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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP

NHÖÕNG YEÂU CAÀU


CHO MOÄT
HEÄ THOÁNG AN TOAØN THÖÏC PHAÅM
DÖÏA VAØO HACCP

Bieân soaïn bôûi

National Board of Experts – HACCP


The Netherlands.

The Hague, the Netherlands: 3rd Version, September 2002

REQUIREMENTS
FOR A
HACCP BASED
FOOD SAFETY SYSTEM

Compiled by the

National Board of Experts – HACCP


The Netherlands.

The Hague, the Netherlands: 3rd Version, September 2002

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP

Ñaây laø baûn dòch tieáng Anh ñöôc cho pheùp veà nhöõng yeâu caàu cuï theå “ Nhöõng yeâu caàu cho heä
thoáng an toaøn thöïc phaåm döïa vaøo HACCP” (phieân baûn thöù 3, 9/2002), moät trong ba taøi lieäu cho
pheùp caáp chöùng chæ cho hoaït ñoäng cuûa heä thoáng HACCP.
Hai loaïi taøi lieäu khaùc; “Nhöõng quy ñònh cuûa giaáy chöùng nhaän” vaø “ Nhöõng quy ñònh cuûa chuyeân
gia hoäi ñoàng quoác gia – HACCP” cuõng ñöôïc phaùt haønh bôûi Hoäi ñoàng quoác gia nhöõng chuyeân gia
– HACCP.

Chöùng chæ cho Heä thoáng an toaøn thöïc phaåm döïa vaøo HACCP ñöôïc duy trì bôûi Hoäi ñoàng quoác gia
nhöõng chuyeân gia – HACCP.

Chöùng chæ/ ñaêng kyù cuûa Heä thoáng an toaøn thöïc phaåm döïa vaøo HACCP caên cöù treân nhöõng
phieân baûn coù tröôùc cuûa yeâu caàu naøy ñöôïc chöùng nhaän bôûi Hoäi ñoàng chöùng nhaän Haø Lan
( RvA) töø naêm 1997.

This is the authorised English translation of the specification “Requirements for a HACCP based Food Safety
System” (3rd version, September 2002), being one of three documents which regulate the Certification Scheme
for Operational HACCP Systems.
The two other documents; the “Certification Regulations” and the “Regulations for the National Board of
Experts – HACCP” are also published by the National Board of Experts – HACCP.

The Certification Scheme for HACCP based Food Safety Systems is maintained by the National Board of
Experts - HACCP.

Certification/Registration of HACCP based Food Safety Systems on the basis of the preceding versions of this
specification has been accredited by the Dutch Accreditation Council (RvA) since 1997.
Copyright 2002 National Board of Experts - HACCP

Price: € 23,00 (excluding VAT).

All rights reserved. No part of this publication may be reproduced and/or published in any form, by means of
printed matters, photocopy, microfilm, recording or any other method or technology, without preceding written
approval by the National Board of Experts - HACCP.

National Board of Experts - HACCP,


Secretariat: P.O. Box 93202, 2509 AE, The Hague, the Netherlands.
Web site: foodsafetymanagement.info
e mail: info@foodsafetymanagement.info

CONTENTS

1 GIÔÙI THIEÄU 4

2 PHAÏM VI AÙP DUÏNG 7

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP

3 NHÖÕNG TAØI LIEÄU THAM KHAÛO 8

4 THUAÄT NGÖÕ VAØ ÑÒNH NGHÓA 9

5 NHÖÕNG YEÂU CAÀU CUÛA HEÄ THOÁNG HACCP 12


5.1 Traùch nhieäm cuûa laõnh ñaïo 12
5.1.1 Chính saùch
5.1.2 Phaïm vi cuûa heä thoáng HACCP
5.1.3 Nhieäm vuï, Traùch nhieäm, Quyeàn haïn
5.1.4 Ñoäi HACCP
5.1.5 Nguoàn löïc
5.1.6 Xem xeùt cuûa laõnh ñaïo
5.2 Thoâng tin saûn phaåm 14
5.2.1 Nhöõng ñaëc tính saûn phaåm
5.2.2 Muïc ñích söû duïng
5.3 Thoâng tin quaù trình 15
5.3.1 Sô ñoà daây chuyeàn saûn phaåm
5.3.2 Maët baèng thieát bò
5.3.3 Kieåm soaùt vaø xaùc nhaän thoâng tin quaù trình
5.4 Chöông trình tieân quyeát 16
5.5 Phaân tích moái nguy 17
5.5.1 Xaùc ñònh moái nguy
5.5.2 Phaân tích HACCP (ruûi ro )
5.6 Phöông phaùp kieåm soaùt 19
5.6.1 Phöông phaùp kieåm soaùt ñaëc bieät
5.6.2 Phöông phaùp kieåm saùot chung
5.7 Thoâng soá vaø giôùi haïn tôùi haïn 20
5.7.1 Quaù trình tôùi haïn vaø thoâng soá saûn phaåm
5.7.2 Giaù trò chæ tieâu, giaù trò hoaït ñoäng tôùi haïn vaø giôùi haïn tôùi haïn
5.8 Giaùm saùt vaø ño löôøng 21
5.9 Haønh ñoäng söõa chöõa 22
5.10 Xaùc nhaän giaù trò söû duïng 23
5.11 Thaåm tra xaùc nhaän 24
5.12 Taøi lieäu vaø hoà sô 26
5.12.1 Taøi lieäu vaø kieåm soaùt taøi lieäu
5.12.2 Hoà sô
6 Phuï luïc 1: Chöông trình tieân quyeát (PRP) 28
7 Phuï luïc II: Moái quan heä giöõa “nhöõng yeâu caàu” 36
vaø nhöõng höôùng daãn cuûa CODEX cho aùp duïng HACCP

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
CONTENTS

1 INTRODUCTION 4

2 SCOPE of APPLICATION 7

3 REFERENCE DOCUMENTS 8

4 TERMS and DEFINITIONS 9

5 HACCP SYSTEM REQUIREMENTS 12


5.1 Management responsibility 12
5.1.1 Policy
5.1.2 Scope of the HACCP system
5.1.3 Task, Responsibilities, Authorities
5.1.4 HACCP team(s)
5.1.5 Resources
5.1.6 Management review
5.2 Product Information 14
5.2.1 Product characteristics
5.2.2 Intended use
5.3 Process Information 15
5.3.1 Flow Diagrams
5.3.2 Layout
5.3.3 Control and Verification of Process Information
5.4 Pre-Requisite Program (PRP) 16
5.5 Hazard Analysis 17
5.5.1 Hazard identification
5.5.2 HACCP analysis (risk)
5.6 Control Measures 19
5.6.1 Specific Control Measures
5.6.2 General Control Measures
5.7 Parameters and Critical Limits 20
5.7.1 Critical process and product parameters
5.7.2 Target values, action-limit values and critical limits
5.8 Monitoring and Measuring 21
5.9 Corrective actions 22
5.10 Validation 23
5.11 Verification 24
5.12 Documentation and records 26
5.12.1 Documents and document control
5.12.2 Records

6 ANNEX I: PRE-REQUISITE PROGRAM (PRP) 28

7 ANNEX II: RELATIONSHIP BETWEEN THE “REQUIREMENTS” 36


AND CODEX GUIDELINES FOR THE APPLICATION OF HACCP

1 GIÔÙI THIEÄU
Nhöõng taøi lieäu tham khaûo ; luaät ñònh ; thoâng tin neàn taûng

An toaøn thöïc phaåm laø moái quan taâm cuûa toaøn caàu. Khoâng chæ bôûi vì quan troïng cho söùc khoeû
coäng ñoàng, maø coøn bôûi vì aûnh höôûng cuûa noù ñeán thöông maïi quoác teá. Hieäu quaû cuûa Heä

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
thoáng an toaøn thöïc phaåm tröôùc heát phaûi quaûn lyù vaø ñaûm baûo söï an toaøn vaø phuø hôïp cuûa thöïc
phaåm.

ÔÛ nhieàu quoác gia treân theá giôùi, luaät ñònh veà an toaøn vaø phuø hôïp cuûa thöïc phaåm yeâu caàu
“HACCP” phaûi coù duø cho doanh nghieäp hay toå chöùc thöïc phaåm, duø cho coù lôïi nhuaän hay khoâng
vaø laø xaû hoäi hay caù nhaân, tieán haønh baát kyø hay taát caû caùc haønh ñoäng sau : sô cheà, cheá bieán,
saûn xuaát, ñoùng goùi, toàn tröõ, vaän chuyeån, phaân phoái, xöû lyù hay baùn hoaëc cung caáp thöïc phaåm.
Theo chæ thò EU 93/43/EEC veà Veä sinh thöïc phaåm cuûa hoaït ñoäng kinh doanh thöïc phaåm trong Lieân
ñoaøn Chaâu Aâu phaûi thöïc hieän HACCP1. Hoï phaûi baûo ñaûm raèng ñaày ñuû caùc qui trình an toaøn
ñöôïc xaùc ñònh, vaên baûn hoaù, duy trì vaø xem xeùt laïi nhöõng vaán ñeà chính cô baûn thöôøng söû duïng
ñeå phaùt trieån heä thoáng HACCP (“Phaân tích moái nguy vaø ñieåm kieåm soaùt tôùi haïn “)

Hoäi ñoàng Joint FAO/WHO Codex Alimentarius moâ taû moät loaït caùc böôùc, bao goàm 7 böôùc chính cho
höôùng daãn aùp duïng heä thoáng HACCP 2.
Codex cuõng khuyeân raèng ño löôøng veä sinh toái thieåu cuõng ñöôïc ñaët ra tröôùc khi HACCP ñöôïc thöïc
hieän : ”Tröôùc khi aùp duïng HACCP cho baát cöù phaàn naøo trong daây chuyeàn thöïc phaåm, phaàn ñoù
phaûi ñöôïc hoaït ñoäng döïa vaøo Codex General Principles of Food Hygiene, neáu thích hôïp Codex Codes
of Practice, and thích hôïp luaät ñònh an toaøn thöïc phaåm.”

Nhöõng chöông trình tieân quyeát phaûi ñöôïc cuï theå vaø vaên baûn hoaù, hoaït ñoäng ñaày ñuû vaø thaåm tra
xaùc nhaän ñeå deã daøng aùp duïng thaønh coâng vaø thöïc hieän HACCP. General Principles of Food
Hygiene 3, ñöôïc ñeà nghò bôûi Codex, hình thaønh moät phaàn beân trong cuûa taøi lieäu naøy “Nhöõng yeâu
caàu cho heä thoáng an toaøn thöïc phaåm döïa vaøo HACCP”.

Nhöõng yeâu caàu an toaøn thöïc phaåm ñaëc bieät ñöôïc neâu chi tieát trong luaät ñònh, caùc quy taéc veä
sinh, yeâu caàu cuûa khaùch haøng hay ngöôøi tieâu thuï. ÔÛ ñaâu maø nhöõng yeâu caàu ñaëc bieät khoâng
toàn taïi, General Principles on Food Hygiene seõ ñöôïc aùp duïng (xem Phuï luïc I). Theâm nöõa, 7 nguyeân
taéc vaø höôùng daãn aùp duïng cuûa HACCP keát hôïp vôùi nhöõng yeáu toá cô baûn trong heä thoáng quaûn
lyù chaát löôïng (ISO 9000) ñeå thieá laäp Nhöõng yeâu caàu cho Heä thoáng an toaøn thöïc phaåm döïa vaøo
HACCP.
Nhöõng taøi lieäu tham khaûo ñöôïc trình baøy trong “Nhöõng yeâu caàu” ñöôïc chæ roõ trong chöông 3.
“Nhöõng yeâu caàu” ñöôïc taäp trung chính vaøo haønh ñoäng vaø hoaït ñoäng ñeå ñaûm baûo an toaøn thöïc
phaåm. Söï ñaûm baûo thuïc phaåm thích hôïp ñöôïc quan taâm nhö laø moät phaàn baét buoäc cuûa heä thoáng
quaûn lyù chaát löôïng, tröø khi söï leäch höôùng coù theå daãn ñeán thuïc phaåm khoâng an toaøn.

Söï caàn thieát cho tieâu chuaån hay yeâu caàu

“Nhöõng yeâu caàu cho Heä thoáng an toaøn thöïc phaåm döïa vaøo HACCP” phaùt trieån bôûi vaø thay theá
döôùi traùch nhieäm cuûa Hoäi ñoàng quoác gia chuyeân gia – HACCP ñeå laøm taøi lieäu/ tieâu chuaån
chuaån. Taát caûboä phaän lieân quan ñeá daây chuyeàn caùc boä phaän ñöôïc ñaïi dieän Hoäi ñoàng quoác gia
chuyeân gia- HACCP.
Nhöõng yeâu caàu ñöôïc söû duïng bôûi boä phaän chöùng nhaän ñeå ñaùnh giaù söï phuø hôïp lieân tuïc cuûa
HACCP- heä thoáng an toaøn thöïc phaåm ñöôïc phaùt trieån vaø thöïc hieän bôûi toå chöùc kinh doanh thöïc
phaåm.

Dó nhieân laø caùc toå chöùc hoaït ñoäng kinh doanh coù theå söû duïng “Nhöõng yeâu caàu” ñeå phaùt trieån
HACCP cuûa hoï – Heä thoáng an toaøn thöïc phaåm.

Chöùng chæ/ Ñaêng kyù HACCP – Heä thoáng an toaøn thöïc phaåm ñöôïc xaùc nhaän laø phöông tieän xaùc
nhaän hình thöùc (moät chöùng chæ) vaø/hoaëc baèng chöùng, thoâng baùo ñöôïc cung caáp vôùi xaùc nhaän

1
EU Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175).
2
Codex Alimentarius Commission, “Hazard Analysis and Critical Control Point (HACCP) System and
Guidelines for its Application”, Annex to CAC/RCP 1-1969, Rev. 3 (1997).
3
Codex Alimentarius Commission, “General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3
(1997), amended 1999.

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
raèng moät saûn phaåm hay dòch vuï phuø hôïp vôùi tieâu chuaån hay yeâu caàu kyõ thuaät ñaõ ñöôïc ñònh
tröôùc. Ñieàu naøy bao goàm khaû naêng cuûa coâng ty ñeå duy trì söï phuø hôïp vôùi tieâu chuaån hoaëc yeâu
caàu.

Ñeå phaùt haønh moät baèng chöùng nhaän HACCP – Heä thoáng an toaøn thöïc phaåm cuûa moät toå chöùc
kinh doanh thöïc phaåm caàn thieát phaûi ñaùnh giaù. Vieäc ñaùnh giaù chöùng nhaän vaø giaùm saùt laïi ñeå
ñaùnh giaù hieäu quaû thöïc hieän bôûi Boä phaän chöùng nhaän laø moät cô quan ñoäc laäp (coù theå laø cuûa
chính phuû hoaëc khoâng) coù traùch nhieäm cuõng nhö laø söï tin töôûng ñeå toå chöùc heä thoáng chöùng
nhaän vôùi taàm quan troïng cuûa taát caû boä phaän lieân quan ñöôïc laø ñaïi dieän.

Ñoái vôùi söï tin töôûng cuûa Boä phaän chöùng nhaän phaûi söû duïng “Nhöõng yeâu caàu” vaø “Quy ñònh
chöùng nhaän” trong chuaån möïc thoáng nhaát. “Nhöõng yeâu caàu” ñöôïc vaên baûn hoaù baèng caùch cho
pheùp caùc ñaùnh giaù hieäu quaû veà tình traïng vaø thöïc hieän HACCP - Heä thoáng an toaøn thöïc phaåm,
cuõng nhö ñöôïc thöïc hieän bôûi toå chöùc kinh doanh thöïc phaåm. Trong “Quy ñònh chöùng nhaän”, tieâu
chuaån ñaëc bieät ñöôïc phaùt bieåu phaûi ñöôïc ñaùp öùng bôûi Boä phaän chöùng nhaän khi löïa choïn moät
ñoäi coù thaåm quyeàn ñaùnh giaù HACCP, vaø nhöõng luaät leä cuûa chính phuû trong quaù trình ñaùnh giaù
chöùng nhaän ñöôïc thieát keá vaø ñeà nghò (VD: thôøi gian ñaùnh giaù toái thieåu) phaûi ñöôïc thöïc hieän
theo.

Quyeàn haïn ñaït ñöôïc khi Boä phaän chöùng nhaän laø ñaïi dieän chính thöùc ñöôïc thöøa nhaän bôûi Boä
phaän coâng nhaän toå chöùc heä thoáng chöùng nhaän cho HACCP - Heä thoáng an toaøn thöïc phaåm vaø
ñöôïc ñaùnh giaù thöôøng xuyeân bôûi Boä phaän ñöôïc coâng nhaän naøy. Söï coâng nhaän quan taâm veà söï
tin caäy vaø thaåm quyeàn cuûa Boä phaän caáp chöùng nhaän.

Noù phaûi ñöôïc hieåu raèng chöùng chæ HACCP – Heä thoáng an toaøn thöïc phaåm thì khoâng phaûi laø
baûo ñaûm cho suï thöïc hieän an toaøn thöïc phaåm lieân tuïc cuûa toå chöùc kinh doanh thöïc phaåm. Giaù trò
gia taêng cho toå chöùc kinh doanh thöïc phaåm vôùi chöùng chæ HACCP - Heä thoáng an toaøn thöïc phaåm
naèm trong nhöõng noã löïc taïo ra bôûi hoaït ñoäng cuûa coâng ty ñeå duy trì heâ thoáng HACCP vaø nhöõng
can keát cuûa hoï ñeå caûi tieán lieân tuïc vieäc thöïc hieän an toaøn thöïc phaåm.

Nhöõng yeâu caàu cho Heä thoáng an toaøn thöïc phaåm döïa vaøo HACCP

Nhöõng yeâu caàu trong tieâu chuaån naøy cung caáp moät caùch cô baûn veà söï phuø hôïp cuûa HACCP -
Heä thoáng an toaøn thöïc phaåm vôùi nhöõng luaät ñònh quoác teá vaø caùc quy taéc thöïc haønh. Chuùng
bao goàm nhöõng yeâu caàu caàn thieát cuûa heä thoáng quaûn lyù. Caáu truùc, söï phoái hôïp vaø moái töông
giao cuûa quaù trình ñaùnh giaù ñöôc moâ taû chi tieát trong hình 1.

Trong moâ taû cuûa moãi ñieàu khoaûn, phaïm vi cuûa nhöõng yeâu caàu ñöôïc neâu chi tieát. Söû duïng
nhöõng ñieàu khoaûn, ñoäi ñaùnh giaù chöùng nhaän xem xeùt caùc taøi lieäu HACCP - Heä thoáng an toaøn
thöïc phaåm cuõng nhö laø caùc haønh ñoäng thöïc hieän hay caùc hoaït ñoäng cuûa heä thoáng treân sô ñoà
maët baèng.

“Nhöõng yeâu caàu” baét ñaàu xaây döïng moät loaït caùc yeâu caàu chung. Moät hoaït ñoäng cuûa HACCP -
Heä thoáng an toaøn thöïc phaåm phaûi laø, möùc toái thieåu, trong söï phuø hôïp vôùi nhöõng yeâu caàu naøy.
Trong phuï luïc II cuûa nhöõng taøi lieäu naøy moãi moät tieâu ñeà hay ñoaïn vaên baûn cuûa “nhöõng yeâu
caàu” daãn tôùi ñoaïn vaên tieáp theo trong taøi lieäu höôùng daãn HACCP cuûa Codex Alimentarius 4.

Figure 1. Caáu truùc cuûa HACCP – Heä thoáng an toaøn thöïc phaåm

4
Codex Alimentarius Commission, “Hazard Analysis and Critical Control Point (HACCP) System and
Guidelines for its Application”, Annex to CAC/RCP 1-1969, Rev. 3 (1997).

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP

 5.11 Thaåm tra xaùc nhaän

5.1 Traùch nhieäm 5.2  5.6.1 Phöông phaùp kieåm soaùt ñaëc bieät lieân quan ñeán 
cuûa laõnh ñaïo  Saûn phaåm  caùc CCP

5.7 5.8 5.9


5.5 Phaân tích moái Giôùi haïn tôùi  Giaùm saùt  Haønh ñoäng 5.10
5.3 nguy haïn söõa chöõa Xaùc nhaän giaù
 Quaù trình  trò söû duïng

5.4  5.6.2 Phöông phaùp kieåm soaùt chung 


 PRP 
Phuï luïc 1

5.12 Taøi lieäu vaø Hoà sô

Ñeå laøm cho heä thoáng roõ raøng vaø coù theå ñaùnh giaù, toå chöùc kinh doanh thöïc phaåm phaûi cung
caáp thoâng tin nhö chæ daãn trong “Nhöõng yeâu caàu”. Cho moãi ñieàu kieän ñaëc bieät (saûn phaåm/ nhoùm
saûn phaåm/ quaù trình/ boä phaän), nhöõng yeâu caàu ñaëc bieät phaûi neâu chi tieát bôûi toå chöùc kinh
doanh thöïc phaåm. Ñoäi ñaùnh giaù chöùng nhaän phaûi ñaùnh giaù hoaøn toaøn heä thoáng chung vaø
nhöõng yeâu caàu ñaëc bieät cuûa coâng ty.
Baûn dòch thöù nhaát cuûa “Nhöõng yeâu caàu” (coøn goïi laø “Tieâu chuaån”) ñöôïc phaùt trieån trong hoaït
ñoäng phuï vôùi moät vaøi Boä phaän chöùng nhaän ôû Haø Lan trong lónh vöïc nguyeân lieäu thöïc phaåm vaø
cheá bieán, döôùi traùch nhieäm vaø quyeàn haïn cuûa Hoäi ñoàng quoác gia caùc chuyeân gia – HACCP. Baûn
dòch thöù nhaát ñöôïc xuaát baûn vaøo 15/5/1996.

Döïa vaøo nhöõng boå sung cuûa Codex Alimentarius (Alinorm 97/13A, Appendix II) trong 1997, moät baûn
söûa laïi Nhöõng yeâu caàu trôû neân caàn thieát. Hoäi ñoàng quoác gia caùc chuyeân gia – HACCP cuõng coù
theå döïa vaøo nhöõng kinh nghieäm cuûa hoï ñeå caûi tieán chaát löôïng cuûa “Nhöõng yeâu caàu”.Phieân
baûn thöù hai cuûa “Nhöõng yeâu caàu” ñöôïc xuaát baûn vaøo 9/1998 vaø dòch sang tieáng Anh vaøo 2/1999.

Nhöõng söï phaùt trieån gaàn ñaây vôùi chi tieát cuï theå cho HACCP – Heä thoáng an toaøn thöïc phaåm vaø
phaùt trieån vôùi Codex, cuõng nhö laø nhöõng ñeà xuaát cho Quy ñònh veä sinh thöïc phaåm (coù lieân quan
tôùi huyû boû tham khaûo hieän taïi cuûa Quy ñònh vaø Chæ thò cuûa EU), caàn phaûi coù baûn söûa theâm :
baûn dòch thöù ba.

1 INTRODUCTION
Reference documents; legislation; background information

Food safety is a global concern. Not only because of the continuing importance for public health, but also
because of its impact on international trade. Effective Food Safety Systems shall therefore manage and ensure
the safety and suitability of foodstuffs.

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In many countries world-wide, legislation on the safety and suitability of foodstuffs requires “HACCP” to be
put in place by any food business or organisation, whether profit-making or not and whether public or private,
carrying out any or all of the following activities: preparation, processing, manufacturing, packaging, storage,
transportation, distribution, handling or offering for sale or supply of foodstuffs. According to EU Directive
93/43/EEC on Food Hygiene all food business operators in the European Union shall implement HACCP 5.
They shall ensure that adequate safety procedures are identified, documented, maintained and reviewed on the
basis of the principles used to develop the system of HACCP (“Hazard Analysis and Critical Control Point”).

The Joint FAO/WHO Codex Alimentarius Commission describes a series of steps, including the 7 HACCP
6
principles giving guidance for the application of the HACCP system .
Also, Codex advises that minimum hygiene measures should be in place before HACCP is implemented: ”Prior
to application of HACCP to any sector of the food chain, that sector should be operating according to the
Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food
safety legislation.”

These prerequisite programs should be well specified and documented, fully operational and verified in order to
facilitate the successful application and implementation of HACCP. The General Principles of Food Hygiene 7,
as recommended by Codex, form an intrinsic part of this document “Requirements for a HACCP based Food
Safety System”.

Specific food safety requirements are detailed in legislation, hygiene codes, customer or consumer
specifications. Where specific requirements do not exist, the General Principles on Food Hygiene will be
applied (see Annex I). Furthermore, the 7 principles and the guidelines for the application of HACCP have been
combined with basic elements of quality management systems (ISO 9000) to establish the Requirements for a
HACCP based Food Safety System.
The reference documents used to formulate the “Requirements” have been specified in Chapter 3.
The “Requirements” are primarily focused on actions and activities to ensure food safety. The assurance of
food suitability is considered to be an obligatory part of a quality management system, unless deviations may
lead to unsafe foodstuffs.

The need for a Standard or Specification

The specification “Requirements for a HACCP based Food Safety System” has been developed by and placed
under the authority of the National Board of Experts – HACCP in order to make a normative
document/standard available. All parties involved in the food chain are represented on the National Board of
Expert - HACCP.
The specification can be used by Certification Bodies to assess the continuous compliance of HACCP-based
Food Safety Systems as developed and implemented by food business operators.

Of course, a food business operator may also use the “Requirements” to develop its HACCP-based Food Safety
System.

Certification/Registration of HACCP-based Food Safety Systems signifies that by means of a


formal statement (a certificate) and/or mark, notice is given with justified confidence that a
product or a service is in conformance with a pre-defined standard or (technical)
specification. This includes the ability of the company to maintain conformance with the
standards or specifications.

5
EU Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175).
6
Codex Alimentarius Commission, “Hazard Analysis and Critical Control Point (HACCP) System and
Guidelines for its Application”, Annex to CAC/RCP 1-1969, Rev. 3 (1997).
7
Codex Alimentarius Commission, “General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3
(1997), amended 1999.

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In order to issue such a formal statement, the HACCP-based Food Safety System of a food
business operator needs to be assessed. Certification and repetitive surveillance audits are to
be effectively performed by a Certifying Body which is an independent institution (whether or
not governmental) that has both the authority as well as the confidence to operate a
certification system within which the interests of all involved parties are represented.

For confidence the Certifying Body must use the published “Requirements” and the “Certification Regulations”
in an agreed manner. The “Requirements” are documented in such a way to allow an effective assessment of
the status and performance of the HACCP-based Food Safety System, as implemented by the food business
operator. In the “Certification Regulations”, specific criteria are stated which have to be met by the Certifying
Body when selecting a competent HACCP audit team, and rules which govern the way the certification process
is designed and offered (e.g. the minimum auditor time) have to be followed.

Authority is obtained when the Certifying Body is formally accredited by a recognised Body to operate the
certification system for HACCP based Food Safety Systems 8 and is audited regularly by this Accreditation
Body. Accreditation concerns the reliability and competence of the Certifying Body.

It must be understood that certification of a HACCP-based Food Safety System is not a guarantee of a food
business operator’s continuous food safety performance. The value added to a food business operator with a
certified HACCP-based Food Safety System lies in the efforts made by the operating company to maintain that
HACCP system and its commitment to continuously improve its food safety performance.

Requirements for a HACCP based Food Safety System

The requirements in this Specification provide a basis for compliance of a HACCP-based Food Safety System
with (inter)national legislation and codes of practice. They include the necessary management system
requirements. The structure, the sequence and interaction of the assessment process is detailed in Figure 1.

In the description of every clause, the scope of the requirements are detailed. Using these clauses, the audit
team assesses the documented HACCP-based Food Safety System as well as the implementation and operation
of the system on the 'shop floor'.

The “Requirements” lay down a generic set of requirements. An operational HACCP-based Food Safety System
shall be, as a minimum, in compliance with these Requirements. In Annex II of this document each heading or
paragraph of the “Requirements” refers to the corresponding text in the HACCP guidance document of Codex
Alimentarius 9.

Figure 1. The structure of a HACCP-based Food Safety System

 5.11 Verification

5.1 Management 5.2  5.6.1 Specific Control Measures 


responsibility  Products  related to CCP’s

8
The certification bodies must meet “General requirements for bodies operating assessment and
certification / registration of quality systems”, ISO/IEC Guide 62:1996 (ISO 45012) and
the Standards for auditing (ISO 10011, Part 1 and 2).
9
Codex Alimentarius Commission, “Hazard Analysis and Critical Control Point (HACCP) System and
Guidelines for its Application”, Annex to CAC/RCP 1-1969, Rev. 3 (1997).

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5.7 5.8 Monitoring 5.9 Corrective


5.5 Hazard Critical limits   actions 5.10
5.4 Analysis Validation
 Processes 

5.4  5.6.2 General Control Measures 


 PRP 
Annex 1

5.12 Documentation and Registration

In order to make the system transparent and enable assessment, the food business operator shall provide
information as indicated in these “Requirements”. For each specific condition (product / product group /
process / sector), specific requirements shall be detailed by the food business operator. The audit team shall
assess this complete system of generic and company specific requirements.

The first version of these “Requirements” (then called “Criteria”) has been developed in co-operation with
several Certification Bodies in the Netherlands in the area of food materials and processing, under the authority
and responsibility of the National Board of Experts - HACCP. The 1st version was published on May 15, 1996.

