Quality Systems as a Tool in Validation of Nutrient Data The EuroFIR Approach

EuroFIR QUALITY SYSTEMS AS A TOOL IN VALIDATION OF NUTRIENT DATA: THE EuroFIR APPROACH Isabel Castanheira 1, Susanne Westenbrink2, Marine Oseredczuk3, Paul Hulshof 4, Peter Hollman 4, Jayne Ireland 3, Anders Møller5, Simonetta Salvini6, Hedwig Beernaert7 , Maria Antónia Calhau1, Paul Finglas8 1 National Institute for Health Dr Ricardo Jorge (INSA), Portugal; 2TNO Quality of Life / NEVO Foundation, the Netherlands; 3French Food Safety Agency (AFSSA), France; 4Wageningen University (WU), The Netherlands; 5Danish Food Information (DFI), Denmark; 6CSPO-Scientific Institute of Tuscany, Italy; 7Scientific Institute of Public Health,(IPH) Belgium; 8Institute of Food Research (IFR), United Kingdom 31st NNDC, Washington, 27 April, 2007 OUTLINE The need of standardized food composition data in Europe The EuroFIR Quality Approach Quality Principles and Practices Preliminary Results Further Developments OBJECTIVES PURPOSE Key issues of Food Composition Data in Europe Provide data in accordance with international standards N N N EuroFIR aims to develop and integrate a comprehensive, coherent and validated databank providing a single, authoritative source of food composition data in Europe. N To assist multicenter studies investigating diet and health relationship Nutritional labelling LIMS EUROFOODS Moller, Ireland et al, 2000 DRAWBACKS Original Literature Manufacturer Level 1 Lab A Lab B Level 2 Archival Data Compiler Y ! ! Archival Data Compiler Z ! ! Level 3 FCD A1 Reference Data Base ! FCD A2 Reference Data Base Level 4 FCD B A B C AIMS & GOALS This work focus on: 1) The contribution of a Quality Framework for scientific validation and exploitation of food composition data 2) The approach to organize quality principles and practices around laboratories, national compilers, databank systems and users and stakeholders purposes and satisfactions 3) Processes, procedures and experiences during the development of framework MATERIALS & METHODS QUALITY PRINCIPLES Fit for purpose Quality Management Quality Assurance Quality Control Quality Requirements Users and Stakeholders satisfaction TOOLS & PRACTICES • Questionnaire • Quality Management Systems based on ISO series • Quality Control of Compilation Process inspired in HACCP (Hazards Analysis of Critical Control Points) • Quality Assurance of Computerized System • Data Quality Assessment System RESULTS QUESTIONAIRE RESULTS Laboratories acreditated Laboratories with Quality System in place Compilers using Data Quality assessement system Compilers with Quality Assurance criteria for computerized system Compliers Institutions holding ISO certification ORGANIZING QUALITY Tools Laboratories 17025 GLP Guidance Document Compilers ISO 9001 ISO 10006 WP 2.3.1 WP 2.3.2 WP 3.1 QTF WP 1.3 WP 1.8 WP 2.4 WP 2.2 ORGANIZING QUALITY(2) Coordinator WP1.3 (INSA) QMS (INSA) WP1.8 (DFVF/AFSSA) CEN (NFA) FID (AFSSA) WP2.4 (DFVF/IFR) Compilation (IFR/UCC) Data Quality (IFR) Training (SLU) Compilation (AFSSA/Nevo) Computerised Systems (Nubel) Quality Indices (CSPO/AFSSA) Training (SLU) Compiler Network (DFVF) Training (SLU) PLANING FRAMEWORK 2005 | 2006| 2007| 2008| 2009 Training, Conform to requirements Document control, Audits Management Reviews Quality Policy Quality Control Quality Assurance Quality Management QUALITY REQUIREMENTS Pre and analytical stages Compilation Defined by Compilers Network: Recommendations from EUROFOODS Food Indexing (Langual) Value documentation Others defined by WP1.8 Databanks Defined by Quality Task Force and Sustainability Platform Technical Recommendations for datasets Criteria in place for computerized system Compliance with regulatory requirements (eg nutrition labelling; assessment of dietary exposure; national consumatio ) Defined by WP1.3 and Research Platform Sampling Sampling Protocols in place according with fit for purpose Analysis Laboratory Acrreditation PT schemes Method Validation Quality Management