Quality Assurance for Research and Development …

1 Quality Assurance forResearch and Developmentand Non-routine AnalysisThis document has been produced primarily by a joint EURACHEM / CITAC Working Group,the membership of which isProf C Adams, Unilever, UKProf K Cammann, ICBFhM, Germanyir HA Deckers, RvA, NetherlandsProf Z Dobkowski, Ind. Chem. Res. Inst., PolandMr D Holcombe, LGC, UKDr PD LaFleur, Kodak, USADr P Radvila, EMPA, SwitzerlandDr C Rohrer, Lenzing AG, AustriaDr W Steck, BASF AG, Germanyir P Vermaercke, , BelgiumEnglish EditionSecond Internet Version, November 1998 First Edition October 1998 Quality Assurance forResearch and Developmentand Non-routine AnalysisThis document has been produced primarily by a joint EURACHEM / CITAC Working Group, themembership of which is listed in Annex A.

2 The secretary would also like to thank all of those individualsand organisations who have contributed comments, advice and background of this Guide was in part supported under contract with the UK Department of Trade andIndustry as part of the National Measurement System Valid Analytical Measurement (VAM) are invited on this document and should be sent to:Mr David HolcombeDrafting Secretary for EURACHEM / CITAC R&D Working GroupLGC, Queens Rd, Teddington, Middlesex, TW11 0LY, United Kingdom(: Int + 44 181 943 7613, 4: Int + 44 181 943 2767, :+: Edition , 1998 ISBN: 0 948926 11 2 Ruling languageThe text may be freely translated into other languages, but where such action results in a dispute overinterpretation, the guidance given in this English version is taken as being the definitive of textCopyright of the guidance presented in this guide is the property of the organisations represented by theworking group members as listed in Annex A.)

3 All rights are reserved. This guidance may bedownloaded for personal and non-commercial use, but no part of the guide may be distributed, publishedor stored in any retrieval system, in any media, by persons other than EURACHEM or CITAC members,without the written consent of the EURACHEM and CITAC Secretariats. Similarly, enquiries regardingthe translation, production and distribution of new editions of this guide should be directed to theEURACHEM and CITAC SecretariatsThis edition is Copyright LGC (Teddington) Ltd, 1998 EURACHEM/CITAC Guide CG2 Internet Edition - 1998iCONTENTSS ectionTitlePage1 Aims and objectives1 Who this guide is for1 Using this Guide1 Emphasis of guidance1 Customers22 Introduction2 What is Research and Development2 Importance of QA3 What needs to be controlled in R&D33 Definitions44 Principles of making Valid Analytical Measurements55 Organisational Quality elements6 Administrative and technical planning of work6 Quality management, corporate and local7 Record keeping and document control7 Staff qualifications.

4 Training and supervision of staff8 Equipment and computer controlled equipment10 Monitoring the Quality system10 Subcontracting126 Technical Quality elements12 Unit operations12 Technical capability of laboratory13 Methodology13 Reagents, reference materials and calibrants14 Calibration and traceability14 Instrument performance15 Use of statistics16 Technical requirement related to particular unit processes (Sampling,isolation of analyte, measurement, validation, measurementuncertainty)187 Analytical task Quality elements21 Preparation and planning before starting work21 While the work is in progress25 When the work is complete268 External verification28 Formal assessment against conventional Quality Assurance standards29 Benchmarking30 Visiting groups / Peer review32 Ranking of organisations33 External Quality assessment procedures34 Conclusions349 Bibliography and references35 Annex A- EURACHEM / CITAC Working Group42 Annex B- Flowchart showing lifecycle of an R&D project44 Annex C- Questionnaire for Analytical Work45 Annex D- Concepts for the accreditation of R&D tests by E- R&D to develop analytical instrumentation49 EURACHEM/CITAC Guide CG2 Internet Edition - 1998iEURACHEM/CITAC

5 Guide CG2 Internet Edition - 199811. AIMS AND this guide is guide is intended to be used by managers and analytical staff, both in industry and theacademic world, involved in the planning, performance and management of non-routinemeasurements in analytical science and associated Research and Development . Thoseresponsible for the evaluation of the Quality of such work will also find the guide useful. Itprovides principles from which assessing organisations such as accreditation or certificationbodies could specify assessment this guide aims to state and promote Quality Assurance (QA) good practice, or at least practicethat meets the professional standards of the peer group.

6 Many of these practices have alreadybeen stated in an earlier CITAC guide (CG1)[1], which provides advice for mainly routineanalysis, and an earlier EURACHEM / WELAC guide [2], which advises on the interpretation ofEN 45001 and ISO Guide 25 for chemistry laboratories. Predictably there is likely to be a highdegree of overlap between what is good practice in a routine situation and what is good practicein a non-routine situation. To avoid duplication those practices are only repeated below where ithas been considered appropriate that further clarification is necessary for non-routine the guidance has not been restated, reference to the relevant part of the CITAC guidehas been stated instead.

7 Thus this guide should be used in conjunction with of is still much discussion as to how applicable the various established qualitystandards/protocols, such as ISO Guide 25 [3], EN 45001 [4], ISO 9000 [5], and OECD Principlesof Good Laboratory Practice (GLP) [6], are to non-routine work. GLP is study based, and thestudies often involve non-routine or developmental work. R&D is compatible with the designelement of ISO 9001. However it is widely argued that non-routine work does not fit easily into ahighly documented and formalised Quality system. For this reason the guidance is directedtowards good practice rather than compliance with formal standards.

8 The two approaches arenot necessarily at odds with one another, but compliance may occasionally place requirementswhich are considered to be over and above what is considered to be best practice. Converselyno single Quality standard necessarily covers all the elements of activity which might beconsidered relevant as best practice. The aim is to produce guidelines for analysts, theircustomers, and their managers, and not a Quality manual template for an organisation. Notealso that external verification, such as can be provided against a formal Quality standard, is notmandatory, even though it may be desirable in some Edition - 1998 EURACHEM/CITAC Guide is anticipated that once this guide is published it may be possible for accreditation bodies andother authoritative organisations to adapt the text for compliance purposes, for example to thepublished standards/protocols mentioned in work regulated by this guidance may be performed for a number of different types ofcustomer, such as: other departments within the same organisation which lack the specialist skills the workdemands; external customers who commission specific tasks.

9 Regulatory bodies which commission the work to help enforce law, regulatory or licencingrequirements; funding bodies which commission large work programmes, within which specific tasks is Research and Development (R&D)? is a scientific investigation aimed at discovering and applying new facts, techniquesand natural laws [7]. At its heart is inquiry into the unknown, addressing questions not previouslyasked. Research is done by a wide range of organisations: universities and colleges;government agencies; industry and contract organisations. Research projects vary widely incontent and also in style, from open ended exploration of concepts to working towards in an industrial context is the work done to finalise the specification of a newproject or new manufacturing process.

10 It uses many of the methods of scientific inquiry, andmay generate much new knowledge, but its aim is to create practicable economic combined term Research and Development can be seen as the work in an industrial orgovernment context concentrating on finding new or improved processes, products etc., andalso on ways of introducing such use of the term R&D may not wholly encompass the activities intended to be covered bythe Guidelines, but has been adopted by the authors as the most appropriate and convenientsingle Guide CG2 Internet Edition - guidelines are intended to cover analytical testing or measurements where for variousreasons the work is non-routine or necessary procedures are not already in place, for example: methods already exists for the analytical problem, but have not previously been applied tothe particular type of sample now encountered.