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Moscow, June 2000 1
GOOD LABORATORY PRACTICES (GLP)
WORKSHOP
Moscow, June 2000
GOOD LABORATORY PRACTICES (GLP)
WORKSHOP
Moscow, June 2000
Instructor: Javier Ruiz
Moscow, June 2000 2
OBJECTIVES OF THE SEMINAR
� Understand the essential requirements of the ISO 17025 Standard� Special attention will be given to organizational aspects of this
standard: Design & Implementation of the Quality System� Identifying practical “means of demonstration” for getting your
“ laboratory working process” in accordance with the “essential requirements” 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 3
AGENDA (I)
TIME CONTENTS
9 – 9:30 h9:30 – 10:30 h
10:30 – 11:30 h
11:30 – 11:45 h
11:45 – 13:30 h
Welcome and PresentationsIntroduction. Good Laboratory Practices (GLP), Quality Management Systems and Laboratory Accreditation. Vocabulary.
Organization of the Laboratory and Personnel Responsabilities.
ISO 17025 requirements. Case study for implementation.Exercise 1. Organization and Documents in the Quality System.
BreakPART I. Setting up Measurement and Testing Faciliti esAccommodation and environmental conditions. Equipment and Measurement traceability.ISO 17025 requirements. Case study for implementation.Exercise 2. Equipment Calibration & Maintenance Records.
First Day, morning
Moscow, June 2000 4
AGENDA (II)
TIME CONTENTS
14:30 – 15:15 h
15:15 – 16:15 h
16:15 – 17:15 h
17:15 – 18 h
PART II. Getting the Laboratory Process under control.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.ISO 17025 requirements. Case study for implementation.
Assuring the quality of test results. ISO 17025 requirements.
Exercise 3. Action Plan after the First Day
First Day, afternoon
Moscow, June 2000 5
AGENDA (III)
TIME CONTENTS
9 – 10:30 h
10:30 – 11:30 h
11:30 – 11:45 h
11:45 – 13:30 h
PART II. Getting the Laboratory Process under contr ol (Cont.)Test Methods and Method Validation. ISO 17025 requirements. Case study for implementation.Exercise 4. Writing Standard Operation Procedures (SOP’s)
PART III. Continuous Improvement ProcessComplaints. Control of Nonconforming Testing. Corrective and Preventive Actions. Management Reviews.ISO 17025 requirements.
Break
Case study for implementation.
Internal Quality Audits. ISO 17025 requirements. Case study for implementation.
Second Day, morning
Moscow, June 2000 6
AGENDA (IV)
TIME CONTENTS
14:30 – 16 h
16 – 17 h
17 – 18 h
PART III. Continuous Improvement Process (Cont.)
Exercise 5. Audit Check ListExercise 3. Action Plan
Summary, Conclusions, Comments and Questions.
Test and Evaluation
The End of the seminar
Second Day, afternoon
Moscow, June 2000 7
PREVIOUS CONCEPTS
ESSENTIAL REQUIREMENTS: The aim or purpose behind every ISO 17025 item. That is “the spirit of the law”
e.g. The laboratory should maintain a documented quality system
MEANS OF DEMONSTRATION: Application of the essential requirements in a specific context. They include evidential proofs that demonstrate that the requirement has been effectively implemented
e.g.: The Quality Manual and 24 Standard Operation Procedures in the laboratory X
Moscow, June 2000 8
METHODOLOGY
�Short presentations to focus critical items of the Standard
� Individual reading, questions and comments�Analysing documents from other laboratories�Doing exercises by teams: facing problems,
identifying solutions�Evaluation of progress: final test
Moscow, June 2000 9
THE ISO 17025 STANDARD INTO PRACTICE:THE LABORATORY KEY PROCESSES
1. The added value process
2. Facilities and Measurement & Testing Equipment
3. The Continuous Improvement Process
Setting up measurement & testing facilities
Getting the laboratory process under control
CONTINUOUS IMPROVEMENT PROCESS
Moscow, June 2000 10
( ISO 17025 )
Laboratory tests
Catalogue
Tender template
Getting the laboratory process under control
Test template
Elaborate the tender
Standard Operation Procedures (SOP's)
Perform the tests
Test items reception
Order/Contract reviewElaborate the
test report
Test report
Tender
LEGEND
Management Performance Indicators- Quality (mistakes, claims,..)- Cost- Time Delivery
Test records
5.8
4.4
5.4
Activity
ProceduralDocuments
Records
Input
Input
Input Output
4.12.2
Moscow, June 2000 11
Setting up measurement & testing facilities
Purchasing services & supplies
Accommodation & environmental
conditions
( ISO 17025 )
Equipment
Measurement traceability
Assuring the quality of test results
List of accepted suppliers
- Intercomparision reports
- Internal statistical tests
...
