Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that “part of quality management focused on providing confidence that quality requirements will be fulfilled”.[1] This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a shift left since it focuses on quality efforts earlier in product development and production (i.e., a shift to the left of a linear process diagram reading left to right)[2] and on avoiding defects in the first place rather than correcting them after the fact.
The terms “quality assurance” and “quality control” are often used interchangeably to refer to ways of ensuring the quality of a service or product.[3] For instance, the term “assurance” is often used in a context such as: Implementation of inspection and structured testing as a measure of quality assurance in a television set software project at Philips Semiconductors is described. [4] where inspection and structured testing are the measurement phase of a quality assurance strategy referred to as the DMAIC model (define, measure, analyze, improve, control). DMAIC is a data-driven quality strategy used to improve processes.[5] The term “control” is the fifth phase of this strategy.
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 accomplished.[3] It is the systematic measurement, comparison with a standard, and monitoring of processes in an associated feedback loop that confers error prevention.[6] This can be contrasted with quality control, which is focused on process output.[7]
Quality assurance includes two principles: “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.[8] The two principles also manifest before the background of developing (engineering) a novel technical product: The task of engineering is to make it work once, while the task of quality assurance is to make it work all the time.[9]
Historically, defining what suitable product or service quality means has been a more difficult process, determined in many ways, from the subjective user-based approach that contains “the different weights that individuals normally attach to quality characteristics,” to the value-based approach which finds consumers linking quality to price and making overall conclusions of quality based on such a relationship.[[10]]. Initial efforts to control the quality of production
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During the Middle Ages, guilds adopted responsibility for the quality of goods and services offered by their members, setting and maintaining certain standards for guild membership.[11]
Royal governments purchasing material were interested in quality control as customers. For this reason, King John of England appointed William de Wrotham to report about the construction and repair of ships.[12] Centuries later, Samuel Pepys, Secretary to the British Admiralty, appointed multiple such overseers to standardize sea rations and naval training.[13]
Prior to the extensive division of labor and mechanization resulting from the Industrial Revolution, it was possible for workers to control the quality of their own products. The Industrial Revolution led to a system in which large groups of people performing a specialized type of work were grouped together under the supervision of a foreman who was appointed to control the quality of work manufactured. During the time of the First World War, manufacturing processes typically became more complex, with larger numbers of workers being supervised. This period saw the widespread introduction of mass production and piece work, which created problems as workmen could now earn more money by the production of extra products, which in turn occasionally led to poor quality workmanship being passed on to the assembly lines. Pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many simple steps (the assembly line) and limited quality control to a few specific individuals, limiting complexity.[14] Ford emphasized standardization of design and component standards to ensure a standard product was produced, while quality was the responsibility of machine inspectors, “placed in each department to cover all operations … at frequent intervals, so that no faulty operation shall proceed for any great length of time.”[[15]]