【正文】 manage risk using recognized risk management tools and/ or internal procedures (., standard operating procedures). Below is a nonexhaustive list of some of these tools (further details in Annex 1 and chapter 8): 此外，制藥行業(yè)和法規(guī)工作者可采用經(jīng)認可的風險管理工具和 /或內(nèi)部程序（比如標準操作規(guī)程）來評估并管理風險。 以下是一些工具的一個不夠詳盡的清單（更詳細的信息見附錄 1和第 8章）： ? Basic risk management facilitation methods (flowcharts, check sheets etc.)。 基本風險管理簡易方法（流程圖、檢查表等） ? Failure Mode Effects Analysis (FMEA)。 失敗模式效果分析（ FMEA） ? Failure Mode, Effects and Criticality Analysis (FMECA)。 失敗模式、效果及危害程度分析（ FMECA） ? Fault Tree Analysis (FTA)。 故障樹形圖分析（ FTA） ? Hazard Analysis and Critical Control Points (HACCP)。 危險分析和關(guān)鍵控制點（ HACCP） ? Hazard Operability Analysis (HAZOP)。 危險可操作性分析（ HAZOP） ? Preliminary Hazard Analysis (PHA)。 事先危險分析（ PHA） ? Risk ranking and filtering。 風險分級與過濾 ? Supporting statistical tools. 輔助 統(tǒng)計工具 It might be appropriate to adapt these tools for use in specific areas pertaining to drug substance and drug (medicinal) product quality. Quality risk management methods and the supporting statistical tools can be used in bination (., Probabilistic Risk Assessment). Combined use provides flexibility that can facilitate the application of quality risk management principles. 可以將這些工具用于原料藥和藥品的某些領(lǐng)域。 質(zhì)量風險管理方法和 輔助統(tǒng)計工具可結(jié)合起來使用（比如 概率風險評估）。結(jié)合使用提供了靈活性，方便質(zhì)量風險管理原則的應(yīng)用。 The degree of rigor and formality of quality risk management should reflect available knowledge and be mensurate with the plexity and/ or criticality of the issue to be addressed. 質(zhì)量風險管理的嚴格和正式程度應(yīng)反映可用的知識，并與要解決的問題的復(fù)雜性和 /或關(guān)鍵性相當。 6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS 將質(zhì)量風險管理融入到工業(yè)和法規(guī)操作中 Quality risk management is a process that supports sciencebased and practical decisions when integrated into quality systems (see Annex II). As outlined in the introduction, appropriate use of quality risk management does not obviate industry’s obligation to ply with regulatory requirements. However, effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a pany’s ability to deal with potential risks, and might affect the extent and level of direct regulatory oversight. In addition, quality risk management can facilitate better use of resources by all parties. 融入到質(zhì)量系統(tǒng)中時， 質(zhì)量風險管理 是一個支持科學實用決策的過程（見附件 II）。簡介部分已指出，質(zhì)量風險管理的使用不 會 免除按照法規(guī)要求行事的義務(wù)。 但是，有效的 質(zhì)量風險管理會推進更多更好的精明決策，會為法規(guī)工作者在公司處理潛在風險的能力方面提供更多的保證， 并會影響 直接法 規(guī)疏忽的范圍和層次。 此外，質(zhì)量風險管理會方便各方更好地使用資源。 Training of both industry and regulatory personnel in quality risk management processes provides for greater understanding of decisionmaking processes and builds confidence in quality risk management outes. 對行業(yè)人員和 法規(guī)工作者進行質(zhì)量風險管理過程的培訓(xùn)能更好地理解決策過程，并對質(zhì)量風險管理成果建立可信度。 Quality risk management should be integrated into existing operations and documented appropriately. Annex II provides examples of situations in which the use of the quality risk management process might provide information that could then beused in a variety of pharmaceutical operations. These examples are provided for illustrative purposes only and should not be considered a definitive or exhaustive list. These examples are not intended to create any new expectations beyond the requirements laid out in the current regulations. 質(zhì)量風險管理應(yīng)適當融入到現(xiàn) 有操作中并做好記錄。 附錄 II舉了一些例子， 在一些情況下質(zhì)量風險管理過程的應(yīng)用 可提供可用于各種制藥操作中的信息。 這些例子只是出于例證性的目的，不應(yīng)被認為是確定的或詳盡的清單。 這些例子不是為了 創(chuàng)建現(xiàn)行法規(guī)中描述的要求以外的新期望。 Examples for industry and regulatory operations (see Annex II): 行業(yè)和法規(guī)操作舉例（見附錄 II） ? Quality management. 質(zhì)量管理 Examples for industry operations and activities (see Annex II): 行業(yè)操作和行為舉例（見附錄 II） ? Development。 研發(fā) ? Facility, equipment and utilities。 設(shè)施、設(shè)備和公用工程 ? Materials management。 物料管理 ? Production。 生產(chǎn) ? Laboratory control and stability testing。 實驗室控制和穩(wěn)定性試驗 ? Packaging and labeling. 包裝和帖簽 Examples for regulatory operations (see Annex II): 法規(guī)操作舉例（見附錄 II） ? Inspection and assessment activities. 檢查與評估活動 While regulatory decisions will continue to be taken on a regional basis, a mon understanding and application of quality risk management principles could facilitate mutual confidence and promote more consistent decisions among regulators on the basis of the same information. This collaboration could be important in the development of policies and guidelines that integrate and support quality risk management practices. 繼續(xù)根據(jù)各區(qū)域進行法規(guī)決策時， 以相同的信息為基礎(chǔ)， 質(zhì)量風險管理原則的 共識和應(yīng)用會有助于建立相互間的信任，并在法規(guī)工作者間達成更為一致的決策。 這個合作對于包括并支持質(zhì)量風險管理做法的政策和指南的發(fā)展是重要的。 7. DEFINITIONS 定義 Decision Maker(s): 決策者 Person(s) with the petence and authority to make appropriate and timely quality risk management decisions. 具有能力與權(quán)力來作出正確及時的質(zhì)量風險管理決定的人。 Detectability: 可檢測性 The ability to discover or determine the existence, presence, or fact of a hazard. 發(fā)現(xiàn)或測定一種危害的存在或真相的能力。 Harm: 危害 Damage to health, including the damage that can occur from loss of product quality or availability. 對健康的危害，包括由于產(chǎn)品質(zhì)量或產(chǎn)品可用性的缺陷而導(dǎo)致的損害。 Hazard: 危險 The potential source of harm (ISO/IEC Guide 51). 危害的潛在來源 (ISO/IEC指南 51) Product Lifecycle: 產(chǎn)品生命周期 All phases in the life of the product from the initial development through marketing until the product’s discontinuation. 產(chǎn)品生命的所有階段，從最初的研發(fā)、經(jīng)過市場營銷、到產(chǎn)品的廢止。 Quality: 質(zhì)量 The degree to which a set of inherent properties of a product, system or process fulfills requirements (see ICH Q6A definition specifically for quality of drug substance and drug (medicinal) products.) 產(chǎn)品、系統(tǒng)或工藝的一組固有性質(zhì)符合要求的程度（見 ICH Q6A原料藥和藥品“質(zhì)量”的定義） Quality Risk Management: 質(zhì)量風險管理 A systematic process for the assessment, control, munication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. 在整個產(chǎn)品生命周期中 ，對藥品質(zhì)量風險進行評估、控制、溝通和審核