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IPLUSO 19571

Quality control

Biomedical Laboratory Sciences
  • ApresentaçãoPresentation
    The curricular unit aims to transmit to students a wide range of knowledge in the field of Quality, namely themes related to Quality Control and Quality Assurance. It is intended that students learn and apply statistical quality control techniques and methodologies that allow, monitoring and improving productive and industrial processes. The domains of the course give students the opportunity to learn how to solve problems in a structured way through the application of quality tools, to analyze data obtained through experimentation that will serve to optimize the performance of processes and product compliance, or even to measure and monitor the stability of processes and their ability to meet customer requirements, as well as the ability to perform audits.
  • ProgramaProgramme
    1. Laboratory quality: management, assurance and control; total testing process; accreditation and certification; ISO 9001, ISO 15189 and ISO/IEC 17025; PDCA; nonconformities, corrective actions, improvement and audits. 2. Statistics and metrology: location and dispersion; normal distribution and z-values; VIM; precision, trueness, accuracy, random and systematic errors. 3. Statistical control: stability; Levey-Jennings charts; limits; type I and II errors, Pfr/Ped, Westgard control rules and out-of-control situations. 4. Analytical performance: specifications, biological variation, calculated and allowable total error, critical systematic error and the Six Sigma metric. 5. Total quality and IQC plan: indicators, materials, levels, target values, frequency, rules, response to failures and review. 6. EQA: commutability, peer groups, bias, SDI, z-score, interpretation and actions. 7. RCV, delta check, index of individuality and introduction to risk management.
  • ObjectivosObjectives
    Students should be able to: 1) Distinguish quality management, quality assurance and quality control, and place accreditation, certification, PDCA and audits in the clinical laboratory context. 2) Apply descriptive statistics and metrological concepts to laboratory data. 3) Calculate statistical parameters and control limits, construct and interpret Levey-Jennings charts, and apply Westgard control rules. 4) Distinguish random from systematic error, recognise out-of-control situations and propose corrective actions. 5) Assess analytical performance using performance specifications, total error, critical systematic error and the Six Sigma metric, selecting IQC strategies. 6) Plan and interpret IQC and EQA, including target values, peer groups, bias, SDI and z-scores. 7) Apply RCV, delta checks and the index of individuality to serial results. 8) Identify nonconformities and understand the foundations of risk management, contributing to continual improvement and patient safety.
  • BibliografiaBibliography
    ISO (2022). ISO 15189:2022, Medical laboratories - Requirements for quality and competence. ISO (2015/2024). ISO 9001:2015/Amd 1:2024, Quality management systems - Requirements. ISO (2026). ISO 19011:2026, Guidelines for auditing management systems. ISO/IEC (2017). ISO/IEC 17025:2017, General requirements for testing and calibration laboratories. JCGM (2012). JCGM 200:2012, International vocabulary of metrology (VIM), 3rd ed. CLSI (2016). C24, 4th ed., Statistical quality control for quantitative measurement procedures. EFLM. Biological Variation Database. Pires, A. R. (2023). Sistemas de gestão da qualidade (3.ª ed.). Sílabo. Westgard, J. O. (2016). Basic QC practices (4th ed.). Westgard QC. Westgard, J. O., & Westgard, S. A. (2014). Basic quality management systems. Westgard QC. Westgard, J. O., Bayat, H., & Westgard, S. A. (2022). Advanced QC strategies: Risk-based design for medical laboratories. Westgard QC.
  • MetodologiaMethodology
    In this curricular unit, the Team-based learning (TBL) methodology is used, with tasks carried out in small groups, allowing the development of the ability to analyze and apply theoretical concepts.
  • LínguaLanguage
    Português
  • TipoType
    Semestral
  • ECTS
    4
  • NaturezaNature
    Mandatory
  • EstágioInternship
    Não