風(fēng)險分析及方法簡述

1、 HYPERLINK / HYPERLINK / 更多企業(yè)學(xué)院： 中小企業(yè)治理全能版183套講座+89700份資料總經(jīng)理、高層治理49套講座+16388份資料中層治理學(xué)院46套講座+6020份資料國學(xué)智慧、易經(jīng)46套講座人力資源學(xué)院56套講座+27123份資料各時期職員培訓(xùn)學(xué)院77套講座+ 324份資料職員治理企業(yè)學(xué)院67套講座+ 8720份資料工廠生產(chǎn)治理學(xué)院52套講座+ 13920份資料財務(wù)治理學(xué)院53套講座+ 17945份資料銷售經(jīng)理學(xué)院56套講座+ 14350份資料銷售人員培訓(xùn)學(xué)院72套講座+ 4879份資料風(fēng)險分析及方法簡述（中英文）1 Basic Risk Management F

2、acilitation Methods 差不多的風(fēng)險治理的便利方法Some of the simple techniques that are commonly used to structure risk management by organizing data and facilitating decision-making are: 下面是一些簡單的通常使用的方法，進行風(fēng)險治理和制定決策： Flowcharts/流程圖 Check Sheets/檢查清單 Process Mapping/過程圖 Cause and Effect Diagrams (also called an Ishi

3、kawa diagram or fish bone diagram)/因果圖（或者叫魚骨圖）2 Failure Mode Effects Analysis (FMEA) 失效模式與效果分析2.1 Describe/描述FMEA (see IEC 60812) provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance. Once failure modes are established, ri

4、sk reduction can be used to eliminate, contain, reduce or control the potential failures. FMEA relies on product and process understanding. FMEA methodically breaks down the analysis of complex processes into manageable steps. It is a powerful tool for summarizing the important modes of failure, fac

5、tors causing these failures and the likely effects of these failures. FMEA提供了工藝潛在失效模式的評估和對產(chǎn)品性能或結(jié)果的潛在阻礙。一旦將建立了失效模式，風(fēng)險的降低可被用來消除、囊括、降低或操縱潛在的失效活動。FMEA依靠于對產(chǎn)品和工藝的理解。FMEA將復(fù)雜的工藝系統(tǒng)地分解為簡單的步驟。FMEA對重要的失效模式、引起失效的因素以及失效可能帶來的后果進行匯總的有力工具。2.2 Potential Areas of Use(s) 使用的潛在區(qū)域FMEA can be used to prioritize risks and

6、monitor the effectiveness of risk control activities. FMEA可用來安排風(fēng)險的優(yōu)先順序，監(jiān)控風(fēng)險操縱活動的有效性。FMEA can be applied to equipment and facilities and might be used to analyze a manufacturing operation and its effect on product or process. It identifies elements/operations within the system that render it vulnerab

7、le. The output/ results of FMEA can be used as a basis for design or further analysis or to guide resource deployment. FMEA可用于設(shè)備和設(shè)施，也可用于分析某一生產(chǎn)操作及其對產(chǎn)品或工藝的阻礙。它可識不系統(tǒng)內(nèi)的元素/操作的弱點。FMEA的結(jié)果可被作為設(shè)計或深入分析或指導(dǎo)資源配置的依據(jù)。3 Failure Mode, Effects and Criticality Analysis (FMECA) 失效模式、效果與關(guān)鍵程度的分析3.1 Describe/描述FMEA might

8、be extended to incorporate an investigation of the degree of severity of the consequences, their respective probabilities of occurrence, and their detectability, thereby becoming a Failure Mode Effect and Criticality Analysis (FMECA; see IEC 60812). In order for such an analysis to be performed, the

9、 product or process specifications should be established. FMECA can identify places where additional preventive actions might be appropriate to minimize risks. FMEA能夠延伸到結(jié)果嚴(yán)峻程度的調(diào)查、發(fā)生的概率和可檢測性，進展為FMECA。為執(zhí)行如此的分析，應(yīng)建立產(chǎn)品或工藝的質(zhì)量標(biāo)準(zhǔn)。FMECA能夠鑒定何時采納預(yù)防措施能夠?qū)L(fēng)險家最小化。3.2 Potential Areas of Use(s) 使用的潛在區(qū)域FMECA applicat

10、ion in the pharmaceutical industry should mostly be utilized for failures and risks associated with manufacturing processes; however, it is not limited to this application. The output of an FMECA is a relative risk “score” for each failure mode, which is used to rank the modes on a relative risk bas

