企業(yè)質(zhì)量風(fēng)險(xiǎn)管理中英文對(duì)照

1、Tabieof【最te新資料亠 WORD文檔§目錄可編輯修改亠I人【Xi1. INTRODUCTION-1引言J1'丿、2. SCOPE范圍3. PRINCIPLES OF QUALITY RISK MANAGEMENT質(zhì)量風(fēng)險(xiǎn)管理原理4. GENERAL QUALITY RISK MANAGEMENT PROCESS質(zhì)量風(fēng)險(xiǎn)管理基本程序4.1 Resp on sibilities職責(zé)分配4.2 In itiat ing a Quality Risk Man ageme nt Process質(zhì)量風(fēng)險(xiǎn)管理的啟動(dòng)4.3 Risk Assessme nt風(fēng)險(xiǎn)評(píng)估4.4 Risk C

2、on trol風(fēng)險(xiǎn)控制4.5 Risk Commu ni cati on風(fēng)險(xiǎn)交流4.6 Risk Review風(fēng)險(xiǎn)回顧5. RISK MANAGEMENT METHODOLOGY風(fēng)險(xiǎn)管理方法學(xué)6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY ANDREGULATORY OPERATIONS工業(yè)及監(jiān)管與質(zhì)量風(fēng)險(xiǎn)管理的整合7. DEFINITIONS定義8. REFERENCES參考資料Annex I: Risk Man ageme nt Methods and Tools附件I:風(fēng)險(xiǎn)管理方法及工具I.1 Basic Risk Mana

3、gement Facilitation MethodsI.1基本風(fēng)險(xiǎn)管理簡(jiǎn)易方法I.2 Failure Mode Effects An alysis (FMEA)I.2失誤模式影響分析(FMEA)I.3 Failure Mode, Effects and Criticality An alysis (FMECA)I.3失誤模式影響及危險(xiǎn)程度分析(FMECA)I.4 Fault Tree An alysis (FTA)I.4故障樹(shù)型分析(FTA)I.5 Hazard An alysis and Critical Con trol Points (HACCP)I.5危害分析及關(guān)鍵控制點(diǎn)(HACCP

4、)I.6 Hazard Operability An alysis (HAZOP)I.6危害可操作性分析(HAZOP)I.7 Preliminary Hazard Analysis (PHA)I.7初步危害分析(PHA)I.8 Risk Ranking and FilteringI.8風(fēng)險(xiǎn)排序及濾除I.9 Supporting Statistical ToolsI.9輔助統(tǒng)計(jì)工具Annex II: Potential Applications for Quality RiskMan ageme nt附件II:質(zhì)量風(fēng)險(xiǎn)管理潛在應(yīng)用前景.II.1 Quality Risk Man ageme nt

5、 as Part of I ntegratedII.1綜合質(zhì)量管理中的質(zhì)量風(fēng)險(xiǎn)管理Quality Man ageme nt11.2 Quality Risk Management as Part of Regulatory Operati ons11.3 Quality Risk Man ageme nt as Part of developme nt11.4 Quality Risk Management for Facilities,Equipme nt and Utilities11.5 Quality Risk Management as Part of MaterialsMan ag

6、eme nt11.6 Quality Risk Management as Part of Production11.7 Quality Risk Management as Part of LaboratoryControl and Stability Studies11.8 Quality Risk Man ageme nt as Part of Packag ing and Labelli ng1. INTRODUCTIONRisk management principles are effectively utilized in many areas of bus in ess and

7、 gover nment in clud ing finan ce, in sura nee, occupati onal safety, public health, pharmacovigila nee, and by age ncies regulati ng these in dustries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represe nt

8、 the full contributions that risk management has to offer. In addition, the importanee of quality systems has been recognized in the pharmaceutical industry and it is I beco ming evide nt that quality risk man ageme nt is a valuable comp onent of an effective quality system.It is commonly understood

9、 that risk is defined as the comb in ati on of the probability of occurre nee ofharm andthe severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive differe nt pote ntial har

