History[edit]
Initial efforts to control the quality of production[edit]
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.
Wartime production[edit]
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]
Out of this also came statistical process control (SPC), which was pioneered by Walter A. Shewhart at Bell Laboratories in the early 1920s. Shewhart developed the control chart in 1924 and the concept of a state of statistical control. Statistical control is equivalent to the concept of exchangeability[16][17] developed by logician William Ernest Johnson, also in 1924, in his book Logic, Part III: The Logical Foundations of Science.[18] Along with a team at AT&T that included Harold Dodge and Harry Romig, he worked to put sampling inspection on a rational statistical basis as well. Shewhart consulted with Colonel Leslie E. Simon in the application of control charts to munitions manufacture at the Army's Picatinny Arsenal in 1934.[19] That successful application helped convince Army Ordnance to engage AT&T's George Edwards to consult on the use of statistical quality control among its divisions and contractors at the outbreak of World War II.[20]
Postwar[edit]
After World War II, many countries' manufacturing capabilities that had been destroyed during the war were rebuilt. General Douglas MacArthur oversaw the rebuilding of Japan. He involved two key people in the development of modern quality concepts: W. Edwards Deming and Joseph Juran. They and others promoted the collaborative concepts of quality to Japanese business and technical groups, and these groups used these concepts in the redevelopment of the Japanese economy.[21]
Although there were many people trying to lead United States industries toward a more comprehensive approach to quality, the US continued to apply the Quality Control (QC) concepts of inspection and sampling to remove defective products from production lines, essentially unaware of or ignoring advances in QA for decades.[22]
Approaches[edit]
Failure testing[edit]
It is valuable to failure test or stress test a complete consumer product. In mechanical terms this is the operation of a product until it fails, often under stresses such as increasing vibration, temperature, and humidity. This may expose many unanticipated weaknesses in the product, and the data is used to drive engineering and manufacturing process improvements. Often quite simple changes can dramatically improve product service, such as changing to mold-resistant paint or adding lock-washer placement to the training for new assembly personnel.
Statistical control[edit]
Statistical control is based on analyses of objective and subjective data.[23] Many organizations use statistical process control as a tool in any quality improvement effort[24] to track quality data. Product quality data is statistically charted to distinguish between common cause variation or special cause variation.[25]
Walter Shewart of Bell Telephone Laboratories recognized that when a product is made, data can be taken from scrutinized areas of a sample lot of the part and statistical variances are then analyzed and charted. Control can then be implemented on the part in the form of rework or scrap, or control can be implemented on the process that made the part, ideally eliminating the defect before more parts can be made like it.[23]
In practice[edit]
Medical industry[edit]
QA is very important in the medical field because it helps to identify the standards of medical equipment and services.[32][33] Hospitals and laboratories make use of external agencies in order to ensure standards for equipment such as X-ray machines, Diagnostic Radiology and AERB. QA is particularly applicable throughout the development and introduction of new medicines and medical devices. The Research Quality Association (RQA) supports and promotes the quality of research in life sciences, through its members and regulatory bodies.
Aerospace industry[edit]
The term product assurance (PA) is often used instead of quality assurance and is, alongside project management and engineering, one of the three primary project functions. Quality assurance is seen as one part of product assurance. Due to the sometimes catastrophic consequences a single failure can have for human lives, the environment, a device, or a mission, product assurance plays a particularly important role here. It has organizational, budgetary and product developmental independence meaning that it reports to highest management only, has its own budget, and does not expend labor to help build a product. Product assurance stands on an equal footing with project management but embraces the customer's point of view.[9]