Due to the modification of the Codex Alimentarius (Alinorm 97/13A, Appendix II) in 1997, a revision of the
Requirements became necessary. The National Board of Experts - HACCP was also able to draw on their
experience in order to improve the quality of the “Requirements”. The 2 nd version of the “Requirements” was
published in September 1998 and translated into English in February 1999.

Recent developments with respect to HACCP-based Food Safety System and developments within Codex, as
well as new proposals for Food Hygiene Regulations (thereby repealing the current referenced EU Directives
and Regulations), have necessitated a further revision: this 3rd version!

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2 Phaïm vi aùp duïng


Trong taøi lieäu naøy, nhöõng yeâu caàu phaûi cuï theå ñöôïc söû duïng trong suoát quaù trình ñaùnh giaù cuûa
hoaït ñoäng heä thoáng HACCP ñeå baûo ñaûm an toaøn cuûa thöïc phaåm trong suoát quaù trình sô cheá, cheá
bieán, saûn xuaát, ñoùng goùi, toàn tröõ, vaän chuyeån, phaân phoái, xöû lyù hoaëc baùn hay cung caáp trong
baát cöù boä phaän naøo cuûa daây chuyeàn thöïc phaåm.

“Nhöõng yeâu caàu” ñöôïc aùp duïng cô baûn ñoái vôùi taát caû doanh nghieäp hay toå chöùc thöïc phaåm, keå
caû taïo ra lôïi nhuaän hay khoâng, keå caû nhaø nöôùc hay caù nhaân.

Thaät söï, toå chöùc kinh doanh thöïc phaåm phaûi xaùc ñònh baát kyø böôùc naøo trong hoaït ñoäng cuûa hoï
laø tôùi haïn ñeå baûo ñaûm an toaøn thöïc phaåm vaø phaûi phaùt trieån, thöïc hieän, duy trì vaø xem xeùt laïi
ñaày ñuû thuû tuïc an toaøn, aùp duïng caùc nguyeân taéc cuûa HACCP, bao goàm nhöõng nguyeân taéc chung
cuûa veä sinh thöïc phaåm, vaø neáu thích hôïp nhöõng quy taéc thöïc haønh vaø luaät ñònh an toaøn thöïc
phaåm coù lieân quan.

“ Nhöõng yeâu caàu” thì khoâng döï ñònh aùp duïng cho nhaø cung caáp vaø/ hoaëc coâng ty dòch vuï kinh
doanh thöïc phaåm, gioáng nhö nhaø cung caáp bao bì, thieát bò phuïc vuï thöïc phaåm, dòch vuï laøm saïch
coâng nghieäp…

2 SCOPE of APPLICATION
In this document, requirements have been specified to be used during the assessment of operational HACCP
systems (HACCP-based Food Safety Systems) which ensure the safety of foodstuffs during preparation,
processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale or
supply in any sector of the food chain.

The “Requirements” are basically applicable to all food businesses or organisations, whether profit-making or
not, and whether public or private.

Obviously, the food business operators shall have identified any step in their activities which is critical to
ensure food safety and shall have developed, implemented, maintained and reviewed adequate safety
procedures, applying the principles of HACCP, including the general principles of food hygiene, and where
appropriate the relevant codes of practice and the food safety legislation.

These “Requirements” are not intended for application by suppliers and / or service companies to food
businesses, like suppliers of packaging, food equipment, industrial cleaning services, etc..

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3 Nhöõng taøi lieäu tham khaûo


“ Nhöõng yeâu caàu cho heä thoáng an toaøn thöïc phaåm döïa vaøo HACCP” döïa vaøo nhöõng taøi lieäu tham
khaûo döôùi ñaây :

1
Theá giôùi :
Joint FAO/WHO Codex Alimentarius Commission,
- General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3 (1997), amended 1999.
- Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application,
Annex to CAC/RCP 1-1969, Rev. 3 (1997).

2
Caáp quoác teá :
European Union
2a. General Food law
Regulation (EC) no 178/2002, laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and laying down procedures in matters
of food safety, dated 28 January 2002.
2b
Council Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175);
Specific legislation and regulations concerning food safety and hygiene have been laid down in Council
Directives such as 64/433/EEC for fresh meat, 71/118/EEC for poultry meat, 89/437/EEC for egg products,
92/46/EEC for dairy products, 92/5/EEC for meat products, 91/493/EEC for fishery products, 94/65/EEC for
minced meat, etc..

2c
Documents under 2b will be repealed by:
Proposal for a Regulation of the European Parliament and of the Council on the hygiene of foodstuffs,
COM/2000/0438 final, 14 July 2000 (COD 2000/0178), and others.

3
Caáp quoác gia :
Netherlands, Food and Commodity Act:
Warenwetregeling Hygiëne van Levensmiddelen, 12 december 1994 (DGVgz/VVP/L 942587).

4
Neáu thích hôïp :
Numerous (International, a/o. Codex) Codes of Practice, Food Commodity Standards and (national) Hygiene
Codes (generic HACCP / hygiene plans).

3 REFERENCE DOCUMENTS
The “Requirements for a HACCP-based Food Safety System” are based on the following reference documents:

1
World-wide:
Joint FAO/WHO Codex Alimentarius Commission,
- General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3 (1997), amended 1999.
- Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application,
Annex to CAC/RCP 1-1969, Rev. 3 (1997).

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2
International level:
European Union
2a. General Food law
Regulation (EC) no 178/2002, laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and laying down procedures in matters
of food safety, dated 28 January 2002.
2b
Council Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175);
Specific legislation and regulations concerning food safety and hygiene have been laid down in Council
Directives such as 64/433/EEC for fresh meat, 71/118/EEC for poultry meat, 89/437/EEC for egg products,
92/46/EEC for dairy products, 92/5/EEC for meat products, 91/493/EEC for fishery products, 94/65/EEC for
minced meat, etc..

2c
Documents under 2b will be repealed by:
Proposal for a Regulation of the European Parliament and of the Council on the hygiene of foodstuffs,
COM/2000/0438 final, 14 July 2000 (COD 2000/0178), and others.

3
National level:
Netherlands, Food and Commodity Act:
Warenwetregeling Hygiëne van Levensmiddelen, 12 december 1994 (DGVgz/VVP/L 942587).

4
Where appropriate:
Numerous (International, a/o. Codex) Codes of Practice, Food Commodity Standards and (national) Hygiene
Codes (generic HACCP / hygiene plans).

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4 Thuaät ngöõ vaø ñònh nghóa

Chæ soá hoaït ñoäng tôùi haïn : Moät giaù trò cho saûn phaåm hay thoâng soá quaù trình quan taâm, ngoaïi
tröø giaù trò giôùi haïn tôùi haïn, chæ ra raèng söï can thieäp trong quaù trình yeâu caàu.
Khía caïnh: Moät yeáu toá cho hoaït ñoäng kinh doanh thöïc phaåm (saûn phaåm, quaù trình, PRP, dòch vuï)
maø coù lieân quan tôùi an toaøn thöïc phaåm.
Chöùng nhaän: Haønh ñoäng cuûa beân thöù ba tuyeân boá raèng coù ñuû ñieàu kieän ñeå xaùc ñònh ñuùng
saûn phaåm, quaù trình hay dòch vuï phuø hôïp vôùi moät tieâu chuaån cuï theå hay taøi lieäu chuaån naøo
khaùc.
Kieåm soaùt (ñoäng töø) : Tieán haønh taát caû nhöõng hoaït ñoäng ñeå ñaûm baûo vaø duy trì söï tuaân thuû
caùc chæ tieâu ñeà ra trong keá hoaïch HACCP.
Söï kieåm soaùt (danh töø) : Traïng thaùi khi caùc thuû tuïc tieán haønh ñuùng ñöôïc tuaân thuû vaø caùc tieâu
chí caàn ñaït ñöôïc.
Bieän phaùp kieåm soaùt : Baát cöù haønh vi vaø hoaït ñoäng naøo ñöôïc duøng ñeå ngaên ngöøa hay loaïi
tröø moät moái nguy ñoái vôùi an toaøn thöïc phaåm, hoaëc giaûm noù xuoáng moät nöùc chaáp nhaän ñöôïc.
Bieän phaùp kieåm soaùt, chung: Moät bieän phaùp kieåm soaùt cuï theå moät phaàn cuûa PRP.
Bieän phaùp kieåm soaùt, cuï theå: Moät bieän phaùp kieåm soaùt taïi CCP.
Haønh ñoäng khaéc phuïc : Baát cöù hoaït ñoäng naøo caàn laøm khi caùc keát quaû giaùm saùt ôû ñieåm
kieåm soaùt tôùi haïn (CCP) cho thaáy ñaõ bò maát kieåm soaùt.
Ñieåm kieåm soaùt tôùi haïn (CCP) : ñieåm taïi ñoù coù theå aùp duïng kieåm soaùt, vaø coù yù nghóa quan
troïng ñeå ngaên ngöøa hay loaïi tröø moät moái nguy cho an toaøn thöïc phaåm hoaëc giaûm noù xuoáng moät
möùc chaáp nhaän ñöôïc.
Giaù tri tôùi haïn : Moät tieâu chí phaân giôùi haïn giöõa phaïm vi chaáp nhaän ñöôïc vaø khoâng chaáp nhaän
ñöôïc.
Chuù yù: Tieâu chuaån naøy ñònh nghóa ngöôõng tôùi haïn cho saûn phaåm hay thoâng soá quaù trình maø
caàn quan taâm cho vieäc giaùm saùt (xem giaù trò hoaït ñoäng tôùi haïn vaø giaù trò muïc tieâu).
Sô ñoà quy trình saûn xuaát : Caùch trình baøy coù heä thoáng trình töï caùc böôùc hay caùc hoaït ñoäng,
thao taùc ñöôïc duøng trong chuaån bò, cheá bieán, saûn xuaát, ñoùng goùi, toàn tröõ, vaän chuyeån, phaân
phoái, xöû lyù hay yeâu caàu ñaët haøng cho moät maët haøng thöïc phaåm cuï theå.
Ngöôøi kinh doanh thöïc phaåm: ngöôøi hay nhoùm ngöôøi chòu traùch nhieäm baûo ñaûm caùc yeâu caàu
veà luaät ñònh cuûa thöïc phaåm ñöôïc ñaùp öùng trong kinh doanh thöïc phaåm döôùi söï kieåm soaùt.
Ngöôøi xöû lyù thöïc phaåm: Baát kyø ngöôøi naøo tieáp xuùc tröïc tieáp vôùi thöïc phaåm ñoùng hay khoâng
ñoùng goùi, duïng cuï thöïc phaåm vaø ñoà duøng naáu aên, hay tieáp xuùc beà maët thöïc phaåm vaø tröôùc
ñoù ñöôïc mong ñôïi tuaân theo yeâu caàu veä sinh thöïc phaåm.
Veä sinh thöïc phaåm: Taát caû ñieàu kieän vaø bieän phaùp caàn thieát ñaûm baûo an toaøn vaø thích hôïp
cuûa thöïc phaåm taïi taát caû coâng ñoaïn cuûa daây chuyeån thöïc phaåm.
An toaøn thöïc phaåm: Ñaûm baûo raèng thöïc phaåm seõ khoâng gaây haïi cho ngöôøi tieâu thuï khi noù
ñöôïc chuaån bò vaø/hoaëc aên theo muïc ñích söû duïng cuûa noù.

Thöïc phaåm thích hôïp: Ñaûm baûo raèng thöïc phaåm chaáp nhaän ñöôïc cho ngöôøi tieâu duøng theo muïc
ñích söû duïng.
Bieän phaùp kieåm soaùt chung: xem bieän phaùp kieåm soaùt, chung
HACCP : Moät heä thoáng xaùc ñònh, ñaùnh giaù vaø kieåm soaùt caùc moái nguy ñaùng keå ñoái vôùi an
toaøn thöïc phaåm.

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Ñaùnh giaù HACCP: Moät kieåm tra ñoäc laäp hay heä thoáng quyeát ñònh heä thoáng HACCP, bao goàm
keá hoaïch HACCP vaø keát quaû lieân quan, phuø hôïp vôùi saép xeáp theo keá hoaïch, thöïc hieän coù hieäu
quaû vaø thích hôïp vôùi vieäc ñaït ñöôïc muïc tieâu ñeà ra.
Ghi chuù: Kieåm tra vieäc phaân tích moái nguy laø yeáu toá caàn thieát cho hoaït ñoäng ñaùnh giaù HACCP.
Keá hoaïch HACCP : Moät taøi lieäu ñöôïc xaây döïng phuø hôïp theo caùc nguyeân taéc cuûa HACCP ñeå
ñaûm baûo kieåm soaùt caùc moái nguy ñaùng keå ñoái vôùi an toaøn thöïc phaåm trong coâng ñoaïn ñöôïc
xem xeùt cuûa daây chuyeàn thöïc phaåm.
HACCP döïa vaøo heä thoáng an toaøn thöïc phaåm: (moät heä thoáng HACCP): Caáu truùc toå chöùc, qui
trình, quaù trình, nguoàn löïc caàn thieát cho vieäc thöïc hieän keá hoaïch HACCP vaø ñaùp öùng caùc muïc
tieâu.
Ñoäi HACCP: Nhoùm caù nhaân (nhieàu lónh vöïc) phaùt trieån, thöïc hieän vaø duy trì heä thoáng moät
HACCP.
Moái nguy : Moät taùc nhaân sinh hoïc, hoaù hoïc hay vaät lyù hoïc cuûa thöïc phaåm, hoaëc tình traïng cuûa
thöïc phaåm coù khaû naêng taùc ñoäng gaây haïi cho söùc khoeû con ngöôøi.
Phaân tích moái nguy : Quaù trình thu thaäp vaø ñaùnh giaù thoâng tin veà caùc moái nguy cuøng caùc ñieàu
kieän daãn ñeán söï xuaát hieän caùc moái nguy ñoù, ñeå quyeát ñònh moái nguy naøo laø ñaùng keå ñoái vôùi
an toaøn thöïc phaåm vaø do ñoù caàn ñöôïc ñeà caäp tôùi trong keá hoaïch HACCP.
Giaùm saùt : Vieäc tieán haønh theo keá hoaïch moät chuoãi caùc quan saùt hay ño ñaïc caùc thoâng soá caàn
kieåm soaùt ñeå ñaùnh giaù xem moät ñieåm kieåm soaùt tôùi haïn coù ñöôïc kieåm soaùt khoâng.
Chöông trình tieân quyeát (PRP): Baát cöù haønh ñoäng cuï theå hay baèng vaên baûn hoaëc ñieàu kieän
thöïc hieän phuø hôïp vôùi Codex General Principles of food hygiene, thöïc haønh saûn xuaát toát vaø luaät
ñònh veà thöïc phaåm, ñeå thieát laäp ñieàu kieän cô baûn phuø hôïp cho saûn xuaát vaø xöû lyù thöïc phaåm
an toaøn taïi taát caû coâng ñoaïn cuûa daây chuyeàn thöïc phaåm.
Haønh ñoäng phoøng ngöøa: Baát cöù bieän phaùp hay haønh ñoäng ñöôïc söû duïng ñeå ngaên ngöøa, ñaùnh
giaù hay giaûm söï taùi dieãn nguyeân nhaân sai leäch toàn taïi, khueáyt taät hay baát kyø tình huoáng khoâng
mong ñôïi khaùc lieân quan tôùi an toaøn thöïc phaåm.
Khaâu ban ñaàu : goàm nhöõng coâng ñoaïn trong chu trình thöïc phaåm coù lieân quan, ví duï: thu hoaïch,
moå thòt, vaét söõa, ñaùnh baét caù vaø taát caû coâng ñoaïn lieân quan saûn xuaát trong loø moå.
Saûn phaåm khoâng cheá bieán: Thöïc phaåm khoâng qua cheá bieán, bao goàm saûn phaåm ñöôïc, ví duï ,
chia, taùch, severed, gôõ xöông, baêm, loät da, nghieàn, caét, laøm saïch, tæa, boùc voû hay xay, laøm laïnh,
ñoùng baênng hay laøm laïnh saâu.
Saûn phaåm cheá bieán: Thöïc phaåm keát quaû töø aùp duïng saûn phaåm khoâng cheá bieán qua xöû lyù
nhö laø ñun noùng, hun khoùi, xöû lyù ñeå laâu, laøm chín, ngaâm, saáy, öôùp, trích, eùp, … hay söï keát hôïp
cuûa caù quaù trình naøy vaø/hoaëc saûn phaåm; thay theá caàn thieát saûn xuaát hay mang laïi theâm nhöõng
ñaëc tính ñaëc bieät cho saûn phaåm.

Ruûi ro: Khaû naêng nguyeân nhaân coù haïi cho söùc khoeû gaây neân bôûi söï coá vaø khaéc nghieät cuûa
moái nguy thoâng thöôøng trong thöïc phaåm khi chuaån bò hay tieâu thuï theo muïc ñích söû duïng.
Giaù trò muïc tieâu: Giaù trò cuûa saûn phaåm hay thoâng soá quaù trình ñöôïc giaùm saùt, muïc tieâu vôùi
giaù trò hoaït ñoäng tôùi haïn (khoaûng thay ñoåi chaáp nhaän) vaø dó nhieân vôùi giaù trò tôùi haïn, nhö vaäy
baûo ñaûm thöïc phaåm an toaøn.
Böôùc : Moät ñieåm, theå thöùc, hoaït ñoäng, thao taùc hay moät giai ñoaïn trong daây chuyeàn thöïc phaåm
keå caû nguyeân lieäu, töø khaâu xöû lyù ban ñaàu tôùi khaâu tieâu thuï saûn phaåm cuoái cuøng.
Söï chöùng thöïc : Baèng chöùng thöïc teá thu ñöôïc chöùng toû caùc nguyeân lyù cô baûn cuûa keá hoaïch
HACCP coù hieäu quaû.

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Söï xaùc minh : Vieäc aùp duïng caùc phöông phaùp, qui trình, thöû nghieäm vaø caùc ñaùnh giaù khaùc
cuøng vôùi vieäc giaùm saùt, ñeå xaùc ñònh xem coù tuaân thuû theo keá hoaïch HACCP khoâng vaø hieäu
quaû cuûa HACCP döïa vaøo heä thoáng an toaøn thöïc phaåm.

4 TERMS and DEFINITIONS


Action-limit value: A value for the product or process parameter under consideration, deduced from the critical
limit value, which indicates that an intervention in the process is required.

Aspect: An element of the food business operation (products, processes, PRP, services) that can interact with
the food safety.

Certification: Action by a third party demonstrating that adequate confidence is given that a duly identified
product, process or service conforms with a specific standard or other normative document.

Control (verb): To take all necessary actions to ensure and maintain compliance with criteria established in the
HACCP plan.

Control (noun): The state wherein correct procedures are being followed and criteria are being met.

Control measure: Any action and activity that can be used to prevent or eliminate a food safety hazard or
reduce it to an acceptable level.

Control measure, general: A measure to control a specific part of the PRP.

Control measure, specific: A measure to control a CCP.

Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of control.

Critical Control Point (CCP): A step at which it is essential that a specific control measure is applied to
prevent or eliminate a food safety hazard or reduce the risk to an acceptable level.(see also Control measure,
specific .

Critical limit: A criterion which separates acceptability from non-acceptability.


Note: This criterion defines the limiting values for the product or process parameter(s) under consideration for
monitoring (see action-limit values and target values).

Flow diagram: A systematic representation of the sequence of steps or operations used in the preparation,
processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale of a
particular food item.

Food business operator: the person or persons responsible for ensuring that the requirements of the
food legislation are met within the food business under his/their control.

Food handler: Any person who directly handles packaged or unpacked food, food equipment and utensils, or
food contact surfaces and is therefore expected to comply with food hygiene requirements.

Food hygiene: All conditions and measures necessary to ensure the safety and suitability of food at all stages of
the food chain.

Food safety: Assurance that food will not cause harm to the consumer when it is prepared and/or eaten
according to its intended use.

Food suitability: Assurance that food is acceptable for human consumption according to its intended use.

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General Control Measure: see: Control measure, general

HACCP (Hazard Analysis and Critical Control Point): a system which identifies, evaluates and controls
hazards which are significant for food safety.

HACCP audit: A systematic and independent examination to determine whether the HACCP
system, including the HACCP plan and related results, comply with planned arrangements,
are implemented effectively and are suitable for the achievement of its objectives.
Note: Examination of the Hazard Analysis is an essential element of the HACCP audit.

HACCP plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards
which are significant for food safety in the segment of the food chain under consideration.

HACCP based Food Safety System: (a HACCP system): The organisational structure, procedures, processes
and resources needed to execute the HACCP plan(s) and meet its objectives.

HACCP team: Group of individuals (multi-disciplinary) who develop, implement and maintain
a HACCP system.
Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse
health effect.

Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to
their presence, to decide which are significant for food safety and should therefore be addressed in the HACCP
plan.

Monitoring: The act of conducting a planned sequence of observations or measurement of control parameters
to assess whether a CCP is under control.

Pre-Requisite Programme (PRP): Any specified and documented activity or facility


implemented in accordance with the Codex General Principles of food hygiene, good
manufacturing practice and appropriate food legislation, in order to establish basic conditions
that are suitable for the production and handling of safe food at all stages of the food chain.
Preventive action: Any measure or activity that will be used to prevent, to eliminate or to reduce the recurrence
of causes for existing deviations, defects or any other undesired situation with respect to food safety.

Primary production: Those steps in the food chain up to and including harvesting, hunting, fishing, milking and
all stages of animal production prior to slaughter.

Products, unprocessed: Foodstuffs which have not undergone a treatment, including products which have been,
for example, divided, parted, severed, boned, minced, skinned, ground, cut, cleaned, trimmed, husked or milled,
chilled, frozen or deep-frozen.

Products, processed: Foodstuffs resulting from the application to unprocessed products of a treatment such as
heating, smoking, curing, maturing, pickling, drying, marinating, extraction, extrusion, etc. or a combination of
these processes and/or products; substances necessary for their manufacture or for giving specific
characteristics to the products may be added.

Risk: The probability of causing an adverse health effect caused by the occurrence and the severity of a
particular hazard in food when prepared and consumed according to its intended use.

Target value: The value of the product or process parameter(s) to be monitored, targeted within action-limit
values (the range of acceptable variations) and certainly within critical limit values, thus securing a safe
product.

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Step: A point, procedure, operation or stage in the food chain, including raw materials, from primary
production to final consumption.

Validation: Obtaining evidence (in advance) that the specific and general control measures of the HACCP plan
are effective.

Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to
determine compliance with the specifications laid down in the HACCP plan and the effectiveness of the
HACCP-based Food Safety System.

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5. Yeâu caàu cuûa heä thoáng HACCP

5.1 Traùch nhieäm quaûn lyù


Ban giám đốc có trách nhiệm bảo đảm an toàn thực phẩm. Trách nhiệm của Ban giám đốc thể hiện qua chính
sách của tổ chức. Ban giám đốc chịu trách nhiệm hoàn toàn với chính sách đã công bố, chính sách này phải
được thể hiện bằng văn bản, được hỗ trợ thực hiện và thông tin cho mọi người trong tổ chức.
Định kỳ, Trưởng ban HACCP cần xem xét lại việc thực hiện chính sách và những thay đổi bên ngoài.
Hệ thống HACCP thể hiện sự cam kết và trách nhiệm đảm bảo cung cấp những thực phẩm an toàn của Ban
Giám đốc. Do đó, hệ thống HACCP đảm bảo tất cả mọi hoạt động yêu cầu đều được xác định, thực hiện và duy
trì có hiệu lực.
5. HACCP SYSTEM REQUIREMENTS

5.1 Management responsibility

The food business operator is responsible for the safety (and suitability) of the produced food.
Therefor, the food business operator shall include the policy with respect to food safety in the policy of the
organisation. The food business operator has ultimate responsibility for the policy of the organisation and shall
document, support and communicate this policy.
Periodically, the Food business operator shall verify the implementation of the policy and review the outcome.
The HACCP system enables the food business operator to demonstrate his commitment and his responsibility
with respect to the supply of safe products. For, the HACCP system ensures that all required activities are
effectively defined, implemented and maintained.

5.1.1 Chính saùch


Ban giaùm ñoác phaûi xaùc laäp vaø vaên baûn hoùa chính saùch an toaøn thöïc phaåm cuûa toå chöùc. Chính
saùch theå hieän söï cam keát cuûa toå chöùc veà an toaøn thöïc phaåm. Chính saùch theå hieän toå chöùc ñaõ
xaùc ñònh töøng vò trí trong daây chuyeàn thöïc phaåm. Chính saùch phaûn aùnh roõ phöông phaùp “ töø
noâng traïi ñeán baøn aên”, baét ñaàu töø vieäc mua nguyeân lieäu. Chính saùch phaûi taäp trung vaøo vaán ñeà
an toaøn thöïc phaåm vaø phaûi ñaùp öùng nhu caàu, mong ñôïi cuûa khaùch haøng.
Chính saùch phaûi bao goàm caùc muïc tieâu cuï theå (hoaït ñoäng döï kieán) ñaûm baûo caûi tieán vaán ñeà an
toaøn thöïc phaåm theo nhöõng ñieàu kieän xem xeùt khaùc nhau.
Ban giaùm ñoác phaûi ñaûm baûo chính saùch ñaõ ñöôïc thaáu hieåu, thöïc hieän vaø duy trì taïi moïi caáp
trong toå chöùc.
5.1. 1.Policy

The food business operator shall define and document (in writing) the policy of the organisation with regard to
food safety. It will demonstrate the commitment of the organisation to safe food.
The policy shall demonstrate that the organisation is fully aware of its position in the food chain. It will reflect
the “farm-to-fork” approach, starting with the purchase and acceptance of raw materials.
The policy shall be focused on the safety of foodstuffs and shall respond to the expectations and needs of its
customers and consumers.
The policy shall include concrete objectives 10 (proposed actions) to ensure and improve food safety for the
period under consideration.
The food business operator shall ensure that the policy is understood, implemented and maintained at all levels
in the organisation.

5.1.2 Phaïm vi cuûa heä thoáng HACCP


10
SMART objectives are Specific, Measurable, Acceptable, Realistic objectives, defined in Time.

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Tröôûng ban HACCP phaûi xaùc ñònh phaïm vi cuûa heä thoáng HACCP.
Phaïm vi phaûi bao goàm daây chuyeàn thöïc phaåm vaø caùc hoat ñoäng kinh doanh thöïc phaåm maø
Tröôûng ban HACCP coù traùch nhieäm:
 Daây chuyeàn thöïc phaåm coù theå goàm, baét ñaàu töø vieäc cung caáp nguyeân lieäu vaø keát thuùc
laø traùch nhieäm cuûa Tröôûng ban HACCP khi maø chuyeån sang hoaït ñoäng kinh doanh thöïc phaåm
khaùc. Vì vaäy, phaïm vi phaûi phuø hôïp vôùi hôïp ñoàng mua vaø baùn
 Taát caû moïi vò trí vaø quaù trình lieân quan ñeán vieäc saûn xuaát vaø löu tröõ thöïc phaåm phaûi
ñöôïc xaùc ñònh ñuùng vaø coù saün khi caàn ñaùnh giaù.
 Taát caû caùc saûn phaåm cung caáp cho thò tröôøng ñaõ qua cheá bieán hoaëc xöû lyù sô boä ñeàu
phaûi ñöôïc chæ roõ.
 Caùc hoaït ñoäng hoã trôï (dòch vuï thueâ ngoaøi nhö ñoùng goùi, löu tröõ, vaän chuyeån) phaûi ñöôïc
ñeà caäp ñuùng caùch.
Thöïc teá, vieäc phaân loaïi saûn phaåm neân chia thaønh nhoùm saûn phaåm. Tuy nhieân coù nhöõng ñieåm
quan troïng caàn löu yù :
 Söï khaùc bieät ñaëc tröng giöõa caùc saûn phaåm rieâng leû phaûi ñöôïc ñaùnh giaù ñuùng tieâu
chuaån.
 So saùnh ñieàu kieän cheá bieán vaø löu tröõ.
 Caùc khía caïnh quan troïng ñoái vôùi an toaøn thöïc phaåm khoâng ñöôïc boû soùt.
Quy luaät chính laø khoâng coù phaàn naøo cuûa hoaït ñoäng kinh doanh thöïc phaåm coù theå bò loaïi tröø
khoûi phaïm vi cuûa heä thoáng HACCP, taát caû moïi hoaït ñoäng ñeàu ñöôïc xaùc ñònh, coù saün ñeå ñaùnh
giaù.

5.1.2 Scope of the HACCP system

The food business operator shall define the extent (the scope) of the HACCP system.
The scope shall comprise that part of the food chain and those activities of the food business for which the food
operator is responsible and can be held liable:
 The part of the food chain for which the food business operator is responsible begins where the
responsibility of the suppliers of raw materials and ingredients ends; the responsibility of the food business
operator ends where another food business in the food chain takes over the responsibility. The scope shall
therefore conform with purchase and sales contracts;
 All locations and process lines where food is manufactured and/or stored by the food business shall be
properly indicated and be available for assessment;
 All products which are supplied to the market by the food business, whether processed or handled, shall
be properly specified;
 All subcontracted activities (outsourced services, like packaging, storage, transport) shall be
 properly dealt with.
For practical reasons the total product assortment may be clustered into product groups. However it is
important that:
 Specific differences between individual end products have been critically evaluated;
 Manufacturing and storage conditions are comparable;
 Important aspects for food safety are not overlooked.

