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Corrective And Preventive Action
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 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. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nonconformity (quality)
In quality management, a nonconformity (sometimes referred to as a non conformance or nonconformance or defect) is a deviation from a specification, a standard, or an expectation. Nonconformities or nonconformance can be classified in seriousness multiple ways, though a typical classification scheme may have three to four levels, including critical, serious, major, and minor. While some situations allow "nonconformity" and "defect" to be used synonymously, some industries distinguish between the two; a nonconformity represents a failure to meet an intended state and specification, while a defect represents a failure to meet fitness for use/normal usage requirements. This can be seen in the international software engineering standard ISO/IEC 25010 (formerly ISO/IEC 9126), which defines a nonconformity as the nonfulfillment of a requirement and a defect as the nonfulfillment of intended usage requirements. Classifying nonconformity When ensuring quality of a product or a service ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
5 Whys
Five whys (or 5 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. The technique was described by Taiichi Ohno at Toyota Motor Corporation. Others at Toyota and elsewhere have criticized the five whys technique for being too basic and having an arbitrarily shallow depth as a root cause analysis tool (see ). Example An example of a problem is: bolts are cross-threading in the engine block on the production line. #''Why?'' – The threads aren't cut cleanly. #''Why?'' – The cutting tool on the lathe wasn't changed today. #''Why?'' – The replacement cutting tool bin was empt ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Management
Total quality management, Total Quality management (TQM), ensures that an organization, product, or service consistently performs as intended, as opposed to Quality Management, which focuses on work process and procedure standards. It has four main components: quality planning, quality assurance, quality control, and quality improvement. Customers recognize that quality is an important attribute when choosing and purchasing products and services. Suppliers can recognize that quality is an important differentiator of their offerings, and endeavor to compete on the quality of their products and the service they offer. Thus, quality management is focused both on product and service quality. Advancement In earlier periods, arts and crafts were led by Master craftsman, master craftspeople or artists who supervised studios, trained apprentices, and oversaw the product development process. With the advent of the Industrial Revolution, steam engines, and mass production, the role of crafts ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Manufacturing
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling Milling may refer to: * Milling (minting), forming narrow ridges around the edge of a coin * Milling (grinding), breaking solid materials into smaller pieces by grinding, crushing, or cutting in a mill * Milling (machining), a process of using ro ..., Granulation (process), granulation, Coated tablet, coating, tablet pressing, and others. Scale-up considerations Cooling While a laboratory may use dry ice as a cooling agent for reaction selectivity, this process gets complicated on an industrial scale. The cost to cool a typical reactor to this temperature is large, and the viscosity of the reagents typically also increases as the temperature lowers, leading to difficult mixing. This results in added costs to stir harder and replace part ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO Standards
The International Organization for Standardization (ISO ; ; ) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes. ISO was founded on 23 February 1947, and () it has published over 25,000 international standards covering almost all aspects of technology and manufacturing. It has over 800 technical committees (TCs) and subcommittees (SCs) to take care of standards development. The organization develops and publishes international standards in technical and nontechnical fields, including everything from manufactured products and technology to food safety, transport, IT, agriculture, and healthcare. More specialized topics like electrical and electronic engineering are instead handled by the International Electrotechnical Commission.Editors of Encyclopedia Britannica. 3 June 2021.Interna ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Documentation Practice
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers. GDocP standards Documentation creation * Contemporaneous with the event they describe * Not handwritten (except for handwritten entries thereon) * When ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Preventive Maintenance
The technical meaning of maintenance involves functional checks, servicing, repairing or replacing of necessary devices, equipment, machinery, building infrastructure and supporting utilities in industrial, business, and residential installations. Terms such as "predictive" or "planned" maintenance describe various cost-effective practices aimed at keeping equipment operational; these activities occur either before or after a potential failure. Definitions Maintenance functions can be defined as maintenance, repair and overhaul (MRO), and MRO is also used for maintenance, repair and operations. Over time, the terminology of maintenance and MRO has begun to become standardized. The United States Department of Defense uses the following definitions: Federal Standard 1037C and from MIL-STD-188 and from the Department of Defense Dictionary of Military and Associated Terms * Any activity—such as tests, measurements, replacements, adjustments, and repairs—intended to retain ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Training
Training is teaching, or developing in oneself or others, any skills and knowledge or fitness that relate to specific useful competencies. Training has specific goals of improving one's capability, capacity, productivity and performance. It forms the core of apprenticeships and provides the backbone of content at institutes of technology (also known as technical colleges or polytechnics). In addition to the basic training required for a trade, occupation or profession, training may continue beyond initial competence to maintain, upgrade and update skills throughout working life. People within some professions and occupations may refer to this sort of training as professional development. Training also refers to the development of physical fitness related to a specific competence, such as sport, martial arts, military applications and some other occupations. Training methods of all types can be improved by setting specific, time-based, and difficult goals. This allows for ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Poka-yoke
is any mechanism in a process that helps an equipment operator to avoid mistakes and defects by preventing, correcting, or drawing attention to human errors as they occur. It is a Japanese term that means "mistake-proofing" or "error prevention", and is also sometimes referred to as a forcing function or a behavior-shaping constraint. The concept was formalized, and the term adopted, by Shigeo Shingo as part of the Toyota Production System. Etymology Poka-yoke was originally ', but as this means "fool-proofing" (or "Idiot proof, idiot-proofing") the name was changed to the milder ''poka-yoke''. Poka-yoke is derived from ' (), a term in shogi that means avoiding an unthinkably bad move. Usage and examples More broadly, the term can refer to any behavior-shaping constraint designed into a process to prevent incorrect operation by the user. A simple poka-yoke example is demonstrated when a driver of the car equipped with a manual gearbox must press on the clutch pedal (a process s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Feeding Tube
A feeding tube is a medical device used to provide nutrition to people who cannot obtain nutrition by mouth, are unable to swallow safely, or need nutritional supplementation. The state of being fed by a feeding tube is called gavage, enteral feeding or tube feeding. Placement may be temporary for the treatment of acute conditions or lifelong in the case of chronic disabilities. A variety of feeding tubes are used in medical practice. They are usually made of polyurethane or silicone. The outer diameter of a feeding tube is measured in French units (each French unit equals mm). They are classified by the site of insertion and intended use. Medical uses There are dozens of conditions that may require tube feeding (enteral nutrition) to prevent or treat malnutrition. Conditions that necessitate feeding tubes include prematurity, failure to thrive (or malnutrition), neurologic and neuromuscular disorders, inability to swallow, anatomical and post-surgical malformations ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nasogastric Intubation
Nasogastric intubation is a medical process involving the insertion of a plastic tube (nasogastric tube or NG tube) through the nose, down the esophagus, and down into the stomach. Orogastric intubation is a similar process involving the insertion of a plastic tube (orogastric tube) through the mouth. Abraham Louis Levin invented the NG tube. Nasogastric tube is also known as Ryle's tube in Commonwealth countries, after John Alfred Ryle. Uses A nasogastric tube is used for feeding and administering drugs and other oral agents such as activated charcoal. For drugs and for minimal quantities of liquid, a syringe is used for injection into the tube. For continuous feeding, a gravity based system is employed, with the solution placed higher than the patient's stomach. If accrued supervision is required for the feeding, the tube is often connected to an electronic pump which can control and measure the patient's intake and signal any interruption in the feeding. Nasogastric tubes ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
