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level: Definitions

Questions and Answers List

level questions: Definitions

Question	Answer
Person(s) with the competence and authority to make appropriate and timely quality risk management decisions	DECISION MAKER(S)
The ability to discover or determine the existence, presence, or fact of a hazard	DETECTABILITY
Damage to health, including the damage that can occur from loss of product quality or availability	HARM
The potential source of harm (ISO/IEC Guide 51).	HAZARD
All phases in the life of the product from the initial development through marketing until the product’s discontinuation.	PRODUCT LIFECYCLE
The degree to which a set of inherent properties of a product, system or process fulfills requirement	QUALITY
A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.	QUALITY RISK MANAGEMENT
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met	QUALITY SYSTEM
The explicit or implicit needs or expectations of the patients or their surrogates. In this document, it refers not only to statutory, legislative, or regulatory, but also to such needs and expectations.	REQUIREMENTS
The combination of the probability of occurrence of harm and the severity of that harm	RISK
The decision to accept risk	RISK ACCEPTANCE
The estimation of the risk associated with the identified hazards	RISK ANALYSIS
A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the IDENTIFICATION of hazards and the ANALYSIS and EVALUATION of risks associated with exposure to those hazards.	RISK ASSESSMENT
The sharing of information about risk and risk management between the decision maker and other stakeholders	RISK COMMUNICATION
Actions implementing risk management decisions	RISK CONTROL