A key principle is that no part of the operation of the food business can be excluded from the scope of
the HACCP system; all activities must be available for assessment.
5.1.3 Nhieäm vuï, traùch nhieäm vaø quyeàn haïn
Tröôûng ban HACCP phaûi cung caáp caùc taøi lieäu thích hôïp neâu roõ nhieäm vuï, traùch nhieäm vaø
quyeàn haïn cuûa nhaân vieân trong caùc vò trí lieân quan ñeán vieäc cheá bieán vaø /hoaëc kieåm soaùt vaø
ñaûm baûo tính an toaøn vaø söï phuø hôïp cuûa thöïc phaåm
Sô ñoà toå chöùc vaø caáu truùc baùo caùo cuûa toå chöùc phaûi ñöôïc laäp thaønh vaên baûn.

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5.1.3 Tasks, responsibilities and authorities
The food business operator shall provide appropriate documentation with respect to the tasks, responsibilities
and authorities of food business operator’s employees who are in positions which involve handling food and / or
controlling and ensuring the safety and suitability of the food.
An organisation chart and the organisation’s reporting structure shall be documented.

5.1.4 Nhoùm HACCP


Ban Giaùm ñoác phaûi thieát laäp moät Ban HACCP (hoaëc caùc nhoùm HACCP khaùc neáu caànt thieát).
Nhoùm HACCP phaûi thieát laäp, thöïc hieän vaø duy trì heä thoáng HACCP.
Thaønh vieân cuûa nhoùm HACCP coù kieán thöùc, chuyeân moân vaø ñöôïc reøn luyeän khaùc caàn thieát
ñeå trieån khai, thöïc hieän vaø duy trì heä thoáng HACCP treân toaøn boä phaïm vi cuûa heä thoáng HACCP.
Tieâu chuaån, khaû naêng toái thieåu cuûa thaønh vieân ban HACCP bao goàm caû khaû naêng chuyeân moân.
Caùc khaû naêng naøy phaûi ñöôïc xaùc ñònh vaø cuï theå hoaù thaønh vaên baûn ñoái vôùi taát caû caùc
thaønh vieân trong nhoùm. Ngoaøi ra, nhieäm vuï - traùch nhieäm vaø quyeàn haïn phaûi cuï theå hoaù thaønh
vaên baûn.
Neáu coù hôn moät nhoùm HACCP thì phaûi chæ ñònh ngöôøi keát noái ñeå hôïp taùc trieån khai, thöïc hieän
vaø duy trì heä thoáng HACCP.
5.1.4 HACCP team(s)

The food business operator shall assemble a HACCP team (or various HACCP teams if so required).
The HACCP team shall develop, implement and maintain the HACCP system.
The organisation shall demonstrate that the members of the HACCP team have the knowledge, expertise and
different disciplines available which are required to develop, implement and maintain a HACCP system
covering the total scope of the HACCP system.
Minimum qualification criteria, including required expertise, shall be defined and documented for all members
of the HACCP team. In addition, the assignment (including tasks, responsibilities and authorities) shall be
documented for the team members.
Whenever more than one HACCP team has been assembled, a co-ordinator shall be appointed to co-ordinate
the development, implementation and maintenance of the HACCP system.

5.1.5 Nguoàn löïc


Ban Giaùm ñoác phaûi kieåm tra caùc yeàu caàu vaø cung caáp ñuùng luùc taát caû caùc nguoàn löïc maø
nhoùm HACCP caàn ñeå trieån khai, thöïc hieän vaø duy trì heä thoáng HACCP. Khi thöïc hieän haønh ñoäng
khaéc phuïc do khaùch haøng hay thuû tuïc thaåm tra xaùc nhaän yeâu caàu caàn phaûi caûi tieán hoaït ñoäng
thì Ban giaùm ñoác phaûi xem xeùt vaán ñeà vaø cung caáp caùc nguoàn löïc thích hôïp ñaûm baûo an toaøn
thöïc phaåm.
5.1.5 Resources

The food business operator shall examine the requests and provide, in a timely manner, all the resources
needed by the HACCP team(s) to develop, implement and maintain the HACCP system.
When corrective actions, verification procedures or customers indicate that operational improvements are
necessary, the food business operator shall examine the issues and provide appropriate resources to ensure
food safety.

5.1.6 Xem xeùt laõnh ñaïo.


Ban Giaùm ñoác phaûi xem xeùt heä thoáng HACCP ñònh kyø theo keá hoaïch, khoâng ñöôïc quaù 12
thaùng ñeå ñaûm baûo tính lieân tuïïc, söï phuø hôïp töông thích vaø hieäu quaû. Vieäc xem xeùt naøy phaûi
ñaùnh giaù nhu caàu thay ñoåi heä thoáng HACCP bao goàm vaán ñeà an toaøn thöïc phaåm, chính saùch

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vaø muïc tieâu. Vieäc xem xeùt naøy phaûi cung caáp baèng chöùng caûi tieán heä thoáng HACCP vaø keát
quaû thöïc hieän.
5.1.6 Management Review

The food business operator shall review the HACCP system at planned intervals, of no more than 12 months,
to ensure continuing suitability, adequacy and effectiveness. The review shall evaluate the need for changes
to the HACCP system, including product safety, policy and objectives.
The review shall provide evidence of the commitment to improve the HACCP system and its performance.

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5.2 Thoâng tin saûn phaåm


5.2.1 Ñaëc tính cuûa saûn phaåm
Moãi loaïi saûn phaåm hoaëc nhoùm saûn phaåm phaûi ñöôïc moâ taû ñaày ñuû thaønh vaên baûn bao goàm
caû tính nhaïy caûm vaø khaû naêng ruûi ro tieàm aån aûnh höôùng ñeán an toaøn thöïc phaåm.
Khi moâ taû ñoä an toaøn cuûa saûn phaåm phaûi lieät keâ ñaày ñuû daây chuyeàn thöïc phaåm , töø khaâu
mua nguyeân vaät lieäu ñeán khaâu phaân phoái saûn phaåm.
Vieäc truy tìm ngöôïc laïi nguyeân vaät lieäu ban ñaàu vaø nhaø cung caáp cuoái cuøng ñeàu phaûi ñöôïc
moâ taû.
Moâ taû ñaëc tính saûn phaåm theo phaïm vi roäng ñeå ñaûm baûo vieäc ñaùnh giaù caùc thuû tuïc an toaøn
thöïc phaåm toaøn dieän hôn. Moâ taû roõ caùc ñaëc tính sau cuûa saûn phaåm:
 Moâ taû chung veà saûn phaåm
 Nguyeân vaät lieäu vaø thaønh phaàn söû duïng
 Moâ taû chung cuûa saûn phaåm nhö ngoaïi quan, troïng löôïng v.v…
 Caùc ñaëc tính cuûa saûn phaåm nhö tính chaát hoùa hoïc, vi sinh vaät, tính chaát vaät lyù
 Caùc yeâu caàu ñaëc tröng nhö ñaùp öùng yeâu caàu luaät phaùp, yeâu caàu cuûa khaùch
haøng
 Phöông phaùp kieåm soaùt chung veà an toaøn (hoùa hoïc, vi sinh vaø vaät lyù)
 Ñoùng goùi, ñieàu kieän löu tröõ, daùn nhaõn (thôøi haïn söû duïng, nhaän daïng saûn phaåm)
 Nhaän daïng caùc saûn phaåm coù nguy cô tieàm aån xöû lyù hoûng

5.2Product Information

5.2.1 Product Characteristics

Each product (or a group of similar products: see 5.1.2) shall be fully specified and documented, including
its sensitivity to and potential for safety risks.
This description of the safety of the product shall encompass the food chain, ranging from raw materials
used to the distribution of the finished products.

The traceability of the raw materials up to and including final supply shall be described.

An extensive specification of the end products is required to ensure a comprehensive assessment of the food
safety procedures. This specification shall clearly define the following product characteristics:
 a general product description;
 raw materials and ingredients used (composition);
 general product specifications such as appearance, weight, etc.;
 specific product specifications such as chemical, microbiological and physical characteristics;
 specific requirements such as appropriate legislation, customer requirements;
 general control of (chemical, microbiological and physical) safety;
 packaging, storage conditions, labelling (shelf life, product identification);
 identification of potential mishandling of the product.

5.2.2 Muïc ñích söû duïng:


Muïc ñích söû duïng saûn phaåm (hoaëc nhoùm saûn phaåm) phaûi ñöôïc xaùc nhaän vaø phaûi ñöôïc vaên
baûn hoaù bôûi vì noù aûnh höôûng tröùc tieáp ñeán caùc ñaëc tính yeâu caàu cuûa saûn phaåm, ví duï:
 Caùc bieän phaùp chuaån bò tröôùc khi söû duïng (gia nhieät hay haâm noùng)
 Laøm maùt vaø löu tröõ ôû nhieät ñoä thích hôïp
 Chæ roõ haïn söû duïng cuoái cuøng vaø ñaëc bieät sau khi môû bao bì

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
 Caùc saûn phaåm söû duïng cho tröôøng hôïp ñaëc bieät, nhoùm khaùch haøng, ngöôøi tieâu
duøng deã bò toån thöông nhö treû sô sinh vaø treû em, phuï nöõ mang thai, ngöôøi giaø, ngöôøi bò dò öùng
hoaëc bò beänh.
Muïc ñích söû duïng cuûa saûn phaåm phaûi ñöôïc xem xeùt caûi tieán lieân tuïc, phaùp luaät lieân quan vaø
caùc qui ñònh phaûi ñöôïc vaên baûn hoaù. Khi caàn thieát, caùc ñaëc tính saûn phaåm vaø quaù trình cheá
bieán caàn phaûi thích öùng phuø hôïp vôùi caùc yeâu caàu phaùp luaät ñaëc bieät. Thoâng tin ghi treân
nhaõn saûn phaåm bao goàm höôùng daãn söû duïng cuõng caàn phaûi phuø hôïp. Nhöõng thay ñoåi naøy
phaûi ñöôïc löu hoà sô.
Neáu saûn phaåm cheá bieán khoâng ñaït hay söû duïng nhaàm saûn phaåm khoâng ñaït coù theå gaây ra
maát an toaøn thöïc phaåm, do ñoù nhöõng saûn phaåm naøy phaûi coù nhöõng thoâng tin thích hôïp ñaûm
baûo luoân saün coù ñeå ngöôøi keá tieáp trong chuoãi daây chuyeàn coù theå truy caäp deã daøng khi cheá
bieán, löu chöõ, chuaån bò hoaëc trình baøy saûn phaåm ñuùng caùch vaø an toaøn. Phaûi deã daøng xaùc
ñònh loâ hoaëc ñôït khi caàn laáy laïi.
Tröôûng ban HACCP phaûi chöùng minh ñöôïc caùc saûn phaåm hoûng söû duïng nhaàm ñeàu ñöôïc ñaùnh
giaù, bao goàm caùc ñieåm kieåm soaùt tôùi haïn nhö ñieàu kieän löu tröõ vaø giai ñoaïn chuaån bò tröôùc
khi duøng.
5.2.2 Intended use

The intended use of the product (or product group) shall be identified and documented since it has a direct
influence on the required product characteristics. For instance, the product may require:
 additional preparation methods (e.g. heating) before consumption, and/or
 cooling and storage at specific temperatures, and/or
 an indication of the ultimate day of use, especially after breaking the packaging, and/or
 the product may be intended for use by specific (vulnerable) groups of the population, such as babies
and children, pregnant women, elderly people, allergenic or sick people.

The intended use of the product shall be continually reviewed; relevant legislation and regulations shall be
documented. When necessary, the product characteristics and manufacturing processes may need to be
adapted to conform with special legislation. Information on the label, including directions for use, may also
need to be adapted. These changes shall be recorded.

If mishandling or misuse of the product can result in unsafe products the products shall bear appropriate
information to ensure that adequate and accessible information is available to the next persons in the food
chain to enable them to handle, store, process, prepare and display the product safely and correctly. It shall
be easy to identify the lot or batch when recall is required.

The food business operator shall demonstrate that it has evaluated whether the intended use or misuse
should include Critical Control Points such as storage conditions and preparation before consumption.

5.3 Thoâng tin quaù trình


5.3.1 Sô ñoà daây chuyeàn saûn xuaát
Tröôûng ban HACCP phaûi coù saün sô ñoà daây chuyeàn saûn xuaát (caùc böôùc quaù trình vaø thieát bò
saûn xuaát) moâ taû ñaày ñuû vaø ñuùng thöïc teá. Khi aùp duïng HACCP cho moät hoaït ñoäng naøo ñaáy
caàn phaûi xem xeùt caùc böôùc tröôùc vaø sau cuûa hoaït ñoäng. Nhoùm HACCP seõ veõ moâ taû vaø
xaùc nhaän.
Sô ñoà daây chuyeàn saûn xuaát cung caáp moät caùi nhìn coù heä thoáng cuûa hoaït ñoäng ñoù, moâ taû
chi tieát taát caû caùc böôùc vaø cung caáp cho nhoùm HACCP caùc thoâng tin thích hôïp ñeå xaây döïng
heä thoáng HACCP.
Sô ñoà daây chuyeàn saûn xuaát phaûi lieät keâ ñöôïc caùc böôùc lieân quan nhö saûn xuaát saûn phaåm bao
goàm caùc ñieåm tôùi haïn nhö :
 Nôi löu tröõ döï bò vaø chuyeån tieáp

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
 OÁng vaän chuyeån, van phaân phoái.v.OÂ(
 Voøng taùi sinh
 Phöông tieän ñeå laøm veä sinh vaø voâ truøng caùc thieát bò vaø duïng cuï bao goàm nôi ñeå
laøm veä sinh.
 Döï phoøng caùc tröôøng hôïp khôûi ñoäng, ngöng maùy hoaëc tröôøng hôïp khaån caáp v.v…

5.3Process information

5.3.1 Flow Diagrams

The food business operator shall make available a complete and actual description of the operation in the
form of flow diagrams (process steps) and layouts (production facilities). When applying HACCP to a given
operation, consideration shall be given to steps preceding and following the specified operation. These
descriptions shall be drawn up and verified by the HACCP team.

The flow diagrams provide a schematic overview of the operation and will describe all the steps in sufficient
detail to provide the HACCP team with adequate information for the HACCP.
The flow diagrams shall take into account all relevant process steps, such as the
manufacturing of the product, including critical points like:
 buffer and interim storage;
 transport pipes, distribution valves, etc.;
 loops for reworking and recycling;
 facilities for cleaning and disinfection of equipment and tools, including cleaning-in-place;
 provision for start up / shut down / emergency stops, etc..

5.3.2 Maët baèng boá trí


Taát caû caùc phöông tieän thuoäc cô sôû haï taàng cuûa phaân xöôûng nhö daây chuyeàn saûn xuaát, khu
vöïc löu tröõ vaø phöông tieän caù nhaân phaûi ñöôïc moâ taû trong keá hoaïch boá trí vò trí laép ñaêït maët
baèng phaân xöôûng.
Trong maët baèng boá trí phaûi chæ roõ caùc haïng muïc sau:
 Voøng saûn phaåm, nhaân söï vaø doøng khoâng khí (tröôøng hôïp caùc phoøng yeâu caàu kyõ
thuaät cao)
 Khu vöïc coù khaû naêng nhieãm cheùo do tieáp xuùc trong quaù trình vaø caùc saûn phaåm do
vaät lieäu töôi, soáng, chaát phuï gia, daàu nhôøn, taùc nhaân laøm maùt, nhaân söï, ñoùng goùi vaø
container khoâng theå loaïi tröø.
5.3.2 Layout

All facilities which are part of the infrastructure of the food business, such as the production lines, storage
areas and personnel facilities, shall be depicted in a layout plan.

In the layout the following items shall be indicated:


 The routing of products, personnel and air flows (in the case of 'high care' rooms);
 The areas where cross contamination of and incidental contact with in-process and finished products
by raw materials, additives, lubricants, cooling agents, personnel, packaging, pallets and containers, cannot
be excluded;
The areas and facilities for personnel use.
5.3.3 Kieåm tra vaø xaùc nhaän thoâng tin quaù trình
Khi thay ñoåi quaù trình saûn xuaát vaø maët baèng boá trí coù theå gaây taùc ñoäng ngöôïc laïi vôùi an
toaøn thöïc phaåm, nhöõng thay ñoåi naøy caàn phaûi ñöôïc baùo caùo vôùi nhoùm HACCP ñeå ñaùnh giaù
moái nguy tieàm aån ñeán an toaøn thöïc phaåm vaø ñöa ra haønh ñoäng phoøng ngöøa töông öùng.

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
Trong baát cöù tröôøng hôïp naøo, tính chính xaùc vaø ñieàu kieän thöïc teá cuûa sô ñoà daây chuyeàn saûn
xuaát ñeàu phaûi ñöôïc nhoùm HACCP xaùc nhaän laø phuø hôïp vôùi traïng thaùi ñöôïc neâu trong taøi
lieäu. Vieäc thaåm tra xaùc nhaän naøy phaûi ñöôïc laäp laïi ñònh kyø (ít nhaát 1 naêm 1 laàn) ñeå xaùc
ñònh vaø boå xung taøi lieäu veà boá trí maët baèng vaø laép ñaët quaù trình. Nhöõng thaåm tra ñònh kyø
naøy phaûi naèm trong thuû tuïc thaåm tra.
5.3.3 Control and Verification of Process Information

Prior to the execution of changes in the production process and layout that could adversely affect food
safety, these changes shall be reported to the HACCP team in order to evaluate potential hazards to food
safety and take preventive actions accordingly.

In any case the accuracy and actuality of the flow diagrams and layout shall be verified by the HACCP team
for compliance with the documented situation. This verification shall be repeated periodically (at least
annually) in order to identify and document modifications to the process installation and layout.
These periodic verifications shall be part of the verification procedure.

5.4 Chöông trình veä sinh tieân quyeát


Tröôûng ban HACCP phaûi coù saün taøi lieäu mieâu taû chöông trình veä sinh tieân quyeát cuûa toå chöùc
ñaày ñuû vaø ñuùng thöïc teá. Thuû tuïc lieân quan ñeán Chöông trình veä sinh tieân quyeát (PRR) phaûi
ñöôïc thieát laäp (ñaëc tröng vaø vaên baûn hoùa) ñaày ñuû caùc hoaït ñoäng vaø thoáng nhaát vôùi heä
thoáng HACCP vaø phaûi ñöôïc xaùc nhaän.
Caùc qui ñònh chung veà veä sinh caù nhaân taïo neàn moùng ñaûm baûo vaán ñeà an toaøn thöïc phaåm.
Tröôûng ban HACCP phaûi quyeát ñònh qui ñònh veä sinh naøo, phöông phaùp thöïc haønh saûn xuaát toát
naøo hoaëc luaät phaùp naøo lieân quan ñeán thöïc phaåm phaûi ñöôïc keå ñeán trong Chöông trình veä sinh
tieân quyeát cuûa toå chöùc. Caùc yeâu caàu cô baûn lieân quan ñeán chöông trình veä sinh tieân quyeát ñaõ
ñöôïc xem xeùt trong phuï luïc I vaø ñöôïc toùm taét trong Baûng 2
Baûng 2: Toùm taét caùc quy ñònh chung veà veä sinh trong an toaøn thöïc phaåm (CAC/RCP 1 – 1969,
Rev. 3 (1997), Amended 1999).

1. Saûn xuaát ban ñaàu 5. Thieát laäp :Veä sinh caù nhaân
1.1 Veä sinh moâi tröôøng 5.1 Tình traïng söùc khoeû
1.2 Saûn xuaát coù veä sinh caùc nguoàn thöïc5.2 Beänh vaø thöông taät
phaåm 5.3 Möùc ñoä saïch seõ caù nhaân
1.3 Cheá bieán, löu tröõ vaø vaän chuyeån 5.4 Cö xöû caù nhaân
1.4 Veä sinh, baûo trì vaø veä sinh caù nhaân
2. Thieát laäp: thieát keá vaø phöông tieän 6. Vaän chuyeån
2.1 Boá trí thieát bò, duïng cuï 6.1 Toång quan
2.2 Nhaø xöôûng vaø phoøng oác 6.2 Caùc yeâu caàu
2.3 Thieát bò duïng cuï 6.3 Söû duïng vaø baûo trì
2.4 Phöông tieän
3. Kieåm soaùt ñieàu haønh 7. Thoâng tin saûn phaåm vaø nhaän thöùc cuûa
3.1 Kieåm soaùt moái nguy thöïc phaåm ngöôøi tieâu duøng
3.2 Caùc khía caïnh chính cuûa heä thoáng kieåm7.1 Xaùc ñònh soá loâ
soaùt veä sinh 7.2 Thoâng tin saûn phaåm
3.3 Caùc yeâu caàu ñaàu vaøo cuûa nguyeân vaät7.3 Daùn nhaõn
lieäu 7.4 Kieán thöùc ngöôøi tieâu duøng
3.4 Ñoùng goùi
3.5 Nöôùc
3.6 Quaûn lyù vaø giaùm saùt
3.7 Taøi lieäu vaø hoà sô.
3.8 Thuû tuïc thu hoài
4. Thieát laäp: baûo trì vaø veä sinh 8 Ñaøo taïo

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
4.1 Baûo trì vaø veä sinh 8.1 Nhaän thöùc vaø traùch nhieäm
4.2 Chöông trình veä sinh 8.2 Chöông trình ñaøo taïo
4.3 Kieåm soaùt raéc roái 8.3 Höôùng daãn vaø giaùm saùt
4.4 Quaûn lyù chaát thaûi 8.4 Ñaøo taïo veà nöôùc giaûi khaùt (refresher)
4.5 Heä thoáng veä sinh

Gioáng nhö saûn phaåm vaø quaù trình, Chöông trình veä sinh tieân quyeát ñöôïc ñöa ra ñeå phaân tích moái
nguy (xem phaàn 5.5) ñeå xaùc ñònh caùc moái nguy tieàm aån vaø quyeát ñònh bieän phaùp caàn thieát ñeå
kieåm soaùt nhöõng moái nguy ñoù.
5.4Pre-requisite program

The food business operator shall make available a complete and actual description of the pre-requisite
program (PRP) of the organisation. The procedures belonging to the PRP shall be well established
(appropriately specified and documented), fully operational and integrated in the HACCP system, and be
verified.

The Codex General Principles of Food Hygiene lay a firm foundation for ensuring food safety and
suitability. The food business operator shall decide which food hygiene principles, good manufacturing
practices and food legislation must be included in the PRP of the organisation 11. The basic requirements
related to the prerequisite program have been reviewed in annex I and are summarised in Figure 2.

Figure 2: Summary of the Codex General Principles of Food Hygiene (CAC/RCP 1-1969,
Rev. 3 (1997), Amended 1999)

1 Primary production 5 Establishment: personal hygiene


1.1 Environmental hygiene 5.1 Health status
1.2 Hygienic production of food sources 5.2 Illness and injuries
1.3 Handling, storage and transport 5.3 Personal cleanliness
1.4 Cleaning, maintenance and personal hygiene 5.4 Personal behaviour
5.5 Visitors
2 Establishment: design and facilities 6 Transportation
2.1 Location 6.1 General
2.2 Premises and rooms 6.2 Requirements
2.3 Equipment 6.3 Use and maintenance
2.4 Facilities
3 Control of operation 7 Product information and consumer
3.1 Control of food hazards awareness
3.2 Key aspects of hygiene control systems 7.1 Batch identification
3.3 Incoming materials requirements 7.2 Product information
3.4 Packaging 7.3 Labelling
3.5 Water 7.4 Consumer education
3.6 Management and supervision
3.7 Documentation and records
3.8 Recall procedures
4 Establishment: maintenance and sanitation 8 Training
4.1 Maintenance and cleaning 8.1 Awareness and responsibilities
4.2 Cleaning programmes 8.2 Training programs
4.3 Pest control 8.3 Instruction and supervision
4.4 Waste management 8.4 Refresher training
4.5 Sanitation systems

11
Codex, General Food Principles state in this respect:
... there will be inevitably situations where some of the food hygiene requirements are not
applicable. The fundamental question in every case is “what is necessary and appropriate on the
grounds of the safety and suitability of food for consumption?
... in deciding whether a requirement is necessary or appropriate, an assessment of the risk should be
made, preferably within the framework of the HACCP approach!”

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
Like the products and the processes, (the procedures belonging to) the PRP will be subjected to the hazard
analysis (see section 5.5) in order to identify potential hazards and to decide in which way the hazards (risk)
need to be controlled (see section 5.6).

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP

5.5 Phaân tích moái nguy


Tröôûng ban HACCP (nhoùm HACCP) phaûi xaùc ñònh, phaân tích vaø ñaùnh giaù caùc moái nguy (sinh
hoïc, hoùa hoïc vaø vaät lyù) tieàm aån coù theå coù taùc ñoäng ngöôïc laïi vôùi an toaøn thöïc phaåm.
Baát cöù khi naøo hoaït ñoäng kinh doanh thay ñoåi coù taùc ñoäng ngöôïc laïi an toaøn thöïc phaåm thì
taát caû caùc böôùc lieân quan trong quaù trình phaân tích ñeàu phaûi ñöôïc caäp nhaät.

5.5Hazard Analysis 12

The food business operator (HACCP team) shall identify, analyse and evaluate all potential (biological,
chemical and physical) hazards that can have an adverse effect on the safety of the products.
Whenever the food business operation changes in a manner that could adversely affect food safety all
relevant steps of the Hazard Analysis shall be up-dated.

5.5.1 Xaùc ñònh moái nguy


Tröôûng ban HACCP phaûi xaùc ñònh vaø ghi nhaän taát caû caùc moái nguy tieàm aån baát lôïi cho an
toaøn thöïc phaåm. Phaïm vi xaùc ñònh bao goàm taát caû caùc khía caïnh hoaït ñoäng trong phaïm vi heä
thoáng HACCP.

5.5.1 Hazard identification

The food business operator (HACCP team) shall identify and register all potential (biological, chemical and
physical) hazards that can have an adverse effect on the safety of the products. The identification shall
include all aspects of the operations within the scope of the HACCP system.

5.5.2 Phaân tích HACCP (nguy haïi)


Hoaït ñoäng ñöôïc ñaùnh giaù phaûi bao goàm taát caû caùc saûn phaåm, quaù trình vaø chöông trình veä
sinh tieân quyeát cuûa ngöôøi chuû phaùp luaät saûn xuaát ra saûn phaåm ñoù. Ñoái vôùi dòch vuï (khoâng
phaûi laø ngöôøi chuû phaùp luaät nhöng baùn saûn phaåm) thì vieäc xaùc ñònh vaø phaân tích moái nguy
ñöôïc giôùi haïn trong phaïm vi dòch vuï cung caáp ví duï nhö tröõ laïnh, ñoùng goùi vaø vaän chuyeån.
Caùc khía caïnh trong xaùc ñònh moái nguy coù theå laø:
- Nguyeân vaät lieäu vaø thaønh phaàn: thaåm tra, kieåm soaùt quaù trình taïi nhaø cung caáp, v.v
- Caùc ñaëc tính cuûa baùn saûn phaåm vaø saûn phaåm cuoái cuøng: xaùc ñònh roõ baûn chaát beân
trong cuûa saûn phaåm, v.v
- Caùc ñaëc tính cuûa quaù trình bao goàm caû dòch vuï thaàu laïi, thueâ ngoaøi, gia coâng cheá bieán
v.v
- Chöông trình veä sinh tieân quyeát (PRP):
 Boá trí vaø laép ñaët nhaø xöôûng, daây chuyeàn saûn xuaát, thieát bò

12
The notion “hazard analysis” consists of two elements, namely the identification of potential hazards
and the execution of a “HACCP analysis”. During the “HACCP analysis” the involved risk is assessed
which may cause an adverse health effect when the food is prepared and consumed according to its
intended use.

The term “risk analysis” is reserved for the process defined by Codex (“Principles and
guidelines for the conduct of microbiological risk assessment”, CAC/GL-30, 1999) which consists of
three components (risk assessment, risk management and risk communication) and which has the
overall objective to ensure public health protection.

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 Vò trí phoøng oác, ñöôøng ñi, nhaø kho vaø khu rieâng bieät ñeå nguyeân vaät
lieäu, baùn saûn phaåm, saûn phaåm cuoái cuøng, heä thoáng thoâng gioù v.v
 Quaù trình saûn xuaát: mua, laøm saïch vaø khöû truøng, ñoùng goùi, baûo
quaûn, kieåm soaùt saâu boï, quaûn lyù chaát thaûi v.v
 Nhaân söï (bao goàm caùc vieäc saép xeáp khaùch tham quan vaø ngöôøi cung caáp dòch vuï
beân ngoaøi, ví duï nhö thôï maùy): veä sinh caù nhaän, kieán thöùc veà veä sinh vaø an toaøn thöïc phaåm,
yeâu caàu khai baùo khi bò beänh hay coù beänh laây nhieãm.

5.5.2 HACCP analysis (risk)


The operations to be evaluated include all products, all processes and the pre-requisite program of the legal
owner of the products. For service organisations (not legal owner, but holder of the products), the hazard
identification and analysis is restricted to the services provided, for instance, cold/frozen storage, packaging
and transport.

