HACCP

HACCP Principles & Application Guidelines

NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA) and comprised of participants from the USDA (Food Safety and Inspection Service), Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention) the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry and state employees. NACMCF provides guidance and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services regarding the microbiological safety of foods.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

DEFINITIONS

HACCP PRINCIPLES

GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES

Introduction

Prerequisite Programs

Education and Training

Developing a HACCP Plan

Assemble the HACCP team

Describe the food and its distribution

Describe the intended use and consumers of the food

Develop a flow diagram which describes the process

Verify the flow diagram

Conduct a hazard analysis (Principle 1)

Determine critical control points (CCPs) (Principle 2)

Establish critical limits (Principle 3)

Establish monitoring procedures (Principle 4)

Establish corrective actions (Principle 5)

Establish verification procedures (Principle 6)

Establish record-keeping and documentation procedures (Principle 7)

IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN

APPENDIX A – Examples of common prerequisite programs

APPENDIX B – Example of a flow diagram for the production of frozen cooked beef patties.

APPENDIX C – Examples of questions to be considered when conducting a hazard analysis

APPENDIX D – Examples of how the stages of hazard analysis are used to identify and evaluate hazards

APPENDIX E – Example I of a CCP decision tree

APPENDIX F – Example II of a CCP decision tree

APPENDIX G – Examples of verification activities

APPENDIX H – Examples of HACCP records

EXECUTIVE SUMMARY
The National Advisory Committee on Microbiological Criteria for Foods (Committee) reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995. The primary goal was to review the Committee’s November 1992 HACCP document, comparing it to current HACCP guidance prepared by the Codex Committee on Food Hygiene. Based upon its review, the Committee made the HACCP principles more concise; revised and added definitions; included sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HACCP principles; and provided an additional decision tree for identifying critical control points (CCPs).

The Committee again endorses HACCP as an effective and rational means of assuring food safety from harvest to consumption. Preventing problems from occurring is the paramount goal underlying any HACCP system. Seven basic principles are employed in the development of HACCP plans that meet the stated goal. These principles include hazard analysis, CCP identification, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record-keeping and documentation. Under such systems, if a deviation occurs indicating that control has been lost, the deviation is detected and appropriate steps are taken to reestablish control in a timely manner to assure that potentially hazardous products do not reach the consumer.

In the application of HACCP, the use of microbiological testing is seldom an effective means of monitoring CCPs because of the time required to obtain results. In most instances, monitoring of CCPs can best be accomplished through the use of physical and chemical tests, and through visual observations. Microbiological criteria do, however, play a role in verifying that the overall HACCP system is working.

The Committee believes that the HACCP principles should be standardized to provide uniformity in training and applying the HACCP system by industry and government. In accordance with the National Academy of Sciences recommendation, the HACCP system must be developed by each food establishment and tailored to its individual product, processing and distribution conditions.

In keeping with the Committee’s charge to provide recommendations to its sponsoring agencies regarding microbiological food safety issues, this document focuses on this area. The Committee recognizes that in order to assure food safety, properly designed HACCP systems must also consider chemical and physical hazards in addition to other biological hazards.

For a successful HACCP program to be properly implemented, management must be committed to a HACCP approach. A commitment by management will indicate an awareness of the benefits and costs of HACCP and include education and training of employees. Benefits, in addition to enhanced assurance of food safety, are better use of resources and timely response to problems.

The Committee designed this document to guide the food industry and advise its sponsoring agencies in the implementation of HACCP systems.

DEFINITIONS
CCP Decision Tree: A sequence of questions to assist in determining whether a control point is a CCP.

Control: (a) To manage the conditions of an operation to maintain compliance with established criteria. (b) The state where correct procedures are being followed and criteria are being met.

Control Measure: Any action or activity that can be used to prevent, eliminate or reduce a significant hazard.

Control Point: Any step at which biological, chemical, or physical factors can be controlled.

Corrective Action: Procedures followed when a deviation occurs.

Criterion: A requirement on which a judgement or decision can be based.

Critical Control Point: A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical Limit: A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard.

Deviation: Failure to meet a critical limit.

HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards.

HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

HACCP System: The result of the implementation of the HACCP Plan.

HACCP Team: The group of people who are responsible for developing, implementing and maintaining the HACCP system.

Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.

Monitor: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.

Prerequisite Programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.

Severity: The seriousness of the effect(s) of a hazard.

Step: A point, procedure, operation or stage in the food system from primary production to final consumption.

Validation: That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.Verification: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

HACCP PRINCIPLES
HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:

Principle 1: Conduct a hazard analysis.

Principle 2: Determine the critical control points (CCPs).

Principle 3: Establish critical limits.

Principle 4: Establish monitoring procedures.

Principle 5: Establish corrective actions.

Principle 6: Establish verification procedures.

Principle 7: Establish record-keeping and documentation procedures.

