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Corrective And Preventative 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, cl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
PDCA
PDCA (plan–do–check–act or plan–do–check–adjust) is an iterative design and management method used in business for the control and continual improvement of processes and products. It is also known as the Shewhart cycle, or the control circle/cycle. Another version of this PDCA cycle is OPDCA. The added "O" stands for ''observation'' or as some versions say: "Observe the current condition." This emphasis on observation and current condition has currency with the literature on lean manufacturing and the Toyota Production System. The PDCA cycle, with Ishikawa's changes, can be traced back to S. Mizuno of the Tokyo Institute of Technology in 1959. PDCA is often confused with PDSA (Plan-Do-Study-Act). Dr. W. Edwards Deming emphasized the PDSA Cycle, not the PDCA Cycle, with a third step emphasis on Study (S), not Check (C). Dr. Deming found that the focus on Check is more about the implementation of a change, with success or failure. His focus was on predicting the results ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Management
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function. Evolution Quality management is a recent phenomenon but important for an organization. Civilizations that supported the arts and crafts allowed clients to choose goods meeting higher quality standards than normal goods. In societies where arts and crafts ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO Standards
The International Organization for Standardization (ISO ) is an 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 (as of November 2022) it has published over 24,500 international standards covering almost all aspects of technology and manufacturing. It has 809 Technical committees and sub committees to take care of standards development. The organization develops and publishes standardization in all technical and nontechnical fields other than electrical and electronic engineering, which is handled by the IEC.Editors of Encyclopedia Britannica. 3 June 2021.International Organization for Standardization" ''Encyclopedia Britannica''. Retrieved 2022-04-26. It is headquartered in Geneva, Switzerland, and works in 167 countries . The three official languages of the ISO are English, Frenc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Automated Manufacturing Practice
Good automated manufacturing practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. More specifically, the ISPE's guide ''The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture'' describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. A group of pharmaceutical professionals have banded toget ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Documentation Practice
Good documentation practice (commonly abbreviated GDP, 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 GDP / 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 GDP / 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. GDP / GDocP standards Documentation creation * Contemporaneous with the event they describe * Not handwritten ... [...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. Over time, this has come to include multiple wordings that describe various cost-effective practices to keep equipment operational; these activities occur either before or after a failure. Definitions Maintenance functions can 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 or restore a func ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Training
Training is teaching, or developing in oneself or others, any skills and knowledge or Physical fitness, fitness that relate to specific practicality, useful Competence (human resources), competencies. Training has specific goals of improving one's wikt:capability, capability, capacity, productivity and wikt:performance, performance. It forms the core of apprenticeships and provides the backbone of content at institute of technology, institutes of technology (also known as technical colleges or polytechnics). In addition to the basic training required for a Trade (profession), trade, Employment, occupation or profession, training may continue beyond initial competence to maintain, upgrade and update skills throughout career, 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 app ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ishikawa Diagram
Ishikawa diagrams (also called fishbone diagrams, herringbone diagrams, cause-and-effect diagrams) are causal diagrams created by Kaoru Ishikawa that show the potential causes of a specific event. Common uses of the Ishikawa diagram are product design and quality defect prevention to identify potential factors causing an overall effect. Each cause or reason for imperfection is a source of variation. Causes are usually grouped into major categories to identify and classify these sources of variation. Overview The ''defect'' is shown as the fish's head, facing to the right, with the ''causes'' extending to the left as fishbones; the ribs branch off the backbone for major causes, with sub-branches for root-causes, to as many levels as required. Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa, who pioneered quality management processes in the Kawasaki shipyards, and in the process became one of the founding fathers of modern management. The basic concept was fi ... [...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. The answer to the fifth why 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 various reasons (see ). Example An example of a problem is: The vehicle will not start. #''Why?'' – The battery is dead. (First why) #''Why?'' – The alternator is not functioning. (Second why) #''Why?'' – The alternator belt has broken. (Third why) #''Why?'' – The alternator belt was well beyond its useful service life and not replaced. (Fourth why) #''Why?'' – The vehicle was not maintained according to the recommended service schedule. (Fifth why, a root cause) The question ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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