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1、1,HACCP System Frame (I)Winston Gao,Outline,Highlights of HACCP Summary of HACCP Position of HACCP Outreach of HACCP Relationship between HACCP, GMP High risk foods: meat/fish, dairy, RTE produce Role: industry- control / compliance, government inspection / verification / enforcement, consumer/hande

2、r education / awareness / precaution Control policy: sampling/testing - non food contact surface, FCS, end product,5,6,Microbiological Results Improving Salmonella Prevalence in US meat/poultry after HACCP implementation in USA,3.8% 4.29% 5.03% 5.31% 7.26% 10.65,2003 2002 2001 2000 1999 1998,7,What

3、is HACCP,Hazard Analysis Critical Control Point,8,Definition of HACCP,HACCP A systematic approach to identifying and assessing hazards and risks associated with a food operation and defining the means of their control. (CFIAs FSEP) Codex:HACCP System and Application Principle- a system which identif

4、ies, evaluates and controls hazards which are significant for food safety NACMCF USA 1997 In my view, HACCP - an internationally recognized, science-based, structured, preventive food safety control system designed to prevent, eliminate or reduce potential biological, chemical or physical hazards, i

5、ncluding those caused by cross-contamination,9,Food Safety Hazard,A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that is will occur in the par

6、ticular type of product being processed, in the absence of those controls.” Hazard: a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect HACCP Advantage Program (OMAFRA) Hazard: A condition or circumstance having the potential to cau

7、se harm. Hazards can be biological, chemical or physical (CFIAs FSEP,Hazard Type,Physical: Chemical: Biological,Physical Hazards,wood Glass Metal Plastic Insect Choking others,Chemical Hazards,Pesticide Vet drug Restrict additive Processing chemicals Agricultural chemicals Environmental chemicals (i

8、.e. heavy metals) Others,Biological Hazards,Bacteria Fungi Viruses Prions Parasites Others,Canadas 10 Least Wanted Foodborne Pathogens,Bacteria: Campylobacter jejuni, Clostridium botulinum, E. coli O157:H7, Listeria monocytogenes, Salmonella, Shigella, Vibrio Viruses: hepatitis A and norovirus Paras

9、ites: Cyclospora,Chinas 10 Least Wanted Foodborne Pathogens(J. Xue / W. Zhang 2013,Vibrio parahemolyticus Salmonella Proteusbacillus vulgaris Bacillus cereus Staphylococcus,Escherichia coli Shigella Clostridium botulinum Vibrio alginolyticus Aeromonas,15,Escherichia coli Shigella Clostridium botulin

10、um Vibrio alginolyticus Aeromonas,Pathogenesis of Foodborne Pathogens,Regular: more expose, more severe symptoms; Bio-toxin: E. Coli O157:H7 (beef) kidney failure, Clostridium botulinum (canned foods) very low dose, some fungi biotoxin-producing Prion: BSE, sheep scrapie Specific Risk Materials (was

11、te brain tissue) incorporated into human nerve system,17,Development Stages of HACCP,Started for US Aircraft Foods at 1960s,EUHACCP Directive in 1993,HACCP regs initiated in USA biological, chemical and physical hazard data collected during normal operating conditions; statistically designed surveys

12、 or mathematical modelling use of a guide approved by competent authorities,49,Validation,Example: Burgers cooking on restaurant grill - Product risks . What are the relevant pathogens? Typical load levels? . Minimum temperature to kill pathogens? - process capability . Variation in the ability to c

13、ook e.g. temperature, fat content and size of burgers, temperature across grill, operator variability,50,Verification Validation,Verification Do what we say, say what we do. Confirming that it is working,Validation It this the right thing to do? Says it will work,Literature,Our plans,Our plans,Our a

14、ctivities,Verification and validation,When to Validate/Revalidate,Validation performed at CCP design or control measure setup for food safety related prerequisite program bullets; Validation performed prior to full implementation of HACCP program; Revalidation performed at any major changes: product

15、s, process, critical equipments, etc,Maintenance of HACCP System,When: any change or situation that could affect hazard analysis or alter HACCP system; What: 1) reassess completeness and effectiveness; 2) revalidate CCP or critical bullets Who: HACCP Coordinator, consultation, QA Manager, etc Trigge

