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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.
Quality management ensures that an organization, product or service is consistent. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality management is a recent phenomenon but very important for an organization. Advanced civilizations that supported the arts and crafts allowed clients to choose goods meeting higher quality standards rather than normal goods. In societies where arts and crafts are the responsibility of master craftsmen or artists, these masters would lead their studios and train and supervise others. The importance of craftsmen diminished as mass production and repetitive work practices were instituted. The aim was to produce large numbers of the same goods.
A valuable process to perform on a whole consumer product is failure testing or stress testing. In mechanical terms this is the operation of a product until it fails, often under stresses such as increasing vibration, temperature, and humidity. This exposes many unanticipated weaknesses in a 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 is based on analyses of objective and subjective data. Many organizations use statistical process control as a tool in any quality improvement effort to track quality data. Any product can be statistically charted as long as they have a common cause variance or special cause variance to track. 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.
The quality of products is dependent upon that of the participating constituents, some of which are sustainable and effectively controlled while others are not. The process(es) which are managed with QA pertain to Total Quality Management. If the specification does not reflect the true quality requirements, the product's quality cannot be guaranteed. For instance, the parameters for a pressure vessel should cover not only the material and dimensions but operating, environmental, safety, reliability and maintainability requirements.
ISO 17025 is an international standard that specifies the general requirements for the competence to carry out tests and or calibrations. There are 15 management requirements and 10 technical requirements. These requirements outline what a laboratory must do to become accred. Management system refers to the organization's structure for managing its processes or activities that transform inputs of resources into a product or service which meets the organization's objectives, such as satisfying the customer's quality requirements, complying with regulations, or meeting environmental objectives. WHO has developed several tools and offers training courses for quality assurance in public health laboratories. The Capability Maturity Model Integration (CMMI) model is widely used to implement Process and Product Quality Assurance (PPQA) in an organization. The CMMI maturity levels can be divided into 5 steps, which a company can achieve by performing specific activities within the organization.