INTRODUCTION TO QUALITY MANAGEMENT SYSTEMS

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INTRODUCTION TO QUALITY MANAGEMENT SYSTEMS

• Paul Finglas (IFR) Isabel Castanheira (INSA)
• Network Compilers, 6thMarch , 2007, Paris

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Outline

• Why Quality Management System
• Quality Principles
• Quality Practices
• QTF Contributions

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WHY QMS in EuroFIR ?

• Standardised national food composition tables
  have to be developed
• One of research needs for compilation process is
  the details of quality assurance steps operated
  under good scientific practice
• Funding international institutions require a
  quality management system in the organisations

EuroFIR aims to develop and integrate a
comprehensive, coherent and validated databank
providing a single, authoritative source of food
composition data in Europe.
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Quality Principles
Fit for purpose
Quality Management
Quality Assurance
Quality Control
Quality Requirements
Users and Stakeholders satisfaction
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Quality Requirements(proposal)

• Eurofoods recommendations for Data Interchange
  and Management
• Data Quality Assessment System,
• Food Indexing (Langual)
• Value documentation,
• Technical recommendations for Datasets
• Quality Management System in place to guarantee
  the above requirements are fulfilled (Document,
  Storage, Evaluate according with above Quality
  requirements)

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Quality Control

• Identification of Hazards and Critical Points
  during compilation process
• Using SOPs to check the critical points
• Testing the precision/ consistency of each
  result (computerized system)
• Testing the NLG result by a comparison of the
  result under estimation with results obtained
  from other tests
• Monitoring the calculation of derived values

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Quality Assurance

• Document Control Establish and maintain
  procedures to control all documents that form
  part of quality requirements (eg SOP template)
• Responsabilities Identification of personnel
  with permission to carry out, to review, or
  approve each SOP and or all compilation process
• Quality level Responsabilities stemming from
  quality requirements such as Inter-organisation
  comparative testing (PT type) suceed
• Training Assuring that all personnel and key
  personnel in particulary have education and are
  well trainned (eg. FoodComp and internal
  training)

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Quality Management

• Evidence that the organisation carries out the
  compilation activity in such way that meets the
  EuroFIR requirements (eg. WP1.8) and satisfies
  the needs of the users and stakeholders (Eg
  Presentation of QMS in EuroFIR workshops)
• Engagement of top management to guarantee that
  organisation has the capability and resources to
  meet the above requirements

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Fit for purpose and users and Stakeholders
satisfaction

• Identification of potential source of error with
  impact in quality of food composition data (eg
  questionable import of data)
• Pre compilation errors (egNon comparable methods
  of analysis)
• Compilation errors (egerror in value
  documentation)
• Post compilation errors (eg inapropriate method
  for recipe handling)
• Development of mechanisms to detect, prevent and
  correct the errors (SOPs)
• Assessment of frequency of monitoring (eg How
  many times the compiler tests the performance of
  a contractor laboratory)
• Requirements for training
• Compliance with regulatory requirements (eg
  nutrition labelling assessment of dietary
  exposure national consumation or others posed by
  governments )

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Quality Practices
FCDB Users
EuroFIR Databank and/or others
National compiler
Laboratory
Pre and analytical stages Compilation
Management Interchange
Combine

Interchange

• QMS
• Compilation Process (HACCP approach)
• Quality Assessment of Data
• Computerized System

Data Sets

• Quality Framework
• EuroFIR
• Standard

ISO 17025
N
Fit for purpose
FCDBy
N
Sampling Plan Analytical Methods Analytical
Quality Control
FCDBz
N
Post compilation errors
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Proposal Quality Management System for Compilers
Requirements
Quality Manual
Quality Plan
PT type
To be developed by EuroFIR QTF
Consistent with QMS of national organisation
Responsabilities
Documentation
Subcontracting
Training
QMS presentation
Technical Competence
Improvements
Top Management Reviews
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QTF Contribution

• Applied HACCP approach to compilation process
  using EUROFOODS documents as starting point and
  members of WP1.8
• Design Quality Requirements for Laboratories
  generating new data according with Quality
  Index System defined by WP 1.8
• Design Quality Management System for compilers
  compatible with those of National Organisation
  holds nFCDBs and sound based on WP 1.8 Quality
  Requirements/Specifications
• Systematic dissemination campaign focus on the
  advantages of conducting compilation activities
  under umbrella of EuroFIR quality framework
• Assistance Criteria on Methods of Analysis
• Develop Quality Practices as simple as possible

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Criteria on Methods of Analysis(SOP)

• Organised methods by category of nutrients
  (Proximates Cholesterol and Fatty Acids) Water
  solubles Vitamins Fat solubles vitamins
  Minerals
• Organise Committees by proximates, vitamins,
  minerals (Analysts Compilers)
• Describe terms of reference
• Develop a Form in connection with value
  documentation
• Discuss results with Compilers and present
  conclusions at Compilers Network

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Criteria on Methods
Protein Analysis (Example)
Tittle Food Method Code Description Method
Headlines Method Principle Codex Method Type
Reference Comments
Tittle Kjeldahl Food All foods Method Code
- ME61 Description - titrimetry, kjeldahl
digestion Method Headlines - Titrimetry FAO
factors Method Principle Total nitrogen
measured by titrimetry,after kjeldahl digestion
is multiplied by food-dependent factors (FAO/WHO
factors) Codex Method Type - Type I or Type II
depends on food Reference- FAO/WHO,
1973 Comments
Codex Classification Fully Docummented Official
Accepted Validated in collaborative trials
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QTF Contribution
Major activity for 2007
Assist compilers to implement (SOPs)
Check and Approve the SOPS
Elaboration of Standard Operation Procedures
(SOPs)
Create a small team INSA , AFSSA, Nubel, KTL,
BfEL, IFR, FRI, NEVO.
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THANKS FOR YOUR ATTENTION
isabel.castanheira_at_sapo.pt