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Cactieuchuan s190 PDF
Cactieuchuan s190 PDF
Cactieuchuan s190 PDF
INTERNATIONAL ISO
STANDARD 22000
FIRST EDITION
2005-09-01
Reference number
ISO 22000 : 2005 (E)
Page 1 of 75
ISO 22000:2005 FOR TRAINING PURPOSE ONLY
Contents Page
1 Scope ................................................................................................................................. ...........................13
2 Normative reference .................................................................................................................................15
3 Terms and definitions ...................................................................................................... ..........................16
4 Food safety management system ..............................................................................................................23
4.1 General requirements ..................................................................................................... .......................23
4.2 Documentation requirements ............................................................................................... .................25
5 Management responsibility .......................................................................................................................27
5.1 Management commitment .................................................................................................... .................27
5.2 Food safety policy ....................................................................................................................................28
5.3 Food safety management system planning ...........................................................................................29
5.4 Responsibility and authority ............................................................................................. .....................29
5.5 Food safety team leader .................................................................................................. .......................30
5.6 Communication............................................................................................................ ............................31
5.7 Emergency preparedness and response ...............................................................................................34
5.8 Management review ........................................................................................................ .......................35
6 Resource management ..............................................................................................................................37
6.1 Provision of resources................................................................................................... ..........................37
6.2 Human resources.......................................................................................................... ...........................37
6.3 Infrastructure ..........................................................................................................................................39
6.4 Work environment ......................................................................................................... .........................39
7 Planning and realization of safe products................................................................................................39
7.1 General.................................................................................................................. ...................................39
7.2 Prerequisite programs (PRPs) ............................................................................................. ..................39
7.3 Preliminary steps to enable hazard analysis ........................................................................................42
7.4 Hazard analysis .......................................................................................................... ..............................48
7.5 Establishing the operational Prerequisite programs (PRPs)..............................................................53
7.6 Establishing the HACCP plan .............................................................................................. ..................53
7.7 Updating of preliminary information and documents specifying the PRP(s) and the
HACCP plan ............................................................................................................................. ......................57
7.8 Verification planning ............................................................................................................................. .57
7.9 Traceability system ...................................................................................................... ...........................59
7.10 Control of nonconformity ..................................................................................................................... .59
8 Validation, verification and improvement of the food safety management system............................66
8.1 General.................................................................................................................. ...................................66
8.2 Validation of control measure combinations ........................................................................................66
8.3 Control of monitoring and measuring...................................................................................................68
8.4 Food safety management system verification ......................................................................................69
8.5 Improvement .............................................................................................................. .............................73
Page 2 of 75
ISO 22000:2005 FOR TRAINING PURPOSE ONLY
Trang
1 Phm vi ........................................................................................................................................................13
2 Tiu chun trch dn..................................................................................................................................15
3 Thut ng v nh ngha ............................................................................................................................16
4 H thng qun l an ton thc phm.......................................................................................................23
4.1 Yu cu chung .........................................................................................................................................23
4.2 Yu cu v h thng ti liu ..................................................................................................................25
5 Trch nhim ca lnh o ........................................................................................................................27
5.1 Cam kt ca lnh o .............................................................................................................................27
5.2 Chnh sch an ton thc phm ..............................................................................................................28
5.3 Hoch nh H thng qun l an ton thc phm...............................................................................29
5.4 Trch nhim v quyn hn ....................................................................................................................29
5.5 Trng nhm an ton thc phm..........................................................................................................30
5.6 Trao i thng tin ...................................................................................................................................31
5.7 S chun b v ng ph vi tnh hung khn cp ................................................................................34
5.8 Xem xt ca lnh o .............................................................................................................................35
6 Qun l ngun lc ......................................................................................................................................37
6.1 Cung cp ngun lc.................................................................................................................................37
6.2 Ngun nhn lc........................................................................................................................................37
6.3 C s h tng ...........................................................................................................................................39
6.4 Mi trng lm vic................................................................................................................................39
7 Hoch nh v to sn phm an ton.......................................................................................................39
7.1 Khi qut..................................................................................................................................................39
7.2 Chng trnh tin quyt (PRPs) ............................................................................................................39
7.3 Cc bc chun b cho hot ng phn tch mi nguy ........................................................................42
7.4 Phn tch mi nguy ..................................................................................................................................48
7.5 Xy dng cc chng trnh vn hnh tin quyt (PRPs) ....................................................................53
7.6 Xy dng k hoch HACCP...................................................................................................................53
7.7 Cp nht cc thng tin ban u v cc ti liu m t cc chng trnh tin quyt
v k hoch HACCP ......................................................................................................................................57
7.8 Hoch nh vic thm tra .......................................................................................................................57
7.9 H thng truy tm ngun gc .................................................................................................................59
7.10 Kim sot s khng ph hp ................................................................................................................59
8 Thm nh, thm tra v ci tin h thng qun l an ton thc phm ...............................................66
8.1 Khi qut..................................................................................................................................................66
8.2 Thm nh t hp cc bin php kim sot .........................................................................................66
8.3 Kim sot theo di v o lng .............................................................................................................68
8.4 Thm tra h thng qun l an ton thc phm ...................................................................................69
8.5 Ci tin .....................................................................................................................................................73
Page 3 of 75
ISO 22000:2005 FOR TRAINING PURPOSE ONLY
FOREWORD
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication
as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard
may be the subject of patent rights. ISO shall not be held responsible for identifying any or all
such patent rights.
ISO 22000 was prepared by Technical Committee ISO/TC 34, Food products.
Page 4 of 75
ISO 22000:2005 FOR TRAINING PURPOSE ONLY
INTRODUCTION
LI GII THIU
Food safety is related to the presence of food-
An ton thc phm lin quan ti s c mt ca
borne hazards in food at the point of
cc mi nguy trong thc phm ti thi im s
consumption (intake by the consumer). As the
dng (ngi tiu dng n thc phm). S xut
introduction of food safety hazards can occur
hin ca cc mi nguy v an ton thc phm
at any stage of the food chain, adequate
c th xy ra bt c giai on no trong
control throughout the food chain is essential.
dy chuyn thc phm, do vic kim sot
Thus, food safety is ensured through the
mt cch y trong c dy chuyn thc
combined efforts of all the parties
phm l rt cn thit. Nh , an ton thc
participating in the food chain
phm c m bo thng qua n lc tng
hp ca tt c cc bn tham gia vo dy
chuyn thc phm
Organizations within the food chain range Cc t chc trong dy chuyn thc phm, bao
from feed producers and primary producers gm t sn xut thc n chn nui, khu ban
through food manufacturers, transport and u n cc n v sn xut thc phm, vn
storage operators and subcontractors to retail chuyn v iu hnh kho bi v cc nh thu
and food service outlets (together with inter- ph n n v bn l, v cc im phc v
related organizations such as producers of n ung (cng vi cc t chc c lin quan
equipment, packaging material, cleaning nh cc n v sn xut thit b, bao b, cht
agents, additives and ingredients). Service ty ra, ph gia v cc thnh phn), bao gm
providers are also included. c cc n v cung cp dch v.
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Recognition of the organization's role and Vic nhn bit vai tr v v tr ca t chc
position within the food chain is essential to trong dy chuyn thc phm l cn thit cho
ensure effective interactive communication vic m bo s trao i thng tin hiu qu
throughout the chain in order to deliver safe trong c dy chuyn nhm chuyn giao thc
food products to the final consumer. An phm an ton n ngi tiu dng cui. Hnh1
example of the communication channels l v d v cc knh thng tin gia cc bn
among interested parties of the food chain is hu quan trong dy chuyn thc phm
shown in Figure 1.
