dr. dorit stehr qm-l ministry of food, agriculture, consumer protection and rural development 1...

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




Quality Management including Internal Audits in Germany

- responsibilities -




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




Position of Lower Saxony




Administrative Structure of the Federal Republic:




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,

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

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.




Organizational Structure

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

LAV

AGT ALB AGEAD AfABAGTAMAGTT AFFL AFU AGQM




AG QM - working committee QM

documented procedures as cross-state framework




• 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




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Quality Management and Audit System

in Lower Saxony




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= Einheitliches Qualitätsmanagement In Niedersächsischen Organisationen

des gesundheitlichen Verbraucherschutzes=

Uniform Quality Management in Official Organisations for Consumer Protection in

Lower Saxony




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QM in Lower Saxony

- basic informations -




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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




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Rural Districts in Lower Saxony

Ministry




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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




Organigram QM

ML

Local Authorityfor Consumer

Protection


Protection


ProtectionLAVES

QM

State-QM

QM QM LAVES-QM

QM ML

Requirements of QMS

Supervision, professional

Connection to Employer

Comments:




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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




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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




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QM in Lower Saxony

- system of internal audits -




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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




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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




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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

• 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)




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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




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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




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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




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




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

Auditschedule II




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:




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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




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• 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




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• 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




Training-on-the-job

On site auditing with trainer (here: inspection of biogas production plant)




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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

dr. dorit stehr qm-l ministry of food, agriculture, consumer protection and rural development 1...

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