Quality control

Character: Compulsory
Session: 1st semester
Credits: 4,5 ECTS

- To define the concept of quality and good laboratory practice.
-To describe standard operating procedures.
-To know the mechanisms and procedures of quality management, as well as the basic tools for quality improvement.
-To know describe and know-how to apply the ISO 9001 and ISO 17025 families of standards.
-To know-how to validate methodologies and calibrate equipment. Know-how to use records and information maintenance procedures

I.- BASIC CONCEPTS
Concepts, evolution and fundamentals of quality and its management. Quality of products, processes and systems. Normative references. Basic tools. Risk management. Design of experiments.
II.- PROCESS CONTROL
Statistical process control and capability studies. Graphs of variables and attributes. Acceptance sampling
III.- ANALYTICAL METHODOLOGY AND QUALITY.
Quality and analytical laboratory. Sampling. Traceability. Reference materials. Equipment management. Calibration. Uncertainty calculation. Analytical methods. Validation. Application to the clinical laboratory.
IV.- EVALUATION OF A TESTING LABORATORY
Intercomparison exercises. Accreditation. Audits. Standard 17025 and Good Laboratory Practice

Basic Bibliography:
C.Camison. “Gestión de la calidad: conceptos, enfoques, modelos y sistemas. Pearson-Prentice Hall, Madrid, 2011
D.H. Besterfield. “Control de calidad (8ª ed)”. Pearson-Prentice Hall, México, 2009
J.R. Evans, W. M. Lindsay. “Administración y control de la calidad”.(7ª ed), Thomson, México, 2008
M. Sangüesa, R.Mateo, L. Ilzarbe. “Teoría y Práctica de la calidad”. Thomson, 2006
Complementary bibliography:
R. Compañó, A. Ríos. “Garantía de la calidad en los laboratorios analíticos”, Ed. Síntesis, Madrid, 2002.
Sagrado S., Bonet E., Medina M.J., Martín Y. “Manual Práctico de calidad en los laboratorios. Enfoque ISO 17025”. Ediciones AENOR. 2004

Knowledge/content:
Con07: To know the basic aspects of quality control and economic management of companies, as well as the legal and ethical aspects of biotechnology.

Skills:
H/D01: Think in an integrated way and approach problems from different perspectives with critical reasoning.
H/D02: Search for, process, analyse/interpret and synthesise relevant information and results from different sources and draw conclusions on issues related to biotechnology.
H/D03: Organise and plan their work.
H/D04: Interpret experimental results and identify consistent and inconsistent elements.
H/D05: Team work.
H/D06: Maintain an ethical commitment, as well as a commitment to equality and integration.
H/D07: Initiative, entrepreneurship and adaptation to new situations (resilience).
H/D08: Leadership and team management
H/D10: Knowing how to analyse data and interpret experimental results specific to the fields of Biotechnology.



Competences
Comp01: Students should be able to gather and interpret relevant data (usually within their area of study) in order to make judgements that include reflection on relevant social, scientific or ethical issues.
Comp02: Students are able, both in writing and orally, to discuss and convey information, ideas, problems and solutions related to Biotechnology to both specialist and non-specialist/general audiences.
Comp03: That students have developed those learning skills necessary to undertake further studies with a high degree of autonomy.
Comp04: That students know how to apply the theoretical-practical knowledge acquired in the degree in a professional manner and are competent in the approach/solution of problems, as well as in the elaboration/defense of arguments in both academic and professional contexts related to innovation and the Biotechnology industry.
Comp05: Study and learn autonomously, with organisation of time and resources, new knowledge and techniques in Biotechnology and acquire the ability to work in a team.
Comp07: Having an integrated vision of the R+D+i process and knowing how to describe the basic concepts of the company, applying them to the Biotechnology company.
Comp08: Clearly appreciate the ethical, social, economic and environmental implications of the professional activity to be carried out, as well as knowing and applying biotechnological risk assessment criteria.

The platforms used will be those available in the USC, Moodle through the virtual classroom of the USC.