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The most effective food safety systems are H thng qun l an ton thc phm hiu
established, operated and updated within the qu nht c thit lp, vn hnh v cp nht
framework of a structured management trn c s cu trc ca h thng qun l v
system and incorporated into the overall hp nht vi cc hot ng qun l chung
management activities of the organization. ca t chc. iu ny em li li ch ti a
This provides maximum benefit for the cho t chc v cc bn hu quan. Tiu
organization and interested parties. This chun ny c lin kt vi tiu chun ISO
International Standard has been aligned with 9001 nhm tng tng thch ca hai tiu
ISO 9001 in order to enhance the chun. Bng so snh tng quan gia tiu
compatibility of the two standards. Cross- chun ny v ISO 9000 c th hin Ph
references between this International Standard lc A.
and ISO 9001 are provided in Annex A
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This International Standard integrates the Control Point (HACCP) system and
principles of the Hazard Analysis and Critical application steps developed by the Codex
During hazard analysis, the organization Trong qu trnh phn tch mi nguy, t chc
determines the strategy to be used to ensure xc nh phng thc c s dng m
hazard control by combining the PRP(s), bo mi nguy c kim sot thng qua s
operational PRP(s) and the HACCP plan kt hp gia chng trnh tin quyt (PRPs),
Page 8 of 75
ISO 22000:2005 FOR TRAINING PURPOSE ONLY
Cross-references between the Codex Bng so snh tng quan gia cc nguyn
Alimentarius Commission HACCP principles tc HACCP v cc bc thc hin ca Codex
and application steps (see Reference [11]) and Alimentarius Commission (xem ti liu tham
this International Standard are provided in kho s [11]) v tiu chun ny c trnh
Annex B by ph lc B.
To facilitate the application of this thun tin cho vic p dng, tiu chun
International Standard, it has been developed ny c xy dng thnh tiu chun c th s
as an auditable standard. However, individual dng cho hot ng nh gi. Tuy nhin, mi
organizations are free to choose the necessary t chc c t do chn la phng php v
methods and approaches to fulfil the cch tip cn cn thit thc hin cc yu
requirements of this International Standard. cu ca tiu chun ny. Nhm h tr cc t
To assist individual organizations with the chc trong vic p dng tiu chun ny, mt
implementation of this International Standard, bn hng dn cch s dng tiu chun c
guidance on its use is provided in ISO/TS trnh by trong ISO/TS 22004
22004
This International Standard allows an Tiu chun ny cho php mt t chc (nh
organization (such as a small and/or less cc t chc nh v/hoc t chc cha
developed organization) to implement an pht trin) p dng mt t hp cc bin
externally developed combination of control php kim sot t bn ngoi
measures.
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ISO 22000:2005 FOR TRAINING PURPOSE ONLY
The aim of this International Standard is to Mc tiu ca tiu chun ny l tiu chun ho
harmonize on a global level the requirements quy m quc t cc yu cu v h thng
for food safety management for businesses qun l an ton thc phm cho cc doanh
within the food chain. It is particularly nghip trong dy chuyn thc phm. Tiu
intended for application by organizations that chun ny ch yu hng n vic p dng
seek a more focused, coherent and integrated cc t chc cn tm kim mt h thng qun
food safety management system than is l hp l, c tch hp v tp trung hn
normally required by law. It requires an vo an ton thc phm ch khng n thun
organization to meet any applicable food l p ng cc yu cu lut nh. Tiu chun
safety related statutory and regulatory ny yu cu mt t chc p ng tt c cc
requirements through its food safety yu cu lut nh v an ton thc phm thng
management system. qua h thng qun l an ton thc phm ca
t chc.
Page 10 of 75
ISO 22000:2005 FOR TRAINING PURPOSE ONLY
Feed producers
Figure 1 Example of Transport and storage operators
communication within the food
Primary
chainfood
Producers of equipments
producers Food
Producersof cleaning and sanitizing
agents
manufacturers
Producers of packaging materials
Secondary food manufacturers
Service providers
Wholesalers Retailers, Food
service operators and caterers
Service
providersprovid
ers
Consumers
NOTE The figure does not show the type of interactive communications along and across the
food chain that by pass immediate suppliers and customers.
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ISO 22000:2005 FOR TRAINING PURPOSE ONLY
Cc n v sn xut thit b
Sn xut thc phm
Cc n v sn xut cc cht ty
ra
Sn xut thc phm (cp 2)
Cc n v sn xut bao b
Cc nh bn s
Cc dch v
Cc nh bn l, dch v n ung,
cung cp thc phm
Ch thch : Hnh ny khng th hin hnh thc trao i thng tin ngang v dc trong dy
chuyn thc phm khi b qua cc nh cung cp v khch hng trung gian.
Page 12 of 75
ISO 22000:2005 FOR TRAINING PURPOSE ONLY
1 Scope 1. Pham vi
a) to plan, implement, operate, maintain and a) Hoch nh, p dng, vn hnh, duy tr v
update a food safety management system cp nht h thng qun l an ton thc
aimed at providing products that, according to phm nhm cung cp sn phm an ton,
their intended use, are safe for the consumer, theo mc ch s dng ca sn phm, cho
ngi tiu dng
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ISO 22000:2005 FOR TRAINING PURPOSE ONLY
g) to seek certification or registration of its g) Tm kim s chng nhn hoc cng nhn
food safety management system by an h thng qun l an ton thc phm t t
external organization, or make a self- chc bn ngoi, hoc t thc hin nh gi
assessment or self-declaration of conformity hoc t cng b mc ph hp vi tiu
to this International Standard. chun ny
All requirements of this International Standard include, but are not limited to, feed producers,
are generic and are intended to be applicable harvesters, farmers, producers of ingredients,
to all organizations in the food chain food manufacturers, retailers, food services,
regardless of size and complexity. This catering services, organizations providing
includes organizations directly or indirectly cleaning and sanitation services,
involved in one or more steps of the food transportation, storage and distribution
chain. Organizations that are directly involved services. Other organizations that are
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ISO 22000:2005 FOR TRAINING PURPOSE ONLY
indirectly involved include, but are not limited tham gia trc tip bao gm, nhng khng
to, suppliers of equipment, cleaning and gii hn, cc t chc sn xut thc n chn
sanitizing agents, packaging material, and nui, thu hoch, cc nng dn, cc t chc
other food contact materials. sn xut cc thnh phn, cc t chc sn
xut thc phm, cc nh bn l, cc dch v
Tt c cc yu cu ca tiu chun ny mang
n ung, dch v cung cp thc phm, cc t
tnh tng qut v nhm p dng cho mi
chc cung cp cc dch v v sinh, kh
t chc trong dy chuyn thc phm khng
trng, vn chuyn, lu kho v phn phi.
phn bit quy m v mc phc tp. iu
Cc t chc khc khng tham gia trc tip,
ny bao gm cc t chc trc tip hoc gin
bao gm nhng khng gii hn, cc t chc
tip tham gia vo mt hoc nhiu cng on
cung cp thit b, cc cht ty ra, bao b, v
trong dy chuyn thc phm. Cc t chc
cc vt liu tip xc vi thc phm khc
This International Standard allows an Tiu chun ny cho php mt t chc, nh cc
organization, such as a small and/or less t chc nh v/hoc cha pht trin (nh nng
developed organization (e.g. a small farm, a tri nh, t chc ng gi-phn phi nh,
small packer-distributor, a small retail or food im bn l nh, dch v n ung), c p
service outlet), to implement an externally dng mt t hp cc bin php kim sot t
developed combination of control measures. bn ngoi
NOTE Guidance on the application of this Ch thch: Hng dn v vic p dng tiu
International Standard is given in ISO/TS chun ny c cung cp ISO/TS22004.
22004.
2 Normative references 2Tiu chun trch dn.
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For the purposes of this document, the terms Cc thut ng v nh ngha c nu trong
and definitions given in ISO 9000 and the ISO 9000 v cc thut ng sau c p dng
following apply. cho tiu chun ny
For the convenience of the users of this thun tin cho ngi s dng tiu chun,
International Standard, some of the mt s nh ngha ca ISO 9000 c trch
definitions in ISO 9000 are quoted with li v b sung thm cc Ch thch ch c gi
added notes that are applicable only to this tr p dng cho tiu chun c th ny
special application.