10、ms, place a different probability on each harm occurring andII.2操作優(yōu)化中的應(yīng)用II.3研發(fā)中的應(yīng)用II.4對(duì)工具、設(shè)備和設(shè)施的質(zhì)量風(fēng)險(xiǎn)管理II.5物料管理中的應(yīng)用II.6生產(chǎn)中的應(yīng)用II.7實(shí)驗(yàn)室控制及穩(wěn)定性研究中的應(yīng)用II.8標(biāo)簽及包裝中的應(yīng)用引言風(fēng)險(xiǎn)管理原理在商業(yè)和政府的許多領(lǐng)域都得到了有效 應(yīng)用，如：金融、保險(xiǎn)、職業(yè)安全、公共衛(wèi)生、藥物 監(jiān)測(cè)及相應(yīng)的監(jiān)管部門(mén)。如今質(zhì)量風(fēng)險(xiǎn)管理在藥企中 雖有應(yīng)用，但范圍有限，并沒(méi)有發(fā)揮岀它的全部效 用。藥企已經(jīng)意識(shí)到了質(zhì)量體系的重要性，而質(zhì)量風(fēng) 險(xiǎn)管理越來(lái)越明顯地成為有效質(zhì)量體系的重要組分。

11、根據(jù)常規(guī)理解，風(fēng)險(xiǎn)被定義為傷害發(fā)生的可能性及嚴(yán) 重程度。然而，要在不同利益集團(tuán)之間尋求風(fēng)險(xiǎn)管理 應(yīng)用方面的共同認(rèn)識(shí)是相當(dāng)困難的，因?yàn)樗麄冋J(rèn)識(shí)到 的潛在危害、各危害發(fā)生的可能性及嚴(yán)重程度都不 同。藥品相關(guān)的利益集團(tuán)很多，如病人、醫(yī)療人員和 政府企業(yè)，但是質(zhì)量風(fēng)險(xiǎn)管理的首要目的是保護(hù)病 人。attribute differe nt severities to each harm .In relati on topharmaceuticals, although there are a variety ofstakeholders, in clud ing patie nts and medical

12、 practiti on ersas well as gover nment and in dustry, the protecti on of thepatient by managing the risk to quality should becon sidered of prime importa nee.The man ufacturi ng and use of a drug (medic in al) product, including its components, necessarily entail some degree of risk. The risk to its

13、 quality is just one component of the藥品生產(chǎn)、使用過(guò)程，包括藥品的成分，都會(huì)不可避免地引入一定的風(fēng)險(xiǎn)。質(zhì)量風(fēng)險(xiǎn)只是其中的一部分。|在產(chǎn)品整個(gè)生命周期中，確保產(chǎn)品的質(zhì)量，使得藥品_|overall risk. It is important to understand that product質(zhì)量方面的重要性質(zhì)與臨床研究中的一致，做到這些quality should be maintained throughout the product是非常重要的。一個(gè)有效的質(zhì)量風(fēng)險(xiǎn)管理方法能通過(guò)lifecycle such that the attributes tha

14、t are important to the|提供前攝措施，確疋控制研發(fā)和生產(chǎn)中潛在的質(zhì)量?jī)諀quality of the drug (medic in al) product rema in con siste nt|題，來(lái)進(jìn)一步確保藥品質(zhì)量。當(dāng)質(zhì)量問(wèn)題岀現(xiàn)時(shí)，應(yīng)|with those used in the cli ni cal studies. An effective quality用質(zhì)量風(fēng)險(xiǎn)管理還能改善決策過(guò)程。有效進(jìn)行質(zhì)量風(fēng)risk management approach can further ensure the high險(xiǎn)管理能促使產(chǎn)生更好更正式?jīng)Q策，增強(qiáng)監(jiān)控者對(duì)公quali

15、ty of the drug (medic in al) product to the patie nt by司處理潛在風(fēng)險(xiǎn)能力的信心，積極影響直接監(jiān)理的程providi ng a proactive means to ide ntify and con trol度和水平。potential quality issues during development andman ufacturi ng. Additi on ally, use of quality riskman ageme nt can improve the decisi on making if a quality's

16、 ability toproblem arises. Effective quality risk man ageme nt can facilitate better and more in formed decisi ons, can provide regulators with greater assura nee of a compa ny deal with potential risks and can beneficially affect the exte nt and level of direct regulatory oversight.The purpose of t

17、his docume nt is to offer a systematic此文件的目的是提供質(zhì)量風(fēng)險(xiǎn)管理方面的系統(tǒng)方approach to quality risk management. It serves as a foun dati on or resource docume nt that is in depe ndent of,I法。作為一個(gè)基礎(chǔ)性、資源性的文件，它獨(dú)立于卻又支持其它ICH質(zhì)量文件，補(bǔ)充藥企和監(jiān)管機(jī)構(gòu)內(nèi)已有的yet supports, other ICH Quality docume nts and compleme nts existi ng quality pr

