quality insurance of belgian inspection authorities: main ... · centre wallon de recherches...

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)


www.cra.wallonie.be

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


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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


www.cra.wallonie.be

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)


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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


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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


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• 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?”



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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


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• 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



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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



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Quality handbook

Organisationnal procedures

Performing procedures, Technical procedures, Instructions,

Recordings, Reports, specifications,…

Level 2: Planning • Documentation management


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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”



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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)



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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



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• 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



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• 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



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Level 4: Check

• recordings

• calibration

• Complaints and appeal

• Nonconformity management

• Internal audit


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



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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



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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?



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Level 4: Check

• recordings

• calibration



• 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



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Level 4: Check


– 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



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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



• Internal audit 1. Objectives 2. Scope of audit

3. Realization 4. Reports

5. Nonconformity 6. Check on next audit



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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



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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


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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…


www.cra.wallonie.be

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

quality insurance of belgian inspection authorities: main ... · centre wallon de recherches...

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