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controllo qualità

Università degli Studi di Padova medicina e chirurgia 2020
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  • Introduction to Quality:
    • Defines quality, tracing its evolution from historical examples (e.g., Genesi I,31, Frederick Taylor) to modern standards and philosophies.
    • Explores the dimensions of product and service quality, including fundamental performance, conformity, reliability, aesthetics, serviceability, and perceived quality.
    • Introduces the 'Quality Cycle' and Deming's process diagram, highlighting the interplay between market needs, design, production, and customer feedback.
    • Details the 'Quality Pyramid' for documentation, covering Quality Manual, procedures, and work instructions.
    • Discusses market quality using the Berry, Parasuraman, Zeithaml model, differentiating between latent, real, and competitive quality, and identifying causes of non-conformities.
  • Quality System Components:
    • Outlines the responsibilities of management, including policy definition, objective setting, and system review.
    • Specifies the structure and content of quality procedures and instructions, emphasizing clarity, logical sequence, and complete documentation for effective process control.
    • Explains the certification process for quality systems, including different types of audits (internal, external) and the importance of corrective actions.
  • ISO 9000:2000 Standards:
    • Illustrates the transition and key changes from ISO 9000:1994 to ISO 9000:2000, focusing on simplification, process orientation, and compatibility with other management standards.
    • Highlights Deming's PDCA cycle (Plan-Do-Check-Act) as a core principle for continuous improvement within the ISO framework.
    • Details the articulation of ISO 9001:2000, covering management responsibility, resource management, product realization, and measurement, analysis, and improvement.
  • Total Quality Management (TQM):
    • Presents TQM as a comprehensive approach centered on customer satisfaction, continuous improvement (Kaizen), and employee involvement.
    • Contrasts Kairyo (radical, technology-driven improvements) with Kaizen (small, continuous improvements).
    • Applies the PDCA cycle to TQM for problem identification, solution implementation, verification, and standardization.
  • Safety Management and Reliability:
    • Integrates safety into quality management, referencing OHSAS 18001:1999 and UNI-INAIL SGSL as key frameworks.
    • Explains the concept of an 'Integrated QSA System' (Quality-Safety-Environment) and its common elements (e.g., policy, responsibilities, risk assessment).
    • Covers the importance of safety policy, risk assessment documentation (DVR), and control measures.
    • Introduces the concepts of product reliability, avaria (failure), and guasto (fault), alongside probabilistic functions like Weibull, exponential negative, and normal distributions for modeling failure rates.
    • Defines Mean Time To Failure (MTTF) and Mean Time Between Failures (MTBF) and provides examples for their calculation and interpretation in reliability analysis.

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