control Point - PDF document

1 1 HACCP Hazard Analysis Critical control
1 HACCP Hazard Analysis Critical control Point Dr Sylvie Mialet Part 1 : definitions and context VetAgro - Sup Campus vétérinaire de Lyon - France 2 CONTEXT (1 ) : official control Official control Issues of control As regards regulations : - Approval - Authorization - Prosecutions - … Includes : - Inspection - Audit - Sampli

2 ng and analysis … Example of definiti
ng and analysis … Example of definition for official control - Article 2 Regulation 882 / 2004 : « any form of control that the competent authority performs for the verification of compliance with food law , including animal health and animal welfaie rules » 3 CONTEXT (2) : official control Official Control Doing OC Conclusions Deci

3 sion Report Planning of OC SUPERVISION
sion Report Planning of OC SUPERVISION Follow up 4 CONTEXT (3) : official control Planned arrangements: PrP , GHP and HACCP plan Audit Legal requirements Inspection internal procedures Assessment Sampling and analysis - results / food safety - technical requirements ( for ex . Time /T ° ) 5 CONTEXT (4) : objective of official

4 control The major objective of official
control The major objective of official control is to assess the risks linked to the process or the plant This risk assessment is conducted at two levels : - on the process : the Competent Authority (CA) has to examine the process and to estimate its capacity to be wholesome and reliable (/ the likelihood of manufacturing

5 safe products ) - on the products : th
safe products ) - on the products : the CA has to verify their compliance with standards and to estimate their level of safety 6 - Estimation of the risk - hazards identification - hazard characterization - exposure assessment = exposure quantification - dose - response analysis - Risks management - Communication about risks QU

6 ANTITATIVE RISK ASSESSMENT ( 1 ) : Defin
ANTITATIVE RISK ASSESSMENT ( 1 ) : Definitions 7 Hazard definition : A biological , chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect or a problem of quality . Informations which have to be gathered at this step : • hazard definition • microbiological characterization includin

7 g pathogenic effect • analytical metho
g pathogenic effect • analytical methods / food material • treatments during process which can reduce or eliminate hazards • description of health adverse effects , incidence and methods for the diagnosis • levels of contamination and type of foodstuff involved • role of foodstuff as a vector QUANTITATIVE RISK ASSESSMENT( 2 )

8 : hazard identification 8 2 aspects •
: hazard identification 8 2 aspects • number of contaminated units in the batches • quantity of hazard in the products ( units ) in the contaminated batches QUANTITATIVE RISK ASSESSMENT(3 ) : level of contamination 9 QUANTITATIVE RISK ASSESSMENT(4 ) : exposure assessment Exposure assessment consists first in describing , s

9 econdly in trying to quantify the exp
econdly in trying to quantify the exposure . That means to estimate the quantity of hazard eaten by the way of contaminated foodstuff The quantification is complex . Several parameters has to be taken into account : • the likelihood that the eaten product is contaminated • the concentration of hazard in contaminate

10 d foodstuff • the consumption habits
d foodstuff • the consumption habits = frequency of consumption of the type of foodstuffs involved • quantity of food eaten For this assessment , different tools may be used : • scientific inquiries about consumption • sociologic inquiries about typology of consummers Who eats what ? How ? How many ? 10 That needs

11 to know: – the symptoms linked to th
to know: – the symptoms linked to the consumption of hazard – the virulence of strains – the populations with major risk (YOPI…Young , Old , Pregnant , Immunodeficient ) That leads to plot the dose - response curve for the studied hazard QUANTITATIVE RISK ASSESSMENT(5 ) : estimation of consequences of exposure

12 11 Example of dose - response curve For
11 Example of dose - response curve For a standard population and for YOPI population ( cfu : colony forming unit) QUANTITATIVE RISK ASSESSMENT(5) :estimation of consequences of exposure 12 Risk : It’s a function of the probabability of an adverse health effect and the severity of that effect , consequential to a hazard .

13 This estimation is based on hazard ide
This estimation is based on hazard identification, dose - response analysis and exposure assesment It can be written as following : there is a likelihood of 0 , 95 that the number of deads linked to the consumption of the contaminated food by the studied hazard , is other 10 per year . QUANTITATIVE RISK ASSESSMENT(5) : estimation o

14 f consequences of exposure 13 Hazard A
f consequences of exposure 13 Hazard Analysis Critical Control Point A system which identifies, evaluates and controls hazards which are significant for food safety (Codex Alimentarius ) . 14 N A S A 15 * NASA, 1960 : Developed in 1960’s by the Pillsbury company (USA), United States Army Laboratories at Natick and the Na

15 tional Aeronautics and Space Administr
tional Aeronautics and Space Administration (NASA) Collaborative effort to develop safe food for astronauts Based on Failure , Mode and Effect Analysis (FMEA) * In food plants at this time : Quality control based on microbiological analysis on end - products Sampling plans cannot detect low levels of contamination « a sort

16 of strainer with big holes » which can
of strainer with big holes » which cannot give confidence in food safety 16 ! REGULATIONS Hygiene requirements Quality control on end - products ! REGULATIONS 17 Efficiency of a sampling plan 1,00 0,80 0,60 0,40 0,20 0,00 0,10 20 40 100 0 80 60 Pourcentage of failures ( Pd in a batch Probability of acception (Pa) 0,90 n = 5 c =