Environmental conditions
historical records
Calibration & maintennance
program
4.6
5.6
5.55.95.3
Moscow, June 2000 12
Quality Strategy of the Laboratory
Prepare the Audit System
Auditors Training
Planning AuditsPerform Audits
CONTINUOUS IMPROVEMENT PROCESS
Quality Policy of the Laboratory
I - InputP - ProcessO - Output (Result)R - Record (Result)Mng - ManagersQA -Quality AssuranceAT - Auditor TeamAA - Audited AreaLAB - Laboratories
Optional Direction
Clients Complaints
Implement Corrective /
Preventive Actions
Improvement Reached
Verify Corrective Actions
Effectiveness
Review of the Quality System
Audit Procedure
Audits Reports
Reports of the quality of tests results
QA
QA
QA
QA
P P P PAT
AT P
P
LAB,QAQA
P
OAA AA
Minutes of the System Review
Nonconforming Reports
Audit Plan
Mng
Mng
I
I
Mng R
RR
R R
R
QA
ATQA
R
Moscow, June 2000 13
EXERCISE 1. Organization and Documents
Group 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 14
EXERCISE 1. Organization and Documents
Group 2. Write the list of chapters / sections of your QualityManual.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 System
Time: 45 min.
Moscow, June 2000 15
ANNEX 1.3. MAP OF DOCUMENTS.
LABEIN
Manual Proced. Generales (MPG)Rev.16/Febrero.00
011. Revisión Stma.Integrado .Rev.10/ Feb.00021. Elaboración Procedim. Rev.9/ Junio.99031. Rev.Contrato Pedido Rev.9/ Julio99041. Control del Diseño. Rev.6/Junio.98051. Control Normas. Rev.5/ Ene.00061. Control Compras. Rev.6/Junio.99062. Control Subcontratac.SW Rev.2/ Ab.98091. Elab. Informes E+ C. Rev.6/Junio.99092. Control herramient.SW Rev.3/ Nov.99101. Inspección y Ensayo. Rev.4/Julio.99131. No Conformidades. Rev.7/ Marzo.99132. Reclamac. Clientes. Rev.4/Abr.99141. Ac. Correct. y Prevent. Rev.6/Marzo.99171. Auditorías Internas. Rev.7/Sep.98181. Form.Cualific. Personal.Rev.7/ Dic.99182. Cualificación Auditores. Rev.4/ Sep.98183. Cualificación Jefe Proyecto.Rev.3/Ene.00
Manual Proc.de Metodología de laDirección Técnica
Rev.2/ Dic.97
Manual Proc.Administrativos (MPA)Rev.9/Enero.00
001. Codific.Unidades Organiz.Rev.7/ Ene.00201. Fact. Clientes, Subvenc. Rev.5/Mayo.98202. Tramitación Demandas. Rev.5/ Mayo.98401. Cumplim. Partes Actividad. Rev.2/ Dic.95403. Renov.Contratos Personal. Rev.3/Ene.00405. Servicio Médico. Rev.1/ Oct.93409. Entradas y Salidas. Rev.1/ Oct.93410. Petición Viajes. Rev.2/Nov.95411. Gestión de Compras. Rev.2/Feb.99415. Utilizac. y Mnto. Pq.Móvil.Rev.3/May.99601. Archivo. Rev.3/Oct.98701. Acceso Sist.Informáticos. Rev.2/Abril.98
702. Seguridad Informática. Rev.1/ Nov.95
Manual del Jefe de Proyecto (MJP)Rev.8/ Julio.99
Guía.01 Guía Jefe Proyecto . Rev.4/ Julio.98Guía.02 Guía Desar.Técn.Proyecto. Rev.2/May.98SM1.Inst.Gral.Seg.,Medio Ambiente Rev.1/ Nov.98001. Gestión Bolsas Trabajos. Rev.6/Enero.99002. Gestión Proyectos Genéricos Rev.4/Marzo.99003. Gestión Proyectos Europeos Rev.1/ Junio.98010. Identificación Documentos. Rev.4/ May.98100. Gestión de Ofertas. Rev.5/Nov.98200. Contratación Apertura Proy. Rev.5/Junio.98201. Planificación Proyectos. Rev.3/Junio.98300. Seguimiento Ejecución Proy. Rev.5/ Junio.98400. Cierre Proyectos. Rev.6/ Junio.99
