 Cleaning and sanitizing

ISO 22000: 7.2.3 and ISO/TS 22002- Comparable


1: 11
10 Measures for Prevention of Cross
ISO 22000: 7.2.3 and ISO/TS 22002- Exceeds Contamination
1: 10.3 and 11 11 Cleaning and sanitizing

ISO 22000: 7.2.3 and ISO/TS 22002- Comparable


1: 11
11 Cleaning and sanitizing
ISO 22000: 7.2.3 and ISO/TS 22002- Comparable
1: 11

10 Measures for Prevention of Cross


ISO 22000: 7.2.3 and ISO/TS 22002- Exceeds Contamination
1: 10.3 and 11 11 Cleaning and sanitizing

ISO 22000: 7.2.3 and ISO/TS 22002- Comparable 11 Cleaning and sanitizing
1: 11
Comparable- but
lacking in a specific
requirement for a supply
chain control.
Consideration of supply 9 Management of purchased
ISO 22002-1: 9 materials
chain control will be
included as a
recommendation in an
FSSC 22000 supplement

Comparable- but
SO 22002-1: 15 ISO 22000: 7.10.4 15 Product recall procedures:
different terminology
ISO 22000: 6.2 and 7.4.4 Comparable

Different: No such
ISO 22000: 7.4.4 provision in FSSC22000

Different: No such
ISO 22000: 7.4.4 provision in FSSC22000

Different: No such
ISO 22000: 7.4.4 provision in FSSC22000

Different: No such
ISO 22000: 7.4.4 provision in FSSC22000
Different: No such
ISO 22000: 7.4.4 provision in FSSC22000

Different: No such
ISO 22000: 7.4.4 provision in FSSC22000

Different: No such
ISO 22000: 7.4.4 provision in FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000

Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Comparable although
ISO 22000: 7.10.4 difference in
ISO 22002-1: 15 terminology

ISO 22000: 7.10.4 and Comparable


ISO 22002-1: 15

15 Product recall procedures


ISO 22000: 7.10.4 and Comparable
ISO 22002-1: 15.2

ISO 22000: 7.10.4 Comparable


ISO/TS 22002-1: 15.2

ISO 22000: 7.10.4 Comparable


ISO/TS 22002-1: 15.2

ISO 22000: 7.10.4 Comparable

ISO 22000: 7.4.4 Comparable


ISO 22000: 7.6.4 Comparable

ISO 22000: 7.6.5 and 7.10 Comparable

ISO 22000: 7.8 and 8.4 Comparable

9 Management of purchased
ISO/TS 22002-1: 9 Comparable materials
ISO/TS 22002-1: 9.2 9 Management of purchased
FSSC 22000 Part 2, Requirements for Comparable materials ,
Certification 2.1.4.1 2.1.4.1 Management of Services

ISO 22000: 7.7 and 8.5.2 Comparable

ISO 22000: 7.6.4 Comparable

ISO 22000: 7.6.4 Comparable

ISO 22000: 7.6.4 Comparable

ISO 22000: 7.6.4 Comparable


ISO 22000: 7.6.5 and 7.10 Comparable

ISO 22000: 7.6.5 and 7.10 Comparable

ISO 22000: 7.6.5 and 7.10.3 Comparable


Comparable, but no
ISO 22000: 7.6.5 and 7.10.3 mention of monitoring
for specific pathogens.

ISO 22000: 7.6.5 and 7.10 Comparable

ISO 22000: 7.6.5 and 7.10 Comparable

ISO 22000: 7.6.5 and 7.10.2 Comparable


ISO 22000: 7.6.5 and 7.10 Comparable

ISO 22000: 7.6.5 and 7.10.3 Comparable

ISO 22000: 7.6.5 and 7.10.2, Comparable

ISO 22000: 7.6.5, 7.10.2 and 8.5.2 Comparable


ISO 22000: 7.6.5 and 7.10.2 and Comparable
8.4.3

ISO 22000: 7.6.5 and 7.10.2 and 8.4 Comparable

ISO 22000: 8.5 Comparable


ISO 22000: 7.10.1 Comparable

ISO 22000: 7.10.1 Comparable

ISO 22000: 7.10 Comparable

ISO 22000: 8 Comparable

ISO 22000: 8.2 Comparable


ISO 22000: 8.3 Comparable

ISO 22000: 8.4.3 Comparable

ISO 22000: 8.4 Comparable


ISO 22000: 8.5 Comparable

ISO 22000: 8.4 Comparable

ISO 22000: 8.2 Comparable

Exceeds- although PCQI


ISO 22000: 6.2.1, 6.2.2 and 7.3.2 not specifically
identified
ISO 22000: 8.2 Comparable

Different: No such a
time specific
ISO 22000: 8.2 requirement in
FSSC22000

Different: No such a
time specific
ISO 22000: 8.2 requirement in
FSSC22000
ISO 22000: 8.2 Comparable

ISO 22000: 8.2 and 8.4.3 Comparable

ISO 22000: 8.5.2 Comparable

Different: No such
ISO 22000: 8 provision in FSSC22000

Different: No such
ISO 22000: 8 provision in FSSC22000

Different: No such
ISO 22000: 8 provision in FSSC22000

Different: No such
ISO 22000: 8 provision in FSSC22000
Different: No such
ISO 22000: 8 provision in FSSC22000

ISO 22000: 8.2 Comparable

ISO 22000: 8.3 Comparable

ISO 22000: 7.8 Comparable

FSSC 22000 Part 2 Requirements for Comparable 2.1.4.7 Environmental monitoring


Certification 2.1.4.7

ISO 22000 8.5 Comparable

Different: No timeline
ISO 22000: 7.6.4 specified in FSSC22000
Comparable, although
no timing expectation
ISO 22000: 7.8 contained within
FSSC22000

ISO 22000: 7.6.4, 7.8 and 8.3 Comparable


ISO 22000: 7.4.4, 7.8 and 8.3 Comparable

ISO 22000: 7.4.4, 7.8 and 8.3 Comparable

ISO 22000: 7.4.4, 7.8 and 8.3 Comparable

ISO 22000: 7.4.4, 7.8 and 8.3 Comparable

ISO 22000: 7.4.4, 7.8 and 8.3 Comparable

ISO 22000: 7.4.4, 7.8 and 8.3 FSSC


22000 Part 2 Requirements for Comparable 2.1.4.1 Management of Services
Certification 2.1.4.1.

ISO 22000: 7.8 Comparable


ISO/TS 22002-1: 11.5 11 Cleaning and sanitizing
FSSC 22000 Part 2: Requirements Comparable, 2.1.4.10 Environmental
for Certification 2.1.4.7 monitoring

ISO/TS 22002-1: 11.5 11 Cleaning and sanitizing


FSSC 22000 Part 2: Requirements for Comparable - 2.1.4.7 Environmental monitoring
Certification 2.1.4.7

ISO/TS 22002-1: 11.5 11 Cleaning and sanitizing


FSSC 22000 Part 2: Requirements for 2.1.4.7 Environmental
Certification 2.1.4.7 monitoring

Comparable - although
ISO/TS 22002-1: 11.5 FSSC 22000 does not
11 Cleaning and sanitizing
FSSC 22000 Part 2: Requirements for address specific
procedures in such 2.1.4.7 Environmental monitoring
Certification 2.1.4.7
detail

ISO/TS 22002-1: 11.5 11 Cleaning and sanitizing


FSSC 22000 Part 2: Requirements for 2.1.4.7 Environmental monitoring
Certification 2.1.4.7

ISO/TS 22002-1: 11.5 Different: No similar 11 Cleaning and sanitizing


FSSC 22000 Part 2: Requirements for requirement in 2.1.4.7 Environmental monitoring
Certification 2.1.4.1 and 2.1.4.7 FSSC22000

ISO/TS 22002-1: 11.5 11 Cleaning and sanitizing


FSSC 22000 Part 2: Requirements for Comparable 2.1.4.10 7 Environmental
Certification 2.1.4.1 and 2.1.4.7 monitoring

Comparable:
Environmental
ISO/TS 22002-1: 11.5 monitoring must meet 11 Cleaning and sanitizing
requirements of ISO
22000
Comparable: However,
FSSC22000 calls for
ISO 22000: 8.5.2 continuous updating but
does not specify a
minimum frequency

ISO 22000: 8.5.2 Comparable

ISO 22000: 8.5.2 Comparable

ISO 22000: 8.5.2 Comparable

ISO 22000: 8.4.2 Comparable


ISO 22000: 8.4 Comparable

ISO 22000: 8.4.2 and 8.5.2 Comparable

ISO 22000: 8.2 Comparable

Different: No such
ISO 22000: 7.8 timeline requirement in
FSSC22000
Different: No such
ISO 22000: 7.8 specific provision in
FSSC22000

ISO 22000: 8.2, 8.4.2 and 8.5.2 Comparable

ISO 22000: 5.5 and 8.5.2 Comparable


ISO 22000: 5.6, 8.2, 8.4.2 and 8.5.2 Comparable

ISO 22000: 5.5, 8.2, 8.4.2 and 8.5.2 Comparable


ISO 22000: 5.5 Comparable

ISO 22000: 5.5 Comparable

Different: No specific
ISO 22000: 5.5 timeline required in
FSSC22000

Different: No such
ISO 22000: 5.5 provision in FSSC22000

ISO 22000: 5.5 Comparable


Different: No specific
ISO 22000: 5.5 timeline requirement in
FSSC22000

ISO 22000: 5.5 Comparable

Different: No such
ISO 22000: 5.5 timeline requirement in
FSSC22000
ISO 22000: 5.5 and 8.4.1 Comparable

ISO 22000: 5.5, 6.2.2 and 7.3.2 Comparable

ISO 22000: 6.2.2, 7.3.2 and 8.4 Comparable


ISO 22000: 5.5 and 6.2.2 Comparable

ISO 22000: 4.2.3 Comparable

ISO 22000: 4.2.3 and 7.4.4 Comparable

ISO 22000: 4.2.3 and 7.6.4 Comparable


ISO 22000: 4.2.3, 7.6.5 and 7.10.2 Comparable

ISO 22000: 4.2.3 and 8 Comparable

ISO 22000: 4.2.3 and 8.3 Comparable

ISO 22000: 4.2.3 and 8.4.3 Comparable

ISO 22000: 4.2.3 and 8.3 Comparable

ISO 22000: 4.2.3 and 7.8 Comparable

ISO 22000: 4.2.3 Comparable

ISO 22000: 4.2.3 and 7.6.4 Comparable


ISO 22000: 4.2.3 and 8.5.2 Comparable

ISO 22000: 4.2.3 and ISO/TS 22002- Comparable 9 Management of purchased


1. 9 materials

ISO 22000: 4.2.3, 5.5, 6.2.2 and 7.3.2 Comparable

ISO 22000: 4.2.3 Comparable

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A
N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable All


ISO/TS 22002-1 and ISO 22000: 4.2 Comparable

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable

ISO/TS 22002-1 and ISO 22000: 4.2 Comparable


Different: No specific
ISO/TS 22002-1 and ISO 22000: 4.2, requirement for
5.1, 5.3 management signature
in FSSC22000

Different: No specific
ISO/TS 22002-1 and ISO 22000: 4.2 retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement

ISO/TS 22002-1 and ISO 22000: 4.2

Different: No specific
retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement
Different: No specific
retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement

ISO/TS 22002-1 and ISO 22000: 4.2

Different: No specific
retention time stipulated
in FSSC22000
ISO/TS 22002-1 and ISO 22000: 4.2 Requirements shall be
detailed in an FSSC
22000 Supplement

ISO/TS 22002-1 and ISO 22000: 4.2

ISO/TS 22002-1 and ISO 22000: 4.2


Different: No specific
retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement
ISO/TS 22002-1 and ISO 22000: 4.2

ISO/TS 22002-1 and ISO 22000: 4.2

Different: No specific
retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
ISO/TS 22002-1 and ISO 22000: 4.2 22000 Supplement ISO/TS 22002-1

ISO/TS 22002-1 and ISO 22000: 4.2 Different: No specific


retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement
Different: No specific
retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement
ISO/TS 22002-1 and ISO 22000: 4.2

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000

ISO/TS 22002-1: 9.2


Different: No two sets of
supply chain
ISO/TS 22002-1: 9.2 requirements in
FSSC22000

Different: No such 9 Management of purchased


ISO/TS 22002-1: 9.2 exemption in FSSC22000 materials

Different: No such
ISO/TS 22002-1: 9.2 exemption in FSSC22000

Different: No such
ISO/TS 22002-1: 9.2 exemption in FSSC22000

Different: No such
ISO/TS 22002-1: 9.2 exemption in FSSC22000

Different: No such
ISO/TS 22002-1: 9.2
exemption in FSSC22000

ISO/TS 22002-1: 9.2 Comparable

Different: No such
ISO/TS 22002-1: 9.2 provision in FSSC22000
ISO/TS 22002-1: 9.2 Comparable

Different: No sprecific
requirement to verify
ISO/TS 22002-1: 9.2 third-party entity
documentation in
FSSC22000

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

Different: There is no
specific requirement in
FSSC22000 for supplied-
ISO/TS 22002-1: 9.2 chain-applied controls,
or to verify third-party
entity documentation

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable


Different: There is no
specific requirement in
ISO/TS 22002-1: 9.2 FSSC22000 for supplied-
chain-applied controls

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

Different: There is no
specific requirement in
ISO/TS 22002-1: 9.2 FSSC22000 for supplied-
chain-applied controls

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

Different: Not addressed


ISO/TS 22002-1: 9.2 specifically in FSSC22000

9 Management of purchased
ISO/TS 22002-1: 9.2 Comparable materials

Different: Not addressed


ISO/TS 22002-1: 9.2 specifically in FSSC22000
ISO/TS 22002-1: 9.2 Comparable

Different: Not addressed


N/A in FSSC22000

Different: Not addressed


N/A in FSSC22000

Different: Not addressed


N/A in FSSC22000

Different: There is no
specific requirement in
FSSC22000 for supplied-
ISO/TS 22002-1: 9.2 chain-applied controls.
This will addressed in an
FSSC 22000 Supplement.

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

9 Management of purchased
materials
ISO/TS 22002-1: 9.3 Comparable 9 Management of purchased
materials

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.2 Comparable

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

ISO/TS 22002-1: 9.2 Comparable


ISO/TS 22002-1: 9.3 Comparable

ISO/TS 22002-1: 9.3 Comparable

9.3 Incoming material requirements

ISO/TS 22002-1: 9.3 Comparable

ISO/TS 22002-1: 9.3 Comparable

Different: There is no
ISO/TS 22002-1: 9.2 mention of frequency in
FSSC22000

ISO/TS 22002-1: 9.2 Comparable

Different: There is no
distinction made in
ISO/TS 22002-1: 9.2 FSSC22000 for
SAHCODHA hazards

Different: FSSC 22000


ISO/TS 22002-1: 9.2 does not specify
verification activity.
Different: FSSC does not
ISO/TS 22002-1: 9.2 prescribe an audit as a
verification activity

Different: There is no
distinction made in
ISO/TS 22002-1: 9.2 FSSC22000 for
SAHCODHA hazards

Different: There is no
distinction or
ISO/TS 22002-1: 9.2 exemptions in
FSSC22000 for qualified
facilities

Different: There is no
distinction or
ISO/TS 22002-1: 9.2 exemptions in
FSSC22000 for qualified
facilities

Different: There is no
mention of frequency in 9.2 Selection and management of
ISO/TS 22002-1: 9.2 suppliers
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of frequency in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of frequency in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 requirement for this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 requirement for this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 requirement for this in
FSSC22000

Different: There is not


ISO/TS 22002-1: 9.2 detailed in FSSC22000

Different: This is not


ISO/TS 22002-1: 9.2 detailed in FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

Different FSSC 22000


does not prescribe an
ISO 17021, Section 7 onsite audit as a
verification activity

Different FSSC 22000


does not prescribe an
ISO/TS 22002-1: 9.2 onsite audit as a
verification activity

Different FSSC 22000


does not prescribe an
ISO/TS 22002-1: 9.2 onsite audit as a
verification activity
Different FSSC 22000
does not prescribe an
ISO/TS 22002-1: 9.2 onsite audit as a
verification activity

Different FSSC 22000


does not prescribe an
ISO/TS 22002-1: 9.2 onsite audit as a
verification activity

Different FSSC 22000


does not prescribe an
ISO/TS 22002-1: 9.2 onsite audit as a
verification activity

Different FSSC 22000


does not prescribe an
ISO/TS 22002-1: 9.2 onsite audit as a
verification activity

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
explicit requirements for
ISO/TS 22002-1: 9.2 documentation in
FSSC22000

Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000

ISO/TS 22002-1: 9.2 Comparable

ISO/TS 22002-1: 9.3 Comparable

ISO/TS 22002-1: 9.3 Comparable

ISO/TS 22002-1: 9.2 Comparable

Comparable

Comparable
9 Management of Purchased
Materials
Comparable

Comparable
Comparable

Comparable

Comparable

ISO/TS 22002-1: 9.2 Comparable


ISO/TS 22002-1: 9.2 Comparable as above

ISO/TS 22002-1: 9.2 as above

ISO/TS 22002-1: 9.2 as above

ISO/TS 22002-1: 9.2 as above

ISO/TS 22002-1: 9.2 as above

ISO/TS 22002-1: 9.2 as above


Different: This s a
specific requirement
ISO/TS 22002-1: 9.2 that is not detailed in as above
FSSC 22000

ISO/TS 22002-1: 9.2 as above

ISO/TS 22002-1: 9.2 as above

ISO/TS 22002-1: 9.2 as above


ISO/TS 22002-1: 9.2 as above

ISO/TS 22002-1: 9.2 as above

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2


ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

Different: There is no
ISO/TS 22002-1: 9.2 explicit requirement for
documentation around
this in FSSC22000

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2


ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2

ISO/TS 22002-1: 9.2


Text from the Relevant Chapter (ISO/TS 22002-1: 2009)