System Defined by WP1.3 FlowChart Quality Index SOPs Quality Management System TG2 contribution on compilation process (1) STEP 1: approach based on HACCP principles at a general level 1. STEP 2: proposal of practical tools for compilers to adapt to t heir organization 1 . In te g r a t io n o f o r ig in a l d a t a in th e da ta b a nk S ta r t U s e r s s te e r in g g ro u p D e c is io n o n w h ic h fo o d s /n u tr ie n ts n e e d to b e a d d e d /u p d a te d 1 Describe the general compilation process => all compilers compilers organizations can fit in => common understanding of compilation within EuroFIR. => benchmarking? Identify hazards within this process Identify critical points of the process A n a ly tic a l p r o g r a m m e L ite r a tu r e r e v ie w p r o fe s s io n a l n e tw o r k SO P C o lle c tio n o f ( o r ig in a l) d a ta fr o m : - L a b o r a t o r ie s - M a n u fa c t u r e s - S c ie n tific p u b lic a tio n - O th e r fo o d c o m p o s itio n ta b le s - C a lc u la tio n s - O th e r 2 I d e n t ific a tio n a n d c o m p r e h e n s io n o f d a ta - R e le v a n t fo o d s - R e le v a n t n u tr ie n ts ( b a c k g r o u n d ) - O th e r r e le v a n t in fo r m a tio n fo r o r ig in a l d a ta q u a lity a s s e s s m e n t CCP 3 U s e d a ta 4 No A r c h iv e r e je c te d d a t a / d o c u m e n t d e c is io n s 5 S to p Yes SO P T h e a tt r ib u t io n o f q u a lity ( in d e x ) to a ll o r ig in a l d a ta . I t is r e la te d to : C C P - S a m p lin g s tr a t e g y - N u m b e r o f s a m p le s - N a tu r e o f m a te r ia l a n a ly s e d - S a m p le h a n d lin g - A n a ly tic a l m e t h o d o r m e t h o d o f c a lc u la tio n ( r e c ip e , c o e ffic ie n ts u s e d , e t c .) 6 - A n a ly tic a l q u a lit y c o n tr o l SO P C o d in g o f d a t a b e fo r e d a t a e n tr y : - Food - N u tr ie n ts - B a c k g r o u n d in fo r m a t io n CCP 7 O r ig in a l d a ta e n tr y / k e y b o a r d in g o r im p o r t d a ta file s 8 2. 3. 1 = general flow chart of the compilation process SO P D a ta c h e c k ( m a n u a l/c o m p u t e r iz e d ) : - C h e c k o n o r ig in a l d a t a e n tr y - C o n s is t e n c y c h e c k s - A d d it io n a l c h e c k s ( e .g . o b s o le te v a lu e s ) 9 C o rre c t 10 No Yes S t o r a g e o f c o m p u t e r iz e d d a ta = A R C H IV A L D A T A B A S E 11 CCP 12 P h y s ic a l s t o r a g e o f o r ig in a l d a ta ( a s b o o k s , file s , a r t ic le s ) 2 . P ro d u c t io n a n d v a lid a t io n o f re p r e s e n t a t iv e d a t a f ro m t h e o r ig in a l d a t a p re v io u s ly s to re d in t h e d a t a b a n k E x t ra c t io n o f a ll t h e a r c h iv a l d a ta a v a ila b le fo r e a c h p a ir f o o d / co m p o ne nt 13 SOP S e le c t io n o f t h e a r c h iv a l d a ta to b e f u r th e r u s e d t o d e t e rm in e a r e p re s e n t a t iv e d a ta 14 SOP S e le c t io n o f a lg o rit h m s t o c a lc u la te - M e a n / m e d ia n v a lu e s - R e c ip e s ( in c lu d in g y ie ld a n d re t e n t io n fa c to rs ) - D e r iv e d n u t rie n t s D e t e r m in e w e ig h in g f a c t o r s t o c a lc u la t e m e a n / m e d ia n v a lu e s CCP 15 SOP A p p lic a t io n o f a lg o r ith m s in o rd e r to p r o d u c e re p re s e n ta t iv e d a t a - C a l c u la te m e a n / m e d ia v a l u e s ( a n d o t h e r s t a t is tic s ) - C a l c u la te re c ip e s / a v e ra g e f o o d s - C a l c u la te d e riv e d n u t r ie n t s 16 SOP V a lid a t io n o f t h e re p r e s e n ta t iv e d a t a * CCP - C o n s is t e n c y c h e c k s p e r n u t rie n t ( g r o u p ) / p e r f o o d g ro u p * - C h e c k o n a s c e n d in g / d e s c e n d in g v a lu e p e r n u t rie n t* - C a lc u la t e n u t rie n t in ta k e f o r re p r e s e n ta t iv e fo o d c o n s u m p tio n d a ta - C h e c k a ra n d o m s a m p le o f d a t a f ro m t h e d a t a b a s e - C h e c k o n o b s o le t e d a t a ( f o