A) Lectures: Lectures given by the lecturer that can have different formats (theory, problems and/or general examples, general guidelines of the subject...). The lecturer may be supported by audiovisual and computer media. All the diagrams and presentations used in the lectures will be made available to students during the course through the virtual classroom of the USC. Similarly, this medium will be used to provide students with any other type of material that the lecturer considers appropriate for the development of the course. Attendance to these classes is recommended.
B) Interactive classes - Seminars: The student actively participates in these classes in different ways: handing in exercises to the teacher; solving exercises in the classroom, etc. Evaluation tests are included in this methodology. Attendance at these classes is compulsory. It is considered an element of continuous assessment of the subject. Submissions will be through the virtual classroom.

C) Practical classes with computer: In this subject, the practical classes are developed in a general classroom, the students must have their own portable devices where they will install the recommended software (Statgraphics centurion) by means of the license available in the ATIC section of the USC. Faculty loan computers are also available. This software operates exclusively on MS Windows operating systems, therefore, it is advisable to have a computer operating under that system. In these classes, the student acquires the skills related to the subject being taught and consolidates the knowledge acquired in the theory classes. Attendance at these classes is compulsory. Absences must be justified by documentary evidence. Exercises will be handed in through the virtual classroom.

D) Tutorials: Tutorials programmed by the teacher and coordinated by the Centre. In general, they will involve 1.5 hours per term for each student. Activities such as supervision of supervised work, clarification of doubts about theory or practices, problems, exercises, readings or other proposed tasks are proposed; as well as the presentation, exhibition, debate or commentary of individual work or work done in small groups. In some cases, the teacher will require students to hand in exercises prior to the tutorial. Attendance at these classes is compulsory.

The evaluation of this subject will be by “continuous assessment” combined with a final exam. The student will have two opportunities.
The final exam will be onsite. The date of the exam will be determined by the Faculty.
For cases of fraudulent performance of exercises or tests, what is stated in the ‘Normativa de avaliación do rendemento académico dos estudantes e de revisión das cualificacións’ (Regulations for the assessment of students' academic performance and the revision of qualifications) will apply.

Attendance in lectures is not compulsory, although it will be positively assessed. An attendance of 80% will be required in the compulsory interactive classes: seminars and tutorials. Attendance to at least one of the scheduled tutorials is compulsory in order to take into account the continuous assessment.
Absences must be justified by documentation, accepting those cases contemplated in the current university regulations.
In any case, in order to pass the subject, it will be an essential requirement to have attended the corresponding computer classroom sessions, and if the absence is justified, it will be made up in agreement with the teacher.
Repeating students who have passed the continuous assessment part of the practicals in a maximum of two previous academic years will retain the grade obtained in the continuous assessment part of the practicals, and will therefore be exempt (unless they wish to do so, in which case, on repeating the practicals the grade will not be retained and the grade obtained in the current academic year will prevail) from attending the corresponding computer classroom sessions, but they will have to take the exam on the content of the practicals
6.1. Continuous assessment, will have a percentage weight of 40% and will consist of::

6.1.1. Work done in seminars and tutorials handed in to the teacher and class participation 20%.
The interactive classes will be used to evaluate: Comp01- Comp05, Comp07 and Comp08.

6.1.2. Interactive practices with computer 20%. The items to be evaluated will be the execution of the practice and the exercises handed in.
The computer exercises will be used to evaluate Comp04
6.2. Final exam, it will deal with the theoretical contents of the subject and practical contents related to the laboratory practices, and will have a percentage weight of 60 %..

The exam will serve to evaluate the following competences: Comp03, Comp04, Comp05 and Comp07.

TYPE OF ACTIVITY: HOURS (ATTENDANCE)
Lectures: 20 h (100 %)
Interactive classes (Seminars): 7 h (100 %)
Practical classes with computer: 10 h (100 %)
Group tutorials:1 h (100 %)
Individual tutorials: 0,5 h (100 %)
Examn and revision: 2 h (100 %)
Personal work: 72 h (0 %)

The material and presentations used by the lecturer in the lecture classes are intended to facilitate and guide learning, but do not replace the consultation and study of the recommended reference texts, nor do they constitute in themselves a reference manual or a text for the preparation of the exam. Students must demonstrate that they have made a personal learning effort beyond the outlines or scripts provided by the lecturer in the lecture classes

Teaching will be taught in Spanish