The hazard identification shall include aspects like:


 raw materials and ingredients: specifications, process control at suppliers, etc.;
 characteristics of interim and end products: intrinsic product specifications, etc.;
 characteristics of used processes, including subcontracted services, etc.;
 prerequisite program (PRP), including aspects like:
- layout of the facility, production lines, installations and equipment;
- location of rooms, routing, storage and separation of raw materials, interim products, end
products, ventilation, etc.;
- production processes, like: purchasing, cleaning and disinfection, packaging, maintenance, pest
control, waste management, etc.;
- personnel (including arrangements for visitors and external service providers, e.g. mechanics):
hygiene, knowledge with regard to food hygiene and food safety, requirement to notify diseases and
infections, etc..

5.5.2 Phaân tích moái nguy


Tröôûng ban HACCP phaûi höôùng daãn, ñieàu haønh quaù trình phaân tích moái nguy ñeå xaùc ñònh caùc
moái nguy töï nhieân coù theå loaïi boû hoaëc laøm giaûm ôø möùc caàn thieát chaáp nhaän ñöôïc cho an
toaøn saûn xuaát thöïc phaåm.
Phaân tích moái nguy bao goàm :
- Khaû naêng xaûy ra vaø möùc ñoä nghieâm troïng cuûa caùc aûnh höôùng baát lôïi ñeán söùc khoeû;
- Ñònh tính vaø/hoaëc ñaùnh giaù ñònh tính söï hieän dieän cuûa moái nguy;
- Caùc vaán ñeà lieân quan ñeán söï toàn taïi vaø sinh soâi cuûa vi sinh vaät;
- Vieäc saûn sinh hoaëc ñoä beàn cuûa caùc chaát ñoäc, hoaù chaát hoaëc caùc taùc nhaân vaät lyù
trong thöïc phaåm;
- Caùc ñieàu kieän daãn ñeán caùc ñieàu treân.
Keát quaû phaân tích phaûi ñöôïc laäp thaønh vaên baûn bao goàm caùc khaùi nieäm vaø quy luaät söû
duïng ñeå xaùc ñònh/ ñaùnh giaù moái nguy.
Tröôûng ban HACCP phaûi xaùc ñònh caùc caáp ñoä ruûi ro chaáp nhaän ñöôïc. Caùc caáp ñoä naøy (noàng
ñoä, tieâu chuaån saûn phaåm hoaëc tieâu chuaån quaù trình) ôû möùc toái thieåu phaûi tuaân theo caùc
yeâu caàu phaùp luaät. Khi phaân tích moái nguy phaûi tính ñeán kinh nghieäm thöïc teá, döõ lieäu thí
nghieäm, baùo caùo chuyeân moân … vaø laäp thaønh vaên baûn.
The food business operator (HACCP team) shall conduct a HACCP analysis to identify which hazards are of
such a nature that their elimination or reduction and control at acceptable levels is essential to the
production of safe food.
In conducting the HACCP analysis, the following shall be included:

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 the likely occurrence of hazards and severity of their adverse health effects;
 the qualitative and/or quantitative evaluation of the presence of hazards;
 the survival or multiplication of micro-organisms of concern;
 the production or persistence of toxins, chemicals or physical agents in foods;
 the conditions leading to the above.

The results of the analysis shall be documented, including the concepts and principles utilised for
determining/estimating the risks.
The food business operator shall define permissible levels of risks. These levels (concentrations, product or
process criteria) must comply, as a minimum, with legal requirements. When conducting the HACCP
analysis, practical experiences, experimental data, professional literature, etc., shall be taken into account
and be documented.

5.6 Phöông phaùp kieåm soaùt


Ban HACCP phaûi xaùc ñònh vaø laäp thaønh vaên baûn caùc phöông phaùp kieåm soaùt ñöôïc aùp duïng
hoaëc thöïc hieän khi xaùc ñònh vaø phaân tích moái nguy ñeå keát luaän möùc ñoä ruûi ro cuûa moái nguy
ñaõ xaùc ñònh ñoù coù yù nghóa vaø caàn phaûi loaïi tröø hoaëc laøm giaûm vaø kieåm soaùt ôû möùc
chaáp nhaän ñöôïc.
Ban HACCP thöïc hieän ñaùnh giaù töøng böôùc trong quaù trình ví duï söû duïng caây phaân tích moái
quan heä nhaân quaû. Vieäc ñaùnh giaù phaûi döïa treân söï thaønh thaïo veà maët chuyeân moân khaùc
nhau cuûa caùc thaønh vieân trong ban vaø söû duïng caùc thoâng tin noäi boä vaø beân ngoaøi.
Taïi moãi böôùc, bao goàm taát caû caùc saûn phaåm, caùc quaù trình vaø taát caû caùc phaàn trong chöông
trình veä sinh tieân quyeát phaûi xaùc ñònh caùc khiaù caïnh ñaùnh giaù. Laäp thaønh vaên baûn vaø theo
doõi caùc lyù do quyeát ñònh ñoù laø ñieåm kieåm soaùt tôùi haïn .
1 phöông phaùp coù theå kieåm soaùt 1 moái nguy hoaëc nhieàu hôn vaø 1 moái nguy coù theå ñöôïc kieåm
soaùt baèng 1 phöông phaùp hoaëc nhieàu hôn.
Phöông phaùp kieåm soaùt phaûi ñöôïc phaân loaïi phöông phaùp chung hay phöông phaùp ñaëc thuø.

5.6 Control Measures

The HACCP team shall identify and document the control measures that are to be applied or implemented
when the hazard identification and HACCP analysis concludes that the risk of an identified hazard is
significant and needs to be eliminated or reduced and controlled at an acceptable level.

The HACCP team shall conduct an assessment of every step in the process, for example with the use of a
decision tree. The assessment shall be based on, amongst other things, the differing expertise within the team
and shall utilise external and internal information.
For each step, including all products, all processes and all parts of the Pre-Requisite Program the assessed
aspects shall be identified. The reasons for deciding whether it is a CCP (critical control point) or not, shall
be documented and traceable.
More than one control measure may be required to control a hazard and more than one hazard may be
controlled by a control measure.
Control measures shall be classified as specific or general control measures.
5.6.1 Phöông phaùp kieåm soaùt ñaëc bieät
Caùc phöông phaùp kieåm soaùt lieân quan ñeán ñieåm kieåm soaùt tôiù haïn ñöôïc phaân loaïi laø phöông
phaùp kieåm soaùt ñaëc bieät. Phöông phaùp kieåm soaùt ñaëc bieät laø caùc haønh ñoäng hoaëc hoaët
ñoäng thöôøng ño ñöôïc baèng caùch thoâng soá lyù hoïc hay hoùa hoïc nhö nhieät ñoä, thôøi gian, ñoä aåm,
Aw, Clo coù saün vaø thoâng soá veà giaùc quan nhö ngoaïi quan vaø keát caáu.
Caùc phöông phaùp kieåm soaùt ñaëc bieät döïa treân caùc thoâng soá chuû quan, vì trong tröôøng hôïp
kieåm tra ngoaïi quan cuûa moät saûn phaåm, quaù trình, sô cheá v.v phaûi coù caùc höôùng daãn, ñaøo
taïo hoã trôï.

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Caùc phöông phaùp kieåm soaùt naøy phaûi ñöôïc theo doõi, ñi keøm vôùi haønh ñoäng khaéc phuïc, xaùc
nhaän giaù trò söû duïng vaø thaåm tra xaùc nhaän. (xem phaàn döôùi)
5.6.1 Specific Control Measures

Control measures related to CCP’s shall be classified as specific control measures. Specific control
measures are actions or activities, often measurable in terms of physical or chemical parameters such as
temperature, time, moisture, pH, Aw, available chlorine, and sensory parameters such as visual appearance
and texture.

Specific control measures based on subjective parameters, as in the case of visual inspection of a product,
process, handling, etc., shall be supported by instructions or specifications, education and training.

Specific control measures shall be monitored, be provided with corrective actions, validated and verified
(see subsequent paragraphs).

5.6.2 Caùc phöông phaùp kieåm soaùt chung


Caùc phöông phaùp kieåm soaùt khoâng lieân quan ñeán caùc ñieåm tôùi haïn ñöôïc phaân loaïi laø phöông
phaùp kieåm soaùt chung. Caùc phöông phaùp naøy laø caùc haønh ñoäng hoaëc hoaït ñoäng naèm trong
chöông trình veä sinh tieân quyeát (xem 5.4). Nhìn chung, caùc phöông phaùp naøy seõ ñaït ñöôïc söï kieåm
soaùt ôû möùc chaáp nhaän ñöôïc.
Caùc phöông phaùp kieåm soaùt chung phaûi ñöôïc laäp thaønh vaên baûn rieâng, cuï theå (nguyeân vaät
lieäu, saûn phaåm, quaù trình, v.v…), höôùng daãn (quaù trình, kieåm soaùt, hoaït ñoäng) vaø caùc thuû tuïc
hoaëc keá hoaïch ví duï keá hoaïch mua haøng, keá hoaïch veä sinh (bao goàm nhaân söï), keá hoaïch baûo
trì, keá hoaïch laøm saïch vaø voâ truøng, vaø keá hoaïch hoã trôï nhö giaùo duïc vaø ñaøo taïo, ngöôøi
quaûn lyù caùc khía caïnh ñaëc thuø, giaùm saùt v.v..
Caùc phöông phaùp chung phaûi ñöôïc xaùc nhaän giaù trò söû duïng (xem 5.10) ñeå bieåu thò chöùc naêng
chính (caùc phaàn ñaëc bieät )øcuûa chöông trình veä sinh tieân quyeát vaø phaûi ñöôïc ban HACCP pheâ
duyeät.
Hieäu löïc kieåm soaùt caùc moái nguy ñaõ ñöôïc xaùc ñònh trong caùc phöông phaùp kieåm soaùt chung
phaûi ñöôïc thaåm tra xaùc nhaän tröôùc (xem 5.11)vaø ñònh kyø.
5.6.2 General Control Measures

Control measures not related to CCP’s shall be classified as general control measures.
General control measures are actions or activities which are part of the prerequisite
program ( see section 5.4). In general, these measures will achieve control at acceptable
levels.
General control measures shall be documented in specifications (raw materials, products, process, etc),
instructions (process, control, operations) and procedures or plans, e.g. purchase plan, hygiene plan
(including personal), maintenance plan, cleaning and disinfection plan, and supported by education and
training plans, operator-specific aspects, supervision, etc..

General control measures shall be validated (see section 5.10) in order to demonstrate the proper
functioning of (the specific part of) the PRP and will subsequently be approved by the HACCP team.

The effectiveness in controlling the identified hazards of the general control measures shall be verified (see
section 5.11) at pre-defined, regular intervals.

5.7 Thoâng soá vaø caùc giôùi haïn troïng yeáu


5.7.1 Quaù trình troïng yeáu vaø caùc thoâng soá saûn phaåm

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Ñoái vôùi töøng loaïi phöông phaùp kieåm soaùt ñaëc bieät, caùc thoâng soá quaù trình vaø/hoaëc thoâng
soá saûn phaåm phaûi ñöôïc xaùc nhaän xem thoâng soá naøo caàn phaûi duy ñöôïc duy trì vieäc kieåm
soaùt taïi böôùc ñoù.
Caùc thoâng soá naøy vaø caùc ñoái soá cuûa noù phaûi ñöôïc laäp thaønh vaên baûn ñeå aùp duïng.

5.7 Parameters and Critical Limits

5.7.1 Critical process and product parameters

For each specific control measure related to a CCP the process and/or product parameters must be
identified which are meant to demonstrate that control at the step is being maintained.

The food business operator shall document the parameters to be applied as well as the arguments for using
these parameters.

5.7.2 Giaù trò chæ tieâu, giaù trò giôùi haïn hoaït ñoäng vaø giôùi haïn troïng yeáu
Tröôûng ban HACCP phaûi xaùc ñònh caùc thoâng soá vaø caùc giôùi haïn troïng yeáu khaùc maø luùc
naøo toå chöùc cuõng phaûi ñaùp öùng khi vaän haønh.
Ngoaøi ra, ñeå ñaùp öùng caùc giôùi haïn troïng yeáu, toå chöùc cuõng phaûi chæ ra ñöôïc caùc giaù trò chæ
tieâu ôû ñieàu kieän hoaït ñoäng bình thöôøng cuûa caùc thoâng soá khaùc vaø caùc giaù trò giôùi haïn cuûa
hoaït ñoäng khi ngöng hoaït ñoäng.
Khi xaùc ñònh caùc giôùi haïn troïng yeáu, caùc giôùi haïn hoaït ñoäng vaø caùc giaù trò chæ tieâu thì caùc
yeâu caàu lieân quan ñeán phaùp luaät, caùc qui ñònh vaø/hoaëc phaân tích moái nguy noäi boä veà an toaøn
thöïc phaåm phaûi ñeàu ñöôïc xem xeùt nhö caùc yeâu caàu.
Tröôûng ban HACCP phaûi thieát laäp vaø duy trì caùc thuû tuïc/ caùc nguoàn löïc thích hôïp ñeå giaùm
saùt caùc giaù trò chæ tieâu (xem 5.8) vaø haønh ñoäng khaéc phuïc (xem 5.9) ñeå thöïc hieän khi caùc
giôùi haïn troïng yeáu vöôït quaù möùc.
5.7.2 Target values, action-limit values and critical limits

Further, the food business operator shall define for the various parameters the critical limit(s) which must
be met at all times during the operation.
Also, normal operational target values are indicated for the various parameters as well as the action-limit
values which indicate when intervention in the operation is required in order to continuously meet the
critical limits.

When determining the critical limits and the deduced action-limit and target values, the requirements of the
relevant legislation and regulations and/or internal risk analysis for the safety of foodstuffs must be
considered as (contractual) requirements.
The food business operator must establish and maintain adequate provisions/procedures for the monitoring
of the target values (see section 5.8) and the corrective actions (see section 5.9) to be executed whenever the
critical limits are exceeded.

In addition the effectiveness of the established parameters and operational values shall be validated (see
section 5.10) to ensure food safety.

5.8 Theo doõi vaø ño löôøng


Tröôûng ban HACCP phaûi thieát laäp vaø duy trì heä thoáng theo doõi ño löôøng ñeå kieåm soaùt moät
caùch hieäu quaû vaø hieäu löïc caùc ñieåm kieåm soaùt tôùi haïn.
Nhöõng söûa chöõa, thay ñoåi trong quaù trình trieån khai heä thoáng giaùm saùt phaûi ñöôïc vaên baûn
hoùa.
Phaûi xaùc ñònh caùc thieát bò giaùm saùt.

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Phöông phaùp ño löôøng vaø / hoaëc caùc höôùng daãn ño löôøng vaø hoà sô ño löôøng phaûi ñöôïc vaên
baûn hoaù.
Ngoaøi ra, caùc phöông phaùp thieát laäp ñoä tin caäy cuûa pheùp ño vaø/hoaëc phöông phaùp hieäu chuaån
thieát bò cuõng phaûi ñöôïc laäp thaønh vaên baûn.
Caùc pheùp ño vaø caùc cuoäc kieåm tra nhaø thaàu phuï chæ ñöôïc chaáp nhaän khi caùc nhaø thaàu phuï
naøy ñaùp öùng ñöôïc caùc tieâu chuaån ISO 17025, ISO 17020 hoaëc ISO/IEC Guide 65 hoaëc caùc tieâu
chuaån quoác gia / Chaâu Aâu coù lieân quan.
Keát quaû giaùm saùt phaûi ñöôïc löu hoà sô vaø keát quaû thöïc haønh phaûi ñöôïc moâ taû trong keá
hoaïch kieåm soaùt quaù trình. Hoà sô bao goàm:
- Baùo caùo giaùm saùt (ngaøy thaùng vaø coù kyù nhaän)
- Hoà sô veà söï cheânh leäch (giôùi haïn hoaït ñoäng vaø giôùi haïn troïng yeáu) vaø keát quaû
thöïc hieän haønh ñoäng khaéc phuïc.

5. 8 Monitoring and measuring

The food business operator shall establish and maintain a monitoring (measuring) system for effective and
efficient control of the Critical Control Points.
The system includes all planned measurements, observations and analysis of the control parameters
determining that the CCP’s are under control.

The justification for the development of the monitoring system shall be documented.
The monitoring (measuring) devices shall be identified.
The methodology of measurement and/or the instructions for measuring and recording of measurements
shall be documented.
In addition, the method for establishing the reliability of the measurements and/or the equipment
(calibration) shall be documented.

Measurements and product tests by subcontractors shall only be accepted where these subcontractors
comply with the relevant criteria of ISO 17025, ISO 17020 or ISO/IEC Guide 65, or the equivalent
European or National standards.

The results of the monitoring shall be documented by means of records and the practices shall be described
in the process control plans. The records shall include:
 monitoring reports (dated and signed);
 records of deviations which have occurred (action limits and critical limits) and corrective actions
taken.

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5.9. Haønh ñoäng khaéc phuïc


Ñoái vôùi moãi ñieåm kieåm soaùt tôùi haïn, toå chöùc phaûi laäp thuû tuïc haønh ñoäng khaéc phuïc ñeå
höôùng daãn thöïc hieän khi caùc giaù trò giôùi haïn hoaït ñoäng hoaëc giaù trò troïng yeáu vöôït möùc.
Thuû tuïc naøy bao goàm böôùc ñieàu tra nguyeân nhaän cuûa söï sai leäch.
Hoà sô caûi tieán do khaéc phuïc phaûi ñöôïc löu tröõ vaø saün coù khi söû duïng, phaûi bao goàm traùch
nhieäm vaø quyeàn haïn cuûa ngöôøi coù lieân quan. Vieäc caûi tieán coù lieân quan ñeán “nhoùm khaån
caáp”. Nhoùm khaån caáp ñaùnh giaù nguyeân nhaân sai leäch vaø quyeát ñònh ñöa ra haønh ñoäng phoøng
ngöøa thích hôïp.
Tröôûng ban HACCP phaûi thieát laäp thuû tuïc thu hoài saûn phaåm töø thò tröôøng/ngöôøi tieâu duøng.
Heä thoáng theo doõi vaø thaåm tra xaùc nhaän saûn phaåm phaûi duøng ñöôïc vaø coù hieäu löïc.
Taát caû caùc haønh ñoäng khaéc phuïc, nguyeân nhaân, keát quaû thöïc hieän vaø caùc caù nhaân lieân
quan ñeàu phaûi löu hoà sô.
Phaûi ñaùnh giaù tính hieäu quaû cuûa haønh ñoäng khaéc phuïc cuûa quaù trình vaø saûn phaåm.
Ñoái vôùi caùc saûn phaåm trong quaù trình maø caùc giôùi haïn troïng yeáu ñeàu vöôït möùc bò xem laø
saûn phaåm khoâng phuø hôïp. Haønh ñoäng khaéc phuïc coù theå :
Veà phöông dieän saûn phaåm:
- Saép xeáp khu vöïc caùch ly daønh cho saûn phaåm thu hoài
- Khu vöïc löu tröõ taïm thôøi
- Thaåm tra xaùc nhaän saûn phaåm khoâng phuø hôïp
- Taùi cheá laïi saûn phaåm
- Huûy boû/ phaân huûy saûn phaåm
Veà phöông dieän quaù trình
- Ñieàu chænh laïi quaù trình
- Ñieàu chænh/ hoaëc söûa chöõa caùc ñieàu kieän cuûa quaù trình
5.9 Corrective Actions
For each Critical Control Point, the food business operator shall document the corrective actions to be
taken if an action-limit value or critical limit is exceeded. The procedure will include the process to
investigate the cause of the deviation.
A documented motivation for the corrective action to be taken shall be available, including the
responsibilities and authorities of the personnel which is involved. The actions to be taken must be
established in advance. This could also involve the formation of a so-called 'emergency team'. This team
shall evaluate the causes of the deviation and shall decide which additional preventive actions are to be
taken (see also section 5.11).
The food business operator shall also establish arrangements that provide procedures for recall of the
products from the market place and/or from end consumers. Proper product identification and a “tracing &
tracking” system shall be operational.
All corrective actions taken, the causes and consequences, and the individuals involved in the corrective
actions will be recorded.
The effectiveness of the corrective actions, for both the process and the product, shall be evaluated.

Product resulting from the process while the critical limit has been exceeded shall be treated as non-
conforming product. The corrective actions may include:
with respect to the product:
 actions ranging from blockades to product recall;
 temporary hold of the product/batch;
 identification of non-conforming products;
 re-work of the product;
 disposal/destruction of the product/batch.
with respect to the process:
 adjusting the process;
 adjustment/correction of process conditions.

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5.10Xaùc nhaän giaù trò söû duïng


Xaùc nhaän giaù trò söû duïng khoâng thuoäc vieäc thaåm tra xaùc nhaän, noù laø moät hoaït ñoäng rieâng
bieät theo keá hoaïch HACCP.
Muïc ñích cuûa vieäc xaùc nhaän giaù trò söû duïng laø ñaûm baûo caùc moái nguy do ban HACCP xaùc
ñònh ban ñaàu ñaõ ñöôïc hoaøn chænh, ñuùng vaø ñöôïc kieåm soaùt coù hieäu löïc theo keá hoaïch ñeà
nghò. Ñaùp öùng muïc ñích cuûa vieäc xaùc nhaän giaù trò söû duïng laø ñieàu caàn thieát ñeå xem xeùt
tính hieäu löïc cuûa baèng chöùng hoã trôï ñaõ ñöôïc duøng trong nghieân cöùu HACCP hay caùc phöông
phaùp kieåm soaùt chung vaø ñaëc bieät, heä thoáng theo doõi vaø haønh ñoäng khaéc phuïc.
Ñeå ñaûm baûo khoâng coù thaønh kieán, tröôûng ban HACCP phaûi thieát laäp moät nhoùm xaùc nhaän
giaù trò söû duïng. Nhoùm naøy coù theå bao goàm caùc thaønh vieân cuûa ban HACCP nhöng cuõng phaûi
coù nhöõng ngöôøi xem xeùt ñoäc laäp ví duï trong hoaït ñoäng kinh doanh cheá bieán thöïc phaåm, ai
khoâng coù lieân quan tröïc tieáp ñeán vieäc thieát laäp keá hoaïch HACCP.
Xaùc nhaän giaù trò söû duïng ñöôïc thöïc hieän ñeå chöùng minh:
- Vieäc thieát laäp danh saùch lieät keâ caùc moái nguy tieàm aån döïa treân caùc döõ lieäu khoa
hoïc vaø danh saùch taát caû caùc moái nguy
- Nhöõng caâu hoûi ñöôïc söû duïng ñeå ñaùnh giaù möùc ñoä yù nghóa phaûi ñöôïc traû lôøi döïa
treân kieán thöùc khoa hoïc vaø kyõ thuaät
- Caùc phöông phaùp kieåm soaùt (chung hay ñaëc bieät) thích hôïp ñeå kieåm soaùt moái nguy, ví
duï nhö: ngaên ngöøa hay loaïi boû, laøm giaûm hay duy trì ôû möùc chaáp nhaän ñöôïc;
- Khoaûng dao ñoäng cuûa caùc thoâng soá kieåm soaùt (hay tieâu chuaån quaù trình) naèm trong
caùc giôùi haïn troïng yeáu ñaõ ñöôïc xaùc ñònh seõ khoâng aûnh höôûng ñeán an toaøn thöïc phaåm;
- Caùc thoâng soá vaø caùc phöông phaùp söû duïng ñeå giaùm saùt caùc phöông phaùp kieåm
soaùt laø thích hôïp;
- Caùc haønh ñoäng khaéc ñoäng khaéc phuïc phuø hôïp, giuùp ngaên ngöøa saûn phaåm khoâng
an toaøn loït ra thò tröôøng vaø chöùng minh caùc tröôøng hôïp sô soùt ñöôïc xöû lyù ngay laäp töùc.
Neáu toå chöùc ñaõ saûn xuaát thöïc phaåm an toaøn trong nhieàu naêm tröôùc khi xaây döïng HACCP. Vì
vaäy, caùc keát quaû theo doõi kieåm soaùt chaát löôïng, keát quaû kieåm tra saûn phaåm, caùc khieáu naïi
cuûa khaùch haøng trong quaù khöù neân söû duïng ñeå laøm chöùng cöù khi xaùc nhaän giaù trò söû duïng
cuûa keá hoaïch HACCP. Löu yù raèng caùc thoâng tin naøy phaûi ñònh löôïng ñöôïc vaø khaùch quan neáu
chuùng höõu ích.
Thaønh vieân cuûa nhoùm xaùc nhaän giaù trò söû duïng vaø caùc hoaït ñoäng cuûa hoï phaûi ñöôïc laäp
thaønh taøi lieäu roõ raøng. Tröôûng ban HACCP phaûi chöùng minh ñöôïc vieäc xaùc nhaän giaù trò söû
duïng ñaõ ñöôïc thöïc hieän ñaày ñuû.
5.10 Validation

Validation is not a part of verification, but a separate activity prior to authorising the HACCP plan 13.

The objective of validation is to ensure that the hazards originally identified by the HACCP team are
complete and correct and that they will be effectively controlled under the proposed plan. To meet the
13
In the document “Hazard Analysis and Critical Control Point (HACCP) system and guidelines
for its application” (Annex to CAC/RCP 1 –1969, Rev.3, 1997) Codex Alimentarius Commission include
validation as a part of verification. There is, however, a clear distinction between the two because they are
separate actions. The distinction lies in justifying what a food business operator plans to do (validation) and
then checking conformity with the planned actions and objectives (verification).

Validation is an essential part of the HACCP process. It is concerned with obtaining objective evidence
that the elements of the HACCP plan will be effective. Validation should be targeted at the assessment of
the scientific and technical inputs into the HACCP plan; it should ensure that the information supporting
the HACCP plan is correct – that the food business operator is “going to do the right things”. Validation
needs to be performed before approval of the HACCP plan by the food business operator and before its
implementation.

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objectives of validation it is necessary to review the effectiveness of the supporting evidence used in the
HACCP study as well as the general and specific control measures, the monitoring system and corrective
actions.
Each time when the food business operation changes in a manner that could adversely affect food safety this
review shall be up-dated.

To ensure absence of bias, the food business operator shall form a validation team. The validation team may
include members of the HACCP team, but must also include independent reviewers e.g. from within the food
business operation, who have not been directly involved in the establishment of the HACCP plan.

Validation is performed by demonstrating that:


 the established list of potential hazards is based on sound scientific data and has included all
hazards;
 the questions used to assess the significance are answered using sound scientific and technical
knowledge;
 the control measures (general or specific) are appropriate to control the hazards, i.e. to prevent or
eliminate, to reduce or maintain at an acceptable level;
 fluctuations of the control parameters (equivalent to a process criterion) within the defined critical
limits will not affect the safety of the product;
 the parameters and methods used to monitor the control measures are appropriate;
 corrective actions are appropriate and will prevent the release of unsafe products and provide
evidence that the situation can be corrected immediately.

Food business operators produced safe food for many years before the introduction of the HACCP system.
Therefore, historical results from on-line Quality Control monitoring, end product testing, customer or
consumer complaints may be used as evidence when validating HACCP plans. It is important to note that
the data must be quantifiable and objective if it is to be useful.

The composition of the validation team and the activities undertaken shall be clearly documented.
The food business operator shall demonstrate satisfactory completion of validation.

