Rationale

Outside sources of contamination (e.g., excessive dust, pest infestation, airborne

microbial and chemical contaminants) can lead to source of exterior contamination that
can enter an establishment.
Food Safety Enhancement Program Manual
Section 3 - HACCP System Documentation
3.1 Prerequisite programs
3.2 !""P plan(s)
3.3 #alidation
3.$ %aintenance and reassessment of the !""P s&stem
3.' ()*P forms
+he !""P s&stem shall include,
Prerequisite programs (see section 3.1)-
!""P plans (see section 3.2)-
#alidation documentation (see section 3.3)-
!""P s&stem maintenance and reassessment procedures (see section 3.$).
3. Prere!uisite "rograms
Prior to developing !""P plans, the establishment shall develop and implement prerequisite
programs to assist in controlling the li.elihood of introducing food safet& ha/ards to the product
through the 0or. environment and operational practices.
+he prerequisite programs shall be documented, updated 0henever there are changes associated
0ith the prerequisite programs and reassessed at least annuall&.
+he prerequisite program requirements outlined in this manual are generic in nature.
*stablishments must ensure that their prerequisite programs reflect the current 0or. environment
and operational practices 0ithin their establishment and compl& 0ith specific commodit&
policies, manuals, procedures and associated regulations.
!n establishment ma& develop their prerequisite programs using a structure other than the one
described in this section as long as the prerequisite program requirements are covered as 0ell as
the monitoring, deviation and record .eeping components.
+here are seven (1) prerequisite programs,
!. Premises
2. +ransportation, Purchasing34eceiving3)hipping and )torage
". *quipment
5. Personnel
*. )anitation and Pest "ontrol
(. 4ecall
6. Operational Prerequisite Programs
*ach prerequisite program is divided into *lements, )ub7elements and 2ullets 0hich include the
requirements.
! 7 Program (e.g., Premises)
!.2 7 *lement (e.g., 2uilding)
!.2.2 7 )ub7element (e.g., 8ighting)
!.2.2.1 7 2ullet (8ighting is appropriate such that food colour is not altered and the intended
production or inspection activit& can be effectivel& conducted.)
*ach establishment must create a documented program that responds to each prerequisite
program bullet requirement (see section 3.1.1). +he documented program shall include,
)pecific programs, procedures or policies as per prerequisite program bullet
requirements-
%onitoring procedure (see section 3.1.2)-
5eviation procedure (see section 3.1.3).
+he record .eeping shall meet the requirements defined in 3.1.$.
+he establishment ma& have to develop more programs, standard operating procedures or tas.s
to meet applicable regulator& requirements and3or to facilitate the control of the prerequisite
program requirements in their establishment. !n& additional food safet& related programs,
procedures or tas.s shall be referenced 0ithin the respective bullet.
#ote$ +he individuals responsible for specific control measures 0ithin a prerequisite program,
monitoring and deviation procedures ma& be identified b& a position title or the term designate.
9n this case, the establishment must be able to demonstrate that individuals have received
adequate training.
3.. Prere!uisite "rograms re!uirements
+he seven prerequisite programs include the follo0ing elements and sub7elements,
%A& Premises %see section 3...&
!.1 Outside Propert&
o !.1.1 Outside Propert&
!.2 2uilding
o !.2.1 2uilding 5esign, "onstruction and %aintenance
o !.2.2 8ighting
o !.2.3 #entilation
o !.2.$ :aste and 9nedible3(ood :aste 5isposal
!.3 )anitar& (acilities
o !.3.1 *mplo&ees (acilities
o !.3.2 and :ashing )tations and )aniti/ing 9nstallations
!.$ :ater3)team39ce ;ualit&, Protection and )uppl&
o !.$.1 :ater3)team39ce ;ualit&, Protection and )uppl&
%'& (rans"ortation) Purchasing*Recei+ing*Shi""ing and Storage %see section 3...,&
2.1 +ransportation
o 2.1.1 (ood "arriers
2.2 Purchasing34eceiving3)hipping and )torage
o 2.2.1 Purchasing34eceiving3)hipping
o 2.2.2 )torage
%C& E!ui"ment %see section 3...3&
".1 *quipment 6eneral
o ".1.1 5esign < 9nstallation
o ".1.2 *quipment %aintenance and "alibration
%D& Personnel %see section 3...-&
5.1 +raining
o 5.1.1 6eneral (ood &giene +raining Program
o 5.1.2 +echnical +raining Program
5.2 6eneral (ood &giene Program
o 5.2.1 6eneral (ood &giene Program
%E& Sanitation and Pest Control %see section 3....&
*.1 )anitation
o *.1.1 )anitation Program
*.2 Pest "ontrol
o *.2.1 Pest "ontrol Program
%F& Recall %see section 3.../&
(.1 4ecall )&stem
o (.1.1 4ecall Plan
o (.1.2 Product "oding and 8abelling
%0& 1"erational Prere!uisite Programs %see 3...2&
6.1 !llergens, =utrients, (ood !dditives and Processing !ids
o 6.1.1 !llergen "ontrol Program
o 6.1.2 (ood !dditives and =utrients
o 6.1.3 (ood Processing !ids
6.2 (oreign %aterial "ontrol Program
o 6.2.1 (oreign %aterial "ontrol Program
*ach prerequisite program sub7element is organi/ed under the follo0ing headings,
+he requirements
4ationale 7 +he rationale explains 0h& the requirement exists
!s the ()*P %anual applies to all food commodit& groups, there 0ill inevitabl& be situations
0here some of the specific requirements are not applicable. +he requirements indicate 0here
such questions are li.el& to arise b& using the phrases 0here necessar&, 0here appropriate or
0here applicable. 9n deciding 0hether a requirement is necessar& or appropriate, an assessment
of the ris. and the regulator& requirements must be made and the result of the assessment must
be recorded.
3... %A& Premises
A. 1utside Pro"erty
A.. 1utside Pro"erty
Re!uirements
A...
2uilding facilit& is located a0a& from or protected against potential sources of external
contaminants that ma& compromise the safet& of food.
+he surrounding3road0a&s are free of debris and refuse, adequatel& drained and maintained to
minimi/e environmental ha/ards.
Rationale
Outside sources of contamination (e.g., excessive dust, pest infestation, airborne
microbial and chemical contaminants) can lead to source of exterior contamination that
can enter an establishment.
A., 'uilding
A.,. 'uilding Design) Construction and Maintenance
Re!uirements
A.,..
+he building is designed and constructed,
to meet regulator& and "(9! program requirements-
so its access is secure-
so the roof, air inta.es, foundation, 0alls, doors and 0indo0s prevent lea.age and entr&
of contaminants and pests-
to effectivel& separate incompatible operations->
to provide h&gienic operations b& means of a regulated flo0 from point of entr& to the
premises to the final product->
to effectivel& prevent cross7contamination due to emplo&ee traffic pattern, food product
flo0 and equipment->
so living quarters and areas 0here animals are .ept are separated from and do not open
directl& into food processing or pac.aging areas-
so incoming materials (food, non7food, pac.aging) are received in an area separate from
food processing areas-
so 0ashrooms, lunchrooms and change rooms are separated from and do not open
directl& into food processing areas-
so separate and adequate facilities are provided for,
o the storage of 0aste and inedible products,>
o the cleaning and saniti/ing of 0aste3inedible equipment,>
o the cleaning of equipment->
to prevent cross7connection bet0een,
o the effluent of human 0astes and production drainage 0astes in the
establishments,
o potable 0ater lines and non7potable 0ater suppl& s&stems-
non7potable re7circulated3reused3rec&cled 0ater has a separate distribution
s&stem 0hich is readil& identifiable in the facilit&
)o drainage and se0age s&stems
o do not pose a ris. of contaminating food and things (e.g. equipment, pac.aging
material) associated 0ith food, and production of food-
o provide adequate and constant removal of the fluid 0astes and prevent 0ater from
flooding the surrounding areas or pooling around drain inlets.
so floors permit liquids to drain to trapped outlets-
so floors, 0alls, doors, 0indo0s, ceilings, overheads and other structures in rooms or
areas 0here food is manufactured, stored, pac.aged, received or shipped are cleanable,
prevent contamination, prohibit deterioration, are suitable for the activities in each area
and are free of an& noxious constituents.>>
> 9f the building is not designed to effectivel& separate incompatible operations and3or to prevent
cross7contamination, operational procedures to control cross7contamination must be defined in
the 6eneral (ood &giene Program 5.2.1.1. and3or the )anitation Program *.1.1.1.
>> )ee 2.2.1.1 for purchasing control of construction material
A.,..,
+he building is maintained so,
the roof, air inta.es, foundation, 0alls, doors and 0indo0s prevent lea.age and entr& of
contaminants and pests-
the drainage and se0age s&stems prevent bac.flo0 and pooling liquids on floors-
floors, 0alls, ceilings, overheads, doors, 0indo0s, stairs, elevators and other structures
exhibit no evidence of degradation that 0ould cause contamination and are cleanable.
Rationale
)creens on 0indo0s, doors that are tight, a roof that does not lea. and air inta.es located
a0a& from potential contaminants are examples of good establishment conditions 0hich
0ill minimi/e the potential for ha/ards such as rodents, pests, insects, non7potable 0ater
and the li.e entering the establishment and compromising activities.
Operational flo0s such as emplo&ee entr& to the establishment and flo0 to 0or. rooms,
ingredient3product flo0s and3or adequate separation or control bet0een incompatible
operations 0ill prevent microbiological, chemical or ph&sical contamination of the
product.
+he absence of cross7connections bet0een the se0age s&stem and other 0aste s&stems
0ill facilitate sanitar& operations, ensure segregation of 0aste and prevent potential for
contamination.
!dequate drainage and3or an adequate 0aste disposal s&stem 0ill prevent cross7
contamination of food, ingredients, pac.aging material, food contact surfaces or the
potable 0ater suppl& (e.g., drain bac.7ups leading to flooding).
+he adequate number, si/e, and location of drains and drain inlets 0ill provide constant
removal of the fluid 0astes and prevent 0ater from flooding the surrounding areas or
pooling around the drain inlet.
+he presence of mechanisms to prevent bac.flo0 (e.g., trapping, venting) 0ill prevent
se0er gases, pests, microorganisms or other contaminants from entering the
establishment through the plumbing s&stem.
(loors that are designed to permit liquids to drain to trapped outlets 0ill prevent 0ater
pooling or stagnant 0ater on floors during operation.
)ome materials have the potential to cause biological, chemical or ph&sical ha/ards.
+hese materials should not be used in the construction of the establishment?s internal
fittings 0here food products are manufactured.
)tructures and materials that can be effectivel& cleaned 0ill minimi/e the development of
unsanitar& conditions (e.g., presence of bacteria, mould).
%aterials that are durable or suitable for the environment or activities in the area 0ill
minimi/e unsuitable conditions (e.g., fla.ing or peeling rust or paint or loose materials).
"eilings and overhead structures that are 0ell designed 0ill minimi/e the build7up of dirt,
condensation and the shedding of particles.
:indo0s that are sealed or equipped 0ith close7fitting screens and doors that are tight
fitting 0ill prevent entr& of contaminants and pests.
:indo0s constructed of, or protected 0ith, unbrea.able materials 0ill prevent foreign
material contamination of food, ingredients, pac.aging materials and food contact
surfaces.
A.,., 3ighting
Re!uirements
A.,.,.
8ighting is appropriate such that food colour is not altered and the intended production or
inspection activit& can be effectivel& conducted.
A.,.,.,
8ight bulbs and fixtures located in areas 0here there is exposed food or pac.aging materials are
of a safet& t&pe or are protected to prevent contamination of food in case of brea.age.
Rationale
9f lighting levels are inadequate for the inspection of food or if the light source alters or
changes the natural colour of food, an incorrect assessment of the food ma& result.
9f lighting levels are inadequate to perform the required tas.s (including but not limited to
inspection to determine product disposition, inspections during processing, inspections
post7sanitation to ensure cleanliness and3or inspections in storage areas, as 0ell as
lighting levels that are adequate for the maintenance of equipment), this ma& prevent an
emplo&ee from identif&ing the potential for or presence of biological, chemical or
ph&sical contamination.
9f a light bulb or lighting fixture brea.s over exposed food, ingredients, pac.aging
materials or food contact surfaces, then a ph&sical foreign material ha/ard can occur.
A.,.3 4entilation
Re!uirements
A.,.3.
#entilation provides sufficient air exchanges to prevent unacceptable accumulations of steam,
condensation or dust and to remove contaminated air. (ilters are cleaned or replaced as
appropriate.
A.,.3.,
#entilation s&stems ensure that air does not flo0 from the most contaminated areas to the least
contaminated areas.
A.,.3.3
:here required, ambient air, compressed air or gases utili/ed in processing equipment that
contact product or pac.aging are appropriatel& sourced and treated to minimi/e contamination of
product and pac.aging.
