Quality Manual - VetAgro Sup · 2020. 5. 26. · Quality Manual Code du document : Manuel Qualité Indice de révision : Version 2 Page 3 sur 15 1. Introduction 1.1 History of VetAgro

Higher Education and Research Institution,

for the training of veterinarians, agricultural engineers and

veterinary public health inspectors

Quality Manual

Writing: Marie BOUCHARD Quality Manager

Audit: Stéphane VAXELAIRE Chief of Staff

Approval: Emmanuelle SOUBEYRAN Dean

Implementation: January 2020

Quality Manual Code du document :

Manuel Qualité

Indice de révision :

Version 2

Page 2 sur 15

Table of Contents

1. Introduction ...................................................................................................................... 3

1.1 History of VetAgro Sup ................................................................................................... 3

1.2. VetAgro Sup in figures .................................................................................................. 3

1.3 Tasks and activities ......................................................................................................... 4

1.4. Purpose of the Quality Manual ................................................................................... 5

2. Scope of the Manual ...................................................................................................... 6

3. Quality Management System ........................................................................................ 7

3.1 Implementation of the Quality Policy ......................................................................... 7

3.1.1. Process mapping ................................................................................................... 8

3.1.2. Monitoring, measurement and analysis ............................................................. 8

3.2. Planning ........................................................................................................................ 10

3.3. Awareness .................................................................................................................... 10

3.4. Documentation requirements ................................................................................... 11

4. Management's Responsibility ....................................................................................... 12

4.1. Quality policy ............................................................................................................... 12

4.2. Planning ........................................................................................................................ 12

4.3. Responsibility, authority, competence and communication ............................... 13

4.3.1. Responsibility and authority ................................................................................ 13

4.3.2. Management representative ............................................................................ 14

4.3.3. Internal communication ..................................................................................... 14

5. Conclusion .......................................................................................................................... 15


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1. Introduction

1.1 History of VetAgro Sup

VetAgro Sup was created in 2010 from the merge of the National Veterinary

School of Lyon, the National School of Veterinary Services and the National

Engineering School of Agricultural Work of Clermont-Ferrand.

VetAgro Sup is a higher education and research establishment under the

supervision of the Ministry of Food and Agriculture. It develops training and

research activities that naturally in line with the key thematic «Global Health»,

a rising from the interface between human, animal and environmental health.

The Institution has expertise that supports national, European and international

economic actors in the fields of Food, Animal Health, Agronomic Sciences and

Environment.

1.2. VetAgro Sup in figures

Sources: VetAgro Sup Facts and Figures 2018


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1.3 Tasks and activities

The main missions of VetAgro Sup are higher education, research and the valorisation

of knowledge through expertise.

Sources: VetAgro Sup Facts and Figures 2018

Higher education

This institution is the only French structure to train agricultural engineers, veterinary

doctors and veterinary public health inspectors within a public establishment of a

scientific, cultural and professional nature (EPCSCP). This model is in line with

international models, reinforcing the international legibility of the establishment.

In addition to the main training courses listed above, VetAgro Sup also offers co-

accredited Masters, Licences and post-DEFV (Diplomas of Veterinary Specialisation)

courses:

o Master " Sectorial Management " ;

o Master "Biodiversity, Ecology and Evolution";

o Master "Integrative Biology and Physiology";

o Master's degree in "Cancer";

o Master "Microbiology";

o Master's Degree in Pharmaceutical Sciences;

o Master's degree in "Territorial Management and Local Development";

o Master's degree in Plant Biology;

o Master's degree in "Biology - Health";

o Master's degree in "Agricultural, food and environmental sciences and

technology";

o Master's Degree in "Comparative Public Policies and Governments";

o Professional degree "Organic Agriculture: Consulting and Development";

o Professional degree "Animal Production: Technologies in Physiology and

Physiopathology";

o Boarding schools (pets, ruminants, horses);

o Residential schools (equine surgery, equine internal medicine, pet surgery,

animal reproduction, pet internal medicine, dermatology, oncology);

o Certificates of Advanced Veterinary Studies;

o Diplomas of Specialized Veterinary Studies.