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5.11 Thaåm tra xaùc nhaän


Tröôûng nhoùm HACCP phaûi thieát laäp, vaên baûn hoùa vaø thöïc hieän thuû tuïc thaåm tra xaùc nhaän
cuûa heä thoáng HACCP. Muïc ñích cuûa vieäc thaåm tra xaùc nhaän laø xaùc ñònh vieäc tuaân thuû caùc
yeâu caàu ñaëc bieät cuûa heä thoáng HACCP vaø xaùc nhaän raèng heä thoáng HACCP hoaït ñoäng coù
hieäu quaû thoâng qua vieäc aùp duïng caùc phöông phaùp thuû tuïc, kieåm tra (bao goàm vieäc laáy maãu
ngaãu nhieân vaø phaân tích) vaø caùc hình thöùc ñaùnh giaù khaùc ñeå hoã trôï vieäc theo doõi giaùm saùt
(xem muïc 5.8)
Thuû tuïc thaåm tra xaùc nhaän phaûi ñöôïc laäp thaønh vaên baûn vaø toái thieåu bao goàm caùc haïng
muïc sau:
- Muïc ñích;
- Phöông phaùp, thuû tuïc tieâu chuaån quaù trình hoaëc caùc pheùp kieåm tra;
- Nhieäm vuï vaø traùch nhieäm;
- Taàn suaát;
- Hoà sô.
Thuû tuïc thaåm tra xaùc nhaän phaûi neâu roõ toái thieåu caùc chuû ñeà sau:
- Xem xeùt heä thoáng HACCP vaø hoà sô töông öùng
- Phaân tích vieäc loaïi boû vaø thu hoài saûn phaåm;
- Ñaùnh giaù taát caû caùc phöông phaùp kieåm soaùt ñaëc bieät, söï cheânh leäch vaø haønh
ñoäng khaéc phuïc ñaõ thöïc hieän ñeå tìm kieám söï xaùc nhaän vieäc thöïc hieän, kieåm soaùt hieäu quaû
caùc ñieåm kieåm soaùt tôùi haïn;
- Ñaùnh giaù taát caû caùc phöông phaùp kieåm soaùt chung ñeå tìm kieám söï xaùc nhaän vieäc
thöïc hieän, kieåm soaùt hieäu quaû caùc moái nguy coù lieân quan;
- Vieäc tuaân thuû sô ñoà daây truyeàn saûn xuaát thöïc teá vaø boá trí maët baèng theo ñuùng taøi
lieäu;
- Phaân tích khieáu naïi khaùch haøng lieân quan ñeán an toaøn vaø veä sinh thöïc
phaåm;
- Ñaùnh giaù söï phuø hôïp vôùi caùc yeâu caàu vaø qui ñònh phaùp luaät (bao goàm caû caùc
yeâu caàu döï kieán thay ñoåi coù theå döï ñoaùn ñöôïc) vaø xaùc ñònh caùc thay ñoåi cuûa yeâu caàu vaø
qui ñònh phaùp luaät lieân quan ñeán an toaøn thöïc phaåm;
- Xem xeùt caùc keõ hôû giöõa möùc ñoä hieän taïi vaø möùc ñoä mong muoán veà maët kieán
thöùc, nhaän thöùc vaø ñaøo taïo cuûa ñoäi nguõ nhaân vieân ñoái vôùi vaán ñeà veä sinh vaø an toaøn thöïc
phaåm, hieäu quaû sau ñaøo taïo;
- Tính nhaát quaùn cuûa taøi lieäu.
Ñaùnh giaù noäi boä
Tröôûng ban HACCP phaûi xaùc ñònh heä thoáng HACCP:
- Phuø hôïp vôùi keá hoaïch ñaõ saép xeáp ?
 Vôùi yeâu caàu cuûa heä thoáng HACCP vaø
 Vôùi yeâu caàu do coâng ty töï thieát laäp
- Coù ñöôïc thöïc hieän vaø duy trì moät caùch hieäu quaû ?
Tröôûng ban HACCP phaûi thieát laäp keá hoaïch ñaùnh giaù noäi boä ñeå xem xeùt tình hình vaø taàm
quan troïng cuûa caùc quaù trình vaø khu vöïc ñöôïc ñaùnh giaù vaø keát quaû cuûa caùc laàn ñaùnh giaù
tröôùc. Tieâu chuaån ñaùnh giaù, phaïm vi, taàn suaát, vaø phöông phaùp ñaùnh giaù phaûi ñöôïc xaùc ñònh
ñeå xem xeùt tình hình vaø taàm quan troïng cuûa caùc quaù trình vaø khu vöïc ñöôïc ñaùnh giaù vaø keát
quaû cuûa caùc laàn ñaùnh giaù tröôùc.
Vieäc löïa choïn chuyeân gia ñaùnh giaù vaø ñieàu haønh cuoäc ñaùnh giaù phaûi ñaûm baûo tính khaùch
quan vaø khoâng thieân vò. Ñaùnh giaù vieân khoâng ñöôïc ñaùnh giaù coâng vieäc cuûa mình.
Traùch nhieäm vaø yeâu caàu laäp keá hoaïch vaø ñieàu haønh ñaùnh giaù noäi boä, baùo caùo keát quaû
vaø löu giöõ hoà sô phaûi ñöôïc xaùc ñònh trong thuû tuïc.

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Xem xeùt laõnh ñaïo


Tröôûng ban HACCP phaûi xem xeùt vaø ñaùnh giaù keát quaû cuûa toaøn boä quaù trình thaåm tra xaùc
nhaän ñònh kyø theo keá hoaïch, khoâng quaù 12 thaùng (xem 5.1.6). Do ñoù, taàn suaát thaàm tra xaùc
nhaän vaø ñaùnh giaù noäi boä phaûi laøm sao ñeå ñaûm baûo tính phuø hôïp, lieân tuïc vaø hieäu löïc cuûa
heä thoáng HACCP. Moät soá yeâu caàu phaûi ñöôïc thaåm tra xaùc nhaän vôùi taàn suaát cao hôn caùc
yeâu caàu khaùc. Ví duï, Kieåm soaùt hieäu quaû cuûa caùc ñieåm kieåm soaùt tôùi haïn coù theå ñaùnh
giaù vôùi taàn suaát ít nhaát 2 laàn moät naêm, trong khi ñoù taàn suaát 1 naêm 1 laàn laø vöøa ñuû ñoái
vôùi thaåm tra xaùc nhaän ñieàu kieän thöïc teá cuûa daây chuyeàn saûn xuaát vaø maët baèng boá trí
(5.5.3).
Tröôûng ban HACCP phaûi thu thaäp vaø phaân tích döõ lieäu ñeå ñaùnh giaù nôi naøo caàn caûi tieán.
Tröôûng ban HACCP phaûi ñaûm baûo caùc haønh ñoäng phoøng ngöøa loaïi boû caùc nguyeân nhaân
caùc söï khoâng phuø hôïp tieàm aån ñöôïc thöïc hieän, khoâng trì hoaõn vaø ngaên ngöøa ñeå chuùng
khoâng xaûy ra nöõa. Caùc haønh ñoäng phoøng ngöøa phaûi phuø hôïp vôùi taùc ñoäng cuûa caùc söï
khoâng phuø hôïp tieàm aån. Hieäu löïc cuûa haønh ñoäng phoøng ngöøa phaûi ñöôïc pheâ chuaån.
Caùc haønh ñoäng sau ñoù phaûi bao goàm vieäc thaåm tra vaø xem xeùt laïi caùc haønh ñoäng tröôùc ñoù.
5.11 Verification

The food business operator shall establish, document and implement procedures for verification of the
HACCP system. The main purpose of verification is to determine compliance with the specifications of the
HACCP system and to confirm that the HACCP system is working effectively through the application of
(auditing) methods, procedures, tests (including random sampling and analysis) and other evaluation, in
addition to monitoring (see section 5.8).

Procedures for verification shall be documented and shall include as a minimum:


 Purpose;
 Methods, standard operating procedures or tests applied;
 Tasks and responsibilities;
 Frequency;
 Records.

The verification procedure shall address, as a minimum, the following topics:

 Review of the HACCP system and its corresponding records;


 Analysis of (near) recalls and product dispositions;
 Assessment of all specific control measures, deviations and corrective actions taken to seek
confirmation of implementation and effective control of CCP's;
 Assessment of all general control measures to seek confirmation of implementation and to
demonstrate an effective control of associated hazards;
 Compliance of the actual flow diagrams and layout with the documented situation;
 Compliance of the PRP documents with the operational situation;
 Analysis of customer and consumer complaints related to hygiene and food safety;
 Review of analytical outcome of random sampling and analysis of products;
 Evaluation of conformity with applicable legislation and regulations (as well as conformity to
foreseeable changes in legislation and regulations) and identification of changes in legislation and
regulations concerning food safety;
 Review of gaps between current and desired level of knowledge, awareness and training of staff with
respect to hygiene and food safety, resulting in effective (on-the-job) training sessions;
 Consistency of the current documentation.

Internal audit

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The food business operator shall determine whether the HACCP system:

 Conforms with the planned arrangements:


 with the “Requirements for a HACCP-based Food Safety System” and
 with the requirements established by the food business operator itself.
 Is effectively implemented and maintained.

The food business operator shall plan an internal audit scheme, taking into consideration the status and
importance of the processes and areas to be audited, as well as the results of previous audits. The audit
criteria, scope, frequency and methods shall be defined, taking into consideration the status and importance
of the processes and area’s to be audited, as well as the results of previous audits.
Selection of auditors and the conduct of audits shall ensure objectivity and impartiality of the audit process.
Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits, for reporting results and
maintaining records shall be defined in a documented procedure.

Management review

The food business operator shall review and evaluate the results of the entire verification process at planned
intervals, of no more than 12 months (see par. 5.1.6). Therefore, the frequency of verification and internal
audits shall be such that the food business operator can ensure continuing suitability, adequacy and
effectiveness of the HACCP-based Food Safety System. Some requirements are to be verified with a higher
frequency than other requirements. For instance, the effective control of CCP’s (5.6.1) may be evaluated
with a frequency of at least twice a year, whereas a frequency of once a year may be sufficient to verify the
actuality of process lines and layout (5.3.3).

The food business operator shall collect and analyse the resulting data to evaluate where improvement is
needed.
The food business operator shall ensure that preventive actions (see 5.9) are taken without undue delay to
eliminate the causes of (potential) non-conformities in order to prevent recurrence (occurrence). The
preventive actions shall be appropriate to the effects of the (potential) non-conformities encountered. The
effectiveness of the preventive actions taken shall be validated.
Follow-up actions shall include the verification and review of actions taken.

5.12 Taøi lieäu vaø hoà sô


5.12.1 Kieåm soaùt taøi lieäu vaø hoà sô
Tröôûng ban HACCP phaûi taøi lieäu hoùa, duy trì heä thoáng HACCP vaø caùc taøi lieäu töông öùng ñeå
ñaûm baûo phuø hôïp vôùi caùc yeâu caàu ñaëc thuø vaø caùc yeâu caàu phaùp luaät phaûi aùp duïng.
Taøi lieäu phaûi phuø hôïp vôùi baûn chaát vaø qui moâ hoaït ñoäng
Tröôûng ban HACCP phaûi thieát laäp vaø duy trì Soå tay HACCP bao goàm caùc noäi dung sau:
- Chính saùch veà an toaøn thöïc phaåm (5.1.1) vaø phaïm vi cuûa heä thoáng HACCP (5.1.2).
Neáu coù caùc yeâu caàu naøo khoâng aùp duïng, thì phaûi ghi roõ trong soå tay HACCP.
- Caùc taøi lieäu ñaëc thuø, thuû tuïc vaø höôùng daãn coâng vieäc cuûa heä thoáng HACCP
- Moâ taû Chuû doanh nghieäp ñaõ ñaùp öùng ñaày ñuû caùc yeâu caàu naøy nhö theá naøo.
Taøi lieäu cuûa heä thoáng HACCP phaûi ñöôïc kieåm soaùt. Moät taøi lieäu ñöôïc thieát laäp ñeå xaùc
ñònh vieäc kieåm soaùt caàn thieát ñeå:
- pheâ chuaån tính ñaày ñuû cuûa taøi lieäu tröôùc khi ban haønh
- xem xeùt vaø caäp nhaät khi caàn thieát vaø pheâ duyeät laïi
- ñaûm baûo tình traïng thay ñoåi vaø soaùt xeùt hieän taïi cuûa taøi lieäu ñeàu ñöôïc xaùc ñònh
- ñaûm baûo caùc phieân baûn coù lieân quan tröôùc ñoù cuûa taøi lieäu phaûi coù saün khi caàn
duøng tôùi

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- ñaûm baûo taøi lieäu deã ñoïc vaø deã xaùc ñònh
- ñaûm baûo caùc taøi lieäu beân ngoaøi phaûi ñöôïc xaùc ñònh vaø coù kieåm soaùt vieäc phaân
phoái
- phoøng ngöøa tröôøng hôïp söû duïng taøi lieäu loãi thôøi vaø nhaän daïng ñöôïc chuùng khi söû
duïng.

5.12 Documentation and records

5.12.1 Documents and document control

The food business operator shall establish a documented HACCP system and shall maintain the HACCP
system and corresponding documentation in order to ensure conformity with the requirements of this
specification and the applicable legislation and regulations.

Documentation should be appropriate to the nature and size of operation.

The food business operator shall establish and maintain a HACCP manual that includes
 The policy of the food business operator with respect to food safety (see par. 5.1.1) and the scope of
the HACCP-based Food Safety System (see par. 5.1.2). If any requirement is considered as inapplicable to
the operator, justification shall be provided in the HACCP manual.
 The documented specifications, procedures and instructions established for the HACCP-based Food
Safety System, or reference to them
 A description how the food business operator has fulfilled the requirements of this Specification.

Documents required by the HACCP-based Food Safety System shall be controlled. A documented procedure
shall be established to define the controls needed:
 to approve documents for adequacy prior to issue,
 to review and update as necessary and re-approve documents,
 to ensure that changes and the current revision status of documents are identified,
 to ensure that relevant versions of applicable documents are available at points of use,
 to ensure that documents remain legible and readily identifiable,
 to ensure that documents of external origin are identified and their distribution controlled,
 to prevent the unintended use of obsolete documents, and to suitably identify them if they are retained
for any purpose

5.1.2.2 Hoà sô
Löu tröõ hoà sô chính saùch vaø hieäu quaû raát caàn thieát cho vieäc aùp duïng heä thoáng HACCP
Hoà sô phaûi ñöôïc thieát laäp vaø duy trì ñeå cung caáp baèng chöùng veà söï phuø hôïp caùc yeâu caàu
vaø heä thoáng HACCP hoaït ñoäng coù hieäu löïc. Hoà sô phaûi deã ñoïc, deã nhaän daïng vaø deã truy
suaát. Phaûi thieát laäp moät thuû tuïc ñeå kieåm soaùt vieäc xaùc ñònh, löu tröõ, baûo veä, truy suaát, thôøi
gian löu tröõ vaø loaïi boû hoà sô.
Caùc loaïi hoà sô goàm :
- Hoà sô chöùng minh caùc thaønh vieân trong ban HACCP coù ñuû kieán thöùc, thaønh thaïo
chuyeân moân vaø caùc qui luaät khaùc;
- Hoà sô lieân quan ñeán xem xeùt laõnh ñaïo, neáu caàn thieát bao goàm caùc haønh ñoäng lieân
quan.
- Hoà sô phaân tích moái nguy vaø caùc nguoàn thoâng tin (phaùp luaät, tieâu chuaån, taøi lieäu
khoa hoïc, quy ñònh veä sinh, GMP, codex) maø nhoùm HACCP söû duïng ñeå xaùc ñònh vaø ñaùnh giaù
moâí nguy;

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
- Hoà sô ñaùnh giaù töøng böôùc quaù trình vaø nguyeân nhaân thieát laäp caùc phöông phaùp
kieåm soaùt ñaëc bieät (lieân quan ñeán caùc ñieåm kieåm soaùt tôùi haïn) vaø caùc phöông phaùp kieåm
soaùt chung.
- Baùo caùo giaùm saùt caùc phöông phaùp kieåm soaùt ñaëc bieät (ngaøy thaùng vaø chöõ kyù)
chöùng minh vieäc kieåm soaùt lieân quan ñeán caùc ñieåm kieåm soaùt tôùi haïn.
- Hoà sô sai leäch cuûa caùc phöông phaùp kieåm soaùt ñaëc bieät (caùc giôùi haïn troïng yeáu bò
vöôït möùc vaø caùc giôùi haïn haønh ñoäng tieâu chuaån) vaø haønh ñoäng khaéc phuïc.
- Hoà sô cuûa chöông trinh thaåm tra xaùc nhaän (bao goàm ñaùnh giaù noäi boä) vaø keát quaû
ñaùnh giaù.
- Hoà sô truy tìm nguoàn goác thöïc phaåm
5.12.2 Records

Efficient and accurate record-keeping is essential to the application of a HACCP system.

Records shall be established and maintained to provide evidence of conformity with requirements and with
the effective working of the HACCP-based Food Safety System. Records shall remain legible, readily
identifiable and retrievable. A documented procedure shall be established to define the controls needed for
identification, storage, protection, retrieval, retention time and disposal of records.

Records that shall be available are:


 Records to demonstrate that the members of the HACCP team have adequate knowledge, expertise
and different disciplines available;
 Records concerning management reviews and, if needed, related actions;
 Records of the hazard analysis and information sources (legislation, standards, literature,
hygiene-codes, GMP, Codex) used by the HACCP teams to identify and evaluate the hazards and risks;
 Records of the assessment of every step in the process and the reasons for establishing the Specific
Control Measures (CCP related) and General Control Measures;
 Monitoring reports (dated and signed) of the Specific Control Measures to demonstrate the control of
the related CCP’s;
 Records of deviations occurred (exceeded action limits and critical action limits) of the Specific
Control Measures and the corrective actions taken;
 Records related to the verification program (including internal audits) and their evaluation;
 Records that are relevant to ensure traceability of food stuffs.

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP

Phuï luïc 1 :

1 Khaâu ban ñaàu


1.1 Veä sinh moâi 1.1.1 Khaâu ban ñaàu khoâng neân tieán haønh ôû nhöõng khu vöïc maø coù caùc chaát
tröôøng gaây nguy haïi daãn ñeán möùc khoâng theå chaáp nhaän ñöôïc cuûa caùc chaát ñoù coù
trong thöïc phaåm. Caàn quan taâm caùc nguoàn gaây oâ nhieãm tieàm aån laø töø moâi
tröôøng.
1.2 Caùc nguoàn thöïc1.2.1 Luoân luoân phaûi löu yù tôùi taùc ñoäng tieàm aån cuûa caùc hoaït ñoäng ôû khaâu
phaåm ñöôïc saûn ban ñaàu, ñoái vôùi tính an toaøn vaø phuø hôïp cuûa thöïc phaåm. Trong tröôøng hôïp
xuaát moät caùch veä naøy, ñieàu naøy bao goàm caû vieäc xaùc ñònh baát cöù ñieåm ñaëc bieät naøo trong
sinh nhöõng hoaït ñoäng ñoù, ôû nôi coù khaû naêng nhieãm baån cao thì phaûi duøng nhöõng
bieän phaùp ñaëc bieät ñeå giaûm ñeán möùc toái thieåu söï nhieãm baån ñoù.
1.2.2 Ñeå khaû thi, vieäc kieåm soaùt phaûi thöïc hieän coù hieäu quaû nhaèm:
- kieåm soaùt söï nhieãm baån töø khoâng khí, ñaát, nöôùc, thöùc aên chaên nuoâi, phaân
boùn (keå caû caùc phaân höõu cô), thuoác tröø dòch haïi, thuoác thuù y hay baát cöù chaát
naøo khaùc duøng trong khaâu ban ñaàu.
- kieåm soaùt tình traïng laønh maïnh cuûa ñoäng thöïc vaät, baûo ñaûm chuùng khoâng
chöùa moái ñe doïa naøo tôùi söùc khoeû con ngöôøi do tieâu thuï thöïc phaåm, hoaëc aûnh
höôûng tôùi söï phuø hôïp cuûa saûn phaåm; vaø
- baûo veä caùc nguoàn cuûa thöïc phaåm khoûi bò nhieãm baån do phaân vaø caùc loaïi
nhieåm baån khaùc.
1.2.3 Ñaëc bieät, caàn quaûn lyù caùc chaát thaûi vaø baûo quaûn moät caùch thích hôïp
caùc chaát coù haïi.
1.2.4 Caùc chöông trình tröïc tieáp cuûa noâng traïi ñeå ñaït ñöôïc nhöõng muïc tieâu ñaëc
bieät veà an toaøn thöïc phaåm, ñang trôû thaønh moät phaàn quan troïng cuûa khaâu ban
ñaàu vaø caàn ñöôïc khuyeán khích.
1.3 Xöû lyù, baûo 1.3.1 Qui trình phaûi ñaûm baûo :
quaûn vaø vaän - phaân loaïi thöïc phaåm vaø caùc thaønh phaàn thöïc phaåm ñeå loaïi boû caùc thaønh
chuyeån phaàn khaùc khoâng thích hôïp cho con ngöôøi;
- huyû caùc chaát khoâng thích hôïp moät caùch veä sinh; vaø
- baûo veä thöïc phaåm vaø caùc thaønh phaàn thöïc phaåm khoûi söï nhieãm baån töø sinh
vaät gaây haïi, hoaëc baèng hoaù hoïc, vaät lyù hay vi sinh, hay caùc chaát khaùc khoâng
ñöôïc pheùp coù trong khi xöû lyù, baûo quaûn vaø vaän chuyeån thöïc phaåm.
1.3.2 Caàn giöõ thöïc phaåm baèng caùc bieän phaùp thích hôïp ñeå thöïc phaåm khoûi bò
hoûng, giaûm chaát löôïng, caùc bieän phaùp ñoù bao goàm caû vieäc kieåm soaùt nhieät
ñoä, ñoä aåm khoâng khí vaø caùc kieåm soaùt khaùc.
1.4 Laøm saïch, baûo 1.4.1 Caàn coù saün caùc phöông tieän vaø caùc qui trình hôïp lyù ñeå ñaûm baûo raèng :
döôõng vaø veä sinh - thöïc hieän hieäu quaû vieäc laøm saïch vaø baûo döôõng caàn thieát;
caù nhaân khaâu ban - duy trì möùc ñoä veä sinh caù nhaân thích hôïp.
ñaàu
2 Cô sôû : thieát keá vaø phöông tieän
2.1 Vò trí
2.1.1 Cô sôû 2.1.1.1 Cô sôû khoâng ñöôïc ñaët ôû nôi, maø sau khi xem xeùt nhöõng bieän phaùp baûo veä,
ngöôøi ta thaáy vaãn coøn moái ñe doaï cho söï an toaøn vaø phuø hôïp cuûa thöïc phaåm. Ñaëc
bieät, vò trí cô sôû thöôøng phaûi ôû xa :
- khu vöïc coù moâi tröôøng oâ nhieãm vaø caùc hoaït ñoäng coâng nghieäp khaùc coù
nhieàu khaû naêng gaây oâ nhieãm thöïc phaåm;
- khu vöïc deã bò ngaäp luït tröø phi coù bieän phaùp baûo veä cô sôû khoûi bò ngaäp luït moät
caùch höõu hieäu;
- khu vöïc deã bò sinh vaät gaây haïi phaù hoaïi;
- khu vöïc coù caùc chaát thaûi, raén hay loûng, maø khoâng theå loaïi boû chuùng moät caùch
hieäu quaû.
2.1.2 Equipment 2.1.2.1 Thieát bò phaûi ñöôïc boá trí ñeå coù theå :
- cho pheùp duy tu baûo döôõng vaø laøm saïch deã daøng;
- vaän haønh ñuùng vôùi muïc ñích söû duïng;
- thuaän lôïi cho vieäc thöïc haønh veä sinh toát keå caû giaùm saùt.
2.2 Nhaø xöôûng vaø caùc phoøng
2.2.1 Thieát keá vaø 2.2.1.1 Nôi thích hôïp laø nôi maø vieäc thieát keá vaø boá trí maët baèng coâng ngheä cho
boá trí cô sôû saûn xuaát cheá bieán thöïc phaåm phaûi taïo ñieàu kieän cho veä sinh thöïc phaåm

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
ñöôïc toát, ñoàng thôøi tính tôùi caû vieäc baûo veä choáng oâ nhieãm cheùo do thöïc
phaåm gaây ra giöõa coâng ñoaïn naøy vôùi coâng ñoaïn khaùc cuõng nhö khi thao taùc
cheá bieán vaø xöû lyù thöïc phaåm.
2.2.2 Caáu truùc vaø
2.2.2.1 Caáu truùc beân trong cô sôû thöïc phaåm phaûi ñöôïc xaây döïng caån thaän baèng
laép raùp beân trong
vaät lieäu beàn chaéc, vaø phaûi ñöôïc duy tu baûo döôõng, laøm saïch deã daøng khi caàn
nhaø xöôûng
thieát, coù theå taåy truøng ñöôïc.
2.2.2.2 Beà maët töôøng, vaùch ngaên vaø saøn nhaø phaûi ñöôïc laøm baèng vaät lieäu
khoâng thaám, khoâng ñoäc haïi vôùi muïc ñích söû duïng.
2.2.2.3 Töôøng vaø vaùch ngaên phaûi coù beà maët nhaün, thích hôïp cho thao taùc .
2.2.2.4 Saøn nhaø phaûi ñöôïc xaây döïng sao cho deã thoaùt nöôùc vaø deã laøm veä sinh.
2.2.2.5 Traàn vaø caùc vaät coá ñònh phía treân traàn phaûi ñöôïc thieát keá, xaây döïng ñeå
laøm sao coù theå giaûm toái ña söï baùm buïi vaø nöôùc ngöng, cuõng nhö khaû naêng rôi
baùm cuûa chuùng.
2.2.2.6 Cöûa soå phaûi deã lau chuøi, ñöôïc thieát keá sao cho coù theå haïn cheá baùm buïi
tôùi möùc thaáp nhaát ôû nhöõng nôi caàn thieát, phaûi laép caùc heä thoáng choáng coân
truøng maø coù khaû naêng thaùo laép vaø laøm saïch ñöôïc ôû nôi caàn thieát, caàn phaûi
coá ñònh caùc cöûa soå.
2.2.2.7 Cöûa ra vaøo phaûi coù beà maët nhaün, khoâng thaám nöôùc, deã lau chuøi vaø khi
caàn phaûi deã taåy truøng.
2.2.2.8 Caùc beà maët tieáp xuùc tröïc tieáp vôùi thöïc phaåm phaûi toát, beàn vöõng, deã
lau chuøi, deã duy tu baûo döôõng vaø taåy truøng. Chuùng phaûi ñöôïc laøm baèng caùc
vaät lieäu nhaün, khoâng thaám nöôùc, trô ñoái vôùi thöïc phaåm, trô ñoái vôùi caùc chaát
taåy röûa, chaát taåy truøng trong nhöõng ñieàu kieän bình thöôøng.
2.2.3 Nhaø xöôûng
2.2.3.1 Nhaø xöôûng vaø caáu truùc nhö vaäy phaûi ñöôïc boá trí, thieát keá vaø xaây döïng
taïm thôøi/löu ñoäng
sao cho traùnh ñöôïc ôû möùc toái ña söï oâ nhieãm thöïc phaåm vaø söï cö truù cuûa sinh
vaø caùc xe baùn
vaät gaây haïi.
haøng rong
2.2.3.2 Khi aùp duïng nhöõng ñieàu kieän vaø yeâu caàu ñaëc bieät naøy, baát kyø moái
nguy naøo cho veä sinh thöïc phaåm lieân quan ñeán nhöõng phöông tieän treân phaûi ñöôïc
xaùc ñònh vaø kieåm soaùt ñaày ñuû ñeå baûo ñaûm an toaøn vaø tính phuø hôïp cuûa thöïc
phaåm.
2.3 Thieát bò
2.3.1 Yeâu caàu chung
2.3.1.1 Thieát bò vaø ñoà ñöïng tieáp xuùc vôùi thöïc phaåm, phaûi ñöôïc thieát keá vaø
cheá taïo ñeå ñaûm baûo khi caàn chuùng ñöôïc laøm saïch, taåy truøng vaø duy tu baûo
döôõng deã daøng traùnh gaây nhieãm baån thöïc phaåm.
2.3.1.2 Thieát bò vaø ñoà ñöïng phaûi ñöôïc laøm baèng vaät lieäu khoâng gaây ñoäc haïi
cho muïc ñích söû duïng.
2.3.1.3 ÔÛ nôi caàn thieát, thieát bò phaûi beàn vaø deã di chuyeån thaùo laép ñeå duy tu
baûo döôõng, ñeå laøm saïch, taåy truøng, giaùm saùt thích hôïp, ví duï deã kieåm tra sinh
vaät gaây haïi chaúng haïn.
2.3.2 Thieát bò cho 2.3.2.1 Ngoaøi nhöõng yeâu caàu chung trong muïc 2.3.1, thieát bò ñeå ñun, xöû lyù nhieät,
kieåm soaùt vaø laøm nguoäi, löu giöõ hay laøm ñoâng laïnh thöïc phaåm phaûi ñöôïc thieát keá laøm sao
giaùm saùt thöïc cho nhanh choùng ñaït ñöôïc nhieät ñoä theo yeâu caàu cuûa thöïc phaåm, nhaèm baûo
phaåm ñaûm tính an toaøn vaø phuø hôïp cuûa thöïc phaåm, vaø ñeå duy trì nhieät ñoä ñoù moät
caùch höõu hieäu.
2.3.2.2 Thieát bò ñoù phaûi ñöôïc thieát keá coù theå giaùm saùt, kieåm soaùt ñöôïc nhieät
ñoä. ÔÛ nhöõng nôi caàn thieát caùc thieát bò ñoù phaûi coù phöông tieän höõu hieäu ñeå
kieåm soaùt vaø giaùm saùt ñoä aåm khoâng khí, doøng khí vaø caùc thoâng soá baát kyø
naøo khaùc coù taùc duïng baát lôïi tôùi tính an toaøn vaø phuø hôïp cuûa thöïc.