13.5 Health status


Subject to legal restrictions in the country of operation, employees shall undergo a
medical examination prior to employment in food contact operations (including site
catering), unless documented hazard or medical assessment indicates otherwise.
Additional medical examinations, where permitted, shall be carried out at intervals
defined by the organization.
13.6 Illness and injuries
Where permitted by law, employees shall be required to report the following
conditions to management for possible exclusion from food-handling areas: jaundice,
diarrhoea, vomiting, fever, sore throat with fever, visibly infected skin lesions (boils, cuts
or sores) and discharges from the ear, eye or nose. People known or suspected to be
infected with, or carrying, a disease or illness transmissible through food shall be
prevented from handling food or materials which come into contact with food.In food-
handling areas, personnel with wounds or burns shall be required to cover them with
specifieddressings. Any lost dressing shall be reported to supervision immediately
13.4 Workwear
and protective clothing
Personnel who work in, or enter into, areas where exposed products and/or materials are
handled shall wear work clothing that is fit for purpose, clean and in good condition (e.g.
free from rips, tears or fraying material).
Clothing mandated for food protection or hygiene purposes shall not be used for any
other purpose. Personal protective equipment, where required, shall be designed to
prevent product contamination and maintained in hygienic condition

NOTE Dressings should be brightly


coloured and metal detectable where appropriate.
13.7 Personal cleanliness
Personnel in food production
areas shall be required to wash and, where required, sanitize hands: a) before starting
any food-handling activities; b) immediately after using the toilet or blowing the nose; c)
immediately after handling any potentially contaminated material. Personnel shall be
required to refrain from sneezing or coughing over materials or products. Spitting
(expectorating) shall be prohibited. Fingernails shall be kept clean and trimmed.
13.8 Personal
behaviour
A documented policy shall describe the behaviours required of personnel in
processing, packing and storageareas. The policy shall at a minimum cover:
a) permissibility of smoking, eating, chewing in
designated areas only; b) control measures to minimize
hazards presented by permitted jewellery, such as that worn by personnel in processing
and storage areas, taking into account religious, ethnic, medical and cultural imperatives;

c) permissibility of personal items, such as smoking materials and


medicines, in designated areas only;
behaviour
A documented policy shall describe the behaviours required of personnel in
processing, packing and storageareas. The policy shall at a minimum cover:
a) permissibility of smoking, eating, chewing in
designated areas only; b) control measures to minimize
hazards presented by permitted jewellery, such as that worn by personnel in processing
and storage areas, taking into account religious, ethnic, medical and cultural imperatives;

c) permissibility of personal items, such as smoking materials and


medicines, in designated areas only;
d) prohibition of the use of
nail polish, false nails and false eyelashes; e)
prohibition of carrying of writing implements behind the ears;
f) maintenance of personal lockers so that they are kept free from
rubbish and soiled clothing;
g) prohibition of storage of product contact tools and equipment in personal
lockers

4.1 General requirements


Buildings shall be designed, constructed and maintained in a manner appropriate to the
nature of the processing operations to be carried out, the food safety hazards associated
with those operations and the potential sources of contamination from the plant
environs. Buildings shall be of durable construction which presents no hazard to the
product. 4.2
Environment
Consideration shall be given to potential sources of contamination from the local
environment.Food production should not be carried out in areas where potentially
harmful substances could enter theproduct.The effectiveness of measures taken to
protect against potential contaminants shall be periodically reviewed.
4.3 Locations of
establishments
The site boundaries shall be clearly identified.
Access to the site shall be controlled.
The site shall be maintained in good order.
Vegetation shall be tended or removed. Roads, yards and parking areas
shall be drained to prevent standing water and shall be maintained.
4 Construction and layout of buildings ( as above)
5.4 Location of equipment
Equipment shall be designed and located so as to facilitate good hygiene practices and
monitoring. Equipment shall be located to permit access for operation, cleaning and
maintenance.
12.1 General requirements
Hygiene, cleaning, incoming materials
inspection and monitoring procedures shall be implemented to avoid creating an
environment conducive to pest activity.
12.2 Pest control programmes
The establishment shall have a nominated person to manage pest
control activities and/or deal with appointed expert contractors. Pest management
programmes shall be documented and shall identify target pests, and address plans,
methods, schedules, control procedures and, where necessary, training requirements.
Programmes shall include a list of chemicals which are approved for use in specified areas
of the establishment.
12.3 Preventing access
Buildings shall be maintained in good repair. Holes,
drains and other potential pest access points shall be sealed. External doors, windows or
ventilation openings shall be designed to minimize the potential for entry of pests.

12.4 Harbourage and infestations


Storage practices shall be designed to minimize the availability of food and water to
pests.Material found to be infested shall be handled in such a way as to prevent
contamination of other materials,products or the establishment.Potential pest
harbourage (e.g. burrows, undergrowth, stored items) shall be removed.Where outside
space is used for storage, stored items shall be protected from weather or pest damage
7.1 General requirements
Systems shall be in place to ensure that waste materials are identified, collected,
removed and disposed of in a manner which prevents contamination of products or
production areas.

4 Construction and layout of buildings ( as above)

5.1 General requirements


Internal layouts shall be designed, constructed and maintained to facilitate good hygiene
and manufacturing practices. The movement patterns of materials, products and people,
and the layout of equipment, shall be designed to protect against potential
contamination sources.

5.4 Location of equipment ( as above)


5.1 General requirements ( as above)
5.7 Storage of food, packaging materials,
ingredients and non-food chemicals Storage areas shall be designed or arranged to allow
segregation of raw materials, work in progress andfinished products. All materials and
products shall be stored off the floor and with sufficient space between the material and
thewalls to allow inspection and pest control activities to be carried out. The storage area
shall be designed to allow maintenance and cleaning, prevent contamination and
minimize deterioration 6.4 Air quality and
ventilation Ventilation
systems shall be designed and constructed such that air does not flow from contaminated
or raw areas to clean areas. Specified air pressure differentials shall be maintained

10.1 General requirements


Programmes shall be in place to prevent, control and detect
contamination. Measures to prevent physical,allergen and microbiological contamination
shall be included.
10.2 Microbiological cross-contamination
Areas where potential for microbiological cross-contamination exists (airborne or from
traffic patterns) shall be identified and a segregation (zoning) plan implemented. A hazard
assessment shall be carried out to determine potential contamination sources,
susceptibility of the product and control measures suitable for these areas as follows:
a) separation of raw from finished or ready to eat (RTE) products;
b) structural segregation — physical barriers, walls or separate buildings;
c) access controls with requirements to change into required workwear;
d) traffic patterns or equipment segregation — people, materials, equipment and tools
(including use of dedicated tools);
e) air pressure differentials.
10.3 Allergen management
Allergens present in the product, either by design or by potential manufacturing cross-
contact, shall be declared. The declaration shall be on the label for consumer products,
and on the label or the accompanying documentation for products ntended for further
processing.
Products shall be protected from unintended allergen cross-contact by cleaning and line
change-over practices and/or product sequencing.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals
Facilities used to store ingredients,
packaging and products shall provide protection from dust, condensation, drains, waste
and other sources of contamination.
9.3 Incoming material requirements (raw/ingredients/packaging)
Delivery vehicles shall be checked prior to, and during, unloading to
verify that the quality and safety of the material has been maintained during transit (e.g.
integrity of seals, freedom from infestation, existence of temperature records).
Materials shall be inspected, tested or covered by COA to verify conformity with specified
requirements prior to acceptance or use. The method of verification shall be
documented.
NOTE The inspection frequency and scope can be based on the hazard presented by the
material and the risk assessment of the specific suppliers.
12.4 Harbourage and infestations
Where outside space is used for storage, stored items shall be protected from
weather or pest damage (e.g. bird droppings).
14.3 Rework usage
Where rework is incorporated into a product as an “in-process” step, the acceptable
quantity, type and conditions of rework use shall be specified. The process step and
method of addition, including any necessary pre-processing stages, shall be defined.
Where rework activities involve removing a product from filled or wrapped packages,
controls shall be put in place to ensure the removal and segregation of packaging
materials and to avoid contamination of the product with extraneous matter.
16.3 Vehicles, conveyances, and containers
Vehicles, conveyances, and containers shall be maintained in a state of repair, cleanliness,
and condition consistent with requirements given in relevant specifications.
Vehicles, conveyances, and containers shall provide protection against damage or
contamination of the product. Control of temperature and humidity shall be applied and
recorded where required by the organization.
Where the same vehicles, conveyances, and containers are
used for food and non-food products, cleaning shall be carried out between loads.
Bulk containers shall be dedicated to food
use only. Where required by the organization, bulk containers shall be dedicated to a
specified material

5.7 Storage of food, packaging materials, ingredients and non-food chemicals


Facilities used
to store ingredients, packaging and products shall provide protection from dust,
condensation, drains, waste and other sources of contamination.
12.4 Harbourage and infestations
Where outside space is used for storage, stored items shall
be protected from weather or pest damage (e.g. bird droppings).
5.7 Storage of food, packaging materials, ingredients and non-food chemicals (as
above)
12.1 General requirements
Hygiene, cleaning, incoming materials inspection and monitoring procedures shall be
implemented to avoid creating an environment conducive to pest activity.
12.5 Monitoring and detection
Pest-monitoring programmes 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 designed and located so as to prevent potential
contamination of materials, products or facilities.

5.4 Location of equipment


Equipment shall be designed and located so as to facilitate good hygiene practices and
monitoring. Equipment shall be located to permit access for operation, cleaning and
maintenance.

5.1 General requirements


Internal layouts shall be designed, constructed and maintained to facilitate good hygiene
and manufacturing practices. The movement patterns of materials, products and people,
and the layout of equipment, shall be designed to protect against potential
contamination sources.
5.2 Internal design, layout and traffic patterns
The building shall provide adequate space, with a logical flow of materials, products and
personnel, and physical separation of raw from processed areas.
5.3 Internal structures and fittings
Process area walls and floors shall be washable or cleanable, as appropriate for the
process or product hazard. Materials of construction shall be resistant to the cleaning
system applied.
5.4 Location of equipment: Equipment shall be designed and located so as to facilitate
good hygiene practices and monitoring. Equipment shall be located to permit access for
operation, cleaning and maintenance.

6.6 Lighting
The lighting provided (natural or artificial) shall allow personnel to
operate in a hygienic manner. The intensity of the lighting should be appropriate to the
nature of the operation. Light fixtures shall be protected to ensure that materials,
product or equipment are not contaminated in the case of breakages.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals: ( as
above)
6.4 Air quality and ventilation
The organization shall establish requirements for filtration,
humidity (RH%) and microbiology of air used as an ingredient or for direct product
contact. Where temperature and/or humidity are deemed critical by the organization, a
control system shall be put in place and monitored. Ventilation (natural or mechanical)
shall be provided to remove excess or unwanted steam, dust and odours, and to facilitate
drying after wet cleaning.
Room air supply quality shall be controlled to minimize risk from airborne microbiological
contamination.Protocols for air quality monitoring and control shall be established in
areas where products which support the growth or survival of microorganisms are
exposed. Ventilation systems shall be designed and constructed such that air does not
flow from contaminated or raw areas to clean areas. Specified air pressure differentials
shall be maintained. Systems shall be accessible for cleaning, filter changing and
maintenance.
Exterior air intake ports shall be examined periodically for physical integrity.
16.1
General requirements:
Materials and products shall be stored in clean, dry, well-ventilated spaces protected
from dust, condensation, fumes, odours or other sources of contamination.

5.3 Internal structures and fittings


External opening windows, roof vents or fan, where present, shall be insect
screened. External opening doors shall be closed or screened when not in use.

12.1 General requirements


Hygiene, cleaning, incoming materials inspection and monitoring procedures shall be
implemented to avoid creating an environment conducive to pest activity.
12.2 Pest control programmes
The establishment shall have a nominated person to manage pest control activities
and/or deal with appointed expert contractors.
Pest management programmes shall be documented and shall identify target pests, and
address plans, methods, schedules, control procedures and, where necessary, training
requirements.

5.1 General requirements


Internal layouts shall be designed, constructed and maintained to
facilitate good hygiene and manufacturing practices. The movement patterns of
materials, products and people, and the layout of equipment, shall be designed to
protect against potential contamination sources.

11.1 General requirements


Cleaning and sanitizing programmes shall be established to ensure that the food-
processing equipment and environment are maintained in a hygienic condition.
Programmes shall be monitored for continuing suitability and effectiveness.
11.2 Cleaning and
sanitizing agents and tools
Facilities and equipment shall be maintained in a condition which facilitates wet or dry
cleaning and/or sanitation.
Cleaning and sanitizing agents and chemicals shall be clearly identified, food grade,
stored separately and used only in accordance with the manufacturer’s instructions.
Tools and equipment shall be of hygienic design and maintained in a condition which
does not present a potential source of extraneous matter.
11.2 Cleaning and sanitizing agents and tools
Cleaning and sanitizing agents and chemicals shall be clearly identified, food grade,
stored separately and used only in accordance with the manufacturer’s instructions
16.2 Warehousing requirement
Waste materials and chemicals (cleaning
products, lubricants, and pesticides) shall be stored separately

6.5 Compressed air and other gases


Where oil is used for compressors and there is potential for the air to
come into contact with the product, the oil used shall be food grade. Use of oil free
compressors is recommended.
8.5 Cleaning plant, utensils and equipment: Wet and dry cleaning
programmes shall be documented to ensure that all plant, utensils and equipment are
cleaned at defined frequencies. The programmes shall specify what is to be cleaned
(including drains), the responsibility, the method of cleaning (e.g. CIP, COP), the use of
dedicated cleaning tools, removal or disassembly requirements and methods for verifying
the effectiveness of the cleaning.
8.6 Preventive and corrective maintenance
Lubricants and heat transfer
fluids shall be food grade where there is a risk of direct or indirect contact with the
product.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals


A separate, secure (locked or
otherwise access controlled) storage area shall be provided for cleaning materials,
chemicals and other hazardous substances.
16.2 Warehousing requirements:
Waste materials and chemicals (cleaning products, lubricants,
and pesticides) s hall be stored separately.
12 Pest Control (as above)

8.5 Cleaning plant, utensils and equipment


Wet and dry cleaning programmes shall be documented to ensure that all plant, utensils
and equipment are cleaned at defined frequencies.
The programmes shall specify what is to be cleaned (including drains), the responsibility,
the method of cleaning (e.g. CIP, COP), the use of dedicated cleaning tools, removal or
disassembly requirements and methods for verifying the effectiveness of the cleaning.

11.1 General requirements


Cleaning and sanitizing programmes shall be established to ensure that the food-
processing equipment and environment are maintained in a hygienic condition.
Programmes shall be monitored for continuing suitability and effectiveness.

6.4 Air quality and ventilation


The organization shall establish requirements for filtration, humidity (RH%) and
microbiology of air used as an ingredient or for direct product contact. Where
temperature and/or humidity are deemed critical by the organization, a control system
shall be put in place and monitored.
8.1 General requirements
Food contact equipment shall be designed and constructed to facilitate cleaning,
disinfection and maintenance. Contact surfaces shall not affect, or be affected by, the
intended product or cleaning system. Food contact equipment shall be constructed of
durable materials able to resist repeated cleaning.

11.1 General requirements


Cleaning and sanitizing programmes shall be established to ensure that the food-
processing equipment and environment are maintained in a hygienic condition.
Programmes shall be monitored for continuing suitability and effectiveness.
8.5 Cleaning plant, utensils and equipment:(as above)
11.2 Cleaning and sanitizing agents and tools (as above)

5.7 Storage of food, packaging materials, ingredients and non-food chemicals Facilities
used to store ingredients, packaging and products shall provide protection from dust,
condensation,
drains, waste and other sources of contamination.

7.1 General requirements


Systems shall be in place to ensure that waste materials are identified, collected,
removed and disposed of in a manner which prevents contamination of products or
production areas.

8.5 Cleaning plant, utensils and equipment:(as above) 11


Cleaning and Sanitizing (as above)
.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals ( as


above)
8.5 Cleaning plant, utensils and equipment (as above)
6.2 Water supply
The supply of potable water shall be sufficient to meet the needs of the production
process(es). Facilities for storage, distribution and, where needed, temperature control of
the water shall be designed to meet specified water quality requirements. Water used
as a product ingredient, including ice or steam (including culinary steam), or in contact
with products or product surfaces, shall meet specified quality and microbiological
requirements relevant to the product.
13.2 Personnel hygiene facilities and toilets
Personnel hygiene facilities shall be available to ensure that the degree of personal
hygiene required by the organization can be maintained. The facilities shall be located
close to the points where hygiene requirements apply and shall be clearly designated.
Establishments shall:
a) provide adequate numbers, locations and means of hygienically washing, drying and,
where required, sanitizing hands (including wash-basins, supply of hot and cold or
temperature controlled water, and soap and/or sanitizer);

6.2 Water supply ( as above)

5.3 Internal structures and fittings


Floors shall be designed to avoid standing water.
In wet process areas, floors shall be sealed and drained. Drains shall be trapped and
covered.
7.4 Drains and drainage
Drains shall be designed, constructed and located so that the risk of contamination of
materials or products is avoided. Drains shall have capacity sufficient to remove expected
flow loads. Drains shall not pass over processing lines.
Drainage direction shall not flow from a contaminated area to a clean area.

6.2 Water supply (as above)


7.3 Waste management and removal
Provision shall be made for the segregation, storage and removal of waste.
7.4 Drains and drainage
Drains shall be designed, constructed and located so that the risk of
contamination of materials or products is avoided. Drains shall have capacity sufficient to
remove expected flow loads. Drains shall not pass over processing lines. Drainage
direction shall not flow from a contaminated area to a clean area.

13.2 Personnel hygiene facilities and toilets (as above)

13.2 Personnel hygiene facilities and toilets (as above)


7.1 General requirements
Systems shall be in place to ensure that waste materials are identified, collected,
removed and disposed of in a manner which prevents contamination of products or
production areas.
7.2 Containers for waste and inedible or hazardous substances
Containers for waste and inedible or hazardous substances shall be:
a) clearly identified for their intended purpose;
b) located in a designated area;
c) constructed of impervious material which can be readily cleaned and sanitized;
d) closed when not in immediate use;
e) locked where the waste may pose a risk to the product.

