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A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality is increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both, and deals with quality and sustainability and their integration.
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".
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products 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 since it focuses on quality earlier in the process.
An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a Standard Inspection Procedure in place to ensure consistent checking. Inspections are usually non-destructive.
Statistical process control (SPC) is a method of quality control which employs statistical methods to monitor and control a process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste. SPC can be applied to any process where the "conforming product" output can be measured. Key tools used in SPC include run charts, control charts, a focus on continuous improvement, and the design of experiments. An example of a process where SPC is applied is manufacturing lines.
A Fagan inspection is a process of trying to find defects in documents during various phases of the software development process. It is named after Michael Fagan, who is credited with being the inventor of formal software inspections.
Poka-yoke is a Japanese term that means "mistake-proofing" or "inadvertent error prevention". A poka-yoke is any mechanism in any process that helps an equipment operator avoid (yokeru) mistakes (poka). Its purpose is to eliminate product defects by preventing, correcting, or drawing attention to human errors as they occur. The concept was formalised, and the term adopted, by Shigeo Shingo as part of the Toyota Production System. It was originally described as baka-yoke, but as this means "fool-proofing" the name was changed to the milder poka-yoke.
A reconfigurable manufacturing system (RMS) is one designed at the outset for rapid change in its structure, as well as its hardware and software components, in order to quickly adjust its production capacity and functionality within a part family in response to sudden market changes or intrinsic system change.
Manufacturing process management (MPM) is a collection of technologies and methods used to define how products are to be manufactured. MPM differs from ERP/MRP which is used to plan the ordering of materials and other resources, set manufacturing schedules, and compile cost data.
Design for manufacturability is the general engineering practice of designing products in such a way that they are easy to manufacture. The concept exists in almost all engineering disciplines, but the implementation differs widely depending on the manufacturing technology. DFM describes the process of designing or engineering a product in order to facilitate the manufacturing process in order to reduce its manufacturing costs. DFM will allow potential problems to be fixed in the design phase which is the least expensive place to address them. Other factors may affect the manufacturability such as the type of raw material, the form of the raw material, dimensional tolerances, and secondary processing such as finishing.
Waste minimisation is a set of processes and practices intended to reduce the amount of waste produced. By reducing or eliminating the generation of harmful and persistent wastes, waste minimisation supports efforts to promote a more sustainable society. Waste minimisation involves redesigning products and processes and/or changing societal patterns of consumption and production.
Zero Defects was a management-led program to eliminate defects in industrial production that enjoyed brief popularity in American industry from 1964 to the early 1970s. Quality expert Philip Crosby later incorporated it into his "Absolutes of Quality Management" and it enjoyed a renaissance in the American automobile industry—as a performance goal more than as a program—in the 1990s. Although applicable to any type of enterprise, it has been primarily adopted within supply chains wherever large volumes of components are being purchased.
Production Part Approval Process(PPAP) is used in the automotive supply chain for establishing confidence in suppliers and their production processes. Actual measurements are taken from the parts produced and are used to complete the various test sheets of PPAP.
"All customer engineering design record and specification requirements are properly understood by the supplier and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate." Version 4, March 1, 2006
Autonomation describes a feature of machine design to effect the principle of jidoka (自働化) used in the Toyota Production System (TPS) and Lean manufacturing. It may be described as "intelligent automation" or "Automation with a human touch". This type of automation implements some supervisory functions rather than production functions. At Toyota, this usually means that if an abnormal situation arises; the machine stops and the worker will stop the production line. It is a quality control process that applies the following four principles:
- Detect the abnormality.
- Stop.
- Fix or correct the immediate condition.
- Investigate the root cause and install a countermeasure.
The ongoing reliability test (ORT) is a hardware test process usually used in manufacturing to ensure that quality of the products is still of the same specifications as the day it first went to production or general availability.
Automated X-ray inspection (AXI) is a technology based on the same principles as automated optical inspection (AOI). It uses X-rays as its source, instead of visible light, to automatically inspect features, which are typically hidden from view.
The acceptable quality limit (AQL) is the worst tolerable process average (mean) in percentage or ratio that is still considered acceptable; that is, it is at an acceptable quality level. Closely related terms are the rejectable quality limit and rejectable quality level (RQL). In a quality control procedure, a process is said to be at an acceptable quality level if the appropriate statistic used to construct a control chart does not fall outside the bounds of the acceptable quality limits. Otherwise, the process is said to be at a rejectable control level.
Lean Six Sigma is a method that relies on a collaborative team effort to improve performance by systematically removing waste and reducing variation. It combines lean manufacturing/lean enterprise and Six Sigma to eliminate the eight kinds of waste (muda): Defects, Over-Production, Waiting, Non-Utilized Talent, Transportation, Inventory, Motion, and Extra-Processing.
Optical sorting is the automated process of sorting solid products using cameras and/or lasers.
Design for Inspection (DFI) is an engineering principle that proposes that inspection methods and measurement instruments used to certify manufacturing conformity, should be considered early in the design of products. Production processes should be designed in such a way that features of the product are easy to inspect with readily available measurement instruments, and so that measurement uncertainty is considered in the tolerance that are applied. The concept can be applied in almost all engineering disciplines. DFI describes the process of designing or engineering a product in order to facilitate the measurement in order to reduce the overall costs of manufacturing and delivering products that satisfy customers.
References
Daizhong Su, Qingbin Zhang and Shifan Zhu. (2009). In-line inspection.