ISO Gestión y buenas prácticas en el sector alimentos

Transcription

1 Labros Bouklis ISO Gestión y buenas prácticas en el sector alimentos INLAC LABROS BOUKLIS 1

2 Food Safety Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use. Source: Codex Alimentarius (WHO) INLAC LABROS BOUKLIS 2

3 Food Safety Protecting People Keeping the Employees and Customers Preventing Food Safety Errors INLAC LABROS BOUKLIS 3

4 Views Compromising on food safety is not a way for a farm or a company to reduce costs. It is actually a very dangerous path, not only for consumers, but also for the farm or company itself and for the sector as a whole. David Byrne, European Commissioner for Health and Consumer Protection INLAC LABROS BOUKLIS 4

5 Views II In a globalized world we all swim in a single microbial sea WHO Director General INLAC LABROS BOUKLIS 5

6 Statements: FOOD SAFETY Assurance that food will not cause harm to the consumer for whom it is prepared and/or eaten according to its intended use WHO INLAC LABROS BOUKLIS 6

7 COMMITMENT We, the Heads of State and Government reaffirm the right of everyone to have access to safe and nutritious food, consistent with the right to adequate food and the fundamental right of everyone to be free from hunger. Rome Declaration on World Food Security, 1996 INLAC LABROS BOUKLIS 7

8 Food Safety Historical Background First food law written in 2500 B.C. Pakistan food laws are dated back First HACCP system was developed between NASA and Pillsbury in Become a regulatory requirements in EU since US FDA also adopted the HACCP approach as part of control mechanism for food safety. INLAC LABROS BOUKLIS 8

9 Food Safety Management System Why it is required? Intense farming and processing of food Increase in meals consumed outside home Increase in ready to eat foods More traveling across the world Increased amount of exotic imported foods Increase in number of susceptible people INLAC LABROS BOUKLIS 9

10 Food Safety Management System FAMI QS Eurepgap GMO Nestlé NQS BRC IoP DS 3027 Friesland Coberco FSS BRC Food ISO 9001 Irish HACCP M&S system GMP standard for Corrugated & Solid Board GFSI Guide Aldi system McDonalds system Ducth HACCP SQF Kraft food system EFSIS IFS GTP GMP AG 9000 INLAC LABROS BOUKLIS 10

11 ISO 22000:2005 A management system designed to enable organizations to control food safety hazards along the food chain in order to ensure that food is safe at the time of consumption ISO 22000:2005, clause 1 INLAC LABROS BOUKLIS 11

12 ISO 22000:2005 Features; First global food safety standard. Harmonizes the voluntary international standards. Employs proven management system principles. Enables a common understanding of what a food safety management system is. INLAC LABROS BOUKLIS 12

13 ISO 22000:2005 Features; Requires legal compliance checking Integrates existing good practice Internal and external monitoring INLAC LABROS BOUKLIS 13

14 ISO 22000:2005 Benefits; Overcomes many of the limitations of traditional approaches to food safety control. Potential to identify all conceivable, reasonably expected hazards. Capable of accommodating the changes. INLAC LABROS BOUKLIS 14

15 ISO 22000:2005 Benefits; Help to target or manage resources to the most critical part of the food operation. Can promote international trade by equalizing food safety control and by increasing confidence in food safety. Applicable to whole food chain. INLAC LABROS BOUKLIS 15

16 Food Food Safety Safety Team Team Product Product Characteristics Characteristics PreRequisite PreRequisite Programs Programs (PRP) (PRP) Description Description of of process 5 process steps steps and and control control measures measures 7.5 Design and redesign 7.5 Design and redesign of operational PRPs of operational PRPs Intended Intended Use Use Flow Flow Diagram Diagram Hazard Hazard identification identification and and acceptable acceptable levels levels Hazard Hazard assessment assessment Identification Identification and and assessment assessment of of control control measures measures 7.6 Design and 7.6 Design and redesign of the HACCP redesign of the HACCP plan plan Validation Validation of of control control measure measure combinations combinations Verification Verification planning planning b 6. a 6.c Steps according to Codex Alimentarius Steps added to Codex Alimentarius Food Safety Management System Improvement loop INLAC LABROS BOUKLIS 16

17 ISO 22005:2007 Traceability Sets out the general principles and basic requirements for system design and implementation of traceability system Uses Codex definition of traceability Requires food/feed business to: Set food safety, quality & other objectives Design a system that meets regulatory & customer requirements & specify the information to be obtained from its suppliers, collected within itself & provided to its customers Establish procedures, documentation, etc Implement the system (training, etc) Monitor the system Review it regularly & Update INLAC LABROS BOUKLIS 17