18、actices, requireme nts, sta ndards, and guideli nes with in the pharmaceutical in dustry and regulatory en vir onmen t. It specifically provides guida nee on the pri nciples and some of the tools of quality risk management that can enable more effective and con siste nt risk based decisi ons, both b

19、y regulators and in dustry, regard ing the quality of drug substa nces and drug (medic in al) products across the product lifecycle. It is not inten ded to create any new expectati ons bey ond the curre nt regulatory requireme nts.質(zhì)量措施、要求、標(biāo)準(zhǔn)和指南。特別是它提供了一些 質(zhì)量風(fēng)險(xiǎn)管理工具的原理指南，這些工具能促使監(jiān)管 者和企業(yè)考慮整個(gè)產(chǎn)品周期中藥用物質(zhì)和藥品的

20、質(zhì) 量，做出更有效、更連續(xù)的基于風(fēng)險(xiǎn)的決策，并不想 在現(xiàn)有法規(guī)之外提岀新的期望。It is neither always appropriate nor always necessary to use a formal risk man ageme nt process (us ing recog ni zed tools and/ or internal procedures e.g., sta ndard operati ng procedures). The use of in formal risk man ageme nt processes (us ing empirical to

21、ols and/ or internal procedures) can also be con sidered acceptable.Appropriate use of quality risk management can facilitate but does not obviate in dustry' s obligati on to compregulatory requireme nts and does not replace appropriate commu ni cati ons betwee n in dustry and regulators.應(yīng)用正式的風(fēng)險(xiǎn)

22、管理程序并非總是合適的或必要的（用已承認(rèn)的工具或內(nèi)部程序，如標(biāo)準(zhǔn)操作規(guī)程）。有時(shí)也允許使用非正式的風(fēng)險(xiǎn)管理程序（用經(jīng)驗(yàn)工具或內(nèi)部程序）。恰當(dāng)運(yùn)用風(fēng)險(xiǎn)管理能方便但不消除企業(yè)遵守法規(guī) 要求的責(zé)任，也不能取代企業(yè)和監(jiān)管者之間必要的溝 通交流。y with2. SCOPE2.范圍This guideli ne provides prin ciples and examples of tools for quality risk man ageme nt that can be applied to differe nt aspects of pharmaceutical quality. These

23、aspects本指南給岀了質(zhì)量風(fēng)險(xiǎn)管理工具的原理和應(yīng)用實(shí)例，這些工具可用于藥品質(zhì)量各方面，即藥用物質(zhì)、藥品、生物和生物技術(shù)產(chǎn)品（包括藥品中用到的原料、溶劑、賦形include development, manufacturing, distribution, and the劑、包裝標(biāo)簽材料等） 生命周期中的研發(fā)、生產(chǎn)、銷售、in specti on and submissi on/review processes throughout the檢察、提交和復(fù)審各過(guò)程。lifecycle of drug substa nces, drug (medic in al) products,3.質(zhì)量風(fēng)險(xiǎn)

24、管理原理biological and biotech no logical products (in cludi ng the use of raw materials, solve nts, excipie nts, packag ing and labeli ng materials in drug (medic in al) products, biological and biotech no logical products).3. PRINCIPLES OF QUALITY RISK質(zhì)量風(fēng)險(xiǎn)管理的兩條基本原理是：1. 評(píng)估質(zhì)量風(fēng)險(xiǎn)應(yīng)基于科學(xué)知識(shí)并最終同對(duì)病人的保 護(hù)聯(lián)系起來(lái)。2.

25、投入的努力程度、管理的正式程度及文件管理水平 應(yīng)與風(fēng)險(xiǎn)水平相適應(yīng)。MANAGEMENTTwo primary principles of quality risk management are: ? The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patie nt; and4.質(zhì)量風(fēng)險(xiǎn)管理基本過(guò)程? The level of effort, formality and documentation o

26、f the quality risk man ageme nt process should be comme nsurate with the level of risk.4. GENERAL QUALITY RISK MANAGEMENT質(zhì)量風(fēng)險(xiǎn)管理是對(duì)藥品質(zhì)量風(fēng)險(xiǎn)進(jìn)行評(píng)估，控制，交 流和審查的系統(tǒng)過(guò)程，這一過(guò)程貫穿藥品整個(gè)生命周 期。圖1給岀了這方面的一個(gè)模型，其他模型也有應(yīng) 用。具體情況不同，框架中各組分受重視水平會(huì)各有 差別，可是一個(gè)有效的管理過(guò)程會(huì)將所有因素納入考 慮，各因素受關(guān)注程度會(huì)因風(fēng)險(xiǎn)的特異而各有區(qū)別PROCESSQuality risk man ageme nt is a

