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The executives of the Powertrain Organization (transmissions, chassis, engines) wanted a methodology where teams (design engineering, manufacturing engineering, and production) could work on recurring chronic problems. In 1986, the assignment was given to develop a manual and a subsequent course that would achieve a new approach to solving ...
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.
Corrective and preventive action (CAPA or simply corrective 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 ...
In science and engineering, root cause analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems. [1] It is widely used in IT operations, manufacturing, telecommunications, industrial process control, accident analysis (e.g., in aviation, [2] rail transport, or nuclear plants), medical diagnosis, the healthcare industry (e.g., for epidemiology ...
An engineering change order (ECO), also called an engineering change notice (ECN), engineering change (EC), or engineering release notice(ERN), is an artifact used to implement changes to components or end products. The ECO is utilized to control and coordinate changes to product designs that evolve over time.
[2] The tool has seen use beyond Toyota, and is now used within Kaizen, lean manufacturing, lean construction and Six Sigma. The five whys were initially developed to understand why new product features or manufacturing techniques were needed, and was not developed for root cause analysis. In other companies, it appears in other forms.
A3 problem solving is a structured problem-solving and continuous-improvement approach, first employed at Toyota and typically used by lean manufacturing practitioners. [1] 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 ...
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2]