NOTE Terms are not defined where they Ch thch : Cc thut ng s khng c
retain their normal dictionary definition. nh ngha li nu chng gi nguyn ngha
Where bold type is used in a definition, this thng dng c nu trong t in. Khi nh
indicates a cross-reference to another term ngha c in m ngha l chng c lin h
defined in this clause, and the number vi mt thut ng khc cng trong iu
reference for the term is given in parentheses. khon ny, v s tham chiu ca thut ng
c lin h c ghi trong ngoc
Concept that food will not cause harm to the Khi nim ch thc phm khng lm tn hi
consumer when it is prepared and/or eaten n ngi s dng khi c ch bin
according to its intended use v/hoc n ng theo mc ch s dng
NOTE 1 Adapted from Reference [11]. Ch thch 1 : Trch t ti liu tham kho s
[11].
does not include other human health aspects
NOTE 2 Food safety is related to the
related to, for example, malnutrition.
occurrence of food safety hazards (3.3) and
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NOTE 2 The food chain also includes the Ch thch 2 : Dy chuyn thc phm bao
production of materials intended to come into gm c hot ng sn xut cc vt liu s
contact with food or raw materials. tip xc trc tip vi thc phm v nguyn
liu
NOTE 1 Adapted from Reference [11]. Ch thch 1: Trch t ti liu tham kho s
[11]
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NOTE 4 In the context of feed and feed Ch thch 4 : Trong phm vi v thc n gia
ingredients, relevant food safety hazards are sc, cc mi nguy v an ton thc phm c
those that may be present in and/or on feed lin quan l cc mi nguy c kh nng c
and feed ingredients and that may mt trong thc n gia sc v cc thnh phn
subsequently be transferred to food through ph v c th c truyn n thc phm
animal consumption of feed and may thus thng qua vic s dng thc n ca gia sc
have the potential to cause an adverse human v do c kh nng gy nh cc hot ng
health effect. In the context of operations khng thuc nhm trc tip x l thc n
other than those directly handling feed and gia sc v thc phm (nh sn xut bao b,
food (e.g. producers of packaging materials, cc cht ty ra..) cc mi nguy v an ton
cleaning agents, etc.), relevant food safety thc phm c lin quan l cc mi nguy c
hazards are those hazards that can be directly th c truyn trc tip hoc gin tip ti
or indirectly transferred to food because of thc phm thng qua mc ch s dng ca
the intended use of the provided products cc sn phm/dch v ny v do c kh
and/or services and thus can have the nng nh hng bt li cho sc kho ca
potential to cause an adverse human health con ngi.
effect.
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Product that will undergo no further Sn phm khng tri qua thm bt k s ch
processing or transformation by the bin hoc bin i no do t chc thc hin
organization
Schematic and systematic presentation of the Bn trnh by mt cch h thng theo dng
sequence and interactions of steps s trnh t v tng tc ca cc bc
cng on
food safety action or activity that can be (an ton thc phm) Hnh ng hoc hot
used to prevent or eliminate a food safety ng c th c s dng ngn nga
hazard (3.3) or reduce itto an acceptable level hoc loi b mt mi nguy (3.3) hoc gim
thiu n n mc chp nhn
NOTE Adapted from Reference [11] Ch thch : Trch t ti liu tham kho s
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[11].
3.8 PRP - prerequisite programme 3.8. PRP- Chng trnh tin quyt
food safety basic conditions and activities (an ton thc phm) iu kin c bn v cc
that are necessary to maintain a hygienic hot ng cn thit duy tr mi trng v
environment throughout the food chain (3.2) sinh trong dy chuyn thc phm (3.2) ph
suitable for the production, handling and hp cho sn xut, x l v cung cp
provision of safe end products (3.5) and safe cc thnh phm (3.5) an ton v thc phm
food for human consumption an ton cho ngi s dng
NOTE The PRPs needed depend on the Ch thch : Cc chng trnh tin quyt cn
segment of the food chain in which the thit ph thuc vo phn khc ca dy
organization operates and the type of chuyn thc phm m t chc tham gia
organization (see Annex C). Examples of v loi t chc (xem ph lc C). Mt s v
equivalent terms are: Good Agricultural d v cc thut ng tng ng : Thc
Practice (GAP), Good Veterinarian Practice hnh sn xut nng nghip tt (GAP), Thc
(GVP), Good Manufacturing Practice (GMP), hnh cng tc th y tt ( GVP), Thc hnh
Good Hygienic Practice (GHP), Good sn xut tt (GMP), Thc hnh v sinh tt
Production Practice (GPP), Good Distribution (GHP), Thc hnh phn phi tt (GDP),
Practice (GDP) and Good Trading Practice Thc hnh thng mi tt (GTP)
(GTP).
Operational prerequisite programme PRP Chng trnh tin quyt (3.8) c nhn
(3.8) identified by the hazard analysis as dng trong qu trnh phn tch mi nguy l
essential in order to control the likelihood of cn thit kim sot kh nng xut hin
introducing food safety hazards (3.3) to ca mi nguy v an ton thc phm (3.3) v/
and/or the contamination or proliferation of hoc s nhim bn hoc s pht trin
food safety hazards in the product(s) or in the ca cc mi nguy v an ton thc phm
processing environment trong (cc) sn phm hoc trong mi trng
sn xut.
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food safety step at which control can be (an ton thc phm) im ti c th thc
applied and is essential to prevent or hin kim sot v cn thit trong vic ngn
eliminate a food safety hazard (3.3) or reduce nga hoc loi b mt mi nguy v an ton
it to an acceptable level thc phm hoc gim thiu n n mc
chp nhn.
NOTE Adapted from Reference [11]. Ch thch : Trch t ti liu tham kho s
[11]
criterion which separates acceptability from Tiu chun phn bit gia chp nhn c
unacceptability v khng chp nhn c
NOTE 1 Adapted from Reference [11]. Ch thch 1: Trch t ti liu tham kho
s[11]
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NOTE 1 For the purposes of this Ch thch 1 : Trong tiu chun ny, s khc
International Standard, a correction relates to phc lin quan n vic x l cc sn phm
the handling of potentially unsafe products, c kh nng khng an ton, v do c s
and can therefore be made in conjunction kt hp vi hnh ng khc phc (3.14)
with a corrective action (3.14).
