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

Quality Management including Internal Audits in Germany - responsibilities -

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

Position of Lower Saxony

Administrative Structure of the Federal Republic:

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

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

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

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)

Quality Management and Audit System in Lower Saxony

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

QM in Lower Saxony - basic informations -

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

Rural Districts in Lower Saxony Ministry

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

Organigram QM

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

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

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

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

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

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

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)

Internal Audits basically identical auditplan in each unit 24 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

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

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

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

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

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)

KVP = continual improvement

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.)

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

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

Independent Scrutiny of the Audit Process