Rationale
!dequate ventilation minimi/es airborne contamination of food (e.g., from aerosols or
condensation droplets).
+he flo0 of contaminated air through an establishment can be a source of bacterial
contaminants for microbiologicall& sensitive food processing areas (e.g., 4ead&7to7*at
processing rooms and aseptic rooms).
+he correct location of air inta.es, the correct si/e of filters, filter cleanliness and the use
of food grade gases all contribute to the prevention of airborne contamination.
A.,.- 5aste and 6nedi7le*Food 5aste Dis"osal
:aste is defined as un0anted materials left over from the manufacturing processes. +his includes
but is not limited to garbage, discarded pac.aging, bro.en pallets, discarded construction
materials etc.
9nedible product or food 0aste is defined as an& food product that is not considered suitable for
human consumption as defined in applicable legislation.
Re!uirements
A.,.-.
+he establishment has and implements documented procedures to control the ha/ards associated
0ith 0aste and inedible3food 0aste products. +he procedures shall include but are not limited to,
!n identification s&stem for utensils and containers used for collection and holding of
0aste and inedible3food 0aste materials-
+he frequenc& of removal of 0aste during operations-
9f applicable, the frequenc& of removal of inedible3food 0aste products during
operations-
9f applicable, procedures for storage of 0aste and inedible3food 0aste products-
9f applicable (see regulator& requirement for the commodit&), a denaturing protocol,
including methods and chemical(s) used for denaturing-
+he frequenc& of removal of 0aste from the establishment-
9f applicable, the frequenc& of removal of inedible3food 0aste product from the
establishment-
Procedures for maintenance of 0aste3inedible3food 0aste equipment (*quipment must be
lea. proof and 0here appropriate, covered).
Rationale
"learl& identified containers and utensils used for 0aste and inedible materials 0ill
prevent container or utensils misuse and cross7contamination of edible products
*ffective procedures 0ill prevent the accumulation of 0aste, inedible or food 0aste
products and the potential contamination of food handling areas, and 0ill minimi/e the
attraction of pests and prevent ob@ectionable odours.
A.3 Sanitary Facilities
A.3. Em"loyees Facilities
Re!uirements
A.3..
:ashrooms have hot and cold or 0arm potable running 0ater, soap dispensers, soap, sanitar&
hand dr&ing equipment or supplies and cleanable 0aste receptacles. and 0ashing notices are
posted in appropriate areas.
A.3..,
!s required, 0ashrooms, lunchrooms and change rooms are provided 0ith adequate floor
drainage and ventilation. +he& are maintained in a manner to prevent contamination.
Rationale
!dequate 0ashroom, change room and lunchroom facilities 0ill ensure that an
appropriate degree of personal h&giene is maintained to protect the safet& of food.
Providing an acceptable area for emplo&ees to change into 0or. clothes 0ill prevent
exterior contaminants from entering the processing areas.
Providing adequate lunch room facilities 0ill discourage emplo&ees from eating and
drin.ing in production areas 0hich can lead to contamination of product.
A.3., Hand-8ashing Stations and Saniti9ing 6nstallations
Re!uirements
A.3.,.
:here required or appropriate, areas of the establishment are provided 0ith an adequate number
of convenientl& located hands free hand70ashing stations 0ith trapped 0aste pipes to drains.
and70ashing stations are properl& maintained and are provided 0ith hot and cold or 0arm
potable running 0ater, soap dispensers, soap, sanitar& hand dr&ing equipment or supplies and
cleanable 0aste receptacles. and70ashing notices are posted in appropriate areas.
A.3.,.,
:here required3appropriate, areas of the establishment are provided 0ith saniti/ing installations,
such as,
)aniti/ing installations for hands-
)aniti/ing installations for boots-
)aniti/ing installations for operational equipment. (=ote, operational equipment ma&
include but is not limited to .nives, utensils, tools, etc.)
)aniti/ing installations are properl& maintained and are provided 0ith potable 0ater at
temperatures and, 0here applicable, chemical concentrations appropriate for their intended use.
Rationale
Personnel are a ma@or source of contaminant.
9f there are enough hand70ashing stations and the& are located in areas that are eas& to
access, personnel are more li.el& to 0ash their hands.
)aniti/ing stations are used to control the potential for cross7contamination from
operational equipment and emplo&ees.
and70ashing stations and saniti/ing installation can become a source of contaminants if
the& are not properl& maintained.
A.- 5ater*6ce*Steam :uality) Protection and Su""ly
A.-. 5ater*6ce*Steam :uality) Protection and Su""ly
Re!uirements
A.-..
+he establishment has and implements documented 0ater safet& procedures to ensure that 0ater
and ice meet the potabilit& requirements of the appropriate regulator& authorit&.
+he 0ater safet& procedures shall include but are not limited to,
=ame or title of personnel responsible for the implementation of the 0ater safet&
procedures-
9dentification of the source of 0ater suppl& (municipalit&, private 0ell(s), storage tan.(s),
etc.)-
:ater sampling and testing schedule(s)-
9dentification of the sampling site(s)-
:ater and ice sampling procedures-
5escription of testing activities to be performed-
:ater potabilit& criteria-
5ocumentation requirements (records should include the 0ater source(s), sampling
site(s), anal&tical results, anal&st and date of sample(s)-
5eviation procedures 0hen 0ater testing results indicate 0ater potabilit& criteria have not
been met-
5eviation procedures to be applied at the establishment in instances 0here the
municipalit& identifies a failure 0ith the 0ater s&stem-
4ecord(s) to be .ept.
A.-..,
:here applicable, the establishment has and implements documented 0ater treatment procedures
to ensure that,
2oiler treatment agents do not pose a ris. for public health.
!n& chemicall& treated 0ater that has direct product impact or is used on product contact
surfaces is potable.
4e7circulated 0ater for reuse poses no ris. to the safet& of food products.
+he 0ater treatment procedures shall include but are not limited to,
=ame or title of personnel responsible for the implementation of the 0ater treatment
procedures-
9dentification of 0ater treatment activities to be performed-
:ater treatment method3frequenc&-
"hemicals used-
Proper handling and application of 0ater treatment chemicals-
!cceptable chemical concentrations-
9f applicable, description of an& automatic 0arning control-
+esting procedure, including testing frequenc&, to ensure proper concentration is
consistentl& met-
5ocumentation requirements (records should include method of treatment, sample site,
anal&tical result, anal&st and date)-
5eviation procedure 0hen the criteria have not been met-
4ecord(s) to be .ept.
A.-..3
:here required, hoses, taps or other similar sources of possible contamination are designed to
prevent bac.7flo0 or bac. siphonage.
A.-..-
:here filters are used the& are .ept effective and maintained in a sanitar& manner.
A.-...
+he volume, temperature and pressure of the potable 0ater3steam are adequate for all operational
and cleanup demands.
A.-../
:here it is necessar& to store 0ater or ice, storage facilities are adequatel& designed,
constructed, and maintained to prevent contamination.
Rationale
:ater, ice and steam can be a source of biological or chemical contaminants.
)ince 0ater, ice and steam can be used for a variet& of purposes (e.g., sanitation, hand
0ashing, as an ingredient or processing aid), it is important to perform 0ater sampling
and testing to confirm potabilit&.
"ollecting 0ater samples from different outlet(s) for each test 0ill ensure that the
establishment?s 0ater distribution s&stem functions properl& and is not a potential source
of 0ater contamination.
+reated 0ater can be a source of contaminants if the chemical treatment or treatment
process is incorrectl& performed and3or monitored.
!n adequate suppl& of potable 0ater 0ith appropriate facilities for its storage and
distribution 0ill prevent contamination of 0ater and ensure the safet& of food.
9f 0ater and steam are not supplied at the necessar& volume, pressure and temperature,
the abilit& to properl& complete certain activities can be compromised (e.g., hand
0ashing, sanitation, product rinsing).
3..., %'& (rans"ortation) Purchasing*Recei+ing*Shi""ing and Storage
'. (rans"ortation
'.. Food Carriers
Re!uirements
'...
"arriers used for transport of food,
are designed, constructed, maintained and cleaned to prevent contamination, damage and
deterioration of the food product-
are equipped, 0here applicable, to maintain food products in a refrigerated or fro/en
state-
are not being used for the transport of an& material or substance that might adulterate the
food product.
'...,
"arriers are loaded, arranged and unloaded in a manner that,
prevents outside contaminants from entering the establishment-
prevents damage and contamination of the finished product, ingredients and incoming
materials that come in contact 0ith the product or are used in preparing the product.
Rationale
"onve&ance vehicles or containers that are not properl& constructed, maintained or
cleaned can lead to a number of ha/ards including,
o Ph&sical contaminants from dust and foreign material-
o "hemical contaminants from unsuitable surfaces or trace chemicals from previous
loads-
o %icrobiological contaminants from previous loads.
!dequate temperature control during transportation 0ill minimi/e microbial gro0th,
toxin formation and spoilage of the food product.
+ransporting food products and loads of non7compatible materials in one vehicle or
container can lead to contamination of the food product. ! ris. assessment should be
performed to ensure food safet& if this situation occurs.
"arriers that are properl& sealed to the building 0hen loading or unloading 0ill prevent
outside contaminants3pests from entering the establishment.
Proper handling of incoming and outgoing material 0ill prevent damage and
contamination of the food and materials.
:hen loads are not properl& handled, loaded and unloaded, contamination can occur
from a variet& of sources. (or example,
o (or.lifts can puncture holes in product containers leading to the introduction of
microorganisms or ph&sical contaminants-
o 9ncompatible products (e.g., non food chemical product versus food product) can
cross7contaminate each other leading to the introduction of chemical
contamination-
o +emperature abuse from prolonged loading and unloading times can lead to the
gro0th of micro organisms.
'., Purchasing*Recei+ing*Shi""ing and Storage
'.,. Purchasing*Recei+ing*Shi""ing
Re!uirements
'.,..
+he establishment has and implements documented purchasing procedures to ensure that,
food products and food animals are safe to consume and meet regulator& requirements
and prescribed standards
(ootnote 1
-
the follo0ing materials3products are safe and3or suitable for use as intended
(ootnote 2
,
o Pac.aging materials that come in direct contact 0ith food products or ma& come
in contact 0ith food products under the intended conditions of use (indirect
contact). )uch materials include, but are not limited to, the follo0ing, paper
0raps, 0axed cardboard boxes, plastic films, s&nthetic casings, nettings, tra&s,
absorbent pads, pouches and bags.
o "onstruction materials used in rooms 0here food is manufactured, stored,
pac.aged, received or shipped. +his includes materials used for the construction
of floors, 0alls and ceiling surfaces as 0ell as coating and @oint sealants.
o =on7food chemical products coming into contact 0ith food or food contact
surfaces such as processing aids, cleaners, disinfectants, saniti/ers.
Footnotes
(ootnote 1
"ontrol measures that the regulated part& could use to ensure that food products
purchased are safe and compliant 0ith regulator& requirements include,
4equesting food product specifications or, 0hen applicable, food animal producer
information.
)electing federall& registered suppliers.
)electing suppliers that provide certificates of anal&sis at a specified frequenc&.
)electing suppliers that are using a !""P7based s&stem or other preventive
control plan in their production and that provide letters of guarantee at a specified
frequenc&.
)ampling and testing food products received at a specified frequenc&.
(ootnote 2
+he information that demonstrates the acceptabilit& and safet& of the pac.aging
materials, the construction materials and the non7food chemical products mentioned
above must come from at least one of the follo0ing options,
+he existing A4eference 8isting of !ccepted "onstruction %aterials, Pac.aging
%aterials and =on7(ood "hemical ProductsA, published b& the "(9!
Previousl& issued "(9! letters of acceptance3no ob@ection
8etters of guarantee from suppliers3manufacturers
8etters of no ob@ection from ealth "anada, or other references from ealth
"anada
Re!uirements related to 3etters of 0uarantee
Note 1: Responsibility for providing letters of guarantee rests with the firm whose trade or
firm name that appears on the material as it is marketed to the establishment.
Note 2: The documentation supporting letters of guarantee may include, but is not limited to,
chemical migration data, physical characteristics or evidences of approval from other
urisdictions such as the !nited "tates of #merica, $urope or #ustralia%New &ealand.
3etters of guarantee for "ac;aging material 0hich is intended to come in direct or indirect
contact 0ith food products must at least contain the follo0ing information.
