good laboratory practices workshop moscow 2000

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  • 1. GOOD LABORATORY PRACTICES (GLP) WORKSHOP Moscow, June 2000 Instructor: Javier Ruiz Moscow, June 2000 1

2. OBJECTIVES OF THE SEMINARUnderstand the essential requirements of the ISO 17025 StandardSpecial attention will be given to organizational aspects of thisstandard: Design & Implementation of the Quality SystemIdentifying practical means of demonstration for getting yourlaboratory working process in accordance with the essentialrequirements of the ISO 17025 Standard (LIST OF ACTIONS,Exercises 3 and 4). Specifically: Description of the organization of the laboratory and list of documents to be elaborated (Exercise 1)Draft the Calibration & maintenance Plan for the equipment (Exercise 2)Understand the continuous improvement cycle of the quality system and the internal quality audits process (Exercise 5) Moscow, June 2000 2 3. AGENDA (I) First Day, morningTIMECONTENTS9 9:30 hWelcome and Presentations9:30 10:30 hIntroduction. Good Laboratory Practices (GLP), Quality ManagementSystems and Laboratory Accreditation. Vocabulary.10:30 11:30 h Organization of the Laboratory and Personnel Responsabilities.ISO 17025 requirements. Case study for implementation.Exercise 1. Organization and Documents in the Quality System.11:30 11:45 h BreakPART I. Setting up Measurement and Testing Facilities11:45 13:30 h Accommodation and environmental conditions. Equipment andMeasurement traceability.ISO 17025 requirements. Case study for implementation.Exercise 2. Equipment Calibration & Maintenance Records.Moscow, June 20003 4. AGENDA (II)First Day, afternoonTIME CONTENTSPART II. Getting the Laboratory Processunder control.14:30 15:15 h Request, Tender and Contract Review. Sampling.Handling and transportation of test items.ISO 17025 requirements. Case study for implementation.Reporting results: Records and Test Reports.15:15 16:15 hISO 17025 requirements. Case study for implementation.Assuring the quality of test results.16:15 17:15 h ISO 17025 requirements.17:15 18 hExercise 3. Action Plan after the First Day Moscow, June 2000 4 5. AGENDA (III) Second Day, morningTIME CONTENTSPART II. Getting the Laboratory Process under control (Cont.)9 10:30 h Test Methods and Method Validation.ISO 17025 requirements. Case study for implementation.Exercise 4. Writing Standard Operation Procedures (SOPs)10:30 11:30 h PART III. Continuous Improvement ProcessComplaints. Control of Nonconforming Testing. Corrective andPreventive Actions. Management Reviews.ISO 17025 requirements.11:30 11:45 hBreak11:45 13:30 h Case study for implementation.Internal Quality Audits. ISO 17025 requirements. Case study forimplementation.Moscow, June 2000 5 6. AGENDA (IV)Second Day, afternoonTIME CONTENTS PART III. Continuous Improvement Process (Cont.)14:30 16 h Exercise 5. Audit Check List Exercise 3. Action Plan16 17 h Summary, Conclusions, Comments and Questions.17 18 h Test and Evaluation The End of the seminarMoscow, June 20006 7. PREVIOUS CONCEPTSESSENTIAL REQUIREMENTS: The aim or purpose behindevery ISO 17025 item. That is the spirit of the law e.g. The laboratory should maintain a documented qualitysystemMEANS OF DEMONSTRATION: Application of the essentialrequirements in a specific context. They include evidentialproofs that demonstrate