2.3.3 Ñoà ñöïng chaát 2.3.3.1 Ñoà ñöïng chaát pheá thaûi, saûn phaåm phuï vaø caùc chaát khoâng aên ñöôïc
pheá thaûi vaø caùc hoaëc chaát nguy hieåm phaûi coù thieát keá ñaëc bieät ñeå deã nhaän bieát, coù caáu truùc
thöù khoâng aên ñöôïcphuø hôïp, nôi caàn thieát phaûi ñöôïc laøm baèng vaät lieäu ít bò hö hoûng.
2.3.3.2 Ñoà chöùa caùc chaát nguy hieåm phaûi ñöôïc phaân bieät roõ vaø khi caàn coù theå
khoaù ñöôïc ñeå traùnh söï nhieãm baån thöïc phaåm do coá yù hay tình.
2.4 Phöông tieän

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
2.4.1 Cung caáp nöôùc
2.4.1.1 Caàn coù heä thoáng cung caáp nöôùc uoáng sao cho luoân luoân ñöôïc ñaày ñuû,
vaø caùc phöông tieän thích hôïp ñeå löu tröõ, phaân phoái nöôùc vaø kieåm soaùt nhieät
ñoä, ñeå ñaûm baûo tính an toaøn vaø phuø hôïp cuûa thöïc phaåm. Nöôùc uoáng ñöôïc laø
nöôùc ñaõ ñöôïc qui ñònh trong laàn xuaát baûn cuoái cuûa “Caùc höôùng daãn veà chaát
löôïng nöôùc uoáng” cuûa Toå chöùc Y teá theá giôùi.
2.4.1.2 Nöôùc khoâng uoáng ñöôïc (ví duï nhö nöôùc duøng ñeå daäp chaùy, saûn xuaát hôi
nöôùc, laøm laïnh vaø caùc muïc ñích khaùc maø khoâng laøm oâ nhieãm thöïc phaåm),
phaûi ñöôïc xaùc ñònh vaø khoâng ñöôïc noái hoaëc khoâng cho pheùp hoài löu vaøo heä
thoáng nöôùc saïch uoáng ñöôïc.
2.4.2 Thoaùt nöôùc
2.4.2.1 Coù thieát keá boá trí heä thoáng thoaùt nöôùc vaø phöông tieän ñoå chaát thaûi hôïp
vaø ñoå chaát thaûi
lyù. Chuùng phaûi ñöôïc thieát keá vaø xaây döïng vaø duy trì sao cho traùnh ñöôïc moái
nguy nhieãm baån cho thöïc phaåm hay gaây nhieãm nguoàn cung caáp nöôùc saïch uoáng
ñöôïc.
2.4.3 Laøm saïch 2.4.3.1 Caàn boá trí caùc phöông tieän phuïc vuï hôïp veä sinh, ñöôïc thieát keá thích hôïp
ñeå laøm saïch thöïc phaåm, ñoà duøng vaø thieát bò. Nhöõng phöông tieän nhö vaäy, neáu
thích hôïp phaûi ñöôïc cung caáp ñuû nöôùc uoáng ñöôïc, nöôùc noùng vaø nöôùc laïnh.
2.4.4 Phöông tieän veä
2.4.4.1 Coù ñaày ñuû phöông tieän ñeå röûa vaø laøm khoâ tay bao goàm chaäu röûa coù
sinh caù nhaân vaø
heä thoáng caáp nöôùc noùng vaø nöôùc laïnh (hoaëc coù nhieät ñoä phuø hôïp, coù thieát
khu vöïc veä sinh
bò kieåm soaùt).

2.4.4.2 Nhaø veä sinh ñöôïc thieát keá hôïp veä sinh
2.4.4.3 Coù caùc phöông tieän, khu vöïc rieâng bieät vaø hôïp lyù ñeå nhaân vieân thay quaàn
aùo.
2.4.4.4 Nhöõng phöông tieän ñeà caäp ôû treân phaûi ñöôïc boá trí vaø thieát keá hôïp lyù.
2.4.5 Kieåm soaùt 2.4.5.1 Caùc phöông tieän ñeå laøm noùng, laøm nguoäi, ñun naáu, laøm laïnh vaø laøm
nhieät ñoä laïnh ñoâng thöïc phaåm, hoaëc ñeå duy trì toát cheá ñoä baûo quaûn maø thöïc phaåm ñaõ
ñöôïc laøm laïnh hay laïnh ñoâng, ñeå giaùm saùt nhieät ñoä thöïc phaåm vaø khi caàn ñeå
kieåm soaùt nhieät ñoä moâi tröôøng xung quanh nhaèm ñaûm baûo tính an toaøn vaø phuø
hôïp cuûa thöïc phaåm.
2.4.6 Chaát löôïng 2.4.6.1 Heä thoáng thoâng gioù töï nhieân hay duøng quaït cöôõng böùc, ñaûm baûo raèng
khoâng khí vaø söï - haïn cheá ñeán möùc toái thieåu nhieãm baån thöïc phaåm (do khoâng khí, ví duï
thoâng gioù nhö töø doøng khí hay nöôùc ngöng tuï);
- kieåm soaùt nhieät ñoä moâi tröôøng xung quanh;
- kieåm soaùt caùc muøi coù theå aûnh höôûng tôùi tính phuø hôïp cuûa thöïc phaåm;
- kieåm soaùt ñoä aåm khoâng khí
2.4.6.2 Caùc heä thoáng thoâng gioù phaûi ñöôïc thieát keá vaø xaây döïng sao cho doøng
khí khoâng ñöôïc chuyeån ñoäng töø khu vöïc oâ nhieãm tôùi khu saïch vaø ôû ñaâu caàn,
heä thoáng thoâng gioù ñoù cuõng ñöôïc tính ñeán, coù cheá ñoä baûo döôõng deã daøng
vaø ñöôïc laøm saïch moät caùch thuaän lôïi.
2.4.7 Aùnh saùng 2.4.7.1 Cöôøng ñoä vaø maøu saéc cuûa aùnh saùng ñuû ñeå ñaûm baûo an toaøn cho saûn
xuaát vaø xöû lyù thöïc phaåm.
2.4.7.2 Nguoàn saùng caàn che chaén ñeå traùnh bò vôõ, caùc maûng vôõ cuûa noù khoâng
theå rôi vaøo thöïc phaåm ñöôïc.
2.4.8 Baûo quaûn
2.4.8.1 Ôû nhöõng nôi caàn thieát phaûi boá trí phöông tieän thích hôïp ñeå baûo quaûn
thöïc phaåm, cuõng nhö baûo quaûn caùc chaát lieäu vaø caùc hoaù chaát phi thöïc phaåm
(nhö caùc chaát taåy röûa, daàu nhôøn, nhieän lieäu).
2.4.8.2 Neáu thích hôïp caùc phöông tieän duøng ñeå baûo quaûn thöïc phaåm phaûi ñöôïc
thieát keá vaø xaây döïng sao cho :
- coù cheá ñoä baûo döôõng duy tu vaø laøm veä sinh thuaän lôïi;
- traùnh ñöôïc sinh vaät gaây haïi xaâm nhaäp vaø aån naùu;
- baûo veä moät caùch höõu hieäu ñeå thöïc phaåm khoûi bò oâ nhieãm trong khi baûo quaûn;
vaø
- khi caàn tao ra ñöôïc moâi tröôøng nhaèm giaûm ñeán möùc toái thieåu söï hö haïi cuûa thöïc
phaåm

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
2.4.8.3 Nhöõng loaïi phöông tieän baûo quaûn, ñöôïc thieát keá, xaây döïng vaø duy trì
ngaên ngöøa söï tình côø hay tai naïn laøm laây nhieãm thöïc phaåm vôùi caùc vaät lieäu
coù haïi.
3 Kieåm soaùt hoaït ñoäng
3.1 Kieåm soaùt caùc 3.1.1 Nhöõng ngöôøi saûn xuaát, kinh doanh thöïc phaåm caàn aùp duïng caùc heä thoáng
moái nguy cho thöïc kieåm soaùt moái nguy cho thöïc phaåm thoâng qua vieäc söû duïng nhöõng heä thoáng nhö
phaåm HACCP. Nhöõng heä thoáng naøy phaûi ñöôïc aùp duïng trong suoát chu trình thöïc phaåm
ñeå kieåm soaùt veà veä sinh thöïc phaåm trong suoát thôøi gian saûn phaåm coøn duøng
ñöôïc.
3.2 Nhöõng khía caïnh chuû choát cuûa heä thoáng kieåm soaùt veä sinh
3.2.1 Thôøi gian vaø 3.2.1.1 Heä thoáng kieåm soaùt cho nhieät ñoä vaø thôøi gian trong suoát quaù trình ñun
nhieät ñoä noùng, laøm laïnh vaø baûo quaûn thì caàn thieát cho quaù trình saûn xuaát vaø ñoùng goùi
veà an toaøn cuûa thöïc phaåm. Heä thoáng kieåm soaùt bao goàm giôùi haïn tôùi haïn,
ñaêng kí vaø kieåm tra ñoä chính xaùc cuûa thieát bò ño.
3.2.2 Caùc khaâu cheá
3.2.2.1 Nhöõng khaâu khaùc aûnh höôûng tôùi veä sinh thöïc phaåm (vaø phaûi quan taâm
bieán ñaëc bieät
tröôùc ñoù) coù theå bao goàm: laøm laïnh, cheá bieán baèng nhieät, chieáu xaï, laøm khoâ,
saáy, baûo quaûn baèng hoaù chaát,
ñoùng goùi ôû möùc chaân khoâng hay coù aùp suaát ñieàu chænh ñöôïc.
3.2.3 Yeâu caàu vi 3.2.3.1 Yeâu caàu kyõ thuaät veà chæ tieâu vi sinh, hoaù hoïc vaø vaät lyù, thì yeâu caàu
sinh vaø yeâu caàu kyõ thuaät ñoù phaûi döïa treân caùc cô sôû khoa hoïc vöõng chaéc vaø khi caàn phaûi neâu
khaùc roõ qui trình giaùm saùt, caùc phöông phaùp phaân tích vaø caùc möùc giôùi haïn xöû lyù.
3.2.4 Nhieãm baån 3.2.4.1 Caàn taùch rieän hieäu quaû giöõa thöïc phaåm thoâ, khoâng cheá bieán töø quaù
cheùo vi sinh trình cung caáp thöïc phaåm.
3.2.4.2 Caàn haïn cheá hoaëc kieåm soaùt vieäc ñi vaøo khu cheá bieán. Ñöôøng ñi vaø qui
trình kieåm soaùt phaûi roõ raøng vaø ñöôïc vaên baûn hoaù.
3.2.4.3 Caùc beà maët duïng cuï, ñoà duøng nhaø beáp, thieát bò, cuõng nhö duïng cuï giaù
laép khaùc caàn phaûi röûa saïch kyõ löôõng vaø tuyø theo choã caàn thieát thì phaûi taåy
truøng sau khi tieáp xaùc vôùi thöïc phaåm thoâ, ñeå ngaên ngöøa söï nhieãm baån.
3.2.5 Nhieãm baån
3.2.5.1 Phaûi coù caùc heä thoáng chuyeân duïng ñeå ñeà phoøng nhieãm baån thöïc phaåm
vaät lyù vaø hoaù hoïc
do coù caùc thöïc theå to (nhö maûnh vôõ thuyû tinh, maûnh kim loaïi cuûa maùy, buïi,
khoùi ñoäc) vaø caùc hoaù chaát khoâng mong muoán khaùc.
3.2.5.2 Ôû nhöõng nôi caàn thieát phaûi duøng ñeán caùc thieát bò phuø hôïp ñeå phaùt
hieän hay phaân loaïi caùc thaønh phaàn neâu treân.
3.3 Yeâu caàu veà nguyeân lieäu ñaàu vaøo
3.3.1 Cuï theå 3.3.1.1 Khoâng ñöôïc pheùp duøng nguyeân lieäu hay thaønh phaàn, neáu bieát noù coù
chöùa kyù sinh truøng, caùc vi sinh vaät khoâng mong muoán, thuoác tröø saâu, thuoác thuù
y, caùc chaát ñoäc haïi, bò phaân huyû hay taïp chaát ngoaïi lai maø caùc chaát ñoù vöôït
qua möùc cho pheùp, theo phaân loaïi thoâng thöôøng vaø/hoaëc cheá bieán. ÔÛ trong ñieàu
kieän thích hôïp caàn phaûi xaùc ñònh vaø aùp duïng kyõ thuaät cho nguyeân lieäu töôi.
3.3.2 Kieåm soaùt taïi 3.3.2.1 ÔÛ trong ñieàu kieän thích hôïp nguyeân lieäu vaø caùc thaønh phaàn töôi chöùa
tieáp nhaän trong nguyeân lieäu caàn ñöôïc kieåm tra vaø phaân loaïi tröôùc khi cheá bieán. Caàn laáy
maãu thöû nghieäm ñeå xaùc ñònh söï phuø hôïp tröôùc khi ñöa vaøo söû duïng. Chæ coù
caùc nguyeân lieäu thoâ hay thaønh phaàn toát, phuø hôïp môùi ñöôïc söû duïng.
3.3.3 Toàn tröõ 3.3.3.1 Döï tröõ nguyeân lieäu thoâ vaø caùc thaønh phaàn cuûa noù phaûi döïa vaøo hieäu
quaû cuûa vieäc toàn tröõ.
3.4 Ñoùng goùi
3.4.1 Thieát keá vaø 3.4.1.1 Kieåu maãu bao bì vaø vaät lieäu laøm bao goùi phaûi ñuû baûo veä ñöôïc saûn phaåm
vaät lieäu khoûi bò nhieãm baån, ngaên chaën ñöôïc hö haïi, thuaän tieän vì vieäc ghi nhaõn ñuùng ñaén.
3.4.2 Vaät lieäu ñoùng3.4.2.1 Vaät lieäu ñoùng goùi hay caùc khí neáu ñöôïc duøng phaûi khoâng ñoäc vaø
goùi vaø caùc khí khoâng taïo moái ñe doaï naøo tôùi tính an toaøn vaø phuø hôïp cuûa thöïc phaåm, theo caùc
ñieàu kieän caát giöõ vaø söû duïng chung ñaõ qui ñònh.
3.4.3 Bao goùi duøng 3.4.3.1 ÔÛ nhöõng nôi caàn thieát neáu bao goùi ñöôïc duøng laïi thì phaûi beàn, deã laøm
laïi saïch vaø nôi caàn deã taåy truøng.
3.5 Nöôùc

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3.5.1 Nöôùc tieáp 3.5.1.1 Chæ coù nöôùc saïch uoáng ñöôïc môùi ñöôïc duøng trong xöû lyù vaø cheá bieán
xuùc vôùi thöïc phaåmthöïc phaåm, tröø nhöõng ngoaïi leä sau ñaây, khoâng nhaát thieát phaûi duøng nöôùc uoáng
ñöôïc :
- nöôùc ñeå saûn xuaát hôi nöôùc, ñeå phoøng chaùy vaø cho nhöõng muïc ñích töông töï
khoâng lieân quan ñeán thöïc phaåm; vaø
- trong moät vaøi quaù trình cheá bieán thöïc phaåm, nhö nöôùc laøm laïnh vaø nöôùc
duøng trong caùc khu vöïc xöû lyù thöïc phaåm, mieãn laø noù khoâng gaây neân moät
moái nguy naøo cho tính an toaøn vaø phuø hôïp cuûa thöïc phaåm (ví duï vieäc duøng
nöôùc bieån saïch).
3.5.2 Nöôùc hoài löu 3.5.2.1 Nöôùc hoài löu neâu ñöôïc söû duïng laïi phaûi ñöôïc xöû lyù vaø duy trì sao cho
qua xöû lyù nöôùc hoài löu khoâng coù moät moái nguy naøo aûnh höôûng tôùi tính an toaøn vaø phuø
hôïp cuûa thöïc phaåm do vieäc söû duïng noù gaây neân. Quaù trình xöû lyù phaûi ñöôïc
giaùm saùt moät caùch höõu hieäu.
3.5.3 Nöôùc hoài löu 3.5.3.1 Coù theå söû duïng nöôùc hoài löu khoâng qua xöû lyù theâm vaø nöôùc thu hoài
chöa qua xöû lyù töø gia coâng thöïc phaåm baèng caùch laøm boác hôi hay laøm khoâ, mieãn laø vieäc
duøng chuùng khoâng gaây moät moái nguy naøo aûnh höôûng tôùi tính an toaøn vaø phuø
hôïp cuûa thöïc phaåm.
3.5.4 Nöôùc ñöôïc 3.5.4.1 nöôùc saïch uoáng ñöôïc phaûi ñöôïc söû duïng.
duøng nhö moät
thaønh phaàn thöïc
phaåm
3.5.5 Nöôùc ñaù vaø 3.5.5.1 Nöôùc ñaù phaûi ñöôïc laøm töø nöôùc phuø hôïp vôùi nöôùc ñaõ ghi ôû muïc 2.4.1.
hôi nöôùc Nöôùc ñaù vaø hôi nöôùc phaûi ñöôïc saûn xuaát, xöû lyù vaø baûo quaûn choáng nhieãm
baån.
3.5.5.2 Hôi nöôùc tieáp xuùc tröïc tieáp vôùi thöïc phaåm hay tieáp xuùc vôùi caùc beà maët
thöïc phaåm phaûi khoâng taïo moái ñe doaï naøo tính an toaøn vaø phuø hôïp cuûa thöïc
phaåm.
3.6 Quaûn lyù vaø giaùm saùt
3.6.1 Loaïi kieåm 3.6.1.1 Loaïi hình cheá ñoä kieåm soaùt vaø giaùm saùt caàn thieát phuï thuoäc vaøo quy moâ
soaùt vaø giaùm saùt doanh nghieäp, tính chaát caùc hoaït ñoäng doanh nghieäp vaø caùc loaïi thöïc phaåm coù lieân
quan.
3.6.2 Yeâu caàu hieåu3.6.2.1 Ngöôøi ñieàu haønh, giaùm saùt vieân phaûi coù ñuû hieåu bieát veà caùc nguyeân
bieát taéc vaø thöïc haønh veä sinh thöïc phaåm, ñeå coù theå ñaùnh giaù caùc moái nguy tieàm
aån, coù haønh ñoäng thích hôïp phoøng ngöøa vaø söûa chöõa, vaø ñaûm baûo söï kieåm
soaùt vaø giaùm saùt ñöôïc thöïc hieän coù hieäu quaû ñöôïc thay theá.
3.7 Taøi lieäu vaø hoà sô
3.7.1 Löu giöõ hoà sô 3.7.1.1 Ôû nôi caàn nhöõng hoà sô taøi lieäu lieân quan saûn xuaát vaø cheá bieán, vaø
phaân phoái phaûi ñöôïc baûo quaûn vaø löu giöõ trong moät thôøi haïn laâu hôn thôøi haïn
söû duïng saûn phaåm.
3.7.2 Tính hieäu quaû 3.7.2.1 Taøi lieäu löu tröõ coù theå laøm taêng theâm söï tin caäy vaø tính hieäu quaû cuûa heä
vaø söï tin caäy thoáng kieåm soaùt an toaøn thöïc phaåm .
3.8 Thuû tuïc thu hoài
3.8.1 Hieäu quaû cuûa3.8.1.1 Caùc nhaø ñieàu haønh phaûi ñaûm baûo caùc qui trình höõu hieäu ñöôïc boá trí ñeà
qui trình giaûi quyeát ngay baát kyø moái nguy naøo tôùi an toaøn thöïc phaåm vaø ñeå thu hoài
toaøn boä, nhanh choùng baát cöù loâ hay meû thöïc phaåm sai loãi naøo töø thò tröôøng.
3.8.2 Theo doõi vaø 3.8.2.1 ÔÛ ñaâu coù moät saûn phaåm phaûi thu hoài vì coù nguy cô gaây haïi tôùi söùc
truy veát khoeû, thì nhöõng saûn phaåm khaùc ñöôïc saûn xuaát trong nhöõng ñieàu kieän töông töï
vaø coù theå coù nguy cô haïi töông töï cho söùc khoeû coäng ñoàng, caàn phaûi ñöôïc
ñaùnh giaù veà maët an toaøn vaø coù theå caàn phaûi thu hoài saûn phaåm ñoù. Caàn xem
xeùt söï caàn thieát phaûi thoâng baùo cho coäng ñoàng.
3.8.3 Huyû hay cheá 3.8.3.1 Caùc saûn phaåm bò thu hoài phaûi ñöôïc ñaët döôùi söï giaùm saùt cho tôùi khi
bieán laïi chuùng ñöôïc huyû boû, ñöôïc duøng cho caùc muïc ñích khaùc khoâng phaûi laø thöïc
phaåm. Saûn phaåm bò thu hoài neáu laïi ñöôïc con ngöôøi söû duïng, phaûi xaùc ñònh veà
tính an toaøn, hay ñöôïc cheá bieán laïi ñeå baûo ñaûm tính an toaøn cuûa chuùng.
4 Cô sôû ; duy tu baûo döôõng vaø veä sinh
4.1 Duy tu baûo döôõng vaø veä sinh

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
4.1.1 Toång quaùt 4.1.1.1 Caùc cô sôû nhaø xöôûng vaø thieát bò duïng cuï caàn ñöôïc giöõ ôû traïng thaùi töï
söûa thích hôïp vaø ôû ñieàu kieän toát ñeå
- taïo thuaän lôïi cho moïi qui trình veä sinh;
- chöùc naêng cuûa noù ñaït ñöôïc nhö ñaõ döï ñònh, ñaëc bieät ôû caùc khaâu tôùi haïn;
- ngaên chaën nhieãm baån thöïc phaåm, nhö töø caùc maûnh kim loaïi, vöõa bong, maûnh
vuïn vaø hoaù chaát.
4.1.1.2 Vieäc laøm saïch phaûi loaïi boû thöïc phaåm dö vaø veát baån, coù theå ñoù laø
moät nguoàn nhieãm baån. Vieäc choïn phöông phaùp vaø vaät lieäu caàn thieát ñeå laøm
saïch tuyø thuoäc vaøo baûn chaát cuûa kinh doanh thöïc phaåm cuûa kinh doanh thöïc
phaåm. Coù theå caàn phaûi taåy truøng sau khi laøm saïch xong.
4.1.1.3 Caùc hoaù chaát ñeå laøm saïch caàn ñöôïc xöû lyù vaø duøng caån thaän theo caùc
chæ daãn cuûa nhaø saûn xuaát.
4.1.1.4 Caàn phaûi baûo quaûn taùch rieâng khoûi saûn phaåm thöïc phaåm, ñöïng trong
caùc ñoà chöùa rieâng, coù theå nhaän bieát ñöôïc ngay, roõ raøng : ñeå traùnh nguy cô (tình
côø hay coá yù) laøm nhieãm baån thöïc phaåm.
4.1.2 Qui trình vaø 4.1.2.1 Qui trình laøm saïch vaø traùnh nhieãm truøng phaûi cuï theå vaø ñöôïc vaên baûn
phöông phaùp laøm hoaù. Nöôùc söû duïng phaûi phuø hôïp vôùi phaàn 2.4.1. Nhieãm baån cuûa thöïc phaåm
saïch töø vôùi hoaù chaát laøm saïch phaûi ñöôïc ngaên ngöøa.
4.2 Chöông trình laøm saïch
4.2.1 Cuï theå 4.2.1.1 Chöông trình laøm saïch vaø taåy truøng phaûi ñaûm baûo laø moïi nôi trong cô sôû
vaø nhaø xöôûng ñeàu phaûi saïch seõ ôû möùc thích hôïp, vaø ngay caû caùc thieát bò söû
duïng ñeå taåy röûa cuõng phaûi saïch seõ.
Moät khi caùc chöông trình soaïn thaûo veà laøm saïch ñöôïc söû duïng, chuùng phaûi neâu
roõ:
- caùc ñòa ñieåm, caùc loaïi thieát bò vaø ñoà duøng caàn laøm saïch;
- traùch nhieäm vaø ñoái vôùi coâng vieäc cuï theå;
- phöông phaùp vaø taàn suaát laøm saïch;
- toå chöùc giaùm saùt theo doõi.
Khi thaáy thích hôïp, caùc chöông trình phaûi ñöôïc bieân soaïn coù sö tham khaûo yù kieán
cuûa caùc chuyeân vieân coù lieân quan vaø coù hieåu bieát veà lónh vöïc naøy.
4.2.2 Giaùm saùt vaø
4.2.2.1 Caùc chöông trình laøm saïch vaø taåy truøng phaûi ñöôïc giaùm saùt lieân tuïc vaø
xaùc nhaän
höõu hieäu veà tính phuø hôïp vaø tính hieäu quaû chuùng vaø khi caàn phaûi ghi vaøo soå
saùch ñeå theo doõi.
4.3 Heä thoáng kieåm dòch
4.3.1 Toång quaùt 4.3.1.1 Caàn phaûi thöïc haønh veä sinh toát ñeå traùnh taïo ra moät moâi tröông thuaän lôïi
cho dòch haïi. Laøm veä sinh toát, kieåm tra caùc vaät lieäu ñaàu vaøo vaø giaùm saùt toát,
coù theå giaûm ñeán möùc toái thieåu söï oâ nhieãm vaø do ñoù haïn cheá vieäc duøng
thuoác tröø dòch haïi.
4.3.2 Caùch ngaên 4.3.2.1 Nhaø xöôûng phaûi ñöôïc söûa sang vaø giöõ gìn saïch seõ ñeå ñeà phoøng dòch haïi
chaën xaâm nhaäp vaø ñeå loaïi tröø bôùt nhöõng ñaïi ñieåm chaên nuoâi coù mang maàm beänh.
4.3.2.2 Caùc hoá, raõnh vaø nhöõng nôi naøo sinh vaät gaây haïi coù theå xaâm nhaäp caàn
phaûi ñöôïc ñaäy kín. Khi khoâng kín (ví duï nhö treân cöûa soå, cöûa ra vaøo vaø heä
thoáng quaït) söû duïng caùc taám löôùi theùp duøng che chaén seõ laøm giaûm vaán ñeà
sinh vaät gaây haïi xaâm nhaäp.
4.3.2.3 Khi coù ñieàu kieän caàn loaïi tröø ñoäng vaät ra khoûi khu ñaát nhaø maùy vaø
nhaø xöôûng, maùy moùc cheá bieán thöïc phaåm.
4.3.3 Sö löu truù vaø
4.3.3.1 Nguoàn thöïc phaåm phaûi ñöôïc giöõ trong nhöõng thuøng ñöïng ñeå traùnh sinh
oâ nhieãm
vaät gaây haïi vaø/hoaëc caùch xa neàn nhaø vaø caùch xa töôøng.
4.3.3.2 Nhöõng khu vöïc caû ôû phía trong vaø ngoaøi nôi xöû lyù thöïc phaåm phaûi ñöôïc
giöõ gìn saïch seõ. Khi caàn pheá thaûi phaûi ñöôïc ñöïng trong caùc thuøng ñaäy naép
hoaëc thuøng ñöïng traùnh sinh vaät gaây haïi.
4.3.4 Giaùm saùt vaø 4.3.4.1 Caùc cô sôû, nhaø xöôûng vaø caùc khu vöïc xung quanh phaûi ñöôïc
thöïc hieän kieåm tra thöôøng kyø ñeå phaùt hieän oâ nhieãm.
4.3.5 Söï tieät tröø 4.3.5.1 Söï
nhieãm sinh vaät gaây haïi phaûi ñöôïc giaûi quyeát ngay vaø
khoâng laøm taùc haïi ñeán tính an toaøn vaø phuø hôïp cuûa thöïc phaåm.
4.4 Quaûn lyù chaát thaûi

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4.4.1 Loaïi boû, toàn
Caàn chuaån bò ñaày ñuû, thích hôïp cho vieäc loaïi boû vaø löu chaát thaûi. Chaát thaûi
tröõ
khoâng ñöôïc toàn taïi trong khi ñang cheá bieán thöïc phaåm, baûo quaûn thöïc phaåm, taïi
caùc khu vöïc laøm vieäc vaø caùc khu laân caän, tröø phi ñoù laø ñieàu khoâng theå traùnh
ñöôïc cho söï vaän haønh thích hôïp cuûa coâng vieäc.
4.4.2 Laøm saïch Nhöõng nôi löu giöõ chaát thaûi phaûi ñöôïc giöõ saïch seõ thích ñaùng.
4.5 Heä thoáng veä sinh
4.5.1 Giaùm saùt 4.5.1.1 Heä thoáng veä sinh phaûi ñöôïc giaùm saùt hieäu quaû.
4.5.2 Thaåm tra 4.5.2.1. Heä thoáng veä sinh caàn ñöôïc xaùc minh ñònh kyø qua caùc cuoäc kieåm tra hay
khi caàn laáy maãu vi sinh vaät ôû moâi tröôøng vaø caùc beà maët tieáp xuùc thöïc phaåm.
4.5.3 Xem xeùt laïi 4.5.3.1 Heä thoáng veä sinh caàn xem laïi ñeàu ñaën vaø coâng taùc naøy phuø hôïp vôùi
caùc tröôøng hôïp thay ñoåi hoaøn caûnh.
5 Cô sôû : Veä sinh caù nhaân
5.1 Tình traïng söùc khoeû
5.1. Phöông rieän 5.1.1.1 Heä thoáng phaûi thieát laäp phöông tieän ngaên ngöøa nhöõng ngöôøi ñöôïc bieát
ngaên ngöøa hay nghi ngôø coù beänh hoaëc laø ngöôøi mang moät maàm beänh naøo ñoù coù theå lan
truyeàn qua thöïc phaåm, thì khoâng ñöôïc pheùp vaøo khu vöïc cheá bieán thöïc phaåm vì
coù khaû naêng hoï laøm laây beänh qua thöïc phaåm. A system shall be in place to prevent
access to any food handling area by people known, or suspected to be suffering from, or to
be a carrier of, a disease or illness likely to be transmitted through food.
5.1.1.2 Baát cöù ngöôøi naøo bò maéc nhö vaäy cuõng phaûi baùo caùo ngay beänh hay
trieäu chöùng beänh cho ban quaûn lyù. Phaûi tieán haønh khaùm beänh cho nhaân vieân
xöû lyù thöïc phaåm neáu coù chæ ñònh veà maët laâm saøng hay dòch teã hoïc.
5.2 Beänh taät vaø toån thöông
5.2.1 Ñieàu kieän 5.2.1.1 Caùc loaïi beänh vaø caùc veát thöông caàn phaûi ñöôïc baùo caùo cho ban quaûn
baùo caùo lyù ñeå nghieân cöùu xem coù caàn khaùm beänh vaø/hoaëc thaáy caàn thieát coù theå loaïi
tröø ra khoûi khaâu coù tieáp xuùc vôùi thöïc phaåm, goàm coù caùc trieäu chöùng hoaëc
beänh sau :
- beänh vaøng da;
- æa chaûy;
- noân möûa;
- soát;
- ñau hoïng coù soát;
- thöông toån nhieãm truøng da roõ reät (nhoït, veát caét,…);
- nöôùc chaûy ræ töø tai, maét hay muõi.
5.3 Veä sinh caù nhaân
5.3.1 Quaàn aùo baûo 5.3.1.1 Nhöõng ngöôøi tieáp xuùc vôùi thöïc phaåm caàn giöõ veä sinh caù nhaân thaät toát,
veä vaø trong ñieàu kieän thích hôïp caàn maëc quaàn aùo baûo veä, ñoäi muõ, ñi giaày.
5.3.2 Veát caét hay 5.3.2.1 Khi moät ngöôøi bò caùc veát thöông nheï ñaõ ñöôïc cho pheùp tieáp tuïc laøm vieäc
veát thöông thì caùc veát caét hay veát thöông, g ñoù phaûi ñöôïc bao boïc baèng baêng khoâng thaám
nöôùc.
5.3.3 Röûa tay 5.3.3.1 Caùc nhaân vieân luoân luoân phaûi röûa tay, saïch seõ ñeå khoâng aûnh höôûng
tôùi tính an toaøn cuûa thöïc phaåm, ví duï:
- luùc baét ñaàu caùc hoaït ñoäng xöû lyù hay tieáp xuùc vôùi thöïc phaåm;
- ngay sau khi ñi veä sinh; vaø
- sau khi xöû lyù hay tieáp xuùc vôùi thöïc phaåm, nguyeân lieäu (ñang thoâ, töôi soáng)
hay baát cöù vaät lieäu naøo khaùc, vì gaây nhieãm baån cho thöïc phaåm khaùc, hoï phaûi
traùnh tieáp xuùc vôùi caùc thöùc aên saün.
5.4 Haønh vi caù nhaân
5.4.1 Huùt thuoác, aên5.4.1.1 Nhöõng ngöôøi tham gia vaøo caùc hoaït ñoäng, thao taùc cheá bieán thöïc phaåm
uoáng, haét hôi caàn traùnh caùc haønh vi coù theå daãn ñeán nhieãm baån thöïc phaåm, ví duï :
- huùt thuoác;
- khaïc nhoå;
- nhai hay aên;
- haét hôi hay ho khi tieáp xuùc vôùi thöïc phaåm maø thöïc phaåm ñoù chöa
ñöôïc baûo veä.
5.4.2 Nöõ trang 5.4.2.1 Khoâng ñöôïc ñeo hay mang treân ngöôøi mình nhöõng ñoà duøng caù nhaân nhö
ñoà trang söùc, ñoàng hoà, keïp toùc hay caùc vaät khaùc, khi nhaân vieân ñoù vaøo khu
vöïc cheá bieán thöïc phaåm vì caùc thöù ñoù laø moät trong nhieàu nguyeân nhaân aûnh
höôûng ñeán tính an toaøn vaø phuø hôïp cuûa thöïc phaåm.

