【正文】 specified (acceptable) level (see Fig. 1). Risk reduction might include actions taken to mitigate the severity and probability of harm. Processes that improve the detectability of hazards and quality risks might also be used as part of a risk control strategy. The implementation of risk reduction measures can introduce new risks into the system or increase the significance of other existing risks. Hence, it might be appropriate to revisit the risk assessment to identify and evaluate any possible change in risk after implementing a risk reduction process.風(fēng)險(xiǎn)降低：其是著眼于當(dāng)風(fēng)險(xiǎn)超過(guò)了某個(gè)特定(可接受)水平(見(jiàn)圖 1)后緩和或避免質(zhì)量風(fēng)險(xiǎn)的過(guò)程。用于風(fēng)險(xiǎn)控制所作工作量應(yīng)該與風(fēng)險(xiǎn)的顯著性相稱。 Risk Control風(fēng)險(xiǎn)控制Risk control: includes decision making to reduce and/or accept risks. The purpose of risk control is to reduce the risk to an acceptable level. The amount of effort used for risk control should be proportional to the significance of the risk. Decision makers might use different processes, including benefitcost analysis, for understanding the optimal level of risk control.風(fēng)險(xiǎn)控制：其包括做出的降低和/或接受風(fēng)險(xiǎn)的決定。另外，一些風(fēng)險(xiǎn)管理工具采用了相對(duì)的風(fēng)險(xiǎn)度量將多種級(jí)別的嚴(yán)重性和概率合并到一個(gè)完整的相對(duì)風(fēng)險(xiǎn)估計(jì)中。在定量風(fēng)險(xiǎn)評(píng)估中，對(duì)一個(gè)風(fēng)險(xiǎn)估計(jì)能提供一個(gè)特定結(jié)果的可能性，給出一系列產(chǎn)生風(fēng)險(xiǎn)狀況。另外，風(fēng)險(xiǎn)還可以運(yùn)用如“高”、“中”或“低”等定性描述詞來(lái)表達(dá)，對(duì)其應(yīng)該盡可能詳細(xì)地確定。The output of a risk assessment is either a quantitative estimate of risk or a qualitative description of a range of risk. When risk is expressed quantitatively, a numerical probability is used. Alternatively, risk can be expressed using qualitative descriptors, such as “high”, “medium”, or “l(fā)ow”, which should be defined in as much detail as possible. Sometimes a risk score is used to further define descriptors in risk ranking. In quantitative risk assessments, a risk estimate provides the likelihood of a specific consequence, given a set of riskgenerating circumstances. Thus, quantitative risk estimation is useful for one particular consequence at a time. Alternatively, some risk management tools use a relative risk measure to bine multiple levels of severity and probability into an overall estimate of relative risk. The intermediate steps within a scoring process can sometimes employ quantitative risk estimation.風(fēng)險(xiǎn)評(píng)估的輸出既是一個(gè)對(duì)風(fēng)險(xiǎn)定量估計(jì)也是一個(gè)對(duì)風(fēng)險(xiǎn)范圍的定性描述。不確定性是由于關(guān)于過(guò)程不完整的知識(shí)以及其期望的或非期望的變異性綜合造成。In doing an effective risk assessment, the robustness of the data set is important because it determines the quality of the output. Revealing assumptions and reasonable sources of uncertainty will enhance confidence in this output and/or help identify its limitations. Uncertainty is due to bination of inplete knowledge about a process and its expected or unexpected variability. Typical sources of uncertainty include gaps in knowledge gaps in pharmaceutical science and process understanding, sources of harm (., failure modes of a process, sources of variability), and probability of detection of problems.在進(jìn)行一個(gè)有效的風(fēng)險(xiǎn)評(píng)估時(shí)，數(shù)據(jù)集的完美性很重要，因?yàn)樗鼪Q定了輸出的質(zhì)量。Risk evaluation: pares the identified and analyzed risk against given risk criteria. Risk evaluations consider the strength of evidence for all three of the fundamental questions.風(fēng)險(xiǎn)評(píng)價(jià)：其是比較已經(jīng)辨識(shí)和分析的風(fēng)險(xiǎn)與給定的風(fēng)險(xiǎn)標(biāo)準(zhǔn)進(jìn)行比較。