Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Session 4 Quality insurance of Belgian
inspection authorities: main process and concrete implementation
15/10/2014 G. DEFAYS (CRA-W), J. DECLERCQ (ILVO),
B. HUYGHEBAERT (CRA-W), D. NUYTTENS (ILVO)
Centre wallon de Recherches agronomiques Département Productions et Filières
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Introduction
Objectives of the ISO accreditation : • To promote the confidence of economic actors and
authorities. • To facilitate the free circulation of goods and services As an accreditation holder (ISO 17020), an inspection organism demonstrates/proves: • Its conformity to specification (laws, standards) • Its credibility (acknowledgement by authorities) • Its skills
Centre wallon de Recherches agronomiques Département Productions et Filières
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Belgian context
• Inspection in Belgium mandatory since 1 september 1995 . • Federal Agency for the Safety of the Food Chain (FAFSC) responsible
and supervising. • Delegates the inspection to 2 independent regional authorities. • Regional authorities are responsible for: Organisation, finances,
accreditation, inspections, follow up,…. • Close collaboration between the two regional authorities.
Flemish Region Institute for Agricultural and
Fisheries Research (ILVO)
Walloon region Centre Wallon de Recherches
Agronomiques (CRA-W)
Responsible for the Flemish region and Brussels capital region
Responsible for the Walloon region and the German speaking region
Centre wallon de Recherches agronomiques Département Productions et Filières
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Belgian context
A Royal Decree lists the 10 conditions that a inspection organisms of sprayer needs to fulfil in order to be authorized on the Belgian territory :
8. It must hold ISO 17020 accreditation or must obtain it before 30 June 2011.
Both ILVO and CRA-W fulfil the conditions and manage their own Quality System (QS)
Centre wallon de Recherches agronomiques Département Productions et Filières
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Inspection of sprayers: main process
The farmer’s sprayer
The sprayer’s inspection
The inspection’s report/certificate
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• Sprayer type
• Location
• Deadline
Input
Client’s needs
Describe all tasks and their order
Inspection of sprayer
• Report
• Payment
Output
Client’s satisfaction
Ressources
• Equipment
• Team
• Infrastructure
• Database
Improvements based on measurements and analysis
Typ
ical
ISO
ad
d-o
n
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ISO 17020 Process mapping: interaction between multiple process
Realization Trade, Marketing
Design
Management process
Pu
rch
ase
QS management process
CLI
ENTS
Logi
siti
c
Faci
litie
s
Hu
man
re
sso
urc
es
Ad
min
istr
atio
n,
fin
ance
CLIEN
TS
Design
Centre wallon de Recherches agronomiques Département Productions et Filières
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Quality System following ISO 17020
Level 1: Organization
Level 2: Planning
Level 3: Realization
Level 4: Check
Level 5: Improving action
Centre wallon de Recherches agronomiques Département Productions et Filières
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Level 1: Organization
• Legal structure
• Scope of activity
• Organization scheme
• Insurance & accounting
• Independence, impartiality, integrity
• Confidentiality
• Technical Manager & Quality Manager
1. To distinct « The inspection organism is
clearly a part of… » 2. To show relations
Precisely described and based on official
documentation or contract: “What? Who? Where?
When?”
