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General principles of auditing a HACCP system according to the NHP – part 1

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  1. General principles of auditing a HACCP system according to the NHP – part 1 26 – 27 June 2006 Workshop RTP 22343 on the New Hygiene package in the animal origin food sector Kosice, Slovakia | H. Claus DVM

  2. INTRODUCTION • Hans Claus DVM • ‘Voedsel en Waren Autoriteit’ of the Netherlands • Dutch Food and Consumer Product Safety Authority • Post academic and in-service training of official veterinarians Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  3. Thank you for inviting me! Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  4. Contents of the discussions • Contributions (3) • Part – 1 General principles of auditing a HACCP system • according to the new Hygiene package(legal aspects.) • Part – 2 Nature and intensity of the official controls/audits based on • risk - focus on final-products controls in shops (practical.) • Part – 3 Implementation of the New Hygiene package in the animal • origin sector (differences in the control process before and • after the NHP adoption) – experience of the Netherlands Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  5. Contents of today’s discussion • Part – 1 • Introduction • Base line concepts • Legal aspects of Implementing and Auditing HACCP • systems (NHP) • Auditing / controlling Retailers and Flexibility Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  6. Introduction Central Department VWA CentreCourt Voedsel en Waren Autoriteit (VWA) Prinses Beatrixlaan 2 2595 AL The Hague Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  7. THE NETHERLANDS Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  8. THE NETHERLANDS in a nut shell • Size:41.526 km² (33.842 km² land / 3.468 km² inland water) • Population:16.407 491 million (est. 2005)[1970: 13 mil. / • 1980: 14 mil. / 1990: 15 mil.] • Capital:Amsterdam • Seat of Government:Den Haag(The Hague) • National anthem: Wilhelmus • Highest point:322,5 meter(Pietersberg) • National Airport:Schiphol(airport aprox. 22 feet below sea level) • National Harbour:Rotterdam (leading in the world) • Currency: EURO[until 1-1- 2002 the Guilder; Exch. rate / 2.203710] Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  9. Approvals (NL) 31-12-2005 • Food Businesses with an approval • Meat 3.796 • Red meat (small capacity) 513 • Fishery products, snails and frog’s legs 1.080 • Veterinary border inspection controls 168 • Life animals and Life animal products 5.921 • Feed 769 • Animal by-products 611 • Aqua products 317 • Total 13.175 • (Source: VWA annual report 2005) Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  10. Workshop or lecture? • Exchange of views and experiences as peers! • Hand-out. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  11. LET US START WITH THE WARMING-UP AT THE BASE LINE! Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  12. Base line concepts • Movie Business FSA • Idea Businessplan EU • Author Guideline Sanco • Script GMP / GHP / HACCP Legislation • Senario Self control system Band width • Director Q-manager Off. Authority / FSA • Actors Workers Officials (Vets/Insp.) • Movie Compliance Food Safety • Money Profit Public Health Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  13. Base line concepts • Supervision(Official Authority)on supervision (Food Business) • Who? State control • Rules of the game? Legislation • Pre- / limiting conditions? Regulations / Nat. guidelines • Responsibility? (EU) / Official Authority (FSA) • Referee? Officials • Competence? Decission (objective evidence) Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  14. Base line concepts • Supervision (Official Authority)on supervision(Food Business) • Who? Food business operator (FBO) • Rules of the game? Legislation / GMP / GHP / SCS • Pre- / limiting conditions? 7 HACCP principles • Responsibility? Management • Referee? Quality manager • Competence? Derived / advisor Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  15. Base line concepts • Inspection Control Audit • Random indications Sequence of indications System indications • Instanteneous picture More observations System observations • Fact oriented More proces oriented SCS oriented • ‘Frozen’ GMP/GHP ‘Dynamic’ GMP/GHP Performance (SCS) • Prerequisites (Prerequisites) HACCP Plan / Dossier • (Personal) Personal Training / performance • Product / facts (Product / facts) Test results • < Vet / Inspector, but public interest first > Independent / 3rd. party • ‘Photo’ ‘Video’ ‘Script / senario’ Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  16. Base line concepts • Official Controls (Auditing): • Type: Food Business Retail Shop • Scope: Total FB Mostly part of activities • QM level: Professional Mostly less professional • Attention: More and more Part of attention • HACCP: Fully implemented Partly / GHP/ flexibility • Non compliance: Warning – admin.fine – (temporary) close down • Effect: Close down whole FB Close down part of activities • Interest: Out of business Still in business Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  17. Base line concepts • Primary sector=> transportation => reception => inspection => lairage => stunning => slaugthering => inspection => weighing/classification => chilling => cutting / boning => storage => • fresh meat • cold store • transportation => meat preparations =>Wholesale trade • meat products • animal by-products Retailer • Consumer Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  18. Base line concepts • GMP / GHP / SCS • Safe + Safe = Safe • Ingredients processing Food • Technical aspects • (direct / indirect) • Prerequisite + …… Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  19. Base line concepts • awareness TQM philosophy • audit HACCP system • control SOP’S process • inspection GMP / GHP product Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  20. Base line concepts • Risk analysis based on Reg. EC 852/2004, art 5 • Identifying hazards. • Identifying CCP’s. • Establishing Critical limits at CCP’s. • Establishing monitoring procedures at CCP’s. • Establishing corrective actions. • Establishing verification procedures. • Establishing documents and records demonstrating the effective • application of the measures 1 – 6. