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 international standards for quality management systems. It was developed in March 1987 by International Organization for Standardization. The goal of it is help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. The ISO refers to the set of standards as a "family", bringing together the standard for quality management systems and a set of "supporting standards", and their presentation as a family facilitates their integrated application within an organisation. ISO 9000 deals with the fundamentals and vocabulary 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. A companion document, ISO/TS 9002, provides guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.
Automotive engineering, along with aerospace engineering and naval architecture, is a branch of vehicle engineering, incorporating elements of mechanical, electrical, electronic, software, and safety engineering as applied to the design, manufacture and operation of motorcycles, automobiles, and trucks and their respective engineering subsystems. It also includes modification of vehicles. Manufacturing domain deals with the creation and assembling the whole parts of automobiles is also included in it. The automotive engineering field is research intensive and involves direct application of mathematical models and formulas. The study of automotive engineering is to design, develop, fabricate, and test vehicles or vehicle components from the concept stage to production stage. Production, development, and manufacturing are the three major functions in this field.
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. A 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.
Automotive design is the process of developing the appearance of motor vehicles, including automobiles, motorcycles, trucks, buses, coaches, and vans.
A measurement system 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.
The Capability Maturity Model Integration (CMMI) defines a process area as, "a cluster of related practices in an area that, when implemented collectively, satisfies a set of goals considered important for making improvement in that area." Both CMMI for Development v1.3 and CMMI for Acquisition v1.3 identify 22 process areas, whereas CMMI for Services v1.3 identifies 24 process areas. Many of the process areas are the same in these three models.
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.
International Automotive Task Force 16949 is an international standard for automotive management systems that is a widely adopted and standardized quality management system for the automotive sector. It was released in 1999 by International Organization for Standardization based on ISO 9001, and the first edition was published in June 1999 as ISO/TS 16949:1999. IATF 16949:2016 replaced ISO/TS 16949 in October 2016 by International Automotive Task Force. The goal of it is provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process.
Production Part Approval Process (PPAP) is used in the Aerospace or 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:
Design review based on failure mode (DRBFM) is a tool originally developed by the Toyota Motor Corporation. This tool was developed based on the philosophy that design problems occur when changes are made to existing engineering designs that have already been proven successful.
In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something ; it is also defined as being suitable for the intended purpose while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is reliable, maintainable, or sustainable. In such ways, the subjectivity of quality is rendered objective via operational definitions and measured with metrics such as proxy measures.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
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 production validation 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.
ETAS GmbH 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% owned by Robert Bosch GmbH.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification.
