Terms of Quality Risk Management

• Predictability: The ability to discover or determine the existence, presence or fact of a hazard.
• Harm: Damage to health, including the damage that can occur from loss of product quality or availability.
• Hazards: The potential source of harm.
• Risk: The combination of the probability of occurrence of harm and the severity of that harm.
• Risk Assessment: 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 hazard.
• Risk Initiation: Identifying the risk using suitable technique such as brain storming process.
• Risk Management: The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risks.
• Quality: The degree to which a set of inherent properties of a product, system or process fulfills requirements.
• Quality Risk Management: A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product life-cycle.
• Quality System: The sum of all aspects of a system that implement quality policy and ensures that quality objectives are met.
• Risk Analysis: The estimation of the risk associated with the identified hazards.
• Risk Control: Actions implementing risk management decisions.
• Risk Mitigation: Systematic reduction in the extent of exposure to a risk and/or the likelihood of its occurrence. Also termed as risk reduction reduction.
• Risk Reduction: Actions taken to lessen the probability of occurrence of harm and the severity of that harm.
• Risk Evaluation: The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.
• Risk identification: The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.
• Risk Communication: The sharing of information about risk and risk management between the decision maker and other stakeholders.
• Risk Summary /Conclusion: It is summary report of observations / mitigation which has high RPN with appropriate actions proposed, target date and responsible person to reduce the identified risk.
• Risk Review Report: Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk.
• Severity: A measure of the possible consequences of a hazard.
• High Risk – The equipment or system or process that will have focused and immediate impact on product quality. (Some of examples: Purified water system, Compression machine, metal detector system, non fill detector system on a packing line, on-line conductivity/Total Organic Carbon in a waters system line, Air handling Unit system for areas where product/materials are exposed during operation, power back up system sterility testing incubator, pure steam)
• Medium Risk – The equipment or system or process expected to have incidental or secondary impact on product quality. (Some of examples: raw water system, over coding machine)
• Low Risk – The non impact shall have no direct or indirect impact on product quality. (Some of examples: Fire alarm system, Effluent treatment plan incinerator, shrink   wrapping machine).
• Effects: The results of an action or inaction (that result or could results from cause).
• Failure Mode: Different ways that a process or sub process can fail to provide the desired results.
• Failure Mode Effect Analysis (FMEA): A systematic method of identifying and preventing product process problem before they occur. It is primarily to evaluate a process prior to its implementation.
• Risk Priority Number (RPN): The risk priority Number or RPN is a numeric assessment of risk assigned to a process, or steps in a process as part of FMEA. Each failure mode gets a numeric score that quantifies likelihood of occurrence, likelihood of detection and severity of impact.