Glossary Terms (Simple List)
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Risk Prioritization Number (RPN)
A quantitative method for determining the level of risk by multiplying the severity, occurrence and detectability rankings of the failure or event. (TR44)
The Risk Priority Number, or RPN, is a numeric assessment of risk assigned to a process, or steps in a process, as part of Failure Modes and Effects Analysis (FMEA), in which a team assigns each failure mode a numeric values that quantifies likelihood of occurrence, likelihood of detection, and severity of impact. (TR54-4)
A quantitative measure used when assessing the level of risk. (TR54-5)
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Risk Prioritization Ranking (RPR)
A qualitative method for determining the level of risk by combining severity, occurrence and detectability rankings of the failure or event. (TR44)
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Risk Priority Level
A relative priority ranking assigned to a risk based on a combination of a) therapeutic use of a product and patient impact due to product unavailability, b) availability of alternatives, and c) likelihood of a shortage. (TR68)
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Risk Priority Number (RPN)
A quantitative measure used when assessing the level of risk. (TR54-2)
The product of severity (S), occurrence (O) and detection (D) used to determine the significance of the risk. (TR54-3)
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Risk Ranking and Filtering (RRF)
Risk ranking and filtering is a tool for comparing and ranking risks. (TR54-4)
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Risk Reduction
The process of decreasing the level of risk. (TR44)
Process for mitigation or avoidance of quality risk when it exceeds a specified (acceptable) level (e.g., reduce severity, probability of harm, and improves detectability of hazards and quality risks). (TR58)
Actions taken to lessen the probability of occurrence of harm and the severity of that harm. (TR54-2) (TR54-5)
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Risk Review
An ongoing monitoring of events, output and results of the risk management process that takes into account new knowledge and experience. [A] step in the risk management process for taking in account of new knowledge and experiences. (TR44) (TR58)
Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk. (TR54-2) (TR54-5)
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Risk-based Triage for Drug Shortages
A process of assessing and assigning priorities for managing drug shortage risks based on criticality and impact to patients (TR68)
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RKN container
The three letter code refers to the type of ULD. Position 1 letter identifies ULD category (certification, ULD type, thermal units). Position 2 letter identifies standard base dimensions. Position 3 letter identifies contour, forklift holes, and other miscellaneous information. Here R is standing for Thermal Certified Aircraft Container. K refers to the dimensions of the container (1,534 x 1,562 mm (60.4 x 61.5 in)). The third letter describes the container’s contour and fork lift capability. Refer to the IATA “ULD Technical Manual” for complete information. (TR58)
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Robustness
The measure of capacity to remain unaffected by small, but deliberate, variations in method parameters and provides an indication of its reliability during normal usage. (TR57) (TR33)