that the requirement has beeneffectively implemented e.g.: The Quality Manual and 24 Standard Operation Proceduresin the laboratory XMoscow, June 2000 7 8. METHODOLOGYShort presentations to focus critical items ofthe StandardIndividual reading, questions and commentsAnalysing documents from other laboratoriesDoing exercises by teams: facing problems,identifying solutionsEvaluation of progress: final test Moscow, June 20008 9. THE ISO 17025 STANDARD INTO PRACTICE:THE LABORATORY KEY PROCESSES1. The added value processGetting the laboratory process under control2. Facilities and Measurement & Testing EquipmentSetting up measurement & testing facilities3. The Continuous Improvement Process CONTINUOUS IMPROVEMENT PROCESSMoscow, June 20009 10. Getting the laboratory process under control 4.12.2 Test LEGEND Test recordsreport Input ActivityLaboratory TendertestsProceduralCatalogueDocuments InputOutput 4.4Elaborate thePerform the Elaborate theRecordsOrder/Contract review tendertests test reportTender Input template5.8 Management Performance Test items receptionTestIndicators template- Quality (mistakes, claims,..) - Cost - Time Delivery 5.4( ISO 17025 ) Standard Operation Procedures (SOPs) Moscow, June 2000 10 11. Setting up measurement & testing facilities 4.6 Purchasing services List of accepted & suppliessuppliers 5.5 5.3 5.9Accommodation &Assuring the quality Equipment environmentalof test resultsconditions Environmental - Intercomparision conditions5.6reportshistorical records Measurement - Internal statisticaltraceability tests ... Calibration & ( ISO 17025 ) maintennance program Moscow, June 200011 12. CONTINUOUS IMPROVEMENT PROCESS I - Input P - Process O - Output (Result)Mng I Mng R R - Record (Result) Mng - ManagersQuality Strategy of Quality Policy ofQA -Quality Assurance the Laboratorythe LaboratoryAT - Auditor Team AA - Audited Area LAB - Laboratories Optional DirectionQAP QAPAT P AA PAA OPrepare the AuditPerform AuditsImplement Improvement Planning Audits Corrective /System ReachedPreventive Actions QA PVerify Corrective ActionsRLAB,QA EffectivenessQA R Reports of the quality ofAudit Procedure tests results QA R ATR AT R MngP Audit Plan Nonconforming Audits Reports Review of the ReportsQARQuality System Minutes of theQA P System ReviewAuditors Training IClients Complaints Moscow, June 2000 12 13. EXERCISE 1. Organization and DocumentsGroup 1. Draw up the organization and management structure of thelaboratory in a scheme (organigrame). Describe the roles andresponsabilities of the personnel in the laboratory (job descriptions)using the template 1.1. Clarify responsabilities in the tasks that wouldaffect the quality of testing activities and results.Materials: Clause 4.1, (specifically paragraph 4.1.5) Annex 1.1.: Quality Manual of LABEIN. Section 3 Annex 1.2.: Confidentiality statement Time: 45 min.Moscow, June 2000 13 14. EXERCISE 1. Organization and DocumentsGroup 2. Write the list of chapters / sections of your Quality Manual.Prepare a list of documents to be written in your laboratory, using thetemplate 1.2 as a reference.Materials: Clause 4.2, and List of Contents ISO 17025 Annex 1.3.: Map of documents of the LABEIN Quality SystemTime: 45 min. Moscow, June 2000 14 15. (Rev.12/ Febrero.00)Manual O rganizacin General (MO G) Rev.7/ Febrero.00 ANNEX 1.3. MAP OF DOCUMENTS.Manual