+he name of the firm issuing the letter of guarantee and date of issue-
+he identification of the pac.aging material b& brand name or code number-
! statement that the pac.aging material complies 0ith Part 2 5ivision 23 of the
"anadian Food and Drug Regulations-
! statement that the firm 0ill provide all supporting documents to demonstrate that the
pac.aging material meets regulator& requirements 0hen requested b& the "anadian (ood
9nspection !genc& (see note 2)-
+he conditions of use for the food pac.aging material such as,
o 5etails in regard to the use (e.g., direct food contact, t&pe of foods)
o +emperature or state at 0hich the food can be pac.aged (e.g., hot fill temperature,
fresh, fro/en)
o 9f applicable, temperature at 0hich the pac.aged food can be processed (e.g.
thermal process 7 maximum temperature 7 maximum exposure time)
o )tate in 0hich the pac.aged food can be stored (e.g. refrigerated, fro/en)
o 9f applicable, temperature at 0hich food product can be reconstituted in the
pac.age (maximum temperature and exposure time)
o Other pertinent limits
+he signature of an official of the firm providing the letter of guarantee.
3etters of guarantee for construction materials used in rooms 0here food is manufactured,
stored, pac.aged, received or shipped, must at least contain the follo0ing information,
+he name of the firm issuing the letter of guarantee and date of issue-
+he identification of the construction material b& brand name or code number-
! statement that the construction material is cleanable, is free of an& noxious constituents
and 0ill not be a source of food contamination through its life c&cle-
! statement that the firm 0ill provide, 0hen requested b& the "anadian (ood 9nspection
!genc&, all supporting documents to demonstrate that the material is safe and suitable for
use as intended (see note 2)-
:here applicable, directions for use in food establishments-
+he signature of an official of the firm providing the letter of guarantee.
3etters of guarantee for non-food chemical "roducts coming into contact 0ith food or food
contact surfaces must at least contain the follo0ing information,
+he name of the firm issuing the letter of guarantee and date of issue-
+he identification of the non7food chemical product b& brand name or code number-
! statement that the non7food chemical product(s) are safe and suitable for use as
intended in food establishments-
! statement that the firm 0ill provide, 0hen requested b& the "anadian (ood 9nspection
!genc&, all supporting documents to demonstrate that the product is safe and3or suitable
for use as intended (see note 2)-
+he directions for use in food establishments including an& pertinent limits, or reference
to label instructions, if information regarding directions for use is available on the label-
+he signature of the firm providing the letter of guarantee.
3ist of materials and non-food chemical "roducts e<em"ted from the su7mission of a letter
of guarantee
+he follo0ing products ma& be used in federall& registered food establishments 0ithout the need
for 0ritten guarantees. +he use of these products must not directl& or indirectl& contaminate food
products during either their application or storage.
Pac.aging materials that do not come in contact 0ith food products.
Printing in.s and adhesives used on the exterior surface of pac.aging materials such as
shipping containers.
o +hese products are exempted provided that the pac.aging materials on 0hich the&
are applied ensures an adequate functional barrier 0hich precludes an& migration
of the chemical components of the in.s3adhesives to either the food or food
contact surfaces.
Pesticide products.
o Pesticide products must bear a Pest "ontrol Product (P"P) registration number on
the label and be used in .eeping 0ith label instructions to preclude direct or
indirect contamination of food products. +he& are not, under an& circumstances,
to be used in or around food handling areas unless it is specified as such on the
label and registered b& the Pest %anagement 4egulator& !genc&-
"hemical products that do not come into contact 0ith food or food contact surfaces such
as,
o "hemical products used in offices or similar non processing areas-
o "hemical products used in 0ashrooms, cafeterias and lunch rooms-
o "hemical products used in heating s&stems-
o "hemical products used in laboratories-
o "hemical products for outdoor use for se0age or 0aste 0ater s&stems-
o "hemical products used in cooling to0ers or evaporator condensers-
o "hemical products used for the cleaning or maintenance of the exterior of
vehicles-
o "hemical products used for fire protection and securit&.
'.,..,
4eturned, defective or suspect product is clearl& identified and isolated in a designated storage
area, 0here it is assessed to determine the appropriate disposition.
'.,..3
Onl& approved and properl& labelled3identified ingredients, products and materials are received
into the establishment.
9ncoming ingredients, products and materials are assessed at receiving to ensure that their
conditions are satisfactor& and that the purchasing specifications have been met.>
> :here organoleptic inspections are not effective as a means of confirming incoming material
acceptabilit&, certificate of anal&sis and3or letters of guarantee ma& be used as a means to verif&
the commitment made b& the suppliers.
:here applicable, receiving of live animals is controlled as per regulator& requirements.
'.,..-
!ll food safet& specifications or requirements of the finished product have been met prior to
shipping to retail3the customer. (e.g., temperature, certificate of anal&sis)
(inished product is adequatel& protected against intentional or unintentional contamination and
deterioration prior to shipping.
Rationale
Prevention of food, ingredient and pac.aging material contamination begins 0ith control
of incoming materials, including live animals.
9nadequate incoming material controls can result in product contamination, inadequate
processing or misrepresentation of the product.
Pac.aging materials shall not impart an& undesirable substance to the food product, either
biologicall&, chemicall& or ph&sicall& and shall protect the food product sufficientl& to
prevent contamination.
4eturned product left the control of the establishment and ma& have been sub@ected to
improper handling causing contamination or deterioration of the product.
"ontrol of returned food products 0ill prevent the contamination of other products.
"ontrols prior to shipping 0ill demonstrate that the finished product met all
specifications prior to shipping.
'.,., Storage
Re!uirements
'.,.,.
+emperatures of storage areas, processing areas, coolers and free/ers meet regulated and3or
acceptable temperatures.
'.,.,.,
9ngredients, finished products and pac.aging materials are handled and stored in a manner to
prevent damage, deterioration and contamination.
:here appropriate, ingredients and finished products present in processing rooms are managed
in a manner to prevent increase of temperature above regulator& requirements and3or acceptable
validated temperatures.
:here appropriate, rotation is controlled to prevent deterioration.
'.,.,.3
=on7food chemicals are received and stored in a dr&, adequatel& ventilated area 0hich is
designed such that there is no possibilit& for cross7contamination of food, pac.aging materials or
food contact surfaces.
:hen required for ongoing use in food handling areas, non7food chemicals are stored in a
manner that prevents contamination of food, food contact surfaces or pac.aging material.
=on7food chemicals are mixed in clean, correctl& labelled containers and dispensed and handled
onl& b& authori/ed and properl& trained personnel.
Rationale
)toring of foods in an appropriatel& controlled environment 0ill prevent contamination
and deterioration of foods.
+he protection of ingredients, food containers and pac.aging materials during storage
0ill prevent contamination from micro organisms, chemicals and foreign material (e.g.,
dust, insects, 0ood chips).
9ngredients and finished products that are not properl& rotated can reach their expir& date
increasing the ris. for the consumer.
9f chemicals are stored securel& and separatel& from food, ingredients, pac.aging
materials and food contact surfaces, contamination (e.g. spillage, accidental use or
lea.age) 0ill be prevented.
3...3 %C& E!ui"ment
C. E!ui"ment 0eneral
C.. Design = 6nstallation
Re!uirements
C...
*quipment is designed, constructed and installed to ensure that,
it meets regulator& and !""P program requirements-
it is capable of delivering the requirements of the process and the sanitation program-
it is accessible for cleaning, saniti/ing, maintenance and inspection and is easil&
disassembled for those purposes-
contamination of the product and food contact surfaces is prevented during operations-
it permits proper drainage and 0here appropriate, it is connected directl& to drains-
it is smooth, non7corrosive, non7absorbent, non7toxic, free from pitting, crac.s and
crevices 0here there are food contact surfaces-
it is, 0here necessar&, exhausted to the outside to prevent condensation.
Btensils are constructed of non7toxic materials, do not present a foreign material ha/ard that
could contaminate the food, and are eas& to clean and saniti/e.
Rationale
:ell7constructed and maintained equipment 0ill minimi/e the potential for biological,
chemical and ph&sical ha/ards.
Pits, crac.s and crevices can provide areas for residues to accumulate and micro
organisms to gro0.
(ood residues that accumulate can contain allergenic components or microorganisms that
can cause cross7contamination.
Poor installation can result in parts or areas that cannot be properl& cleaned, saniti/ed and
inspected.
*quipment that cannot be adequatel& inspected can result in ha/ards not being detected.
*quipment food contact surfaces that are not suitable for the activities being performed
can impart ha/ards to the products.
*quipment used for cleaning and saniti/ing that is capable of delivering the requirements
of the sanitation program 0ill facilitate a sanitar& environment. (e.g., temperature
indicators, rac.s, reels, hoses, "9P s&stem).
C.., E!ui"ment Maintenance and Cali7ration
Re!uirements
C..,.
+he establishment has and implements a documented Preventative *quipment %aintenance
Program 0hich includes but is not limited to,
! list of equipment that ma& impact on food safet& requiring regular maintenance-
! preventative maintenance schedule or frequenc& of preventative maintenance activities-
+he maintenance procedures to perform for each preventative maintenance tas.-
4ecords to be .ept to demonstrate that the preventative maintenance tas.s have been
completed.
#ote $ +he maintenance procedures are based on the equipment manufacturer?s manual or
equivalent, or are based on operating conditions that could affect the condition of the equipment.
#ote ,$ *quipment and pieces of equipment requiring regular maintenance that must be included
in the Preventative %aintenance Program,
Processing equipment used to prevent, eliminate or reduce the li.el& occurrence of
identified ha/ards. (or example, pasteuri/er.
Pieces of equipment that come in contact 0ith food.
*quipment located above exposed food product that could contaminate food product if
not 0ell maintained.
C..,.,
+he establishment has and implements a documented *quipment "alibration Program 0hich
includes but is not limited to,
! list of equipment monitoring and controlling devices that ma& impact on food safet&
requiring regular calibration-
! calibration schedule or frequenc& of calibration activities-
+he calibration procedures to perform for each calibration tas.-
4ecords to be .ept to demonstrate that the calibration tas.s have been completed.
Note: The calibration procedures are based on the equipment manufacturer's manual or
equivalent.
Rationale
!n effective maintenance program 0ill ensure that equipment performs consistentl& as
intended and prevents contamination of food, ingredients or pac.aging materials.
"ontrolling devices must be accurate because the& are used in critical processes 0hich
impact on food safet&.
3...- %D& Personnel
D. (raining
D.. 0eneral Food Hygiene (raining
Re!uirements
D...
+he establishment has and implements a documented general food h&giene training program
0hich includes but is not limited to,
+he establishment?s general food h&giene program (see 5.2.1.1)-
! list of emplo&ee positions 0ho must receive the training-
o !ll food handling emplo&ees and other emplo&ees that ma& 0or. in food
handling areas (e.g., maintenance staff, qualit& assurance (;!) staff, supervisors,
etc.)
+he frequenc& of training-
o +he training is delivered at the start of emplo&ment, 0henever changes are made
to the program and reinforced at appropriate intervals
4ecords to be .ept to prove completion of personnel training.
Rationale
*stablishment personnel pla& a ma@or role in the production of safe food.
Proper training reduces the ris. of biological, chemical and ph&sical contamination.
+raining increases a0areness of potential ha/ards and the responsibilities that personnel
have to minimi/e contamination ris.s.
D.., (echnical (raining
Re!uirements
D..,.
+he establishment has and implements a documented +echnical +raining Program 0hich
includes but is not limited to,
+echnical training necessar& to implement an& programs or procedures that are part of,
o +he applicable prerequisite programs,
o +he ""P(s), if applicable
o +he process control(s), if
!n& additional external technical training that is necessar& to ensure current .no0ledge
of equipment and process technolog& (e.g., licenses3certification required to operate
equipment 7 pasteuri/er operator?s certification 3 retort operator?s certification)-
! list of emplo&ee positions 0ho must receive the training-
+he frequenc& of training-
o +he training is delivered before the beginning of assignment and reinforced
0henever changes are made and at appropriate intervals
! method to confirm that the training has been effectivel& understood-
4ecords to be .ept to prove completion of personnel training.
Rationale
+raining is delivered to ensure that personnel understand and are competent in procedures
0hich the& are designated to perform.
Proper training reduces the ris. of biological, chemical and ph&sical contamination of
food.
D., 0eneral Food Hygiene Program
D.,. 0eneral Food Hygiene Program
Re!uirements
D.,..
+he establishment has and implements a documented 6eneral (ood &giene Program 0hich
includes, but is not limited to,
6ood %anufacturing and Personnel &giene Practices,
o %ethods for hand 0ashing3saniti/ing-
o "orrect use of protective clothing, hair coverings, gloves, foot0ear-
o Prohibited practices at the establishment-
o &gienic handling of food-
o "orrect use of utensils and equipment-
o )torage of personal effects to prevent cross7contamination-
o :here required, restricted access to areas of the facilities b& specific emplo&ees
to prevent cross7contamination-
o :hen required, procedures to prevent contamination due to the process flo0,
emplo&ee flo0, product flo0, equipment or incompatible operations-
o :hen required, procedures to prevent cross7contamination during production. (or
example,
procedures to follo0 0hen,
product falls on the floor,
product is exposed to dripping condensation-
Procedures for visitors and contractors during production including,
o restricted access,
o h&gienic practices-
Personnel ealth )tatus,
o the program must clearl& state that personnel must advise management 0hen
.no0n to be suffering from a disease li.el& to be transmitted through food-
o no person is permitted to 0or. in a food handling area 0hen he or she is .no0n to
be suffering or a carrier of a disease li.el& to be transmitted through food-
o emplo&ees having open cuts or 0ounds should not handle food or food contact
surfaces unless the in@ur& is completel& protected b& a secure 0aterproof
covering.