11、is.制藥企業(yè)的FMECA應(yīng)最大的利用與生產(chǎn)工藝相聯(lián)系的失效和風(fēng)險，然而不局限于這一應(yīng)用。FMECA的結(jié)果是每一風(fēng)險模式的相對的風(fēng)險“中心”，用來分級相對風(fēng)險依照。4 Fault Tree Analysis (FTA) 失誤樹分析4.1 Describe/描述The FTA tool (see IEC 61025) is an approach that assumes failure of the functionality of a product or process. This tool evaluates system (or sub-system) failures one at

12、a time but can combine multiple causes of failure by identifying causal chains. The results are represented pictorially in the form of a tree of fault modes. At each level in the tree, combinations of fault modes are described with logical operators (AND, OR, etc.). FTA relies on the experts process

13、 understanding to identify causal factors. 失誤樹分析是假定產(chǎn)品或工藝性能的失效的方法。這些工具評估系統(tǒng)失效，然而能夠結(jié)合失效的多種緣故。在樹的每一個水平內(nèi)，應(yīng)描述失效模式的結(jié)合。FTA依靠于專家的工藝?yán)斫馊ヨb不起因。4.2 Potential Areas of Use(s) 潛在區(qū)域的使用FTA can be used to establish the pathway to the root cause of the failure. FTA can be used to investigate complaints or deviations in

14、 order to fully understand their root cause and to ensure that intended improvements will fully resolve the issue and not lead to other issues (i.e. solve one problem yet cause a different problem). Fault Tree Analysis is an effective tool for evaluating how multiple factors affect a given issue. Th

15、e output of an FTA includes a visual representation of failure modes. It is useful both for risk assessment and in developing monitoring programs. FTA可用于建立失效起因的途徑。FTA可用于調(diào)查投訴或偏差，以便全面理解它們的起因，確保預(yù)定的改進能全面解決爭議，同時可不能導(dǎo)致其他的爭議（例如：解決完一個問題然而引起了其他的問題）。失誤樹分析是評估多種因素如何樣阻礙爭議的有效的工具。失誤樹分析的結(jié)果包括失效模式的可見的代表。這對風(fēng)險評估和進展監(jiān)控系統(tǒng)是

16、有用的。5 Hazard Analysis and Critical Control Points (HACCP) 危害分析和關(guān)鍵操縱點5.1 Describe/描述HACCP is a systematic, proactive, and preventive tool for assuring product quality, reliability, and safety (see WHO Technical Report Series No 908, 2003 Annex 7). It is a structured approach that applies technical an

17、d scientific principles to analyze, evaluate, prevent, and control the risk or adverse consequence(s) of hazard(s) due to the design, development, production, and use of products. HACCP是確保產(chǎn)品質(zhì)量、可靠性和安全（見WHO技術(shù)報告系列）系統(tǒng)的、積極的、預(yù)防性的工具。它是一綜合性的方法，運用技術(shù)和科學(xué)的原則去分析、評估、預(yù)防和操縱由藥品的設(shè)計、研發(fā)、生產(chǎn)、風(fēng)險和使用引起的風(fēng)險或危害的后果。HACCP consis

18、ts of the following seven steps: HACCP包括以下七個步驟：(1) conduct a hazard analysis and identify preventive measures for each step of the process; 執(zhí)行危害分析，確定過程每一步驟的預(yù)防性措施(2) determine the critical control points; 決定關(guān)鍵操縱點(3) establish critical limits; 設(shè)立關(guān)鍵限度(4) establish a system to monitor the critical contr

19、ol points; 設(shè)定監(jiān)測關(guān)鍵操縱點的系統(tǒng)。(5) establish the corrective action to be taken when monitoring indicates that the critical control points are not in a state of control; 設(shè)立關(guān)鍵操縱不受控時的采取的整改措施(6) establish system to verify that the HACCP system is working effectively; 設(shè)立證實HACCP有效工作的系統(tǒng)(7) establish a record-keep

20、ing system. 設(shè)定記錄保持的系統(tǒng)5.2 Potential Areas of Use(s) 使用的潛在的區(qū)域HACCP might be used to identify and manage risks associated with physical, chemical and biological hazards (including microbiological contamination). HACCP is most useful when product and process understanding is sufficiently comprehensive t

21、o support identification of critical control points. The output of a HACCP analysis is risk management information that facilitates monitoring of critical points not only in the manufacturing process but also in other life cycle phases.HACCP可被用來證實和操縱與物理、化學(xué)和生物危害（包括微生物的污染）有關(guān)的風(fēng)險。當(dāng)有全面的產(chǎn)品和工藝?yán)斫庵С株P(guān)鍵操縱點的識不時

22、，HACCP是最有用的工具。HACCP分析的結(jié)果是風(fēng)險治理的信息，它便于生產(chǎn)工藝和其他生命周期時期的關(guān)鍵操縱點。6 Hazard Operability Analysis (HAZOP) 危害與可操作性/運行分析6.1 Describe/描述HAZOP (see IEC 61882) is based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming techniq