8.2 Hygienic design


Equipment shall be able to meet established principles of hygienic design,
including: a)
smooth, accessible, cleanable surfaces, self draining in wet process areas;
b) use of materials compatible with intended products and cleaning or
flushing agents;

5.4 Location of equipment


Equipment shall be designed and located so as to facilitate good
hygiene practices and monitoring. Equipment shall be located to permit access for
operation, cleaning and maintenance.

8.3 Product contact surfaces


Product contact surfaces shall be constructed from materials designed
for food use. They shall be impermeable and rust or corrosion free.

8.1 General requirements


Food contact equipment shall be designed and constructed to facilitate
cleaning, disinfection and maintenance. Contact surfaces shall not affect, or be affected
by, the intended product or cleaning system. Food contact equipment shall be
constructed of durable materials able to resist repeated cleaning.

8.1 General requirements


Food contact equipment shall be designed and constructed to facilitate
cleaning, disinfection and maintenance. Contact surfaces shall not affect, or be affected
by, the intended product or cleaning system. Food contact equipment shall be
constructed of durable materials able to resist repeated cleaning.

10.3 Allergen management


Products shall be protected from unintended
allergen cross-contact by cleaning and line change-over practices and/or product
sequencing.
8.2 Hygienic design (as above)

16.3 Vehicles, conveyances, and containers


Vehicles, conveyances, and containers shall be maintained in a state of repair, cleanliness,
and condition consistent with requirements given in relevant specifications.
Vehicles, conveyances, and containers shall provide protection against damage or
contamination of the product. Control of temperature and humidity shall be applied and
recorded where required by the organization.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals


Facilities used to store ingredients, packaging and products shall provide protection from
dust, condensation, drains, waste and other sources of contamination.
Storage areas shall be dry and well ventilated. Monitoring and control of temperature
and humidity shall be applied where specified.
8.4 Temperature control and monitoring equipment
Equipment used for thermal processes shall be able to meet the temperature gradient
and holding conditions given in relevant product specifications.
Equipment shall provide for the monitoring and control of the temperature.
16.2 Warehousing requirements
Effective control of warehousing temperature, humidity and other environmental
conditions shall be provided where required by product or storage specifications.

8.3 Product contact surfaces (as above)


8.4 Temperature control and monitoring equipment (as above)
8.6 Preventive and corrective maintenance
A preventive maintenance programme shall be in place.
The preventive maintenance programme shall include all devices used to monitor and/or
control food safety hazards.
NOTE Examples of such devices include screens and filters (including air filters), magnets,
metal detectors and X-ray detectors. Corrective maintenance shall be carried out in such
a way that production on adjoining lines or equipment is not at risk of contamination.
6.5 Compressed air and other gases
Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing
and/or filling shall be constructed and maintained so as to prevent contamination.
Gases intended for direct or incidental product contact (including those used for
transporting, blowing or drying materials, products or equipment) shall be from a source
approved for food contact use, filtered to remove dust, oil and water.
Where oil is used for compressors and there is potential for the air to come into contact
with the product, the oil used shall be food grade. Use of oil free compressors is
recommended.

All Sections

This
Technical Specification specifies requirements for establishing, implementing and
maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.

Part 2, 2.1.4.1 Management of Services


11 Cleaning and Sanitizing (as above)

10 Measures for Prevention of Cross Contamination ( as above)

11 Cleaning and Sanitizing ( as above)


5.7 Storage of food, packaging materials, ingredients and non-food chemicals
Storage areas
shall be designed or arranged to allow segregation of raw materials, work in progress and
finished products. 6.2
Water supply: The supply of potable water shall be sufficient to meet the needs of the
production process(es). Facilities for storage, distribution and, where needed,
temperature control of the water shall be designed to meet specified water quality
requirements. Water used as a product ingredient, including ice or steam (including
culinary steam), or in contact with products or product surfaces, shall meet specified
quality and microbiological requirements relevant to the product.
9.3
Incoming material requirements (raw/ingredients/packaging)
Materials shall be inspected, tested or covered by COA to verify conformity with specified
requirements prior to acceptance or use. The method of verification shall be
documented.
14.1 General requirements
Rework shall be stored, handled and used in such a way that product
safety, quality, traceability and regulatory compliance are maintained.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals


Facilities used to store ingredients, packaging and products shall provide protection from
dust, condensation, drains, waste and other sources of contamination.
Storage areas shall be dry and well ventilated. Monitoring and control of temperature
and humidity shall be applied where specified.
9.3 Incoming material requirements
(raw/ingredients/packaging)
Delivery vehicles shall be checked prior to, and during, unloading to verify that the
quality and safety of the material has been maintained during transit (e.g. integrity of
seals, freedom from infestation, existence of temperature records).
14.3 Rework usage
Where rework is incorporated
into a product as an “in-process” step, the acceptable quantity, type and conditions of
rework use shall be specified. The process step and method of addition, including any
necessary pre-processing stages, shall be defined. Where rework activities involve
removing a product from filled or wrapped packages, controls shall be put in place to
ensure the removal and segregation of packaging materials and to avoid contamination of
the product with extraneous matter.
16.3 Vehicles, conveyances, and containers
Vehicles, conveyances, and containers shall
provide protection against damage or contamination of the product. Control of
temperature and humidity shall be applied and recorded where required by the
organization.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals ( as
above)
9.3 Incoming material requirements (raw/ingredients/packaging) (as above)
16.3 Vehicles, conveyances, and containers ( as above)

5.7 Storage of food, packaging materials, ingredients and non-food chemicals ( as


above)
14.3 Rework usage ( as above)

16.3 Vehicles, conveyances, and containers (as


above)

8.5 Cleaning plant, utensils and equipment


Wet and dry cleaning programmes shall be documented to ensure that all plant, utensils
and equipment are cleaned at defined frequencies.
The programmes shall specify what is to be cleaned (including drains), the responsibility,
the method of cleaning (e.g. CIP, COP), the use of dedicated cleaning tools, removal or
disassembly requirements and methods for verifying the effectiveness of the cleaning.
16.3 Vehicles,
conveyances, and containers Vehicles,
conveyances, and containers shall be maintained in a state of repair, cleanliness, and
condition consistent with requirements given in relevant specifications.

10.1 General requirements


Programmes shall be in place to prevent, control and detect contamination. Measures to
prevent physical, allergen and microbiological contamination shall be included.(and as
above)

5.7 Storage of food, packaging materials, ingredients and non-food chemicals


Storage areas
shall be dry and well ventilated. Monitoring and control of temperature and humidity
shall be applied where specified. Materials and products shall be stored in clean, dry,
well-ventilated spaces protected from dust, condensation, fumes, odours or other
sources of contamination.
6.4 Air quality and ventilation (as above)

16.1 General requirements


Materials and products shall be stored in clean, dry, well-ventilated spaces protected
from dust, condensation, fumes, odours or other sources of contamination.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals
Facilities used to store ingredients, packaging
and products shall provide protection from dust, condensation, drains, waste and other
sources of contamination.
Storage areas shall be dry and well ventilated. Monitoring and control of temperature
and humidity shall be applied where specified.
10.3 Allergen management
Allergens present in the product, either by design or by potential manufacturing cross-
contact, shall be declared. The declaration shall be on the label for consumer products,
and on the label or the accompanying documentation for products intended for further
processing.
Products shall be protected from unintended allergen cross-contact by cleaning and line
change-over practices and/or product sequencing.

14.1 General requirements


Rework shall be stored, handled and used in such a way that product safety, quality,
traceability and regulatory compliance are maintained.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals


(as
above)
9.3 Incoming material requirements (raw/ingredients/packaging)
Materials which do not conform to relevant specifications shall be handled under a
documented procedure which ensures they are prevented from unintended use.
Access points to bulk material receiving lines shall be identified, capped and locked.
Discharge into such systems shall take place only after approval and verification of the
material to be received.
10 Measures for prevention of cross-contamination (as above)
16 Warehousing (as above)

8.5 Cleaning plant, utensils and equipment (as above)


8.6 Preventive and corrective maintenance
A preventive maintenance programme shall be in place. The preventive maintenance
programme shall include all devices used to monitor and/or control food safety
hazards.
11 Cleaning and sanitizing (as above)
16 Warehousing (as above)
10.4 Physical contamination
Where brittle materials are used, periodic inspection requirements and defined
procedures in case of breakage shall be put in place.
Brittle materials, such as glass and hard plastic components in equipment, should be
avoided where possible. Glass breakage records shall be maintained.
Based on hazard assessment, measures shall be put in place to prevent, control or detect
potential contamination.
NOTE 1 Examples of such measures include:
a) adequate covers over equipment or containers for exposed materials or products;
b) use of screens, magnets, sieves or filters;
c) use of detection or rejection devices such as metal detectors or X-ray.
NOTE 2 Sources of potential contamination include wooden pallets and tools, rubber
seals, and personal protective clothing and equipment

10.1 General requirements


Programmes shall be in place to prevent, control and detect contamination. Measures to
prevent physical, allergen and microbiological contamination

10.1 General requirements


Programmes shall be in place to prevent, control and detect contamination. Measures to
prevent physical, allergen and microbiological contamination shall be included
10.1 General requirements
Programmes shall be in place to prevent, control and detect contamination. Measures to
prevent physical, allergen and microbiological contamination shall be included

6.2 Water supply


Water used as a product ingredient, including ice or steam
(including culinary steam), or in contact with products or product surfaces, shall meet
specified quality and microbiological requirements relevant to the product

16.1 General requirements


Materials and products shall be stored in clean, dry, well-ventilated spaces protected
from dust, condensation, fumes, odours or other sources of contamination.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals


Facilities used to store ingredients, packaging and products shall provide protection from
dust, condensation, drains, waste and other sources of contamination.

16.1 General requirements


Materials and products shall be stored in clean, dry, well-ventilated spaces protected
from dust, condensation, fumes, odours or other sources of contamination.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals


Facilities used to store ingredients, packaging and products shall provide protection from
dust, condensation, drains, waste and other sources of contamination.
16.2 Warehousing requirements
A separate area or other means of segregating
materials identified as non-conforming shall be provided.
9.1 General requirements
Purchasing of materials which impact food safety shall be controlled to ensure that the
suppliers used have the capability to meet the specified requirements. The conformance
of incoming materials to specified purchase requirements shall be verified.
9.2 Selection and management of suppliers
There shall be a defined process for the selection, approval and monitoring of suppliers.
The process used shall be justified by hazard assessment, including the potential risk to
the final product, and shall include:
a) assessment of the supplier’s ability to meet quality and food safety expectations,
requirements and specifications;
b) description of how suppliers are assessed;
NOTE Examples of a description of how suppliers are assessed include:
1) audit of the supplying site prior to accepting materials for production;
2) appropriate third party certification.
c) monitoring the performance of the supplier to assure continued approval status.
NOTE Monitoring includes conformity with material or product specifications, fulfilment
of COA requirements,satisfactory audit outcomes.
9.3 Incoming material requirements (raw/ingredients/packaging)
Delivery vehicles shall be checked prior to, and during, unloading to verify that the
quality and safety of the material has been maintained during transit (e.g. integrity of
seals, freedom from infestation, existence of temperature records).
Materials shall be inspected, tested or covered by COA to verify conformity with specified
requirements prior to acceptance or use. The method of verification shall be
documented.
NOTE The inspection frequency and scope can be based on the hazard presented by the
material and the risk assessment of the specific suppliers.
Materials which do not conform to relevant specifications shall be handled under a
documented procedure which ensures they are prevented from unintended use.
Access points to bulk material receiving lines shall be identified, capped and locked.
Discharge into such systems shall take place only after approval and verification of the
material to be received.
15.1 General requirements
Systems shall be in place to ensure that products failing to meet required food safety
standards can be identified, located and removed from all necessary points of the supply
chain.
4.2 Environment
Consideration shall be given to potential sources of contamination from the local
environment.
Food production should not be carried out in areas where potentially harmful substances
could enter the product.
The effectiveness of measures taken to protect against potential contaminants shall be
periodically reviewed.
10 Measures for prevention of cross-contamination
10.1 General requirements
Programmes shall be in place to prevent, control and detect contamination. Measures to
prevent physical, allergen and microbiological contamination shall be included .

5.1 General requirements


Internal layouts shall be designed, constructed and maintained to facilitate good hygiene
and manufacturing practices. The movement patterns of materials, products and people,
and the layout of equipment, shall be designed to protect against potential
contamination sources.
8 Equipment suitability, cleaning and maintenance
8.1 General requirements
Food contact equipment shall be designed and constructed to facilitate cleaning,
disinfection and maintenance.
Contact surfaces shall not affect, or be affected by, the intended product or cleaning
system. Food contact equipment shall be constructed of durable materials able to resist
repeated cleaning.
10.3 Allergen management
Allergens present in the product, either by design or by potential manufacturing cross-
contact, shall be declared. The declaration shall be on the label for consumer products,
and on the label or the accompanying documentation for products intended for further
processing. Products shall be protected from unintended allergen cross-contact by
cleaning and line change-over practices and/or product sequencing.
14.2 Storage, identification and traceability
Segregation requirements for rework (e.g. allergen) shall be
documented and met.
11.1 General requirements
Cleaning and sanitizing programmes shall be established to ensure that the food-
processing equipment and environment are maintained in a hygienic condition.
Programmes shall be monitored for continuing suitability and effectiveness.
11.2 Cleaning and sanitizing agents and tools
Facilities and equipment shall be maintained in a condition which facilitates wet or dry
cleaning and/or sanitation.
Cleaning and sanitizing agents and chemicals shall be clearly identified, food grade,
stored separately and used only in accordance with the manufacturer’s instructions.
Tools and equipment shall be of hygienic design and maintained in a condition which
does not present a potential source of extraneous matter.
11.3 Cleaning and sanitizing programmes
Cleaning and sanitizing programmes shall be established and validated by the
organization to ensure that all parts of the establishment and equipment are cleaned
and/or sanitized to a defined schedule, including the cleaning of cleaning equipment.
Cleaning and/or sanitizing programmes shall specify at a minimum:
a) areas, items of equipment and utensils to be cleaned and/or sanitized;
b) responsibility for the tasks specified;
c) cleaning/sanitizing method and frequency;
d) monitoring and verification arrangements;
e) post-clean inspections;
f) pre start-up inspections.
10.3 Allergen management
Allergens present in the product, either by design or by potential manufacturing cross-
contact, shall be declared. The declaration shall be on the label for consumer products,
and on the label or the accompanying documentation for products intended for further
processing.
Products shall be protected from unintended allergen cross-contact by cleaning and line
change-over practices and/or product sequencing.
NOTE Manufacturing cross-contact can arise from either: 1) traces of product from the
previous production run which cannot be adequately cleaned from the product line due
to technical limitations; or
2) when contact is likely to occur, in the normal manufacturing process, with products or
ingredients that are produced on separate lines, or in the same or adjacent processing
areas.
Rework containing allergen(s) shall be used only:
a) in products which contain the same allergen(s) by design; or
b) through a process which is demonstrated to remove or destroy the allergenic material.
NOTE For general rework requirements, see Clause 14.
Employees handling food should receive specific training in allergen awareness and
associated manufacturing
practices.

11 Cleaning and sanitizing (as above)

10.3 Allergen management ( as above)


11 Cleaning and sanitizing (as above)

11 Cleaning and sanitizing (as above)


9.1 General requirements
Purchasing of materials which impact food safety shall be controlled to ensure that the
suppliers used have the capability to meet the specified requirements. The conformance
of incoming materials to specified purchase requirements shall be verified.
9.2 Selection and management of suppliers
There shall be a defined process for the selection, approval and monitoring of suppliers.
The process used shall be justified by hazard assessment, including the potential risk to
the final product, and shall include:
a) assessment of the supplier’s ability to meet quality and food safety expectations,
requirements and specifications;
b) description of how suppliers are assessed;
NOTE Examples of a description of how suppliers are assessed include:
1) audit of the supplying site prior to accepting materials for production;
2) appropriate third party certification.
c) monitoring the performance of the supplier to assure continued approval status.
NOTE Monitoring includes conformity with material or product specifications, fulfilment
of COA requirements, satisfactory audit outcomes.
9.3 Incoming material requirements (raw/ingredients/packaging)
Delivery vehicles shall be checked prior to, and during, unloading to verify that the
quality and safety of the material has been maintained during transit (e.g. integrity of
seals, freedom from infestation, existence of temperature records).
Materials shall be inspected, tested or covered by COA to verify conformity with specified
requirements prior to acceptance or use. The method of verification shall be
documented.
NOTE The inspection frequency and scope can be based on the hazard presented by the
material and the risk assessment of the specific suppliers.

15.1 General requirements.


Systems shall be in place to ensure that products failing to meet required food safety
standards can be identified, located and removed from all necessary points of the supply
chain.
15.2 Product recall requirements. A list of key contacts in the event of a
recall shall be maintained. Where products are withdrawn due to immediate health
hazards, the safety of other products produced under the same conditions shall be
evaluated. The need for public warnings shall be considered.
15.2 Product recall requirements
A list of key contacts in the event of a recall shall be maintained.
Where products are withdrawn due to immediate health hazards, the safety of other
products produced under the same conditions shall be evaluated. The need for public
warnings shall be considered.
9 Management of purchased materials
9.1 General requirements
Purchasing of materials which impact food safety shall be controlled to ensure that the
suppliers used have the capability to meet the specified requirements. The conformance
of incoming materials to specified purchase requirements shall be verified.
9.2 Selection and management of suppliers
There shall be a defined process for the selection, approval and monitoring of
suppliers. The process used shall be justified by hazard assessment, including the
potential risk to the final product, and shall include:
a) assessment of the supplier’s ability to meet quality and food safety expectations,
requirements and specifications;
b) description of how suppliers are assessed;
NOTE Examples of a description of how suppliers are assessed include:
1) audit of the supplying site prior to accepting materials for production;
2) appropriate third party certification.
c) monitoring the performance of the supplier to assure continued approval status.
NOTE Monitoring includes conformity with material or product specifications, fulfilment
of COA requirements, satisfactory audit outcomes.
11.5 Monitoring sanitation effectiveness
Cleaning and sanitation programmes shall be monitored at frequencies specified by the
organization to ensure their continuing suitability and effectiveness .