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  21. TIME FOR THE LEGAL ASPECTS Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  22. Legal aspects • Why legal aspects ? • ‘La raison d’être’ • Understand the meaning; • Make it your backbone! Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  23. Legal context – Hygiene Package OFFICIAL CONTROLS 882/2004 FEED 183/2005 HYGIENE 852/2004 853/2004 854/2004 99/2002 H 5 183/2005 ANIMAL BY- PRODUCTS 1774/2004 GMO 1829/2004 1830/2004 OTHER DIRECTIVES & REG. TSE / RES General Food Law 178/2002 EC Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  24. Legal context – Hygiene Package SANCO 660107 / 2005 TQM ISO 9001 / 19011 / 22000 SCS / HACCP Flexibility GMP / GHP 853/2004 854/2004 882/2004 852/2004 178/2002 Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  25. Food safety legislation Survey of the Hygiene Package • General Food law – Regulation 178/2002. • H 1 – Hygiene of foodstuffs – Regulation 852/2004. • H 2 – Hygiene rules for food of animal origin – Regulation 853/2004. • H 3 – Official controls (meat inspection) – Regulation 854/2004. • H 4 – Animal health – 2002/99 EC. • H 5 – Repealing 17 directives. • Feed Hygiene 183/2005 EC (January 12.) • Official Feed & Food Controls – Regulation 882/2004. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  26. Legal aspects • (1)Under Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, and in particular Article 4(6) thereof, the competent authorities of the Member States are required to carry out internal audits or have external audits carried out in order to ensure that they are achieving the objectives of that Regulation. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  27. Inspection and control versus audit • Inspection / control is what you see, observe and view the situation. • Audit is the art of finding out what you do not see. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  28. Legal aspects • Article 2(6) of Regulation (EU) 882/2004: definition of ‘audit’: • ‘Audit’ means a systematic and independent examination to determine whether activities and related results • comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.” • Audit: general and supervision oriented • System expert Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  29. Legal aspects • ‘Control’(not official) is an objective observation of the compliance/conformity or non-compliance/non-conformity of the course of a process with legal requirements and/or SOP’s in a food business. • Control is based on visible evidence or observations • Control: process/matter oriented • Risk expert Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  30. Legal aspects • Art. 2(7) of Reg. EC 882/2004, definition of inspection • ‘Inspection’ means the examination of any aspect of feed, food, animal health and animal welfare in order to verify that such aspect(s) comply with legal requirements of feed or food law, animal health and animal welfare. • Inspection is a systematic observation of visible evidence • Inspection: subject matter/product oriented • Product expert Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  31. Legal aspects • Inspections and controls are also ‘verifications’ of compliance of the Self Control System with the Food Law and therefore in line with audits. • Inspections and controls are part of an interim verification. • Basic know-how of auditing and audits is necessary! • Audit is part of official controls • Auditing, controlling and inspecting will be a ‘great’ part of your work as officials! Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  32. Legal aspects We will highlight some of the legal aspects Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  33. Legal aspects • Slides marked with a * at the end of the title are just mentioned for the sake of information and • to complete the (electronic) hand-out Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  34. Legal aspects (implementing)* • Implementingand Auditing HACCP Systems • 1. Guiding Principles: • 1.a Compliance with planned arrangements;largely document review but also on-site and are the planned arrangements are suitable to achieve the objectives . • 1.b Effective implementation; assessment of effectiveness of the extent to which planned results are achieved, on-site operational implementation has to be included. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  35. Legal aspects (implementing)* • 1.c Suitability to achieve objectives; of official controls / frequency and the methods having regard to the structure of the production chain(s) and to production practices and volume. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  36. Legal aspects (implementing)* • 2. Audit reporting; • 2.1Conclusionsshould address compliance with the planned arrangements / effectiveness of the implementation / suitability of the planned arrangements to achieve the stated objectives, as appropriate based on objective evidence • 2.2Recommendationsshould address the end-resultto be delivered rather than means of correcting non-compliance. Recommendations should be based on sound conclusions! Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  37. Legal aspects (implementing)* • 3. Follow-up of audit results; Where appropriate, an actionplan should be drawn up and delivered by the auditee. It should propose time-bound corrective and preventive action to address any weakness identified by the audit Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  38. Legal aspects (implementing)* • 3.1Action planto assess whether the proposed corrective and preventive action is sufficient to address the recommendations of the audit report‘action plans’ should include risk-based prioritisation and timeframes for completion of corrective and preventive action. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  39. Legal aspects (implementing)* • 3.2Corrective and preventive action;should not be confined to addressing specific technical requirements but should, where appropriate, include system-wide measures. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  40. Legal aspects (implementing)* • A root-cause analysis of any non-compliance should be conducted by the auditeein order to determine the most appropriate corrective and preventive action. Any differences of opinion between the auditee and audit team should be resolved. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  41. Legal aspects (implementing)* • 3.3Close-out:Mechanisms should be established to ensure that action plans are appropriate and that corrective and preventive actions are effectively completed in a timely manner. Procedures for verifying the close-out of the action plan should be agreed between the auditee and the audit team. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  42. Legal aspects (implementing)* • 4.Audit review and dissemination of best practice; The implications of audit findings for other sectors and regions should be considered, For this purpose, reports should be made available to other sectors and regions within the Member State and to the Commission. • 5.Resources;Member States should ensure that competent authorities have sufficient implementing powers, and resources, with the appropriate authority, to establish, implement and maintain an effective audit system. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  43. Legal aspects (implementing)* • 6. Auditor competence; 6.1 Generic knowledge and skills – audit principles, procedures and techniques; management/organisational skills. • 6.2 Specific technical knowledge and skills. • 6.3 Personal attributes. • 6.4Education • 6.5Work experience • 6.6 Auditor training and experience Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  44. Legal aspects (auditing)* • Implementing and auditingHACCP systems • 1. Nature of the Audit Process: • 1.1Systematic approach;should be applied to for the planning, conduct, follow-up and management of audits. • The audit process should: • Be the result of a transparent planning process • identifying risk-based priorities in line. • Form part of an audit programme that ensures • adequate coverage of all relevant areas of activity. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  45. Legal aspects (auditing)* • (continuation) • Be supported by documented audit procedures and • records to ensure consistency between auditors. • Include procedures for generating audit findings, • including the identification of evidence ofcompliance • and non-compliance. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  46. Legal aspects (auditing)* • (continuation) • Include procedures to review audit conclusions, in • order to identify system-wide strengths and • weaknesses in the control system. • Be monitored and reviewed to ensure the audit • programme's objectives have been met and to • identify opportunities for improvement. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  47. Legal aspects (auditing)* • 1.2 Transparency • In order to demonstrate the audit process is transparent, documented procedures should, in particular, include a clearly defined audit planning process, audit criteria and audit report-approval and distribution mechanisms. • Management and implementation of the audit process should be transparent to all relevant stakeholders. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  48. Legal aspects (auditing) • 1.3 Independence • The audit system, audit body and auditors should beindependent of the activity being audited and free frombias and conflicts of interest. • Auditors should not audit areas or activities for which they have direct responsibility. • Where the audit team makes recommendations for corrective and preventive action, the auditee should choose the methods to be applied for such action. Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  49. Legal aspects (auditing) • 1.3 Independence • Auditees should not be in a position to impede the audit programme, findings or conclusions! Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM

  50. Legal aspects (auditing)* • 1.4 Independent scrutiny • In order to check whether the audit process is achieving its objectives, the audit process should be subject to scrutiny by an independent person or body. • Such independent person or body should have sufficient authority, expertise and resources to carry out this task effectively. • Such independent persons should have access to the audit process and be empowered to contribute fully to it Workshop RTP 22343 on the New Hygiene Package - Kosice, Slovakia | H. Claus DVM