NOTE 2 A correction may be, for example, Ch thch 2 : S khc phc c th, v d nh,
reprocessing, further processing, and/or ti ch, ch bin thm, v/hoc loi b hu
elimination of the adverse consequences of qu bt li ca s khng ph hp (nh s
the nonconformity (such as disposal for other dng cho mc ch khc hoc ghi nhn c
use or specific labelling). bit)
NOTE 2 Corrective action includes cause Ch thch 2 : Hnh ng khc phc bao gm
analysis and is taken to prevent recurrence. phn tch nguyn nhn v hnh ng
ngn nga ti din
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3.15. Thm nh
3.15 validation
food safety obtaining evidence that the (an ton thc phm) Thu thp cc bng
control measures (3.7) managed by the chng l cc bin php kim sot (3.7)
HACCP plan and by the operational PRPs c quy nh trong k hoch HACCP v
(3.9) are capable of being effective cc chng trnh tin quyt PRPs vn hnh
c hiu qu
confirmation, through the provision of S khng nh, thng qua vic cung cp
objective evidence, that specified bng chng khch quan, l cc yu cu quy
requirements have been fulfilled [ISO nh c thc hin [ISO 9000, nh ngha
9000:2000, definition 3.8.4] 3.8.4]
immediate and/or planned activity to ensure Hot ng kp thi v/hoc theo k hoch
application of the most recent information m bo vic p dng cc thng tin mi
nht
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The organization shall establish, document, T chc PHI (1) xy dng, lp vn bn,
implement and maintain an effective food thc hin v duy tr mt h thng qun l
safety management system and update it an ton thc phm hiu qu v cp nht
when necessary in accordance with the h thng ny khi cn thit theo cc yu cu
requirements of this International Standard. ca tiu chun ny
The organization shall define the scope of the T chc PHI (2) xc nh phm vi ca h
food safety management system. The scope thng qun l an ton thc phm. Phm vi
shall specify the products or product PHI (3) nu r cc sn phm hoc nhm
categories, processes and production sites that sn phm, cc quy trnh v cc a im sn
are addressed by the food safety management xut c qun l bi h thng qun l
system. an ton thc phm
a) ensure that food safety hazards that may be a) m bo cc mi nguy v an ton thc
reasonably expected to occur in relation to phm c kh nng xy ra vi sn phm
products within the scope of the system are trong phm vi ca h thng qun l c
identified, evaluated and controlled in such a nhn dng , nh gi v kim sot sao cho
manner that the products of the organization cc sn phm ca t chc khng, trc tip
do not, directly or indirectly, harm the hoc gin tip, lm tn hi ngi s dng
consumer,
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Where an organization chooses to outsource Khi t chc chn ngun bn ngoi cho bt
any process that may affect end product k qu trnh no nh hng n s ph hp
conformity, the organization shall ensure ca thnh phm, t chc PHI (5) m bo
control over such processes. Control of such kim sot c cc qu trnh . Vic kim
outsourced processes shall be identified and sot cc qu trnh do ngun bn ngoi PHI
documented within the food safety (6) c nhn bit v vn bn ho trong h
management system. thng qun l an ton thc phm
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b) Cc th tc dng vn bn v cc h s
b) documented procedures and records
theo yu cu ca tiu chun ny, v
required by this International Standard, and
The controls shall ensure that all proposed Vic kim sot PHI (10) m bo tt c
changes are reviewed prior to implementation cc xut thay i c xem xt trc khi
to determine their effects on food safety and p dng nhm xc nh s nh hng ca
their impact on the food safety management cc thay i ny v tc ng ca chng i
system. vi H thng qun l an ton thc phm
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g) to prevent the unintended use of obsolete g. ngn nga vic s dng v tnh cc ti
documents, and to ensure that they are liu li thi, v p dng cc du hiu nhn
suitably identified as such if they are retained bit thch hp nu chng c gi li v mc
for any purpose. ch no
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a) showing food safety is supported by the a. Chng t an ton thc phm c duy tr
business objectives of the organization, thng qua cc mc tiu hot ng ca t
chc
c) establishing the food safety policy, c. Thit lp chnh sch an ton thc phm
5.2 Food safety policy 5.2. Chnh sch an ton thc phm
Top management shall define, document and Lnh o cao nht PHI (16) xc nh, lp
communicate its food safety policy. vn bn v truyn t chnh sch an ton
thc phm ca t chc
Top management shall ensure that the food Lnh o cao nht PHI (17) m bo
safety policy chnh sch an ton thc phm
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b. ph hp vi cc yu cu php lut v ch
b) conforms with both statutory and
nh v cc yu cu c tho thun vi
regulatory requirements and with mutually
khch hng v an ton thc phm
agreed food safety requirements of
customers,
d) is reviewed for continued suitability (see d. c xem xt lun thch hp (xem 5.8)
5.8),
5.3 Food safety management system 5.3. Hoch nh h thng qun l an ton
planning thc phm
Top management shall ensure that Lnh o cao nht PHI (18) m bo
a) planning of the food safety management a. tin hnh hoch nh h thng qun l an
system is carried out to meet requirements ton thc phm p ng cc yu cu nu
given in 4.1 as well as the objectives of the trong 4.1 cng nh cc mc tiu ca t chc
organization that support food safety, and v an ton thc phm, v
b) the integrity of the food safety b. tnh nht qun ca h thng qun l an
management system is maintained when ton thc phm c duy tr khi cc thay i
changes to the food safety management i vi h thng qun l an ton thc phm
system are planned and implemented. c hoch nh v thc hin
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All personnel shall have responsibility to Tt c cc nhn vin PHI (20) c trch
report problems with the food safety nhim bo co cc vn v h thng qun
management system to identified person(s). l an ton thc phm cho (cc) c nhn
Designated personnel shall have defined c ch nh. Ngi c ch nh PHI
responsibility and authority to initiate and (21) c trch nhim v quyn hn khi xng
record actions. v ghi chp cc hnh ng
5.5 Food safety team leader 5.5. Trng nhm an ton thc phm
Top management shall appoint a food safety Lnh o cao nht PHI (22) ch nh mt
team leader who, irrespective of other trng nhm an ton thc phm, ngoi cc
responsibilities, shall have the responsibility trch nhim khc, PHI (23) c trch nhim
and authority v quyn hn
a) to manage a food safety team (see 7.3.2) a. qun l nhm an ton thc phm (xem
and organize its work, 7.3.2) v t chc cng vic ca nhm
c) to ensure that the food safety management c. m bo h thng qun l an ton thc
system is established, implemented, phm c thit lp, thc hin, duy tr v
maintained and updated, and cp nht, v
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NOTE The responsibility of the food safety Ch thch : trch nhim ca trng nhm an
team leader may include liaison with external ton thc phm c th bao gm c quan h
parties on matters relating to the food safety vi bn ngoi v cc vn c lin quan
management system. n an ton thc phm
b) customers or consumers, in particular in b. khch hng hoc ngi tiu dng, lin
relation to product information (including quan n cc thng tin v sn phm (bao
instructions regarding intended use, specific gm hng dn v mc ch s dng, yu
storage requirements and, as appropriate, cu c th v bo qun, v, khi thch hp,
shelf life), enquiries, contracts or thng tin v hn s dng), x l cc yu
orderhandling including amendments, and cu, cc hp ng hoc n t hng , k c
customer feedback including customer cc sa i, v phn hi ca khch hng bao
complaints, gm c cc khiu ni
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The organization shall establish, implement T chc PHI (30) thit lp, thc hin v
and maintain effective arrangements for duy tr s sp xp hiu qu vic trao i
communicating with personnel on issues thng tin vi cc nhn vin v cc vn c
having an impact on food safety. tc ng n an ton thc phm
In order to maintain the effectiveness of the duy tr tnh hiu qu ca h thng qun
food safety management system, the l an ton thc phm, t chc PHI (31)
organization shall ensure that the food safety m bo l nhm an ton thc phm c
team is informed in a timely manner of thng bo kp thi v cc thay i, bao gm
changes, including but not limited to the nhng khng gii hn trong
following:
b) raw materials, ingredients and services; b. cc nguyn liu, thnh phn v cc dch
v
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h. cc yu cu php lut v ch nh
h) statutory and regulatory requirements;
i) knowledge regarding food safety hazards i. cc kin thc lin quan n an ton thc
and control measures; phm v cc bin php kim sot
The food safety team shall ensure that this Nhm an ton thc phm PHI (32) m
information is included in the updating of the bo cc thng tin ny c a vo hot
food safety management system (see 8.5.2). ng cp nht h thng qun l an ton
Top management shall ensure that relevant thc phm (xem 8.5.2). Lnh o cao nht
information is included as input to the PHI (33) m bo cc thng tin lin
management review (see 5.8.2). quan tr thnh u vo ca xem xt ca lnh
o (xem 5.8.2)
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Top management shall review the Lnh o cao nht PHI (35) nh k xem
organization's food safety management xt h thng qun l an ton thc phm,
system at planned intervals to ensure its m bo n lun thch hp, tho ng v c
continuing suitability, adequacy and hiu lc. Vic xem xt ny PHI (36) nh
effectiveness. This review shall include gi c c hi ci tin v nhu cu thay i
assessing opportunities for improvement and i vi h thng qun l an ton thc phm,
the need for change to the food safety k c chnh sch v an ton thc phm. H
management system, including the food s xem xt ca lnh o PHI (37) c
safety policy. Records of management duy tr (xem 4.2.3)
reviews shall be maintained (see 4.2.3).
