The United States Food and Drug Administration is a federal agency of the 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 and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
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.
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
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, medicine, healthcare industry, etc. Root cause analysis is a form of inductive and deductive inference.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.
Food safety is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry-to-market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market-to-consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer. Food safety, nutrition and food security are closely related. Unhealthy food creates a cycle of disease and malnutrition that affects infants and adults as well.
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 term fish processing refers to the processes associated with fish and fish products between the time fish are caught or harvested, and the time the final product is delivered to the customer. Although the term refers specifically to fish, in practice it is extended to cover any aquatic organisms harvested for commercial purposes, whether caught in wild fisheries or harvested from aquaculture or fish farming.
Farm assurance is product certification for agricultural products that emphasises the principles of quality assurance. The emphasis on quality assurance means that, in addition to product inspection, farm assurance schemes may include standards and certification for traceability, production methods, transport, and supplies.
Raw meat generally refers to any type of uncooked muscle tissue of an animal used for food. In the meat production industry, the term ‘meat’ refers specifically to mammalian flesh, while the words ‘poultry’ and ‘seafood’ are used to differentiate between the tissue of birds and aquatic creatures.
Michael R. Taylor is an American lawyer who has played leadership roles in the US Food and Drug Administration, agrochemical company Monsanto, and law firm King & Spalding. He currently co-chairs the board of STOP Foodborne Illness, a non-profit that supports victims of serious illness and their families in efforts to strengthen food safety culture and practices in government and industry.
A fish company is a company which specializes in the processing of fish products. Fish that are processed by a fish company include cod, hake, haddock, tuna, herring, mackerel, salmon and pollock.
The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authority to regulate the way foods are grown, harvested and processed. The law grants the FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires the FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.
The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is the public health regulatory agency responsible for ensuring that United States' commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. The FSIS draws its authority from the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957 and the Egg Products Inspection Act of 1970. The FSIS also acts as a national health department and is responsible for the safety of public food-related establishments as well as business investigation.
Safefood 360°, Inc. is a food safety management software company founded in Dublin, Ireland, and now headquartered in Manhattan, New York, United States. The main products of Safefood 360°, Inc. is web-based food safety management system, which is used by food manufacturing businesses for managing food safety programs and supply chains.
Cold-pressed juice is juice that uses a hydraulic press to extract juice from fruit and vegetables, as opposed to other methods such as centrifugal or single auger.
Food defense is the protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents introduced for the purpose of causing harm. It addresses additional concerns including physical, personnel and operational security.
Bergstrom Nutrition is a United States dietary supplement manufacturer. As of June 2015, they are the only North American manufactures of methylsulfonylmethane (MSM), an ingredient utilized in dietary supplement products. Bergstrom Nutrition use proprietary technologies for the distillation and purification of MSM. This along with their extensive published safety data allowed their product to be self-affirmed as "Generally recognized as safe" (GRAS) receiving a letter of non-objection from the United States Food and Drug Administration.
ISO 22300:2021, Security and resilience – Vocabulary, is an international standard developed by ISO/TC 292 Security and resilience. This document defines terms used in security and resilience standards and includes 360 terms and definitions. This edition was published in the beginning of 2021 and replaces the second edition from 2018.