27、 systematic process for the assessme nt, con trol, commu ni cati on and review of risks to the quality of the drug (medic in al) product across the product lifecycle. A model for quality risk management is outl ined in the diagram (Figure 1). Other models could be used. The emphasis on each comp one

28、nt of the framework might differ from case to case but a robust process will in corporate con siderati on of all the eleme nts at a level of detail that is comme nsurate with the specific risk.Figure 1:典型質(zhì)量風(fēng)險(xiǎn)管理過(guò)程簡(jiǎn)介啟動(dòng)質(zhì)量風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)管理工具由于決策行為隨時(shí)都可能發(fā)生，上圖就沒(méi)有顯示決策 點(diǎn)。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(diào)整風(fēng)險(xiǎn)模型；也可能用于管理 過(guò)

29、程的終止。注解：圖中的“不可接受”項(xiàng)不僅指違 背了法令法規(guī)要求，也表示風(fēng)險(xiǎn)管理過(guò)程需要重頭再 來(lái)。Decisi on no des are not show n in the diagram above because decisions can occur at any point in the process. These decisi ons might be to retur n to the previous step and seek further information, to adjust the risk models or even to term in ate the

30、risk man ageme nt process based upon in formati onthat supports such a decisi on.Note:“ unacceptable in”he flowchart does not only refer to statutory, legislative or regulatory requirements, but also to the need to revisit the risk assessment process.4.1 Resp on sibilities4.1.職責(zé)分配Quality risk manage

31、ment activities are usually, but not質(zhì)量風(fēng)險(xiǎn)管理經(jīng)常是但也不總是由交叉學(xué)科團(tuán)隊(duì)執(zhí)always, undertaken by interdisciplinaryteams. When行。除了要有風(fēng)險(xiǎn)管理方面的經(jīng)驗(yàn)人士，團(tuán)隊(duì)還應(yīng)包teams are formed, they should include experts from the括相關(guān)領(lǐng)域的專家（例如：質(zhì)量小組、事業(yè)發(fā)展、工appropriate areas (e.g., quality un it, bus in ess developme nt.程、管理，生產(chǎn)、行銷、法律、統(tǒng)計(jì)和臨床方面等。engin

32、 eeri ng, regulatory affairs,producti on operati ons,決策者必須負(fù)責(zé)組織協(xié)調(diào)各部門(mén)之間的關(guān)系，保障團(tuán)sales and marketing, legal, statistics and clinical)in隊(duì)各項(xiàng)功能的有效發(fā)揮，確保整個(gè)管理過(guò)程得以合理addition to individuals who are knowledgeable about the展開(kāi)、不斷完善、反復(fù)審查，保障有足夠的資源供團(tuán)quality risk man ageme nt process.隊(duì)使用。Decisi on makers should? take r

33、esp on sibilityfor coord in at ingquality riskmanagement across various functions and departments oftheir orga ni zati on; and? assure that a quality risk management process is defined,deployed and reviewed and that adequate resources areavailable.4.2 In itiat ing a Quality Risk Man ageme nt Process

34、4.2質(zhì)量風(fēng)險(xiǎn)管理的啟動(dòng)Quality risk man ageme nt should in clude systematic質(zhì)量風(fēng)險(xiǎn)管理應(yīng)包括這樣一些系統(tǒng)程序，這些設(shè)計(jì)好processes desig ned to coord in ate, facilitate and improve的程序用來(lái)協(xié)調(diào)，推動(dòng)和改善那些風(fēng)險(xiǎn)方面基于科學(xué)science-based decision making with respect to risk.認(rèn)識(shí)的決定。一項(xiàng)管理程序的發(fā)起和設(shè)計(jì)可能要經(jīng)過(guò)Possible steps used to initiate and plan a quality risk如下

35、步驟：man ageme nt process might in clude the follow ing:?定義存在的難題和風(fēng)險(xiǎn)問(wèn)題，包括識(shí)別潛在風(fēng)險(xiǎn)的相? Define the problem and/or risk question, including關(guān)假設(shè)；pertinent assumptions identifying the potential for risk;?收集風(fēng)險(xiǎn)評(píng)估相關(guān)的關(guān)于潛在危險(xiǎn)、危害或人體健康? Assemble background information and/ or data on the影響的背景信息和數(shù)據(jù)；pote ntial hazard, ha