11.5 Monitoring sanitation effectiveness (as above)

11.5 Monitoring sanitation effectiveness (as above)

11.5 Monitoring sanitation effectiveness (as above)

11.5 Monitoring sanitation effectiveness (as above)

11.5 Monitoring sanitation effectiveness (as above)

11.5 Monitoring sanitation effectiveness (as above)

11.5 Monitoring sanitation effectiveness (as above)


9 Management of purchased materials ( as above)
Prerequisite programmes on food safety —
Part 1:
Food manufacturing
Prerequisite programmes on food safety —
Part 1:
Food manufacturing
9.2 Selection and management of suppliers
There shall be a defined process for the selection, approval and monitoring of suppliers.
The process used
shall be justified by hazard assessment, including the potential risk to the final product,
and shall include:
a) assessment of the supplier’s ability to meet quality and food safety expectations,
requirements and specifications;
b) description of how suppliers are assessed;
NOTE Examples of a description of how suppliers are assessed include:
1) audit of the supplying site prior to accepting materials for production;
2) appropriate third party certification.
c) monitoring the performance of the supplier to assure continued approval status.
NOTE Monitoring includes conformity with material or product specifications, fulfilment
9.3 Incoming material requirements (raw/ingredients/packaging)
Delivery vehicles shall be checked prior to, and during, unloading to verify that the
quality and safety of the
material has been maintained during transit (e.g. integrity of seals, freedom from
infestation, existence of
temperature records).
Materials shall be inspected, tested or covered by COA to verify conformity with specified
requirements prior
to acceptance or use. The method of verification shall be documented.
NOTE The inspection frequency and scope can be based on the hazard presented by the
material and the risk
assessment of the specific suppliers.
9.2 Selection and management of suppliers
There shall be a defined process for the selection, approval and monitoring of suppliers.
The process used
shall be justified by hazard assessment, including the potential risk to the final product,
and shall include:
a) assessment of the supplier’s ability to meet quality and food safety expectations,
requirements and specifications;
b) description of how suppliers are assessed;
NOTE Examples of a description of how suppliers are assessed include:
1) audit of the supplying site prior to accepting materials for production;
2) appropriate third party certification.
c) monitoring the performance of the supplier to assure continued approval status.
NOTE Monitoring includes conformity with material or product specifications, fulfilment
of COA requirements,
satisfactory audit outcomes.
9.2 Selection and management of suppliers
9.2 Selection and management of suppliers There shall be a defined
process for the selection, approval and monitoring of suppliers. The process used shall be
justified by hazard assessment, including the potential risk to the final product, and shall
include:
a) assessment of the supplier’s ability to meet quality and food safety expectations,
requirements and specifications;
b) description of how suppliers are assessed;
NOTE Examples of a description of how suppliers are assessed include:
1) audit of the supplying site prior to accepting materials for production;
2) appropriate third party certification.
c) monitoring the performance of the supplier to assure continued approval status.
NOTE Monitoring includes conformity with material or product specifications, fulfilment
of COA requirements, satisfactory audit outcomes.
Clause Reference
ISO 22000: 2005

6.2 Human Resources (re training)

7.2 Prerequisite programmes (PRPs)


7 Planning and realization of safe
products

6.2 Human resources (training)


4 Food safety management system
7 Planning and
realization of safe products

7 Planning and realization of safe


products
7.10 Control of nonconformity
5.4 Responsibility and authority:
6.1 Provision of
resources: 6.2
Human resources

7 Planning and realization of safe produc


7.3.3 Product Characterisitcs
7.10 Control of Non Conformity

7.3.3 Product Characterisitcs


7.3.3 Product Characterisitcs
7.4.1 Hazard analysis
Annex C -
(informative)

7.3.3 Product Characteristics


7.4.1 Hazard analysis
7.3.3 Product Characteristics
7.4 Hazard analysis
7.6 Establishing the
HACCP plan
7.10 Control of Nonconformity
7.3 Preliminary steps to enable hazard
analysis

7.10 Control of nonconformity


7.10 Control of nonconformity

4 Food safety management system


7 Planning and
realization of safe products

4 Food safety management system:


7.2 Prerequisite
programmes (PRPs)
7.3 Preliminary steps to enable
hazard analysis
7.4 Hazard analysis
4 Food safety management system:
7.2 Prerequisite
programmes (PRPs)
7.3 Preliminary steps to enable
hazard analysis
7.4 Hazard analysis

7.4 Hazard analysis


7.6.1 HACCP plan:
7.4.4 Selection and assessment of
control measures
7.5 Establishing the
operational prerequisite programmes
(PRPs):
7.6.2 Identification of critical control
points (CCPs)
7.10.4 Withdrawals

7.5 Establishing the operational


prerequisite programmes (PRPs)
7.6.4 System
for the monitoring of critical control
points
8.3 Control of monitoring and
measuring
7.6.5 Actions when monitoring results
exceed critical limits
7.10 Control of
nonconformity

7.8 Verification planning:


8 Validation, verification
and improvement of the food safety
management system
4 Food safety management system
4.2 Documentation
Requirements 7.7
Updating of preliminary information
and documents specifying the PRPs
and the HACCP plan
8.5.2
Updating the food safety management
system

7.4 Hazard analysis


7.4.2 Hazard identification and
determination of acceptable levels
7.6.1 HACCP
plan:

7.2 Prerequisite Programmes (PRPs)


7.3.3 Product
characteristics
7.3.3 Product characteristics, 7.4.2
Hazard identification and
determination of acceptable levels

7.3.3 Product characteristics,


7.4 .2 Hazard identification and
determination of acceptable levels

7.3 Preliminary Steps to enable hazard


Analysis
7.4 Hazard Analysis

7.4 Hazard analysis

7.4.3 Hazard assessment


7.3.3 Product characteristics

7.4.2 Hazard identification and


determination of acceptable levels

7.3.3 Product characteristics


7.3.3 Product characteristics
7.3.5 Flow diagrams,
process steps and control measures

7.3.3.2 Characteristics of end products


2.1.4.6
Management of allergens:

7.3.3 Product characteristics


7.3.5 Flow diagrams,
process steps and control measures
7.3.4 Intended use

7.2.3 When selecting and/or


establishing PRP(s)

7.4.2 Hazard identification and


determination of acceptable levels
7.5 Establishing the operational
prerequisite programmes (OPRPs)
7.6.2
Identification of critical control points
(CCPs)

7.5 Establishing the operational


prerequisite programmes (PRPs)
7.6.2
Identification of critical control points
(CCPs

7.4.4 Selection and assessment of


control measures
7.6.2 Identification of
critical control points (CCPs
7.2 Prerequisite programmes (PRPs)
7.4.4 Selection
and assessment of control measures

7.5 Establishing the operational


prerequisite programmes (PRPs)
7.6
Establishing the HACCP plan

7.4.4 Selection and assessment of


control measures
7.6.2 Identification
of critical control points (CCPs):

7.6.3 Determination of critical limits


for critical control points

3 Terms and Definitions


7 Planning and realization
of safe products
7.3.3.2 Characteristics of end products

7.2.3 When selecting and/or


establishing PRP(s)
7.2.3 When selecting and/or
establishing PRP(s)

7.2.3 When selecting and/or


establishing PRP(s)

7.2.3 When selecting and/or


establishing PRP(s)

7.2.3 When selecting and/or


establishing PRP(s)
7.10.4 Withdrawals
6.2 Human Resources
7.4.4 Selection and
assessment of control measures

7.4.4 Selection and assessment of


control measures
7.4 Hazard analysis
7.10.4 Withdrawals

7.4.4 Selection and assessment of


control measures
7.6.4 System for the monitoring of critic

7.6.5 Actions when monitoring results


exceed critical limits
7.10 Control of
nonconformity

7.8 Verification planning


8.4 Food safety management
system verification
7.7 Updating of preliminary
information and documents specifying
the PRPs and the HACCP plan

8.5.2 Updating the food safety


management system

7.6.4 System for the monitoring of


critical control points
7.6.5 Actions when monitoring results
exceed critical limits
7.10 Control of nonconformity

7.6.5 Actions when monitoring results


exceed critical limits
7.10.3 Handling of potentially
unsafe products
7.6.5 Actions when monitoring results
exceed critical limits
7.10.3 Handling of potentially
unsafe products

7.6.5 Actions when monitoring results


exceed critical limits
7.10 Control of nonconformity

7.6.5 Actions when monitoring results


exceed critical limits
7.10 Control of nonconformity
exceed critical limits
7.10 Control of nonconformity

7.6.5 Actions when monitoring results


exceed critical limits
7.10.2 Corrective actions

7.6.5 Actions when monitoring results


exceed critical limits
7.10.2
Corrective actions
8.5.2 Updating the food safety
management system
7.6.5 Actions when monitoring results
exceed critical limits
7.10.2 Corrective
actions
8.4 Food safety management system
verification

8.5 Improvement
7.10 Control of nonconformity

8 Validation, verification and


improvement of the food safety
management system

8.2 Validation of control measure


combinations
8.3 Control of monitoring and
measuring

8.4 Food safety management system


verification

8.4 Food safety management system


verification
8.5 Improvement

8.4 Food safety management system


verification

8.2 Validation of control measure


combinations

6.2 Human resources 7.3


Preliminary steps to enable hazard
analysis
8.2 Validation of control measure
combinations
8.2 Validation of control measure
combinations

8.2 Validation of control measure


combinations

8.5.2 Updating the food safety


management system

8 Validation, verification and


improvement of the food safety
management system
8 Validation, verification and
improvement of the food safety
management system

8.2 Validation of control measure


combinations

8.3 Control of monitoring and


measuring

7.8 Verification planning

8.5 Improvement

7.6.4 System for the monitoring of


critical control points
7.8 Verification planning

7.6.4 System for the monitoring of


critical control points
7.8 Verification planning
7.6.4 System for the monitoring of
critical control points
7.8 Verification planning

8.3 Control of monitoring and


measuring

7.8 Verification planning


8.5 Improvement

8.4 Food safety management system


verification
8.4 Food safety management system
verification

8.4 Food safety management system


verification
8.5 Improvement

8.2 Validation of control measure combi

7.8 Verification planning


8.2 Validation of control measure
combinations
8.4 Food safety
management system verification
8.5
Improvement

5.5 Food safety team leader


8.5 Improvement
5.6 Communication
8.2 Validation of control
measure combinations
8.4.2 Evaluation of
individual verification results

8.5.2 Updating the food safety


management system

5.5 Food safety team leader


8.2 Validation of control
measure combinations
8.4.2 Evaluation of
individual verification results
8.5.2 Updating the food safety
management system
5.5 Food safety team leader
5.5 Food safety team leader
8.4 Food safety
management system verification

5.5 Food safety team leader


6.2 Human resources
7.3.2 Food
safety team

6.2 Human resources


7.3.2 Food safety team
8.4 Food
safety management system verification
5.5 Food safety team leader
6.2 Human resources

4.2.3 Control of records

4.2.3 Control of records


7.4 Hazard analysis

4.2.3 Control of records


7.6 Establishing the HACCP plan
4.2.3 Control of records
7.6.5 Actions when monitoring
results exceed critical limits
7.10.2 Corrective actions

4.2.3 Control of records


8 Validation, verification and
improvement of the food safety
management system

4.2.3 Control of records


8.3 Control of monitoring and
measuring
4.2.3 Control of records
8.4.3 Analysis of results of
verification activities
4.2.3 Control of records
8.3 Control of monitoring and
measuring
4.2.3 Control of records
7.8 Verification planning
4.2.3 Control of records
4.2.3 Control of records
7.6.4 System for the monitoring of
critical control points
4.2.3 Control of records
8.5.2 Updating the food safety
management system
4.2.3 Control of records

4.2.3 Control of records


5.5 Food safety team leader
6.2.2 Competence, awareness
and training
7.3.2 Food safety team

4.2.3 Control of records


All
4.2 Documentation requirements
4.2 Documentation requirements
5.1 Management commitment
5.3 Food safety management system
planning
Text from the Relevant Chapter (ISO 22000: 2005)

6.2 Human resources


6.2.1 General
The food safety team and the other personnel carrying out activities having an impact on food
safety shall be competent and shall have appropriate education, training, skills and experience.
Where the assistance of external experts is required for the development, implementation,
operation or assessment of the food safety management system, records of agreement or
contracts defining the responsibility and authority of external experts shall be available.
6.2.2 Competence, awareness and training
The organization shall
a) identify the necessary competencies for personnel whose activities have an impact on food
safety,
b) provide training or take other action to ensure personnel have the necessary competencies,
c) ensure that personnel responsible for monitoring, corrections and corrective actions of the
food safety management system are trained,
d) evaluate the implementation and the effectiveness of a), b) and c),
e) ensure that the personnel are aware of the relevance and importance of their individual
activities in contributing to food safety,
f) ensure that the requirement for effective communication (see 5.6) is understood by all
personnel whose activities have an impact on food safety, and
g) maintain appropriate records of training and actions described in b) and c). 7.2.1
The organization shall establish, implement and maintain PRP(s) to assist in controlling
a) the likelihood of introducing food safety hazards to the product through the work
environment,
b) biological, chemical and physical contamination of the product(s), including cross
contamination between products, and
c) food safety hazard levels in the product and product processing environment.
7.2.3 When selecting and/or establishing PRP(s), the organization shall consider and utilize
appropriate information [e.g. statutory and regulatory requirements, customer requirements,
recognized guidelines, Codex Alimentarius Commission (Codex) principles and codes of
practices, national, international or sector standards].
NOTE Annex C gives a list of relevant Codex publications.
The organization shall consider the following when establishing these programmes:
a) construction and lay-out of buildings and associated utilities;
b) lay-out of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) the suitability of equipment and its accessibility for cleaning, maintenance and preventative
maintenance;
f) management of purchased materials (e.g. raw materials, ingredients, chemicals and
packaging), supplies (e.g. water, air, steam and ice), disposals (e.g. waste and sewage) and
handling of products (e.g. storage and transportation);
g) measures for the prevention of cross contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene;
k) other aspects as appropriate.
Verification of PRP(s) shall be planned (see 7.8) and PRP(s) shall be modified as necessary (see
7.7). Records of verifications and modifications shall be maintained.
Documents should specify how activities included in the PRP(s) are managed.

6.2.2 Competence, awareness and training


The organization shall
a) identify the necessary competencies for personnel whose activities have an impact on food
safety,
b) provide training or take other action to ensure personnel have the necessary competencies,
c) ensure that personnel responsible for monitoring, corrections and corrective actions of the
food safety management system are trained,
d) evaluate the implementation and the effectiveness of a), b) and c),
e) ensure that the personnel are aware of the relevance and importance of their individual
activities in contributing to food safety,
f) ensure that the requirement for effective communication (see 5.6) is understood by all
personnel whose activities have an impact on food safety, and
g) maintain appropriate records of training and actions described in b) and c).
4.1 General requirements
The organization shall establish, document, implement and maintain an effective food safety
management system and update it when necessary in accordance with the requirements of this
International Standard.
The organization shall define the scope of the food safety management system. The scope shall
specify the products or product categories, processes and production sites that are addressed
by the food safety management system.
7.1 General
The organization shall plan and develop the
processes needed for the realization of safe products. The organization shall implement,
operate and ensure the effectiveness of the planned activities and any changes to those
activities. This includes PRP(s) as well as operational PRP(s) and/or the HACCP plan.

7.1 General
The organization shall plan and develop the processes needed for the realization of safe
products.
The organization shall implement, operate and ensure the effectiveness of the planned
activities and any changes to those activities. This includes PRP(s) as well as operational PRP(s)
and/or the HACCP plan.

7.10.1 Corrections
The organization shall ensure that when critical limits for CCP(s) are exceeded (see 7.6.5), or
there is a loss of control of operational PRP(s), the products affected are identified and
controlled with regard to their use and release.
Top management shall ensure that responsibilities and authorities are defined and
communicated within the organization to ensure the effective operation and maintenance of
the food safety management system. All personnel shall have responsibility to report problems
with the food safety management system to identified person(s). Designated personnel shall
have defined responsibility and authority to initiate and record actions.
The organization shall provide adequate
resources for the establishment, implementation, maintenance and updating of the food safety
management system.
6.2.1 General
The food safety team and the other personnel carrying out activities having an
impact on food safety shall be competent and shall have appropriate education, training, skills
and experience .

7.2.1 The organization shall establish, implement and maintain PRP(s) to assist in controlling
a) the likelihood of introducing food safety hazards to the product through the work
environment,
b) biological, chemical and physical contamination of the product(s), including cross
contamination between products, and
c) food safety hazard levels in the product and product processing environment.
7.3.3.1 Raw materials, ingredients and product-contact materials All
raw materials, ingredients and product-contact materials shall be described in documents to
the extent needed to conduct the hazard analysis (see 7.4), including the following, as
appropriate:
a) biological, chemical and physical characteristics;
b) composition of formulated ingredients, including additives and processing aids;
c) origin;
d) method of production;
e) packaging and delivery methods;
f) storage conditions and shelf life;
g) preparation and/or handling before use or processing;
h) food safety-related acceptance criteria or specifications of purchased materials and
ingredients appropriate to their intended uses.
The organization shall identify statutory and regulatory food safety requirements related to the
above. The descriptions shall be kept up-to-date including, when required, in accordance with
7.7.
7.10 Control of Nonconformity (as above)

7.3.3.1 Raw materials, ingredients and product-contact materials ( as above)


7.3.5.2
Description of process steps and control measures
The existing control measures, process parameters and/or the rigorousness with which they are
applied, or procedures that may influence food safety, shall be described to the extent needed
to conduct the hazard analysis (see 7.4).
External requirements (e.g. from regulatory authorities or customers) that may impact the
choice and the rigorousness of the control measures shall also be described.
The descriptions shall be updated in accordance with 7.7.
7.3.3.1 Raw materials, ingredients and product-contact materials: All raw
materials, ingredients and product-contact materials shall be described in documents to the
extent needed to conduct the hazard analysis (see 7.4), including the following, as appropriate:
a) biological, chemical and physical characteristics; b) composition of formulated ingredients,
including additives and processing aids; c) origin; d) method of production; e) packaging and
delivery methods; f) storage conditions and shelf life; g) preparation and/or handling before use
or processing; h) food safety-related acceptance criteria or specifications of purchased
materials and ingredients appropriate to their intended uses. The organization shall identify
statutory and regulatory food safety requirements related to the above.
7.4.1 Hazard analysis
General: The food safety team shall conduct a hazard analysis to determine which hazards need
to be controlled, the degree of control required to ensure food safety, and which combination
of control measures is required
Annex C -(informative)
Codex references providing examples of control measures, including
prerequisite programmes and guidance for their selection and use.

