introduction to the audit system(s) of germany using the example of lower saxony
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Introduction to the audit system(s) of Germany using the example of Lower Saxony. Quality Management including Internal Audits in Germany - responsibilities -. The Political System in Germany. Baden-Würtemberg. Bayern. Berlin. Brandenburg. Bremen. Hamburg. Hessen. Mecklenburg-Vorpommern. - PowerPoint PPT PresentationTRANSCRIPT
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
1
Introduction to the audit system(s) of Germany
using the example of Lower Saxony
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
Quality Management including Internal Audits in Germany
- responsibilities -
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
Baden-Würtemberg Bayern Berlin Brandenburg Bremen Hamburg Hessen Mecklenburg-Vorpommern
Niedersachsen Nordrhein-Westfalen Rheinland-Pfalz Saarland Sachsen Sachsen-Anhalt Schleswig-Holstein Thüringen
The Political System in Germany
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
Position of Lower Saxony
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
Administrative Structure of the Federal Republic:
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
Competence of Legislation in Germany:
Bund German Federation
Federal Law regulates all essential matter of facts:- Laws: e.g. LFGB,- Regulations/ Acts: e.g. Tier-LMHV,- administrative Regulations: e.g. AVV RÜb,
Länder
Land Law is limited to:- Laws for specific Execution,- Regulations for Responsibilities,- administrative Legislation
concurrent legislationArt. 74 (1) No 20 GC
Federal law shall override Land Law.
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
Organizational Structure
LAV Länderarbeitsgemeinschaft Verbraucherschutz -Veterinary Authorities of the States of the Federal Republic of Germany
LAV
AGT ALB AGEAD AfABAGTAMAGTT AFFL AFU AGQM
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
AG QM - working committee QM
documented procedures as cross-state framework
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
• 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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
10
Quality Management and Audit System
in Lower Saxony
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
11
= Einheitliches Qualitätsmanagement In Niedersächsischen Organisationen
des gesundheitlichen Verbraucherschutzes=
Uniform Quality Management in Official Organisations for Consumer Protection in
Lower Saxony
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
12
QM in Lower Saxony- basic informations -
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
13
Relevant -public- Authoritiesfor 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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
14
Rural Districts in Lower Saxony
Ministry
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
15
Lower Saxony Ministry for Nutrition, Agriculture, Consumer Protection and Rural Development , Department 2
-ML-
36 Administrative (Rural) Districts
6 Independant Cities 5 Local Authorities (Abattoirs)
Lower Saxony Federal State Office for Consumer
Protection and Food Safety -LAVES-
professional supervision disciplinary and
professional supervision
The Official Authorities
responsible for control and sampling:food, animal health and animal welfare
responsible for control and sampling:feed, veterinary drugs
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
Organigram QM
ML
Local Authorityfor Consumer
Protection
Local Authorityfor Consumer
Protection
Local Authorityfor Consumer
ProtectionLAVES
QM
State-QM
QM QM LAVES-QM
QM ML
Requirements of QMS
Supervision, professional
Connection to Employer
Comments:
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
17
Documentation over all sectors: 298 documents
Operations Sheets, Forms/Checklists referring to each
working station
Documented Procedures, Tables higher ranking
Manual uniform, statewide only one
integrated horizontal approach
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
19
QM in Lower Saxony- system of internal audits -
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
22Internal 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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
23Internal 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)
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
24Internal 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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
26
Evaluation of audit results, example of 2009:
0
5
10
15
20
25
30
35
40
1 2 3 4 5 6 7 8 9 10
43 audits 33 38 27 9 35 19 0 3 0 19 183
basic process 1 2 3 4 5 6 7 8 9 10
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
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 documents10:15 Management- and employees process11:15 Systemic process11:45 Customers process I13:00 Lunch break
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
time topic13:30 Customers process II14:30 Process of internal organization, purchasing15:00 Other processes: IaC, KAIZEN, additional
process15:30 Discussion within the auditteam, draft report
16:15 Discussion with auditee, comments, final audit report
16:30 The end
Auditschedule II
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
basic document: documented audit body procedurefurthermore (records):audit-5years-planaudit(detail)plandeclaration of confidencefinal audit reportreport including follow-up result for each audit findingauditees action planannual quality report (management review)
Documentation of audit process in Lower Saxony:
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
30
KVP = continual improvement
from all processes
MPA-10-002-00Corrective and
preventive actions
MPA-10-003-00 Official
suggestion system
MPA-10-001-00 Internal audits Management
process
MFB-10-003-00Quality report
Efficiency
Improvement
BVW
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
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
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
Training-on-the-jobOn site auditing with trainer (here: inspection of biogas production plant)
Dr. Dorit Stehr QM-L
www.ml.niedersachsen.de
Ministry of Food, Agriculture, Consumer Protection and Rural Development
34
Independent Scrutiny of the Audit Process
independent scrutinyby staff of accreditaion body
competent authority
professional supervision (ML)
examination of suitability
auditplan,5 years-plan, audit report, action plancertificate for the unit
evaluation MANCP, annual report,emergencyplan, follow-up results
evaluation of the entire system in Lower Saxony.
certificate for the entire System in Lower Saxony
result of independent scrutiny
audit system EQUINOexamination of compliance
and effective implementation
Individual auditplan,5 years-plan
audit report
MANCP, annual report
emergencyplan