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c. cc s thay i c th nh hng n an
c) changing circumstances that can affect
ton thc phm (xem 5.6.2)
food safety (see 5.6.2),
d) emergency situations, accidents (see 5.7) d. cc tnh hung khn cp, cc s c (xem
and withdrawals (see 7.10.4), 5.7) v cc trng hp thu hi sn phm
(xem 7.10.4)
The data shall be presented in a manner that Cc d liu PHI (39) c trnh by sao
enables top management to relate the cho lnh o cao nht c th kt ni cc
information to stated objectives of the food thng tin ny vi cc mc tiu ra cho
safety management system. h thng qun l an ton thc phm
The output from the management review u ra ca vic xem xt ca lnh o PHI
shall include decisions and actions related to (40) bao gm cc quyt nh v hnh ng
lin quan n
a) assurance of food safety (see 4.1), a. m bo an ton thc phm (xem 4.1)
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The organization shall provide adequate T chc PHI (41) cung cp cc ngun lc
resources for the establishment, y thit lp, thc hin, duy tr v cp
implementation, maintenance and updating of nht h thng qun l an ton thc phm
the food safety management system.
The food safety team and the other personnel Nhm an ton thc phm v cc nhn vin
carrying out activities having an impact on thc hin cc cng vic c tc ng n an
food safety shall be competent and shall have ton thc phm PHI (42) c nng lc v
appropriate education, training, skills and PHI (43) c gio dc, o to, c k
experience. nng v kinh nghim thch hp
experts shall be available.
Where the assistance of external experts is
required for the development, Khi cn c s h tr ca cc chuyn gia bn
implementation, operation or assessment of ngoi trong vic xy dng, thc hin, vn
the food safety management system, records hnh hoc nh gi h thng an ton thc
of agreement or contracts defining the phm, PHI (44) c h s v cc tho thun
responsibility and authority of external hoc hp ng xc nh r trch nhim v
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6.2.2 Competence, awareness and training 6.2.2. Nng lc, nhn thc v o to
b) provide training or take other action to b. tin hnh o to hay nhng hnh ng
ensure personnel have the necessary khc m bo ngi lao ng c nng
competencies, lc cn thit
e) ensure that the personnel are aware of the e. m bo ngi lao ng nhn thc c
relevance and importance of their individual mi lin quan v tm quan trng ca cc
activities in contributing to food safety, hot ng ca h i vi an ton thc phm
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6.3. C s h tng
6.3 Infrastructure
The organization shall provide the resources T chc PHI (46) cung cp ngun lc cho
for the establishment and maintenance of the vic thit lp v duy tr c s h tng cn
infrastructure needed to implement the thit thc hin cc yu cu ca tiu
requirements of this International Standard. chun ny
The organization shall provide the resources T chc PHI (47) cung cp ngun lc cho
for the establishment, management and vic thit lp, qun l v duy tr mi trng
maintenance of the work environment needed lm vic cn thit thc hin cc yu cu
to implement the requirements of this ca tiu chun ny
International Standard.
The organization shall plan and develop the T chc PHI (48) hoch nh v trin khai
processes needed for the realization of safe cc qu trnh cn thit cho vic to sn
products. phm an ton
The organization shall implement, operate T chc PHI (49) p dng, thc hin v
and ensure the effectiveness of the planned m bo tnh hiu qu/hiu lc ca cc hot
activities and any changes to those activities. ng hoch nh cng nh bt k s thay
This includes PRP(s) as well as operational i no. iu ny bao gm cc chng trnh
PRP(s) and/or the HACCP plan. tin quyt (PRPs) v cc chng trnh vn
hnh tin quyt (Operation PRPs) v /hoc
k hoch HACCP
7.2 Prerequisite programmes (PRPs) 7.2. Chng trnh tin quyt (PRPs)
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b) be appropriate to the size and type of the b. ph hp vi quy m v loi hnh hot
operation and the nature of the products being ng cng nh bn cht ca sn phm c
manufactured and/or handled, sn xut v /hoc x l
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7.2.3 When selecting and/or establishing 7.2.3. Khi la chn v/hoc xy dng cc
PRP(s), the organization shall consider and chng trnh tin quyt t chc PHI (53)
utilize appropriate information [e.g. statutory xem xt v s dng cc thng tin cn thit
and regulatory requirements, customer (nh cc yu cu lut nh, yu cu ca
requirements, recognized guidelines, Codex khch hng, cc hng dn c cng nhn,
Alimentarius Commission (Codex) principles cc nguyn tc ca Codex, cc quy tc thc
and codes of practices, national, international hnh, cc tiu chun quc gia, quc t, hoc
or sector standards]. tiu chun ngnh)
The organization shall consider the following Khi xy dng cc chng trnh trn, t chc
when establishing these programmes: PHI (54) xem xt cc iu sau y
c) supplies of air, water, energy and other c. h thng cung cp kh, nc, nng lng
utilities; v cc tin ch khc
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g) measures for the prevention of cross g. cc bin php ngn nga s nhim bn
contamination; cho
Verification of PRP(s) shall be planned (see Vic thm tra cc chng trnh tin quyt
7.8) and PRP(s) shall be modified as PHI (55) c hoch nh (Xem 7.8) v
necessary (see 7.7). Records of verifications cc chng trnh tin quyt PHI (56) c
and modifications shall be maintained. iu chnh khi cn thit (xem 7.7). H s
thm tra v h s ghi nhn cc iu chnh
PHI (57) c duy tr
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A food safety team shall be appointed. PHI (60) thit lp nhm An ton thc
phm
The food safety team shall have a Nhm An ton thc phm PHI (61) gm
combination of multi-disciplinary knowledge nhng thnh vin c nhng kin thc v kinh
and experience in developing and nghim a dng trong vic xy dng v p
implementing the food safety management dng h thng qun l an ton thc phm.
system. This includes, but need not be limited Kin thc ny bao gm, nhng khng gii
to, the organization's products, processes, hn, cc sn phm ca t chc, cc quy
equipment and food safety hazards within the trnh, thit b, cc mi nguy v an ton thc
scope of the food safety management system. phm trong phm vi ca h thng qun l an
ton thc phm
Records shall be maintained that demonstrate H s chng t nhm An ton thc phm c
that the food safety team has the required kin thc v kinh nghim theo yu cu
knowledge and experience (see 6.2.2). (xem 6.2.2) PHI (62) c duy tr
7.3.3.1 Raw materials, ingredients and 7.3.3.1. Nguyn liu, cc thnh phn v
product-contact materials vt liu tip xc vi sn phm
All raw materials, ingredients and product- Tt c cc nguyn liu , cc thnh phn v
contact materials shall be described in vt liu tip xc vi sn phm PHI (63)
documents to the extent needed to conduct c m t trong cc ti liu mc cn thit
the hazard analysis (see 7.4), including the cho vic phn tch cc mi nguy (xem 7.4),
following, as appropriate: khi thch hp bao gm nhng iu sau y
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The organization shall identify statutory and T chc PHI (64) nhn dng cc yu cu
regulatory food safety requirements related to php lut v ch nh v an ton thc phm
the above. lin quan n cc ni dung trn
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e) packaging; e. bao gi
f) labelling relating to food safety and/or f. cc thng tin trn nhn lin quan n an
instructions for handling, preparation and ton thc phm v/hoc hng dn cch x
usage; l, chun b v s dng;
The organization shall identify statutory and T chc PHI (67) nhn bit cc yu cu
regulatory food safety requirements related to php lut v ch nh v an ton thc phm
the above. lin quan n cc vn trn
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7.3.4. Mc ch s dng
7.3.4 Intended use
The intended use, the reasonably expected Mc ch s dng sn phm, bao gm cch
handling of the end product, and any s dng ng v nhng kh nng sai st , s
unintended but reasonably expected dng nhm ln thnh phm PHI (69) c
mishandling and misuse of the end product xem xt v m t bng vn bn, mc
shall be considered and shall be described in cn thit cho vic thc hin phn tch mi
documents to the extent needed to conduct nguy.(xem 7.4)
the hazard analysis (see 7.4).