7.3.3.1 Raw materials, ingredients and product-contact materials ( as above)


7.4 Hazard
analysis
7.4.1 General
The food safety team shall conduct a hazard analysis to determine which hazards need to be
controlled, the degree of control required to ensure food safety, and which combination of
control measures is required.
7.3.3.1 Raw materials, ingredients and product-contact materials ( as above)
7.4 Hazard analysis (as above)

7.6.2 Identification of critical control points (CCPs)


For each hazard that is to be controlled by the HACCP plan, CCP(s) shall be identified for the
control measures identified (see 7.4.4).
7.10 Control of nonconformity
7.10.1 Corrections
The organization shall ensure that when critical limits for CCP(s) are exceeded (see 7.6.5), or
there is a loss of control of operational PRP(s), the products affected are identified and
controlled with regard to their use and release.
A documented procedure shall be established and maintained defining a)
the identification and assessment of affected end products to determine their proper handling
(see 7.10.3), and
b) a review of the corrections carried out.
Products manufactured under conditions where critical limits have been exceeded
are potentially unsafe products and shall be handled in accordance with 7.10.3.
Products manufactured under conditions where operational PRP(s) have not been
conformed with shall be evaluated with respect to the cause(s) of the nonconformity and to
the consequences thereof in terms of food safety and shall, where necessary, be handled in
accordance with 7.10.3. The evaluation shall be recorded.

7.6.2 Identification of critical control points (CCPs) For


each hazard that is to be controlled by the HACCP plan, CCP(s) shall be identified for the control
measures identified (see 7.4.4).
7.3.3.2 Characteristics of end products
The characteristics of end products shall be described in documents to the extent needed to
conduct the hazard analysis (see 7.4), including information on the following, as appropriate:
a) product name or similar identification;
b) composition;
c) biological, chemical and physical characteristics relevant for food safety;
d) intended shelf life and storage conditions;
e) packaging;

7.10.1 Corrections
The organization shall ensure that when critical limits for CCP(s) are exceeded (see 7.6.5), or
there is a loss of control of operational PRP(s), the products affected are identified and
controlled with regard to their use and release. A documented procedure shall be established
and maintained defining a) the identification and assessment of affected end products to
determine their proper handling (see 7.10.3), and
b) a review of the corrections carried out.
Products manufactured under conditions where critical limits have been exceeded are
potentially unsafe products and shall be handled in accordance with 7.10.3. Products
manufactured under conditions where operational PRP(s) have not been conformed with shall
be evaluated with respect to the cause(s) of the nonconformity and to the consequences
thereof in terms of food safety and shall, where necessary, be handled in accordance with
7.10.3. The evaluation shall be recorded.
All corrections shall be approved by the responsible person(s), and shall be recorded together
with information on the nature of the nonconformity, its cause(s) and consequence(s),
including information needed for traceability purposes related to the nonconforming lots.
Products manufactured under conditions where critical limits have been exceeded are
potentially unsafe products and shall be handled in accordance with 7.10.3. Products
manufactured under conditions where operational PRP(s) have not been conformed with shall
be evaluated with respect to the cause(s) of the nonconformity and to the consequences
thereof in terms of food safety and shall, where necessary, be handled in accordance with
7.10.3. The evaluation shall be recorded.
All corrections shall be approved by the responsible person(s), and shall be recorded together
with information on the nature of the nonconformity, its cause(s) and consequence(s),
including information needed for traceability purposes related to the nonconforming lots.

4.1 General requirements


The organization shall establish, document, implement and maintain an effective food safety
management system and update it when necessary in accordance with the requirements of this
International Standard. The organization shall define the scope of the food safety management
system. The scope shall specify the products or product categories, processes and production
sites that are addressed by the food safety management system.

7.1 General
The organization shall plan and develop the processes needed for the realization of safe
products. The organization shall implement, operate and ensure the effectiveness of the
planned activities and any changes to those activities. This includes PRP(s) as well as
operational PRP(s) and/or the HACCP plan.

4.1 General requirements. (as above)

7.2.1 The organization shall establish, implement and maintain PRP(s) to assist in controlling
a) the likelihood of introducing food safety hazards to the product through the work
environment,
b) biological, chemical and physical contamination of the product(s), including cross
contamination between products, and c) food safety hazard levels in the product and product
processing environment

7.3.1 General
All relevant information needed to conduct the hazard analysis shall be collected, maintained,
updated and documented. Records shall be maintained.

7.4.1 General
The food safety team shall conduct a hazard analysis to determine which hazards need to be
controlled, the degree of control required to ensure food safety, and which combination of
control measures is required.
4.2.1 General
The food safety management system documentation shall include
a) documented statements of a food safety policy and related objectives (see 5.2),
b) documented procedures and records required by this International Standard, and
c) documents needed by the organization to ensure the effective development, implementation
and updating of the food safety management system.

5.5 Food safety team leader


Top management shall appoint a food safety team leader who, irrespective of other
responsibilities, shall have the responsibility and authority
a) to manage a food safety team (see 7.3.2) and organize its work,
b) to ensure relevant training and education of the food safety team members (see 6.2.1),
c) to ensure that the food safety management system is established, implemented, maintained
and updated, and
d) to report to the organization's top management on the effectiveness and suitability of the
food safety management system

6.2.1 General
The food safety team and the other personnel carrying out activities having an impact
on food safety shall be competent and shall have appropriate education, training, skills and
experience.

7.4.1 General
The food safety team shall conduct a hazard analysis to determine which hazards need to be
controlled, the degree of control required to ensure food safety, and which combination of
control measures is required
Written analysis:
7.6.1 HACCP plan: The HACCP plan shall be documented and shall include the following
information for each identified critical control point (CCP): a) food safety hazard(s) to be
controlled at the CCP (see 7.4.4); b) control measure(s) (see 7.4.4) c) critical limit(s) (see 7.6.3);
d) monitoring procedure(s) (see 7.6.4); e) corrections and corrective action(s) to be taken if
critical limits are exceeded (see 7.6.5); f) responsibilities and authorities;
7.4.4 Selection and assessment of control measures
Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall
be selected which is capable of preventing, eliminating or reducing these food safety hazards to
defined acceptable levels.
In this selection, each of the control measures as described in 7.3.5.2 shall
be reviewed with respect to its effectiveness against the identified food safety hazards. The
control measures selected shall be categorized as to whether they need to be managed
through operational PRP(s) or by the HACCP plan.
7.5 Establishing the operational prerequisite
programmes (PRPs): The operational PRPs shall be
documented and shall include the following information for each programme: a) food safety
hazard(s) to be controlled by the programme (see 7.4.4); b) control measure(s) (see 7.4.4); c)
monitoring procedures that demonstrate that the operational PRPs are implemented; d)
corrections and corrective actions to be taken if monitoring shows that the operational PRPs
are not in control (see 7.10.1 and 7.10.2, respectively); e) responsibilities and authorities; f)
record(s) of monitoring
7.6.2 Identification of critical control points (CCPs)
For each hazard that is to be controlled by the HACCP plan, CCP(s) shall be identified for the
control measures identified (see 7.4.4).
7.10.4 Withdrawals
To enable and facilitate the complete and timely withdrawal of lots of end products which have
been identified as unsafe a) top management shall appoint personnel having the authority to
initiate a withdrawal and personnel responsible for executing the withdrawal, and
b) the organization shall establish and maintain a documented procedure for
1) notification to relevant interested parties (e.g. statutory and regulatory authorities,
customers and/or consumers),
2) handling of withdrawn products as well as affected lots of the products still in stock, and 3)
the sequence of actions to be taken.

7.5 Establishing the operational prerequisite programmes (PRPs)


The operational PRPs shall be documented and shall include the following
information for each programme:
a) food safety hazard(s) to be controlled by the programme (see 7.4.4);
b) control measure(s) (see 7.4.4);
c) monitoring procedures that demonstrate that the operational PRPs are implemented;
d) corrections and corrective actions to be taken if monitoring shows that the operational PRPs
are not in control (see 7.10.1 and 7.10.2, respectively);
e) responsibilities and authorities;
f) record(s) of monitoring.
7.6.4 System for the monitoring of critical control points
A monitoring system shall be established for each CCP to demonstrate that the CCP is in
control. The system shall include all scheduled measurements or observations relative to the
critical limit(s).
8.3 Control of monitoring and measuring
The organization shall provide evidence that the specified
monitoring and measuring methods and equipment are adequate to ensure the performance
of the monitoring and measuring procedures. Where necessary to ensure valid results, the
measuring equipment and methods used a) shall be calibrated or verified at specified intervals,
or prior to use, against measurement standards traceable to international or national
measurement standards; where no such standards exist, the basis used for calibration or
verification shall be recorded, b) shall be adjusted or re-adjusted as necessary, c) shall be
identified to enable the calibration status to be determined, d) shall be safeguarded from
adjustments that would invalidate the measurement results, and e) shall be protected from
damage and deterioration. Records of the results of calibration and verification shall be
maintained.
7.6.5 Actions when monitoring results exceed critical limits
Planned corrections and corrective actions to be taken when critical limits are exceeded shall
be specified in the HACCP plan. The actions shall ensure that the cause of nonconformity is
identified, that the parameter(s) controlled at the CCP is (are) brought back under control, and
that recurrence is prevented (see 7.10.2).
Documented procedures shall be established and maintained for the appropriate handling of
potentially unsafe
products to ensure that they are not released until they have been evaluated (see 7.10.3).
7.10 Control of
nonconformity
7.10.1 Corrections
The organization shall ensure that when critical limits for CCP(s) are exceeded
(see 7.6.5), or there is a loss of control of operational PRP(s), the products affected are
identified and controlled with regard to their use and release.
A documented procedure shall be established and maintained defining
a) the identification and assessment of affected end products to determine their proper
handling (see 7.10.3), and
b) a review of the corrections carried out.
7.8 Verification planning: Verification planning shall define the purpose, methods, frequencies
and responsibilities for the verification activities.
The verification activities shall confirm that
a) the PRP(s) are implemented (see 7.2),
b) input to the hazard analysis (see 7.3) is continually updated,
c) the operational PRP(s) (see 7.5) and the elements within the
HACCP plan (see 7.6.1) are implemented and effective,
d) hazard levels are within identified acceptable levels (see
7.4.2), and e) other procedures required by the organization
are implemented and effective. The output of this planning shall be in a form suitable for the
organization's method of operations. Verification results shall be recorded and shall be
communicated to the food safety team. Verification results shall be
provided to enable the analysis of the results of the verification activities (see 8.4.3). If system
verification is based on testing of end product samples, and where such test samples show
nonconformity with the acceptable level of the food safety hazard (see 7.4.2), the affected lots
of product shall be handled as potentially unsafe in accordance with 7.10.3.

8.1 General
The food safety team shall plan and implement the processes needed to validate control
measures and/or control measure combinations, and to verify and improve the food safety
management system.
4.1 General requirements:
The organization shall establish, document, implement and maintain an effective food
safety management system and update it when necessary in accordance with the requirements
of this International Standard.
The organization shall define the scope of the food safety management system. The scope shall
specify the products or product categories, processes and production sites that are addressed
by the food safety management system.
4.2.1 General
The food safety management system documentation shall include
a) documented statements of a food safety policy and related objectives (see 5.2),
b) documented procedures and records required by this International Standard, and
c) documents needed by the organization to ensure the effective development, implementation
and updating of the food safety management system.
7.7 Updating of preliminary information and documents specifying the PRPs and the
HACCP plan
Following the establishment of operational PRP(s) (see 7.5) and/or the HACCP plan (see 7.6),
the organization shall update the following information, if necessary:
a) product characteristics (see 7.3.3);
b) intended use (see 7.3.4);
c) flow diagrams (see 7.3.5.1);
d) process steps (see 7.3.5.2);
e) control measures (see 7.3.5.2).
If necessary, the HACCP plan (see 7.6.1) and the procedures and instructions specifying the
PRP(s) (see 7.2) shall be amended .
8.5.2 Updating the food safety management system
Top management shall ensure that the food safety management system is continually updated.

7.4.1 General
The food safety team shall conduct a hazard analysis to determine which hazards need to be
controlled, the degree of control required to ensure food safety, and which combination of
control measures is required
7.4.2 Hazard identification and determination of acceptable levels
7.4.2.1 All food safety hazards that are reasonably expected to occur in relation to the type of
product, type of process and actual processing facilities shall be identified and recorded. The
identification shall be based on a) the preliminary information and data collected according to
7.3,
b) experience,
c) external information including, to the extent possible, epidemiological and other historical
data, and
d) information from the food chain on food safety hazards that may be of relevance for the
safety of the end products, intermediate products and the food at consumption.
The step(s) (from raw materials, processing and distribution) at which each food safety hazard
may be introduced shall be indicated.
7.6.1 HACCP plan:
The HACCP plan shall be documented and shall include the following information
for each identified critical control point (CCP): a) food safety hazard(s) to be controlled at the
CCP (see 7.4.4); b) control measure(s) (see 7.4.4) c) critical limit(s) (see 7.6.3); d) monitoring
procedure(s) (see 7.6.4); e) corrections and corrective action(s) to be taken if critical limits are
exceeded (see 7.6.5); f) responsibilities and authorities;
7.2 Prerequisite programmes (PRPs)
7.2.1 The organization shall establish, implement and maintain PRP(s) to assist in controlling
a) the likelihood of introducing food safety hazards to the product through the work
environment,
b) biological, chemical and physical contamination of the product(s), including cross
contamination between products, and
c) food safety hazard levels in the product and product processing
environment. 7.3.3 Product characteristics
7.3.3.1 Raw materials, ingredients and product-contact materials
All raw materials, ingredients and product-contact materials shall be described in documents to
the extent needed to conduct the hazard analysis (see 7.4), including the following, as
appropriate:
a) biological, chemical and physical characteristics;
b) composition of formulated ingredients, including additives and processing aids;
c) origin;
d) method of production;
e) packaging and delivery methods;
f) storage conditions and shelf life;
g) preparation and/or handling before use or processing;
h) food safety-related acceptance criteria or specifications of purchased materials and
ingredients appropriate to their intended use.
7.3.3 Product characteristics (as above), 7.4
Hazard Analysis 7.4.2
Hazard identification and determination of acceptable levels
7.4.2.1 All food safety hazards that are reasonably expected to occur in relation to the type of
product, type of process and actual processing facilities shall be identified and recorded. The
identification shall be based on
a) the preliminary information and data collected according to 7.3,
b) experience,
c) external information including, to the extent possible, epidemiological and other historical
data, and
d) information from the food chain on food safety hazards that may be of relevance for the
safety of the end products, intermediate products and the food at consumption.

7.3.3 Product characteristics (as above), 7.4


Hazard identification and determination of acceptable levels (as above)

7.3 Preliminary Steps to enable hazard Analysis (as above)


7.4 Hazard Analysis

7.4 Hazard analysis (as above)


7.4.1 General
The food safety team shall conduct a hazard analysis to determine which hazards need to be
controlled, the degree of control required to ensure food safety, and which combination of
control measures is required

7.4.3 Hazard assessment


A hazard assessment shall be conducted to determine, for each food safety hazard identified
(see 7.4.2), whether its elimination or reduction to acceptable levels is essential to the
production of a safe food, and whether its control is needed to enable the defined acceptable
levels to be met.
Each food safety hazard shall be evaluated according to the possible severity of adverse health
effects and the likelihood of their occurrence. The methodology used shall be described, and
the results of the food safety hazard assessment shall be recorded.
7.3.3 Product characteristics
b) composition of formulated ingredients, including additives and processing aids;

7.4.2.2 When identifying the hazards, consideration shall be given to


a) the steps preceding and following the specified operation,
b) the process equipment, utilities/services and surroundings, and
c) the preceding and following links in the food chain.

