System Design Definitions

• Quality system: The organizational structure, responsibilities, procedures, and resources for implementing quality management

• Quality management: That aspect of overall management function that determines and implements the quality policy

• Quality policy: The overall quality intentions and direction of an organization, as regards quality, formally expressed by top management

• Quality control: The operational techniques and activities that are used to fulfill requirements for quality

• Quality assurance: All those planned and systematic actions necessary to provide adequate confidence that a product will satisfy given requirements

These terms are used to define quality systems and their implementation (10,11).

The elements of putting a system together are detailed in the publication Food Processing Industry Quality System Guidelines (12). These guidelines were written by a committee of experts and adapted from American National Standards Institute/American Society for Quality Control (ANSI/ASQC) Q9004-3-1993, Quality Management and Quality System Elements—Guidelines for Processed Materials. The monograph includes definitions of terms used in quality systems; management responsibility; quality systems principles; economics—quality-related cost considerations; quality in marketing, specification, design/ development, procurement, and production; product verification; measuring and control of test equipment; nonconformity, corrective action, handling, and postproduction functions; quality documentation and records; personnel; product safety and liability; and use of quality methods.

The International Organization for Standardization (ISO) in Geneva, Switzerland, has developed a series that provides a framework in the development of quality plans. They are:

• ISO 9000 Quality Management and Quality Assurance Standards: Guidelines for Selection and Use

• ISO 9001 Quality Systems: Model for Quality Assurance in Design, Development, Production, Installation, and Servicing

• ISO 9002 Quality Systems: Model for Quality Assurance in Production, Installation, and Servicing

• ISO 9003 Quality Systems: Model for Quality Assurance in Final Inspection and Test

• ISO 9004 Quality Management and Quality System Element Guidelines

• ISO A 8402 Management and Quality Assurance Vocabulary

The Malcolm Baldridge National Quality Award is presented by the President of the United States to companies in the manufacturing and service industries. The criteria consist of seven categories: leadership, strategic planning, customer and market focus, information and analysis, human resources focus, process management, and business results. It is a good model and provides yardsticks by which companies can be recognized for both business excellence and quality achievements.

Although models provide a good framework in the development and implementation of quality plans, the models need to be adapted to individual business segments.

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