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
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Chef de Département a.i
Ph. Druart
Coordinateur
d’Unité U6
Nutrition animale
et durabilité
E. Froidmont
Coordinateur
d’Unité U5
Stratégies
phytotechniques
J-P. Goffart
Coordinateur
d’Unité U7
Mode d’élevage,
bien-être et
qualité
J. Wavreille
Services support
Cf. page 2
Organigramme D2
Coordinateur
d’Unité U8
Machines et
infrastructures
B. Huyghebaert
Techn.expé/proj
Y. Delcorps
D. Verhulst
B. Vervaeren
Resp. R&D
Monogastriques
J. Wavreille
Rexpé/projet
J. Wavreille
V. Decruyenaere
V. Remience
A.Turlot
M.Moerman
S.Dufourny
Techn.expé/proj
P. Bosch
R. Bride
J-P. Ghys
Resp. R&D
Obtentions
végétales
L. Couvreur
Resp. R&D
Phytotechnie
grandes cultures
J-P. Goffart
Resp. R&D
Phytotechnie
horticole
H. Magein
Rexpé/projet
J-P. Goffart
M. Abras
D. Arlotti
F. Ben Abdallah
A.Delcour
Techn.expé/proj
D. Chaboteaux
L. Thomas
Rexpé/projet
H. Magein
S. Farvacque
Techn.expé/proj
F. Duchene
A. Marcoux
J-L. Prion
Techn.expé/proj
O. Coban
P. Gillet
G. Kets
V. Monjoie
L. Van Den
Wyngaert
P. Cocu
Ouvrier expé/proj
R. Chanet
D. Delooz
J.Detal
Ouvrier expé/proj
G. Vervotte
Resp. R&D
Rexpé/projet
Economie
Ph. Burny
Resp. R&D
Nutrition animale
et durabilité
E. Froidmont
Rexpé/projet
D. Franckson
E. Froidmont
P. Rondia
Techn.expé/proj
M. Didelez
S.Mathieux
F. Rouelle
V. Servais
A. Verbiest
Ouvrier expé/proj
Y. Letellier
Resp. R&D
Machines et
tracteurs
F. Rabier
Resp. R&D
Application
intrants
B. Huyghebaert
Resp. R&D
Infrastructures
agricoles
F. Rabier
Rtechn. 17020
SIP
B. Huyghebaert
Ress
G. Dubois Inspecteurs
M. De Geyter
P. Bienfait
P. Vanhufel
T. François
Rexpé/projet
F. Rabier
G.Defays
Rexpé/projet
B. Huyghebaert
G.Defays
Rexpé/projet
F. Rabier
Techn.expé/proj
D. Breuse, J. Bruart, G.
Dubois, J-P. Pierard,
J-F.Pollart
Rexpé/projet
DHS-VCU
G. Jacquemin
Filière Grandes
cultures
Rexpé/projet
H. Louppe
Secrétaire
K. D’Andrea
Filière Porcine (FPW)
Rexpé/projet
S. Renard
Techn.expé/projet
E. Montfort
Rcom
P. Maquet
Secrétaire
L.Rochette
Filière Lait
Rexpé/projet
C.Bauraind
Secrétariat
I.Monnart
Resp. R&D
Ruminants
V. Decruyenaere
Rlabo
PUL
B. Huyghebaert
Superviseurs
G.Defays
B. Huyghebaert
G.Dubois
Gestionnaire
administratif
N. Van de Walle
Rexpé/projet
PI
L. CouvreurOuvrier expé/
projet
N. Boulanger
P. Sansdrap
Th.Relekom
D. Louis
Ouvrier expé/proj
B.Beguin, F.De Cuyper,
A.Delooz
Level 1: Organization • Organization scheme
Centre wallon de Recherches agronomiques Département Productions et Filières
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Level 1: Organization
• Legal structure
• Scope of activity
• Organization scheme
• Insurance & accounting
• Independence, impartiality, integrity
• Confidentiality
• Technical Manager & Quality Manager
In adequacy with level of risk during inspection activities
• Measures to avoid pressures (commercial, financial, etc) and influences (internal or external)
• To define the level of independence (A, B, C)
• Code of conduct • Salary of staff not based
on inspection results Rely on :
• Staff involvement by signature of contract
• Protection of all stored data concerning inspection
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Level 2: Planning
• Politic of quality
• Documentation management
• Staff
• Facilities
• Equipment
Official statement by the management
• Adapted to the type, domain and volume of
activity • All the points of the ISO
must be treated • Always up to date • Fully controlled (redaction, evaluation,
publication, distribution, identification,…)
Need of a specific tool Material for Quality
Auditor
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
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Quality handbook
Organisationnal procedures
Performing procedures, Technical procedures, Instructions,
Recordings, Reports, specifications,…
Level 2: Planning • Documentation management
Centre wallon de Recherches agronomiques Département Productions et Filières
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Processus
organisation
d’inspection
Processus
gestion
documentaire
Processus
réalisation
d’inspection
Processus
Amélioration
continue
Processus
gestion des
ressources
PO-SIP-CONVOC
Planification et
convocation
PO-SIP-BD
Gestion de la
base de données
PO-SIP-COMPTA
Comptabilité et
facturation
PO-CRAW-DOC
