L1: QC II with Instrumentation

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    Created by
    Naur Heh

    Subdecks (2)

    Cards (53)

    • Total Quality Control System
      Quality, Quality Assurance, Quality Control, Quality Management
    • A combination of attributes or characteristics of a product, which when compared to a standard, serves as a basis for measuring the uniformity of the product and determine its degree of acceptability
      Quality
    • Ability to fulfill customer's needs and expectations
      Quality
    • Why is quality important?
      • Clients expect quality
      • Poor quality results in rework at additional cost; recall
      • Poor quality cost lives
    • How to ensure quality?
      Plan, Act, Evaluate (Monitor Review), Improve
    • Relates to the studies made and plans developed for assuring quality of a product prospectively.
      Quality Assurance
    • Refers to a program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.
      Quality Assurance
    • A tool which gives the assurance that a product conforms to standards and specifications through a system of inspection, analysis, and action.
      Quality Control
    • A concept, approach, or tool used by manufacturing companies whereby management and labor join forces to build quality into products while helping to assure the company's financial success.
      Total Quality Management
    • T - total organization using
      Q - quality thinking and methods to
      M - manage
    • Doing things right, the first time, and every time
    • Continually improve quality and service while minimizing costs and maximizing resource utilization.
      Total Quality Management Basic Principle
    • Directed towards defect prevention (proactive) rather than defect detection (after the fact).
      Total Quality Management Changed Emphasis
    • Factors affecting TQM
      Customer, Process Improvement, Total Involvement
    • TQM Goal
      Safety, Purity, Effective, Quality
    • Advantages of TQM:
      • Production of quality pharmaceutical products
      • Improve productivity and customer satisfaction
      • Maximize profit
      • Minimize operating cost
      • Guarantees product efficacy
      • Guarantees product conforms to regulatory requirements (cGMP, FDA regulations)
    • An overall management plan to guarantee the integrity of data.
      Quality Assurance
    • The system
      Quality Assurance
    • Ensure public recognition and credibility through the maintenance of standards
      Quality Assurance
    • Fit for purpose and Right first time
      Quality Assurance
    • A series of analytical measurements used to assess the quality of the analytical data
      Quality Control
    • The tools
      Quality Control
    • Process employed to ensure a certain level of quality in a product of service.
      Quality Control
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