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The master's degree "Social and Health Policy Issues", in which VetAgro Sup

participates, is open to veterinary students and agricultural engineers.

Research

The teacher-researchers on both campuses work in 9 Mixed Research Units (UMR), 3

Own Units or as a teacher-researcher in individual scientific activity in a research unit

outside VetAgro Sup. They work together on common themes:

o Accompanying the transition of agricultural and agri-food production systems;

o Controlling health risks;

o Promoting quality of life and combating disabling human and animal diseases.

Exploitation of knowledge/expertise

Given the quality of expertise of its researchers, the competence of its technical staff

and the performance of its scientific equipment, VetAgro Sup offers a wide range of

services to industrialists and institutional partners:

o Organoleptic, nutritional and health analyses of food;

o Auditing and monitoring of farms, animal welfare;

o Agronomic expertise;

o Territorial development engineering;

o Development of new animal models, new therapeutics and medical devices;

o Clinical and preclinical analyses;

o Wildlife;

o Clinical and diagnostic expertise.

In its 2016-2020 Establishment Project, VetAgro Sup sets out all of its assets enabling it

to be a major player in the development of global health. It wishes to make it the

central axis of its action and thus contribute to the physical, mental and social well-

being of mankind.

1.4. Purpose of the Quality Manual

The Quality Manual gives a description of VetAgro Sup's Quality Management System,

based on the ISO 9001 standard (current version). The process approach of the system

allows a transverse piloting of the Establishment in all its components and allows to go

beyond the organization chart.

This VetAgro Sup system presentation complies with the European Association of

Veterinary Education Establishments (AEEEV) standards and integrates the ESG

standards (Standards and Guidelines for quality assurance in the European higher

education area), which are also monitored by the Commission of Engineers degrees

(CTI).

It is an evolving quality document, revised as necessary, under the responsibility of the

VetAgro Sup Quality Manager, which describes the implementation of VetAgro Sup's

quality policy, the targeted objectives associated with it and the measurement of the

effectiveness of this implementation.


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Diffusion

The Quality Manual (current version) is available on the Intranet and the VetAgro

Sup’s website.

Modification and updating

The Quality Manual is modified whenever the VetAgro Sup organization requires it.

However, it is reviewed at least once a year.

2. Scope of the Manual

The Quality Management System applies to the different functional units of VetAgro

sup, whether they are in charge of teaching activities (initial and further training),

scientific activities, exploitation of results/expertise activities or associated support or

management activities.

VetAgro Sup has chosen to set up its Quality Management System on the basis of the

ISO 9001 standard, without, however, opting for certification for the entire perimeter

of VetAgro Sup.

At the same time, within VetAgro Sup, certain technical platforms have implemented

a specific QMS, according to standards adapted to the activity.

For example:

BioVetim has been compliant with Good Laboratory

Practices - GLP (decree of 14 March 2000 - ANSM) since

2002;

Biovivo is accredited by the AAALAC (Association for

Assessment and Accreditation of Laboratory Animal Care

International) and offers to conduct GLP-compliant study

phases;

LMAP/LNR STEC is accredited, for certain analyses it carries

out, by the COFRAC laboratories section, according to the

NF EN ISO/CEI 17 025 standard, under the n°1-5902 (scope

available on www.cofrac.fr);

BRC CryAnim is certified NF S-96 900 and ISO 9001;

The licence Pro ABCD, carried by VetAgro Sup and the

Clermont Auvergne University is certified ISO 9001 for its

activities of coordination of the network of partner

establishments;

CPVL fully meets the requirements of ISO 9001, in

accordance with the expectations of ANSES, which audits its


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operation ;

The Leptospires and Veterinary Analysis Laboratory (LAV) and the food

characterization laboratories operate according to the principles of ISO 9001, while

the Medical Biology Laboratory bases its operation on a QMS that follows the

requirements of ISO 15 189 with the aim of being able to accommodate a clinical

pathology resident. Finally, the Toxicology laboratory is based on the ISO 17025

standard for carrying out its analyses.