Manuales Proc.Específicos de cadaUn/ Lab.o Servicio (MPE's)
PE.Un/Lab/ Sev.-XX-O Proce. Organización
PE.Un/Lab/ Sev.-XX-E Proc. Ensayo
PE.Un/Lab/ Sev.-XX-C Proc. Calibración
PE-Un/Lab/Sev.-XX-M Proc. Metodología
Manual de Gestión Integrada (MGI)Rev.8/ Febrero.00
Manual Organización General (MOG)Rev.7/Febrero.00
• Manual Integrado Ensayos y Calibración (MIEC)Rev.7/ Junio.99
(Rev.12/Febrero.00)
Cuaderno de Formatos de Registros deMPG-MJP-AC
Rev.4/ Febrero.00
Moscow, June 2000 16
TEMPLATE 1.2. MAP OF
DOCUMENTS
General Quality Procedures (GQP)Rev.1/December.00
01. 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
SOP.01.
/
Fractional composition
Quality Manual (QM)Rev.1/September. 00
(Rev.1/December.00)
Standard Operation Procedures (SOP)Rev.1/December.00
SOP.02.Concentration of actual resins
SOP.03.Volumetric fraction of benzyl
SOP.04.Test on a copper lamina
SOP.05.Chill and Cloud Points
SOP.06.Contents of water soluble acids and alkalis
SOP.07.Ash content
SOP.08.…
Moscow, June 2000 17
EXERCISE 2. EQUIPMENT CONTROL PLAN
Group 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 2000 18
ACTION / TASK Responsible(Person
in Charge of)
TargetDate
Status
TEMPLATE 3.1. LIST OF ACTIONS
Moscow, June 2000 19
EXERCISE 2. EQUIPMENT CONTROL PLAN
Group 2. Prepare the Calibration and Maintenance Records for three (3)of the measurement and test equipment. To do that, use the template 2.1.
Materials:•Clause 5.5.5, ISO 17025•CALIBRA data base of LABEIN
Time: 30 min.
Moscow, June 2000 20
EXERCISE 3. LIST OF ACTIONS
Prepare the List of Actions (see template 3.1) for the implementation ofthe quality system in your laboratory, according to the requirements ofthe ISO 17025 standard reviewed during this seminar.
Materials:• ISO 17025• Conclusions of the exercises
Time: 45 min at the end of the first day45 min at the end of the second day
Moscow, June 2000 21
EXERCISE 4. STANDARD OPERATION PROCEDURES
Read the SOP’s structure included in Annex 3.1. Write the scheme of aSOP of your laboratory.
Materials:•Clause 5.4, ISO 17025•Example of SOP’s of a chemical laboratory (Cromatography,Elemental Analysis, ...)
Time: 45 min.
Moscow, June 2000 22
EXERCISE 5a. CONTINUOUS IMPROVEMENT PROCESS
Group 1. Design a general quality procedure which covers clauses 4.8;4.9; 4.10; 4.11; 4.13 and 4.14 of ISO 17025.
Materials:•Clauses below, ISO 17025•Program of Audit (Annex 5.1)•Quality Laboratories Procedure (Annex 5.2)
Time: 45 min.
Moscow, June 2000 23
EXERCISE 5b. QUALITY AUDIT CHECK LIST
Group 2. Prepare the Check List to use as a base for an internalqualityaudit of your laboratory. To do that, read and adapt the checklist (Annex5.3) used in LABEIN for auditing testing and calibration activities.
