Understanding compliance terminology is essential for navigating regulatory requirements. This glossary covers the most common terms across manufacturing compliance frameworks.
APQPAdvanced Product Quality Planning — structured method for defining and executing steps to ensure product satisfies customers.AS9100Aerospace quality management system standard based on ISO 9001 with additional aerospace-specific requirements.CAPACorrective and Preventive Action — a systematic approach to identifying, investigating, and addressing the root causes of quality problems.CFRCode of Federal Regulations — the codification of federal rules published in the Federal Register, including FDA regulations.cGMPCurrent Good Manufacturing Practice — FDA regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards.DHFDesign History File — documentation containing the design and development history of a finished medical device.DHRDevice History Record — documentation containing the production history of a specific medical device unit or batch.DMRDevice Master Record — compilation of records containing procedures and specifications for a finished medical device.FSMAFood Safety Modernization Act — FDA regulation shifting focus from responding to foodborne illness to preventing it.GxPGood Practice — umbrella term for quality guidelines and regulations including GMP, GLP, GCP, and GDP.HACCPHazard Analysis and Critical Control Points — systematic preventive approach to food safety addressing physical, chemical, and biological hazards.IATFInternational Automotive Task Force — group of automotive manufacturers and trade associations that developed IATF 16949.ICHInternational Council for Harmonisation — organization providing harmonized guidelines for pharmaceutical development and registration.ISOInternational Organization for Standardization — independent organization developing voluntary international standards.MDRMedical Device Regulation — EU regulation governing medical devices, replacing the Medical Device Directive.NADCAPNational Aerospace and Defense Contractors Accreditation Program — industry-managed accreditation program for special processes.NCRNonconformance Report — document recording a deviation from specified requirements.OOSOut of Specification — test result falling outside established acceptance criteria.PPAPProduction Part Approval Process — automotive industry standard for evidence that all customer requirements are understood and met.QMSQuality Management System — formalized system documenting processes, procedures, and responsibilities for achieving quality policies and objectives.QMSRQuality Management System Regulation — FDA regulation harmonizing US medical device requirements with ISO 13485.RCARoot Cause Analysis — systematic process for identifying the underlying causes of problems or events.SOPStandard Operating Procedure — documented step-by-step instructions for routine operations.SQFSafe Quality Food — GFSI-benchmarked food safety and quality certification program.UDIUnique Device Identification — system for identifying medical devices through distribution and use.