Quality Management Acronyms and their Definitions
CAPA: Corrective and preventive action (CAPA) pertains to the identification of actual and potential problems in regard to quality control. Once identified, steps can be taken to prevent any recurrences or occurrences. These steps are investigated to determine their success.
eMDR: electronic Medical Device Reporting - requires manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive.
EQMS: Enterprise quality management software (EQMS) optimizes quality, ensures compliance and reduces costs and risk for world-class clients across a range of regulated industries. EQMS allows organizations to manage all quality control processes in a centralized database and enables site level, process level and role-based security.
FRACAS: A failure reporting, analysis and corrective action system (FRACAS) collects data on past failures. Users can then analyze those failures and identify possible corrective actions for implementation.
FSMA: The Food Safety Modernization Act (FSMA) was signed into law in 2011 and gives the FDA much more authority in order to address food-borne illnesses and other safety issues concerning our food system. The FSMA stresses preventative measures and controls to improve quality control, increases supplier accountability, establishes mandated inspection frequency, and gives the FDA recall authority.
GCP: Good clinical practice (GCP) addresses quality assurance issues regarding clinical trials that deal with human subjects. It is provided by the International Conference of Harmonisation (ICH). It not only concerns the ethical treatment of humans in clinical trials but proper documentation of the clinical trial as well.
GFSI: Launched in 2000, the Global Food Safety initiative established a benchmark for the continuous improvement of food safety management to ensure confidence in the delivery of safe food to consumers worldwide, and provides a platform for collaboration between the worlds' leading food safety experts.
GLP: Good laboratory practice (GLP) concerns data quality in non-clinical health and environment chemical safety programs. The principles of GLP address organization and personnel responsibilities, quality assurance, facility testing, equipment and material safety, study testing, record keeping, and more.
GMP: Good manufacturing practices (GMP) are a system of guidelines to ensure quality control and consumer safety in the manufacturing process. These guidelines are based off a number of principles, including hygiene, quality controls, effective training, CAPA, complaints management, auditing, transparency, and more.
GxP: Good x Practice pertains to a number of quality control and safety issues in manufacturing for a wide variety of industries. The x could stand for a number of different aspects of quality control and safety. Some of the more common good practice guidelines include GMP, GCP, and GLP.
HACCP: Hazard analysis critical control points (HACCP) is a preventative system designed to identify any hazards (physical, biological and chemical) that can hurt the integrity of the final product. There are mandatory HACCP programs for meat, juice and seafood, as well as many other voluntary HACCP programs designed to promote health safety.
ISO: The International Organization for Standardization is responsible for providing guidelines for quality management, waste reduction, and worker safety. ISO standards undergo a lengthy multi-step process before they become standards. Sparta Systems' suite of quality management products helps companies comply with a number of different standards, including ISO 9001:2008, ISO 13485, and ISO 22000.
CFR: The Code of Federal Regulations (CFR) is the codification of all general and permanent rules published in the Federal Register. There are 50 titles total. TrackWise helps organizations comply with the rules and regulations in Title 21: Foods and Drugs.
EHS: An environment, health, and safety (EHS) system is concerned with sustainability and how the organization is complying with all regulations regarding the environment and worker safety. An EHS system aims to improve waste reduction, ensure compliance with increasing regulations, and reduce a company's carbon footprint to meet public expectations.
MDR: The Medical Device Reporting regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
PRT: Product registration tracking helps regulatory affairs professionals track the status of product registrations and submissions for each market they sell to across geographically dispersed operations and correspond to the specific requirements of each regional health authority.
QMS: A quality management system (QMS) is a set of business processes, policies and procedures implemented to ensure optimal quality management and meet customer requirements. The criteria for a quality management system are defined in ISO 9001:2008.
REACH: Registration, Evaluation, Authorization, and Restrictions of Chemicals (REACH) is a European regulation that addresses chemical substance safety across the supply chain. It is enforced by all members of the EU as well as Norway, Iceland, and Liechtenstein and was passed in 2007. The regulation is 849 pages and is considered the toughest regulation on chemical substances and chemical safety in the world.
SQM: Supplier Quality Management is the process of qualifying, selecting, and monitoring suppliers and supply chain partners. The goal is to have a system of tools in place so you can reduce the potential risk to your own company by a supplier through cleanly integrated, efficient and cost-effective quality processes.
TSCA: A law signed in 1976 to promote chemical safety for humans and the environment. The Toxic Substances Control Act (TSCA) gives the EPA authority to require chemical companies to keep records, report any hazards, and test new chemicals. All pre-existing chemicals before the law was signed are exempt, and special attention is paid to PCBs, asbestos, and lead-based paint. The TSCA requires the EPA to keep an inventory on all chemicals that are manufactured and processed in the United States.
UDI Compliance: The FDA is finalizing a unique device identification system (UDI) that will be used to identify medical devices in their production and use. The system was established to ensure patient safety, improve innovation in medical device manufacturing, and better monitor devices post market. The FDA has set up a schedule for UDI compliance for medical device manufacturers depending on the medical device, and the final compliance date for Class 1 devices will be September 24, 2020.