【正文】 必要的資源；? Specify a timeline, deliverables and appropriate level of decision making for the risk management process.指定風險管理程序的時限、交付日期與決策水平。質(zhì)量風險評估開始于一個明確的問題或風險問題。在風險評估時，作為明確定義風險的輔助工具，通常如下這三個基本問題是非常有用的：1. What might go wrong?什么可能出錯?2. What is the likelihood (probability) it will go wrong?會出錯的可能性(概率)是什么?3. What are the consequences (severity)?結(jié)果(嚴重性)是什么?Risk identification: is a systematic use of information to identify hazards referring to the risk question or problem description. Information can include historical data, theoretical analysis, informed opinions, and the concerns of stakeholders. Risk identification addresses the “What might go wrong?” question, including identifying the possible consequences. This provides the basis for further steps in the quality risk management process.風險辨識：其是指參照風險問題或問題描述，系統(tǒng)地運用信息來辨識危險因素。風險辨識關(guān)注“什么可能出錯?”這個問題，包括辨識可能的結(jié)果。Risk analysis: is the estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms. In some risk management tools, the ability to detect the harm(detectability) also factors in the estimation of risk.風險分析：其是對風險所關(guān)聯(lián)已經(jīng)辨識了的危險因素進行估計。在一些風險管理工具中，探測傷害的能力(可檢測性)同樣是在估計風險中的因素。風險評價考慮到了所有這三個基本問題的證據(jù)強度。顯示假設(shè)及合理資源不確定性將會加強輸出的可靠性，并且/或有助于辨識其限度。典型的不確定來源包括制藥科學知識差距、對過程理解差距、傷害來源(如一個過程的失效模式，變異行來源)以及發(fā)現(xiàn)問題概率。當風險被定量地表達，則運用數(shù)值表達它的概率。一些時候，使用“風險記分”來進一步確定描述風險的排列。因此，定量風險評估對于在某個時間的特定后果非常有用。在一個記分過程的中間步驟有時候可以使用定量風險評估。風險控制的目的是降低風險到一個可接受的水平。決策者可能會采用不同的過程，包括收益成本分析，來了解最佳的風險控制水平。風險降低可能包括用于減緩傷害的嚴重性和概率所采取的行動。通過實施風險降低措施，新的風險可能被引入到系統(tǒng)中或者顯著增加其它已經(jīng)存在的風險。Risk acceptance: is a decision to accept risk. Risk acceptance can be a formal decision to accept the residual risk or it can be a passive decision in which residual risks are not specified. For some types of harms, even the best quality risk management practices might not entirely eliminate risk. In these circumstances, it might be agreed that an appropriate quality risk management strategy has been applied and that quality risk is reduced to a specified (acceptable) level. This (specified) acceptable level will depend on many parameters and should be decided on a casebycase basis.接受風險：其是一個接受風險的決定。對于一些類型的傷害，甚至最好的質(zhì)量風險實踐也未必能全部消除風險。這個(特定)可接受的水平將會取決于許多參數(shù)，并且具體情況具體判斷定。 ., regulators and industry, industry and the patient, within a pany, industry or regulatory authority, etc. The included information might relate to the existence, nature, form, probability, severity, acceptability, control, treatment, detectability or other aspects of risks to quality. Communication need not be carried out for each and every risk acceptance. Between the industry and regulatory authorities, munication concerning quality risk management decisions might be effected through existing channels as specified in regulations and guidances.風險溝通：是在決策者和其它人員之間分享有關(guān)風險和風險管理的信息。質(zhì)量風險管理過程的輸出/結(jié)果應當進行適當?shù)臏贤ê痛鏅n(見圖 1 的實線箭頭)。所包括的信息應該與質(zhì)量風險的存在性、性質(zhì)、形式、概率、嚴重性、可接受性、控制、處理、可檢測性或其它有關(guān)方面。如果在業(yè)界和藥政當局之間，就可能受影響進行質(zhì)量風險管理決策溝通，則這些溝通可能通過現(xiàn)有的規(guī)章或指南中所說明的渠道來進行。應當實施一個評審或?qū)κ录M行監(jiān)控的機制。一旦開始了某個質(zhì)量風險管理過程，則該過程應該一直應用于可能影響初始質(zhì)量風險管理決策的事件，而不管那些事件是已被計劃的(如產(chǎn)品評審、檢查、審計、變更控制結(jié)果)或未計劃的(如從失敗調(diào)查的根本原因、檢查、召回)。風險評審可能包括對風險接受決策重新考慮( 節(jié))。在現(xiàn)有關(guān)于風險概率，嚴重性和一些事件的可檢測性評估知識的基礎(chǔ)上，其提供文件的，透明的和可重復的方法來實現(xiàn)質(zhì)量風險管理程序的步驟。此類方法繼續(xù)提供有用的信息，這些信息可以支持諸如處理投訴、質(zhì)量缺陷、偏差與資源分配。以下并非是這些工具的一個詳盡的列表(詳細在附件 1 和第 8 章)：? Basic risk management facilitation methods (flowcharts, check sheets etc.)。 故障模式效應分析(FMEA)；? Failure Mode, Effects and Criticality Analysis (FMECA)。 故障樹分析(FTA)；? Hazard Analysis and Critical Control Points (HACCP)。 危害及可操作性分析(HAZOP)；? Preliminary Hazard Analysis (PHA)。 風險排行與過濾；? Supporting statistical tools. 輔助性統(tǒng)計工具。質(zhì)量風險管理方法以及輔助統(tǒng)計工具可以聯(lián)合使用(如，概率性風險評估)。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)量風險管理的嚴格程度與和形式應當反映可利用的知識和所關(guān)注問題的復雜性，和/或嚴重性相當。正如在簡介中所簡述的，恰當?shù)剡\用質(zhì)量風險管理并不能免除業(yè)界遵守藥政的要求。另外，質(zhì)量風險管理可以促使資源能被所有部門更好地運用。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 be used 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)量風險管理應該與現(xiàn)有的運作和相應文件系統(tǒng)恰當整合。所提供的這些例子只是出于說明的目的，其不應該被認為是一個權(quán)威性的或詳盡的列表。Examples for industry and regulatory operations (see Annex II):業(yè)界與藥政運作的例子(見附錄 II)：? Quality management. 質(zhì)量管理。 開發(fā)；? Facility, equipment and utilities。 物料管理；? Production。 實驗控制和穩(wěn)定性試驗；? Packaging and 。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.當藥政決策將會持續(xù)在某個區(qū)域基礎(chǔ)上應用時，對質(zhì)量風險管理原則的一般了解和應用可以在相同的信息基礎(chǔ)上促進管理者之間的相互信心并且促使他們做出更一致的決策。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.有能力和權(quán)力做出恰當?shù)牟⒓皶r的質(zhì)量風險決策的人。Harm: 傷害：Damage to health, including the damage that can occur from loss of product quality or availability.對健康的損害，包括可能由于產(chǎn)品質(zhì)量或有效性損失引起的損害。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.從最初的開發(fā)到上市，直到產(chǎn)品的停止這個產(chǎn)品生命的所有階段。A systematic process for the assessment, control, munication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.用于評估，控制，溝通和評審藥物(醫(yī)療)產(chǎn)品貫穿整個產(chǎn)品生命周期質(zhì)量風險的一個系統(tǒng)化過