它是對(duì)發(fā)生事件可能性與及災(zāi)害嚴(yán)重性進(jìn)行定量或定性過(guò)程。這為進(jìn)一步的質(zhì)量風(fēng)險(xiǎn)管理過(guò)程奠定了基礎(chǔ)。這些信息可能包括歷史數(shù)據(jù)、理論分析、意見(jiàn)以及風(fēng)險(xiǎn)涉眾的考慮。當(dāng)被討論的風(fēng)險(xiǎn)被明確定義后，則將會(huì)很容易確定適當(dāng)?shù)娘L(fēng)險(xiǎn)管理工具(見(jiàn)第 5 節(jié)中的例子)和需要用于風(fēng)險(xiǎn)問(wèn)題說(shuō)明的資料類型。 Risk Assessment 風(fēng)險(xiǎn)評(píng)估Risk assessment: consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards (as defined below). Quality risk assessments begin with a welldefined problem description or risk question. When the risk in question is well defined, an appropriate risk management tool (see examples in section 5) and the types of information needed to address the risk question will be more readily identifiable. As an aid to clearly defining the risk(s) for risk assessment purposes, three fundamental questions are often helpful:風(fēng)險(xiǎn)評(píng)估：其包括辨識(shí)危險(xiǎn)因素與暴露在這些危險(xiǎn)因素(定義于后)相關(guān)風(fēng)險(xiǎn)的分析和評(píng)估。收集與風(fēng)險(xiǎn)評(píng)估相關(guān)的潛在危險(xiǎn)、傷害或影響人體健康的背景信息和資料和/或數(shù)據(jù)；? Identify a leader and necessary resources?？赡苡糜趩?dòng)和策劃一個(gè)質(zhì)量風(fēng)險(xiǎn)管理過(guò)程的步驟可能包括以下幾點(diǎn)：? Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk。 and負(fù)責(zé)在其組織內(nèi)各職能部門間協(xié)調(diào)質(zhì)量風(fēng)險(xiǎn)管理；以及，? assure that a quality risk management process is defined, deployed and reviewed and that adequate resources are available.確保明確，開(kāi)展與評(píng)審了質(zhì)量風(fēng)險(xiǎn)管理過(guò)程，并有適當(dāng)?shù)馁Y源。當(dāng)形成一個(gè)團(tuán)隊(duì)時(shí)，應(yīng)當(dāng)要包括適當(dāng)領(lǐng)域的專家(例如，質(zhì)量部門、商業(yè)開(kāi)發(fā)、工程、藥政、生產(chǎn)運(yùn)行、銷售和市場(chǎng)、法律和臨床)，及精通質(zhì)量風(fēng)險(xiǎn)管理過(guò)程的個(gè)人。（注：在流程圖中的“不接受”不僅僅是依據(jù)法定、立法或藥政要求，同樣也需要返回風(fēng)險(xiǎn)評(píng)估過(guò)程。Figure 1: Overview of a typical quality risk management process圖 1：典型的質(zhì)量風(fēng)險(xiǎn)管理過(guò)程概述unacceptable不接受Risk Review 風(fēng)險(xiǎn)評(píng)審Risk Control 風(fēng)險(xiǎn)控制Initiate Quality Risk Management Process啟動(dòng)風(fēng)險(xiǎn)管理過(guò)程風(fēng)險(xiǎn)控制Risk Reduction 風(fēng)險(xiǎn)降低Risk Acceptance 接受風(fēng)險(xiǎn)Output / Result of the Quality Risk Management Process質(zhì)量風(fēng)險(xiǎn)管理程序的輸出/結(jié)果風(fēng)險(xiǎn)控制Review Events 事件評(píng)審Risk Communication 風(fēng)險(xiǎn)溝通Risk Management tools 風(fēng)險(xiǎn)管理工具Risk Assessment 風(fēng)險(xiǎn)評(píng)估Risk Identification 風(fēng)險(xiǎn)辯識(shí)Analysis Risk 風(fēng)險(xiǎn)分析Risk Evaluationun 風(fēng)險(xiǎn)評(píng)價(jià) Decision nodes are not shown in the diagram above because decisions can occur at any point in the process. These decisions might be to return to the previous step and seek further information, to adjust the risk models or even to terminate the risk management process based upon information that supports such a decision. Note: “unacceptable” in the flowchart does not only refer to statutory, legislative or regulatory requirements, but also to the need to revisit the risk assessment process.在上圖中并未標(biāo)明判斷結(jié)點(diǎn)，因?yàn)榕袛嗫沙霈F(xiàn)在這個(gè)過(guò)程中的任何一個(gè)點(diǎn)。也可以使用其他模式。4. GENERAL QUALITY RISK MANAGEMENT PROCESS 常規(guī)質(zhì)量風(fēng)險(xiǎn)管理程序Quality risk management is a systematic process for the assessment, control, munication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. A model for quality risk management is outlined in the diagram (Figure 1). Other models could be used. The emphasis on each ponent of the framework might differ from case to case but a robust process will incorporate consideration of all the elements at a level of detail