7.3.3.1 Raw materials, ingredients and product-contact materials


All raw materials, ingredients and product-contact materials shall be described in documents to
the extent needed to conduct the hazard analysis (see 7.4), including the following, as
appropriate:
a) biological, chemical and physical characteristics;
b) composition of formulated ingredients, including additives and processing aids;
c) origin;
d) method of production;
e) packaging and delivery methods;
f) storage conditions and shelf life;
g) preparation and/or handling before use or processing;
h) food safety-related acceptance criteria or specifications of purchased materials and
ingredients appropriate to their intended uses.
The organization shall identify statutory and regulatory food safety requirements related to the
above. The descriptions shall be kept up-to-date including, when required, in accordance with
7.7.
All raw materials, ingredients and product-contact materials shall be described in documents to
the extent
needed to conduct the hazard analysis (see 7.4), including the following, as appropriate:
a) biological, chemical and physical characteristics;
b) composition of formulated ingredients, including additives and processing aids;
c) origin;
d) method of production;
e) packaging and delivery methods;
f) storage conditions and shelf life;
g) preparation and/or handling before use or processing;
h) food safety-related acceptance criteria or specifications of purchased materials and
ingredients appropriate to their intended uses.
The organization shall identify statutory and regulatory food safety requirements related to the
above.
The descriptions shall be kept up-to-date including, when required, in accordance with 7.7
7.3.5 Flow diagrams, process steps and
control measures
7.3.5.1 Flow diagrams
Flow diagrams shall be prepared for the products or process categories covered by the food
safety management system. Flow diagrams shall provide a basis for evaluating the possible
occurrence, increase or introduction of food safety hazards.
Flow diagrams shall be clear, accurate and sufficiently detailed. Flow diagrams shall, as
appropriate, include the following:
a) the sequence and interaction of all steps in the operation;
b) any outsourced processes and subcontracted work;
c) where raw materials, ingredients and intermediate products enter the flow;
d) where reworking and recycling take place;
e) where end products, intermediate products, by-products and waste are released or
removed.
In accordance with 7.8, the food safety team shall verify the accuracy of the flow diagrams by
on-site checking. Verified flow diagrams shall be maintained as records.
7.3.5.2 Description of process steps and control measures
The existing control measures, process parameters and/or the rigorousness with which they are
applied, or procedures that may influence food safety, shall be described to the extent needed
7.3.3.2 Characteristics
to conduct of end products
the hazard analysis (see 7.4).
The characteristics
External of end
requirements (e.g.products shall be described
from regulatory authoritiesinordocuments
customers)tothat
the may
extent needed
impact theto
conduct
choice andthethe
hazard analysis (see
rigorousness 7.4),
of the including
control information
measures on be
shall also thedescribed.
following, as appropriate:
f) labelling relating
to food safety and/or instructions for handling, preparation and usage;

7.3.3.1 Raw materials, ingredients and product-contact materials (as above)


7.3.5 Flow diagrams, process steps and control measures ( as above)
7.3.4 Intended use
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
shall be described in documents to the extent needed to conduct the hazard analysis (see 7.4).

7.2.3 When selecting and/or establishing PRP(s), the organization shall consider and utilize
appropriate information [e.g. statutory and regulatory requirements, customer requirements,
recognized guidelines, Codex Alimentarius Commission (Codex) principles and codes of
practices, national, international or sector standards].
NOTE Annex C gives a list of relevant Codex publications.The organization shall consider the
following when establishing these programmes:
a) construction and lay-out of buildings and associated utilities;
b) lay-out of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) the suitability of equipment and its accessibility for cleaning, maintenance and preventative
maintenance;
f) management of purchased materials (e.g. raw materials, ingredients, chemicals and
packaging), supplies (e.g. water, air, steam and ice), disposals (e.g. waste and sewage) and
handling of products (e.g. storage and transportation);
g) measures for the prevention of cross contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene;
k) other aspects as appropriate.

7.4.2 Hazard identification and determination of acceptable levels All food safety hazards
that are reasonably expected to occur in relation to the type of product, type of process and
actual processing facilities shall be identified and recorded.
The operational PRPs shall be documented and shall include the following information for each
programme: a) food safety hazard(s) to be controlled by the programme (see 7.4.4); b) control
measure(s) (see 7.4.4); c) monitoring procedures that demonstrate that the operational PRPs
are implemented; d) corrections and corrective actions to be taken if monitoring shows that the
operational PRPs are not in control (see 7.10.1 and 7.10.2, respectively); e) responsibilities and
authorities; f) record(s) of monitoring.
7.6.2 Identification of critical control points (CCPs)
For each hazard that is to be controlled by the HACCP plan, CCP(s) shall be identified for the
control measures identified (see 7.4.4).

7.5 Establishing the operational prerequisite programmes (PRPs) ( as above )


7.6.2 Identification of critical control points (CCPs): (as above)
7.8 Verification
planning ( as above )
7.4.4 Selection and assessment of control measures
Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall
be selected which is capable of preventing, eliminating or reducing these food safety hazards to
defined acceptable levels.
In this selection, each of the control measures as described in 7.3.5.2 shall be reviewed with
respect to its effectiveness against the identified food safety hazards.
The control measures selected shall be categorized as to whether they need to be managed
through operational PRP(s) or by the HACCP plan.
The selection and categorization shall be carried out using a logical approach that includes
assessments with regard to the following:
a) its effect on identified food safety hazards relative to the strictness applied;
b) its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable
immediate corrections);
c) its place within the system relative to other control measures;
d) the likelihood of failure in the functioning of a control measure or significant processing
variability;
e) the severity of the consequence(s) in the case of failure in its functioning;
f) whether the control measure is specifically established and applied to eliminate or
significantly reduce the level of hazard(s);
g) synergistic effects (i.e. interaction that occurs between two or more measures resulting in
their combined effect being higher than the sum of their individual effects). Control measures
categorized as belonging to the HACCP plan shall be implemented in accordance with 7.6.
Other control measures shall be implemented as operational PRPs according to 7.5.
The methodology and parameters used for this categorization shall be described in documents,
and the results of the assessment shall be recorded.
7.6.2 Identification of critical control points (CCPs) (as above) .
7.2.1 The organization shall establish, implement and maintain PRP(s) to assist in controlling
a) the likelihood of introducing food safety hazards to the product through the work
environment,
b) biological, chemical and physical contamination of the product(s), including cross
contamination between products, and
c) food safety hazard levels in the product and product processing environment.
7.4.4 Selection and assessment of control measures (as above )
7.5 Establishing the operational prerequisite programmes (PRPs) ( as
above)
7.6 Establishing the HACCP plan
7.6.1 HACCP plan
The HACCP plan shall be documented and shall include the following information for each
identified critical control point (CCP):
a) food safety hazard(s) to be controlled at the CCP (see 7.4.4);
b) control measure(s) (see 7.4.4)
c) critical limit(s) (see 7.6.3);
d) monitoring procedure(s) (see 7.6.4);
e) corrections and corrective action(s) to be taken if critical limits are exceeded (see 7.6.5);
f) responsibilities and authorities;
g) record(s) of monitoring.
7.4.4 Selection and assessment of control measures (as above )
7.6.2 Identification of critical control points (CCPs): For each hazard that is to be
controlled by the HACCP plan, CCP(s) shall be identified for the control measures identified (see
7.4.4).

7.6.3 Determination of critical limits for critical control points


Critical limits shall be determined for the monitoring established for each CCP.
Critical limits shall be established to ensure that the identified acceptable level of the food
safety hazard in the end product (see 7.4.2) is not exceeded.
Critical limits shall be measurable.
The rationale for the chosen critical limits shall be documented.
Critical limits based on subjective data (such as visual inspection of product, process, handling,
etc.) shall be supported by instructions or specifications and/or education and training.

3.3 Food safety hazard :


biological, chemical or physical agent in food, or condition of food, with the potential to cause
an adverse health effect NOTE 3 Food safety hazards include allergens.
7 Planning and realization of safe products
7.1 General
The organization shall plan and develop the processes needed for the realization of safe
products.
1 Scope
This Technical Specification specifies requirements for establishing, implementing and
maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.
7.3.3.2 Characteristics of end products
The characteristics of end products shall be described in documents to the extent needed to
conduct the hazard analysis (see 7.4), including information on the following, as appropriate
f) labelling
relating to food safety and/or instructions for handling, preparation and usage;

7.2.3 When selecting and/or establishing PRP(s), the organization shall consider and utilize
appropriate information [e.g. statutory and regulatory requirements, customer requirements,
recognized guidelines, Codex Alimentarius Commission (Codex) principles and codes of
practices, national, international or sector
standards].
NOTE Annex C gives a list of relevant Codex publications.
The organization shall consider the following when establishing these programmes:
a) construction and lay-out of buildings and associated utilities;
b) lay-out of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) the suitability of equipment and its accessibility for cleaning, maintenance and preventative
maintenance;
f) management of purchased materials (e.g. raw materials, ingredients, chemicals and
packaging), supplies (e.g. water, air, steam and ice), disposals (e.g. waste and sewage) and
handling of products (e.g. storage and transportation);
g) measures for the prevention of cross contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene;
k) other aspects as appropriate.
Verification of PRP(s) shall be planned (see 7.8) and PRP(s) shall be modified as necessary (see
7.7). Records of verifications and modifications shall be maintained.
Documents should specify how activities included in the PRP(s) are managed
7.2.3 When selecting and/or establishing PRP(s) ( as above)

7.2.3 When selecting and/or establishing PRP(s) ( as above)

7.2.3 When selecting and/or establishing PRP(s) ( as above)

7.2.3 When selecting and/or establishing PRP(s) ( as above)


7.10.4 Withdrawals
To enable and facilitate the complete and timely withdrawal of lots of end products which have
been identified as unsafe
a) top management shall appoint personnel having the authority to initiate a withdrawal and
personnel responsible for executing the withdrawal, and b) the organization shall establish and
maintain a documented procedure for 1) notification to relevant interested parties (e.g.
statutory and regulatory authorities, customers and/or consumers),
2) handling of withdrawn products as well as affected lots of the products still in stock, and
3) the sequence of actions to be taken.
6.2 Human Resources (As above)
7.4.4 Selection and assessment of control measures
Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall
be selected which is capable of preventing, eliminating or reducing these food safety hazards to
defined acceptable levels. In this selection, each of the control measures as described in
7.3.5.2 shall be reviewed with respect to its effectiveness against the identified food safety
hazards.
The control measures selected shall be categorized as to whether they need to be managed
through operational PRP(s) or by the HACCP plan. The selection and categorization shall be
carried out using a logical approach that includes assessments with regard to the following:
a) its effect on identified food safety hazards relative to the strictness applied;
b) its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable
immediate corrections);
c) its place within the system relative to other control measures;
d) the likelihood of failure in the functioning of a control measure or significant processing
variability;
e) the severity of the consequence(s) in the case of failure in its functioning;
f) whether the control measure is specifically established and applied to eliminate or
significantly reduce the level of hazard(s);
g) synergistic effects (i.e. interaction that occurs between two or more measures resulting in
their combined effect being higher than the sum of their individual effects).
Control measures categorized as belonging to the HACCP plan shall be implemented in
accordance with 7.6. Other control measures shall be implemented as operational PRPs
according to 7.5.
The methodology and parameters used for this categorization shall be described in documents,
and the results of the assessment shall be recorded.

7.4.4 Selection and assessment of control measures (as above )


7.10.4 Withdrawals
To enable and facilitate the complete and timely withdrawal of lots of end products which have
been identified as unsafe
a) top management shall appoint personnel having the authority to initiate a withdrawal and
personnel responsible for executing the withdrawal, and b) the organization shall establish and
maintain a documented procedure for 1)
notification to relevant interested parties (e.g. statutory and regulatory authorities, customers
and/or consumers), 2) handling of withdrawn products as well as affected lots of the products
still in stock, and 3) the sequence of actions to be taken.
Withdrawn products shall be secured or held under supervision until they are destroyed, used
for purposes other than originally intended, determined to be safe for the same (or other)
intended use, or reprocessed in a manner to ensure they become safe.
The cause, extent and result of a withdrawal shall be recorded and reported to top
management as input to the management review (see 5.8.2).
The organization shall verify and record the effectiveness of the withdrawal programme
through the use of appropriate techniques (e.g. mock withdrawal or practice withdrawal)

7.4.4 Selection and assessment of control measures


The control measures selected shall be categorized as to whether they need to be
managed through operational PRP(s) or by the HACCP plan
7.6.4 System for the monitoring of critical control points
A monitoring system shall be established for each CCP to demonstrate that the CCP is in
control. The system shall include all scheduled measurements or observations relative to the
critical limit(s). The monitoring system shall consist of relevant procedures, instructions and
records that cover the following:
a) measurements or observations that provide results within an adequate time frame;
b) monitoring devices used;
c) applicable calibration methods (see 8.3);
d) monitoring frequency;
e) responsibility and authority related to monitoring and evaluation of monitoring results;
f) record requirements and methods.
The monitoring methods and frequency shall be capable of determining when the critical limits
have been exceeded in time for the product to be isolated before it is used or consumed

7.6.5 Actions when monitoring results exceed critical limits


Planned corrections and corrective actions to be taken when critical limits are exceeded shall
be specified in the HACCP plan. The actions shall ensure that the cause of nonconformity is
identified, that the parameter(s) controlled at the CCP is (are) brought back under control, and
that recurrence is prevented (see 7.10.2).

Documented procedures shall be established and maintained for the appropriate handling of
potentially unsafe products to ensure that they are not released until they have been evaluated
(see 7.10.3).
7.10 Control of nonconformity
7.10.1 Corrections
The organization shall ensure that when critical limits for
CCP(s) are exceeded (see 7.6.5), or there is a loss of control of operational PRP(s), the products
affected are identified and controlled with regard to their use and release.
A documented procedure shall be established and maintained defining
a) the identification and assessment of affected end products to determine their proper
handling (see 7.10.3), and b) a review of the corrections carried out.

7.8 Verification planning


Verification planning shall define the purpose, methods, frequencies and responsibilities for the
verification activities.
8.4 Food safety management system verification (as above)
7.7 Updating of preliminary information and documents specifying the PRPs and the HACCP
plan
Following the establishment of operational PRP(s) (see 7.5) and/or the HACCP plan (see 7.6),
the organization shall update the following information, if necessary:
a) product characteristics (see 7.3.3);
b) intended use (see 7.3.4);
c) flow diagrams (see 7.3.5.1);
d) process steps (see 7.3.5.2);
e) control measures (see 7.3.5.2).
If necessary, the HACCP plan (see 7.6.1) and the procedures and instructions specifying the
PRP(s) (see 7.2) shall be amended.
8.5.2 Updating the food safety management system
Top management shall ensure that the food safety management system is continually updated.
In order to achieve this, the food safety team shall evaluate the food safety management
system at planned intervals. The team shall then consider whether it is necessary to review the
hazard analysis (see 7.4), the established operational PRP(s) (see 7.5) and the HACCP plan (see
7.6.1).

7.6.4 System for the monitoring of critical control points


A monitoring system shall be established for each CCP to demonstrate that the CCP is in
control. The system shall include all scheduled measurements or observations relative to the
critical limit(s).
The monitoring system shall consist of relevant procedures, instructions and records that cover
the following:
a) measurements or observations that provide results within an adequate time frame;
b) monitoring devices used;
c) applicable calibration methods (see 8.3);
d) monitoring frequency;
e) responsibility and authority related to monitoring and evaluation of monitoring results;
f) record requirements and methods.
The monitoring methods and frequency shall be capable of determining when the critical limits
have been exceeded in time for the product to be isolated before it is used or consumed.
7.6.5 Actions when monitoring results exceed critical limits
Planned corrections and corrective actions to be taken when critical limits are exceeded shall
be specified in the HACCP plan. The actions shall ensure that the cause of nonconformity is
identified, that the parameter(s) controlled at the CCP is (are) brought back under control, and
that recurrence is prevented (see 7.10.2).
Documented procedures shall be established and maintained for the appropriate handling of
potentially unsafe products to ensure that they are not released until they have been evaluated
(see 7.10.3).
7.10.1 Corrections
The organization shall ensure that when critical limits for CCP(s) are exceeded (see 7.6.5), or
there is a loss of control of operational PRP(s), the products affected are identified and
controlled with regard to their use and release.
A documented procedure shall be established and maintained defining
a) the identification and assessment of affected end products to determine their proper
handling (see 7.10.3), and b) a review of the corrections carried out.
Products manufactured under conditions where critical limits have been exceeded are
potentially unsafe products and shall be handled in accordance with 7.10.3. Products
manufactured under conditions where operational PRP(s) have not been conformed with shall
be evaluated with respect to the cause(s) of the nonconformity and to the consequences
thereof in terms of food safety and shall, where necessary, be handled in accordance with
7.10.3. The evaluation shall be recorded.

7.6.5 Actions when monitoring results exceed critical limits


Planned corrections and corrective actions to be taken when critical limits are exceeded shall
be specified in the HACCP plan. The actions shall ensure that the cause of nonconformity is
identified, that the parameter(s) controlled at the CCP is (are) brought back under control, and
that recurrence is prevented (see 7.10.2).
Documented procedures shall be established and maintained for the appropriate handling of
potentially unsafe products to ensure that they are not released until they have been evaluated
(see 7.10.3).
7.10.3.1 General
The organization shall handle nonconforming products by taking action(s) to prevent
the nonconforming product from entering the food chain unless it is possible to ensure that
a) the food safety hazard(s) of concern has(ve) been reduced to the defined acceptable levels,
b) the food safety hazard(s) of concern will be reduced to identified acceptable levels (see
7.4.2) prior to entering into the food chain, or c) the product still meets the defined acceptable
level(s) of the food safety hazard(s) of concern despite the nonconformity.
All lots of product that may have been affected by a nonconforming situation shall be held
under control of the organization until they have been evaluated.
If products that have left the control of the organization are subsequently determined to be
unsafe, the organization shall notify relevant interested parties and initiate a withdrawal (see
7.10.4).
NOTE The term “withdrawal” includes recall. The controls and related responses and
authorization for dealing with potentially unsafe products shall be documented.
7.6.5 Actions when monitoring results exceed critical limits
Planned corrections and corrective actions to be taken when critical limits are exceeded shall
be specified in the HACCP plan. The actions shall ensure that the cause of nonconformity is
identified, that the parameter(s) controlled at the CCP is (are) brought back under control, and
that recurrence is prevented (see 7.10.2).
Documented procedures shall be established and maintained for the appropriate handling of
potentially unsafe products to ensure that they are not released until they have been evaluated
(see 7.10.3).
7.10.3.1 General
The organization shall handle nonconforming products by taking action(s) to prevent
the nonconforming product from entering the food chain unless it is possible to ensure that
a) the food safety hazard(s) of concern has(ve) been reduced to the defined acceptable levels,
b) the food safety hazard(s) of concern will be reduced to identified acceptable levels (see
7.4.2) prior to entering into the food chain, or c) the product still meets the defined acceptable
level(s) of the food safety hazard(s) of concern despite the nonconformity.
All lots of product that may have been affected by a nonconforming situation shall be held
under control of the organization until they have been evaluated.
If products that have left the control of the organization are subsequently determined to be
unsafe, the organization shall notify relevant interested parties and initiate a withdrawal (see
7.10.4).
NOTE The term “withdrawal” includes recall. The controls and related responses and
authorization for dealing with potentially unsafe products shall be documented.