Maîtrise de la
documentation et
des
enregistrements
PO-SIP-INSPEC
Inspection d’un
pulvérisateur
PT-SIP-GC
Méthode
d’inspection des
pulvérisateurs de
grande culture
PT-SIP-AR
Méthode
d’inspection des
pulvérisateurs
d’arboriculture
PO-CRAW-
REVDIR
Organisation des
revues de
direction
PO-CRAW-PERS
Organisation du
personnel
PO-CRAW-AUDIT
Organisation des
audits
PO-Francini-EQU
Gestion des
équipements
PO-Francini-
RECLAM
Gestion des
réclamations
PO-DEP-
NCACAP
Maîtrise des non-
conformités,
actions correctives
et préventives
PO-Francini-BAT
Gestion des
bâtiments
PO-SIP-AFSCA
Transmission des
informations à
l’AFSCA
PO-Francini-
RECENREG
Réception et
enregistrement
PE-SIP-MO…
Mode opératoire
des équipements
PE-SIP-MO…
Mode opératoire
des équipements
PE-SIP-MO…
Modes opératoires
des équipements
PO-SIP-SITE
Gestion des sites
d’inspections
PE-SIP-ETA…
Procédures
d’étalonnage des
équipements
PE-SIP-ETA…
Procédures
d’étalonnage des
équipements
PE-SIP-ETA…
Procédures
d’étalonnage des
équipements
PO-SIP-SECU
Sécurité et
prévention
Manuel Qualité Norme ISO 17020
Réglementation
en vigueur
PO-SIP-SUPERV
Gestion de la
supervision
PO-CRAW-FORM
Organisation de la
formation du
personnel
PO-SIP-CAM
Gestion des
camionnettes
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Level 2: Planning
• Staff – Every function must be described (tasks, training level,
…) function form (RQ, Inspectors, RT,…)
– Every function must have substitutes organization scheme
– Everybody must be regularly supervised (also on site) surpervision reports
– Based on training, experience, level of qualifications and evaluations reports
Complete “Staff folders”
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Level 2: Planning
• Politic of quality
• Documentation management
• Staff
• Facilities
• Equipment
• Rules of access and use • Procedures for purchases (selection,
evaluation, check at reception, …) • Stocks must be checked (calibration
if needed)
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Level 2: Planning
• Equipment
– ID for every equipment
– Up to date “Equipment folders” with all:
• ID, repairs, calibrations, in/out, …
– Software validation (even Excel macro)
– Data protection
– backup
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Level 3: Realization
• Contract review
• Inspection methods/procedures
• Sprayer handling
• Certificate/reports
• subcontracting
Belgium = notification to attend (determined by law)
• Based on references (legislation, standards)
• Designed to avoid hazards
• Fully described (documentation management)
• Comprising the day by day planning and organization of
inspections Material for Technical
Auditor
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Level 3: Realization
• Contract review
• Inspection methods/procedures
• Sprayer handling
• Certificate/reports
• subcontracting
• Unique identification (by serial number or
attributed ID) • Check before inspection
(preparation, anomaly) • Measures to avoid the
damaging
• ID • References (law,
standards) • Global results and sub-
results (ok, ko, NC) • Responsibilities (name) Favorite element of
auditors
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
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Level 4: Check
• recordings
• calibration
• Complaints and appeal
• Nonconformity management
• Internal audit
Quality System following ISO 17020
Typical ISO
add
-on
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Level 4: Check
• Recordings, to evaluate the inspections, traceability by ID of the certificates
– All measurements and observations realized during the inspections
– A copy of every certificate
– plannings, check-list, …
– All data recorded directly (on-site) or as fast as possible
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Level 4: Check
• Recordings, to evaluate the process in general – Staff trainings and habilitations
– Equipment calibrations
– Internal audit reports
– Nonconformity reports
– Meeting reports
– …
Everything should be recorded
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
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Level 4: Check
• calibration
– Initial calibration before use
– Follow a strict planning
– Linked to national measurement standards
– Follow existing standardized procedures
– Regular check (≠ calibration) daily?
