초록 ▼

주요 연구개발 내용 및 범위는 다음과 같다.
1. 정량적 위해평가(QRA) 방법론 개발
○ 식품제조공정에서의 QRA활용을 위한 방법론 개발
○ 대상식품별 미생물학적, 화학적 위해요소에 대한 QRA 활용
○ HACCP System에서의 QRA 활용
2. QRA-HACCP 매뉴얼 제시
○ 유제품에 대한 Hazard Identification
○ QRA를 활용한 품목별 HACCP System 개발
○ 대상 식품별 QRA-HACCP 매뉴얼 작성
3. QRA-HACCP 정보시스템 구축용 모델

주요 연구개발 내용 및 범위는 다음과 같다.
1. 정량적 위해평가(QRA) 방법론 개발
○ 식품제조공정에서의 QRA활용을 위한 방법론 개발
○ 대상식품별 미생물학적, 화학적 위해요소에 대한 QRA 활용
○ HACCP System에서의 QRA 활용
2. QRA-HACCP 매뉴얼 제시
○ 유제품에 대한 Hazard Identification
○ QRA를 활용한 품목별 HACCP System 개발
○ 대상 식품별 QRA-HACCP 매뉴얼 작성
3. QRA-HACCP 정보시스템 구축용 모델 개발
○ HACCP 정보화 관련 자료수집 및 요구조사 분석
○ HACCP 실시단계, 항목의 그룹화 및 주요문서의 표준화
○ 데이타 모델링
○ HACCP 정보시스템 구축을 위한 모델 제시

Abstract ▼

Hazard Analysis Critical Control Point(HACCP) system is recognized worldwide as a most effective and scientific control system for food safety, And it became a mandatorily required tool for guarantee of food safety in the international food trades under the WTO rule.
However, application of HACCP

Hazard Analysis Critical Control Point(HACCP) system is recognized worldwide as a most effective and scientific control system for food safety, And it became a mandatorily required tool for guarantee of food safety in the international food trades under the WTO rule.
However, application of HACCP system in food industries has disclosed technical problems, Most of the information obtainedthrough hazard analysis was a qualitative data, which was not fit for determination of critical control points and for estabilishiment of critical limits.
To get quantitative information, the elements of Quantitative Risk Assessment (QRA) need to be applied to HACCP system QRA is recognized by risk not hazard for food safety control, and analysed by quantitative measure. To minimize the uncertainty and variability of risks, simulation method is used for QRA approach. QRA is composed of four steps; hazard identification, exposure assessment, dose-response assessment, and risk characterization. The result data from QRA shows the estimation of the probability of occurrence of adverse effects on health following consumption of the food in question.
Using QRA in conjuction with HACCP system will help make more explicit the outcome of HACCP. QRA provides a way of establishing the relationship between building safety in to the product, and process control setting on a quantitatives basis.
This study was to develop HACCP system model for the processed milk, dried milk, and ice-cream plants in order to activate HACCP application in the food industries.
Especially QRA approach was adopted for microbiological and chemical hazard analysis to get more scientific evidences for decision of critical control points in plants.
This study could be categorized by three parts (1) development of simulation model for basic QRA implementation, (2) development of QRA-HACCP manual for the processed milk, dried milk, and ice-cream plants, (3) development of HACCP information system. Theses models would contribute to the HACCP activation in industries and achieve stabilization leading to and acceptable and safety food product, The results are summarized as follows.
(1) We suggested QRA simulation model applicable for HACCP system to verify CCPs and establish CLs as a quantitative approach, and described how control criteria could be specified in the HACCP system. This was based on identification of potentially hazardous organisms and of information on the numbers present in raw materials used in food processing.
(2) Hazard identification for dairy products was carried out through reference review and biological and chemical laboratory analysis, Information on hazardous materials related with dairy products was arranged and summarized to the hazard database through the data collection using science and technology database of the Korea Institute of Science and Technology Information(KINTI) and reference hazard database from Guelph Food Technology Centre in Canada Biological, chemical, and physical hazards were classified by incoming materials and process steps. And for the laboratory examination we used Listeris monocytogenes, Salmonella spp. and E. coli as a major microbial hazard factor, and Aflatoxin M1 as a chemical hazard factor.
(3) Estimation of risks using QRA simulation model in each products showed very low level of risk. Risk level of dried milk was evaluated relatively higher than that of processed milk or ice-cream.
(4) Hazard index for the hazard analysis was suggested as Hazard Index(HI) - Sensitivity level Severity level. Sensitivity analysis tree with science-based evidence. And also scenario analysis was pllied for cirtical limit decision. Time-temperature critical limit for ice-cream process step was 79.4℃/30sec for steilization, and for processed milk 74.3℃/10sec in case of HTST. The critical limit for dried milk in storage temperature before sterilization 5℃/24sec.
(5) QRA-HACCP manual, which comprises CCP and critical limit decision using QRA, QRA-HACCP plan, and principles of general sanitation operating procesures, was prepared as a comprehensive output of this study.
(6) To develop the HACCP information system HACCP system was analysed by pre-process, main process, and post-process steps, and designed for information system by linking between information and several outcome data during processing, and reproduced with conceptional database through conbination of major process steps, and calculating correlations among QRA-HACCP information system.
QRA still has lots of waak points due to the lack of reliable data. However, if more scientific and practical data are available, QRA can be more accurate and practical tool for the food safety assurance. To reduce the uncertainty and variability, the development of simulation model should be further studied through applying more practical data.

