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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.
A primary purpose of a package is to ensure the safety of a product during transportation and storage. If a product is damaged during this process, then the package has failed to accomplish a primary objective and the customer will either return the product or be unlikely to purchase the product altogether. [4]
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
Quality Improvement can be distinguished from Quality Control in that Quality Improvement is the purposeful change of a process to improve the reliability of achieving an outcome. Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome.
Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [1]
Packaging engineering, also package engineering, packaging technology and packaging science, is a broad topic ranging from design conceptualization to product placement. All steps along the manufacturing process, and more, must be taken into account in the design of the package for any given product.
Process efficiency can be enhanced by reducing the margins necessary to ensure product specifications are met. [11] This can be done by improving the control of the process to minimize the effect of disturbances on the process. The efficiency is improved in a two step method of narrowing the variance and shifting the target. [11]