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5.5 Khaùch tham quan
5.5.1 Saïch seõ vaø 5.5.1.1 Khaùch tham quan vaøo caùc khu vöïc saûn xuaát, cheá bieán hay xöû lyù thöïc
haønh vi phaåm phaûi maëc quaàn aùo baûo veä vaø toân troïng caùc ñieàu khoaûn khaùc qui ñònh
veà veä sinh caù nhaân trong khu vöïc naøy.
6 Vaän chuyeån
6.1 Toång quaùt 6.1.1 Thöïc
phaåm caàn phaûi ñöôïc baûo veä ñaày ñuû trong quaù trình vaän
chuyeån ñeå baûo ñaûm an toaøn veä sinh thöïc phaåm.
6.2 Yeâu caàu 6.2.1 Khi caàn caùc phöông tieän vaän chuyeån vaø caùc loaïi thuøng caàn phaûi ñöôïc thieát
keá vaø cheá taïo sao cho :
- khoâng laøm nhieãm baån thöïc phaåm hay caùc bao goùi;
- coù theå ñöôïc röûa saïch deã daøng vaø khi caàn ñöôïc taåy ueá;
- phaân loaïi roõ raøng caùc loaïi thöïc phaåm khaùc nhau, hoaëc khi caàn caùc thöïc phaåm
phaûi ñöôïc taùch rieâng ra khoûi loaïi haøng khoâng phaûi thöïc phaåm trong quaù trình
vaän chuyeån;
- baûo veä höõu hieäu ñeå choáng nhieãm baån, keå caû buïi vaø khoùi;
- coù theå duy trì coù hieäu quaû nhieät ñoä, ñoä aåm, tieåu khí haäu vaø caùc ñieàu kieän
khaùc caàn thieát ñeå baûo veä thöïc phaåm choáng laïi vi truøng ñoäc haïi hay vi sinh
khoâng mong muoán phaùt trieån, choáng laïi söï hö haïi coù theå laøm cho thöïc phaåm
khoâng phuø hôïp vôùi tieâu thuï;
- cho pheùp kieåm soaùt ñöôïc nhieät ñoä, ñoä aåm vaø caùc ñieàu kieän caàn thieát khaùc.
6.3 Söû duïng vaø
6.3.1 Caùc phöông tieän vaän chuyeån vaø caùc loaïi thuøng ñöïng duøng ñeå vaän chuyeån
baûo quaûn
thöïc phaåm phaûi ñöôïc giöõ gìn saïch seõ ,ñöôïc söõa chöõa vaø ñieàu kieän toát.
6.3.2 Khi cuøng moät phöông tieän vaän chuyeån hay cuøng loaïi thuøng ñöïng duøng ñeå
vaän chuyeån caùc thöïc phaåm khaùc nhau, hoaëc duøng cho caùc chaát khoâng phaûi thöïc
phaåm thì caàn phaûi laøm saïch vaø neáu caàn phaûi taåy ueá sau khi chuyeân chôû hoaëc
chöùa ñöïng haøng xong.
6.3.3 Khi thích hôïp, ñaëc bieät khi chuyeân chôû baèng phöông tieän chuyeân chôû lôùn thì
thuøng ñöïng, caùc phöông tieän phaûi ñöôïc ñònh roõ vaø ñaùnh daáu chæ duøng cho thöïc
phaåm, vaø chæ ñöôïc duøng cho muïc ñích ñoù maø thoâi.
7 Thoâng tin veà saûn phaåm vaø söï hieåu bieát cuûa ngöôøi tieâu duøng
7.1 Xaùc ñònh loâ
7.1.1 Vieäc xaùc ñònh loâ haøng laø caàn thieát khi thu hoài saûn phaåm, vaø noù cuõng
haøng
giuùp cho vieäc quay voøng haøng toàn kho coù hieäu quaû(phaàn 3.2.3). Moãi thuøng
ñöïng thöïc phaåm ghi roõ ngöôøi saûn xuaát vaø loâ haøng. (Aùp duïng theo tieâu chuaån
chung cho vieäc ghi nhaõn caùc thöïc phaåm ñoùng goùi saün, CODEX STAN 1-1985).
7.2 Thoâng ti veà saûn
7.2.1 Taát caû caùc saûn phaåm thöïc phaåm phaûi ñöôïc keøm theo hoaëc coù thoâng tin
phaåm
ñaày ñuû ñeå ngöôøi tieáp theo trong chu trình thöïc phaåm coù theå thao taùc, trình baøy,
baûo quaûn, chuaån bò söû duïng saûn phaåm moät caùch an toaøn vaø ñuùng ñaén.
7.3 Ghi nhaõn 7.3.1 Nhöõng thöïc phaåm ñoùng goùi saün phaûi ñöôïc ghi nhaõn vôùi nhöõng chæ daãn
roõ raøng ñeå ngöôøi tieáp theo trong chu trình thöïc phaåm coù theå thao taùc, trình baøy,
baûo quaûn, chuaån bò söû duïng saûn phaåm moät caùch an toaøn (Aùp duïng theo tieâu
chuaån chung cho vieäc ghi nhaõn caùc thöïc phaåm ñoùng goùi saün, CODEX STAN 1-
1985).
7.4 Giaùo duïc ngöôøi7.4.1 Caùc chöông trình giaùo duïc söùc khoeû phaûi bao goàm caû veä sinh thöïc phaåm
tieâu duøng noùi chung. Nhöõng chöông trình nhö vaäy seõ khieán ngöôøi tieâu duøng hieåu ñöôïc taàm
quan troïng cuûa baát cöù thoâng tin naøo veà thöïc phaåm vaø tuaân theo baát cöù chæ
daãn naøo keøm theo saûn phaåm, vaø löïa choïn sau khi ñaõ coù thoâng tin. Ñaëc bieät,
ngöôøi tieâu duøng seõ ñöôïc thoâng tin veà moái lieân quan giöõa söï kieåm soaùt veà thôøi
gian/nhieät ñoä vaø laây lan beänh taät qua thöïc phaåm.
8 Ñaøo taïo
8.1 Hieåu bieát vaø
8.1.1 Taát caû caùc nhaân vieân phaûi bieát vai troø vaø traùch nhieäm cuûa hoï trong vieäc
traùch nhieäm
baûo veä thöïc phaåm khoûi bò nhieãm baån vaø hö haïi.
8.1.2 Nhöõng ngöôøi xöû lyù thöïc phaåm phaûi coù hieåu bieát vaø kyõ naêng caàn thieát
ñeå xöû lyù thöïc phaåm moät caùch veä sinh. Nhöõng ngöôøi xöû lyù caùc hoaù chaát taåy
röûa maïnh hay caùc hoaù chaát coù tieàm naêng ñoäc haïi khaùc caàn ñöôïc hoïc veà caùc
kyõ thuaät xöû lyù cho an toaøn.

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8.2 Chöông trình ñaøo8.2.1 Nhöõng yeáu toá caàn löu yù khi yeâu caàu ñaùnh giaù möùc ñoä ñaøo taïo bao goàm:
taïo - tính chaát cuûa thöïc phaåm, ñaëc bieät khaû naêng cuûa coù theå keùo daøi söï
taêng tröôûng cuûa caùc vi sinh vaät gaây beänh hay gaây hö haïi;
- tuyø theo ñoù thöïc phaåm seõ ñöôïc xöû lyù vaø bao goùi, bao goàm caû khaû
naêng ñaùnh giaù möùc ñoä nhieãm baån;
- quy moâ vaø tính chaát cuûa cheá bieán hay caàn chuaån bò theâm, tröôùc khaâu
tieâu thuï cuoái cuøng;
- caùc ñieàu kieän maø theo ñoù thöïc phaåm phaûi ñöôïc baûo quaûn; vaø
- thôøi haïn döï tính tröôùc khi tieâu thuï.
8.3 Giaûng daïy vaø 8.3.1 Caàn coù söï ñaùnh giaù ñònh kyø veà hieäu quaû cuûa chöông trình ñaøo taïo vaø
giaùm saùt giaûng daïy, cuõng nhö söï giaùm saùt vaø kieåm tra thöôøng xuyeân ñeå baûo ñaûm laø
caùc thuû tuïc ñaõ ñöôïc chaáp haønh moät caùch hieäu quaû.
8.3.2 Caùc nhaø quaûn lyù vaø giaùm saùt vieân cuûa caùc qui trình thöïc phaåm phaûi coù
hieåu bieát caàn thieát veà nhöõng nguyeân taéc vaø caùc caùch thöïc haønh veä sinh thöïc
phaåm ñeå coù theå luaän xeùt veà caùc moái nguy tieàm aån vaø coù haønh ñoäng caàn
thieát ñeå söûa chöõa thieáu xoùt (xem phaàn 3.5).
8.4 Ñaøo taïo laïi 8.4.1 Caùc chöông trình ñaøo taïo caàn ñöôïc xem xeùt laïi thöôøng xuyeân vaø caäp nhaät
khi caàn thieát.
8.4.2 Caàn coù heä thoáng saün saøng ñeå ñaûm baûo laø nhöõng ngöôøi xöû lyù thöïc
phaåm vaãn hieåu bieát veà taát caû caùc thuû tuïc caàn thieát ñeå duy trì tính an toaøn vaø
phuø hôïp cuûa thöïc phaåm.
6. ANNEX I Pre-requisite program (PRP)
(Reference: Codex Alimentarius, “General Principles of Food Hygiene”, CAC/RCP 1-1969, Rev. 3 (1997),
Amended 1999)

1 Primary production
1.1 Environmental 1.1.1 Primary food production shall not be carried out in areas where the presence of
hygiene potentially harmful substances will lead to an unacceptable level of such substances in
food. Potential sources of contamination from the environment shall be considered.
1.2 Hygienic 1.2.1 The potential effects of primary production activities on the safety and
production of food suitability of food shall be considered at all times. In particular, this
sources includes identifying any specific points in such activities where a high
probability of contamination may exist and taking specific measures to
minimise that probability.
1.2.2 As far as practicable, measures shall be implemented to:
- control contamination from air, soil, water, feedstuffs, fertilisers (including natural
fertilisers), pesticides, veterinary drugs or any other agent used in primary production;
- control plant and animal health so that it does not pose a threat to human health through
food consumption, or adversely affect the suitability of the product;
- protect food sources from faecal and other contamination.
1.2.3 In particular, care shall be taken to manage waste and store harmful
substances appropriately.
1.2.4 On-farm programmes which achieve specific food safety goals are becoming an
important part of primary production and shall be encouraged.
1.3 Handling, 1.3.1 Procedures shall be in place to:
storage and - sort food and food ingredients to segregate material which is evidently unfit for
transport human consumption;
- dispose of any rejected material in a hygienic manner;
- protect food and food ingredients from contamination by pests, or by chemical,
physical or microbiological contaminants or other objectionable substances during
handling, storage and transport.
1.3.2 Care shall be taken, so far as is reasonably practicable, to prevent deterioration
and spoilage through appropriate measures which may include
controlling temperature, humidity, and/or other controls.
1.4 Cleaning, 1.4.1 Appropriate facilities and procedures shall be in place to ensure that:
maintenance and - any necessary cleaning and maintenance is carried out effectively;
personal hygiene - an appropriate degree of personal hygiene is maintained.

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2 Establishment: design and facilities


2.1 Location
2.1.1 Establishments 2.1.1.1 Establishments shall not be located anywhere where it is clear that there is a
threat to food safety or suitability. In particular, establishments shall normally be
located away from:
- environmentally polluted areas and industrial activities which pose a serious threat
to contamination of food;
- areas subject to flooding unless sufficient safeguards are provided;
- areas prone to infestations of pests;
- areas from which waste, either solid or liquid, cannot be removed effectively.
2.1.2 Equipment 2.1.2.1 Equipment shall be located so that it:
- permits adequate maintenance and cleaning;
- functions in accordance with its intended use;
- facilitates good hygiene practices, including monitoring.
2.2 Premises and rooms
2.2.1 Design and 2.2.1.1 Where appropriate, the internal design and layout of food establishments shall
layout permit good food hygiene practices, including protection against harmful cross-
contamination.
2.2.2 Internal 2.2.2.1 Structures within food establishments shall be soundly built of durable materials
structures and and be easy to maintain, clean and where appropriate, disinfect.
fittings 2.2.2.2 The surfaces of walls, partitions and floors shall be made of impervious
materials with no toxic effect in intended use.
2.2.2.3 Walls and partitions shall have a smooth surface up to a height appropriate to
the operation.
2.2.2.4 Floors shall be constructed to allow adequate drainage and cleaning.
2.2.2.5 Ceilings and overhead fixtures shall be constructed and finished to minimise the
build up of dirt and condensation and the shedding of particles.
2.2.2.6 Windows shall be easy to clean, constructed to minimise build up of dirt and
where necessary, fitted with removable and cleanable insect-proof screens. Where
necessary windows shall be fixed.
2.2.2.7 Doors shall have smooth, non-absorbent surfaces and shall be easy to clean and
disinfect.
2.2.2.8 Working surfaces that come into direct contact with food shall be of sound
condition, durable and easy to clean, maintain and disinfect. They shall be made of
smooth, non-absorbent materials and inert to food, detergents and disinfectants under
normal operating conditions.
2.2.3 Temporary / 2.2.3.1 Premises and structures shall be located, designed and constructed to avoid, as
mobile premises; far as is reasonably practicable, contaminating food and harbouring
vending machines pests.
2.2.3.2 Any food hygiene hazards associated with such facilities shall be adequately
identified and controlled to ensure the safety and suitability of food.
2.3 Equipment
2.3.1 General 2.3.1.1 Equipment and re-usable containers coming into contact with food shall be
designed and constructed to ensure that, where necessary, they can be adequately
cleaned, disinfected and maintained to avoid the contamination of food.
2.3.1.2 Equipment and containers shall be made of materials with no toxic effect in
intended use.
2.3.1.3 Where necessary, equipment is durable and movable or
capable of being disassembled to allow for maintenance, cleaning, disinfection, monitoring
and, for example, to facilitate inspection for pests.
2.3.2 Food control 2.3.2.1 In addition to the general requirements in paragraph 2.3.1, equipment used to
and monitoring cook, heat treat, cool, store or freeze food shall be designed to achieve the required
equipment food temperatures as rapidly as necessary in the interests of food safety and suitability,
and to be effectively maintained.
2.3.2.2 Such equipment shall also be designed to allow temperatures to be monitored
and controlled. Where necessary, such equipment shall have effective means of
controlling and monitoring humidity, air-flow and any other condition likely to have a
detrimental effect on the safety or suitability of food.

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2.3.3 Containers for 2.3.3.1 Containers for waste, by-products, and inedible or dangerous substances shall
waste and inedible be identifiable, suitably constructed and where appropriate made of impervious
substances material.
2.3.3.2 Containers used to hold dangerous substances shall be identified and, where
appropriate, shall be lockable to prevent malicious or accidental contamination of food.
2.4 Facilities
2.4.1 Water supply 2.4.1.1 An adequate supply of potable water with appropriate facilities for its storage,
distribution and temperature control, shall be available whenever necessary. Potable
water shall, as a minimum, meet the specifications published in the WHO Guidelines for
Drinking Water Quality.
2.4.1.2 Separate non-potable water systems (e.g. fire control, steam production,
refrigeration) shall be identified and shall not connect with, or allow reflux into,
potable water systems.
2.4.2 Drainage and 2.4.2.1 Drainage and waste disposal systems shall be available, designed, constructed
waste disposal and maintained in such a way as to avoid contamination of food products and potable
water supply.
2.4.3 Cleaning 2.4.3.1 Adequate facilities, suitable designated, are provided for cleaning food utensils
and equipment. If necessary these facilities shall have an adequate supply of hot and
cold potable water.
2.4.4 Personnel 2.4.4.1 Adequate means of hygienically washing and drying hands, including wash
hygiene facilities basins and a supply of cold and hot (suitable temperature) water are provided.
and toilets 2.4.4.2 Lavatories of appropriate hygienic design are provided.
2.4.4.3 Adequate changing facilities for personnel are provided.
2.4.4.4 The afore-mentioned facilities are suitable located and designated.
2.4.5 Temperature 2.4.5.1 Facilities for heating, cooling or freezing food products, or storing refrigerated
control or frozen foods are suitable to meet the specified conditions for ensuring food safety.
2.4.6 Air quality and 2.4.6.1 Mechanical or natural ventilation ensures:
ventilation - minimisation of air-borne contamination of food (e.g. from aerosols and
condensation droplets)
- control of ambient temperatures
- control of humidity
2.4.6.2 Ventilation systems are designed and constructed so that air does not flow from
contaminated areas to clean areas and they can be adequately maintained and cleaned.
2.4.7 Lighting 2.4.7.1 The intensity and colour of the lighting is sufficient to ensure the production and
handling of safe food products.
2.4.7.2 Where appropriate, lighting fixtures are protected to ensure that food products
are not contaminated by breakage.
2.4.8 Storage 2.4.8.1 Adequate facilities for storage of food ingredients and non-food materials (e.g.
cleaning materials, lubricants, fuels) are provided.
2.4.8.2 Food storage facilities are designed and constructed to:
- permit adequate maintenance and cleaning ;
- avoid pest access and harbourage;
- enable food to be effectively protected from contamination;
- provide the necessary environment to prevent spoilage.
2.4.8.3 Facilities for storage are designed, constructed and maintained to ensure that
malicious or accidental contamination of food products with harmful materials is
prevented.
3 Control of operation
3.1 Control of food 3.1.1 Food business operators shall control food hazards through the use of systems
hazards such as HACCP. These systems shall be applied throughout the food chain to control
food hygiene throughout the shelf life of the product.
3.2 Key aspects of hygiene control systems
3.2.1 Time and 3.2.1.1 Control systems for temperature and time during heating, cooling and storage
temperature control are in place where necessary for the production and handling of safe food. Control
systems include critical limits, registration and testing of accuracy of measuring
equipment.
3.2.2 Specific 3.2.2.1 Other steps which contribute to food hygiene (and which must therefore be
process steps considered) may include chilling, thermal processing, irradiation, drying, chemical
preservation, vacuum or modified atmospheric packaging.

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3.2.3 3.2.3.1 Where microbiological, chemical or physical specifications are relevant for food
Microbiological and safety, such specifications shall be based on sound scientific principles and state, where
other specifications appropriate, monitoring procedures, action limits and analytical methods.
3.2.4 3.2.4.1 Where appropriate, effective separation of raw, unprocessed food from
Microbiological processed food applies.
cross-contamination 3.2.4.2 Where appropriate, access to processing areas are restricted or controlled.
Access and control procedures are defined and documented.
3.2.4.3 All surfaces, utensils, equipment, fixtures and fittings are cleaned and where
necessary, disinfected after contact with raw food, to prevent contamination.
3.2.5 Physical and 3.2.5.1 Systems are in place to prevent contamination of food products by foreign
chemical bodies (e.g. glass, metal, dust, harmful fumes) and hazardous chemicals.
contamination 3.2.5.2 Suitable and effective detection or screening devices are used where necessary.
3.3 Incoming materials requirements
3.3.1 Specifications 3.3.1.1 No raw material or ingredient shall be accepted by an establishment if it is
known to contain parasites, undesirable micro-organisms, pesticides, veterinary drugs
or toxic, decomposed or extraneous substances which would not be reduced to an
acceptable level by normal sorting and/or processing. Where appropriate,
specifications for raw materials shall be identified and applied.
3.3.2 Control at 3.3.2.1 Raw materials or ingredients shall, where appropriate, be inspected and sorted
reception before processing. Where necessary, laboratory tests shall be carried out to establish
fitness for use. Only sound, suitable raw materials or ingredients shall be used.
3.3.3 Stock rotation 3.3.3.1 Stocks of raw materials and ingredients shall be subject to effective stock
rotation.
3.4 Packaging
3.4.1 Design and 3.4.1.1 Packaging design and materials shall provide adequate protection for products
materials to minimise contamination, prevent damage and accommodate proper labelling.
3.4.2 “Food-grade” 3.4.2.1 Packaging materials and gases shall be non-toxic and not pose a threat to the safety
materials and gases and suitability of food under the specified conditions, storage and use.
3.4.3 Reusable 3.4.3.1 Re-usable packaging shall be suitably durable, easy to clean and, where
packaging necessary, disinfect.
3.5 Water
3.5.1 Water in 3.5.1.1 Only potable water shall be used in food handling and processing, with the
contact with food following exceptions:
- for steam production, fire control and similar purposes not connected with food
- in certain processes (e.g. chilling) and in food handling areas provided it does not
constitute a hazard to the safety of food (e.g. use of clean sea-water).
3.5.2 Reuse of re- 3.5.2.1 Re-circulated water for re-use shall be treated and maintained in such a
circulated, treated condition that no hazards for food safety occur. The treatment process shall be
water effectively monitored.
3.5.3 Reuse of re- 3.5.3.1 Re-circulated water which has received no further treatment and water
circulated, non- recovered from processing of food by evaporation or drying may be used, provided its
treated water use does not constitute a risk to the safety and suitability of food.
3.5.4 As an 3.5.4.1 Potable water shall be used.
ingredient
3.5.5 Ice and steam 3.5.5.1 Ice shall be made from water complying with section 2.4.1. Ice and steam shall
be produced, handled and stored to protect them from contamination.
3.5.5.2 Steam used in direct contact with food or food contact surfaces shall not contain
any agent which is hazardous for food safety.
3.6 Management and supervision
3.6.1 Type of control 3.6.1.1 The type of control and supervision needed will depend on the size of the
and supervision business, the nature of its activities and the types of food involved.
3.6.2 Knowledge 3.6.2.1 Managers and supervisors shall have enough knowledge of food hygiene
required principles and practices to be able to judge potential risks, take appropriate preventive
and corrective action, and ensure that effective monitoring and supervision takes place.

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3.7 Documentation and records


3.7.1 Retain records 3.7.1.1 Where necessary, appropriate records of processing, production and
distribution shall be kept and retained for a period that exceeds the shelf life
of the product.
3.7.2 Effectiveness 3.7.2.1 Documentation can enhance the credibility and effectiveness of the food safety
and credibility control system.
3.8 Recall procedures
3.8.1 Effective 3.8.1.1 Managers shall ensure that effective procedures are in place to deal with any food
procedures safety hazard and to enable the complete, rapid recall of any implicated batch of finished
food from the market.
3.8.2 Tracing & 3.8.2.1 Where a product has been withdrawn because of an immediate health hazard,
tracking other products which are produced under similar conditions, and which may present a
similar hazard to public health, shall be evaluated for safety and may need to be
withdrawn. The need for public warnings shall be considered.
3.8.3 Destroy or 3.8.3.1 Recalled products shall be held under supervision until they are destroyed, used
reprocess for purposes other than human consumption, determined to be safe for human
consumption, or reprocessed in a manner to ensure their safety.
4 Establishment: maintenance and sanitation
4.1 Maintenance and cleaning
4.1.1 General 4.1.1.1 Establishments and equipment shall be kept in an appropriate state of repair and
condition to:
- facilitate all sanitation procedures;
- function as intended, particularly at critical steps;
- prevent contamination of food, e.g. from metal shards, flaking plaster, debris and
chemicals.
4.1.1.2 Cleaning shall remove food residues and dirt that may be a source of
contamination. The necessary cleaning methods and materials will depend
on the nature of the food business. Disinfection may be necessary after
cleaning.
4.1.1.3 Cleaning chemicals shall be handled and used carefully and in accordance with
manufacturers’ instructions
4.1.1.4 Cleaning chemicals shall be stored, where necessary, separately from food, in
clearly identified containers to avoid the risk of (malicious or accidental) contamination
of food.
4.1.2 Cleaning 4.1.2.1 The cleaning and disinfecting method(s) shall be specified and documented. The
procedures and water used will comply with section 2.4.1. Contamination of food with cleaning chemicals
methods shall be prevented.
4.2 Cleaning programmes
4.2.1 Specifications 4.2.1.1 Cleaning and disinfection programmes shall ensure that all parts of the establishment
are appropriately clean, and shall include the cleaning of
cleaning equipment.
Where documented cleaning programmes are used, they shall specify:
- areas, items of equipment and utensils to be cleaned;
- responsibility for particular tasks;
- method and frequency of cleaning;
- monitoring arrangements.
Where appropriate, programmes shall be drawn up in consultation with relevant expert
advisors.
4.2.2 Monitoring and 4.2.2.1Cleaning and disinfection programmes shall be continually and effectively
verification monitored for their suitability and effectiveness and where necessary, documented.
4.3 Pest control
4.3.1 General 4.3.1.1 Good hygiene practices shall be employed to avoid creating an
environment conducive to pests. Good sanitation, inspection of incoming
materials and effective monitoring can minimise the likelihood of infestation
and thereby limit the need for pesticides.
4.3.2 Preventing 4.3.2.1 Buildings shall be kept in good repair and condition to prevent pest access and to
access eliminate potential breeding sites.