36、rm or huma n health impact releva nt to?確定領(lǐng)導(dǎo)人和重要資源；the risk assessme nt;?詳細(xì)說(shuō)明決策的時(shí)間表，可交付性和適當(dāng)?shù)臉?biāo)準(zhǔn)。? Ide ntify a leader and n ecessary resources;? Specify a timeline, deliverables and appropriate level of decisi on making for the risk man ageme nt process.4.3 Risk Assessme ntRisk assessment consists of

37、the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards (as defined below). Quality risk assessme nts begi n with a well-defi ned problem descripti on or risk question. When the risk in question is well defined, an appropriate risk management

38、tool (see examples in secti on 5) and the types of in formati on n eeded to address the risk question will be more readily identifiable. As an aid to clearly defining the risk(s) for risk assessment purposes, three fun dame ntal questi ons are ofte n helpful:1. What might go wrong?2. What is the lik

39、elihood (probability) it will go wrong?3. What are the con seque nces (severity)?Risk identificationis a systematic use of information toidentify hazards referring to the risk question or problem description. Informationcan include historical data,theoretical an alysis, in formed opinions, and the c

40、on cer ns of stakeholders. Risk identification addresses the “ What might go wrong? ” question, including identifyingthepossible con seque nces. This provides the basis for further steps in the quality risk man ageme nt process.Risk analysis is the estimation of the risk associated with the identifi

41、ed hazards. It is the qualitative or quantitative process of linking the likelihood of occurrenee and4.3風(fēng)險(xiǎn)評(píng)估風(fēng)險(xiǎn)評(píng)估：此過(guò)程進(jìn)行危險(xiǎn)確認(rèn)并對(duì)接觸這些危險(xiǎn)所 帶來(lái)的風(fēng)險(xiǎn)進(jìn)行分析評(píng)價(jià)。它以一個(gè)定義明確的難點(diǎn) 描敘或風(fēng)險(xiǎn)問(wèn)題開(kāi)始，當(dāng)風(fēng)險(xiǎn)明確后，選擇合適而有 針對(duì)性的管理工具和信息類型將會(huì)變得更容易。以下 三個(gè)基本問(wèn)題將有助于給岀風(fēng)險(xiǎn)的清晰定義。1. 什么可能會(huì)出錯(cuò)？2. 岀錯(cuò)的可能性有多大？3. 岀錯(cuò)的后果和嚴(yán)重性有哪些？風(fēng)險(xiǎn)鑒定： 參照風(fēng)險(xiǎn)問(wèn)題或難點(diǎn)描敘，系統(tǒng)利用已有 信息去鑒定危險(xiǎn)。這些信

42、息包括歷史數(shù)據(jù)、理論分 析、多方面觀點(diǎn)和風(fēng)險(xiǎn)承擔(dān)人的意見(jiàn)。風(fēng)險(xiǎn)鑒定時(shí)提 出“什么會(huì)出錯(cuò)”這一問(wèn)題，同時(shí)還確定可能答案。 這一過(guò)程為后續(xù)步驟奠定了基礎(chǔ)。風(fēng)險(xiǎn)分析： 估計(jì)與已確認(rèn)危險(xiǎn)相聯(lián)系的風(fēng)險(xiǎn)，這是對(duì)危害發(fā)生的可能性和嚴(yán)重程度進(jìn)行定性和定量分析的過(guò)程。風(fēng)險(xiǎn)評(píng)價(jià)中同樣也應(yīng)用到某些管理工具檢測(cè)危severity of harms. In some risk management tools, the ability to detect the harm (detectability) also factors in the estimation of risk.害的能力（檢測(cè)能力）。Risk eva

43、luation compares the identified and analyzed risk against given risk criteria. Risk evaluations consider the stre ngth of evide nee for all three of the fun dame ntal questi ons.In doing an effective risk assessme nt, the robust ness of the data set is important because it determines the quality of

44、the output. Reveali ng assumpti ons and reas on able sources of un certa inty will enhance con fide nee in this output and/or help identify its limitations. Uncertainty is due to comb in ati on of in complete kno wledge about a process and its expected or unexpected variability. Typical sources of u

45、n certa intyin cludegaps in kno wledge gaps inpharmaceutical scie nee and process un dersta nding, sources of harm (e.g., failure modes of a process, sources of variability), and probability of detecti on of problems.The output of a risk assessment is either a quantitative estimate of risk or a qual

46、itative description of a range of risk. When risk is expressed quantitatively, a numerical probability is used. Alter natively, risk can be expressed using qualitative descriptors, such as“ high ”"low "which should be defined in as much detail as possible. Sometimes a "risk score"

