Quality & Compliance Glossary

A root-cause questioning method that repeatedly asks why a problem occurred to move from visible symptoms toward underlying causes.

An observation or conclusion from an audit that identifies conformity, nonconformity or another issue requiring evaluation or follow-up.

The coordinated planning, execution, reporting and follow-up of audits within a structured and traceable process.

The state in which an organization can demonstrate that processes, records, responsibilities and evidence are controlled and readily available for an audit.

A traceable record of relevant system activities and changes showing what happened, when it happened and, where applicable, who performed the action.

A globally used food safety certification standard for food manufacturing sites, covering product safety, quality, legality and management system controls.

The capability to continue priority products and services at an acceptable level during disruption and to recover in a controlled way.

A structured process for addressing causes of actual or potential problems through corrective or preventive measures and verifying that actions are effective.

A formal process for proposing, assessing, approving, implementing and documenting changes that can affect quality, compliance, products or validated processes.

The structured management of required skills, qualifications, training and evidence to ensure people are competent to perform assigned roles and activities.

The structured management of legal, regulatory, certification and internal obligations, including responsibilities, evidence, actions and periodic checks.

A legal or other requirement that an organization must comply with, or chooses to comply with, within the scope of its management system.

An ongoing approach to improving processes, performance and outcomes through structured evaluation, actions, learning and measurable improvement initiatives.

A document whose creation, approval, revision, distribution and withdrawal are managed through defined controls to ensure authorized and current information is used.

An action taken to eliminate the cause of a detected nonconformity, incident or other unwanted condition and reduce the chance of recurrence.

A step in a food process where control is essential to prevent or eliminate a food-safety hazard or reduce it to an acceptable level.

A documented approach defining how an organization can retrieve, transfer and appropriately remove its data and dependencies when ending a software relationship.

The rules and controls that determine how long records or data are kept, how they remain accessible and protected, and when they are disposed of.

An unplanned departure from an approved procedure, process, specification or expected condition that should be documented and evaluated for impact.

The process of ensuring that approved documents are current, traceable, accessible to the right people and protected against uncontrolled change or use.

The organized management of documents throughout their lifecycle, including creation, review, approval, publication, retrieval, revision and retirement.

The controls used to identify, approve, publish and trace document revisions so users work from the correct current version and obsolete versions remain controlled.

A planned, evidence-based check that confirms an implemented corrective action or CAPA achieved its intended result and remains effective.

A digital platform used to manage quality processes, controlled information, responsibilities, evidence and improvement activities within a connected management system.

An electronic signing action used to record a person's approval, review or other sign-off on an electronic record.

The European Union regulation governing medical devices, including requirements for safety, performance, quality systems, clinical evidence and post-market activities.

The FDA medical device quality system regulation that incorporates ISO 13485:2016 by reference and governs quality system requirements for applicable device manufacturers.

A visual cause-analysis method that groups possible causes of a problem into structured categories so teams can investigate them systematically.

A food safety management system certification scheme based on ISO 22000, sector-specific prerequisite programmes and additional FSSC requirements.

A systematic food safety approach used to identify, evaluate and control significant hazards at defined points in a food production process.

A structured, team-based study that uses guide words to identify deviations from design intent that could create hazards or operability problems.

Health, Safety and Environment: an integrated management scope for occupational health, workplace safety and environmental risks, obligations, incidents and performance.

A structured evaluation of the potential consequences of a proposed change before approval and implementation.

An unplanned event or condition that resulted in, or could contribute to, harm, loss, nonconformance or operational disruption.

The structured process for reporting, assessing, investigating, following up and learning from incidents and related events.

A management system for establishing, operating and continually improving controls that protect the confidentiality, integrity and availability of information.

The international standard specifying requirements for a quality management system focused on consistent performance, customer requirements and continual improvement.

The international quality management system standard specifying regulatory-focused requirements for organizations involved in the design, manufacture and lifecycle of medical devices.

The international standard specifying requirements for an environmental management system used to manage environmental responsibilities and improve environmental performance.

The international standard defining a systematic process for identifying, evaluating, controlling and monitoring risks associated with medical devices throughout their lifecycle.

The international standard specifying requirements for a food safety management system for organizations directly or indirectly involved in the food chain.

The international standard specifying requirements for an occupational health and safety management system to manage OH&S risks and improve safety performance.

The international standard specifying competence, impartiality and consistent-operation requirements for testing and calibration laboratories.

The international standard specifying requirements for establishing, implementing, maintaining and continually improving an information security management system.

A structured process for evaluating and controlling safety, operational and compliance risks before significant technical, organizational or process changes are implemented.

An event that did not result in injury, damage or loss but had the potential to do so under slightly different circumstances.

A situation in which a product, process, activity or result fails to meet a defined requirement, specification, procedure or standard.

A prioritization method that ranks problem or cause categories by frequency, cost or other impact so teams can focus investigation and improvement effort where it matters most.

An iterative four-step improvement cycle—Plan, Do, Check and Act—used to control processes, evaluate results and drive continual improvement.

A systematic approach to preventing major incidents by managing hazards associated with hazardous processes, substances, equipment, procedures and organizational change.

An integrated management approach covering quality, occupational health, safety and environmental responsibilities within an organization.

A structured system of processes, responsibilities, controls and documented information used to manage quality and continually improve organizational performance.

The principal EU chemicals regulation requiring industry to understand, communicate and manage risks associated with chemical substances.

A structured assessment used to identify hazards or uncertainties, estimate their risk and determine whether controls or further action are required.

The coordinated process of identifying, assessing, treating, monitoring and communicating risks that could affect objectives, safety, quality or compliance.

A grid that combines likelihood and consequence or severity ratings to support consistent risk evaluation and prioritization.

An access-control model in which permissions are assigned to organizational roles and users receive access through the roles they are authorized to perform.

A systematic approach for identifying the underlying causes of a problem or event instead of addressing only its immediate symptoms.

European legislation aimed at preventing major accidents involving dangerous substances and limiting their consequences for people and the environment.

An authentication approach that allows a user to use one account and authentication process to access multiple connected applications.

A controlled document describing the approved steps, responsibilities and requirements for performing a recurring activity consistently.

A structured evaluation of a supplier's processes, controls and evidence against defined quality, regulatory or contractual requirements.

A risk-based process for evaluating and approving a supplier's ability to consistently meet defined quality, technical and regulatory requirements.

The systematic qualification, monitoring and improvement of suppliers to ensure purchased products and services consistently meet defined quality and compliance requirements.

The ability to follow the history, status, location or relationships of information, materials, products, actions or decisions through a process.