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2: Introduction to Quality Principles

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    • Identify significant contributions to the field of quality
    • Evaluate Total Quality Management
    • Apply the Plan-Do-Check-Act Cycle
    • Understand and apply Juran’s ‘fitness for use’ definition of quality
    • Distinguish between inspection, audit, surveillance, prevention

    • 2.1: History of Quality
      Quality philosophies have been around for as long as humankind. Standards of quality were necessarily different thousands of years ago and, some might say, lower by our standards today. Where you and I might throw away a half-rotten apple, the nomadic cave dweller would likely judge the unspoiled half as a great dinner.
    • 2.2: Quality Pioneers
      Good quality management techniques are as numerous and varied as the types of biotechnology companies that use them. Most companies will lean towards a ‘favored' quality philosophy, but few rely on just one. It is much better to draw from several schools thought. We will present some of the major contributors to the field of quality below. You are encouraged to research more on these pioneers' interesting backgrounds!
    • 2.3: The Juran Trilogy
      Dr. Joseph Juran was one of the foremost experts in the area of quality. Juran believed that to achieve quality, you must start with organizational goals, policies, and vision. Converting organizational goals into results is accomplished through three managerial processes called the JURAN TRILOGY: Quality Planning, Quality Control, and Quality Improvement (The Juran Institute, 2016).
    • 2.4: Feigenbaum - Total Quality Management (TQM)
    • 2.5: Company Culture and Employee Needs
      Quality professionals are limited in their ability to alter the culture of a manufacturing organization. For real change to occur, everyone in the organization must be motivated to change. A successful company takes care of its employees' basic needs by cultivating a culture of respect, fairness, and rewards for a job well done. These key ingredients are powerful motivators that inspire employees to work hard and conscientiously for the company.
    • 2.6: Establishing Quality Control - The Essentials
      Every company develops a routine way of doing things, but what happens when the way they are doing things no longer works for reasons out of their control? What if the market changes? What happens when the customer needs change? What about the needs of their workforce? How an organization adapts to a rapidly changing market and customer base is crucial to its survival.
    • 2.7: Inspection, Audit, and Surveillance
    • 2.8: Validation of Processes and Equipment
    • 2.9: Nonconformance
      When a process, product, or raw material is out of specification, it is called a nonconformance. Inspections, audits, and surveillance will occasionally uncover nonconformance or defects. Nonconformance problems are placed in one of three categories based on the product defect: critical, major, and minor.

    This page titled 2: Introduction to Quality Principles is shared under a CC BY license and was authored, remixed, and/or curated by Jack O'Grady.

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