Rationale
*stablishment emplo&ees pla& a ma@or role in the production of safe food
*mplo&ees, visitors or contractors that do not follo0 the establishment?s rules can cause
contamination of food.
Personnel suffering from disease through food (e.g., )almonella, epatitis !) can
contaminate the food being produced. +he contaminated food products can transmit the
disease to the consumer.
5eveloping and enforcing a food h&giene program 0ill reduce potential ha/ards and
minimi/e contamination ris.s.
3.... %E& Sanitation and Pest Control
E. Sanitation
E.. Sanitation Program
Re!uirements
E...
+he establishment has and implements a documented )anitation Program 0hich includes but is
not limited to,
+he sanitation schedule3frequenc& for all equipment and for all rooms 0ithin the
establishment including livestoc. holding facilities, utensils, 0aste and inedible3food
0aste equipment and facilities, 0or. gear etc. that, if not .ept in a clean3sanitar&
condition, 0ould have a negative effect on food safet&-
"leaning and saniti/ing procedures including,
o 5etails and specifics describing the method and procedures for equipment and
room cleaning and saniti/ing,
o +he chemicals required,
o +he chemical concentration level required,
o Proper handling and application of chemicals (duration of application, etc.)
o +he chemical solution temperatures, 0here applicable,
o *quipment disassembl& and assembl& instructions,
o %ethods to prevent cross7contamination, 0here necessar&-
ouse.eeping and sanitation procedures required during operations-
Pre7operational inspection procedures-
*nvironmental sampling procedures, if an&-
"orrective actions to be ta.en for non7compliant situations observed during pre7
operational inspection activities and unsatisfactor& environmental testing results-
4ecords to be .ept.
Rationale
9mproper or inadequate sanitation activities can lead to contamination of food,
ingredients, pac.aging materials and food contact surfaces.
+he use of improper chemical concentrations and3or improper chemical application or
rinsing procedures can lead to both chemical contamination (e.g., chemical residue due to
poor rinsing, no7rinse chemicals in excess of approved concentration) and biological
contamination (e.g., bacteria not effectivel& removed from food contact surfaces).
"hemical contamination can also be caused b& allergens that are not effectivel& removed
from food contact surfaces.
"hemical or biological contamination can be caused b& cross7contamination from
cleaning activities during operation.
E., Pest Control
E.,. Pest Control Program
Re!uirements
E.,..
+he establishment has and implements a documented Pest "ontrol Program 0hich includes but is
not limited to,
:here applicable, the name of the pest control compan& or the name of the person
contracted for the pest control program-
+he name of the person at the establishment assigned responsibilit& for pest control-
! schedule or frequenc& of pest control activities-
Pest control procedures for the exterior and interior of the establishment including,
o +he pest control activities to be performed-
o +he chemicals required for the effective implementation of the pest control
program-
o +he methods for proper handling and application of pest control chemicals-
o +he t&pe and location of pest control devices-
o "orrective actions to be ta.en for non7compliant situations observed during pest
control activities,
o 4ecords to be .ept.
Rationale
Pests (e.g., insects, rodents and birds) can contaminate food, ingredients, pac.aging materials
and food contact surfaces. Pests in or around an establishment can lead to contamination from
dropping, larvae and dead insects or animals.
3.../ %F& Recall
F. Recall System
F.. Recall Plan
#ote$ (or detailed information on developing a recall plan, please refer to the "(9! :eb site.
+he "(9! representatives 0ill use the information described on the "(9! :eb site to assess
completeness of the establishment 0ritten recall plan.
Re!uirements
F...
+he establishment has and implements a documented 4ecall Plan 0hich includes but is not
limited to,
=ames of emplo&ees on the 4ecall %anagement +eam including position, contact phone
numbers and responsibilities.
o +he personnel identified b& the operator as responsible for the coordination and
implementation of the recall shall be available for contact 0ith "(9! at an& time
during the food safet& recall.
=otification3"omplaint (ile including,
o 4ecording of the initial notification3complaint information-
o 4ecording of investigation results including the root cause anal&sis-
o 4ecording of investigation results of other products that ma& be affected b& the
ha/ard-
o 4ecording of corrective and preventative actions ta.en based on the investigation
results and root cause(s)-
o 4ecording of verification results of corrective and preventive actions ta.en.
4ecall "ontact 8ist 7 "(9! =otification including,
o title of the "(9! contact-
o contact telephone number-
o contact fax number.
+he "(9! contact must at least include the !rea 4ecall "oordinator of the
"(9! in the !rea 0here the recalling establishment is located-
%ethods to trace product.
o %aintain product identification throughout the process until final pac.aging,
including,
ra0 ingredient tracing-
premixing of ingredients ahead of use-
re0or..
o "oding s&stem documentation.
"ode mar.s used and the exact meaning of the code.
%ethod(s) to record the amount of each lot code of each product produced.
5istribution records and distribution record s&stem for each lot of product including,
o name of the account and address-
o t&pe of account (e.g., manufacturer, distributor, retailer)-
o product name and lot code-
o 0ho to contact at the account-
o telephone number and other contact numbers consistent 0ith the documented
method of contact during the recall (e.g. fax number, e7mail address)-
o amount of product shipped to each account.
=ote, !ll distribution records must be up7to7date, legible, accurate and properl&
filed. +hus, there should be no time dela& in providing documents to the "(9!.
(urther, as the "(9! must be able to evaluate and use the product distribution
records in an efficient and timel& manner, it is preferred that all distribution
records be provided in a commonl& accessible format li.e %) *xcel, %) !ccess,
or C%8. )hould the distribution records be pass0ord protected it 0ill be
necessar& to include the pass0ord 0ith the provided records.
)tep b& step recall procedures 0hich 0ill be follo0ed during a recall, including,
o !ssemble the recall management team-
o 9mmediate notification of the "(9! 4ecall "oordinator in the area 0here the
recalling establishment is located. +he notification must include
a detailed description of the nature of the problem
the name, brand, si/e, code or lot numbers affected
details of complaints received and an& reported illnesses
the distribution of the product 7 local or national
0hen 0as the product distributed (specific dates)
label(s) of the product(s) 0hich ma& be recalled
the total quantit& of product produced, in inventor& and distributed
the name of the establishment?s contact 0ith the "(9!
the name and telephone number(s) for the establishment after7hours
contact
o 9dentif& all products to be recalled-
o 5etain and segregate all products to be recalled 0hich are in the establishment?s
control-
o Prepare the press release, if required-
o Prepare the distribution list-
o Prepare and distribute the notice of recall-
o #erif& the effectiveness of the recall-
o 5ocument the follo0ing actions,
"ontrol of the recalled product(s)-
5isposition of the recalled product(s)-
9dentif& and correct the cause of the recall if the problem occurred at the
establishment.
%ethods to assess the effectiveness of the establishment?s recall notification.
Procedures for testing the recall plan.
o Procedures used to confirm current information for the people on a recall contact
list and to verif& the capabilit& of the program to rapidl& identif& and control a
code lot of product and reconcile the amount of product produced, in inventor&
and in distribution
4ecords to be .ept in case of recalls.
Rationale
(ood recalls can be triggered b& a number of ha/ards 0ithin or external to a facilit&.
;uic.l& re7gaining control of implicated lots of product is crucial in preventing the ris.
of ha/ard to consumers.
F.., Product Coding and 3a7elling
Re!uirements
F..,.
+he establishment has and implements documented operational procedures to ensure that,
finished products are correctl& and legibl& coded-
the finished product label information accuratel& represents the product name and the
composition of the product on 0hich the label is affixed.
+he procedure to prevent incorrect labelling3coding shall include but is not limited to,
the names or title of personnel responsible for particular tas.-
frequenc& of activit&-
description of the tas. to be performed-
corrective actions to be ta.en 0hen product is mislabelled or miscoded-
operational records to be .ept.
Rationale
(ood product must be correctl& labelled to enable the next person in the food chain to
handle, displa&, store, and use the product safel&.
9ncorrectl& coded expir& dates can result in consumers storing the product past the
intended shelf life, leading to potential food safet& ha/ards.
9ncorrect labelling or coding can ma.e product recall difficult or unfeasible if a ha/ard is
associated 0ith the mislabelled or miscoded product.
3...2 %0& 1"erational Prere!uisite Programs
0. Allergens) #utrients) Food Additi+es and Processing Aids
0.. Allergen Control Program
(or h&persensitive individuals, certain foods and their derivatives can cause allergic reactions.
(ood allerg& is an abnormal immune response to proteins found in food. !llergic reactions
cannot occur in the absence of proteins. +hese proteins (antigens) are capable of stimulating the
production of antibodies in the bod&, thereb&, triggering allergic reactions. 9mmediate response to
an allergic reaction can range in severit& from a s.in rash or itching of the mouth, to migraine
headaches, a drop in blood pressure, anaph&laxis (a ver& severe allergic reactions to food
involving failure of multiple organ s&stems), and death. +here is no cure for food allergies and
the onl& 0a& for an allergic individual to protect themselves is strict avoidance of the allergen.
+his sub7element outlines the requirements that an !llergen "ontrol Program must meet to
control the use of ingredients identified as allergens in an establishment, as 0ell as to prevent or
identif& the presence of undeclared allergen ingredients in finished food products.
Bnli.e microbial ha/ards, there is no lethalit& or post processing step that 0ill reduce or
eliminate the presence of undeclared allergens in food products. !llergen ha/ard control is
dependent on prevention throughout the process as 0ell as appropriate product labelling to
ensure full disclosure of a product?s contents.
+he list of the priorit& food allergens is available on the "(9! 0ebsite.
!lthough sulphites are not considered to be true allergens, for sensitive persons the& produce an
adverse reaction 0hich can be life threatening. 9t is the serious outcome of the reaction that has
resulted in the inclusion of sulphites on the priorit& allergen list.
9ngredients 0hich can cause non7immune reactions such as lactose intolerance should be
considered 0hen developing this control program.
! compan& ma& have to identif& additional allergens of specific concern to its product or its
target mar.et. %anufacturers exporting outside of "anada should be a0are that the list of priorit&
allergens in other countries ma& be different from those listed in "anada.
#1(E $ *ach of the requirements outlined belo0 ma& not be applicable to an establishment. 9n
cases 0here an operator determines that a certain requirement does not appl&, the result of the
ris. assessment must be available for "(9! revie0.
#1(E ,$ 4eference to existing prerequisite programs or ""Ps that cover the requirements
mentioned in this section is acceptable. +he purpose of the allergen control program is to gather
all of the allergen controls in one location in the !""P s&stem.
Re!uirements
0...
:here applicable, documented procedures and3or policies are developed and implemented to
ensure proper control of ne0 or modified product formulations. +his must include a minimum
of,
! product development and approval process flo0 including steps to be follo0ed 0hen
modifications to existing product formulations are made-
"ommunication lin.s among all the steps in the chain of production once a ne0
formulation or changes in a formulation have been approved.
0...,
:here applicable, documented procedures and3or policies related to purchasing of ingredients
are developed and implemented to ensure proper control and identification of allergens for
incoming ingredients. +his must include a minimum of,
identification of an& allergens not allo0ed in an establishment if such a polic& is in place-
a list of approved suppliers and ingredients-
supplier specification for each ingredient or ingredient blend clearl& listing each
ingredient and, 0here applicable, components of ingredients-
documentation indicating that the supplier 0ill,
o meet the establishment?s specifications-
o notif& the establishment 0hen a change is made to their ingredient blend formula
0hich adds or eliminates an allergen or in the case of sulphites, increases or
decreases the level of sulphites.
0...3
:here applicable, documented procedures and3or policies are developed and implemented to
ensure proper control of ne0 or modified labels. +his must include a minimum of,
a label approval process including steps to be follo0ed in case of re7approval of product
labels resulting from modifications to existing product formulations-
communication lin.s among all the steps in the chain of production once a ne0 label, or
changes to a label, have been approved.
0...-
:here applicable, documented procedures and3or policies related to receiving of ingredients and
externall& printed labels are developed and implemented to ensure that,
onl& approved ingredients from approved suppliers3sources are received-
the labels of approved ingredients received match the establishment?s finished product list
of ingredients and components of ingredients-
+he mandator& requirements that appear on externall& printed labels are accurate.
0....