Groups of users and, where appropriate, Nhm i tng s dng, v khi cn thit,
groups of consumers shall be identified for nhm i tng tiu th PHI (70) c
each product, and consumer groups known to nhn dng cho tng loi sn phm, va(
be especially vulnerable to specific food PHI (71) xem xt n cc nhm i tng
safety hazards shall be considered. nhy cm vi cc mi nguy c th
7.3.5 Flow diagrams, process steps and 7.3.5. S quy trnh sn xut, cc cng
control measures on v cc bin php kim sot
Flow diagrams shall be prepared for the S quy trnh sn xut PHI (73) c
products or process categories covered by the thit lp cho cc nhm sn phm hoc nhm
food safety management system. Flow quy trnh thuc phm vi ca h thng qun
diagrams shall provide a basis for evaluating l an ton thc phm. S quy trnh sn
the possible occurrence, increase or xut PHI (74) cung cp c s nh gi
introduction of food safety hazards. kh nng xy ra, s pht trin hoc xut
hin cc mi nguy v an ton thc phm
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In accordance with 7.8, the food safety team Theo yu cu ca iu khon 7.8, nhm An
shall verify the accuracy of the flow diagrams ton thc phm PHI (77) thm tra ti ch
by on-site checking. Verified flow diagrams tnh chnh xc ca s quy trnh sn xut.
shall be maintained as records. S quy trnh sn xut thm tra PHI
(78) c lu h s
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The food safety team shall conduct a hazard Nhm an ton thc phm PHI (82) thc
analysis to determine which hazards need to hin vic phn tch mi nguy xc nh
be controlled, the degree of control required mi nguy no cn c kim sot, mc
to ensure food safety, and which combination kim sot yu cu m bo an ton
of control measures is required. thc phm, cng nh s cn thit phi phi
hp cc bin php kim sot
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a) the preliminary information and data a. cc thng tin ban u v d liu c thu
collected according to 7.3, thp theo yu cu ca 7.3
d) information from the food chain on food d. Cc thng tin t dy chuyn thc phm
safety hazards that may be of relevance for lin quan n cc mi nguy c kh nng nh
the safety of the end products, intermediate hng n an ton ca thnh phm, bn
products and the food at consumption. thnh phm v vic s dng thc phm
The step(s) (from raw materials, processing PHI (85) ch ra cc cng on (t nguyn
and distribution) at which each food safety liu, sn xut v phn phi) m mi nguy v
hazard may be introduced shall be indicated. an ton thc phm c kh nng xut hin
7.4.2.2 When identifying the hazards, 7.4.2.2 Khi nhn dng cc mi nguy,
consideration shall be given to PHI (86) xem xt
a) the steps preceding and following the a. cc cng on trc v sau cng on
specified operation, ang xem xt
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7.4.2.3 For each of the food safety hazards 7.4.2.3 Khi c th, PHI (87) xc nh mc
identified, the acceptable level of the food chp nhn thnh phm i vi tng mi
safety hazard in the end product shall be nguy v an ton thc phm c nhn dng.
determined whenever possible. The Khi xc nh mc chp nhn PHI(88)
determined level shall take into account quan tm n cc yu cu lut nh , yu
established statutory and regulatory cu v an ton thc phm ca khch hng,
requirements, customer food safety mc ch s dng do khch hng xc nh
requirements, the intended use by the v cc thng tin khc c lin quan. Cc lp
customer and other relevant data. The lun v kt qu xc nh mc chp nhn
justification for, and the result of, the PHI (89) c lu h s
determination shall be recorded.
Each food safety hazard shall be evaluated Mi mi nguy v an ton thc phm PHI
according to the possible severity of adverse (91) c nh gi da trn c s mc
health effects and the likelihood of their nghim trng ca cc nh hng bt li n
occurrence. The methodology used shall be sc khe v kh nng xy ra ca cc mi
described, and the results of the food safety nguy. Phng php nh gi c s dng
hazard assessment shall be recorded. PHI (92) c m t , v kt qu nh gi
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In this selection, each of the control measures Trong qu trnh l chn, mi bin php kim
as described in 7.3.5.2 shall be reviewed with sot c nu trong 7.3.5.2, PHI (95) c
respect to its effectiveness against the xem xt v tnh hiu qu ca n i vi cc
identified food safety hazards. mi nguy c nhn dng
The control measures selected shall be Cc bin php kim sot c la chn
categorized as to whether they need to be PHI (96) c phn loi theo mc cn
managed through operational PRP(s) or by thit phi qun l bng k hoch HACCP
the HACCP plan. hay bng cc chng trnh vn hnh tin
quyt (operational PRPs)
The selection and categorization shall be S chn la v phn loi PHI (97) c
carried out using a logical approach that thc hin thng qua vic tip cn mt cch
includes assessments with regard to the hp l bao gm vic nh gi cc vn
following: sau
a) its effect on identified food safety hazards a. s tc ng ca bin php kim sot i
relative to the strictness applied; vi mi nguy v an ton thc phm tng
ng vi mc nghim ngt c p dng
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b) its feasibility for monitoring (e.g. ability to b. tnh kh thi ca vic gim st (V d: kh
be monitored in a timely manner to enable nng gim st kp thi m bo cc bin
immediate corrections); php khc phc c thc hin tc thi)
c) its place within the system relative to other c. v tr ca bin php kim sot trong h
control measures; thng tng xng vi cc bin php khc
d) the likelihood of failure in the functioning d. kh nng sai lch ca bin php kim
of a control measure or significant processing sot hoc cc s bin thin ng k ca quy
variability; trnh sn xut
f) whether the control measure is specifically f. bin php kim sot c c thit k v
established and applied to eliminate or c p dng c bit loi b hoc
significantly reduce the level of hazard(s); gim thiu ng k mc ca cc mi nguy
Control measures categorized as belonging to Cc bin php kim sot thuc k hoch
the HACCP plan shall be implemented in HACCP PHI (98) c trin khai theo yu
accordance with 7.6. Other control measures cu ca 7.6. Cc bin php khc PHI (99)
shall be implemented as operational PRPs c thc hin chng trnh vn hnh tin
according to 7.5. quyt nh yu cu ca 7.5
The methodology and parameters used for Phng php v cc tiu ch s dng cho
this categorization shall be described in vic phn loi PHI (100) c m t bng
documents, and the results of the assessment vn bn, v kt qu ca vic nh gi
shall be recorded. PHI (101) c lu h s
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The operational PRPs shall be documented (Cc) chng trnh vn hnh tin quyt
and shall include the following information PHI (102) c vn bn ha v mi
for each programme: chng trnh PHI (103) bao gm cc thong
tin sau y
The HACCP plan shall be documented and K hoch HACCP PHI (104) c vn
shall include the following information for bn ho v PHI (105) bao gm cc thng
each identified critical control point (CCP): tin sau y cho mi CCP c xc nh
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The rationale for the chosen critical limits L do chn Gii hn ti hn PHI (110)
shall be documented. c vn bn ho
7.6.4 System for the monitoring of critical 7.6.4. H thng gim st cc im kim
control points sot ti hn
The monitoring system shall consist of H thng gim st PHI (114) bao gm
relevant procedures, instructions and records cc th tc, hng dn v cc h s lien
that cover the following: quan, bao gm cc vn sau
a) measurements or observations that provide a. vic o lng hoc quan st nhm cung
results within an adequate time frame; cp kt qu trong thi gian yu cu
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d. tn xut gim st
d) monitoring frequency;
The monitoring methods and frequency shall Cc bin php gim st & tn xut gim st
be capable of determining when the critical PHI (115) c kh nng xc nh kp thi
limits have been exceeded in time for the thi im thng s vt gii hn ti hn
product to be isolated before it is used or thc hin c lp sn phm trc khi chng
consumed. c s dng hoc tiu dng
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(xem7.10.3)
e) control measures (see 7.3.5.2). e. cc bin php kim sot (xem 7.3.5.2)
If necessary, the HACCP plan (see 7.6.1) and Khi cn thit, k hoch HACCP (xem 7.6.1)
the procedures and instructions specifying the v cc th tc, cc hng dn v chng
PRP(s) (see 7.2) shall be amended. trnh tin quyt PRPs (xem 7.2) PHI (120)
c iu chnh
Verification planning shall define the Hoch nh vic thm tra PHI (121) xc
purpose, methods, frequencies and nh mc ch, cc phng php, tn xut v
responsibilities for the verification activities. cc trch nhim cho cc hot ng thm tra.
