2. The HACCP approach BUILDING CAPACITY OF SME’s ON EU FOOD & PACKAGING STANDARDS Thessaloniki 11.06.2012

4. Food safety safe guarding food from anything that could harm the health of consumers Legal requirement Safety throughout food chain Businesses must identify and control risks to food safety (HACCP approach) Industry anxious to maintain safety and quality of their products Media reaction in case of failure Consumer concerns

5. Safe foods - benefits Satisfied/loyal customers/consumers Good reputation Less wastage Good working conditions Compliance with legislation Compliance with customer requirements The cost of poor hygiene Food poisoning Bad reputation Customer/consumer complaints Poor working conditions Penalties: Legal customers

6. Protect the consumer by preventing contamination Be proactive & reactive Meet legislative requirements to produce safe food Meet customer demands and expectations Brand protection Own business and customers Industry reputation not a competitive issue

7. A documented system to ensure the safety of foods FSMS could be certified with an international Standard (optional) ISO 22000:2005 BRC IFS GFSI The legal requirement is to establish a procedure to ensure safety according to the HACCP principles

9. It is the acronym for Hazard Analysis & Critical Control Points HACCP is a system which – identifies, – evaluates, and – controls hazards which are significant for food safety

10. In other words….. A systematic approach…… to identify hazards & risks… Associated with a)the Manufacture, Distribution & Use of a Food And b) with DEFINITION of preventive measures

11. Effectiveness as a PREVENTIVE safety tool Participative nature (everyone is involved) Open system (easy to understand) Adaptability (to any process) Worldwide acceptance (Codex)

12. Both inspection & sampling/testing approaches are NOT effective in a food business where hazards are non uniformly distributed Preventive process control based approach is the only sensible route to assure product safety

13. It takes time to obtain microbiological results Cannot hold in-process material waiting for test results Expense & technical expertise required to perform microbiological tests. Testing Only Identifies EFFECTS not the CAUSES Many SAMPLES are needed to obtain meaningful information about a Batch of Food

14. Be Overly Prescriptive Dilute Resources by Targeting BOTH Safety & Quality Issues Be Viewed as a means to FIX design problems created during product development.

15. Multidisciplinary team Chairperson Experts (QA, R&D, Production, Maintenance, etc) Assemble the HACCP team List products included in scope of plan List "Hazards to Consider“ Associated with the selected Product/Process Define the Terms of Reference Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system Prerequisite programmes

16. 1.Conduct a Hazard Analysis 2.Determine the Critical Control Points 3.Establish Critical Limits 4.Set up methods to monitor Critical Control Points. 5.Establish Corrective Actions to be taken when the process exceeds the critical limits. 6.Establish Recordkeeping Procedures 7.Establish Verification Methods & Audit Schedule

17. Basis for HACCP system “A step at which control can be applied effectively and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.” Would you hold the product if this point was not controlled?

18. If a critical limit deviation occurs product must be held and corrective action taken. The number of CCP’s must be manageable. The vital few.

19. Different facilities producing the same product should have very similar CCP’s Different facilities could have different hazards and CCP’s because of layouts, etc. Critical Control Points must be used for Food Safety only The Goal is Hazard Elimination

20. Criteria are supported by research and/or technical literature and/or experience Criteria are specific, quantifiable and provide a yes/no response The technology for controlling the CCP is readily available at a reasonable cost Monitoring is continuous and the operation is automatically adjusted to maintain control The potential hazard is prevented or eliminated From: Corlett, D.A. Pierson, M.D. 1992 - HACCP Principles and Applications.

21. Those activities other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to plan Verification Is the HACCP plan being followed as written? Validation Is the HACCP plan scientifically and technically sound?

23. Definition The application of the HACCP tool to the study of a new or conceptual product or process design during the development phase, normally in the absence of operational data.

24. Exponential increase of Failure Costs Failure cost Design Manufacturing Consumer The later we find and try to fix problems with our product design, the more it costs.

25. Why d-HACCP? Contributes to ‘Safe by Design’ Policy –Ensures that we design adequate controls to ensure a safe design- before we start making it ! Prevents wasting money –due to inadequate process or product design May be used to evaluate and decide on a processing route

26. Design Control Point (DCP) vs CCP DCP's differ from CCPs in that they are "generic" to a particular product group, not specific to an individual product/process line, DCP's are not identified following a formal HACCP study using "real" line data. As such they can form the input for a detailed HACCP study

27. What information is needed? Product design Broad idea of formulation List of ingredients List of packaging material types Specific GMP requirements Microbiological predictions (if appropriate) Process design Proposed process flow List of all equipment options Time aspects (storage times, delays, process times) Planned control and monitoring features

28. How is it done? Identify potential hazards Identify control that exist or will be required Identify DCPs State Critical Limits and propose monitoring Where choices in process route or material occur, evaluate each one in parallel

30. Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles Documents and records should be proportional to the nature and size of the food business to demonstrate the effective application of HACCP Principles Arrangements may be laid down in order to facilitate the implementation of HACCP by certain FBOs, in particular by allowing the use of procedures set out in guides for the application of HACCP principles

31. http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_haccp_en.pdf

32. To identify those food businesses where flexibility would be appropriate, To explain the “procedure based on the HACCP principles”, To place HACCP in the wider context of food hygiene and prerequisite requirements, To explain the role of guides to good practice and generic HACCP guides, including the need for documentation, and To identify the extent of flexibility applicable to the HACCP principles.

33. FBOs should have a system in place to identify and control significant hazards on a permanent basis and adapt that system whenever necessary. This can be achieved e.g. by the correct implementation of prerequisite requirements and good hygienic practices, by applying HACCP principles (possibly in a simplified way), by using guides to good practice or by a combination of those.

35. Compliance with requirements of regulation 852/2004 and/or specific standards (i.e Reg 853/2004) Not covered Additional requirements of international standards for the FSMS certification

36. Legislation Codex Alimentarius Alinorm 97/13 GMP guides if relevant Literature Experience of inspector

37. Select a representative study (choose the most critical product/process) Ask the site to provide all the supporting documentation

38. Has someone appropriate been given responsibility for implementation of HACCP ? What training has been given (or what is his/her experience ?

39. How many studies ? Does this fit logically with the range of products and processes ? Are all products and processes covered ?

40. It is clear to you (without explanation) what products and processes are considered ? Are the essential product characteristics given ? Which legislation/GMP guide covers this ?

41. Is it clear to you ? Is it logical (compared to the product/process type) ? Any special consumer groups identified (e.g people with allergenic reaction or intolerances ?

42. Process not Engineering based ! Does it compare with your factory tour ?

43. Clearly described in sufficient detail Realistic

44. Procedures, Actions, Design Features which will prevent hazards occurring NEVER measurements, monitoring or inspection Verify that these measures are really in place.

45. Must be stated for CCPs only Must be logically related to the hazard and it’s control measures Check for Legal requirements Are they really measurable ?

46. Clear statement of what is to be done right away to protect the consumer Must be understood by all Must be recorded and auditable Should include some remedial action

47. There is a simple series of relationships that you should see in the HACCP tables… If the relationships are wrong or absent, then the study won’t work.

48. Monitoring Vague Forces measurement of foreign bodies ? Specific All related