These structures have specific documentation in accordance with the chosen

reference frame. Their support activities, centralised by the Establishment, are carried

out under the cover of a Collaboration Charter.

3. Quality Management System

3.1 Implementation of the Quality Policy

The drafting and dissemination of the Quality Policy by the management shows its

commitment to do everything possible to obtain the satisfaction of all stakeholders, to

maintain performance and to adopt a continuous improvement approach.

VetAgro Sup wants to maintain and bring to life a quality management system

adapted to the teaching, research, development and support processes of the

institution. VetAgro Sup also aims to set up or maintain quality management systems

within the laboratories and technical platforms according to the reference systems

adapted to each activity (COFRAC ISO NF EN CEI 17 025 accreditation, GLP

compliance, AAALAC accreditation, ISO 9001 or NF S96-900 certification).

To reach this level, quality objectives are defined by management, taking into

account the needs and obligations of the organization, the results of management

reviews, current performance and the degree of satisfaction of stakeholders. These

objectives are validated during the quality management review.


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In order to meet the requirements of the defined objectives, management implements

quality planning. The objectives are consistent with the quality policy; they are

translated into quality indicators.

The fundamental management principles, defined by the management of VetAgro

Sup, to achieve the quality objectives are:

o The development of listening to the stakeholders through a better

understanding of the needs expressed;

o The involvement of all VetAgro Sup departments and divisions;

o The continuous improvement which constitutes a permanent objective;

o Decision-making based on the analysis of data and information collected;

o The process approach.

3.1.1. Process mapping

3.1.2. Monitoring, measurement and analysis

a. Improvements and corrective/preventive actions

The main objective of VetAgro Sup's quality approach is to put in place the necessary


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conditions for the continuous improvement of practices. To this end, non-conformities

and complaints must be seen as opportunities for improvement and their reporting is

encouraged.

The non-respect of a requirement defined by a reference frame or an internal

document, as well as any positive or negative information coming from a third party

(internal or external stakeholders) must be recorded by the MAN-QUAL process

"Implementing Quality Management", to maintain the efficiency of the VetAgro Sup

QMS and to install the Establishment in a sustainable continuous improvement process.

The collection of this information can be done in several ways:

o Following an audit (internal or external);

o By the evaluation of process indicators;

o By the occurrence of a problem, recurring or not;

o By the review of Quality documents;

o By feedback from various stakeholders (CHUV customers, VetAgro Sup staff and

services, students, suppliers, external service providers, etc.).

Any possibility of improvement is also the subject of a "Improvement Actions" form.

This form gives guidelines for:

o Define the dysfunction;

o Highlighting its source;

o Analyze and describe its identified root cause;

o Define the actions to be taken (immediate actions to deal with the

consequences of the malfunction, corrective actions to eliminate the causes

of the malfunction and prevent its recurrence, and preventive actions to

eliminate the causes of a potential malfunction following a risk analysis).

o Define the action plan (who? does what? for when? how?) ;

o Verify and evaluate the effectiveness of the actions implemented.

It will only be completed at the end of this last stage.

All the "improvement sheets" are analyzed and synthesized for the quality

management review.

b. Audits

VetAgro Sup sets up internal audits according to a frequency defined in the audit plan

in order to continuously improve. A dozen or so VetAgro Sup staff, from different core

businesses, are authorized to carry out audits following an accreditation process that

includes theoretical and practical training. The establishment also has a very strong

culture of evaluation and welcomes several times a year and according to the

specific schedules for each evaluation, external auditors / evaluators / inspectors,

both French and international.

c. Indicators

In accordance with the requirements of the ISO 9001 standard, each process is

measured by indicators set in quality management reviews. These indicators make it

possible to analyze the operation and efficiency of the processes, to measure the

results obtained, to define areas for improvement and to set targeted and measurable


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objectives for staff and stakeholders in the process. They include, for example, the

indicators of the Contract of Objectives and Performance (COP) and those of the

accreditations of the two curricula (AEEEV and AVMA for the veterinary curriculum,

and CTI for the agronomy curriculum).