:here applicable, documented procedures associated 0ith
:eighing32lending3%ixing3(ormulation are developed and implemented to ensure that the
correct ingredient is added to the correct product as indicated in the formula. +his must include a
minimum of,
the names or titles of personnel responsible for these particular tas.s-
methods or instructions for the tas.(s) to be performed-
corrective actions to be ta.en 0hen deviant situations occur during an& of these steps-
operational records to be .ept.
0.../
:here applicable, documented procedures and3or policies related to the use of re0or. are
developed and implemented to ensure that the re0or. formulation ingredients and the product
formulation ingredients match, specificall& as it applies to allergen ingredients.
0...2
:here applicable, documented procedures related to labelling of finished product are developed
and implemented to ensure that the finished product label information accuratel& represents the
product name and the composition of the product on 0hich the label is affixed. +his must include
a minimum of,
the names or title of personnel responsible for particular tas.s-
frequenc& of activit&-
methods or instructions for the tas.(s) to be performed-
corrective actions to be ta.en 0hen product is mislabelled-
operational records to be .ept.
0...>
:here applicable, documented procedures and3or policies for disposal of obsolete materials are
developed and implemented to prevent their inadvertent use. Obsolete materials include,
labels (refers to an& pre7printed pac.aging that bears a list of ingredients)-
formula documents-
ingredients and 0or. in process.
0...?
:here applicable, documented procedures and3or policies are developed and implemented to
control cross7contamination of undeclared allergens in the food products. Procedures include as a
minimum, the management and control of,
production scheduling if dedicated lines for allergens are not available-
traffic patterns of emplo&ees 0ho handle allergens and non allergens-
the traffic flo0 and handling of ingredients containing allergens during receiving, storage,
processing and pac.aging-
dedicated or segregated storage of ingredients containing allergens-
the identification and sanitation of bul. containers housing allergens or ingredients
containing allergens-
dedicated utensils, equipment and areas used to handle allergens-
the handling and storage of re0or. product(s) containing allergen ingredients-
cleaning of equipment3food contact surfaces3areas during operations if dedicated
lines3equipment3areas for allergens are not available.
Rationale
"onsumers 0ho have food allergies and intolerances rel& on accurate label information
on food products to avoid eating foods that contain ingredients to 0hich the& ma& be
sensitive.
9f these foods, or their derivatives, are undeclared or declared incorrectl& on the label, or
if inadvertent cross7contamination occurs during production, the results can be serious
and sometimes fatal.
0.., Food Additi+es and #utrients
Re!uirements
+his sub7element applies to three operational activities requiring control measures.
1. +he use of food additives identified in ealth "anadaDs 8ists of Permitted (ood !dditives
for 0hich a maximum level of use is determined. (+he 1' lists of permitted food additives
are meant to replace the food additive tables housed under 5ivision 1E of the Food and
Drug Regulations.)
2. +he use of nutrients listed in Part 5 7 #itamins, %inerals and !mino !cids of the Food
and Drug Regulations for 0hich a minimal and maximal amount is specified in Part 2 of
the 4egulations.
3. +he use of modified atmosphere pac.aging s&stems.
o %odified atmosphere pac.aging, an& atmosphere in an enclosed pac.age 0hich
differs from normal atmospheric air mixtures. +his includes vacuum pac..
0..,.
:here applicable, documented procedures associated 0ith (ormulation and !ddition of food
additives and nutrients are developed and implemented to ensure that the concentrations remain
0ithin the allo0able parameters specified in the Food & Drug Regulations. +his must include a
minimum of,
the name of the food additive or nutrient-
the food product in or upon 0hich the food additive or nutrient is added-
the standards to be met (limit of acceptabilit& 7 maximum and, 0hen applicable,
minimum amount)-
the names or titles of personnel responsible for particular tas.s at the formulation and
food additives or nutrients addition steps-
the methods or instructions for the tas.(s) to be performed-
the frequenc& of the tas.(s) to be performed-
the corrective actions to be ta.en 0hen the standards are not met-
the operational records to be .ept.
0..,.,
:here applicable, documented procedures associated 0ith modified atmosphere pac.aging
s&stems are developed and implemented to ensure that the standards defining the modified
atmosphere are met. +his must include a minimum of,
a description of the modified atmosphere pac.aging s&stem used-
the standards to be met (e.g. gas mixture, vacuum, seal integrit& of pac.age)-
the names or titles of personnel responsible for particular tas.s at the modified
atmosphere pac.aging step-
the methods or instructions for the tas.(s) to be performed-
the frequenc& of the tas.(s) to be performed-
the corrective actions to be ta.en 0hen the standards are not met-
the operational records to be .ept.
Rationale
(ood additives are regulated in "anada under the Food and Drug Regulations. !ll
permitted food additives and their conditions of use are identified in ealth "anadaDs
8ists of Permitted (ood !dditives 0hich are available on ealth "anadaDs 0ebsite. *ach
authori/ed food additive has been rigorousl& evaluated b& scientists from ealth "anada.
+he authori/ed food additives do not pose a ha/ard to the health of the consumers if used
according to the regulations.
+he addition of vitamins and minerals to food in "anada is controlled b& the Food and
Drug Regulations and onl& food fortified 0ith certain nutrients, and to levels specified in
the Regulations, ma& be sold in "anada. +he food manufacturers must control the
addition of vitamins and minerals to ensure that consumers receive the nutrients the&
need but are not exposed to levels that are dangerousl& high.
!s per the ealth "anada polic& for differentiating food additives and processing aids, a
reactive gas that can interact 0ith a food constituent is an example of a substance that is
considered to be a food additive because of the technical effect on the food, even if there
is no residue of the gas in or on the finished food. +he gas affects the characteristics of
the food such that the finished food that is offered to the consumer is not in the same state
it 0ould have been if the gas had not been used. +he food manufacturers are responsible
for ensuring that the use of a modified atmosphere pac.aging s&stem does not create a
food safet& ris. during the pac.aging step and for the duration of the intended shelf life.
0..3 Food Processing Aids
Re!uirements
+his sub7element applies to food processing aids for 0hich maximum levels of use have been
established b& ealth "anada.
9n order to avoid confusion, please consult the ealth "anada polic& for differentiating food
additives and processing aids at the follo0ing lin..
0..3.
:here applicable, documented procedures associated 0ith steps 0here food processing aids are
used are developed and implemented to ensure that the concentrations remain 0ithin the
allo0able parameters specified for the use of that particular processing aid. +his must include a
minimum of,
+he identification of the step(s) 0here food processing aids are used-
the name of the food processing aids used-
the standards to be met (limit of acceptabilit&)-
the names or titles of personnel responsible for particular tas.s at the identified steps-
the methods or instructions for the tas.(s) to be performed-
the frequenc& of the tas.(s) to be performed-
the corrective actions to be ta.en 0hen the standards are not met-
the operational records to be .ept.
Rationale
+he food chemicals considered as processing aids are evaluated and approved b& ealth
"anada. +hese food chemicals do not pose a ha/ard to the health of the consumers if used
according to the conditions of use approved b& ealth "anada. +he food manufacturers
are responsible to ensure that the conditions of use are respected.
0., Foreign Material Control Program
0.,. Foreign Material Control Program
Note: Reference to existing prerequisite programs or !s that cover the requirements
mentioned in this section is acceptable.
Re!uirements
0.,..
:here applicable, the establishment has and implements documented procedures to control the
contamination of product b& foreign material. +his ma& include but is not limited to the
follo0ing elements.
Procedures related to the control of pieces of equipment that can be a source of potential
contamination such as .nives, needles or cheese 0ires.
Procedures related to the handling of glass, brittle plastic, ceramic and or other similar
materials 0hich present a ris. of brea.age and contamination of products.
2rea.age procedures 0here products are pac.ed into glass or other brittle materials.
Procedures related to the visual inspection of food products.
Procedures related to the use of 0ood 0here 0ood cannot be avoided.
0.,..,
:here applicable, the establishment has and implements a documented program for monitoring
equipment such as filters, sieves, magnets, metal detectors, x7ra& equipment, optical sorting
equipment, scanner technolog&, in7line container cleaning, etc. that is3are used to detect and3or
remove foreign materials. +he program includes but is not limited to,
! list of foreign material detection and3or removal equipment used at the establishment
:here applicable, the sensitivit& of detectors and best practices that must be applied to
reach this sensitivit& (e.g. the nature of the food, si/es of food, pac.aging, location of
equipment, speed of lines, potential environmental effects, etc.)
:here applicable, the mesh and3or gauge si/e of filters and sieves
:here applicable, the strength of magnets
+he names or titles of personnel responsible for ensuring that the equipment is 0or.ing
effectivel&
+he methods, instructions or procedures for tests or observations to be performed
+he frequenc& of the tests or observations to be performed
+he corrective actions to be ta.en on the equipment and on the product 0hen the
equipment is not 0or.ing effectivel&>
+he record(s) to be completed
+he program shall also include procedures to follo0 0hen products are re@ected b& detection
s&stems or 0hen foreign materials are removed b& removal s&stems. +he procedures include but
are not limited to,
"ontrols3mechanisms in place to ensure that the re@ected product is effectivel& segregated
and managed
+he names or titles of personnel responsible for examining an& re@ected products or
removed foreign materials, investigating the cause of the re@ection and the presence of
foreign material, and appl&ing corrective measures>>
%ethods or instructions for examination of re@ected products
+he record(s) to be completed.
>:hen a detector is discovered not to be 0or.ing during a test, the corrective actions must
include a combination of segregation and re7inspection of all products that have passed through
the detector since it 0as last tested to be 0or.ing. :here defective filters, sieves or magnets are
identified, the potential for contamination of products shall be investigated and appropriate
actions ta.en.
>> 9ncluding anal&sis of the results of the investigation performed on re@ected product to
determine if trends exist (i.e., multiple false re@ections) that ma& suggest an error 0ith the
detector or indicate that the settings are too sensitive for a particular product and require
ad@ustment.
=ote, "alibration and maintenance of equipment used to detect and3or remove foreign materials
are covered under 3.1.1.3 7 ".1.2 *quipment %aintenance and "alibration.
Rationale
+he ris. of product contamination are prevented, reduced or eliminated b& the effective use of
equipment to detect3remove foreign materials and3or the implementation of other control
procedures.
3.., Monitoring "rocedures %for "rere!uisite "rograms&
5ocumented monitoring procedures shall be established for each prerequisite program bullet and
shall specif& an& tests, measurements or observations to assess 0hether,
the programs, policies, standard operating procedures and tas.s defined or referenced in
the prerequisite programs are effectivel& implemented-
the standards are met.
+he monitoring procedure shall at least include,
=ame or title of personnel responsible for the monitoring and evaluation of monitoring
results-
%onitoring frequenc&-
+he standard(s) to be met-
%ethods or instructions for testing, measurements or observations to be performed-
*xact title of the record(s) used to document monitoring results-
4ecord .eeping instructions (see section 3.1.$).
+he monitoring frequenc& must,
be auditable3measurable (i.e., as required is not auditable)-
provide effective control to ensure the prerequisite program requirements are consistentl&
met-
be at a minimum of once per &ear.
)tandards are criteria or specifications that can be @udged or evaluated and that define the limit of
acceptabilit& associated 0ith a prerequisite program requirement. "riteria must be measurable.
+hese ma& either be quantitative (e.g., degrees) or qualitative (e.g., no holes in the carrier,
product is stored off the floor). "riteria must be clearl& described to be easil& understood and
uniforml& applied b& those responsible for monitoring.
+here ma& be specific regulator& standards that appl& to specific prerequisite program
requirements. +he establishment ma& require higher standards than the existing regulator&
requirements. 9n this case, the "(9! staff 0ould verif& compliance to the regulator& standards.
+o ensure validit& of results, tests, methods and instructions must be described in enough detail
to ensure consistenc& in deliver& bet0een different monitors.
3..3 De+iation "rocedures %for "rere!uisite "rograms&
5ocumented deviation procedures shall specif& an& planned or appropriate corrective actions to
be ta.en 0hen monitoring results demonstrate that,
the programs, policies, standard operating procedures and tas.s defined or referenced in
the prerequisite programs are not effectivel& implemented-
the standards are not met.
+he deviation procedure shall at least include,
=ame or title of personnel that have the responsibilit& and authorit& to ta.e actions.
9nstructions on corrective actions to be ta.en.>
*xact title of the record(s) used to describe the deviation and to document all actions
ta.en in response to a deviation.
4ecord .eeping instructions (see section 3.1.$).
> +he deviation procedure for prerequisite programs shall at least instruct the responsible
emplo&ees to perform and document the follo0ing activities,
5escribe the deviation and its cause.
+a.e immediate actions to control affected or potentiall& affected product.>>
9mplement corrective actions to restore control of the prerequisite program
requirement(s).
#erif& the effectiveness of corrective actions ta.en.
