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