7.6.5 Actions when monitoring results exceed critical limits ( as above)


7.10 Control of nonconformity (as above)

7.6.5 Actions when monitoring results exceed critical limits ( as above)


7.10.2 Corrective actions
Data derived from the monitoring of operational PRPs and CCPs shall be evaluated by
designated person(s) with sufficient knowledge (see 6.2) and authority (see 5.4) to initiate
corrective actions.
Corrective actions shall be initiated when critical limits are exceeded (see 7.6.5) or when there
is a lack of conformity with operational PRP(s).
The organization shall establish and maintain documented procedures that specify appropriate
actions to identify and eliminate the cause of detected nonconformities, to prevent recurrence,
and to bring the process or system back into control after nonconformity is encountered. These
actions include
a) reviewing nonconformities (including customer complaints),
b) reviewing trends in monitoring results that may indicate development towards loss of
control,
c) determining the cause(s) of nonconformities,
d) evaluating the need for action to ensure that nonconformities do not recur,
e) determining and implementing the actions needed,
f) recording the results of corrective actions taken, and
g) reviewing corrective actions taken to ensure that they are effective.
Corrective actions shall be recorded.
7.10.3 Handling of potentially unsafe products ( as above)
actions include
a) reviewing nonconformities (including customer complaints),
b) reviewing trends in monitoring results that may indicate development towards loss of
control,
c) determining the cause(s) of nonconformities,
d) evaluating the need for action to ensure that nonconformities do not recur,
e) determining and implementing the actions needed,
f) recording the results of corrective actions taken, and
g) reviewing corrective actions taken to ensure that they are effective.
Corrective actions shall be recorded.
7.10.3 Handling of potentially unsafe products ( as above)

7.6.5 Actions when monitoring results exceed critical limits (as above)
7.10.2 Corrective actions ( as above)

7.6.5 Actions when monitoring results exceed critical limits (as above)
7.10.2 Corrective actions ( as above)
8.5.2 Updating the food safety management system
Top management shall ensure that the food safety management system is continually updated.
In order to achieve this, the food safety team shall evaluate the food safety management
system at planned intervals. The team shall then consider whether it is necessary to review the
hazard analysis (see 7.4), the established operational PRP(s) (see 7.5) and the HACCP plan (see
7.6.1).
The evaluation and updating activities shall be based on
a) input from communication, external as well as internal, as stated in 5.6,
b) input from other information concerning the suitability, adequacy and effectiveness of the
food safety management system,
c) output from the analysis of results of verification activities (see 8.4.3), and
d) output from management review (see 5.8.3).
System updating activities shall be recorded and reported, in an appropriate manner, as input
to the management review (see 5.8.2).
7.6.5 Actions when monitoring results exceed critical limits (as above)
7.10.2 Corrective actions ( as above)
8.4 Food safety management system verification
8.4.3 Analysis of results of verification activities
The food safety team shall analyse the results of verification activities, including the results of
the internal audits (see 8.4.1) and external audits. The analysis shall be carried out in order
a) to confirm that the overall performance of the system meets the planned arrangements and
the food safety management system requirements established by the organization,
b) to identify the need for updating or improving the food safety management system,
c) to identify trends which indicate a higher incidence of potentially unsafe products,
d) to establish information for planning of the internal audit programme concerning the status
and importance of areas to be audited, and
e) to provide evidence that any corrections and corrective actions that have been taken are
effective. The results of the analysis and the resulting activities shall be recorded and shall be
reported, in an appropriate manner, to top management as input to the management review
(see 5.8.2). It shall also be used as an input for updating the food safety management system
(see 8.5.2).

8.5.2 Updating the food safety management system


Top management shall ensure that the food safety management system is continually updated.
In order to achieve this, the food safety team shall evaluate the food safety management
system at planned intervals. The team shall then consider whether it is necessary to review the
hazard analysis (see 7.4), the established operational PRP(s) (see 7.5) and the HACCP plan (see
7.6.1).
The evaluation and updating activities shall be based on
a) input from communication, external as well as internal, as stated in 5.6,
b) input from other information concerning the suitability, adequacy and effectiveness of the
food safety management system,
c) output from the analysis of results of verification activities (see 8.4.3), and
d) output from management review (see 5.8.3).
System updating activities shall be recorded and reported, in an appropriate manner, as input
to the management review (see 5.8.2).
7.10.1 Corrections
The organization shall ensure that when critical limits for CCP(s) are exceeded (see 7.6.5), or
there is a loss of control of operational PRP(s), the products affected are identified and
controlled with regard to their use and release.
A documented procedure shall be established and maintained defining
a) the identification and assessment of affected end products to determine their proper
handling (see 7.10.3), and
b) a review of the corrections carried out.
Products manufactured under conditions where critical limits have been exceeded are
potentially unsafe products and shall be handled in accordance with 7.10.3. Products
manufactured under conditions where operational PRP(s) have not been conformed with shall
be evaluated with respect to the cause(s) of the nonconformity and to the consequences
thereof in terms of food safety and shall, where necessary, be handled in accordance with
7.10.3. The evaluation shall be recorded.

8.1 General
The food safety team shall plan and implement the processes needed to validate control
measures and/or control measure combinations, and to verify and improve the food safety
management system. Records of the results of calibration and verification shall be
maintained.

8.2 Validation of control measure combinations


Prior to implementation of control measures to be included in operational PRP(s) and the
HACCP plan and after any change therein (see 8.5.2), the organization shall validate (see 3.15)
that
a) the selected control measures are capable of achieving the intended control of the food
safety hazard(s) for which they are designated, and
b) the control measures are effective and capable of, in combination, ensuring control of the
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 of the above elements cannot be
confirmed, the control measure and/or combinations thereof shall be modified and re-assessed
(see 7.4.4).
Modifications may include changes in control measures (i.e. process parameters, rigorousness
and/or their combination) and/or change(s) in the raw materials, manufacturing technologies,
end product characteristics, methods of distribution and/or intended use of the end product.
8.3 Control of monitoring and measuring
The organization shall provide evidence that the specified monitoring and measuring methods
and equipment rformance of the monitoring and measuring procedures.
Where necessary to ensure valid results, the measuring equipment and methods used
a) shall be calibrated or verified at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards; where no such
standards exist, the basis used for calibration or verification shall be recorded,
b) shall be adjusted or re-adjusted as necessary,
c) shall be identified to enable the calibration status to be determined,
d) shall be safeguarded from adjustments that would invalidate the measurement results, and
e) shall be protected from damage and deterioration.
Records of the results of calibration and verification shall be maintained.
In addition, the organization shall assess the validity of the previous measurement results when
the equipment or process is found not to conform to requirements. If the measuring
equipment is nonconforming, the organization shall take action appropriate for the equipment
and any product affected. Records of such assessment and resulting actions shall be
maintained.
When used in the monitoring and measurement of specified requirements, the ability of
computer software to satisfy the intended application shall be confirmed. This shall be
undertaken prior to initial use and shall be reconfirmed as necessary.

8.4.3 Analysis of results of verification activities


The food safety team shall analyse the results of verification activities, including the results of
the internal audits (see 8.4.1) and external audits. The analysis shall be carried out in order
a) to confirm that the overall performance of the system meets the planned arrangements and
the food safety management system requirements established by the organization,
b) to identify the need for updating or improving the food safety management system,
c) to identify trends which indicate a higher incidence of potentially unsafe products,
d) to establish information for planning of the internal audit programme concerning the status
and importance of areas to be audited, and
e) to provide evidence that any corrections and corrective actions that have been taken are
effective.
The results of the analysis and the resulting activities shall be recorded and shall be reported, in
an appropriate manner, to top management as input to the management review (see 5.8.2). It
shall also be used as an input for updating the food safety management system (see 8.5.2).
8.4 Food safety management system verification ( as above)
8.5.1 Continual improvement
Top management shall ensure that the organization continually improves the effectiveness of
the food safety management system through the use of communication (see 5.6), management
review (see 5.8), internal audit (see 8.4.1), evaluation of individual verification results (see
8.4.2), analysis of results of verification activities (see 8.4.3), validation of control measure
combinations (see 8.2), corrective actions (see 7.10.2) and food safety management system
updating (see 8.5.2).

8.5.2 Updating the food safety management system


Top management shall ensure that the food safety management system is continually updated.
In order to achieve this, the food safety team shall evaluate the food safety management
system at planned intervals. The team shall then consider whether it is necessary to review the
hazard analysis (see 7.4), the established operational PRP(s) (see 7.5) and the HACCP plan (see
7.6.1).
The evaluation and updating activities shall be based on
a) input from communication, external as well as internal, as stated in 5.6,
b) input from other information concerning the suitability, adequacy and effectiveness of the
food safety management system,
c) output from the analysis of results of verification activities (see 8.4.3), and
d) output from management review (see 5.8.3).
System updating activities shall be recorded and reported, in an appropriate manner, as input
to the
management review (see 5.8.2).

8.4 Food safety management system verification ( as above)

8.2 Validation of control measure combinations


Prior to implementation of control measures to be included in operational PRP(s) and the
HACCP plan and after any change therein (see 8.5.2), the organization shall validate (see 3.15)
that
a) the selected control measures are capable of achieving the intended control of the food
safety hazard(s) for which they are designated, and
b) the control measures are effective and capable of, in combination, ensuring control of the
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 of the above elements cannot be
confirmed, the control measure and/or combinations thereof shall be modified and re-assessed
(see 7.4.4).
Modifications may include changes in control measures (i.e. process parameters, rigorousness
and/or their combination) and/or change(s) in the raw materials, manufacturing technologies,
end product characteristics, methods of distribution and/or intended use of the end product.
6.2.1 General (as above)
6.2.2 Competence, awareness and training ( as above)
7.3.2 Food safety team (as above)
8.2 Validation of control measure combinations
Prior to implementation of control measures to be included in operational PRP(s) and the
HACCP plan and after any change therein (see 8.5.2), the organization shall validate (see 3.15)
that
a) the selected control measures are capable of achieving the intended control of the food
safety hazard(s) for which they are designated, and
b) the control measures are effective and capable of, in combination, ensuring control of the
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 of the above elements cannot be
confirmed, the control measure and/or combinations thereof shall be modified and re-assessed
(see 7.4.4).
Modifications may include changes in control measures (i.e. process parameters, rigorousness
and/or their combination) and/or change(s) in the raw materials, manufacturing technologies,
end product characteristics, methods of distribution and/or intended use of the end product.
8.2 Validation of control measure combinations (as above)

8.2 Validation of control measure combinations (as above) 8.4.3


Analysis of results of verification activities (as above)

8.5.2 Updating the food safety management system


Top management shall ensure that the food safety management system is continually updated.
In order to achieve this, the food safety team shall evaluate the food safety management
system at planned intervals. The team shall then consider whether it is necessary to review the
hazard analysis (see 7.4), the established operational PRP(s) (see 7.5) and the HACCP plan (see
7.6.1).
The evaluation and updating activities shall be based on
a) input from communication, external as well as internal, as stated in 5.6,
b) input from other information concerning the suitability, adequacy and effectiveness of the
food safety management system,
c) output from the analysis of results of verification activities (see 8.4.3), and
d) output from management review (see 5.8.3).
System updating activities shall be recorded and reported, in an appropriate manner, as input
to the management review (see 5.8.2).

8 Validation, verification and improvement of the food safety management system (as above)
8 Validation, verification and improvement of the food safety management system (as above)

8.2 Validation of control measure combinations (as above)

8.3 Control of monitoring and measuring (as above)

7.8 Verification planning (as above)

8.5.1 Continual improvement


Top management shall ensure that the organization continually improves the effectiveness of
the food safety management system through the use of communication (see 5.6), management
review (see 5.8), internal audit (see 8.4.1), evaluation of individual verification results (see
8.4.2), analysis of results of verification activities (see 8.4.3), validation of control measure
combinations (see 8.2), corrective actions (see 7.10.2) and food safety management system
updating (see 8.5.2).

7.6.4 System for the monitoring of critical control points (as above)
7.8 Verification planning
Verification planning shall define the purpose, methods, frequencies and responsibilities for the
verification activities. The verification activities shall confirm that
a) the PRP(s) are implemented (see 7.2),
b) input to the hazard analysis (see 7.3) is continually updated,
c) the operational PRP(s) (see 7.5) and the elements within the HACCP plan (see 7.6.1) are
implemented and effective,
d) hazard levels are within identified acceptable levels (see 7.4.2), and
e) other procedures required by the organization are implemented and effective.
The output of this planning shall be in a form suitable for the organization's method of
operations.
Verification results shall be recorded and shall be communicated to the food safety team.
Verification results shall be provided to enable the analysis of the results of the verification
activities (see 8.4.3).
If system verification is based on testing of end product samples, and where such test samples
show nonconformity with the acceptable level of the food safety hazard (see 7.4.2), the
affected lots of product shall be handled as potentially unsafe in accordance with 7.10.3.

7.6.4 System for the monitoring of critical control points


A monitoring system shall be established for each CCP to demonstrate that the CCP is in
control. The system shall include all scheduled measurements or observations relative to the
critical limit(s).
The monitoring system shall consist of relevant procedures, instructions and records that cover
the following:
a) measurements or observations that provide results within an adequate time frame;
b) monitoring devices used;
c) applicable calibration methods (see 8.3);
d) monitoring frequency;
e) responsibility and authority related to monitoring and evaluation of monitoring results;
f) record requirements and methods.
The monitoring methods and frequency shall be capable of determining when the critical limits
have been exceeded in time for the product to be isolated before it is used or consumed.
7.8 Verification
planning
Verification planning shall define the purpose, methods, frequencies and responsibilities for the
verification
activities. The verification activities shall confirm that
a) the PRP(s) are implemented (see 7.2),
b) input to the hazard analysis (see 7.3) is continually updated,
c) the operational PRP(s) (see 7.5) and the elements within the HACCP plan (see 7.6.1) are
implemented and effective,
d) hazard levels are within identified acceptable levels (see 7.4.2), and
7.6.4 System for the monitoring of critical control points
A monitoring system shall be established for each CCP to demonstrate that the CCP is in
control. The system shall include all scheduled measurements or observations relative to the
critical limit(s).
The monitoring system shall consist of relevant procedures, instructions and records that cover
the following:
a) measurements or observations that provide results within an adequate time frame;
b) monitoring devices used;
c) applicable calibration methods (see 8.3);
d) monitoring frequency;
e) responsibility and authority related to monitoring and evaluation of monitoring results;
f) record requirements and methods.
The monitoring methods and frequency shall be capable of determining when the critical limits
have been exceeded in time for the product to be isolated before it is used or consumed.
7.8 Verification
planning
Verification planning shall define the purpose, methods, frequencies and responsibilities for the
verification
activities. The verification activities shall confirm that
a) the PRP(s) are implemented (see 7.2),
b) input to the hazard analysis (see 7.3) is continually updated,
c) the operational PRP(s) (see 7.5) and the elements within the HACCP plan (see 7.6.1) are
implemented and effective,
d) hazard levels are within identified acceptable levels (see 7.4.2), and
e) other procedures required by the organization are implemented and effective.
The output of this planning shall be in a form suitable for the organization's method of
operations.
Verification results shall be recorded and shall be communicated to the food safety team.
Verification results shall be provided to enable the analysis of the results of the verification
activities (see 8.4.3).
If system verification is based on testing of end product samples, and where such test samples
show nonconformity with the acceptable level of the food safety hazard (see 7.4.2), the
affected lots of product shall be handled as potentially unsafe in accordance with 7.10.3.
8.3 Control of
monitoring and measuring
The organization shall provide evidence that the specified monitoring and measuring methods
and equipment are adequate to ensure the performance of the monitoring and measuring
procedures. Where necessary to ensure valid results, the measuring equipment and methods
used
a) shall be calibrated or verified at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards; where no such
standards exist, the basis used for calibration or verification shall be recorded,
b) shall be adjusted or re-adjusted as necessary,
c) shall be identified to enable the calibration status to be determined,
d) shall be safeguarded from adjustments that would invalidate the measurement results, and
e) shall be protected from damage and deterioration.
Records of the results of calibration and verification shall be maintained.

7.8 Verification planning (as above)


8.5.2 Updating the food safety management system
Top management shall ensure that the food safety management system is continually updated.
In order to achieve this, the food safety team shall evaluate the food safety management
system at planned intervals. The team shall then consider whether it is necessary to review the
hazard analysis (see 7.4), the established operational PRP(s) (see 7.5) and the HACCP plan (see
7.6.1).
The evaluation and updating activities shall be based on
a) input from communication, external as well as internal, as stated in 5.6,
b) input from other information concerning the suitability, adequacy and effectiveness of the
food safety management system,
c) output from the analysis of results of verification activities (see 8.4.3), and
d) output from management review (see 5.8.3).
System updating activities shall be recorded and reported, in an appropriate manner, as input
to the management review (see 5.8.2).

8.4.2 Evaluation of individual verification results


The food safety team shall systematically evaluate the individual results of planned verification
(see 7.8). If verification does not demonstrate conformity with the planned arrangements, the
organization shall take action to achieve the required conformity. Such action shall include, but
is not limited to, review of a) existing procedures and communication channels (see 5.6 and
7.7),
b) the conclusions of the hazard analysis (see 7.4), the established operational PRP(s) (see 7.5)
and the HACCP plan (see 7.6.1), c) the PRP(s) (see 7.2), and
d) the effectiveness of human resource management and of training activities (see 6.2).
8.4 Food safety management system verification (as above)

8.4.2 Evaluation of individual verification results ( as above) 8.5.2


Updating the food safety management system ( as above)

8.2 Validation of control measure combinations


Prior to implementation of control measures to be included in operational PRP(s) and the
HACCP plan and after any change therein (see 8.5.2), the organization shall validate (see 3.15)
that
a) the selected control measures are capable of achieving the intended control of the food
safety hazard(s) for which they are designated, and
b) the control measures are effective and capable of, in combination, ensuring control of the
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 of the above elements cannot be
confirmed, the control measure and/or combinations thereof shall be modified and re-assessed
(see 7.4.4).
Modifications may include changes in control measures (i.e. process parameters, rigorousness
and/or their combination) and/or change(s) in the raw materials, manufacturing technologies,
end product characteristics, methods of distribution and/or intended use of the end product.