*valuate the need to implement additional measures to prevent reoccurrence of the
deviation.>>>
#erif& effectiveness of preventative measures if ta.en.
>> :hen product is affected or potentiall& affected, the individual 0ith authorit& shall,
Prevent the on7going production of non7compliant product-
"ontrol the non7compliant product that has been produced-
!ssess if other products are implicated in relation to the cause of the deviation-
Perform an assessment of the affected product to determine if the product ma& be
released (see section 3.2.1.3.1)-
5etermine the disposition of noncompliant product (see section 3.2.1.3.2).
>>> Preventative measures shall be applied 0hen,
Product is affected or potentiall& affected-
4epeated deviations are noted during monitoring activities 0hich ma& indicate a trend
to0ard a loss of control.
3..- Record ;ee"ing %for "rere!uisite "rograms&
4ecords shall be .ept to demonstrate the effective application of the prerequisite programs and to
facilitate official verifications b& the "(9! or other competent authorit&. 4ecords shall be
established to document,
+he monitoring results, including the recording of actual quantifiable values (e.g.,
temperature), 0hen applicable-
!ll information and actions ta.en in response to a deviation identified as a result of
monitoring.
4ecords must be up7to7date, legible, accurate and properl& filed.
*ach monitoring record and3or action ta.en in response to a deviation shall be signed or initialed
b& the emplo&ee ma.ing the entr& using a permanent in. pen or, 0hen computer records are
used, the record ma& be signed electronicall&. %onitoring records and3or action ta.en in response
to a deviation shall be dated.
5eviation records shall identif& a target date for completion of preventative measures.
!n& incorrect entr& made to a record and subsequentl& changed shall be crossed out and initialed
b& the emplo&ee ma.ing the change.
3., HACCP "lan%s&
*stablishments shall conduct a complete ha/ard anal&sis for all of their processes and products in
order to identif& and control all ha/ards effectivel&.
! !""P Plan is a 0ritten document designed in accordance 0ith the follo0ing steps to ensure
control of food safet& ha/ards 0ithin an establishment.
+here are 12 steps to developing each !""P plan. +hese steps are as follo0s,
1. !ssemble the !""P team
2. 5escribe the product and identif& its intended use
3. 8ist product ingredients and incoming material
$. "onstruct a process flo0 diagram and confirm its accurac&
'. "onstruct a plant schematic and confirm its accurac&
E. 9dentif& and anal&/e ha/ards (Principle 1)
1. 5etermine critical control point(s) (""P) and other control measures i.e. process control
(P") and prerequisite programs (PP) (Principle 2)
F. *stablish critical limits for ""P (Principle 3)
G. *stablish monitoring procedures for ""P (Principle $)
1H. *stablish deviation procedures for ""P (Principle ')
11. *stablish verification procedures for ""P (Principle E)
12. *stablish record .eeping for ""P (Principle 1)
)teps 1 to ' are preliminar& steps to enable ha/ard anal&sis. )teps E to 12 incorporate the 1
principles of !""P developed b& the "odex !limentarius "ommission.
!ll relevant information needed to conduct the preliminar& steps, the ha/ard anal&sis, and the
establishment of the critical control points and process controls shall be documented, updated
0henever there are changes, and reassessed at least annuall&.
()*P has created specific forms that can be used for the documentation of a !""P plan. 9f an
establishment uses other documentation than the one describe belo0 to capture the "odex
!limentarius !""P approach, the content must be equivalent and meet the requirements of
this manual.
+he ()*P7!""P Plan forms are,
(orm 1, Product 5escription
(orm 2, 8ist of Product 9ngredients and 9ncoming %aterial
(orm 3, Process (lo0 5iagram
(orm $, Plant )chematic
(orm ', 2iological a/ard 9dentification
(orm E, "hemical a/ard 9dentification
(orm 1, Ph&sical a/ard 9dentification
(orm F, 5ecision +ree 7 ""P determination and other "ontrol %easures (PP, P")
(orm G, a/ards =ot "ontrolled b& the establishment
(orm 1H, "ritical "ontrol Point(s)
(orm 11, Process "ontrol(s), 0hen applicable
2lan. template forms, including an example of an alternative form that 0ill allo0 for the
combination of forms ', E, 1, F and G can be found in section 3.'.
9n performing the step b& step anal&sis above, the !""P team ma& determine that several
products share similar ha/ards, processing steps or equipment. 9n that case, the !""P team
ma& group these products or processes into one !""P plan.
9f an establishment chooses to group dissimilar processes or products into one !""P plan, the&
0ill be required to demonstrate to the "(9! that the !""P plan identifies and controls all
potential ha/ards to each process or product.
3.,. Descri7e "roduct and identify its intended use %Form &
+he description of finished products shall be documented in form 1 or equivalent to the extent
needed to conduct the ha/ard anal&sis, including information on the follo0ing, as appropriate,
Process3product t&pe name-
Product name-
9mportant product characteristics-
9ntended use-
Pac.aging-
9ntended shelf life and storage conditions-
:here the product 0ill be sold-
8abelling instructions relating to food safet&-
)pecial distribution control.
+he !""P team shall identif& regulator& food safet& requirements related to the above.
3.,.. Process*"roduct ty"e name
+he generic or common name of the product famil& or process covered b& the !""P plan shall
be documented in form 1 or equivalent.
3.,.., Product name
+he brand name and3or common name of the individual products covered b& the !""P plan
shall be documented in form 1 or equivalent. 4eference to a list of product names is acceptable.
3.,..3 6m"ortant "roduct characteristics
+he ph&sio7chemical characteristics of the product (such as p, !0, salt content, concentration
of preservatives, etc.) that could affect food safet& if not properl& controlled shall be documented
in form 1 or equivalent.
3.,..- 6ntended use
+he intended use is based on the expected uses of the product b& the end user (e.g., read&7to7eat
food product, read&7to7coo., for further processing).
+he intended use shall be described in form 1 or equivalent.
3.,... Pac;aging
!ll t&pes of pac.aging to be used b& the establishment for the final product (e.g., drums, pails,
cr&ovac bags, modified atmosphere, hermeticall& sealed) and their applicable si/e (e.g.,
consumer7si/e, bul. pac.s destined for further processing) shall be documented in form 1 or
equivalent to enable ha/ard anal&sis.
! reference to a list of t&pes of pac.aging and applicable si/es is acceptable.
3.,../ 6ntended shelf life and storage conditions
+he intended shelf life of the product under normal mar.eting conditions at a given storage
temperature and, 0here applicable, humidit& shall be documented in form 1 or equivalent to
enable ha/ard anal&sis.
:hen establishing product shelf life, it is the responsibilit& of the manufacturer to ensure and to
demonstrate that the safet& of the food product can be retained throughout the maximum period
specified.
3.,..2 5here the "roduct 8ill 7e sold
+he points of sale, target groups of users and, 0here appropriate, more specific groups of
consumers shall be identified on form 1 or equivalent for each product (e.g., retail, general
population, infants, hospital). %ore specificall& consumer groups .no0n to be especiall&
vulnerable to specific food safet& ha/ards shall be considered.
3.,..> 3a7elling instructions related to food safety
!n& labelling instructions for handling, preparation and usage 0hich have an impact of food
safet& shall be identified in form 1 or equivalent (e.g., coo.ing and storage instructions, best
before date).
3.,..? S"ecial distri7ution control
)pecial controls required during transportation and storage (e.g., temperature, humidit&) shall be
documented in form 1 or equivalent.
3.,., 3ist "roduct ingredients and incoming materials %Form ,&
!ll ingredients, including composition of formulated ingredients (0ith reference to other
documents if needed), additives, processing aids and incoming materials that come in contact
0ith the product or are used in preparing the product shall be described in form 2 or equivalent,
to the extent needed to conduct the ha/ard anal&sis.
Particular care must be ta.en for additives, processing aids and ingredients (including second
generation ingredients), that have received regulator& approval for specific products onl&.
3.,.3 Construct a "rocess flo8 diagram and confirm its accuracy %Form 3&
(lo0 diagram(s) shall be prepared for the product(s) or process categories covered b& the
!""P plan. (lo0 diagrams shall provide a basis for evaluating the possible occurrence or
introduction of and3or increase in food safet& ha/ards.
(lo0 diagrams shall be clear, accurate and sufficientl& detailed. (lo0 diagrams shall, as
appropriate, include,
+he sequence and interaction of all steps in the operation from receiving to final
shipping-
+he introduction of ingredients and intermediate products into the process flo0-
+he introduction of product for re0or.ing.
+he !""P team shall verif& the accurac& and completeness of the flo0 diagrams b& on7site
chec.ing.
3.,.- Construct a "lant schematic and confirm its accuracy %Form -&
! plant schematic shall be prepared for the products or process categories covered b& the
!""P plan. Plant schematic provides a basis for evaluating potential areas of cross7
contamination b& pathogens, foreign materials, chemicals or allergens.
Plant schematic shall be clear, accurate and sufficientl& detailed. Plant schematic shall at least
include,
+he flo0s of ra0 products, ingredients and finished products.
+he flo0s of pac.aging materials.
+he emplo&ee traffic pattern throughout the establishment including change rooms,
0ashrooms and lunchrooms.
+he flo0s of the 0aste, inedible products, chemicals, and other non7food products that
could cause cross7contamination.
+he hand3boot 0ashing and saniti/ing installations.
+he !""P team shall verif& the accurac& and completeness of the plant schematic b& on7site
chec.ing.
+he overall evaluation of potential areas of cross7contamination at the establishment should
include an& other plant schematic from other !""P plan(s).
3.,.. 6dentify and analy9e ha9ards %HACCP Princi"le & %Forms .) /) 2&
+he ha/ard identification shall be based on,
+he information collected according to 3.2.1 to 3.2.$.
*mplo&ees? .no0ledge and experience on practical aspects of the establishment
operations.
5ocumented production issues such as files on production re0or., returned products,
product complaints and recalls.
*xternal information including reference texts, scientific publications, and government
guides such as the "(9!?s 4eference 5atabase for a/ard 9dentification.
9f biological (2), chemical (") or ph&sical (P) ha/ards associated 0ith the ingredients and
incoming materials are identified, the letters 2, " or P shall be indicated in form 2 or equivalent
beside each corresponding ingredient or incoming material. +he ha/ards shall be full& described
in forms ', E, 1 or equivalent.
9f biological, chemical or ph&sical ha/ards associated 0ith the processing steps are identified, the
letters 2, " or P shall be indicated in form 3 or equivalent beside each corresponding step. +he
ha/ards shall be full& described in forms ', E, 1 or equivalent.
9f biological, chemical or ph&sical ha/ards associated 0ith cross7contamination points are
identified, the letters 2, " or P shall be indicated in form $ or equivalent at the corresponding
cross7contamination point. +he ha/ards shall be full& described in forms ', E, 1 or equivalent.
3.,./ Determination of CCP and other control measures %HACCP Princi"le ,&
%Form >&
(or each ha/ard identified, an anal&sis shall be conducted to determine,
+he li.el& occurrence of the ha/ard.
+he severit& of possible adverse health effect associated 0ith the ha/ard.
9f the identified ha/ard is controlled b& prerequisite programs.
9f the identified ha/ard is partiall& controlled b& a process control.
9f the identified ha/ard is controlled at a ""P.
9f the identified ha/ard is out of the establishment?s control.
+he establishment shall use (orm F or equivalent to document the ha/ard anal&sis as 0ell as the
prerequisite programs, the process controls (P") and the ""P selected to control the food safet&
ha/ards identified.
!ll P"(s) and ""P(s) associated 0ith the processing steps shall be indicated beside the
corresponding step in form 3 or equivalent.
#ote$ +o facilitate verification b& "(9! representatives, ()*P recommends establishments
number the ""P sequentiall& and identif& the ha/ard(s) each controls i.e., 2 for biological, " for
chemical, P for ph&sical ha/ards. (e.g., ""P172"P, ""P272).
3.,./. @sing form > - decision tree - CCP determination and other control measures %PP)
PC&
Form > - Column
8ist each ingredient and incoming material, process step and cross7contamination point 0here a
ha/ard has been identified. Bse one line per ha/ard.
Form > - Column ,
"ategori/e (biological, chemical, ph&sical) and full& describe each of the identified ha/ards.
:here multiple ha/ards exist at one point, each ha/ard should be anal&/ed separatel&.
(or each ha/ard, determine 0hether it is full& controlled b& one or more prerequisite programs.
9f the ans0er is &es, identif& the prerequisite program bullet(s) that provides full control over this
ha/ard.
+o assess 0hether the ha/ard is full& controlled b& a prerequisite program, the !""P team
must first revie0 the documented 0ritten program(s) for the specific bullet(s). +he& must then
conduct a record revie0 and on7site observations to ensure that the policies and procedures in
place provide effective control over the ha/ard identified in the !""P plan.
9f the !""P team determines that the ha/ard is not full& controlled b& a prerequisite program,
proceed to ;uestion 1.