3.2. Planning

The second VetAgro Sup Quality Management Review was held on 20 March 2019. It

initiates a regular (annual), methodical review process undertaken by Management

to determine the relevance, adequacy, effectiveness and efficiency of the QMS in

relation to the analysis of the environment (strengths and weaknesses / threats and

opportunities) and the internal and external issues arising from it. It decides on the

need to adapt the Quality Policy and quality objectives to the changing needs of the

stakeholders.

At the end of each Quality Management Review, an action plan (nature of the action,

implementation period, definition of responsibilities) is defined, with targeted

objectives. The quality committee must review all these parameters after 6 months and

report on what has already been achieved and what remains to be done.

Continuous improvement is also regularly discussed during the various councils (Board

of Directors, Scientific Council, Teaching and Student Life Council, etc.). Efficient

reporting of these board meetings allows for regular updates of the action plan.

3.3. Awareness

Awareness of quality and the quality management system is carried out by:

o Meetings of the quality committee (quality managers and correspondents),

o Intra-departmental quality meetings, on specific topics related or not to

evaluations,

o Items in General Meetings to all staff,

o The quality points mentioned in the minutes of the Management Committee

meetings,

o Circulation of the quality management review report,

o The participation of the members of the Quality, Health and Safety Division in

the COMHYC (Comité d'Hygiène des Cliniques),

o Internal quality training offered to all staff (training in auditing, document

writing, metrology, system quality or VetAgro Sup QMS),

o The participation of members of the Quality, Health and Safety Department in

the discussions and improvements to be implemented following the various

external audits, assessments and inspections to which the establishment is

subject as a result of its activities.

These meetings make it possible to:

o to give information on the general functioning of the quality management

system;

o to make the staff aware of their quality function in the performance of their

daily work;


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o to take into account everyone's comments and proposals for possible

improvements;

o to give concrete expression to the application of quality at all levels.

This awareness-raising is carried out by the staff of the quality, health and safety

department and/or the quality correspondents.

3.4. Documentation requirements

The documentation system of VetAgro Sup follows the following pyramidal

organization:

The Quality policy, which specifies the commitment of the Management,

formalizes its strategy, from which its objectives are derived;

The quality manual, which describes the organization of the Establishment from

the point of view of quality;

The process sheets, which formalize the framework of the Quality Management

System;

The procedures, which describe an action or a task in a global way;

The operating procedures and instructions, which describe an action or task in

detail, and which serve as a training support at the workstation for newcomers;

Records, which are evidence of the completion of the actions mentioned in

the procedures and operating procedures;

Appendices, which are all other documents that need to be mastered. They

may be indispensable for understanding.

Elaboration and codification of documents

The quality manual is written and kept up to date by the VetAgro Sup Quality

Quality Policy

Quality Manual

Process Sheets

Procedures

Operating procedures

Records - Appendices - Instructions


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Manager. It is approved by the Management of VetAgro Sup.

The process sheets are written by the quality manager or the quality correspondent(s)

concerned. All other documents may be written by any person with the skills to

describe the tasks and procedures.

The elaboration of the internal quality documents is carried out according to the

procedure MAN-QUAL-P001.

In order to uniquely identify each element of the quality management system, each

quality document is identified by a document code. The codification is defined by the

annex MAN-QUAL-P001-A01.

4. Management's Responsibility

4.1. Quality policy

VetAgro Sup has a global quality policy, taking care of the follow-up of all correlated

activities and their results, as well as the implementation of curative, corrective and

preventive actions.

4.2. Planning

The quality approach is at the service of VetAgro Sup's strategy development and

management. During the quality management review, indicators are analyzed and

objectives are set. This analysis makes it possible to plan any changes to the quality

management system and to rule on its effectiveness. It is also decided on the possibility

of modifying or creating processes, modifying or creating indicators, adapting the

necessary resources (personnel, training, material, documentation).