23、ue for identifying hazards using so-called “guide-words”. “Guide-words” (e.g., No, More, Other Than, Part of, etc.) are applied to relevant parameters (e.g., contamination, temperature) to help identify potential deviations from normal use or design intentions. It often uses a team of people with ex

24、pertise covering the design of the process or product and its application. HAZOP基于如此的理論假定來自設(shè)計和操作的偏差引來了風(fēng)險事件。這是系統(tǒng)的鑒定危害的頭腦風(fēng)暴技巧，確實是所謂的“指導(dǎo)詞”。 “指導(dǎo)詞”（非、更多的、而不是，部分）被用于相關(guān)的參數(shù)（例如：污染、溫度），關(guān)心鑒定來自正常使用或設(shè)計用途的潛在偏差。通常是利用涵蓋工藝或產(chǎn)品的設(shè)計和其利用的專家人員。PHA-Pro軟件介紹與下載PHA-Prowiki軟件/wiki是目前世界上銷量第一的分析軟件，集合了HAZOP,HACCP,LOPA,FMEA,FTA,ET

25、A,WHATIF等等各種分析引導(dǎo)。通過導(dǎo)航引導(dǎo)分析。發(fā)的那個PDF文件希望對大伙兒有所關(guān)心。里面有簡單的操作講明。風(fēng)險治理在藥品生產(chǎn)中的應(yīng)用摘要 簡要介紹了國內(nèi)藥品生產(chǎn)企業(yè)應(yīng)用風(fēng)險治理現(xiàn)狀,描述了對風(fēng)險治理的理解,概述了風(fēng)險治理的幾個應(yīng)用工具,重點闡述了風(fēng)險分析常用的失敗模式與阻礙分析(FMEA)方法。 關(guān)鍵詞 風(fēng)險治理;失敗模式與阻礙分析;風(fēng)險優(yōu)先數(shù) 中圖分類號R951 文獻標(biāo)識碼B 文章編號1673-7210(2008)12(b)-089-02 21世紀(jì)以來,美國食品藥品監(jiān)督治理局等藥政治理部門相繼提出了以風(fēng)險治理為基礎(chǔ)的藥品質(zhì)量治理概念。ICH Q9(風(fēng)險治理)的公布正式確定了風(fēng)險治理的

26、概念,為企業(yè)進行風(fēng)險治理提供了依據(jù)及指導(dǎo)。在原料藥、制劑、生物制品和生物技術(shù)產(chǎn)品的整個產(chǎn)品生命周期內(nèi),質(zhì)量風(fēng)險治理能夠運用于藥物質(zhì)量的所有方面,包括研發(fā)、生產(chǎn)、發(fā)放和檢查及遞交評審過程。作為國內(nèi)藥品生產(chǎn)企業(yè),要適應(yīng)法規(guī)的新變化,對生產(chǎn)過程中的藥品質(zhì)量風(fēng)險進行治理。文中通過對風(fēng)險概念的理解、風(fēng)險治理的常用工具以及如何應(yīng)用等幾個方面的問題進行探討,以期為藥品生產(chǎn)企業(yè)的生產(chǎn)過程質(zhì)量風(fēng)險治理提供參考。1 國內(nèi)藥品生產(chǎn)企業(yè)應(yīng)用風(fēng)險治理現(xiàn)狀隨著中國企業(yè)國際化和中國市場全球化程度的不斷提高,風(fēng)險治理正日益成為中國企業(yè)所面臨的重要課題,特不是2006年國資委公布中央企業(yè)全面風(fēng)險治理指引等相關(guān)文件以來,中國企業(yè)

27、差不多全面步入了“風(fēng)險治理年”。然而,前不久由甫瀚公司托付獨立第三方進行的一項名為“中國大陸風(fēng)險氣壓計”的調(diào)查結(jié)果卻顯示,國內(nèi)企業(yè)風(fēng)險治理現(xiàn)狀不容樂觀,不管是在風(fēng)險承受能力依舊風(fēng)險治理能力上都處于較低水平。 在這項調(diào)查中,只有9%的內(nèi)地上市公司高管表示,其公司在識不和治理所有潛在重大風(fēng)險方面進行得“特不有效”。這一比例遠遠低于美國(53%)、英國(37%)以及中國香港(22%)等大多數(shù)國家和地區(qū)的水平,這清晰地表明中國內(nèi)地企業(yè)在風(fēng)險治理方面與世界的差距。報告得出的結(jié)論顯示,內(nèi)地大型上市公司盡管在資產(chǎn)規(guī)模、盈利能力、市場占有率方面成長迅速,但在風(fēng)險治理能力上表現(xiàn)欠佳,高水平、系統(tǒng)性風(fēng)險治理架構(gòu)的

