【文章內容簡介】 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. 由于決策行為隨時都可能發(fā)生，上圖就沒有顯示決策點。這些決策有可能被反饋到上一步以尋求更多信息，這些信息可用于調整風險模型；也可能用于管理過程的終止。注解：圖中的“不可接受”項不僅指違背了法令法規(guī)要求，也表示風險管理過程需要重頭再來。 Responsibilities . 職責分配 Quality risk management activities are usually, but not always, undertaken by interdisciplinary teams. When teams are formed, they should include experts from the appropriate areas (., quality unit, business development, engineering, regulatory affairs, production operations, sales and marketing, legal, statistics and clinical) in addition to individuals who are knowledgeable about the quality risk management process. Decision makers should ? take responsibility for coordinating quality risk management across various functions and departments of their organization。 and ? assure that a quality risk management process is defined, deployed and reviewed and that adequate resources are available. 質量風險管理經常是但也不總是由交叉學科團隊執(zhí)行。除了要有風險管理方面的經驗人士，團隊還應包括相關領域的專家（ 例如：質量小組、事業(yè)發(fā)展、工程、管理，生產、行銷、法律、統(tǒng)計和臨床方面等。決策者必須負責組織協(xié)調各部門之間的關系，保障團隊各項功能的有效發(fā)揮，確保整個管理過程得以合理展開、不斷完善、反復審查，保障有足夠的資源供團隊使用。 Initiating a Quality Risk Management Process 質量風險管理的啟動Quality risk management should include systematic processes designed to coordinate, facilitate and improve sciencebased decision making with respect to risk. Possible steps used to initiate and plan a quality risk management process might include the following: ? Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk。 ? Assemble background information and/ or data on the potential hazard, harm or human health impact relevant to the risk assessment。 ? Identify a leader and necessary resources。 ? Specify a timeline, deliverables and appropriate level of decision making for the risk management process. 質量風險管理應包括這樣一些系統(tǒng)程序，這些設計好的程序用來協(xié)調，推動和改善那些風險方面基于科學認識的決定。一項管理程序的發(fā)起和設計可能要經過如下步驟：?定義存在的難題和風險問題，包括識別潛在風險的相關假設；?收集風險評估相關的關于潛在危險、危害或人體健康影響的背景信息和數據；?確定領導人和重要資源；?詳細說明決策的時間表，可交付性和適當的標準。 Risk Assessment 風險評估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: 1. What might go wrong? 2. What is the likelihood (probability) it will go wrong? 3. What are the consequences (severity)? 風險評估：此過程進行危險確認并對接觸這些危險所帶來的風險進行分析評價。它以一個定義明確的難點描敘或風險問題開始，當風險明確后，選擇合適而有針對性的管理工具和信息類型將會變得更容易。以下三個基本問題將有助于給出風險的清晰定義。1. 什么可能會出錯？2. 出錯的可能性有多大？3. 出錯的后果和嚴重性有哪些？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. 風險鑒定：參照風險問題或難點描敘，系統(tǒng)利用已有信息去鑒定危險。這些信息包括歷史數據、理論分析、多方面觀點和風險承擔人的意見。風險鑒定時提出“什么會出錯”這一問題，同時還確定可能答案。這一過程為后續(xù)步驟奠定了基礎。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：估計與已確認危險相聯(lián)系的風險，這是對危害發(fā)生的可能性和嚴重程度進行定性和定量分析的過程。風險評價中同樣也應用到某些管理工具檢測危害的能力（檢測能力）。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. 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 limi