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Sunday, 5 March 2017

Quality Assurance in pharmacy

Quality assurance (QA) is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention in quality assurance differs subtly from defect detection and rejection in quality control  and has been referred to as a shift left as it focuses on quality earlier in the process.
The terms "quality assurance" and "quality control" are often used interchangeably to refer to ways of ensuring the quality of a service or product.  For instance, the term "assurance" is often used as follows: Implementation of inspection and structured testing as a measure of quality assurance in a television set software project at Philips Semiconductors is described. The term "control", however, is used to describe the fifth phase of the DMAIC model. DMAIC is a data-driven quality strategy used to improve processes.
Quality assurance comprises administrative and procedural activities implemented in a quality system  so that requirements and goals for a product, service or activity will be fulfilled. It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention.  This can be contrasted with quality control , which is focused on process output.
Two principles included in quality assurance are: "Fit for purpose" (the product should be suitable for the intended purpose); and "right first time" (mistakes should be eliminated). QA includes management of the quality  of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes.
Suitable quality is determined by product users, clients or customers, not by society in general. It is not related to cost, and adjectives or descriptors such as "high" and "poor" are not applicable. For example, a low priced product may be viewed as having high quality because it is disposable, whereas another may be viewed as having poor quality because it is not disposable


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