危害分析和關鍵控制點

HACCP (Hazard Analysis and Critical Control Points 危害分析和關鍵控制點)是一種科學、理性、有系統的方法，用來識別、評審及控制在生產、處理、製造、準備以及食物使用中的危害，以確保食物食用時的安全。這套體系是用來識別在食物生產過程中可能產生危害的地方，並加以控制以預防產生危害。

飲食行業和監督機構都是依靠在生產過程中抽檢或對成品的隨機抽樣來確保食品的安全，這種模式較為被動，而不是主動預防，這形成了對一個世界公認和進取的食物安全控制管理體系，以及評審機制的需求。

美國、澳洲和新加坡等地，已經成功將HACCP (Hazard Analysis and Critical Control Points危害分析和關鍵控制點)系統與廣為人知的品質管理體系標準ISO 9001整合採用，國際標準化組織(ISO) 並特此開發了ISO 15161 – 飲食行業推行ISO9001應用指南，這反映了全球的食物加工設備和飲食服務業界對單一國際性的食物安全和品質的管理體系的渴求。

認證計劃

香港品質保證局的HACCP認證計劃建基於Codex的”HACCP System and Guidelines”及”Recommended International Code of Practice General Principles of Food Hygiene”兩項最被廣泛認可的食物安全體系指引。在建立HACCP體系前，HACCP小組需先行執行一個前期計劃以鑑定每個程序上可能出現的潛在危害，定下關鍵控制點，再加上一套有效的監察系統並執行適當的糾正措施以確保不安全的產品已被識別及隔離。推行HACCP系統體現了食物製造商對提供安全食品予顧客的決心。

HACCP七項主要功能

1. 進行危害分析
2. 識別重點控制項目 (CCPs)
3. 為每一CCPs制定控制極限
4. 監控CCPs的要求和建立控制過程
5. 制定糾正措施
6. 建立文件的程序
7. 建立体系验证的程序

認證的效益

· 內部過程的改進
· 通過定期審核維持體系及與符合法規要求減少責任的發生
· 加強買家的信心
· 減少顧客審核的次數
· 為企業加強競爭優勢
· 提供企業形象
· 建立體系驗證的程序

香港近年因本地製造的食物品質欠佳或處理不當而發生的食物事故屢見不鮮例如壽司被檢出李斯特菌；預先包裝中式湯品含蠟樣芽胞桿菌；午餐飯盒懷疑受產氣莢膜梭狀芽孢桿菌和蠟樣芽胞桿菌污染而引致食物中毒等事件不勝枚舉。這些食物事故能夠避免嗎？實施＂食物安全重點控制＂(HACCP) 系統能夠減少這些事故發生嗎？本文將介紹HACCP如何為食物安全把關。

什麼是HACCP？

“食物安全重點控制”是一套針對食物製造過程的安全管理系統，英文簡稱為HACCP。HACCP的起源可追溯至1960年代，最初是為了美國太空發展計劃而研發的，控制重點的概念在當時首次被提出並應用於生產安全和零污染的太空食品。自1970年代起，多個規模較大的食物製造商相繼把HACCP應用於生產普羅大眾的食物。1990年代，世界衞生組織和食品法典委員會等國際機構一致認為HACCP系統是預防食物中出現物理、化學和微生物危害的最有效系統。過去數十年，某些已發展國家已強制要求一些食品的生產過程實施HACCP。目前美國法例規定肉類和家禽、水產和果汁產品製造商須強制實施HACCP，加拿大也規定聯邦註冊的肉類和家禽加工廠須實施HACCP，而澳洲則要求一些高風險食物業者執行以HACCP為基礎的食物安全計劃。

HACCP系統–符合成本效益的方法
HACCP系統通過科學和有系統的方法，識別、評估及控制食物製造過程中(由選購、收貨、運輸、貯存、配製、處理、烹煮以至食用)各種可能產生的危害。HACCP系統把食物安全管制融合在食物製造過程的每個環節中，著重積極預防，而不是單靠對製成品的檢測來保證食物安全。因此，HACCP系統在保證食物安全方面極具成本效益，長遠可節省不少成本。業界可能因推行HACCP系統的資金問題而卻步，其實只要優先在高風險食物的生產過程實施，其餘則逐步分段量力施行，便可分攤成本，循序漸進地完善系統。

HACCP系統的原理
HACCP系統的原理是找出可能產生的具體危害，並訂立相應的控制方法，從而確保食物達至安全標準。由生產以至消費者食用整個食物鏈中，各個環節都可應用HACCP系統。HACCP公認有七項原則：

分析危害：找出所有潛在的生物、化學或物理危害，以便擬定控制措施；
確定控制重點：確定食物製造過程中可以控制的關鍵環節，以便採取有效的糾正措施，預防、消除危害或把危害降低到可接受的水平；
訂定每個控制重點的監控標準：以危害的程度為可接受而不至於影響食物安全為標準；
設立控制重點的監察程序：通過觀察及量度工作，以及存備準確的紀錄來評估控制重點是否受到控制；
制定矯正程序：當控制重點的監控結果顯示未能達標或失控時，便須立刻採取矯正行動；
制定確認程序：採用各種方法、程序、測試、採樣及其他評估方式，以確定HACCP系統運作良好；
設立紀錄系統：作為有效執行HACCP系統的證明。紀錄應包括監察及確認工作的結果，以及控制重點出問題時的矯正行動等。
推行HACCP系統對食物業的好處
推行HACCP系統對消費者、食物業和政府三方均有好處。患食源性疾病的風險減低，公眾的健康更有保障。食品的品質穩定可增強消費者對產品的信心。HACCP系統可以減少回收和浪費食物，亦可提高進入市場的機會，故省卻不少成本，利潤得以提高。由於營運風險降低，法律和保險費用亦隨之減少。食物業要推行HACCP系統，推行的人員(廠方人員或借助HACCP認證機構等外界人員)必須對產品有深入的認識和具備有關的專業知識，才能建立一套行之有效的HACCP系統。下期我們會再深入探討如何推行HACCP系統。