Definitions

Action plan = measures to correct errors or eliminate system errors in order to prevent recurrence Adverse event (AE) = something more than a deviation, abbreviated to AE (or RAE = Registered AE) Audit = control / comparison “live and learn”, with checklists and questions Audit report = contains: minutes, reviewed topics, who conducted what, conclusions Checklist = point-wise enumeration of conditions to be controlled Contribute = employees must actively participate in the HES work, §§ 4 og 5.3 Control = comparison, synonymous with audit Deviation = something missing, error in relation to written procedures. See adverse events. Deviation message = form where deviations and proposals are registered Deviation overview = graphs and tables that display all or a specific extract of deviation messages Instructions = recommended procedure (most often when a person should do something) Internal control (IC) = Own (self) control, synonymous term for quality management Motivate = set in motion, - not to be confused with the desire to create feelings Procedure = written procedure, description of a process in which many participate (From the Latin “procedere”: To show the order of execution and requirements for the execution of each phase (= Method), and who is involved in every phase with which responsibility) Quality = Properties Quality Management (QM) = a craft that requires active use of specific methods Quality plan = includes all activities that are used for preventing errors Responsibility = the ability to give answers when needed Risk = probability x consequence Routine = agreed procedure (oral) System = when specified parts work together System error = error that recurs, that happens because the system allows it User survey = questionnaire answered by users, customers, relatives, etc. Verify = check if it is true, from the Latin “Verus” = true, “facere” = make