AMEDK3-010 LO1 Quality Management Concepts

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What is a Quality Manual?

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A document that outlines the quality management system (QMS) of an organisation. It describes the company's quality policy, procedures, and processes for achieving quality objectives.

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What is the purpose of a Quality Manual?

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To provide a clear and concise overview of the organisation's commitment to quality, and to guide employees in implementing and maintaining the QMS.

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What are some common elements found in a Quality Manual?

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Quality policy and objectives, Scope of the QMS, Responsibilities and authorities, Procedures and work instructions, Document control, Records management, Management review, Continuous improvement.

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What is TQM?

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Total Quality Management (TQM) is a management approach that focuses on continuous improvement of all aspects of an organization with the aim of achieving customer satisfaction and organizational excellence.

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Name 3 common QMS/TQM tools.

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PDCA Cycle: (Plan-Do-Check-Act) A cyclical process for continuous improvement. Fishbone Diagram: (Ishikawa or Cause-and-Effect Diagram) A tool for identifying potential causes of a problem. Pareto Chart: A bar graph that ranks causes of a problem from most to least significant.

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What is a Control Chart?

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A graphical tool used to monitor process variation over time and identify trends or out-of-control conditions.

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What is the purpose of a Flowchart?

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To visually represent the steps in a process, facilitating analysis and improvement.

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What is a Histogram?

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A graphical representation of the distribution of data, showing the frequency of different values.

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What is the purpose of a Scatter Diagram?

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To identify the relationship between two variables and determine if there is a correlation.

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Why are QMS/TQM tools important?

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They provide a structured approach to problem-solving, process improvement, and quality management, enabling organizations to achieve their quality objectives and enhance customer satisfaction.