16、rs: new regulatory requirements, new product/process, food recall, customer complaint, new formulation, new equipments, unsatisfactory lab results, etc,Reassessment of HACCP system,When: at least annually reassess the entire HACCP system Frequency: not before audit or at the end of or beginning of t

17、he year, should be done at various times over the course of the year What: written program review, record review, onsite observation and assessment, interview,55,Apply Statistical Process Control to HACCP Studies (I,Determine Monitoring Frequencies, Critical Limits and CCPs A Case Study - pH of Acid

18、ified Sauce - C.L. Maximum pH 4.6 (assuming Aw.85) - Calculated Average = 4.3 - Standard Deviation (S.D.) = .08 - +/- 3 S.D. = 4.06 4.54 - Ensure upper limit 4.54 Max limit 4.6 So what is critical limit in specific procssing facility, 4.6 or 4.3,Apply Statistical Process Control to HACCP Studies (II

19、,Determine Critical Limit A Case Study Chicken Wing Frying - Regulatory Limit 82C - Under specific processing situation: - Average frying temp: 84C - Standard deviation (SD): 0.5C - +/- 3 SD: 82.5 85.5C Ensure lower temp limit regulatory limit So Critical Limit should be 84C or 82C,57,HACCP PLAN CAS

20、ES,Poultry processing 1) raw poultry Physical (metal, bone)/quality (foreign material, bone, feather, etc) 2) RTE poultry physical (metal, bone)/bacterial (temp, MAP)/chemical (allergen, formula, label) Salad manufacturing physical (metal)/bacterial (temp, preservative) / chemical (formula, allergen

21、/label) Pasta manufacturing Physical (metal)/bacterial (temp. preservative, MAP)/chemical (allergen, formula, label,What is HACCP again,A set of guidelines to guide production of safe/quality product Defined by Codex with 12 steps (HACCP method/methodology) Can be applied across all stages of food c

22、ontinuum Being applied by other consumer product sectors Only Food Safety Control Tool,58,59,Technology of HACCP,HACCP is control and management over technological factors Different from ISO9000 Technology of HACCP and technological requirements for HACCP team members Technical support of HACCP appl

23、ication is prerequisite and crucial Hazard analysis CCP Establishment of CL HACCP verification,60,HACCP,Hygiene,Risk,Poor hygiene,Hygiene required,Over hygiene control,Acceptable level,What does HACCP do,61,HACCP is not a zero risk control system, only a system that reduces food safety hazard to an

24、acceptable level and to improve continuously,62,Application of HACCP Concept,1) Application in food industry Formulate GMP HACCP plan GMP/SSOP/HACCP GHP、GAP、GVP HACCP regulation 2) Application in other industry Packaging industry: PACsecure HACCP-based standard Auto industry,63,Relationship between

25、GMP and HACCP,Basic generic requirements for hygiene,Specific safety parameters,Good manufacturing practice (GMP,Safety based on application of risk assessment and control,Standard operating procedures (SOP,HACCP plan and documentation,64,HACCP,GMP (GHP,ISO,Voluntary,Mandatory,Resource: EU Food Safe

26、ty Audio Material,Mandatory,65,Quiz: Your HACCP Knowledge (True or False,HACCP is a quality control system. HACCP is a government-implemented program. HACCP is maintenance free after implementation, you just need to do the initial paperwork and implement the system, and you can become certified. HAC

27、CP controls all hazards and is the solution to every problem. HACCP is for food manufacturing facilities only. HACCP presents the same obstacles for all companies. HACCP applies only to certain commodities HACCP can apply to all commodity groups, manufacturing types and all stages of food continuum,

28、66,Quiz,1. Basic concepts: food safety, food quality, food security/defence, food hygiene, food suitability, GMP, GHP, GVP, GAP, SOP, SSOP, ISO, FSEP, HACCP (System or Program), HACCP Principles, HACCP procedure, HACCP concept, HACCP plan, HACCP auditing, HACCP certification, Food Safety, Food Safety Recall, Food Safety Management System, CCP, Process

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