Food Safety Management Systems

1. BUILDING CAPACITY OF SME’s ON EU FOOD & PACKAGING STANDARDS Food Safety Management Systems The HACCP approach Thessaloniki 11.06.2012

2. FSMS & importance for Food Businesses

3. The importance of Food Safety • 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

4. The importance of Food Safety

5. Why manage food safety? • 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

6. Food Safety Management Systems • 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

7. The HACCP approach

8. What is HACCP • 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

9. What is HACCP In other words…..

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

11. Prevention vs QC • 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

12. Limitations of Microbiological testing • 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

13. HACCP should NOT… • Be Overly Prescriptive • Dilute Resources by Targeting BOTH Safety & Quality Issues • Be Viewed as a means to FIX design problems created during product development.

14. HACCP – before you start…

15. The 7 HACCP principles • Conduct a Hazard Analysis • Determine the Critical Control Points • Establish Critical Limits • Set up methods to monitor Critical Control Points. • Establish Corrective Actions to be taken when the process exceeds the critical limits. • Establish Recordkeeping Procedures • Establish Verification Methods & Audit Schedule

16. Critical Control Point - CCP • 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 thispoint was not controlled?

17. What determines a CCP? • 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.

18. Number of CCPs • 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

19. The ideal CCP From: Corlett, D.A. Pierson, M.D. 1992 - HACCP Principles and Applications. • 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

20. Verification & Validation • 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?

21. The design HACCP (d-HACCP ) approach

22. 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.

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

24. 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

25. 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

26. What information is needed?

27. 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

28. HACCP Requirements for SMEs

29. The 852/2004 regulation • 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

30. Guidance document http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_haccp_en.pdf

31. Purposes • 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.

32. Procedure based on HACCP principles • 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.

33. HACCP inspection by Competent Authorities

34. What a CA examines • 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

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

36. The inspection approach • Select a representative study (choose the most critical product/process) • Ask the site to provide all the supporting documentation

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

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

39. Product description • 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 ?

40. Intended use • 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 ?

41. Flow chart • Process not Engineering based ! • Does it compare with your factory tour ?

42. Hazards • Clearly described in sufficient detail • Realistic

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

44. Critical limits • 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 ?

45. Corrective action • 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

46. Putting it all together • 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.

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

48. Thank you for your attention!