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)

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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

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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

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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

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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

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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

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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

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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

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( 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

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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

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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

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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.

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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.

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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

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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.…

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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.

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ACTION / TASK Responsible(Person

in Charge of)

TargetDate

Status

TEMPLATE 3.1. LIST OF ACTIONS

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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.

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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

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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.

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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.

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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.

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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

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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.

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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).

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EXAM (3)

1. An “Standard Operation Procedure (SOP)” in a testinglaboratory should include:

1. OBJECT2. SCOPE3. REFERENCES4. DEFINITIONS5. EQUIPMENT6. DESCRIPTION6. RESPONSABILITIES7. MODIFICATIONS8. RECORDS

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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).

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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)

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EXAM (6-10)

6. C7. C8. A9.B10.A