1. INSTITUTE of FOOD SCIENCE & TECHNOLOGY South Wales and the West of England The CHANGING FACE of AUDITING Eastwood Park Conference Centre 13 October 2011 NATIONAL AUDITS by the FVO John Hukku BVMS, MSc, DTVM, MRCVS Formerly Regional Meat Hygiene Adviser in MAFF and Veterinary Meat Hygiene Adviser in Food Standards Agency 1

2. WHAT is the FVO? FVO = Food & Veterinary Office of DG-SANCO The Commission, as guardian of the European Community Treaties, is responsible for ensuring that EU legislation on food safety, animal health & welfare, and plant health is properly implemented and enforced in Member States. As a Commission service, the FVO plays the essential role in fulfilling this task. 2

3. How does FVO achieve this? 3

4. The MISSION of the FVO is to fulfil the following criteria through audits, inspections and related activities - 4

5. (1) To check on compliance with the legislative requirements of EU food safety and quality, animal health and welfare, and plant health in MSs; & (2) To check on compliance with EU legislative requirements for the export of Third Countries products into the EU; 5

6. (3) To contribute to the development of EU policy in food safety, animal health and welfare, as well as plant health; (4) To contribute to the development and implementation of effective control systems in food safety, animal health and welfare, and plant health; and (5) To inform stakeholders of the outcome of its audits and inspections. 6

7. What legal authority does FVO have to enable it to function? Regulation 882/2004 Article 45 (Community Controls in Member States) 7

8. Article 45 authorizes Commission Experts to audit in MSs (± National Experts), in order to verify the following – (1) that Official Controls take place in accordance with “National Control Plan”; & (2) that National Control Plans are being implemented, including “On-the-Spot” assessments of Official Controls in reality. 8

9. (3) Competent Authorities function correctly and are well organised. ------------------------------------------------------------------------- EU Commission (FVO) shall report on its Missions in MSs (paper & internet). Report may contain recommendations for MSs to improve compliance with laws on food, feed, animal health and welfare, which MSs must implement. 9

10. 1 Experts in Food/Feed Hygiene, ABP, and Animal Health/Welfare from MSs. 2 Must be fluent in English (language of the Commission). 3 FVO currently has c.80 Inspectors. Who are the FVO Auditors? 10

11. 3 Inspectors are chosen on basis of rigorous examinations and interviews. 4 Trained for at least 6 months before being permitted to work as Lead Auditor. 5 Supported by “National Experts” from all MSs (who also receive special training). 11

12. Who audits the auditors? As an “Inspection Body”, FVO is obliged to operate to standards defined in ISO 17020:2004 (internationally accepted standards for Inspection Bodies). ISO grants “accreditation” to “Inspection Bodies”, etc. 12

13. FVO Annual AUDIT PROGRAMME is listed on Commission’s Web Site – usually twice a year - in advance. Member States’ Central Competent Authority is notified of dates for such audit missions c.30 days in advance – sometimes less. 13

14. Organization & Planning of Audits FVO contacts FSA or DEFRA to announce dates & general location of audit mission, e.g. Wales, Scotland, Northern Ireland or particular parts of England – often two different regions per mission. CCA will inform Local Authorities if audits are scheduled in their territory where LA has been delegated powers as “Competent Authority”. CCA will also indicate sector to be audited. 14

15. Let us now assume audit location has been chosen, and all relevant parties notified – including industrial sector. FVO will have indicated length of its Mission – usually 2 weeks, including Initial and Concluding Meetings with the CCA. FVO will also notify number of establishments to be visited for REALITY CHECKS. FVO always chooses 50% of establishments. During all missions, documentary checks always precede Reality Checks - and may also be partially repeated at the conclusion of the reality checks. 15

16. Essential Documentary Checks - 1 Processes covered by Establishment Approval. Inspectors always ask for Checklists, to verify exactly what compliance checks were made, and when. They may ask about experience of CA staff who carry out these compliance checks. They always ask for APPROVAL DOCUMENTS, relating to all factories visited – LAs often asked for a list of all locally-approved establishments. 16

17. Essential Documentary Checks - 2 Standard Operating Procedures (SOPs). Pre-Requisite Programmes as foundation for HACCP food safety controls. 17

18. Essential Documentary Checks - 3 HACCP Plan for each establishment, including essential Process Flows & fully documented Hazard Analysis. All monitoring documents (for PRPs and CCPs) 18

19. CCP MONITORING Documents Includes – – Oven temperatures – Cooked Product temperatures – Time/temperature relationships – Metal detection – Calibration of Metal Detector – Microbiology of surfaces and final products – Chemical Composition 19

20. REALITY CHECKS - 1 Inspectors will expect Operators to demonstrate - – Establishment in normal operation. – Pre-Requisites programmes in action, including monitoring & records. – how their HACCP Plan works in practice. – CP Monitoring and corrective actions in reality. 20

21. REALITY CHECKS - 2 Inspectors will also expect Local Authority Health officials to demonstrate how they audit both Operator “Own-Checks” and the application of the Seven HACCP Principles. They will also expect LA officials to produce documentation of such audits. 21

22. In conclusion …….. For FVO audits, ensure that – You can produce a VALID approval document for scrutiny, together with - Up-to-date Factory Layout drawing & accurate Process Flow diagram for HACCP purposes. Pre-Requisite Programmes are genuinely implemented & fully documented. HACCP Plan is accurately designed, correctly implemented, and fully documented. 22

23. and finally …….. If you conscientiously implement the issues listed above, an FVO audit will be a piece of cake, and the Inspectors will compliment you! However, take my advice – don’t try to bluff the FVO inspectors - that never works!! So – GOOD LUCK! 23