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Level 4: Check
• recordings
• calibration
• Complaints and appeal
• Nonconformity management
• Internal audit
A whole process for all complaints
= procedures to record and to treat
Always proposed to farmers
Final check by analysis during review by
management
Process to manage all dysfunctions of the QS or
the inspections = procedures to record and
treat
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
www.cra.wallonie.be
Level 4: Check
• Nonconformity management
– Responsibilities (decisions) and authorizations (actions) are well defined within the staff
– Always a first correction as soon as NC is detected
– The relevance to stop the inspection and to contact the client must always be evaluated
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
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Enregistrement NC (description)
Correction NC
Correction efficace? AC nécessaire ?
Description AC
Réalisation AC
Evaluation de l’efficacité de l’AC
Analyse d’impact sur résultats
antérieurs, et analyse de causes
de la NC
AC efficace?
Clôture NC
OUI
Tout membre du personnel
Rlabo, Dir. étude, Rtechn.ISO17020, Rexpé si problème technique
RQ, si problème organisationnel
Rlabo, ,Dir. Étude, Rtechn.ISO 17020, Rexpé
si problème technique
RQ si problème organisationnel
RQ
OUI
OUI
NON
Rlabo, Dir. étude, Rtechn.ISO17020, Rexpé si problème technique
RQ si problème organisationnel
Tout membre du personnel
NON
Vérification de l’AC
RQ
RQ
NON
NC recording
NC first correction Impacts & causes
analysis
Effective? Corrective action?
CA description
CA realization
CA check
CA evaluation
Effective?
Close?
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Level 4: Check
• recordings
• calibration
• Complaints and appeal
• Nonconformity management
• Internal audit 1. Objectives 2. Scope of audit
3. Realization 4. Reports
5. Nonconformity 6. Check on next audit
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
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Level 5: Improving action
• Corrective actions
• Review by the management
Directly linked to NC management
• Analysis of causes • Choice of actions
• Check of correction
Review of all results: • Inspections
• Audits • NC
• Complaints and appeals • …
Must product proposals of improvements
Quality System following ISO 17020
Centre wallon de Recherches agronomiques Département Productions et Filières
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Implementation of ISO 17020 Commitment of the management team
Raising awareness of the staff
Audit of existing system
Objectives definition
Means implementation
Looking for improvements
Solutions implementation
Results measurements
First official audit
Continuous improvement
Documentation
9 – 18 months
Implementation
3 months
Corrective actions
3 months
Current situation
Internal audit
Centre wallon de Recherches agronomiques Département Productions et Filières
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Conclusions
• The doubt is not allowed in any case • The visibility, the production of proofs and performance indicators,
represent a great part of the work • The more defined, the more difficult to manage • Complaints and Nonconformity management process are time
consuming • Time consuming to implement adaptations or changements
(documentation management) • Continuous improvement process = never ending story • Most of the budget goes to RQ and external audit team
(accreditation organism) • Sometimes the Auditors go to far • Gain: better service? Yes : QS forced us to question ourselves
constantly Improvement, impartiality, uniformity…
Centre wallon de Recherches agronomiques Département Productions et Filières
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Thanks for your attention
Institute for Agricultural and Fisheries Research (ILVO)
Wallon de Recherches Agronomiques (CRA-W)
ILVO – Agrotechnics Burgemeesters van Gansberghelaan 115 bus 1 9820 Merelbeke (Belgium) Tel + 32 (0) 9 272 27 57 Fax + 32 (0) 9 272 28 02 e-mail: [email protected] website: www.ilvo.vlaanderen.be
CRA-w -Département Génie Rural Chaussée de Namur 146 5030 Gembloux (Belgique) Tel +32 (0)81 62 71 67 Fax +32 (0)81 61 58 47 e-mail:servicepulvé[email protected] website: www.cra.wallonie.be