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.
Safety engineering is an engineering discipline which assures that engineered systems provide acceptable levels of safety. It is strongly related to industrial engineering/systems engineering, and the subset system safety engineering. Safety engineering assures that a life-critical system behaves as needed, even when components fail.
Ishikawa diagrams are causal diagrams created by Kaoru Ishikawa that show the potential causes of a specific event.
In science and engineering, root cause analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems. It is widely used in IT operations, manufacturing, telecommunications, industrial process control, accident analysis (e.g., in aviation, rail transport, or nuclear plants), medical diagnosis, the healthcare industry (e.g., for epidemiology), etc. Root cause analysis is a form of inductive inference (first create a theory, or root, based on empirical evidence, or causes) and deductive inference (test the theory, i.e., the underlying causal mechanisms, with empirical data).
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.
Troubleshooting is a form of problem solving, often applied to repair failed products or processes on a machine or a system. It is a logical, systematic search for the source of a problem in order to solve it, and make the product or process operational again. Troubleshooting is needed to identify the symptoms. Determining the most likely cause is a process of elimination—eliminating potential causes of a problem. Finally, troubleshooting requires confirmation that the solution restores the product or process to its working state.
Reliability engineering is a sub-discipline of systems engineering that emphasizes the ability of equipment to function without failure. Reliability is defined as the probability that a product, system, or service will perform its intended function adequately for a specified period of time, OR will operate in a defined environment without failure. 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.
Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation but has similarities to Design for Six Sigma (DFSS).
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.
DMAIC or define, measure, analyze, improve and control refers to a data-driven improvement cycle used for optimizing and stabilizing business processes and designs. The DMAIC improvement cycle is the core tool used to drive Six Sigma projects. However, DMAIC is not exclusive to Six Sigma and can be used as the framework for other improvement applications.
Failure mode effects and criticality analysis (FMECA) is an extension of failure mode and effects analysis (FMEA).
Five whys is an iterative interrogative technique used to explore the cause-and-effect relationships underlying a particular problem. The primary goal of the technique is to determine the root cause of a defect or problem by repeating the question "why?" five times, each time directing the current "why" to the answer of the previous "why". The method asserts that the answer to the fifth "why" asked in this manner should reveal the root cause of the problem.
A failure reporting, analysis, and corrective action system (FRACAS) is a system, sometimes carried out using software, that provides a process for reporting, classifying, analyzing failures, and planning corrective actions in response to those failures. It is typically used in an industrial environment to collect data, record and analyze system failures. A FRACAS system may attempt to manage multiple failure reports and produces a history of failure and corrective actions. FRACAS records the problems related to a product or process and their associated root causes and failure analyses to assist in identifying and implementing corrective actions.
The seven management and planning tools have their roots in operations research work done after World War II and the Japanese total quality control (TQC) research.
Accident analysis is a process carried out in order to determine the cause or causes of an accident so as to prevent further accidents of a similar kind. It is part of accident investigation or incident investigation. These analyses may be performed by a range of experts, including forensic scientists, forensic engineers or health and safety advisers. Accident investigators, particularly those in the aircraft industry, are colloquially known as "tin-kickers". Health and safety and patient safety professionals prefer using the term "incident" in place of the term "accident". Its retrospective nature means that accident analysis is primarily an exercise of directed explanation; conducted using the theories or methods the analyst has to hand, which directs the way in which the events, aspects, or features of accident phenomena are highlighted and explained. These analyses are also invaluable in determining ways to prevent future incidents from occurring. They provide good insight by determining root causes, into what failures occurred that led to the incident.
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.
Corrective and preventive action consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-conformance. Non-conformance is identified after systematic evaluation and analysis of the root cause of the non-conformance. Non-conformance may be a market complaint or customer complaint or failure of machinery or a quality management system, or misinterpretation of written instructions to carry out work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. The Eight disciplines problem solving method, or 8D framework, can be used as an effective method of structuring a CAPA.
The seven basic tools of quality are a fixed set of visual exercises identified as being most helpful in troubleshooting issues related to quality. They are called basic because they are suitable for people with little formal training in statistics and because they can be used to solve the vast majority of quality-related issues.
Process Decision Program Chart (PDPC) is a technique designed to help prepare contingency plans. The emphasis of the PDPC is to identify the consequential impact of failure on activity plans, and create appropriate contingency plans to limit risks. Process diagrams and planning tree diagrams are extended by a couple of levels when the PDPC is applied to the bottom level tasks on those diagrams.
A3 problem solving is a structured problem-solving and continuous-improvement approach, first employed at Toyota and typically used by lean manufacturing practitioners. It provides a simple and strict procedure that guides problem solving by workers. The approach typically uses a single sheet of ISO A3-size paper, which is the source of its name. More contemporary versions include the Systems-oriented A3