Materials:•Clause 4.13, ISO 17025•Check List of LABEIN (Annex 5.3)•Program of Audit (Annex 5.1)
Time: 45 min.
Moscow, June 2000 24
De: J. Ruiz (SI), Z. Goiri (AC), A. Bonilla (LA)A: J. M. Bárcena, A. Cortés, P. Santisteban, M. Vázquez
ASUNTO: AUDITORÍA A LAS ACTIVIDADES DE E+C - LDFecha: 13.04.99OBJETIVO:Evaluar el cumplimiento de los requisitos establecidos por la norma EN 45001 en las actividades de E+C del laboratorio, así como la implantación del sistema de calidad de LABEIN, definido en el Manual de Calidad de Ensayos y Calibración, en los procedimientos de Labein y en los procedimientos específicos aplicables.
ALCANCE:La auditoría afecta a los laboratorios de edificación (LD) en sus instalaciones de Olabeaga. Se revisarán las bolsas siguientes: BOLSA MATERIALES E INSTALACIONES (9901B029), BOLSA ACÚSTICA AMBIENTAL (9901B039), BOLSA ACÚSTICA DE EDIFICIOS (9901B044). Asimismo, se revisarán otros aspectos generales del laboratorio, tales como el control y archivo de documentación, control de normas, registros de formación del personal, software de la unidad, etc. y se realizará el seguimiento de las No Conformidades que se encuentren abiertas en el momento de la auditoría.
PROGRAMA DE TRABAJO:08:30-08:45 Reunión inicial de presentación de los objetivos de la auditoría y del plan de trabajo. Designación del coordinador de la auditoría por parte del laboratorio. Entrega de la documentación específica existente (procedimientos) al equipo auditor.08:45-10:45 Revisión de aspectos generales: ofertas, cierres, no conformidades, procedimientos específicos, registros de formación, acreditaciones, etc. 10:45-13:30 Entrevistas con los responsables de las bolsas auditadas. Podrán ser auditados otras bolsas o proyectos si el equipo auditor lo considera necesario para comprobar de los elementos aplicables del sistema de calidad E+C de LABEIN.J. Ruiz A. Bonilla Z. GoiriMATERIALES E INSTALACIONES ACÚSTICA DE EDIFICIOS ACÚSTICA AMBIENTAL(Pedro Santisteban) (Azucena Cortés) (Manuel Vázquez)
15:00-16:30 Reunión del equipo auditor. Análisis e identificación de las desviaciones16:30-17:30 Reunión final de presentación de conclusiones.
ANNEX 5.1. EXAMPLE OF A PROGRAM OF
AUDIT
Moscow, June 2000 25
EXAM (1)
1. Define what a“Quality System” is.The organizational structure, responsibilities, procedures, processes and resources for implementig quality management.
QUALITY MANAGEMENT. That aspect of the overall management function that determines and implements the quality policy.
Moscow, June 2000 26
EXAM (2)
2. What does “Measurement Traceability” means?
Where the concept is applicable, it means that all measurements are traceable through certificates held by the laboratory, either national or international standard or to a certified reference material (CRM).
Moscow, June 2000 27
EXAM (3)
1. An “Standard Operation Procedure (SOP)” in a testinglaboratory should include:
1. OBJECT2. SCOPE3. REFERENCES4. DEFINITIONS5. EQUIPMENT6. DESCRIPTION6. RESPONSABILITIES7. MODIFICATIONS8. RECORDS
Moscow, June 2000 28
EXAM (4)
1. ¿Why Accreditation schemes, and accredited laboratoriesare needed in modern societies?
Because of the need of conformity assessment ofproducts, with the independent judge of accreditedlaboratories, inspection entities and certification bodies(third party). The goal is to reach markets with safe andhigh quality products, with no need of governmentsinvolved directly in every certification process (but onlyin mandatory regulations related to high risk activities-products).
Moscow, June 2000 29
EXAM (5)
5. A documented Quality Systemin a testing laboratoryshould include:
A. Quality ManualB. General Quality ProceduresC. Standard Operation ProceduresD. Records standarized (templates or formats)
Moscow, June 2000 30
EXAM (6-10)
6. C7. C8. A9.B10.A