Form > - :uestion
;1. "ould a control measure(s) be used b& the establishment at an& process stepI
"ould a control measure occur at this step 7 or at an& other process step 7 to control the ha/ardI
5oes the establishment have or could the& add a process step to control the ha/ardI
9f the ans0er is &es, describe the control measure and proceed to ;2.
9f the ans0er is no (a control measure cannot be implemented at a process step), identif& ho0 the
ha/ard 0ill be controlled before or after the manufacturing process on (orm G or equivalent and
proceed to the next identified ha/ard.
Form > - :uestion ,
;2. 9s it li.el& that contamination 0ith the identified ha/ard could occur in excess of the
acceptable level or could increase to an unacceptable levelI
;uestion 2 refers to the probabilit& and seriousness of the ha/ard. 9f there 0ere no controls in
place, ho0 li.el& is this ha/ard to occur in excess of acceptable levelsI>
> !cceptable level 7 +he level at 0hich the finished product 0ill not cause harm to the consumer
0hen it is prepared and3or consumed according to its intended use.
"onduct a ha/ard anal&sis based on all the information that the !""P team has gathered.
9f information gathered suggests that contamination 0ith the identified ha/ard could increase to
an unacceptable level and result in a health ha/ard, ans0er &es and proceed to ;uestion 3.
9dentif& the acceptable level of the food safet& ha/ard in the finished product, 0herever possible.
9f contamination is not li.el& to occur, or is not .no0n to affect the safet& of the product, ans0er
no and proceed to the next identified ha/ard. (or further reference, the !""P team must
document the reasons for ans0ering no.
Form > - :uestion 3
;3. 9s this process step specificall& designed to prevent, eliminate or reduce the li.el&
occurrence of the identified ha/ard to an acceptable levelI
9f the process step has been specificall& designed to prevent, eliminate or reduce the li.el&
occurrence of the ha/ard to an acceptable level, ans0er &es. 5esignate this process step as a ""P
and identif& it in the last column. 9f the ans0er is no, proceed to ;uestion $.
#ote$ ;uestion 3 applies onl& to processing steps. (or incoming materials, 0rite not applicable
(=3!) and proceed to ;uestion $.
Form > - :uestion -
;$. :ill a subsequent step eliminate the identified ha/ard or reduce its li.el& occurrence to an
acceptable levelI
!ns0er no if no subsequent processing steps listed on the process flo0 diagram 0ill eliminate or
reduce the ha/ard to an acceptable level. 5esignate this process step a ""P and identif& it in the
last column and proceed to the next identified ha/ard.
9f the ans0er is &es, identif& the subsequent step or steps that control the ha/ard. +hen proceed to
;uestion '.
Form > - :uestion .
;'. 5oes this step provide partial control of the identified ha/ardI
9f the ans0er is &es, this process step is a process control. *nter the process control number in the
last column then proceed to the next identified ha/ard. 9f the ans0er is no, proceed to the next
identified ha/ard.
3.,./., Ha9ards not controlled 7y the esta7lishment %Form ?&
!ll ha/ards that affect the establishment products shall be anal&/ed. a/ards that are out of the
control of the establishment, as 0ell as a description of ho0 the ha/ard is controlled before or
after the production process shall be documented on form G or equivalent.
3.,.2 Critical control "oints %Form A&
! ""P is a point or a step at 0hich a control measure is applied and 0here it is essential to
prevent or eliminate one or more food safet& ha/ards or reduce them to an acceptable level.
*ach ""P shall be documented in form 1H or equivalent and shall include the follo0ing
information,
a/ard(s) to be controlled at the ""P and description of control measure(s)-
"ritical limit(s) (see section 3.2.1.1).
%onitoring procedure(s) (see section 3.2.1.2).
5eviation procedures (see section 3.2.1.3).
#erification procedure(s) (see section 3.2.1.$).
+he record .eeping shall meet the requirements defined in 3.2.1.'.
+he ""P shall be validated, updated 0henever there are changes associated 0ith the ""P and
reassessed at least annuall&.
#ote$ +he individual(s) responsible for monitoring, deviation and verification procedures ma& be
identified b& a position title or the term designate. 9n this case, the establishment must be able to
demonstrate that individuals have received adequate training.
3.,.2. Critical limits %HACCP Princi"le 3&
"ritical limits are criteria that separate acceptabilit& from unacceptabilit&. +hese parameters, if
properl& maintained, 0ill confirm the safet& of the product.
"ritical limits shall be determined for the monitoring established for each ""P. One or more
critical limits ma& be used to control the identified ha/ards.
"ritical limits shall be established to ensure that the identified acceptable level of the food safet&
ha/ard in the finished product is not exceeded. :here government regulations exist, the critical
limit, at a minimum, must meet those regulations. 9n this case, the "(9! staff 0ould verif&
compliance to the regulations.
"ritical limits shall be measurable. "ritical limits based on sub@ective data (such as visual
inspection of product) shall be clearl& described to be easil& understood and uniforml& applied
b& those responsible for monitoring.
3.,.2., Monitoring "rocedures %for CCPs& %HACCP Princi"le -&
5ocumented monitoring procedures shall be established for each ""P and shall specif& an&
tests, measurements or observations to assess 0hether,
the control measure is functioning as intended-
the critical limits are met.
+he monitoring procedures shall at least include,
=ame or title of personnel responsible for the monitoring and evaluation of monitoring
results.
%onitoring frequenc&.
%ethods or instructions for tests, measurements or observations to be performed.
*xact title of the record(s) used to document monitoring results.
4ecord .eeping instructions (see section 3.2.1.').
+he monitoring methods and frequenc& shall be able to detect loss of control at the ""P in time
for the product to be isolated before it leaves the control of the producing establishment.
!ll monitoring devices3equipment requiring maintenance and calibration for accurac& must be
controlled through the preventative maintenance and calibration programs.
3.,.2.3 De+iation "rocedures %for CCPs& %HACCP Princi"le .&
5ocumented deviation procedures shall specif& an& planned or appropriate corrective actions to
be ta.en 0hen monitoring results demonstrate that,
the control measure is not functioning as intended-
the critical limits are not met.
+he deviation procedure shall at least include,
=ame or title of personnel that have the responsibilit& and authorit& to ta.e actions.
9nstructions on corrective actions to be ta.en.>
*xact title of the record(s) used to describe the deviation and to document all actions
ta.en in response to a deviation.
4ecord .eeping instructions (see section 3.2.1.').
> +he deviation procedure for a ""P shall at least instruct the responsible emplo&ees to perform
and document the follo0ing activities,
5escribe the deviation and its cause.
+a.e immediate action(s) to control affected or potentiall& affected product(s).>>
9mplement corrective action(s) to restore control of the ""P.
#erif& the effectiveness of corrective action(s) to ensure that the parameter(s) controlled
at the ""P is (are) brought bac. under control.
9mplement measures to prevent reoccurrence of the deviation.
#erif& the effectiveness of preventative measures ta.en.
>> :hen product is affected or potentiall& affected, individual 0ith authorit& shall,
prevent the on7going production of non7compliant product-
control the non7compliant product that has been produced-
assess if other products are implicated in relation to the cause of the deviation-
perform an assessment of the affected product to determine if the product ma& be
released (see section 3.2.1.3.1)-
5etermine the disposition of noncompliant product (see section 3.2.1.3.2).
5ocumented procedures shall be established and maintained for the appropriate handling of
potentiall& unsafe products to ensure that the& are not released until the& have been evaluated.
:hen an unforeseen ha/ard is identified, the compan& should perform a reassessment to
determine 0hether the ne0l& identified ha/ard should be incorporated into the !""P plan.
!n& deviation at a ""P 0ill require an evaluation of the supporting P"(s), 0here appropriate, as
part of the deviation procedures associated 0ith that ""P.
3.,.2.3. Assessment for release
=o product that is in@urious to health or other0ise adulterated as a result of the deviation ma& be
allo0ed to enter commerce. :hen found to be in deviation, each lot of product shall onl& be
released as acceptable 0hen an& of the follo0ing conditions appl&,
*vidence other than the monitoring data demonstrates that the ""P has been effective.
*vidence sho0s that the combined effect of multiple control measures for that particular
product complies 0ith the identified acceptable levels for the ha/ard(s) concerned.
+he results of sampling, anal&sis and3or other verification activities demonstrate that the
affected lot of product complies 0ith the identified acceptable levels for the ha/ard(s)
concerned.
+he controls and results of the assessment shall be documented.
3.,.2.3., Dis"osition of noncom"liant "roduct
(ollo0ing assessment, if the lot of product is not acceptable for release it shall be handled b& one
of the follo0ing activities,
4eprocessing or further processing 0ithin or outside the establishment, as per applicable
regulator& requirements, to ensure that the ha/ard is eliminated or reduced to acceptable
levels, or
5estruction and3or disposal as 0aste.
+he disposition of the noncompliant product shall be documented.
3.,.2.- 4erification "rocedures %for CCPs& %HACCP Princi"le /&
#erification is the application of methods, procedures, tests, sampling and other evaluations, in
addition to monitoring, to determine 0hether,
a control measure 0ithin a ""P is or has been operating as intended-
monitoring and deviation procedures are conducted according to the 0ritten program-
the record .eeping meets the requirements defined in 3.2.1.'-
the ""Ps are under control-
+here are trends in monitoring results that ma& indicate development to0ards loss of
control.
5ocumented verification procedures shall be established and shall at least include,
=ame or title of personnel responsible for the verification.
#erification frequenc&.
! description of the activities to be conducted, including but not limited to,
o direct observation of monitoring activities-
o intervie0 of persons responsible for monitoring and deviation procedures-
o direct observation of corrective actions ta.en, if possible-
o revie0 of records documenting the monitoring activities-
o revie0 of records documenting the actions ta.en in response to a deviation-
o :hen applicable, product testing to confirm that the ""P is properl&
implemented and achieves the intended outcome.
5eviation procedures 0hen the results of the verification demonstrate that,
o the monitoring or deviation activities are not conducted according to the 0ritten
program.
o the ""P is not effective to maintain control of the ha/ard.
o there is a trend to0ards a loss of control.
*xact title of the record used to document verification results.
4ecord .eeping instructions (see section 3.2.1.').
#ote$ ! distinction must be made on the verification record to differentiate bet0een a record
revie0 and an on7site observation.
#erification shall be carried out b& someone other than the person 0ho is responsible for
performing the monitoring activities (i.e. #erifiers cannot verif& their o0n 0or.).
+he frequenc& of verification should be sufficient to confirm that the ""P(s) remains in control
of an& ha/ards.
3.,.2.. Record ;ee"ing %for CCPs& %HACCP Princi"le 2&
4ecords shall be .ept to demonstrate the effective application of the critical control points and to
facilitate official verifications b& the "(9! or other competent authorit&.
4ecords shall be established to document,
the monitoring results, including, 0hen necessar&, the recording of quantifiable values
(e.g., temperature, time, !0, p) as prescribed in the ""P(s)-
all information and actions ta.en in response to a deviation identified as a result of
monitoring and verification-
the verification results.
4ecords must be up7to7date, legible, accurate and properl& filed.
*ach entr& on a monitoring, deviation and verification record shall include the date and the exact
time of the event, and shall be signed or initialed b& the emplo&ee ma.ing the entr& using a
permanent in. pen or, 0here computer records are used, electronicall&.
5eviation records shall identif& a target date for completion of preventative measures.
!n& incorrect entr& made to a record and subsequentl& changed shall be crossed out and initialed
b& the emplo&ee ma.ing the change.
3.,.> Process controls %Form &
:here more than one step in an overall process ma& contribute to the reduction of a particular
ha/ard, process controls ma& be developed for the earl& points of the process 0here the ha/ard
cannot be full& controlled, but a subsequent step 0ill result in the elimination or reduction of this
particular ha/ard to an acceptable level. +his final control 0ould be determined to be a ""P.
9n the %eat and Poultr& commodit&, "(9! has designed some process controls as an integral part
of an overall inspection program, such as the %oderni/ed Poultr& 9nspection Program. 9n this
case, the P"s are mandated. +he mandated P" standards are published in the applicable "(9!
specific program %anual of Procedures (%OP), and must be implemented as outlined in the
%OP. 9f additional mandated P"s are developed b& the "(9!, the& 0ill be published in the
appropriate manuals.
9n an& commodities (including %eat < Poultr&) sub@ect to ()*P, operators ma& also develop
their o0n process controls, 0here multiple process steps provide control over one specific
ha/ard. +hese operators 0ould be expected to validate the entire procedure to demonstrate that
their process control meets all of the necessar& parameters and is effective. +he resulting material
must be submitted to the "(9! !rea ()*P "oordinator for revie0 and acceptance, prior to
implementation.