de Gestin Integrada (MGI)LABEINRev.8/ Febrero.00 Manual Integrado Ensayos y Calibracin (MIEC)Rev.7/ Junio.99Manual Proced. Generales (MPG) Manual del Jefe de Proyecto (MJP)Manual Proc.Administrativos (MPA) Rev.16/ Febrero.00Rev.8/ Julio.99Rev.9/ Enero.00011. Revisin Stma.Integrado .Rev.10/ Feb.00 Gua.01 Gua Jefe Proyecto . Rev.4/ Julio.98 001. Codific.Unidades Organiz.Rev.7/ Ene.00021. Elaboracin Procedim. Rev.9/ Junio.99 Gua.02 Gua Desar.Tcn.Proyecto. Rev.2/ May.98201. Fact. Clientes, Subvenc. Rev.5/ Mayo.98031. Rev.Contrato Pedido Rev.9/ Julio99 SM1.Inst.Gral.Seg.,Medio Ambiente Rev.1/ Nov.98202. Tramitacin Demandas. Rev.5/ Mayo.98041. Control del Diseo. Rev.6/ Junio.98401. Cumplim. Partes Actividad. Rev.2/ Dic.95 001. Gestin Bolsas Trabajos. Rev.6/ Enero.99051. Control Normas. Rev.5/ Ene.00403. Renov.Contratos Personal. Rev.3/ Ene.00 002. Gestin Proyectos Genricos Rev.4/ Marzo.99061. Control Compras. Rev.6/ Junio.99 405. Servicio Mdico. Rev.1/ Oct.93 003. Gestin Proyectos Europeos Rev.1/ Junio.98062. Control Subcontratac.SW Rev.2/ Ab.98 409. Entradas y Salidas. Rev.1/ Oct.93 010. Identificacin Documentos. Rev.4/ May.98410. Peticin Viajes. Rev.2/ Nov.95091. Elab. Informes E+ C. Rev.6/ Junio.99100. Gestin de Ofertas. Rev.5/ Nov.98 411. Gestin de Compras. Rev.2/ Feb.99092. Control herramient.SW Rev.3/ Nov.99 200. Contratacin Apertura Proy. Rev.5/ Junio.98 415. Utilizac. y Mnto. Pq.Mvil.Rev.3/ May.99101. Inspeccin y Ensayo. Rev.4/ Julio.99201. Planificacin Proyectos. Rev.3/ Junio.98601. Archivo. Rev.3/ Oct.98131. No Conformidades. Rev.7/ Marzo.99 300. Seguimiento Ejecucin Proy. Rev.5/ Junio.98 701. Acceso Sist.Informticos. Rev.2/ Abril.98132. Reclamac. Clientes. Rev.4/ Abr.99 400. Cierre Proyectos. Rev.6/ Junio.99 702. Seguridad Informtica. Rev.1/ Nov.95141. Ac. Correct. y Prevent. Rev.6/ Marzo.99171. Auditoras Internas. Rev.7/ Sep.98 Manuales Proc.Especficos de cada Cuaderno de Formatos de Registros de181. Form.Cualific. Personal.Rev.7/ Dic.99 Un/ Lab.o Servicio (MPEs)MPG-MJP-AC182. Cualificacin Auditores. Rev.4/ Sep.98183. Cualificacin Jefe Proyecto.Rev.3/ Ene.00Rev.4/ Febrero.00 PE.Un/ Lab/ Sev.-XX-O Proce. Organizacin Manual Proc.de Metodologa de laPE.Un/ Lab/ Sev.-XX-E Proc. EnsayoDireccin TcnicaPE.Un/ Lab/ Sev.-XX-C Proc. Calibracin Moscow, June 2000Rev.2/ Dic.97PE-Un/ Lab/ Sev.-XX-M Proc. Metodologa 15 16. (Rev .1/December.00) Quality Manual (QM)Rev.1/September. 00 TEMPLATE 1.2.MAP OFDOCUMENTSGeneral Quality Procedures (GQP)Rev.1/December.0001. Control of Laboratory Operations Rev. 1/Dec. 0002. Control of Measurement and Testing Facilities Rev. 1/ Sep.00.03.Continuous Improvement Process Rev. 1/Dec. 00/Standard Operation Procedures (SOP) Rev.1/December.00SOP.01.Fractional compositionSOP.02. oncentration of actual resinsCSOP.03. olumetric fraction of benzylVSOP.04. est on a copper laminaTSOP.05. hill and Cloud PointsCSOP.06. ontents of water soluble acids and alkalisCSOP.07. sh contentASOP.08.Moscow, June 2000 16 17. EXERCISE 2. EQUIPMENT CONTROL PLANGroup 1. Identify the way of ensuring traceability (external calibration,bought of certified materials,...) of three (3) of the measurement and testequipment. Write your proposals in a List of Actions (template 3.1) .(See Clause 5.6, ISO 17025) Time: 30 min. Moscow, June 200017

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