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Diff Sim HA RA 1 Differences and similarities between HACCP and Risk Analysis Mike van Schothorst.

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Presentation on theme: "Diff Sim HA RA 1 Differences and similarities between HACCP and Risk Analysis Mike van Schothorst."— Presentation transcript:

1 Diff Sim HA RA 1 Differences and similarities between HACCP and Risk Analysis Mike van Schothorst

2 Diff Sim HA RA 2 Terminology

3 Diff Sim HA RA 3 CommunicationCommunication HazardRisk Safety HACCP Hazard Analysis / Risk Analysis ALOPFSO MRA MRM

4 Diff Sim HA RA 4 HazardHazard A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect Codex Alimentarius, 1997

5 Diff Sim HA RA 5 RiskRisk A function of the probability of an adverse health effect and the severity of that effect consequential to a hazard in food

6 Diff Sim HA RA 6 Risk Analysis A regulatory tool to maintain or enhance the supply of safe food, both locally produced and imported, in a certain country It is not only an analysis, it includes also risk management

7 Diff Sim HA RA 7 Risk Analysis Risk Communication Microbiological Risk Assessment Microbiological Risk Management Policy based Science based Interactive exchange of information and opinions concerning risks and control measures MRA MRM

8 Diff Sim HA RA 8 Risk Analysis and HACCP identification quantification decision control review GovernmentGovernment IndustryIndustry HACCPHACCP Assessment Management RISKRISK Factory MarketMarket

9 Diff Sim HA RA 9 HACCPHACCP An operational system to select and implement effective control measures to ensure the safety of a food product Microbiological Risk Assessment ( MRA ) A procedure to provide data that are used in the selection of appropriate risk reduction measures

10 Diff Sim HA RA 10 The HACCP system Risk Analysis compared with

11 Diff Sim HA RA 11 Codex HACCP Guidelines 1. Assemble HACCP team 2. Describe product 3. Identify intended use 4. Construct flow diagram 5. Confirm on-site flow diagram 6. List all potential hazards, conduct a hazard analysis and consider control measure Apply principles 2 - 7

12 Diff Sim HA RA Conduct a hazard analysis 2. Determine the CCPs 3. Establish critical limit(s) 4. Establish a monitoring system 5. Establish corrective actions 6. Establish verification procedures 7. Establish documentation HACCP Principles

13 Diff Sim HA RA 13 (1) Assemble HACCP team  Obtain top management commitment  Appoint a leader and a secretary  Assure participation of experts in QA, microbiology, chemistry, food technology  Assure co-operation of other experts  Define scope of the study  Set priorities

14 Diff Sim HA RA 14 Assemble Risk Assessment team Same general principles apply, but Risk managers are mainly governmental regulators and scientists, while a HACCP team consists mainly of production people. The pathogen and food of concern is often already decided upon by the Risk Managers MRA

15 Diff Sim HA RA 15 (2) Describe product  Formulation and composition Raw materials & ingredients Parameters influencing safety  Processing  Packaging  Distribution

16 Diff Sim HA RA 16 Products to analysed Same general principles apply, but the product is a commodity, not a specific one. It is a product produced in different manners by different manufacturers, including manufacturers in other countries MRA

17 Diff Sim HA RA 17 (3) Identify intended use Food service establishments Caterers Hospitals General population Specific groups of the population Preparation practices Exportation

18 Diff Sim HA RA 18 Use of Products Same categories may apply, however, products for export may need to be treated separately because of the differences in use and users MRA

19 Diff Sim HA RA 19 (4) Construct flow diagram  Cover all steps which might have an influence on the safety of the product  Include important data such as time & temperature  Indicate hygiene level of areas and barriers  Indicate personnel movements etc. Raw materials Mixing Heating Filling

20 Diff Sim HA RA 20 Perform a Product / Pathogen / Pathway ( PPP ) analysis The fate of the pathogen of concern from “farm to fork” will be described in detail, data concerning conditions at the various steps need to be collected and treated, growth, survival etc. will be “modelled” MRA

21 Diff Sim HA RA 21 (5) On - Site confirmation of flow diagram  Check correctness of information  Check whether important information was not overlooked  Check during all periods of operation and cleaning, but also during idle hours  Discuss practices with operators

22 Diff Sim HA RA 22 PPP confirmation The pathway and its conditions need to be checked, models need to be validated and the outcomes verified as far as possible. Uncertainties need to be identified. the PPP in risk analysis is less specific as the one used in HACCP MRA

23 Diff Sim HA RA 23 (6) List all hazards associated with each step, conduct a Hazard Analysis, consider any measures to control identified hazards Determine which potential hazards are significant and should be controled

24 Diff Sim HA RA 24 Hazard identification The hazard of concern is identified by MRM. Important aspects of the ecology and behaviour of the pathogen are collected. This is particularly difficult when the risk of a “new” pathogen is assessed in HACCP hazard identification means determination which hazards are significant MRA

25 Diff Sim HA RA 25 Perform a Hazard Analysis Collect and interpret information on hazards and conditions leading to their presence at unacceptable levels and decide which need to be controlled "the analysis of hazards must be quantitative if it is to be meaningful" ICMSF 1988 HA is not RA

