28个质量管理术语解释

　　1.Annual Review-An evaluation，conducted at least annually,that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.

　　年度回顾——至少每年进行一次的一种评价活动，即，对每种药物的质量标准进行评估以决定是否需要对药物规程或生产制造或控制程序进行变更。

　　2.CAPA-Corrective and preventive action：A systematic approach that includes actions needed to correct (“correction”), prevent recurrence (“corrective action”),and eliminate the cause of potential nonconforming product and other quality problems (preventive action) (21CFR 820.100).

　　CAPA——Corrective and prevention action，纠正和预防措施，一种系统方法，包括：需要改正的行为(纠正)、预防再次发生(纠正行为)、消除潜在的非一致性产品和其它质量问题产生的原因(预防行为)(21 CFR 800.100)。

　　3.Continual Improvement-Ongoing activities to evaluate and positively change products，processes，and the quality system to increase effectiveness.

　　持续改进——不断发展行为，以提高效力为目的，对产品、工艺和质量系统进行评估和积极变更。

　　4.Correction-Repair，rework，or adjustment relating to the disposition of an existing discrepancy.

　　纠正——对已经存在的偏差进行补救、返工或调整。

　　5.Corrective Action-Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence.

　　纠偏措施——为消除现存偏差或其它不合乎要求的情况、预防问题的再次发生所采取的行动。

　　6.Customer-A person or organization (internal or external) that receives a product or service anywhere along the product’s life cycle.

　　消费者——在产品整个生命周期的任何阶段，收到产品或服务的个人或组织(内部或外部的)。

　　7.Discrepancy-Datum or result outside of the expected range;an unfulfilled requirementmay;be called non-conformity，defect, deviation,out-of-specification,out-of-limit,out-of-trend.

　　偏差——在预期结果范围外的数据或结果;没有达到的要求;也称作非一致性、缺陷、偏离、超标或超出趋势。

　　8.Harm-Damage to health, including the damage that can occur from the loss of product quality or availability.

　　危害——损害健康，包括：因产品质量或有效性缺失引起的损害。

　　9.Non-conformity-A deficiency in a characteristic，product specification,process parameter,record,or procedure that renders the quality of a product unacceptable,indeterminate,or not according to specified requirements.

　　非一致性——特性、产品规程、工艺参数、记录或程序上的缺陷，使产品质量不可接受、不确定或不符合特定要求。

　　10.Preventive Action-Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence.

　　预防措施——为消除潜在偏差或其它不合乎要求的情况、预防此类问题的再次发生所采取的措施。

　　11.Product/Service-The intended results of activities or processes;products/services can be tangible or intangible.

　　产品/服务——行动或工艺的预期内结果，产品/服务可以是有形或无形的。

　　12.Quality-A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs.

　　质量——对产品或服务能力是否满足消费者规定或默认的需求的一种衡量方式。

　　13.Quality Assurance-Proactive and retrospective activities that provide confidence that requirements are fulfilled.

　　质量保证——前瞻或回顾性的活动，以提供符合要求的信心。

　　14.Quality Control-The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible.

　　质量控制——在产品或服务生产过程中采取的步骤，以确保产品/服务符合要求并能够重复。

　　15.Quality Management-Accountability for the successful implementation of the quality system。

　　质量管理——成功贯彻质量系统的责任。

　　16.Quality Objectives-Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy.

　　质量目标——可测量的特定活动或过程，以符合质量政策所界定的目的和方向。

　　17.Quality Plan-The documented result of quality planning that is disseminated to all relevant levels of the organization.

　　质量计划——质量文件化的计划结果，要求传达到组织结构中的所有层次。

　　18.Quality Planning-A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives.

　　质量规划——一项管理活动，设定质量目标，并详细规定达到该目标所需要的操作和/或质量系统流程以及资源。

　　19.Quality Policy-A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve.

　　质量政策——组织最高层所发布的与满足消费者需求相关的目的和方向的声明，它与组织的战略方向(要努力获得的质量期望)类似。

　　20.Quality System-Formalized business practices that define management responsibilities for organizational structure, processes,procedures，and resources needed to fulfill product/service requirements,customer satisfaction，and continual improvement.

　　质量系统——正式的商业实践，它详细规定了管理者在组织结构、工艺、程序和资源中的职责，以履行产品/服务、满足消费者以及进行持续改进。

　　21.Quality Unit-A group organized within an organization to promote quality in general practice.

　　质量单位——在日常实践中为提高质量，在组织内部成立的一个团体。

　　22.Risk-The combination of the probability of occurrence of harm and the severity of that harm.

　　风险——危害发生的可能性和严重度的组合。

　　23.Risk Assessment-A systematic process for organizing information to support a risk decision that is made within a risk management process.The process consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

　　风险评估——为了支撑风险判断，在风险管理程序内所进行的一种系统性组织信息的流程。该方法由危害的确认、分析和评价与危害相关的风险几部分组成。

　　24. Risk Management-The systematic application of quality management policies，procedures,and practices to the tasks of assessing,controlling,communicating,and reviewing risk.

　　风险管理——质量管理政策、程序和实践操作的系统性运用，任务是对风险进行评估、控制、沟通和回顾。

　　25. Senior Management-Top management officials in a firm who have the authority and responsibility to mobilize resources.

　　高层管理——企业内的高级管理人员，具有动员资源的授权和职责。

　　26.Stakeholder-An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improvements.

　　利益相关者——个体或组织，在对质量系统框架内或商业化工艺改进中的转让、结果、指标，拥有相应权利和利益，例如，股东等。

　　27.Verification-Confirmation，through the provision of objective evidence,that specified requirements have been fulfilled. (Reference:The ASQ Auditing Handbook,3rd edition,ASQ Quality Audit Division,J.P. Russell,Editor).

　　确认——证实，通过提供客观证据对规定要求已得到满足的认定。

　　28.Validation-Confirmation，through the provision of objective evidence,that the requirements for a specific intended use or application have been fulfilled. (Reference: The ASQ Auditing Handbook,3rd edition，ASQ Quality Audit Division,J.P.Russell，Editor).

　　验证——证实，通过提供客观证据对特定的预期使用或应用要求已得到满足的认定。

来源：实验与分析