The verification activities shall confirm that Hot ng thm tra PHI (122) xc nhn
cc iu sau
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c) the operational PRP(s) (see 7.5) and the c. cc chng trnh vn hnh tin quyt
elements within the HACCP plan (see 7.6.1) (operational PRPs) (xem 7.5) v cc yu t
are implemented and effective, trong k hoch HACCP (xem 7.6.1) c
trin khai p dng v c hiu qu
The output of this planning shall be in a form u ra ca vic hoch nh PHI (123)
suitable for the organization's method of dng ph hp vi phng thc hot ng ca
operations. t chc
Verification results shall be recorded and Kt qu thm tra PHI (124) c ghi h s
shall be communicated to the food safety v PHI (125) c thng tin cho Nhm An
team. Verification results shall be provided to Ton Thc Phm. Kt qu thm tra PHI
enable the analysis of the results of the (126) c cung cp thc hin hot ng
verification activities (see 8.4.3). phn tch kt qu ca cc hot ng thm tra
(xem 8.4.3).
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The organization shall establish and apply a T chc PHI (128) thit lp v p dng
traceability system that enables the mt h thng truy tm ngun gc sn phm
identification of product lots and their c kh nng nhn dng cc l sn phm v
relation to batches of raw materials, lin h ca l sn phm vi cc l nguyn
processing and delivery records. liu, l sn xut v cc h s v giao hng
The traceability system shall be able to H thng truy vt PHI (129) c kh nng
identify incoming material from the nhn dng nguyn liu u vo t cc nh
immediate suppliers and the initial cung cp trung gian v ni phn phi u
distribution route of the end product. tin ca thnh phm
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b) a review of the corrections carried out. b. vic xem xt s khc phc c thc
hin
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Corrective actions shall be initiated when Hnh ng khc phc PHI (141) c
critical limits are exceeded (see 7.6.5) or xng khi gii hn ti hn vt chun
when there is a lack of conformity with (xem 7.6.5) hoc khi c cc thiu st trong
operational PRP(s). p dng cc chng trnh vn hnh tin
quyt
The organization shall establish and maintain T chc PHI(142) thit lp v duy tr th
documented procedures that specify tc dng vn bn, xc nh c th cc hnh
appropriate actions to identify and eliminate ng thch hp nhn dng v loi b
the cause of detected nonconformities, to nguyn nhn ca cc khng ph hp c
prevent recurrence, and to bring the process pht hin, nhm ngn nga s ti din, v
or system back into control after ti lp li s kim sot i vi quy trnh
nonconformity is encountered. These actions v h thng sau khi s khng ph hp xy
include ra. Cc hnh ng ny bao gm
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b) the food safety hazard(s) of concern will b. cc mi nguy v an ton thc phm cn
be reduced to identified acceptable levels (see quan tm s c gim thiu n mc
7.4.2) prior to entering into the food chain, or chp nhn xc nh, trc khi tham gia
vo dy chuyn thc phm, hoc
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a) evidence other than the monitoring system a. c bng chng b sung bn cnh h
demonstrates that the control measures have thng gim st chng t l cc bin
been effective; php kim sot c hiu qu
b) evidence shows that the combined effect of b. bng chng chng minh hiu qu tng
the control measures for that particular hp ca cc bin php kim sot cho sn
product complies with the performance phm ang xem xt ph hp vi kt qu
intended (i.e. identified acceptable levels as mong i ( vd mc chp nhn xc nh
identified in accordance with 7.4.2); ph hp vi mc c xc nh 7.4.2)
Following evaluation, if the lot of product is Sau khi nh gi, nu l sn phm khng
not acceptable for release it shall be handled c chp nhn cho xut xng, chng
by one of the following activities: PHI (148) c x l bng mt trong cc
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hot ng sau
To enable and facilitate the complete and c th thc hin thun li vic thu hi
timely withdrawal of lots of end products mt cch ton din v kp thi cc l sn
which have been identified as unsafe phm c nhn bit l khng an ton
a) top management shall appoint personnel a. lnh o cao nht PHI (149) ch nh
having the authority to initiate a withdrawal thnh vin c thm quyn quyt nh
and personnel responsible for executing the vic thu hi v thnh vin thc hin vic thu
withdrawal, and hi, v
b) the organization shall establish and b. t chc PHI (150) thit lp v duy tr
maintain a documented procedure for mt th tc dng vn bn cho vic
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The cause, extent and result of a withdrawal Nguyn nhn, phm vi v kt qu ca vic
shall be recorded and reported to top thu hi PHI (152) c lu h s v bo
management as input to the management co cho lnh o cao nht nh l thng tin
review (see 5.8.2). u vo cho vic xem xt ca lnh o
(xem5.8.2)
The organization shall verify and record the T chc PHI (153) thm tra v ghi h s
effectiveness of the withdrawal programme tnh hiu qu ca chng trnh thu hi thng
through the use of appropriate techniques qua vic s dng mt s k thut thch hp
(e.g. mock withdrawal or practice (nh cc t thu hi th nghim/ thc hnh
withdrawal). thu hi.)
The food safety team shall plan and Nhm An Ton Thc Phm PHI (154) lp
implement the processes needed to validate k hoch v thc hin vic thm nh cc
control measures and/or control measure bin php kim v tin hnh thm tra v ci
combinations, and to verify and improve the tin h thng qun l an ton thc phm
food safety management system.
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a) the selected control measures are capable a. bin php kim sot c chn kh
of achieving the intended control of the food nng em li s kim sot mong mun vi
safety hazard(s) for which they are cc mi nguy v an ton thc phm c
designated, and kim sot bng bin php ang xt, v
b) the control measures are effective and b. cc bin php kim sot khi phi hp vi
capable of, in combination, ensuring control nhau, c hiu qu v kh nng m bo
of the identified food safety hazard(s) to s kim sot vi cc mi nguy v an ton
obtain end products that meet the defined thc phm sao cho thnh phm p ng
acceptable levels. c mc chp nhn xc nh
If the result of the validation shows that one Trong trng hp kt qu thm nh cho
or both of the above elements cannot be thy mt hoc c hai vn trn khng
confirmed, the control measure and/or c xc nhn, cc bin php kim sot
combinations thereof shall be modified and v/ hoc t hp cc bin php kim sot
re-assessed (see 7.4.4). PHI (156) c iu chnh v nh gi
li (xem 7.4.4)
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The organization shall provide evidence that T chc PHI (157) cung cp bng chng
the specified monitoring and measuring v s y v cc phng php v thit b
methods and equipment are adequate to theo di v o lng m bo vic thc
ensure the performance of the monitoring and hin cc th tc theo di v o lng
measuring procedures.