목차 Contents

• 최종보고서 ...1
• 표지 ...2
• 제출문 ...3
• 차례 ...4
• 표차례 ...8
• 그림차례 ...14
• 요약문 ...22
• SUMMARY ...27
• CONTENTS ...30
• 제1장 서론 ...34
• 제1절 연구개발의 필요성 ...34
• 제2절 연구개발의 목표 ...36
• 제3절 연구개발내용 ...36
• 1. Hazard Identification 및 HACCP 정보시스템 구축용 모델 개발(제1세부) ...36
• 2. 정량적 위해핑가(QRA) 방법론 개발 및 HACCP 매뉴얼 제시(제2세부) ...37
• 3. 미생물학적 위해요소 분석 및 허용한계치 설정(협동) ...38
• 제2장 정량적 위해평가방법론의 개발 ...39
• 제1절 서론 ...39
• 제2절 정량적 위해핑가(QRA)의 기본이론 ...41
• 1. QRA의 정의 ...41
• 2. QRA 구성요소 ...45
• 3. QRA 최근 연구동향 ...52
• 4. 현제까지의 QRA에 대한 검토 ...54
• 제3절 정량적위해평가방법론 개발 ...56
• 1. 기본활용체계 ...56
• 2. Hazard Identification ...56
• 3. Exposure Assessment ...61
• 4. Dose-response Assessment ...66
• 5. Simulation Model 개발 ...66
• 제3장 유제품에 대한 Hazard Identification ...68
• 제1절 유제품에 대한 Hazard factors ...68
• 1. 원부재료 위해요소 ...68
• 2. 제조공정단계에서의 위해요소 ...70
• 제2절 국내 유제품에서의 병원성 미생물 발생 동향 ...73
• 제3절 제외국의 유제품에서의 병원성 미생물 발생 동향 ...78
• 제4절 위해요소 결정 ...80
• 1. 미생물학적 위해요소 ...80
• 2. 화학적 위해요소 ...81
• 제5절 미생물학적 위해요소분석 ...83
• 1. 재료 및 방법 ...83
• 2. 품목별 위해요소 분석 ...85
• 제6절 화학적 위해요소 분석 ...93
• 1. 국내 Aflatoxin Ml의 오염수준 ...93
• 제4장 정량적위해평가 방법의 활용 ...98
• 제1절 미생물학적 위해요소에 대한 QRA의 활용 ...98
• 1. 아이스크림 ...98
• 2. 가공유 ...155
• 3. 탈지분유 ...188
• 제2절 화학적 위혜요소에 대한 QRA의 활용(유제품에서의 Aflatoxin M1 발생 추정) ...209
• 1. Aflatoxin의 위해성 ...209
• 2. QRA 방법을 이용한 Aflatoxin M1 발생추정 ...210
• 제3절 QRA모델에 대한 검중 ...215
• 1. 개발된 QRA모델에 대한 검증 및 한계점 ...215
• 2. QRA 방법 개발을 위한 제언 ...218
• 제5장 HACCP System에서의 QRA의 활용 ...220
• 제1절 현행 HACCP 시스템에서 도출되는 문제점 ...220
• 제2절 QRA결과를 활용한 HACCP 시스템의 보완 ...223
• 1. QRA의 활용을 위한 기본이론 ...223
• 2. 위해요소분석에서의 활용 ...225
• 3. 중요관리점(CCP) 및 허용한계치(CL) 분석에서의 활용 ...239
• 4. Predictive Food Microbiology Model을 이용한 HACCP 시스템 보완 ...252
• 제6장 QRA를 활용한 품목별 HACCP System 개발 ...265
• 제1절 QRA-HACCP plan ...265
• 1. QRA-HACCP plan 기본원칙 ...265
• 2. 일반위생관리기준 기본원칙 ...298
• 제2절 품목별 QRA-HACCCP 일반모델 ...303
• 1. 아이스크림제품에 대한 QRA-HACCP 모델 ...303
• 2. 가공유제품에 대한 QRA-HACCP 모델 ...321
• 3. 탈지분유제품에 대한 QRA-HACCP 모델 ...330
• 제7장 QRA-HACCP 정보시스템 구축용 모델 개발 ...334
• 제1절 서론 ...334
• 제2절 HACCP정보화관련 자료수집 및 요구조사 분석 ...335
• 1. 기초 자료 조사 ...335
• 2. 사용자요구분석 ...349
• 제3절 HACCP 항목의 그룹화 및 주요문서의 정형화 ...353
• 1. HACCP 실시단계 ...353
• 2. 문서, 항목 emd의 분석 등 ...357
• 제4절 데이터 모델링 ...387
• 1. ASP(Application Service Provider) 소개 ...387
• 2. 프로세스(업무주제) 모델링 ...393
• 3. HACCP 시스템의 데이터모델링 ...417
• 제5절 HACCP 정보시스템 구축을 위한 모델 제시 ...420
• 1. HACCP 정보시스템 배경 ...420
• 2. HACCP 정보시스템 구성 ...421
• 3. 개발환경 정의 ...422
• 4. 제공기능 ...423
• 5. 결론 ...424
• 제8장 결론 및 요약 ...425
• 1) 정량적 위해평가 방법론(QRA)의 개발...426
• 2) 유제품에 대한 Hazard Identification...427
• 3) 정량적 위해평가 방법의 활용...427
• 4) HACCP 시스템에서의 QRA 활용...428
• 5) QRA를 활용한 품목별 HACCP 시스템 개발...430
• 6) QRA-HACCP 정보시스템 구축 모델 개발...430
• 참고문헌 ...431