o d s a n d n u t rie n t s ) V a lid a t io n o f f o o d n a m e s (in c o n s is te n c ie s , le g a l a s p e c t s ) * E x a m p le s o f d iff e re n t o p t io n s fo r v a lid a tio n 17 C o r re c t e rro r s / in c o n s is t e n c ie s t h a t w e r e id e n t ifie d d u rin g v a lid a t io n 18 SOP D e t e r m in e c o n f id e n c e c o d e o f t h e r e p re s e n t a t iv e v a l u e 19 S to ra g e o f r e p re s e n t a t iv e c o m p u t e riz e d d a t a = REFERENCE DATABAS E 20 3 . D is s e m in a t io n SOP S e le c t r e p re s e n t a t iv e d a t a t o b e p u b lis h e d o r d is s e m in a t e d - S e le c t f o o d s a n d n u t r ie n t s - C re a t e d a ta f ile s c o n ta in in g s e le c te d f o o d s a n d n u t rie n ts - C re a t e o t h e r f ile s w it h b a c k g r o u n d in fo r m a tio n 21 S to ra g e o f d a t a s e le c t e d f o r d is s e m in a t io n =U SER D ATAB ASE 1 =U SER D ATAB ASE 2 =ETC 22 D is s e m in a t e d a t a 23 S to p - P aper - C D -r o m - I n te rn e t - e -m a il - F ile TG2 contribution on compilation process (2) STEP 2: propose practical tools for compilers to adapt to their organization 4. Proposal of general standard operating procedures (SOPs) for each critical step identified in the flow chart => SOPs for attribution of quality indices and coding of nutrients, foods and background information. TITLE => for other general SOPs, involve compilers outside this taskgroup. NUMBER/VERSION SCOPE 2 = general SOPs OBJECTIVE DEFINITIONS RESPONSIBILITIES PROCEDURE REMARKS REFERENCES APPENDICES Contents Material technical requirements Archival of data Training of personnel When? Who? How? Exceptions Checkings and corrections of errors Quality Assurance Issues for Computerized Systems Limit requirements to a set minimum of minimum requirements • • • • • • • Network configuration of FCDBs Software development and application Security aspects List of required Standard Operating Procedures (SOPs) The necessity for contingency plans Back ups and archives Responsibilities DESIGN National compiler EuroFIR Databank and/or others Interchange FCDB Users Compilation Management Interchange QMS Compilation Process (HACCP approach) Quality Index System Computerized System Sampling Plan Analytical Methods Analytical Quality Control Post compilation errors Laboratory Pre and analytical stages Combine ISO 17025 Quality Framework EuroFIR Standard Data Sets N Fit for purpose FCDByN FCDBzN Quality Management System for Compilers Requirements Requirements Quality Manual Quality Manual Quality Plan Quality Plan To be developed by EuroFIR QTF PT type PT type Documentation Documentation Responsabilities Responsabilities Subcontracting Subcontracting Training Training QMS presentation QMS presentation Consistent with QMS of national organisation Technical Competence Technical Competence Improvements Improvements Top Management Top Management Reviews Reviews TRAINING Block: Data Quality Role of Quality Management Systems Analytical data quality Quality Aspects of compilation process Data expert systems EuroFIR Quality Issues EuroFIR Quality Issues 2007 ACHIVEMENTS Compilation Process Compilation Process Flow-chart Hazards& SOPs Quality Management Systems Criteria Lab Selection PTschemes Guidance Document (Compilers & Lab) Quality Index Draft Prototype system for quality assessment of data from scientific publications Computerized System Quality assurance criteria computerized system Training Lectures Food Comp Course Bratislava TOWARDS CERTIFICATION Certification AUDITING QUALITY PRACTICES IMPLEMENTATION OF QUALITY REQUIREMENTS CONCENSUS ON QUALITY REQUIREMENTS SIGNIFICANCE DRAWING CONCLUSIONS Quality Policy founded in open and constructive debate solves former inconsistences, observed in previous projects Quality principles and practices validated by fit for purpose are fundamental in assuring improved quality for the exchange of data acrossEurope and beyond WE THANK YOU FOR ATTENTION www.eurofir.net