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Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1] This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): [2] [3]
The first edition of Juran's Quality Control Handbook was published in 1951. He also developed the "Juran's trilogy", an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control, and quality improvement. These functions all play a vital role when evaluating quality.
Control Plan A copy of the Control Plan, reviewed and signed off by supplier and customer. The Control Plan follows the PFMEA steps, and provides more details on how the "potential issues" are checked in the incoming quality, assembly process or during inspections of finished products. Measurement System Analysis Studies
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Statistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste scrap.
Closely related terms are the rejectable quality limit and rejectable quality level (RQL). [ 1 ] [ 2 ] In a quality control procedure, a process is said to be at an acceptable quality level if the appropriate statistic used to construct a control chart does not fall outside the bounds of the acceptable quality limits.
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
By understanding the commercial process, a framework for quality specifications can be established and used as the foundation of a control strategy. Process design [2] is the first of three stages of process validation. Data from the development phase is gathered and analyzed to understand end-to-end system processes. These data are used to ...
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