17 0 c = 2 1,00 0,80 0,60 0,40 0,20 0,00 0
0 c = 2 1,00 0,80 0,60 0,40 0,20 0,00 0,10 1 5 10 0 Pourcentage of failures (Pd in a batch Probability of acception (Pa) 0,90 15 0,05 n = 30 c = 0 n = 15 c = 0 n = 60 c = 0 18 The plan n = 5 and c = 0 • Question 1 : How many failures in the batch to have 9 times/ 10 a positive result ( reject 9 times on 10 ) ? Response 1 :

18 40 % or more , only deeply contaminated
40 % or more , only deeply contaminated batches will be rejected . • Question 2 : And when the batch contains only 1 % failures or less ? Response 2 : It will be accepted in 9 , 5 fois cases / 10 19 • Question 3 : Is it possible to increase the efficiency of plans ? Response 3 : yes with n = 60 et c = 0 ( after , the plan won’t b

19 e economically or technically feasible )
e economically or technically feasible ) ; it will be possible to detect in 90 % of the cases batches with 5 % of failures • Question 4 : what is the risk of non - detection of failures regarding the sampling plan ? Response 4 : if, for example , the batch contains 10 % of contaminated units you’ll have nearly - 1 % of likel

20 ihood to reject it with the plan n = 5 a
ihood to reject it with the plan n = 5 and c = 2 - 50 % of likelihood to reject it with the plan n = 5 and c = 0 - 81 % of likelihood to reject it with the plan n = 15 and c = 0 - 95 % of likelihood to reject it with the plan n = 30 and c= 0 - 99 % of likelihood to reject it with the plan n = 60 and c = 0 20 During the 90’s: the de

21 velopment of the concept • 1992 : Nati
velopment of the concept • 1992 : National Advisory Committee on Microbiological Criteria for Food - USA (NACMCF) Concept HACCP + 7 principles • 1993 : adoption of the Codex Alimentarius Guide = worldwide recognition • 1993 : included in European regulation = Directive 93/43 21 At an international level : • Codex ali

22 mentarius : Codex Commitee on Food Hyg
mentarius : Codex Commitee on Food Hygiene guide for the validation of control measures � HACCP target : official control • OIE : takes into account life animal and its health / consequences on foodstuffs 22 HACCP – Definitions and framework H . A . C . C . P . is a tool : • to assess hazards • to establish co

23 ntrol systems that focusses on prevent
ntrol systems that focusses on prevention rather than relying mainly on end - product testing . • to give the evidence that those measures are well applied on site and that they are efficient 23 • Regulation 178/2002 article 14 Food shall not be placed on the market if it is unsafe Food shall be deemed to be unsafe if it i

24 s a) injurious to health b) unfit for
s a) injurious to health b) unfit for human consumption Unfit for human consumption : as regards normal conditions of use because of contamination, putrefaction , adulteration Injurious to health : • Probable immediate and/or short - term and/or t long - term effects on the 24 • Regulation 852 /2004 article 5 = Hazar

25 d analysis and critical control point
d analysis and critical control point - « Food business operator shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles » - 7 principles as described by the Codex - shall apply only to food business operators carrying out any stage of production, processing and distr

26 ibution of food after primary productio
ibution of food after primary production, and those associated operations listed in annex 1 25 Regulation and own initiative Pyramide of the requirements Quality management system Specific procedures of the plant Good hygienic practices guides Applied hygiene principles Own checks based on principles of H.A.C.C.P . General

27 principles of hygiene Premises Equipmen
principles of hygiene Premises Equipment Methods 26 Quality management HACCP GHP Own initiative Regular provisions GHP applied and documented Quality management system HACCP plan 27 • « PMS « = Food safety control plan describes measures settled in the plant to insure hygiene and food safety / biological , chemical and p

28 hysical hazards • Includes the elemen
hysical hazards • Includes the elements for putting up the procedures and the evidence of implementation FBO obligations GMP or PrPO Traceability unsafe food control HACCP 28 FBO obligations . Regulation (EC) n ° 2073/2005 of 15 november 2005 on microbiological criteria for foodstuffs GMP guides PMS Validation and verificat

29 ion procedures HACCP 29 Principles Contr
ion procedures HACCP 29 Principles Control measures Food safety GMP HACCP Microbiological criteria = validation and verification 30 • Food safety cannot be insured through end - product testing only • Regular microbiological criteria are applied on products and at stages of the food chain where there is no other efficient

30 tool to improve safety level Fundamenta
tool to improve safety level Fundamentals 31 FBO obligations • C omply with microbiological criteria • Withdraw or recall unsafe food from the market = ability to identify hazards and control them OFFICIAL CONTROLS 32 HACCP : 7 principles of Codex Alimentarius Principle n ° 1 : Conduct a hazard analysis â

31 €“ list all potential hazards associate
€“ list all potential hazards associated with each step of the process , – estimate the likely occurrence of hazards and severity of adverse effects , – consider any measure to control identified hazard . Principle n ° 2 : Determine the Critical Control Points ( CCPs ) Principle n ° 3 : Establish critical limit (s) for

32 each CCP Principle n ° 4 : Establish a
each CCP Principle n ° 4 : Establish a monitoring system for each CCP Principle n ° 5 : Establish corrective actions in order to deal with deviations when occur Principe n ° 6 : Establish verification procedures to determine if the HACCP system is working effectively Principe n ° 7 : Establish documentation and record kee