Introduction to the audit system(s) of Germany using the example of Lower Saxony

1. Introduction to the audit system(s) of Germanyusing the example of Lower Saxony

2. Quality Management including Internal Audits in Germany - responsibilities -

3. The Political System in Germany Baden-Würtemberg Bayern Berlin Brandenburg Bremen Hamburg Hessen Mecklenburg-Vorpommern Niedersachsen Nordrhein-Westfalen Rheinland-Pfalz Saarland Sachsen Sachsen-Anhalt Schleswig-Holstein Thüringen

4. Position of Lower Saxony

5. Administrative Structure of the Federal Republic:

6. Competence of Legislation in Germany: • Federal Law regulates all essential matter offacts: • Laws: e.g. LFGB, • Regulations/ Acts: e.g. Tier-LMHV, • administrative Regulations: e.g. AVV RÜb, concurrent legislationArt. 74 (1) No 20 GC Bund German Federation • Land Law is limited to: • Laws for specific Execution, • Regulations for Responsibilities, • administrative Legislation Federal law shall override Land Law. Länder

7. LAV Länderarbeitsgemeinschaft Verbraucherschutz - Veterinary Authorities of the States of the Federal Republic of Germany Organizational Structure

8. AG QM - working committee QM documented procedures as cross-state framework

9. 16 different solutions for implementation of quality management (from specific in each authority to statewide approach) 16 auditsystems, basically not comparible (f.e.: statewide or not, over all sections or not, based on ISO standards or not, directly combined with professional supervision or not) Situation in the federal german system

10. Quality Management and Audit System in Lower Saxony

11. = Einheitliches Qualitätsmanagement In Niedersächsischen Organisationen des gesundheitlichen Verbraucherschutzes = Uniform Quality Management in Official Organisations for Consumer Protection in Lower Saxony

12. QM in Lower Saxony - basic informations -

13. Lower Saxony Ministry of Food, Agriculture, Consumer Protection and Rural Development, ML Lower Saxony Federal State Office for Consumer Protection and Food Safety, LAVES (ISO 9001 Certification achieved in 2007) competent authorities of 36 administrative districts, 6 independant cities and 5 other local authorities Relevant -public- Authoritiesfor Consumer Protection

14. Rural Districts in Lower Saxony Ministry

15. The Official Authorities responsible for control and sampling: food, animal health and animal welfare responsible for control and sampling: feed, veterinary drugs

16. Organigram QM

17. Documentation over all sectors: 298 documents Manual uniform, statewide only one integrated horizontal approach Documented Procedures, Tables higher ranking Operations Sheets, Forms/Checklists referring to each working station

18. statewide on the basis of documented procedures uniform, of consistently high quality, with facility for creating additional documents in each unit effective and efficient coordination between central and local level training of the staff appropriate facilities and equipment Official controls/ inspection of plants (not „audit“):

19. QM in Lower Saxony - system of internal audits -

20. System of internal audits („internal“ = within all official authorities for consumer protection in Lower Saxony), created on basis of DIN EN ISO 19011 and Decision 2006/677/EC responsible for audit body: QM-L

21. good coordination of annual audit programme lower costs for each organization uniform audits all over Lower Saxony experienced auditors, high level audits comparible audit results, evaluation possible: good overview over all units learning (audit-)organization by continual improvement Arguments for a statewide system (one central audit body):

22. since 5 years basically one audit /y in each organization (bigger organizations up to five/y): regular, not risk based furthermore: in special situations (f.e. dioxine in feed) non-regular audits 24 trained auditors, senior auditors with individual certification (TÜV), audit team (four-eyes principle): leader and co-auditor, sometimes with the advice of technical experts Internal Audits

23. Internal Audits billing: flat-rate (auditee pays to auditor-delegating authority) annual audit schedule made by QM-L at request of the authorities, updates publicated monthly (audit programme) average of 50 audits/y in Lower Saxony all sectors of Reg. 882/2004 covered within five years („5-years plan“ under the responsibility of each unit, checked by auditors) 23

24. Internal Audits basically identical auditplan in each unit on site auditing (auditors attend controls of plants, sampling a.s.o. for verification) audits are representative spot tests in regular units an audit lasts one day auditors and audit body are independant 24

25. evaluation of audit results by controlling group (continual improvement; KAIZEN), summeries are publicated on CIRCA platform annual report by controlling group for the management committee (input for management review) all audit evidences and findings maintain at the audit client (local office); responsable for continual improvement: top management of each authority high acceptance in all organizations Further information:

26. Evaluation of audit results, example of 2009:

27. Auditschedule I -part of audit(detail)plan-

28. Auditschedule II

29. basic document: documented audit body procedure furthermore (records): audit-5years-plan audit(detail)plan declaration of confidence final audit report report including follow-up result for each audit finding auditees action plan annual quality report (management review) Documentation of audit process in Lower Saxony:

30. KVP = continual improvement

31. persons with adequate personal attributes, only from involved organisations, recommended by controlling group basically all professional categories possible, highly qualified apprenticeship proven, many years of work experience profound knowledge and skills of QMS proven -often QM in their own organization- independency of the auditee: no disciplinary supervision function of the auditors (s.a.) Requirements for auditors

32. 1 d theoretical foundations 4 d training-on-the-job (1 d x as audit team leader and 1 d x as co-auditor under supervision) after this 2 d/y advanced training for continual professional development Maintenance and improvement of competence

33. Training-on-the-job On site auditing with trainer (here: inspection of biogas production plant)

34. Independent Scrutiny of the Audit Process