Organisation of the Chains Quality Assurance System

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Organisation of the Chains Quality Assurance
System
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Limagrains corn chains
Factory
Transformation into ingredients
Seed
Chains Quality Assurance System
A Quality Assurance System has been set up,
covering the whole corn chains
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Objectives of the Chains Quality Assurance System

• To control the whole Limagrain corn chain
• from breeding to processing,
• for conventional (non-GMO) and GMO productions.
• To guarantee to all customers (external or
  internal) and to authorities
• the total traceability of the products
• the suitability of the products to the customer
  requirements

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Chains Quality Assurance System
THE ACTORS

• Management
• Quality Assurance Department
• Chains Quality Correspondents
• Operators

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The actors of the Chains Quality Assurance System
a role for each one

• Define and set up the quality assurance policy
  / Warrant of this application outside the
  Group
• Write / Conceive / Manage the documents of
  the system
• Train / Coordinate / Support / Consult /
• Follow up/ Audit
• Define and elaborate the sites documents of
  the system
• Network of the Chains Quality Assurance
  Department
• Transcribe the rules in the sites organisation
• Write and manage the sites documents /
  Follow up
• Participate in writing to the elaboration of
  the sites documents
• Practical implement of the measures.

Management
Quality Assurance Department
Chains Quality Correspondents
Operators
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A network of Quality Correspondents all along the
corn chain
1 Correspondent
3 brands 3 correspondents
2 sites 2 Correspondents
2 sites 2 correspondents
1 correspondent
1 Correspondent
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The Chains Quality Assurance System s documents
The Quality Assurance System puts together the
rules to satisfy the customers into different
documents

• Chains Quality Assurance Manual
• Common Quality Plan (CoQP)
• Chains Quality Plan (ChQP)
• Sites Documents

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Chains Quality Assurance Manual

• Describes the functioning and the architecture
  of the System.
• Explains what type of general rules have been
  set up all along the chain in order to control a
  conventional chain and/or a chain with the
  correct approved GMO .
• Refers to the other systems documents (CoQP,
  ChQP, procedures).

A declaration of management statement of
commitment figures at the top of the Manual and
expresses the involvement of the Group Managers
into this system.
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Common Quality Plan

• An internal document applied to all societies of
  the corn chain, from breeding to transformation.
• A document putting together the general rules
  common to the different affiliates or services of
  the corn chain.
• Exemples of common rules
• control of the documents,
• rules of traceability,
• regulatory requirements,
• audit,
• training,
• ...

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Chains Quality Plans

• Internal documents, specific to a specie, an
  activity, a geographical area.
• ? Ex ChQP 02 Corn Seed Production - Europe
• ChQP 03 Corn seed marketing Europe
• They retail the rules to be applied on a site.
• ? Ex - sampling methods to use
• quality controls management,
• sub-contractors production management (isolation
  distances, records, audits, ),
• plant process management (cleaning,training,
  records, quality controls, )
• ...

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Chains Quality Assurance System
Chains Quality Assurance Manual
Management Statement of Commitment
ChQP Breeding
ChQP Seeds Production
ChQP Marketing
ChQP Grain Production
ChQP Transfor-mation
ChQP RD
CoQP
Transcription
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Site s Documents

• Transcription of the rules defined in the Chains
  Quality Plans and the Common Quality Plan,
  depending on the organization of each site.
• It is a group of quality documents, procedures,
  records,...
• The documents are written by the Chains Quality
  Correspondents and the operators of each sites.

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The Coordination Committee objectives

• Coordinate the actions concerning the Quality
  Assurance in the corn chain
• Organize internal audits and Management Reviews
• Set up the corrective actions
• Develop the communication supports
• Follow the molecular tools development

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The Management Review

• Ensure that the integrated Chain Quality
  Assurance System remains efficient and coherent
  with the defined quality policy.
• Ensure the continuous improvment of the System
  (internal quality audit reports, status of
  corrective actions)
• Ensure customer satisfaction.

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Quality Assurance Coordination Committee
- Breeding, varietal creation - Seed
Production - Grain Production, Drying, Storage -
Ingredients - Quality Assurance DAI
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The Biotech Database
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The Biotech Database
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The Techcom in the Biotech Database
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The contacts

• Marketing (seeds ingredients) and Quality
  Assurance

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The Techcom meetings
Techcom s aim find the ways to valorize our
Quality Assurance procedures towards our
customers
.

• Assess the campaign s situation and prepare the
  next commercial campaign
• Come up to our customers expectations prepare
  sales brochures, communication tools...
• Anticipate potential crisis and be ready to face
  them

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Communication tools conceived

• The Commitment Charter of Groupe Limagrain.
• An e-mail address for each external request
  linked to Quality Assurance
  assurance.qualite_at_limagrain.com
• The marketing chain brochure

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Molecular controls in the Quality Assurance
System
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Molecular controls in the Quality Assurance System
All along the chain, the efficiency of the
procedures set up are assessed by molecular
controls on both the conventional and GMO chains .
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Conventional chain
Our organisation
Quality Assurance Department
AGROGENE
GMO detection analyses to check for adventitious
presence
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Conventional chain
Role To be the liaison between the detection lab
and the different operators of the chain To be a
technical support for the operators To follow up
the technological breakthrough that could be
applied for quality control purposes To follow up
at an international level the workshops set up to
work on GMO detection issues To follow up at an
international level the standardization works
related to GMO detection
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Conventional chain
Molecular analyses Analyzed species corn and
oilseed rape Principle PCR based method either
qualitative or quantitative Targets DNA
sequences that allow us to detect all the
transformation events currently commercialized in
Europe and in North America territories
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Why Agrogene ?
Reliable Perform Quantitative analyses
(TaqMan). Specialized in plants
Participate in the elaboration of French and
European norms regarding GMO detection methods
Internal RD Participate in European
and International ring tests Own licenses
assuring the legality of our analyses Own a
civil liability insurance in case of
litigation Subsidiary of Celera AgGen, PE
Corp.,world-wide leader in GMO detection
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GMO chain
Our organisation
Quality Assurance Department
Routine laboratories
Chain
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GMO chain

• Molecular analyses
• Event specific PCR or Southern to check that our
  material
• Contains the authorized transformation event
  
• ? Identity testing
• Does not contain any other transformation events
  
• ? Purity testing

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GMO chain
Role Make sure that we have the molecular tools
for each transformation event entering a breeding
program Be a technical support for the routine
laboratories