IDENTIFYING DATA 2019_20
Subject (*) QUALITY CONTROL AND ASSURANCE Code 19204220
Study programme
Bachelor's Degree in Biotechnology (2009)
 Cycle 1st
Descriptors Credits Type Year Period
3 Optional 1Q
Language
Català
Department Biochemistry and Biotechnology
Coordinator
TORIBIO MATIAS, RICARDO
 E-mail ricardo.toribio@urv.cat
Lecturers
TORIBIO MATIAS, RICARDO
Web
General description and relevant information Quality Assurance and Control consists of a series of activities that minimize the uncertainty associated with analytical results and verify compliance with previously defined quality requirements.

Competences
Type A Code Competences Specific
 A8 Analyse appropriately data and experimental results from the fields of biotechnology with statistical techniques and be able to interpret it.
Type B Code Competences Transversal
Type C Code Competences Nuclear

Learning outcomes
Type A Code Learning outcomes
 A8 Design a quality assurance plan in a Department of clinical biochemistry.
Type B Code Learning outcomes
Type C Code Learning outcomes

Contents
Topic Sub-topic
1. Introduction Introduction to quality.
2. ISO regulations Accreditation and certification.
3. ISO 9001 ISO 9001 regulations: organization and documents.
4. Quality management system Documentation of the quality management system.
5. Audit Audit of the quality management system. Steps and preparation.
6. Good laboratory practices Basis of good laboratory practices.
7. Hosting plan Managing the incorporation of personnel in laboratories.
8. Sample management Steps in the process of collecting and managing samples in laboratories.
9. Validation of analytical methods Steps to follow in the process of validation of an analysis method.
10. Tools to control quality Tools and strategies used to control quality in an analytical procedure.

Planning
Methodologies  ::  Tests
  Competences (*) Class hours
 Hours outside the classroom
 (**) Total hours
Introductory activities
A8
 1 0 1
Lecture
A8
 20 29 49
Personal attention
A8
 1 0 1
Presentations / oral communications
A8
 8 12 20
 
Mixed tests
A8
 4 0 4
 
(*) On e-learning, hours of virtual attendance of the teacher.
(**) The information in the planning table is for guidance only and does not take into account the heterogeneity of the students.

Methodologies
Methodologies
  Description
Introductory activities Quality objectives in the clinical laboratory.
Lecture Exposition of the contents of the subject: implementation of the guarantee of quality, evaluation and validation of methods, documented procedures.
Personal attention Time the teacher has reserved to attend and solve doubts to the students.
Presentations / oral communications Oral presentation by students of a specific subject (previous written presentation).

Personalized attention
Description
manuel.suarez@urv.cat Office 105 Department of biochemistry of biotechnology

Assessment
Methodologies Competences Description Weight        
Presentations / oral communications
A8
 Oral presentation by students of a specific subject (previous written presentation).
 30%
Mixed tests
A8
 The content of the lectures will be assessed through objective multiple-choice tests.

The continuous assessment system involves to carry out two objective tests during the course. 		70%
Others  

The minimum grade to pass the subject is a 4/10 for each of the methodologies evaluated.

 
Other comments and second exam session

The second call consists of an objective test that has a weight of 70%. The mark of the presentations/exhibitions are maintained. The minimum mark in each evaluation has to be a 4/10.

During the evaluation tests, mobile phones, tablets and other devices that are not expressly authorized for the test, must be turned off and out of sight.

The demonstrable fraudulent realization of some evaluation activity of a subject both in material and virtual and electronic support entails the student's failure mark of this evaluation activity. Regardless of this, given the seriousness of the events, the center may propose the initiation of a disciplinary file, which will be opened by resolution of the rector

.

Sources of information

Basic Badia, E, Enfoque ISO 9000: Normalización, Homologación, Certificación, Acreditación, Aseguramiento (ISO ) 9000, Editorial Deusto, 1998
Fuentes Arderiu, X, Guia per al control intern de la qualitat de la mesura de magnituds biològiques utilitzant materials de control, Associació Catalana de Ciències de Laboratori Clínic, Invitro veritas 2006
Burtis CA, Ashwood ER, Tietz Textbook of Clinical Chemistry 2nd ed, W.B. Saunders Company , Philadelphia, 2001
Fuentes X, Castiñeiras M J, Queraltó J M, Bioquímica Clínica y Patologia Molecular, Editorial Reverté, 1998
Gonzalez de Buitrago, JM, Bioquímica Clínica, Editorial McGraw-Hill , 1998
González Sastre F, Bioquímica Clínica, Barcanova, Barcelona 1993
, Sistemas de gestión de la calidad. Requisitos. (ISO 9001:2008) , Ediciones AENOR, 2008
Kaplan LA, Pesce AJ , Clinical Chemistry, Theory, Analysis, and correlation, The C.V. Mosby Company , St Louis 2009
Todd Sanford Davidsohn, Henry’s Clinical Diagnosis and Management, Saunders, Philadelphia, 2001
Compaño R, Ríos A, Garantía de la Calidad en los Laboratorios analíticos, Editorial Síntesis, 2002
Fernandez Espina C, Gestión de la calidad en el Laboratorio Clínico, Editorial médica panamericana, 2005
Departament de treball, Industria, Comerç i Turisme, Manual d’aplicació de la ISO 9001:2000 en els Laboratoris Clínics, Generalitat de Catalunya, 2003
Noblejas M, La gestión por processos en el Laboratorio Clínico según la Norma UNE-EN ISO 9001, Ediciones AENOR, 2006
Salas A, La norma UNE-EN ISO 9001 en laboratorios clínicos. Guía práctica para su implantación, Ediciones AENOR, 2009

UNE-EN ISO 15189:2013 Laboratorios Clínicos. Requisitos particulares para la Calidad y la Competencia

ICH HARMONISED TRIPARTITE GUIDELINE. VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1). International Council On Harmonisation

Analytical Procedures and Methods Validation for Drugs and Biologics. Guidance for Industry, January 2015. Food and Drug Administration (FDA)

Complementary

http://www.acclc.cat

http://www.aefa.es/

http://www.clinchem.org/

http://ifcc.org/

http://www.labtestsonline.es/

http://www.seqc.es/
Recommendations

Subjects that are recommended to be taken simultaneously
VACCINES AND PHARMACEUTICAL DRUGS/19204206

Subjects that it is recommended to have taken before
ANALYTICAL AND INSTRUMENTAL CHEMISTRY/19204116
(*)The teaching guide is the document in which the URV publishes the information about all its courses. It is a public document and cannot be modified. Only in exceptional cases can it be revised by the competent agent or duly revised so that it is in line with current legislation.