7.8 Verification planning


Verification planning shall define the purpose, methods, frequencies and responsibilities for the
verification activities. The verification activities shall confirm that
a) the PRP(s) are implemented (see 7.2),
b) input to the hazard analysis (see 7.3) is continually updated,
c) the operational PRP(s) (see 7.5) and the elements within the HACCP plan (see 7.6.1) are
implemented and effective,
d) hazard levels are within identified acceptable levels (see 7.4.2), and
e) other procedures required by the organization are implemented and effective.
The output of this planning shall be in a form suitable for the organization's method of
operations.
Verification results shall be recorded and shall be communicated to the food safety team.
Verification results shall be provided to enable the analysis of the results of the verification
activities (see 8.4.3).
If system verification is based on testing of end product samples, and where such test samples
show nonconformity with the acceptable level of the food safety hazard (see 7.4.2), the
affected lots of product shall be handled as potentially unsafe in accordance with 7.10.3.
operations.
Verification results shall be recorded and shall be communicated to the food safety team.
Verification results shall be provided to enable the analysis of the results of the verification
activities (see 8.4.3).
If system verification is based on testing of end product samples, and where such test samples
show nonconformity with the acceptable level of the food safety hazard (see 7.4.2), the
affected lots of product shall be handled as potentially unsafe in accordance with 7.10.3.

8.2 Validation of control measure combinations


Prior to implementation of control measures to be included in operational PRP(s) and the
HACCP plan and after any change therein (see 8.5.2), the organization shall validate (see 3.15)
that
a) the selected control measures are capable of achieving the intended control of the food
safety hazard(s) for which they are designated, and
b) the control measures are effective and capable of, in combination, ensuring control of the
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 of the above elements cannot be
confirmed, the control measure and/or combinations thereof shall be modified and re-assessed
(see 7.4.4).
Modifications may include changes in control measures (i.e. process parameters, rigorousness
and/or their combination) and/or change(s) in the raw materials, manufacturing technologies,
end product characteristics, methods of distribution and/or intended use of the end product.

8.4.2 Evaluation of individual verification results ( as above)


8.5.2 Updating the food safety management system ( as above)

5.5 Food safety team leader


Top management shall appoint a food safety team leader who, irrespective of other
responsibilities, shall have the responsibility and authority
a) to manage a food safety team (see 7.3.2) and organize its work,
b) to ensure relevant training and education of the food safety team members (see 6.2.1),
c) to ensure that the food safety management system is established, implemented, maintained
and updated, d) to report to the organization's top management on the effectiveness and
suitability of the food safety management system.
NOTE The responsibility of the food safety team leader may include liaison with external parties
on matters relating to the food safety management system.
8.5.2 Updating the food safety management system ( as above)
5.6.1 External communication
To ensure that sufficient information on issues concerning food safety is available throughout
the food chain, the organization shall establish, implement and maintain effective
arrangements for communicating with
a) suppliers and contractors,
b) customers or consumers, in particular in relation to product information (including
instructions regarding intended use, specific storage requirements and, as appropriate, shelf
life), enquiries, contracts or orderhandling including amendments, and customer feedback
including customer complaints, c) statutory and regulatory authorities, and
d) other organizations that have an impact on, or will be affected by, the effectiveness or
updating of the food safety management system.
Such communication shall provide information on food safety aspects of the organization's
products that may be relevant to other organizations in the food chain. This applies especially
to known food safety hazards that need to be controlled by other organizations in the food
chain. Records of communications shall be maintained. Food safety requirements from
statutory and regulatory authorities and customers shall be available.
Designated personnel shall have defined responsibility and authority to communicate
externally any information concerning food safety. Information obtained through external
communication shall be included as input to system updating (see 8.5.2) and management
review (see 5.8.2).
5.6.2 Internal communication
The organization shall establish, implement and maintain effective arrangements for
communicating with personnel on issues having an impact on food safety.
In order to maintain the effectiveness of the food safety management system, the organization
shall ensure that the food safety team is informed in a timely manner of changes, including but
not limited to the following:
a) products or new products;
b) raw materials, ingredients and services;
c) production systems and equipment;
d) production premises, location of equipment, surrounding environment;
e) cleaning and sanitation programmes;
f) packaging, storage and distribution systems;
g) personnel qualification levels and/or allocation of responsibilities and authorizations;
h) statutory and regulatory requirements;
i) knowledge regarding food safety hazards and control measures;
j) customer, sector and other requirements that the organization observes;
k) relevant enquiries from external interested parties;
l) complaints indicating food safety hazards associated with the product;

5.5 Food safety team leader ( as above)


8.2 Validation of control measure combinations (as above)
8.4.2 Evaluation of individual verification results (as above)
8.5.2 Updating the food safety management system ( as
above)
5.5 Food safety team leader
Top management shall appoint a food safety team leader who, irrespective of other
responsibilities, shall have the responsibility and authority
a) to manage a food safety team (see 7.3.2) and organize its work,
b) to ensure relevant training and education of the food safety team members (see 6.2.1),
c) to ensure that the food safety management system is established, implemented, maintained
and updated, d) to report to the organization's top management on the effectiveness and
suitability of the food safety management system.
NOTE The responsibility of the food safety team leader may include liaison with external parties
on matters relating to the food safety management system.
5.5 Food safety team leader ( as above)
8.4.1 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the
food safety management system
a) conforms to the planned arrangements, to the food safety management system
requirements established by the organization, and to the requirements of this International
Standard, and
b) is effectively implemented and updated.
An audit programme shall be planned, taking into consideration the importance of the
processes and areas to be audited, as well as any updating actions resulting from previous
audits (see 8.5.2 and 5.8.2). criteria, scope, frequency and methods shall be defined. Selection
of auditors and the conduct of audits shall ensure the objectivity and impartiality of the audit
process. Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits, and for reporting
results and maintaining records, shall be defined in a documented procedure.
The management responsible for the area being audited shall ensure that actions are taken
without undue delay to eliminate detected nonconformities and their causes. Follow-up
activities shall include the verification of the actions taken and the reporting of the verification
results.

5.5 Food safety team leader (as above)


6.2.2 Competence, awareness and training
The organization shall
a) identify the necessary competencies for personnel whose activities have an impact on food
safety,
b) provide training or take other action to ensure personnel have the necessary competencies,
c) ensure that personnel responsible for monitoring, corrections and corrective actions of the
food safety management system are trained,
d) evaluate the implementation and the effectiveness of a), b) and c),
e) ensure that the personnel are aware of the relevance and importance of their individual
activities in contributing to food safety,
f) ensure that the requirement for effective communication (see 5.6) is understood by all
personnel whose activities have an impact on food safety, and
g) maintain appropriate records of training and actions described in b) and c).
7.3.2 Food safety team
A food safety team shall be appointed.
The food safety team shall have a combination of multi-disciplinary knowledge and experience
in developing and implementing the food safety management system. This includes, but need
not be limited to, the organization's products, processes, equipment and food safety hazards
within the scope of the food safety management system. Records shall be maintained that
demonstrate that the food safety team has the required knowledge and experience (see 6.2.2).

6.2.2 Competence, awareness and training ( as above)


7.3.2 Food safety team ( as above)
8.4 Food safety management system verification ( as above)
5.5 Food safety team leader ( as above)
6.2.2 Competence, awareness and training ( as above)

4.2.3 Control of records


Records shall be established and maintained to provide evidence of conformity to requirements
and evidence of the effective operation of the food safety management system. Records shall
remain legible, readily identifiable and retrievable. A documented procedure shall be
established to define the controls needed for the identification, storage, protection, retrieval,
retention time and disposition of records

4.2.3 Control of records (as above)


7.4.4 Selection and assessment of control measures
Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall
be selected which is capable of preventing, eliminating or reducing these food safety hazards to
defined acceptable levels.
In this selection, each of the control measures as described in 7.3.5.2 shall be reviewed with
respect to its effectiveness against the identified food safety hazards.
The control measures selected shall be categorized as to whether they need to be managed
through operational PRP(s) or by the HACCP plan.

4.2.3 Control of records (as above)


7.6.4 System for the monitoring of critical control points
A monitoring system shall be established for each CCP to demonstrate that the CCP is in
control. The system shall include all scheduled measurements or observations relative to the
critical limit(s).
The monitoring system shall consist of relevant procedures, instructions and records that cover
the following:
a) measurements or observations that provide results within an adequate time frame;
b) monitoring devices used;
c) applicable calibration methods (see 8.3);
d) monitoring frequency;
e) responsibility and authority related to monitoring and evaluation of monitoring results;
f) record requirements and methods.
The monitoring methods and frequency shall be capable of determining when the critical limits
have been exceeded in time for the product to be isolated before it is used or consumed.
4.2.3 Control of records (as above) 7.6.5
Actions when monitoring results exceed critical limits
Planned corrections and corrective actions to be taken when critical limits are exceeded shall
be specified in the HACCP plan. The actions shall ensure that the cause of nonconformity is
identified, that the parameter(s) controlled at the CCP is (are) brought back under control, and
that recurrence is prevented (see 7.10.2). Documented procedures shall be established and
maintained for the appropriate handling of potentially unsafe products to ensure that they are
not released until they have been evaluated (see 7.10.3).
7.10.2 Corrective actions
Data derived from the monitoring of operational PRPs and CCPs shall be evaluated by
designated person(s) with sufficient knowledge (see 6.2) and authority (see 5.4) to initiate
corrective actions. Corrective actions shall be initiated when critical limits are exceeded (see
7.6.5) or when there is a lack of conformity with operational PRP(s).
The organization shall establish and maintain documented procedures that specify appropriate
actions to identify and eliminate the cause of detected nonconformities, to prevent recurrence,
and to bring the process or system back into control after nonconformity is encountered. These
actions include
a) reviewing nonconformities (including customer complaints),
b) reviewing trends in monitoring results that may indicate development towards loss of
control,
c) determining the cause(s) of nonconformities,
d) evaluating the need for action to ensure that nonconformities do not recur,
e) determining and implementing the actions needed,
f) recording the results of corrective actions taken, and
g) reviewing corrective actions taken to ensure that they are effective.
Corrective actions shall be recorded.

4.2.3 Control of records (as above)


8 Validation, verification and improvement of the food safety management system (as
above)

4.2.3 Control of records (as above)


8.3 Control of monitoring and measuring (as above)

4.2.3 Control of records (as above)


8.4.3 Analysis of results of verification activities (as above)

4.2.3 Control of records (as above)


8.3 Control of monitoring and measuring (as above)

4.2.3 Control of records (as above)


7.8 Verification planning (as above)
4.2.3 Control of records (as above)

4.2.3 Control of records (as above)


7.6.4 System for the monitoring of critical control points (as above)
4.2.3 Control of records (as above)
8.5.2 Updating the food safety management system (as above)

4.2.3 Control of records (as above)

4.2.3 Control of records (as above)


5.5 Food safety team leader (as above)
6.2.2 Competence, awareness and training (as above)
7.3.2 Food safety team (as above)

4.2.3 Control of records (as above)


Requirements for records and documentation of precedures throughout
4.2 Documentation requirements
4.2.1 General
The food safety management system documentation shall include
a) documented statements of a food safety policy and related objectives (see 5.2),
b) documented procedures and records required by this International Standard, and
c) documents needed by the organization to ensure the effective development, implementation
and updating of the food safety management system.
4.2.2 Control of documents
Documents required by the food safety management system shall be controlled. Records are a
special type of document and shall be controlled according to the requirements given in 4.2.3.
The controls shall ensure that all proposed changes are reviewed prior to implementation to
determine their effects on food safety and their impact on the food safety management
system.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update documents as necessary, and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that relevant documents of external origin are identified and their distribution
controlled, and
g) to prevent the unintended use of obsolete documents, and to ensure that they are suitably
identified as such if they are retained for any purpose.
4.2.3 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements
and evidence of the effective operation of the food safety management system. Records shall
remain legible, readily identifiable and retrievable. A documented procedure shall be
established to define the controls needed for the identification, storage, protection, retrieval,
retention time and disposition of records.
4.2 Documentation requirements (as above) 5.1
Management commitment
Top management shall provide evidence of its commitment to the development and
implementation of the food safety management system and to continually improving its
effectiveness by
a) showing food safety is supported by the business objectives of the organization,
b) communicating to the organization the importance of meeting the requirements of this
International Standard, any statutory and regulatory requirements, as well as customer
requirements relating to food safety,
c) establishing the food safety policy,
d) conducting management reviews, and
e) ensuring the availability of resources.5.3 Food safety management system planning
Top management shall ensure that
a) planning of the food safety management system is carried out to meet requirements given in
4.1 as well as the objectives of the organization that support food safety, and
b) the integrity of the food safety management system is maintained when changes to the food
safety management system are planned and implemented.
5.3 Food safety management system planning
Top management shall ensure that
a) planning of the food safety management system is carried out to meet requirements given in
4.1 as well as the objectives of the organization that support food safety, and
b) the integrity of the food safety management system is maintained when changes to the food
safety management system are planned and implemented.

4.2 Documentation requirements (as above)


FSSC 22000 Additional Requirements
2.1.4.1 Management of Services
1) The organization in the food chain shall ensure that all services that
may have an impact on food safety:
a) have specified requirements which are regularly reviewed,
b) are described in documents to the extent needed to conduct hazard
analysis,
c) are managed in conformance with the requirements of technical
specification for sector PRPs,
d) are assessed and approved demonstrating compliance with specified
equirements,
e) are monitored to assure continued service provider approval status.
2) The services referred to in 1) above shall include at least:
a) utilities,
b) transport and storage,
c) maintenance,
d) cleaning and
e) outsourced services.
3) The organization shall implement a system to assure that when analysis
critical to the verification of food safety is undertaken, this is conducted
by a competent laboratory that has the capability to produce precise and
repeatable test results using validated test methods and best practices
(e.g. successful participation in proficiency testing programs, regulatory
approved programs or accreditation to international standards such as ISO
17025).
2.1.4.1 Management of Services 1)
The organization in the food chain shall ensure that all services that may
have an impact on food safety:
a) have specified requirements which are regularly reviewed,
b) are described in documents to the extent needed to conduct hazard
analysis,
c) are managed in conformance with the requirements of technical
specification for sector PRPs,
d) are assessed and approved demonstrating compliance with specified
requirements,
e) are monitored to assure continued service provider approval status.
2) The services referred to in 1) above shall include at least:
a) utilities, b) transport and storage, c) maintenance, d) cleaning and e)
outsourced services.
3) The organization shall implement a system to assure that when analysis
critical to the verification of food safety is undertaken, this is conducted
by a competent laboratory that has the capability to produce precise and
repeatable test results using validated test methods and best practices
(e.g. successful participation in proficiency testing programs, regulatory
approved programs or accreditation to international standards such as
ISO 17025).
2.1.4.4 Food Fraud Prevention
1) The organization shall have a documented and implemented
vulnerability assessment procedure in place that:
a) identifies potential vulnerabilities,
b) develops control measures, and
c) prioritises them against the identified vulnerabilities.
2) To identify the vulnerabilities, the organization shall assess the
susceptibility of its products to potential food fraud acts. The
organization shall put in place appropriate control measures to reduce or
eliminate the identified vulnerabilities.
1) All policies, procedures and
records are included in a food fraud prevention plan supported by the
organization’s Food Safety Management System for all its products.
2) The plan shall comply with applicable legislation.
2.1.4.4 Vulnerability assessment
1) The organization shall document, establish and maintain a documented
procedure for food fraud vulnerability assessment that:
a) identifies potential vulnerabilities,
b) develops preventive measures, and
c) prioritises them against the vulnerabilities.
2) In order to identify the vulnerabilities, the organization shall assess the
susceptibility of its products to potential acts of food fraud.
2.1.4.7 Environmental monitoring
The organization shall ensure that an environmental monitoring program
is in place to verify the effectiveness of cleaning and sanitation programs
which shall meet the verification requirements as described in ISO 22000.
2.1.4.6 Management of allergens
1) A documented allergen management plan shall be in place
that includes:
a) risk assessment addressing potential allergen cross contamination;
b) control measures to reduce or eliminate the risk of cross
contamination;
c) validation and verification of effective implementation.
2) All finished products intentionally or potentially containing allergenic
materials are labeled according to the allergen labelling regulations in the
country of manufacture and country of destination.
2.1.4.6 Management of allergens:
1) A documented allergen management plan shall be in
place that includes:
a) risk assessment addressing potential allergen cross contamination;
b) control measures to reduce or eliminate the risk of cross
contamination;
c) validation and verification of effective implementation.
2) All finished products intentionally or potentially containing allergenic
materials are labeled according to the allergen labelling regulations in the
country of manufacture and country of destination.
2.1.4.2 Product labelling:
The organization shall ensure that the finished product is labelled
according to the applicable food regulations in the country of intended
sale.
2.1.4.1 Management of Services ( as above)
2.1.4.7 Environmental monitoring
The organization shall ensure that an environmental monitoring program
is in place to verify the effectiveness of cleaning and sanitation programs
which shall meet the verification requirements as described in ISO 22000.
2.1.4.1 Management of Services ( as above)
2.1.4.7 Environmental monitoring
The organization shall ensure that an environmental
monitoring program is in place to verify the effectiveness of cleaning and
sanitation programs which shall meet the verification requirements as
described in ISO 22000.

2.1.4.7 Environmental monitoring (as above)

2.1.4.7 Environmental monitoring (as above)

2.1.4.7 Environmental monitoring (as above)

2.1.4.7 Environmental monitoring (as above)

2.1.4.1.Management of Services (as above)


2.1.4.7 Environmental monitoring (as above)

2.1.4.1.Management of Services (as above)


2.1.4.7 Environmental monitoring (as above)