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. 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 are 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.
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success.
Statistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste scrap. 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.
Design for Six Sigma (DFSS) is an engineering design process, business process management method related to traditional Six Sigma. It is used in many industries, like finance, marketing, basic engineering, process industries, waste management, and electronics. It is based on the use of statistical tools like linear regression and enables empirical research similar to that performed in other fields, such as social science. While the tools and order used in Six Sigma require a process to be in place and functioning, DFSS has the objective of determining the needs of customers and the business, and driving those needs into the product solution so created. It is used for product or process design in contrast with process improvement. Measurement is the most important part of most Six Sigma or DFSS tools, but whereas in Six Sigma measurements are made from an existing process, DFSS focuses on gaining a deep insight into customer needs and using these to inform every design decision and trade-off.
Failure mode and effects analysis is the process of reviewing as many components, assemblies, and subsystems as possible to identify potential failure modes in a system and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet. There are numerous variations of such worksheets. An FMEA can be a qualitative analysis, but may be put on a quantitative basis when mathematical failure rate models are combined with a statistical failure mode ratio database. It was one of the first highly structured, systematic techniques for failure analysis. It was developed by reliability engineers in the late 1950s to study problems that might arise from malfunctions of military systems. An FMEA is often the first step of a system reliability study.
The International Material Data System (IMDS) is a global data repository that contains information on materials used by the automotive industry. Several leading auto manufacturers use the IMDS to maintain data for various reporting requirements.
Reliability engineering is a sub-discipline of systems engineering that emphasizes the ability of equipment to function without failure. Reliability describes the ability of a system or component to function under stated conditions for a specified period of time. Reliability is closely related to availability, which is typically described as the ability of a component or system to function at a specified moment or interval of time.
A measurement systems analysis (MSA) is a thorough assessment of a measurement process, and typically includes a specially designed experiment that seeks to identify the components of variation in that measurement process. Just as processes that produce a product may vary, the process of obtaining measurements and data may also have variation and produce incorrect results. A measurement systems analysis evaluates the test method, measuring instruments, and the entire process of obtaining measurements to ensure the integrity of data used for analysis and to understand the implications of measurement error for decisions made about a product or process. Proper measurement system analysis is critical for producing a consistent product in manufacturing and when left uncontrolled can result in a drift of key parameters and unusable final products. MSA is also an important element of Six Sigma methodology and of other quality management systems. MSA analyzes the collection of equipment, operations, procedures, software and personnel that affects the assignment of a number to a measurement characteristic.
QS9000 was a quality standard developed by a joint effort of the "Big Three" American automakers, General Motors, Chrysler and Ford. It was introduced to the industry in 1994. It has been adopted by several heavy truck manufacturers in the U.S. as well. Essentially all suppliers to the US automakers needed to implement a standard QS9000 system, before its termination.
IATF 16949:2016 is a technical specification aimed at the development of a quality management system which provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process. It is based on the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999. IATF 16949:2016 replaced ISO/TS 16949 in October 2016.
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, 1 March 2006
Eight Disciplines Methodology (8D) is a method or model developed at Ford Motor Company used to approach and to resolve problems, typically employed by quality engineers or other professionals. Focused on product and process improvement, its purpose is to identify, correct, and eliminate recurring problems. It establishes a permanent corrective action based on statistical analysis of the problem and on the origin of the problem by determining the root causes. Although it originally comprised eight stages, or 'disciplines', it was later augmented by an initial planning stage. 8D follows the logic of the PDCA cycle. The disciplines are:
Pre-production cars are vehicles that allow the automaker to find problems before a new model goes on sale to the public. Pre-production cars come after prototypes, or development mules which themselves are preceded by concept cars. Pre-production vehicles are followed by production vehicles in the mass production of them for distribution through car dealerships.
Quality engineering is the discipline of engineering concerned with the principles and practice of product and service quality assurance and control. In software development, it is the management, development, operation and maintenance of IT systems and enterprise architectures with a high quality standard.
CSA CAN3-Z299 is a series of quality assurance standards developed by the Canadian Standards Association in the 1970s. It is an alternative to the ISO 9000 series of standards. The stated objectives of the Z299 series of standards are:
The Automotive Industry Action Group (AIAG) is a not-for-profit association founded in 1982 and based in Southfield, Michigan. It was originally created to develop recommendations and a framework for the improvement of quality in the North American automotive industry. The association's areas of interest have expanded to include product quality standards, bar code and RFID standards, materials management, EDI, returnable containers and packaging systems, and regulatory and customs issues.
The Automotive Network Exchange (ANX), a large private extranet that connects automotive suppliers to automotive manufacturers. Founded in 1995 by Automotive Industry Action Group, ANX since 1999 has been owned and operated by ANXeBusiness Corp., formerly a division of Leidos/SAIC but acquired in 2006 by One Equity Partners. Since 2006, ANX has expanded into other markets and now provides managed security, compliance assurance, and connectivity services to businesses in the healthcare and retail as well as automotive sectors.
ISO 26262, titled "Road vehicles – Functional safety", is an international standard for functional safety of electrical and/or electronic systems that are installed in serial production road vehicles, defined by the International Organization for Standardization (ISO) in 2011, and revised in 2018.
A First Article Inspection (FAI) is a design verification process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report. The FAI process usually consists of fully testing and inspecting either the first part produced by the new process or a sample from the first batch of parts. First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete. If the manufacturer doesn't have the in-house capability or if the purchaser requests, the first article inspection may be conducted by an approved subcontract supplier such as a dimensional inspection/metrology laboratory.
The ETAS Group is a German company which designs tools for the development of embedded systems for the automotive industry and other sectors of the embedded industry. ETAS is 100-percent subsidiary of Robert Bosch GmbH.