18 Food chain INLAC LABROS BOUKLIS 18

19 Entry of Hazards in Food Chain INLAC LABROS BOUKLIS 19

20 Food chain and process approach Consideration to effect of the food chain on organization s operation Identification, application and management of a system of processes within the organization Ongoing control over linkage, combination and interaction of individual processes within the system of processes INLAC LABROS BOUKLIS 20

21 Process Approach Act How to improve next time? Check Did things happen according to plan? Plan What to do? How to do it? Do Do what was planned A desired result is achieved more efficiently when related resources and activities are managed as a process INLAC LABROS BOUKLIS 21

22 Common Theme Traceability & Transparency Grower Suppliers Processor Supply Chain Distribution Retail QSR Export Being able to trace materials & transportation from farmers / growers, to final package, and delivery to receiving company INLAC LABROS BOUKLIS 22

23 Process Approach Management Processes I Product Design I O I O Process Design I O Project Planning I O I O Production I O O I O Measurement, Analysis, and Improvement Resource Processes INLAC LABROS BOUKLIS 23

24 Process Approach Benefits; Lower costs and shorter cycle times through effective use of resources Improved, consistent and predictable results Focused and prioritised improvement opportunities INLAC LABROS BOUKLIS 24

25 FSMS Process model INLAC LABROS BOUKLIS 25

26 Key elements ISO 22000:2005 Interactive Communication Systems Approach to FSM Pre requisite Programs HACCP Principles Control Food Safety Hazards INLAC LABROS BOUKLIS 26

27 Increased demand for voluntary international standards Globalization of trade in products and services Outsourcing and foreign investment Deregulation/privatization of public services The climate change challenge and energy efficiency mandates Public demand for consumer safety, environmental protection, corporate social responsibility Need for international solidarity to face global terrorism, pandemics and natural disasters & pace of innovation and convergence of new technologies INLAC LABROS BOUKLIS 27

28 World Trade Report 2005 Section II Trade, Standards and the WTO Economics of standards and trade Institutions and policy issues Standards in the multi-lateral trading system INLAC LABROS BOUKLIS 28

29 ISO/TC 34, Food products Working Groups on: Food Safety Management Systems, GMOs, Traceability systems, Food irradiation Subcommittees (mostly test methods) on: Seeds; Fruits and vegetables; Cereals; Milk; Meat and poultry; Spices; Tea; Microbiology; Animal feeding stuffs; Fats and oils; Sensory analysis; Coffee 711 published standards, 55 participating countries, 49 observer countries Active liaisons with Codex Alimentarius Commission INLAC LABROS BOUKLIS 29

30 ISO Family of Standards New Family initiated in 2001 Four Standards so far: ISO 22000:2005 Food safety management system Requirements ISO 22003: Requirements for bodies providing audit and certification of food safety management systems ISO TS 22004: Guidance on the application of ISO ISO 22005:2007 Traceability in the feed and food chain INLAC LABROS BOUKLIS 30

31 What food businesses were looking for? Better planning, less post-process verification More efficient & dynamic hazard control Systematic management of prerequisite programs Better documentation Communication among trade partners Resource optimization (internally & along food chains) INLAC LABROS BOUKLIS 31

32 ISO Outline Section 1 Scope Section 2 Normative Reference Section 3 Terms & Definitions Section 4 Food Safety Management System Section 5 Management Responsibility Section 6 Resource Management Section 7 Planning & Realization of Safe Products Section 8 Verification, Validation & Improvement INLAC LABROS BOUKLIS 32

33 Scope: what is ISO 22000:2005? A management system standard (based on ISO 9001:2000) & specific to food safety management (not quality, etc) Based on Codex - HACCP approach with some innovations Designed for all segments of food chain & all types of food business (micro to global) Enables a food business to plan, implement, operate, maintain and update a system to provide safe end products and demonstrate conformity with applicable regulatory requirements INLAC LABROS BOUKLIS 33

34 Easy to use Checklist A new publication, in collaboration with ITC: ISO 22000, Food safety management systems - An easy-to-use checklist for small business - Are you ready? Enables small businesses to assess their readiness to implement the new ISO standard Available in Spanish INLAC LABROS BOUKLIS 34

35 ISO 22000: 2005 Scope Normative references Terms and definitions Requirements Annex(s) INLAC LABROS BOUKLIS 35

36 Application All requirements of this International Standard are generic and are intended to be applicable to all organisations in the food chain, regardless of type, size and complexity. This includes organizations directly or indirectly involved in one or more steps of the food chain The standard allows small and/or less developed organization to implement an externally developed combination of control measures INLAC LABROS BOUKLIS 36

37 ISO standard - Requirements Section 4: Food Safety Management System (FSMS) General Requirements Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning and Realization of Safe Products Section 8: Validation, Verification and Improvement of the Food Safety Management System INLAC LABROS BOUKLIS 37