28、普遍缺失差不多成為制約中國企業(yè)成功走向國際市場的一大因素。關(guān)于正加快國際化步伐的中國企業(yè)而言,提高風(fēng)險治理水平已成為增強國際競爭力的當(dāng)務(wù)之急。 2 風(fēng)險治理的正確理解 通常,風(fēng)險被理解定義為危害出現(xiàn)的可能性和危害嚴(yán)峻性的結(jié)合。風(fēng)險分析即是用以評估和辨不設(shè)備或工藝功能關(guān)鍵參數(shù)的方法。 風(fēng)險治理的程序為:風(fēng)險評估,風(fēng)險操縱,風(fēng)險交流。具體見表1。 風(fēng)險評估所得結(jié)果是對風(fēng)險的定量可能,如從0到1(0到 100%),或是對風(fēng)險范圍的定性描述,比如“高”,“中”或“低”。 風(fēng)險操縱的目的在于將風(fēng)險降低到一個可同意水平。 風(fēng)險交流是在決策者及其他有關(guān)方進行風(fēng)險及其治理方面信息的交換和共享。 3 風(fēng)險治理的

29、工具 風(fēng)險治理的工具共有以下幾種:失敗模式與阻礙分析(FMEA );失敗模式、阻礙和關(guān)鍵點分析( FMECA );失敗(故障)樹狀分析法( FTA );危害源分析與關(guān)鍵操縱點(HACCP);危險可操作性分析(HAZOP) ;初步危害源分析(PHA) ;風(fēng)險評級和過濾;支持性統(tǒng)計學(xué)分析工具。 其中,FMEA是由美國航天局在阿波羅項目中被開發(fā)的,是一種用來確定潛在失效模式及其緣故的分析方法。具體來講,通過實行FMEA,可在產(chǎn)品設(shè)計或生產(chǎn)工藝真正實現(xiàn)之前發(fā)覺產(chǎn)品的弱點。FMEA是一種提供了定量評價故障及其潛在隱患的預(yù)防性方法,認為是最一般有用形式的風(fēng)險分析,具體如下:發(fā)生幾率(probability

30、 of occurrence,O);失敗的嚴(yán)峻程度(severity of the failure,S);檢測概率(probability of detection,D)。 關(guān)于定量進行的風(fēng)險評估,三個因素的“發(fā)生可能性(O)”、“缺陷的嚴(yán)峻性(S)” 和“檢測概率(D)”通常賦值為110。這些數(shù)值相乘,其結(jié)果是風(fēng)險優(yōu)先數(shù)(RPN)。RPN=OSD。 該風(fēng)險優(yōu)先數(shù)(RPN)從而得到11 000的數(shù)值。RPN 最壞的情況是1 000,最好的情況是1。公司在采取降低風(fēng)險措施的前提下需要決定RPN值,這就要提出風(fēng)險分析。當(dāng)再次進行評估時,這些措施應(yīng)該產(chǎn)生效果,RPN要低于限度值(執(zhí)行措施后)。它也能

31、夠在具體的應(yīng)用領(lǐng)域進行 (如計算機系統(tǒng)的風(fēng)險分析)。因此關(guān)于風(fēng)險分析,FMEA是一個特不靈活的方法。 發(fā)生幾率(O):事件發(fā)生的頻率,要記錄特定的失效緣故和機制,多長時刻發(fā)生一次以及發(fā)生的幾率。失敗發(fā)生越頻繁,風(fēng)險越高,假如為10,則表示幾乎確信要發(fā)生,會時常發(fā)生,發(fā)生概率為1代表幾乎可不能發(fā)生。Risk analysis by FMEA as an element of analytical validation References and further reading may be available for this article. To view references and f

32、urther reading you must HYPERLINK /science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_coverDate=12%2F05%2F2009&_rdoc=1&_fmt=full&_orig=search&_cdi=5266&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=d045a793134cf0d39

33、4ce12d30d4065e2 purchase this article.J.F. van Leeuwen, , M.J. Nauta, , D. de Kaste, Y.M.C.F. Odekerken-Rombouts, M.T. Oldenhof, M.J. Vredenbregt, , and D.M. BarendsaNational Institute for Public Health and the Environment, RIVM, Centre for Quality of Chemical-Pharmaceutical Products, Bilthoven, The

34、 NetherlandsbNational Institute for Public Health and the Environment, RIVM, Laboratory for Zoonoses and Environmental Microbiology, Bilthoven, The NetherlandscCurrent affiliation: Medicines Evaluation Board, CBG, The Hague, The NetherlandsdCurrent affiliation: National Food Institute, Danish Technical University (DTU), Sborg, DenmarkReceived 6 April 2009; accepted 28 June 2009. Availa