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4.3.2.2 Holes, drains and other places where pests are likely to gain access shall be kept
sealed. Where sealing is not possible (e.g. open windows, doors and ventilators)
measures like wire mesh screens shall be in place to reduce the problem of pest entry.
4.3.2.3 Animals shall, wherever possible, be excluded from the grounds of factories and
food processing plants.
4.3.3 Harbourage and4.3.3.1 Potential food sources shall be stored in pest-proof containers and/or stacked
infestation above the ground and away from walls.
4.3.3.2 Areas both inside and outside food premises shall be kept clean.
Where appropriate, refuse shall be stored in covered, pest-proof containers.
4.3.4 Monitoring and 4.3.4.1 Records of regular examination of establishments and surroundings shall be
detection available.
4.3.5 Eradication 4.3.5.1 Pest infestations shall be dealt with immediately and shall be carried out without
posing a threat to the safety or suitability of food.
4.4 Waste management
4.4.1 Removal, Suitable provision must be made for the removal and storage of waste.
storage Waste must not be allowed to accumulate in food handling, food storage,
and other working areas and the adjoining environment except so far as is
unavoidable for the proper functioning of the business.
4.4.2 Cleaning Waste stores must be kept appropriately clean.
4.5 Sanitation systems
4.5.1 Monitoring 4.5.1.1 Sanitation systems shall be monitored for effectiveness
4.5.2 Verification 4.5.2.1.Sanitation systems shall be periodically verified by inspections or, where appropriate,
by microbiological sampling of environment and food contact surfaces and regularly
reviewed and adapted to reflect changed circumstances.
4.5.3 Review 4.5.3.1 Sanitation systems shall be regularly reviewed and adapted to reflect changed
circumstances.
5 Establishment: personal hygiene
5.1 Health status
5.1.1 Access 5.1.1.1 A system shall be in place to prevent access to any food handling area by people
prevention known, or suspected to be suffering from, or to be a carrier of, a disease or illness likely
to be transmitted through food.
5.1.1.2 Any person so affected shall immediately report illness or symptoms of illness to
the management. Medical examination of a food handler shall be carried out if clinically
or epidemiologically necessary.
5.2 Illness and injuries
5.2.1 Conditions to be5.2.1.1 Conditions which shall be reported to management in order to assess the need for
reported medical examination and/or possible exclusion from food handling, include:
- jaundice
- diarrhoea
- vomiting
- fever
- sore throat with fever
- visibly infected skin lesions (boils, cuts, etc.)
- discharges from the ear, eye or nose
5.3 Personal cleanliness
5.3.1 Protective 5.3.1.1 Food handlers shall maintain a high degree of personal cleanliness and, where
clothing appropriate, wear suitable protective clothing, head covering and
footwear.
5.3.2 Cuts and wounds5.3.2.1 When personnel with a minor injury are permitted to continue working, cuts and
wounds shall be covered by suitable waterproof dressings.
5.3.3 Washing hands 5.3.3.1 Personnel shall always wash their hands when personal cleanliness may affect
food safety, for example:
at the start of food handling activities;
immediately after using the toilet;
after handling raw food or any contaminated material which could result in
contamination of other food items; they shall avoid handling ready-to-eat food, where
appropriate.
5.4 Personal behaviour

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5.4.1 Smoking, eating,5.4.1.1 People engaged in food handling activities shall refrain from behaviour which
sneezing could result in contamination of food, for example:
smoking;
spitting;
chewing or eating;
sneezing or coughing over unprotected food.
5.4.2 Jewellery 5.4.2.1 Personal effects such as jewellery, watches, pins or other items shall not be worn
or brought into food handling areas if they pose a threat to the safety and suitability of
food.
5.5 Visitors
5.5.1 Cleanliness and 5.5.1.1Visitors to food manufacturing, processing or handling areas shall, where
behaviour appropriate, wear protective clothing and adhere to the other personal
hygiene provisions in this section.
6 Transportation
6.1 General 6.1.1 Food shall be adequately protected during transport to assure food safety.
6.2 Requirements 6.2.1 Where necessary, conveyances and bulk containers shall be designed and
constructed so that they:
- do not contaminate foods or packaging;
- can be effectively cleaned and, where necessary, disinfected;
- permit effective separation of different foods or foods from non-food items where necessary
during transport;
- provide effective protection from contamination, including dust and fumes;
- can effectively maintain the temperature, humidity, atmosphere and other conditions
necessary to protect food from harmful or undesirable microbial growth and deterioration
likely to render it unsuitable for consumption;
- allow any necessary temperature, humidity and other conditions to be
checked.
6.3 Use and 6.3.1 Conveyances and containers for transporting food shall be kept in an appropriate state
maintenance of cleanliness, repair and condition.
6.3.2 Where the same conveyance or container is used for transporting different foods or
non-foods, effective cleaning and, where necessary, disinfection shall take place between
loads.
6.3.3 Where appropriate, particularly in bulk transport, containers and conveyances shall
be designated and marked for food use only and be used only for that purpose.
7 Product information and consumer awareness
7.1 Batch 7.1.1 Batch identification is essential in product recall and also helps effective stock
identification rotation (section 3.2.3). Each container of food shall be permanently marked to identify
the producer and the batch (see: Codex General Standard for the Labelling of Pre-
packaged Foods, Codex STAN 1-1985).
7.2 Product 7.2.1 All food products shall be accompanied by or bear adequate information to enable
information the next person in the food chain to handle, display, store, prepare and use the product
safely and correctly.
7.3 Labelling 7.3.1 Pre-packaged foods shall be labelled with clear instructions to enable the next
person in the food chain to handle, display, store and use the product
safely (see: Codex General Standard for the Labelling of Pre-packaged Foods, Codex
STAN 1-1985).
7.4 Consumer 7.4.1 Health education programmes shall cover general food hygiene. Such programmes
education shall enable consumers to understand the importance of any product information, follow
any instructions accompanying products and make informed choices. In particular,
consumers shall be informed of the relationship between time/temperature control and
food-borne illness.
8 Training
8.1 Awareness and 8.1.1 All personnel shall be aware of their role and responsibility in protecting food from
responsibilities contamination or deterioration.
8.1.2 Food handlers shall have the necessary knowledge and skills to enable them to
handle food hygienically. Those who handle strong cleaning chemicals or other
potentially hazardous chemicals shall be instructed in safe handling techniques.

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8.2 Training programs8.2.1 Factors to take into account in assessing the level of training required include:
- the nature of the food, in particular its ability to sustain growth of pathogenic or
spoilage micro-organisms;
- the manner in which the food is handled and packed, including the probability of
contamination;
- the extent and nature of processing or further preparation before final consumption;
- the conditions under which the food will be stored;
- the expected length of time before consumption.
8.3 Instruction and 8.3.1 Periodic assessments of the effectiveness of training and instruction programmes
supervision shall be carried out, as well as routine supervision and checks to ensure that procedures
are being implemented effectively.
8.3.2 Managers and supervisors of food processes shall have the necessary knowledge of
food hygiene principles and practices to be able to judge potential risks and take the
necessary action to remedy deficiencies (see section 3.5).
8.4 Refresher training8.4.1 Training programmes shall be routinely reviewed and updated where necessary.
8.4.2 Systems shall be in place to ensure that food handlers remain aware of all
procedures necessary to maintain the safety and suitability of food.

Phuï luïc II
Moái lieân heä giöõa “caùc yeâu caàu” vaø Höôùng daãn cuûa boä luaät aùp duïng HACCP
HACCP SYSTEM CODEX
REQUIREMENTS
5.1 Traùch nhieäm cuûa laõnh ñaïo 1. Thaønh laäp ñoäi HACCP
5.1.1 Chính saùch Hoaït ñoäng saûn xuaát thöïc phaåm neân ñaûm baûo raèng
5.1.2 Phaïm vi muïc ñích saûn phaåm rieâng veà hieåu bieát vaø kinh
5.1.3 Nhieäm vuï, Traùch nhieäm, Quyeàn nghieäm coù khaû naêng cho söï phaùt trieån coù hieäu quaû
haïn keá hoaïch HACCP. Toát nhaát vieäc naøy ñöôïc hoaøn
5.1.4 Ñoäi HACCP thaønh bôûi vieäc thaønh laäp nhoùm nhieàu chuyeân gia
5.1.5 Nguoàn löïc chuyeân moân khaùc nhau. ÔÛ nôi naøo khoâng coù kinh
5.1.6 Xem xeùt cuûa laõnh ñaïo nghieäm veà lónh vöïc naøy chuyeân gia tö vaán neân laáy töø
caùc nguoàn khaùc. Phaïm vi cuûa keá hoaïch HACCP phaûi
ñöôïc xaùc minh. Phaïm vi neân moâ taû töøng phaàn trong
daây chuyeàn thöïc phaåm lieân quan vaø nhöõng loaïi moái
nguy chung phaûi nhaéc ñeán
5.2 Thoâng tin saûn phaåm 2. Moâ taû saûn phaåm
5.2.1 Ñaëc tính saûn phaåm Moâ taû ñaày ñuû veà saûn phaåm phaûi veõ ra, bao goàm
5.2.2 Muïc ñích söû duïng thoâng tin an toaøn thích öùng nhö : thaønh phaàn caáu taïo,
caáu truùc lyù hoïc/hoaù hoïc (bao goàm Aw, pH…), lyù tính
(xöû lyù nhieät, ñoäng ñaëc, nöôùc muoái, khoùi…), ñoùng
goùi, ñoä beàn vaø ñieàu kieän baûo quaûn vaø phöông phaùp
phaân phoái.

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3. Xaùc ñònh muïc ñích söû duïng


Vieäc söû duïng coù muïc ñích ñoái vôùi saûn phaåm phaûi
döïa treân cô sôû mong ñôïi cuûa ngöôøi söû duïng hoaëc
khaùch haøng. Trong moät soá tröôøng hôïp ñaëc bieät,
nhoùm ngöôøi deã bò toån thöông nhö trung taâm dinh
döôõng, thì caàn phaûi ñöôïc quan taâm.
5.3 Thoâng ti quaù trình 4. Thieát laäp sô ñoà daây chuyeàn saûn xuaát
5.3.1 Sô doà daây chuyeàn saûn xuaát Sô ñoà tieán trình saûn xuaát phaûi do ñoäi HACCP thieát
5.3.2 Maët baèng laäp. Sô ñoà naøy phaûi bao goàm taát caû caùc böôùc trong
5.3.3 Kieåm soaùt / Thaåm tra thoâng tin quaù trình saûn xuaát cho saûn phaåm cuï theå. Khi öùng
quaù trình duïng HACCP cho moät hoaït ñoäng cuï theå, vaàn ñeà quan
taâm laø phaûi chuù troïng nhöõng böôùc tröôùc vaø sau hoaït
ñoäng cuï theå ñoù.

5. Kieåm tra thöïc teá sô ñoà daây chuyeàn saûn xuaát


Ñoäi HACCP phaûi xaùc nhaän caùc böôùc thöïc cuûa hoaït
ñoäng cheá bieán töông öùng vôùi sô ñoà tieán trình saûn
xuaát trong taát caû coâng ñoaïn, trong toaøn boä thôøi gian
hoaït ñoäng vaø ñieàu chænh sô ñoà tieán trình neáu thích
hôïp.
5.4 Chöông trình veä sinh tieân quyeát Öu tieân aùp duïng HACCP ñeán baát kyø boä phaän naøo
cuûa daây chuyeàn thöïc phaåm, boä phaän ñoù hoaït ñoäng
döïa vaøo Codex General Principles of Food Hygiene, thích
hôïp theâm Codex Codes of Practice vaø luaät ñònh veà an
toaøn thöïc phaåm.

Chaéc chaén seõ coù nhöõng tình huoáng maø moät vaøi yeâu
caàu veà veä sinh thöïc phaåm khoâng ñöôïc aùp duïng. Neàn
taûng cuûa caâu hoûi trong moãi tröôøng hôïp laø ‘ Caùi gì
caàn thieát vaø thích hôïp neàn taûng cho an toaøn vaø phuø
hôïp cho tieâu thuï thöïc phaåm?’ Trong vieäc quyeát ñònh
yeâu caàu naøo laø caàn thieát hoaëc thích hôïp, thieát laäp
ñaùnh giaù cho söï ruûi ro, toát nhaát laø vôùi boä khung cuûa
tieáp caän HACCP.
5.5 Phanâ tích moái nguy 6. Laäp danh saùch taát caû caùc moái nguy tieàm aån lieân
5.5.1 Xaùc ñònh moái nguy (moái nguy quan ñeán moãi böôùc, tieán haønh phaân tích moái nguy, vaø
tieàm aån) nghieân cöùu caùc bieän phaùp kieåm soaùt caùc moái nguy
5.5.2 Phaân tích HACCP (ruûi ro) ñaõ ñöôïc xaùc ñònh.
- Ñoäi HACCP phaûi laäp danh saùch taát caû caùc moái nguy
coù khaû naêng xaûy ra ôû moãi böôùc, töø khaâu xöû lyù ban
ñaàu, gia coâng, cheá bieán vaø phaân phoái tôùi ñieåm tieâu
thuï.
- Tieáp ñoù ñoäi HACCP phaûi tieán haønh phaân tích moái
nguy ñeå xaùc ñònh cho keá hoaïch HACCP, nhöõng moái
nguy naøo coù tính chaát ra sao ñeå khi loaïi boû hay giaûm
chuùng xuoáng tôùi möùc chaáp nhaän ñöôïc seõ coù yù
nghóa quan troïng cho saûn xuaát thöïc phaåm ñöôïc an toaøn.
Trong khi tieán haønh phaân tích moái nguy, baát cöù khi
naøo coù theå, caàn xem xeùt caùc yeáu toá sau ñaây:
- Khaû naêng xaûy ra caùc moái nguy vaø möùc ñoä
nghieâm troïng cuûa nhöõng taùc haïi cuûa chuùng aûnh
höôûng tôùi söùc khoeû con ngöôøi.
- Ñaùnh giaù ñònh tính vaø/hoaëc ñònh löôïng söï coù
maët cuûa caùc moái nguy.
- Söï soáng soùt hay phaùt trieån cuûa caùc vi sinh
vaät.
- Söï saûn sinh hay toàn taïi trong thöïc phaåm cuûa
caùc ñoäc toá, caùc taùc nhaân hoaù hoïc, vaät lyù.
- Caùc ñieàu kieän daãn ñeán nhö treân.
Ñoäi HACCP phaûi nghieân cöùu xem coù nhöõng bieän

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
phaùp kieåm soaùt naøo coù theå ñöôïc aùp duïng cho moãi
moái nguy. Coù theå caàn ñeán nhieàu bieän phaùp kieåm
soaùt ñeå kieåm soaùt moät moái nguy ñaëc hieäu, vaø nhieàu
moái nguy coù theå ñöôïc kieåm soaùt bôûi moät bieän phaùp
kieåm soaùt ñaëc hieäu.
5.6 Phöông phaùp kieåm soaùt 7. Xaùc ñònh ñieåm kieåm soaùt tôùi haïn
5.6.1 Phöông phaùp kieåm soaùt ñaëc bieät Coù theå coù nhieàu ñieåm kieåm soaùt tôùi haïn aùp duïng
(lieân quan tôùi CCP) lieân quan tôùi moät moái nguy.
5.6.2 Phöông phaùp kieåm soaùt chung Coù theå aùp duïng moát caùch quyeát ñònh bieåu ñoà hình
caây ñeå xaùc ñònh moät CCP trong heä thoáng HACCP, ñoù
laø moät caùch tieáp caän hôïp lyù. Caàn aùp duïng bieåu ñoà
quyeát ñònh hình caây moät caùch linh hoaït, tuyø theo thao
taùc hoaït ñoäng naøo trong saûn xuaát, nhö gieát moå, cheá
bieán, baûo quaûn, phaân phoái hay caùc vieäc khaùc. Caàn
duøng noù laøm chæ daãn ñeå xaùc ñònh caùc CCP. Thí duï
veõ bieåu ñoà quyeát ñònh hình caây naøy coù theå khoâng
aùp duïng cho taát caû moïi tình huoáng. Coù theå duøng caùc
caùch tieáp caän khaùc. Neân ñaøo taïo veà caùch aùp duïng
bieåu ñoà quyeát ñònh hình caây.
Khi xaùc ñònh ñöôïc moái nguy ôû moät böôùc cheá bieán nôi
caàn kieåm soaùt veà tính an toaøn cuûa saûn phaåm, vaø neáu
taïi böôùc ñoù hay taïi böôùc naøo khaùc ñaõ khoâng coù
bieän phaùp kieåm soaùt, thì luùc ñoù phaûi caûi tieán saûn
phaåm hay quaù trình taïi böôùc ñoù hay taïi böôùc tröôùc
hoaëc sau ñoù, ñeå ñöa vaøo bieän phaùp kieåm soaùt.
Töø khi aùp duïng caây quyeát ñònh cuûa Codex, noù ñöôïc
söû duïng hieäu quaû nhieàu laàn cho muïc ñích huaán luyeän.
Noù khoâng phaûi luoân luoân ñöôïc aùp duïng cho cho caùc
hoaït ñoäng cuûa thöïc phaåm vaø tröôùc ñoù noù ñöôïc söû
duïng lieân keát vôùi söï ñaùnh giaù chuyeân nghieäp vaø boå
sung khi caàn.

5.7 Thoâng soá vaø giôùi haïn 8. Laäp giôùi haïn tôùi haïn cho töøng CCP
5.7.1 Quaù trình troïng yeáu vaø thoâng
Neáu coù theå phaûi xaùc ñònh roõ vaø pheâ duyeät caùc giôùi
soá saûn phaåm
haïn tôùi haïn cho töøng ñieåm kieåm soaùt tôùi haïn. Trong
5.7.2 Giaù trò chæ tieâu, giaù trò hoaït
vaøi tröôøng hôïp, caàn thieát laäp nhieàu giôùi haïn tôùi haïn
ñoäng giôùi haïn, giôùi haïn troïng yeáu
cho moät böôùc cuï theå. Caùc tieâu chí thöôøng duøng bao
goàm caùc soá ño nhieät ñoä, thôøi gian, ñoä aåm, pH, löôïng
clo, vaø caùc thoâng soá caûm quan nhö hình daïng beà ngoaøi
vaø caáu truùc.
5.8 Giaùm saùt 9. Thieát laäp heä thoáng giaùm saùt cho moãi CCP
Giaùm saùt laø ño ñaïc hay quan saùt theo lòch trình caùc
thoâng soá cuûa CCP ñeå so saùnh chuùng vôùi caùc giôùi
haïn tôùi haïn cuûa noù. Caùc theå thöùc giaùm saùt phaûi ñuû
khaû naêng phaùt hieän CCP bò maát kieåm soaùt. Hôn nöõa,
toát nhaát vieäc giaùm saùt phaûi cung caáp thoâng tin naøy
ñuùng luùc ñeå hieäu chænh nhaèm ñaûm baûo kieåm soaùt
quaù trình, ngaên ngöøa vi phaïm caùc giôùi haïn tôùi haïn,
taïi nhöõng nôi coù theå, phaûi neâu caùc bieän phaùp hieäu
chænh khi caùc keát quaû giaùm saùt cho thaáy coù xu höôùng
maát kieåm soaùt taïi moät CCP. Phaûi hieäu chænh tröôùc khi
xaûy ra sai leäch.
Caùc döõ lieäu giaùm saùt ñöôïc phaûi do moät nhaân vieân
ñöôïc chæ ñònh, nhaân vieân naøy phaûi coù kieán thöùc vaø
coù quyeàn haïn ñaùnh giaù, ñeå coù theå tieán haønh caùc
söûa ñoåi khi caàn thieát. Neáu vieäc giaùm saùt khoâng lieân
tuïc, thì taàn suaát giaùm saùt caàn phaûi ñuû daøy ñeå ñaûm

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kieåm soaùt ñöôïc CCP.


Phaûi thöïc hieän nhanh choùng haàu heát caùc theå thöùc
giaùm saùt caùc CCP vì chuùng lieân quan ñeán caùc quaù
trình saûn xuaát ñang dieãn ra vaø seõ khoâng coù thôøi gian
ñeå tieán haønh caùc pheùp thöû phaân tích keùo daøi. Caùc
pheùp ño vaät lyù vaø hoaù hoïc thöôøng ñöôïc öa duøng hôn
so vôùi pheùp thöû vi sinh hoïc bôûi vì coù theå tieán haønh
thöû nhanh choùng vaø coù theå luaän chæ ra caùch kieåm
soaùt vi sinh cho saûn phaåm.
Moïi ghi cheùp vaø taøi lieäu lieân quan tôùi vieäc giaùm saùt
caùc CCP phaûi coù chöõ kyù cuûa ngöôøi thöïc hieän giaùm
saùt vaø cuûa ngöôøi chòu traùch nhieäm xem xeùt laïi cuûa
coâng ty.
5.9 Haønh ñoäng söõa chöõa 10. Thieát laäp haønh ñoäng söõa chöõa
Phaûi thieát laäp caùc haønh ñoäng khaéc phuïc cho töøng
CCP trong heä thoáng HACCP ñeå xöû lyù caùc sai leäch khi
chuùng xaûy ra. Caùc hoaït ñoäng phaûi ñaûm baûo laø CCP
ñaõ ñöôïc kieåm soaùt trôû laïi. Caùc hoaït ñoäng naøy phaûi
bao goàm caû vieäc söû duïng hôïp lyù caùc saûn phaåm bò
aûnh höôûng bôûi söï sai leäch. Söï sai leäch vaø caùc theå
thöùc söû duïng saûn phaåm phaûi coù ghi cheùp trong taøi
lieäu löu tröõ veà HACCP.
5.10 Kieåm tra xaùc nhaän giaù tri ban ñaàu
5.11Kieåm tra xaùc nhaän laïi 11. Thieát laäp caùc thuû tuïc kieåm tra xaùc nhaän
Thieát laäp caùc thuû tuïc kieåm tra xaùc nhaän. Coù theå
duøng caùc phöông phaùp kieåmtra xaùc nhaän vaø kieåm tra
ñaùnh giaù, caùc qui trình vaø caùc pheùp thöû nghieäm, bao
goàm vieäc laáy maãu ngaãu nhieân vaø phaân tích, coù theå
söû duïng ñeå xaùc ñònh heä thoáng HACCP coù laøm vieäc
toát khoâng. Taàn suaát kieåm tra xaùc nhaän caàn ñuû ñeå
khaúng ñònh laø heä thoáng HACCP ñang hoaït ñoäng hieäu
quaû.
Caùc ví duï veà caùc hoaït ñoäng kieåm tra xaùc nhaän bao
goàm :
- xem xeùt laïi heä thoáng HACCP cuøng hoà sô
ghi cheùp;
- xem xeùt laïi caùc sai leäch vaø caùc caùch söû
duïng saûn phaåm;
- khaúng ñònh laø caùc CCP ñang ñöôïc kieåm
soaùt.
Khi coù theå, hoaït ñoäng kieåm tra xaùc nhaän phaûi bao
goàm caùc hoaït ñoäng khaúng ñònh tính hieäu quaû cuûa taát
caû caùc yeáu toá cuûa keá hoaïch HACCP.
5.12 Taøi lieäu vaø hoà sô 12 Thieát laäp taøi lieäu vaø hoà sô :
5.12.1 Taøi lieäu, kieåm soaùt taøi lieäu Vieäc löu giöõ hoà sô coù hieäu quaû vaø chính xaùc ñoùng
5.12.2 Hoà sô vai troø quan troïng trong aùp duïng heä thoáng HACCP. Caùc
thuû tuïc HACCP phaûi ñöôïc ghi thaønh vaên baûn. Vieäc
laäp taøi lieäu vaø löu giöõ hoà sô phaûi phuø hôïp vôùi tính
chaát vaø qui moâ quaù trình hoaït ñoäng.
Caùc ví duï veà laäp taøi lieäu laø:
- phaân tích moái nguy;
- xaùc ñònh caùc CCP;
- xaùc ñònh caùc giôùi haïn tôùi haïn.
Caùc ví duï veà hoà sô laø :
- caùc hoaït ñoäng giaùm saùt CCP;
- caùc sai leäch vaø caùc haønh ñoäng khaéc phuïc
keøm theo;
- nhöõng söûa ñoåi veà heä thoáng HACCP.

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP

7 ANNEX II
Relationship between the “Requirements” and Codex guidelines for the application of HACCP

HACCP SYSTEM REQUIREMENTS CODEX

5.1 Responsibility of Management 1. Assemble HACCP team


5.1.1 Policy The food operation shall assure that the appropriate product
5.1.2 Scope specific knowledge and expertise is available for the
5.1.3 Task, Responsibility, Authority development of an effective HACCP plan. This may best be
5.1.4 HACCP team accomplished by assembling a multi-disciplinary team.
5.1.5 Resources Where such expertise is not available on site, expert advice
5.1.6 Management review shall be obtained from other sources.
The scope of the HACCP plan shall be identified. The scope
shall describe which segment of the food chain is involved
and the general classes of hazards to be addressed.

5.2 Product Information 2. Describe product


5.2.1 Product Characteristics A full description of the product shall be drawn up,
5.2.2 Intended use including relevant safety information such as: composition,
physical/chemical structure (including Aw, pH, etc.),
microcidal/static treatments (heat-treatment,
freezing, brining, smoking, etc.), packaging, durability and
storage conditions and method of distribution.

3. Identify intended use


The intended use shall be based on the expected uses of the
product by the end user or consumer. In specific cases,
vulnerable groups of the population, e.g. institutional
feeding, may have to be considered.

5.3 Process Information 4. Create flow diagram


5.3.1 Flow Diagrams The HACCP team shall create the flow diagram. The flow
5.3.2 Layout diagram shall cover all steps in the operation. When
5.3.3 Control / Verification of Process Information applying HACCP to a given operation, consideration shall
be given to steps preceding and following the specified
operation.

5. On-site confirmation of flow diagram


The HACCP team shall confirm the processing operation
against the flow diagram during all stages and hours of
operation and amend the flow diagram where appropriate.

5.4 Pre-Requisite Program (PRP) Prior to application of HACCP to any sector of the food
chain, that sector shall be operating according to the Codex
General Principles of Food Hygiene, the appropriate Codex
Codes of Practice and appropriate food safety legislation.

Inevitably, there will be situations where some of the food


hygiene requirements are not applicable. The fundamental
question in every case is “what is necessary and appropriate
on the grounds of the safety and suitability of food for
consumption?” In deciding whether a requirement is
necessary or appropriate, an assessment of the risk shall be
made, preferably within the framework of the HACCP
approach.

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Caùc yeâu caàu cô baûn cuûa Heä thoáng HACCP
5.5 Hazard Analysis 6. List all potential hazards associated with each step,
5.5.1 Hazard Identification (potential contaminants) conduct a hazard analysis, and consider any measures to
5.5.2 HACCP Analysis (risk) control identified hazards. The HACCP team shall list all
hazards which may reasonably be expected to occur at each
step, from primary production, processing, manufacture and
distribution until the point of consumption.

The HACCP team shall then conduct a hazard analysis to


identify for the HACCP plan which hazards are of such a
nature that their elimination or reduction to acceptable levels
is essential to the production of safe food.
In conducting the hazard analysis, the following shall be
included wherever possible:
the likely occurrence of hazards and severity of their adverse
health effects;
the qualitative and/or quantitative evaluation of the presence
of hazards;
survival or multiplication of micro-organisms of concern;
production or persistence in foods of toxins, chemicals or
physical agents;
conditions leading to the above.

The HACCP team must then consider what control measures


exist, if any, which can be applied to each hazard. More than
one control measure may be required to control a specific
hazard(s) and more than one hazard may be controlled by a
specified control measure.
5.6 Control Measures 7. Determine Critical Control Points
5.6.1 Specific Control Measures (CCP related) There may be more than one CCP at which control is
5.6.2 General Control Measures applied to address the same hazard.
The determination of a CCP in the HACCP system can be
facilitated by the application of a decision tree, which
promotes a logical reasoning approach. Application of a
decision tree should be flexible, whether the operation is for
production, slaughter, processing, storage, distribution, etc.
It should be used for guidance when determining CCP’s.
The decision tree example may not be applicable to all
situations. Other approaches may be used.
Training in the application of the decision tree is
recommended.
If a hazard has been identified at a step where control is
necessary for safety, and no control measure exists at that
step or any other, then the product or process shall be
modified at that step, or at any earlier or later stage, to
include a control measure.

Since the publication of the decision tree by Codex, its use


has been implemented many times for training purposes. It is
not always applicable to all food operations and therefore it
should be used in conjunction with professional judgement
and modified where appropriate.

5.8 Parameters and limits 8. Establish critical limits for each CCP
5.8.1 Critical process and product parameters Critical limits must be specified and validated, if possible,
5.8.2 Target values, action-limit values, critical for each Critical Control Point. In some cases more than one
limits critical limit will be elaborated at a particular step. Criteria
often used include measurements of temperature, time,
moisture level, pH, Aw, available chlorine, and sensory
parameters such as visual appearance and texture.

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5.8 Monitoring 9. Establish a monitoring system for each CCP
Monitoring is the scheduled measurement or observation of
a CCP relative to its critical limits. The monitoring
procedures must be able to detect loss of control at the CCP.
Furthermore, monitoring shall ideally provide this
information in time to make adjustments to ensure control of
the process is maintained to prevent violation of the critical
limits. Where possible, process adjustments shall be made
when monitoring results indicate a trend towards loss of
control at a CCP. These adjustments should be made before
a deviation occurs.
A designated suitably-qualified person must evaluate data
derived from monitoring and have authority to carry out
corrective actions when indicated. If monitoring is not
continuous, then the amount or frequency of monitoring
must be sufficient to guarantee the CCP is in control.
Most monitoring procedures for CCP’s will need to be done
rapidly because they relate to on-line processes and there
will not be time for lengthy analytical testing. Physical and
chemical measurements are often preferred to
microbiological testing because they may be done rapidly
and can often indicate the microbiological control of the
product.
All records and documents associated with monitoring
CCP’s must be signed by the person(s) doing the monitoring
and by a responsible reviewing official(s) of the company.

5.9 Corrective Actions 10. Establish corrective actions


Specific corrective actions must be developed for each CCP
in the HACCP system in order to deal with deviations when
they occur. The actions must ensure that the CCP has been
brought under control. Actions taken must also include
proper disposal of the affected product. Deviation and
product disposal procedures must be documented in the
HACCP records.

5.10 Validation
5.11 Verification 11. Establish verification procedures
Establish procedures for verification. Verification and
auditing methods, procedures and tests, including random
sampling and analysis, can be used to determine if the
HACCP system is working correctly. The frequency of
verification shall be sufficient to confirm that the HACCP
system is working effectively. Examples of verification
activities include:
Review of the HACCP system and its records;
Review of deviations and product disposal;
Confirmation that CCP’s are kept under control.
Where possible, validation activities shall include actions to
confirm the efficacy of all elements of the HACCP plan.

5.12 Documentation and Records 12 Establish Documentation and Records:


5.12.1 Documents, Document Control Efficient and accurate record-keeping is essential to the
5.12.2 Records application of a HACCP system. HACCP procedures shall
be documented. Documentation and record-keeping shall be
appropriate to the nature and size of the operation.
Documentation examples are:
Hazard analysis
CCP determination
Critical limit determination

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Record examples are:
CCP monitoring activities
Deviations and associated corrective actions
Modifications of the HACCP system

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