26 Diff Sim HA RA 26 Hazard Determination Presence of agent in raw material probable ? Presence of agent in line or environment probable ? NO YES Unaccept. contamination at this step probable ? Unaccept. survival, persistence or increase at this step probable ? YES NO YES Reduction, if any, at a further step adequate ? No hazard* YES** HAZARD No hazard* NO * Not a hazard to be controlled at this step ** Reduction step becomes thus a CCP Questions to be answered for each potential hazard for each step

27 Diff Sim HA RA 27 Acceptable levels ( 1 ) Not all levels (or sizes) of all agents are harmful to all individuals under all conditions Agents (contaminants) are acceptable as long as their levels remain below a certain maximum

28 Diff Sim HA RA 28 Acceptable levels ( 2 ) Products with a good record of safety are used as a “benchmark” New products, or changed products should be as safe as the “benchmark” Performance Objectives are “benchmarks” set by authorities

29 Diff Sim HA RA 29 Hazard Analysis of aflatoxin in milk Maximum Level accepted 15 μg / kg Q1: Presence of hazard at unacceptable levels in raw material Q2: Persistent during processing Q3: Recontamination Q4: Increase during shelf-life Q5: Reduction during preparation Possible Probable Likely No CCP

30 Diff Sim HA RA 30 HA of Listeria in hotdogs Maximum Level accepted <100 / g ? Q1: Presence of hazard at unacceptable levels in raw meat Q2: Survival during processing Q3: Recontamination Q4: Increase during shelf-life Q5: Reduction during preparation Possible Probable Likely No or CCP

31 Diff Sim HA RA 31 Assessment of probability Possible Probable Likely Reasonably expected to occur These are semi - quantitative expressions of probability, based on analytical data or expert knowledge

32 Diff Sim HA RA 32 ProbabilitiesProbabilities Risk assessors use “models” to calculate probabilities of survival, persistence, growth etc. Models for recontamination are being developed the same models can be and are used in HACCP MRA

33 Diff Sim HA RA 33 MRA components  Hazard identification which pathogen will be assessed  Hazard characterization what are the effects and what influences the effects  Exposure assessment how often and how many will be ingested  Risk characterization what is the chance that the effects will happen MRA

34 Diff Sim HA RA 34 Hazard characterization curve of Listeria monocytogenes Log No of cases per 100,000 Log No of ingested L.m., all servings contaminated worst - case scenario Buchanan e.a MRA

35 Diff Sim HA RA 35 Probabilistic calculation of exposure MRA

36 Diff Sim HA RA 36  the chance for a person of falling ill by consuming a food  the estimated number of illnesses (e.g. per year in a country) due to consumption of a specific food/pathogen combination  risk estimates for different processing, distribution and consumer use conditions and risk reduction scenarios Outcomes of MRAs HACCP in product development uses also different scenarios, but the outcome is a level of safety, not a level of risk MRA

37 Diff Sim HA RA 37 7) Determine Control Measures  Determine where measures must be taken (CCPs)  Determine how and to which extent they are to be controlled at these CCPs  Establish the critical limits and monitoring procedures

38 Diff Sim HA RA 38 MRM components  Preliminary MRM activities which pathogen / food will be assessed and why  Evaluation of MRM options selection of control measures  Implementation of MRM decisions communicate with stakeholders and follow-up  Monitoring and Review collect epidemiological and other data, revise decisions if appropriate MRM

39 Diff Sim HA RA 39 Control measures Risk managers are responsible for the evaluation and selection of control measures. Food business operators are responsible for their execution in HACCP both activities are in the same hands MRM

40 Diff Sim HA RA 40 Establish Critical Limits They must assure that the required level of safety is obtained This level can be the “benchmark” or the “Performance Objective (PO)” The PO may be the outcome of MRM evaluation

41 Diff Sim HA RA 41 Performance Objective ( PO ) The maximum frequency and / or concentration of a microbial hazard in a food at a specified step in the food chain before time of consumption that still provides or contributes to the achievement of an Food Safety Objective or Appropriate Level Of Protection, as applicable. A PO is an acceptable level of a hazard in HACCP terminology MRM

42 Diff Sim HA RA 42 9) Monitoring in HACCP The act of conducting a planned sequence of observations or measurement of control parameters to assess whether a CCP is under control Monitoring and Review in MRM  Assessment of effectiveness of measures taken  Review risk management and / or assessment as necessary (new option, new information)

43 Diff Sim HA RA 43 An example of differences and similarities Product Pathogen Pathway of Listeria monocytogenes in a specific paté produced according to GHP and HACCP and a “generic” paté, as used in Microbiological Risk Assessment

44 Diff Sim HA RA 44 PPP of L. monocytogenes (paté 1) Log. Lm./g safe level RecontaminationGrowth GHP and HACCP assure safety of specific product HACCP

45 Diff Sim HA RA 45 PPP of L. monocytogenes (paté 2) Log. Lm./g Input for MRA RecontaminationGrowth Change conditions ? A “generic product” under general conditions in a country MRA

46 Diff Sim HA RA 46 Risk estimates of listeriosis per 100 Mio inhabitants of the USA which level acceptable ? level of L. monocytogenes

47 Diff Sim HA RA 47 Risk Acceptability concept Intolerable region Acceptable region ALARA region As low as reasonably achievable Severity At which levels are these lines set ?

48 Diff Sim HA RA 48

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