38 Section 4 General Requirements Scope of the Food Safety Management System Documentation requirements More than twenty six types of documents required by ISO 22000:2005 Twenty eight mandatory records required by ISO 22000:2005 Documents needed by the organization to ensure effective development, implementation and updating of the FSMS INLAC LABROS BOUKLIS 38

39 Section 4 Documentation requirement Mandatory documented procedures specified by ISO 22000:2005 Control of documents Control of records Corrections Corrective actions Handling potentially unsafe product Withdrawals Internal audits INLAC LABROS BOUKLIS 39

40 Section 5 Management Responsibility Management commitment Food Safety Policy Food safety management system planning Responsibility and authority INLAC LABROS BOUKLIS 40

41 Section 5 Management Responsibility Food safety team leader External communication Suppliers and contractors Customers/consumers Statutory and regulatory authorities Other organizations Internal communication INLAC LABROS BOUKLIS 41

42 Section 5 Management Responsibility Emergency preparedness and response Documented procedures to manage potential emergency situations and accidents Management Review Review input: Food safety related requirements Review output INLAC LABROS BOUKLIS 42

43 Section 6 Resource Management The organization shall provide adequate resources for; Establishment Implementation Maintenance Updating INLAC LABROS BOUKLIS 43

44 Section 6 Resource Management Human Resource Food safety team and personnel impacting food safety External experts Competence, Awareness and Training Infrastructure Buildings Process equipment Utilities Surrounding areas Supporting services INLAC LABROS BOUKLIS 44

45 Section 6 Resource Management Work Environment Measures to prevent cross contamination Work space requirements Protective work wear requirements Availability and location of employee facilities INLAC LABROS BOUKLIS 45

46 Section 7 Planning and Realization of Safe Products The organization shall plan and develop the processes needed for the realization of safe products The organization shall implement, operate and ensure the effectiveness of the planned activities and any change to those activities including; Pre-requisite programmes ( PRPs) Operational PRPs HACCP plan INLAC LABROS BOUKLIS 46

47 Section 7 Planning and Realization of Safe Products Prerequisite programmes (PRPs) Preliminary steps to enable hazard analysis Hazard analysis Establishing the operational prerequisite programmes (PRPs) Establishing the HACCP plan INLAC LABROS BOUKLIS 47

48 Planning of safe food INLAC LABROS BOUKLIS 48

49 Decision tree INLAC LABROS BOUKLIS 49

50 Updating PRPs and HACCP plan The organization shall update the following information; Product characteristics Intended use Process steps Control measures HACCP plan Procedures instructions specifying PRPs INLAC LABROS BOUKLIS 50

51 Verification planning Shall define the purpose, methods, frequencies and responsibilities for the verification activities Output of planning suites to organization s method of operation Verification results enables analysis of the result of verification activities INLAC LABROS BOUKLIS 51

52 Traceability system The system shall enables the identification of product lots and their relation to batches of raw material, processing and delivery records. The system shall be able to identify incoming material from the suppliers and the initial distribution route of the product. INLAC LABROS BOUKLIS 52

53 Control of non conformity Corrections Corrective actions Handling potentially unsafe products Evaluation of release Disposition of Nonconforming products Withdrawals INLAC LABROS BOUKLIS 53

54 Validation, Verification and Improvement The food safety team shall plan and implement the processes needed to validate control measures, its combination, and to verify and improve the FSMS. Validation of control measure combination Control of monitoring and measuring INLAC LABROS BOUKLIS 54

55 Validation, Verification and Improvement FSMS verification Internal audits Evaluation of individual verification results Analysis of results of verification activities Improvement Updating the Food safety management system INLAC LABROS BOUKLIS 55

56 FSMS Overview INLAC LABROS BOUKLIS 56

57 Bibliography ISO 22000:2005 Food safety management systems - Requirements for any organization in the food chain ISO22005:2007 Traceability in the feed and food chain - General principles and basic requirements for system design and implementation ISO 9001:2000. Quality management system-requirements Codex Alimentarius Food Hygiene Basic Texts (2001) Reference websites: & INTRODUCTION TO ISO 22000:2005 Food Safety Training Courses on International Standards & Regulations : A project funded by European Union & implemented by URS Overview of the ISO Family of Standards, Kevin McKinley, DeputyD eputy-secretary-general, ISO Central Secretariat, Albert Chambers, ISO/TC 34 Working Group p Expert and Vice-Chair, Canadian Advisory Committee, ISO/TC 34: Joint UNCTAD/WTO Informal Information Session on Private Standards/ 25 June 2007, Geneva INLAC LABROS BOUKLIS 57