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4.3. Responsibility, authority, competence and communication

4.3.1. Responsibility and authority

The organisation chart of VetAgro Sup in application is available on the institutional

Internet site (simplified version) and on the Institution's Intranet site (detailed version).

Sources : VetAgro Sup Facts and figures 2018

Each functional unit draws up detailed organization charts under its own responsibility.

It shall indicate the main tasks of each agent of VetAgro Sup. These organization

charts shall be supplemented by job descriptions summarizing, for each member of

staff, the duties and tasks carried out and the level of mastery of the skills identified.

These job descriptions are reviewed each year during the professional interview and

modified if necessary.

The Management provides the resources necessary for the correct operation and

improvement of the Quality Management System, as well as for compliance with

customer requirements. The departments, assisted by the Quality Manager, make the

best use of these resources to optimize working conditions and customer satisfaction.


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Each year, the Human Resources department carries out a survey of individual

continuing education needs. These records are completed by each employee and

validated by the line manager.

These training records are studied by management, which defines priority training

areas.

An annual training plan is drawn up. It includes the quality training provided in-house.

The quality of training is measured by an on-the-job evaluation, while its long-term

effectiveness is assessed by managers during annual interviews.

The quality manager shall report periodically on the functioning of the quality

management system. His role is to raise staff awareness and develop the quality spirit

at all levels of the establishment.

The responsibilities of the Quality Manager are supplemented by the responsibilities of

each employee, who guarantee quality at their level of operation, implementing the

Quality policy established by Management for the entire establishment.

4.3.2. Management representative

Management appoints its quality manager to represent the management and ensure

compliance with the Quality System. As part of his duties, he participates in particular

in the implementation of the institution's Quality Policy and ensures compliance with

the Quality requirements of its internal and external customers. To this end, he has the

organizational independence to resolve issues relating to quality management.

VetAgro Sup's quality department, which also coordinates health and safety actions,

is made up of 7 quality specialists, including a metrologist, each of whom specialises

in the application of a quality reference system and is delegated to those VetAgro

Sup laboratories or entities that require it, the prevention advisor and the accreditation

advisor. This team ensures, in collaboration with the personnel of the entities

concerned, the deployment and monitoring of quality management systems, thus

meeting the requirements of the authorities (ANSM for GLP-compliant laboratories and

DDPP for certain structures such as pet shops or breeding station) and auditors in the

context of accreditations and certifications.

The Accreditation Advisor (member of the Management Board) is appointed by

VetAgro Sup. He is responsible for defining the accreditation strategy of the

Establishment. He programs, prepares and monitors the activities necessary to

maintain the current accreditations: AEEEV, AVMA and CTI/EUR-ACE. He is also in

charge of supervising the evaluation by HCERES.

He is in charge of coordinating the drafting of progress reports and self-assessment

reports prior to visits by delegations, and coordinates the visits.

4.3.3. Internal communication

Communication takes place at the different levels of the Institution:

o At the weekly Management Committee meetings: The quality, health


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and safety points are mentioned in the report distributed to all;

o During Quality Management Reviews which judge the effectiveness of

each process, previously analyzed and reviewed by its pilot in

collaboration with the quality managers;

o During the distribution of internal or external audit reports or during

summaries of audits carried out, particularly during meetings;

o On the Intranet, where the QMS documents are available;

o On the Internet site, where information from the Quality-Hygiene Safety

division and information concerning accreditations (planning,

certifications and accreditations) is available.

5. Conclusion

This manual is not intended to be exhaustive on a subject as vast as "quality

management" but to give a global vision of quality as it is deployed within VetAgro

Sup. To date, the quality document base is composed of nearly 600 documents, which

are constantly reviewed and updated, contributing to the efficiency of the QMS.

The reading of this quality manual highlights the willingness of VetAgro Sup

management to instill a quality approach in all the activities of the Establishment, of

which continuous improvement is the mainstay.

Documents

Quality Manual - VetAgro Sup · 2020. 5. 26. · Quality Manual Code du document : Manuel Qualité Indice de révision : Version 2 Page 3 sur 15 1. Introduction 1.1 History of VetAgro