*ach P" shall be documented in form 11 or equivalent and shall include the follo0ing
information,
(ood safet& ha/ard(s) to be controlled at the P"-
+he ""P number to 0hich the P" is lin.ed-
%onitoring procedures (see section 3.2.F.1)-
5eviation procedures (see section 3.2.F.2)-
#erification procedures (see section 3.2.F.3).
+he record .eeping shall meet the requirements defined in section 3.2.F.$.
+he P"s shall be updated 0henever there are changes associated 0ith the process control
requirements and reassessed at least annuall&.
3.,.>. Monitoring "rocedures %for PCs&
5ocumented monitoring procedures shall specif& an& tests, measurements or observations to
assess 0hether the process control standards are met.
+he monitoring procedures shall at least include,
=ame or title of personnel responsible for the monitoring and evaluation of monitoring
results.
%onitoring frequenc&.
+he standard(s) to be met.
%ethods or instructions to ta.e measurements, perform tests or conduct observations.
*xact title of the record(s) used to document monitoring results.
+he record .eeping instructions (see section 3.2.F.$).
3.,.>., De+iation "rocedures %for PCs&
5ocumented deviation procedures shall specif& an& planned or appropriate corrective actions to
be ta.en 0hen monitoring results demonstrate that the P" standards are not met.
+he deviation procedure shall at least include,
=ame or title of personnel that have the responsibilit& and authorit& to ta.e actions.
9nstructions on corrective actions to be ta.en.>
*xact title of the record(s) used to describe the deviation and to document all actions
ta.en in response to a deviation.
+he record .eeping instructions (see section 3.2.F.$).
> +he deviation procedure for process controls shall at least instruct the responsible emplo&ees to
perform and document the follo0ing activities,
5escribe the deviation and its cause.
9mplement corrective actions to restore control of the P".
#erif& the effectiveness of corrective actions ta.en.
9f the immediate actions are not found to be effective, the follo0ing additional activities must be
performed and documented,
Perform an immediate monitoring activit& at the related do0nstream ""P to assess
potential product impact.
9mplement measures to prevent reoccurrence of the P" deviation.
#erif& the effectiveness of preventative measures for the P" deviation.
3.,.>.3 4erification "rocedures %for PCs&
5ocumented verification procedures shall specif& an& planned sequence of observations, tests
and other evaluations, in addition to monitoring, to determine 0hether,
monitoring and deviation procedures are conducted according to the 0ritten program-
the record .eeping meets the requirements defined in section 3.2.F.$-
the controls in place are effective to meet the P" standards.
+he verification procedures shall at least include,
=ame or title of personnel responsible for the verification.
#erification frequenc&.
! description of the activities to be conducted, including but not limited to,
o direct observation of monitoring activities-
o intervie0 of persons responsible for monitoring and deviation procedures-
o direct observation of corrective actions ta.en, if possible-
o revie0 of records documenting the monitoring activities-
o revie0 of records documenting the actions ta.en in response to a deviation.
5eviation procedures 0hen the results of the verification demonstrate that,
o the monitoring or deviation activities are not conducted according to the 0ritten
program-
o the P" is not effective to maintain control of the standards.
*xact title of the record used to document verification results.
+he record .eeping instructions (see section 3.2.F.$).
#erification shall be carried out b& someone other than the person 0ho is responsible for
performing the monitoring activities (i.e., verifiers cannot verif& their o0n 0or.).
3.,.>.- Record ;ee"ing %for PCs&
4ecords shall be .ept to demonstrate the effective application of the process controls and to
facilitate official verifications b& the "(9! or other competent authorit&.
4ecords shall be established to document,
the monitoring results, including, 0hen necessar&, the recording of quantifiable values as
prescribed in the process control.
all information and actions ta.en in response to a deviation identified as a result of
monitoring and verification.
the verification results.
4ecords must be up7to7date, legible, accurate and properl& filed.
*ach entr& on a monitoring, deviation and verification record shall include the date and the exact
time of the event, and shall be signed or initialed b& the emplo&ee ma.ing the entr& using a
permanent in. pen or, 0here computer records are used, electronicall&.
5eviation records shall identif& a target date for completion of preventative measures.
!n& incorrect entr& made to a record and subsequentl& changed shall be crossed out and initialed
b& the emplo&ee ma.ing the change.
3.3 4alidation
*ver& establishment shall demonstrate that the critical control points are capable, on a consistent
basis, of achieving the intended level of ha/ard control.
#alidation is performed at the time the ""P is designed, or 0hen changes indicate the need for
re7validation. #alidation of a ""P is, 0henever possible, performed before it is full&
implemented.
5epending on the ""P that is being validated, the validation documentation ma& include,
)cientific, technical or regulator& support to demonstrate that the selected critical limit is
effective for control of the ha/ard.
"ommissioned testing data specific for a piece of equipment (e.g. pasteuri/er) to
demonstrate that the equipment is capable of meeting the selected critical limit.
)upporting data to demonstrate that the monitoring procedures are effective enough to
detect loss of control at a ""P before the finished product leaves the control of the
producing establishment.
"(9! ma& request validation documentation for an& control measures 0ithin the !""P s&stem
that have an immediate impact on food safet&.
3.- Maintenance and reassessment of the HACCP system
3.-. HACCP system maintenance "rocedures
:henever an& changes or situations occur that could affect the ha/ard anal&sis or alter the
!""P s&stem, the establishment shall,
update the parts of the !""P s&stem affected b& the changes or situations-
reassess completeness and effectiveness of the updated part of the !""P s&stem-
revalidate all ""Ps affected b& the changes.
ere are examples of potential triggers 0hich could lead to the need to update and3or to perform
a reassessment of parts of the !""P s&stem,
=e0 regulator& requirements related to food safet&
=e0 product
=oncompliant situations identified during monitoring and verification activities
"onsumer3client complaints
(ood safet& recalls
Bnsatisfactor& laborator& results
=on compliance identified during "(9! verifications
=e0 product line that can potentiall& cause cross7contamination
=e0 ingredients or incoming materials that come in contact 0ith the product or are used
for preparing the product
=e0 process step
=e0 technolog& or piece of equipment that impacts on the level of a ha/ard
=e03on7going construction or change in the product flo0 and or emplo&ee traffic
patterns resulting in a potential for cross contamination
=e0 control measure for an identified ha/ard
"hange made in product formulation or preparation
"hange made in production volume 0hich impacts on the product flo0, sanitation
schedule, emplo&ee training, etc.
"hange made in the application of a ""P (e.g. change in critical limit)
+he establishment has and implements documented procedures to ensure that the !""P s&stem
is effectivel& maintained.
+he procedures shall include as a minimum,
name or title of personnel responsible to ma.e changes to the !""P s&stem-
name or title of personnel responsible to ensure that the changes are implemented
effectivel&-
a method to identif& the revised versions-
the use of a log boo. or equivalent 0hich must at least contain the follo0ing information,
o a description of the changes-
o the signature or initials of responsible person 0ho made the change-
o 0here the changes occurred in the !""P s&stem-
o the dates 0hen changes are implemented, reassessed and, if necessar&, validated-
o the signature or initials of responsible person 0ho ensure that the changes are
implemented effectivel&-
o the revision date or number that correlates 0ith document changed.
2enefits of implementing effective maintenance procedures,
!""P s&stem documents are approved for adequac& b& competent personnel prior to
issue.
"hanges are identified 0hen a situation affecting the ha/ard anal&sis occurs 0hich
demonstrates effective maintenance of the !""P s&stem to "(9! or other competent
authorit&.
4evised versions are identified.
4elevant versions of applicable documents are available at points of use.
Bnintended use of obsolete documents is prevented.
3.-., HACCP system reassessment "rocedures
:henever an& changes or situations occur that could affect the ha/ard anal&sis or alter the
!""P s&stem, the establishment shall reassess completeness and effectiveness of the updated
part of the !""P s&stem and document the reassessment activities conducted in the !""P
s&stem modification log boo. as described in 3.$.1.
!t least annuall&, the establishment shall reassess its entire !""P s&stem to determine 0hether
the s&stem,
is up to date-
identifies all food safet& ha/ards-
has control measures in place for all food safet& ha/ards 0hich ma& be controlled b& the
establishment-
results in the desired outcomes-
conforms to current regulator& and "(9! program requirements-
conforms to the requirements defined in the ()*P manual.
5ocumented reassessment procedures shall be established and shall at least include the follo0ing
' components,
. Res"onsi7ility) fre!uency and record ;ee"ing
+he individual(s) responsible for the reassessment activities.
+he frequenc& of reassessment activities or Adetails and specificsA of reassessment
activities (i.e., the establishment ma& specif& that the required reassessment activities are
conducted at various times over the course of the &ear).
*xact title of record(s) used to document,
o 4eassessment results-
o "hanges made to the !""P s&stem-
o !n& other corrective actions ta.en.
,. Reassessment of the HACCP System Maintenance Procedures
! revie0 of the changes or situations that occurred at the establishment that should have
triggered an update of the !""P s&stem to ensure that the maintenance procedures in
place are effective.
%ore specificall&, a revie0 of the actions ta.en in response to situations indicating a
trend to0ard or a loss of control to ensure that the applicable sections of the !""P
s&stem have been updated and reassessed accordingl&. +he follo0ing situations shall be
included in the revie0,
o "lient or consumer food safet& related complaints-
o Bnsatisfactor& laborator& results-
o =oncompliant situations identified during monitoring and verification activities-
o =oncompliant situations resulting in a recall-
o =oncompliance identified during "(9! verifications.
3. Reassessment of HACCP Plan%s&
! revie0 of the product descriptions, list of ingredients and incoming materials, process
flo0 diagrams and schematic diagrams to ensure that the&,
o !re up to date-
o 9dentif& all food safet& ha/ards.
! revie0 of all ha/ards identified in the !""P plan in order to ensure that,
o +he& are accurate-
o "ontrol measures are identified.
! revie0 of the Process "ontrol(s) and ""P(s) to ensure that the&,
o !re up to date, and 0here required, re7validated-
o 4esult in the desired outcomes-
o "onform to regulator& requirements-
o "onform to the requirements defined in the ()*P manual.
-. Reassessment of Prere!uisite Programs
! 0ritten revie0, a record revie0 and an on7site assessment of all prerequisite programs
to ensure that the&,
o !re up to date-
o "onform to regulator& requirements-
o "onform to the requirements defined in the ()*P manual-
o !re conducted according to the 0ritten programs-
o 4esult in the desired outcomes.
.. Reassessment of Record Design
! revie0 of the records used to document monitoring, deviation and verification results
to ensure the& are designed to provide all information required in the ()*P manual.
=ote, :hen an operator identifies a deficienc& 0ith their !""P s&stem design during
performance of their reassessment activities, it is the responsibilit& of the operator to determine
the appropriate deadline for completion of corrective measures and 0hether or not additional
interim measures are required to control an& food7safet& related ha/ards 0hich ma& have
resulted from the deficienc&.
3.. FSEP forms
Form $ Product Descri"tion
"lic. on image for larger vie0
5escription for (orm 1, Product 5escription
Form ,$ 3ist of Product 6ngredients and 6ncoming Material
"lic. on image for larger vie0
5escription for (orm 2, 8ist of Product 9ngredients and 9ncoming
%aterial
Form 3$ Process Flo8 Diagram
"lic. on image for larger vie0
5escription for (orm 3, Process (lo0 5iagram
Form -$ Plant Schematic
"lic. on image for larger vie0
5escription for (orm $, Plant )chematic
Form .$ 'iological Ha9ard 6dentification
"lic. on image for larger vie0
5escription for (orm ', 2iological a/ard 9dentification
Form /$ Chemical Ha9ard 6dentification
"lic. on image for larger vie0
5escription for (orm E, "hemical a/ard 9dentification
Form 2$ Physical Ha9ard 6dentification
"lic. on image for larger vie0
5escription for (orm 1, Ph&sical a/ard 9dentification
Form >$ Decision (ree - CCP Determination and 1ther Control Measures
"lic. on image for larger vie0
5escription for (orm F, 5ecision +ree 7 ""P 5etermination and
Other "ontrol %easures
Form ?$ Ha9ards #ot Controlled 7y the Esta7lishment
"lic. on image for larger vie0
5escription for (orm G, a/ards =ot "ontrolled b& the
*stablishment
Form A$ Critical Control Point%s&
"lic. on image for larger vie0
5escription for (orm 1H, "ritical "ontrol Point(s)
Form $ Process Control%s& %PC&
"lic. on image for larger vie0
5escription for (orm 11, Process "ontrol(s) (P")
E<am"le of an E!ui+alent Form $ FSEP Forms .) /) 2) > and ? Com7ined into one Form
"lic. on image for larger vie0
5escription for *xample of an *quivalent (orm , ()*P (orms ',
E, 1, F and G "ombined into one (orm
Previous
+able of "ontents
=ext
5ate modified,
2H1$7H17H2