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

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

3. Mecklenburg-Vorpommern
The Political System in Germany
16 Bundesländer
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 of facts:
Laws: e.g. LFGB,
Regulations/ Acts: e.g. Tier-LMHV,
administrative Regulations: e.g. AVV RÜb,
concurrent legislation Art. 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. Situation in the federal german system
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)

10. Quality Management and Audit System
in Lower Saxony

11. Einheitliches Qualitätsmanagement In Niedersächsischen Organisationen =
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. Relevant -public- Authorities for Consumer Protection
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

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. Official controls/ inspection of plants (not „audit“):
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

19. - system of internal audits -
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 and Decision 2006/677/EC
responsible for audit body: QM-L

21. Arguments for a statewide system (one central audit body):
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

22. Internal Audits
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

23. Internal Audits 23
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)

24. Internal Audits basically identical auditplan in each unit24
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

25. Further information:
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

26. Evaluation of audit results, example of 2009:
43 audits 33 38 27 9 35 19 3
183
basic process 1 2 4 5 6 7 8 10

27. Auditschedule I -part of audit(detail)plan- time topic 9:00
Meeting of the auditteam
9:15
Introduction/short visit of all locations
9:45
Review of specific local documents
10:15
Management- and employees process
11:15
Systemic process
11:45
Customers process I
13:00
Lunch break

28. Auditschedule II time topic 13:30 Customers process II 14:30
Process of internal organization, purchasing
15:00
Other processes: IaC, KAIZEN, additional process
15:30
Discussion within the auditteam, draft report
16:15
Discussion with auditee, comments, final audit report
16:30
The end

29. Documentation of audit process in Lower Saxony:
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)

30. KVP = continual improvement

31. Requirements for auditors
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.)

32. Maintenance and improvement of competence
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

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

34. Independent Scrutiny of the Audit Process