a) shall be calibrated or verified at specified a. PHI (158) c hiu chun hoc kim
intervals, or prior to use, against tra xc nhn nh k, hoc trc khi s dng,
measurement standards traceable to da trn cc chun o lng quc gia hay
international or national measurement quc t; khi khng c cc chun ny th
standards; where no such standards exist, the cn c c s dng hiu chun hoc
basis used for calibration or verification shall kim tra xc nhn PHI (159) c lu h s
be recorded,
c) shall be identified to enable the calibration c. PHI (161) c nhn bit gip xc
status to be determined, nh trng thi hiu chun
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In addition, the organization shall assess the Ngoi ra, khi thit b hoc quy trnh c
validity of the previous measurement results pht hin khng ph hp vi yu cu, t
when the equipment or process is found not chc PHI (165) nh gi gi tr hiu lc
to conform to requirements. If the measuring ca cc kt qu o trc . Nu thit b o
equipment is nonconforming, the khng ph hp, t chc PHI (166) tin
organization shall take action appropriate for hnh cc hnh ng thch hp i vi thit
the equipment and any product affected. b v bt k sn phm no b nh hng.
Records of such assessment and resulting PHI (167) duy tr h s v kt qu nh
actions shall be maintained. gi v cc hnh ng c thc hin sau
nh gi
When used in the monitoring and Khi s dng phn mm my tnh theo di
measurement of specified requirements, the v o lng cc yu cu nht nh, PHI
ability of computer software to satisfy the (168) khng nh chng c kh nng p
intended application shall be confirmed. This ng vic p dng d kin. Vic ny PHI
shall be undertaken prior to initial use and (169) c thc hin trc ln s dng u
shall be reconfirmed as necessary. tin v PHI (170) c xc nhn li khi
cn thit
8.4 Food safety management system 8.4. Thm tra h thng qun l an ton
verification thc phm
The organization shall conduct internal audits T chc PHI (171) tin hnh nh gi ni
at planned intervals to determine whether the b nh k theo k hoch xc nh xem
food safety management system h thng qun l an ton thc phm
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a. c ph hp vi cc b tr sp xp c
a) conforms to the planned arrangements, to
hoch nh, ph hp vi cc yu cu ca h
the food safety management system
thng qun l an ton thc phm do t chc
requirements established bythe organization,
thit lp v vi cc yu cu ca tiu chun
and to the requirements of this International
ny, v
Standard, and
An audit programme shall be planned, taking T chc PHI (172) hoch nh chng
into consideration the importance of the trnh nh gi c ch n tm quan trng
processes and areas to be audited, as well as ca cc qu trnh v khu vc c nh gi,
any updating actions resulting from previous cng nh cc hnh ng cp nht tip theo
audits (see 8.5.2 and 5.8.2). The audit criteria, sau cuc nh gi ln trc (xem 8.5.2 v
scope, frequency and methods shall be 5.8.2). Chun mc, phm vi, tn xut v
defined. Selection of auditors and the conduct phng php nh gi PHI (173) c xc
of audits shall ensure the objectivity and nh. Vic la chn chuyn gia nh gi v
impartiality of the audit process. Auditors t chc nh gi PHI (174) m bo tnh
shall not audit their own work. khch quan v v t ca qu trnh nh gi.
Cc chuyn gia nh gi khng c nh
gi cng vic ca mnh
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The food safety team shall systematically Nhm an ton thc phm PHI (178) nh
evaluate the individual results of planned gi mt cch h thng cc kt qu thm tra
verification (see 7.8). n l c tin hnh theo hoch nh (xem
7.8).
b) the conclusions of the hazard analysis (see b. kt lun ca hot ng phn tch mi
7.4), the established operational PRP(s) (see nguy (xem 7.4), cc chng trnh vn hnh
7.5) and the HACCP plan (see 7.6.1), tin quyt (xem 7.5) v k hoch HACCP
(xem 7.6.1) c thit lp
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The food safety team shall analyse the results Nhm an ton thc phm PHI (181) phn
of verification activities, including the results tch cc kt qu ca cc hot ng thm tra,
of the internal audits (see 8.4.1) and external bao gm kt qu ca nh gi ni b (xem
audits. The analysis shall be carried out in 8.4.1) v nh gi ca bn ngoi. Hot ng
order phn tch PHI (182) c thc hin
c) to identify trends which indicate a higher c. nhn ra xu hng gia tng v kh nng
incidence of potentially unsafe products, to ra cc sn phm c nguy c khng an
ton
d) to establish information for planning of the d. xc nh cc thng tin cho vic hoch
internal audit programme concerning the nh chng trnh nh gi ni b c ch
status and importance of areas to be audited, n tnh trng v tm quan trng ca cc
and khu vc c nh gi, v
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The results of the analysis and the resulting Cc kt qu phn tch v cc hnh ng ny
activities shall be recorded and shall be sinh t vic phn tch PHI (183) c lu
reported, in an appropriate manner, to top h s v PHI (184) c bo co mt cch
management as input to the management thch hp vi lnh o cao nht lm u
review (see 5.8.2). It shall also be used as an vo cho vic xem xt ca lnh o (xem
input for updating the food safety 5.8.2). Cc kt qu ny PHI (185) c s
management system (see 8.5.2). dng lm thng tin cho vic cp nht h
thng qun l an ton thc phm (xem
8.5.2).
Top management shall ensure that the Lnh o cao nht PHI (186) m bo l
organization continually improves the t chc thng xuyn nng cao hiu lc ca
effectiveness of the food safety management h thng qun l an ton thc phm thng
system through the use of communication qua vic trao i thng tin (xem 5.6), xem
(see 5.6), management review (see 5.8), xt ca lnh o (xem 5.8), nh gi ni b
internal audit (see 8.4.1), evaluation of (xem 8.4.1), nh gi cc kt qu thm tra
individual verification results (see 8.4.2), n l (xem 8.4.2), phn tch cc kt qu
analysis of results of verification activities ca cc hot ng thm tra (xem 8.4.3),
(see 8.4.3), validation of control measure thm nh s t hp cc bin php kim
combinations (see 8.2), corrective actions sot (xem 8.2), cc hnh ng khc phc
(see 7.10.2) and food safety management (xem 7.10.2) v vic cp nht h thng qun
system updating (see 8.5.2). l an ton thc phm (xem 8.5.2).
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8.5.2 Updating the food safety 8.5.2. Cp nht h thng qun l an ton
management system thc phm
Top management shall ensure that the food Lnh o cao nht PHI (187) m bo
safety management system is continually rng h thng qun l an ton thc phm
updated. c cp nht thng xuyn
In order to achieve this, the food safety team thc hin iu ny, nhm an ton thc
shall evaluate the food safety management phm PHI (188) nh gi h thng
system at planned intervals. The team shall qun l an ton thc phm theo k hoch
then consider whether it is necessary to nh k. Sau , nhm PHI(189) xem
review the hazard analysis (see 7.4), the xt s cn thit PHI (190) xem xt li bn
established operational PRP(s) (see 7.5) and phn tch mi nguy (xem 7.4), cc chng
the HACCP plan (see 7.6.1). trnh vn hnh tin quyt (xem 7.5) v k
hoch HACCP (xem 7.6.1)
The evaluation and updating activities shall Vic nh gi v cp nht PHI (191) da
be based on trn c s
b) input from other information concerning b. u vo ca cc thng tin khc lin quan
the suitability, adequacy and effectiveness of n s ph hp, tho ng v hiu qu ca
the food safety management system, h thng qun l an ton thc phm
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System updating activities shall be recorded Hot ng cp nht h thng PHI (192)
and reported, in an appropriate manner, as c lu h s v bo co mt cch thch
input to the management review (see 5.8.2). hp lm u vo cho xem xt ca lnh
o ( xem 5.8.2)
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