47、; is used to further defi ne descriptors in risk ranking. Inqua ntitativeriskassessments, a risk estimate provides the likelihood of a specific consequenee, given a set of risk-generating風(fēng)險(xiǎn)評(píng)估：將經(jīng)過(guò)分析和鑒定的風(fēng)險(xiǎn)同給定標(biāo)準(zhǔn)作比 較，考慮三個(gè)基本問(wèn)題的證據(jù)力。風(fēng)險(xiǎn)評(píng)估中，數(shù)據(jù) 的有效性決定了評(píng)估結(jié)果的質(zhì)量。揭示、設(shè)想、分析 不確定性的來(lái)源將有助于增強(qiáng)對(duì)結(jié)果的信心、識(shí)別結(jié) 果的局限性。對(duì)過(guò)程了解不充分、過(guò)程

48、中可預(yù)見(jiàn)及不 可預(yù)見(jiàn)變動(dòng)的發(fā)生，都將導(dǎo)致不確定性的發(fā)生。知識(shí) 結(jié)構(gòu)的不完整，有限的藥學(xué)發(fā)展水平、不充分的過(guò)程 理解、危險(xiǎn)來(lái)源（不成功的過(guò)程模式、變動(dòng)的來(lái)源）及 問(wèn)題被發(fā)現(xiàn)的可能性都是不確定性的典型來(lái)源。評(píng)估結(jié)果可以是對(duì)風(fēng)險(xiǎn)的定量表示，也可以是對(duì)分險(xiǎn)程度的定性描述。定量表示時(shí)可用數(shù)值表示可能性，用 高、中、低來(lái)給風(fēng)險(xiǎn)排序時(shí)，各個(gè)詞的適用范圍都 要詳細(xì)規(guī)定，有時(shí)候還用到風(fēng)險(xiǎn)評(píng)分來(lái)進(jìn)一步定義。 定量評(píng)估能對(duì)給定的風(fēng)險(xiǎn)衍生環(huán)境中特定結(jié)果發(fā)生的 可能性做岀判斷。因此，定量評(píng)估一次只能評(píng)判一個(gè) 特定結(jié)果。于是一些管理工具用到相對(duì)衡量尺度，將 多重水平的嚴(yán)重性和可能性結(jié)合起來(lái)，以完成對(duì)相對(duì) 風(fēng)險(xiǎn)的整體評(píng)估。

49、評(píng)分過(guò)程的中間步驟有時(shí)也用到定 量風(fēng)險(xiǎn)估計(jì)方法。“I-刀,medium , orcircumstances. Thus, quantitative risk estimation is useful for one particular con seque nee at a time. Alter natively, some risk management tools use a relative risk measure to combine multiple levels of severity and probability into an overall estimate of re

50、lative risk. The in termediate steps within a scori ng process can sometimes employ quantitative risk estimation.4.4 Risk Con trolRisk 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 f

51、or risk control should be proportional to the significance of the risk. Decision makers might use different processes, includingbenefit-cost analysis, for understanding theoptimal level of risk con trol.Risk con trol might focus on the follow ing questi ons:? Is the risk above an acceptable level? W

52、hat can be done to reduce or elim in ate risks? What is the appropriate bala nce among ben efits, risks and resources? Are new risks introduced as a result of the identified risks being con trolled?Risk reduction focuses on processes for mitigation or avoidance of quality risk when it exceeds a spec

53、ified (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 be4.4風(fēng)險(xiǎn)控制風(fēng)險(xiǎn)控制包括風(fēng)險(xiǎn)抑低和風(fēng)險(xiǎn)接受兩方面的決策過(guò)程，進(jìn)行控制的目的是將風(fēng)險(xiǎn)降低到可接受水平，投入努力量應(yīng)與風(fēng)險(xiǎn)的嚴(yán)重程度相襯。決策者應(yīng)用包括 效益-耗費(fèi)比分析在

54、內(nèi)的不同的程序去理解風(fēng)險(xiǎn)控制的 最佳水平。風(fēng)險(xiǎn)控制過(guò)程中以下問(wèn)題會(huì)受到關(guān)注： 風(fēng)險(xiǎn)水平是否高于可接受水平之上？ 怎樣做才能降低乃至消除風(fēng)險(xiǎn)？ 如何尋求效益、風(fēng)險(xiǎn)和資源之間的合適平衡？ 對(duì)已確定風(fēng)險(xiǎn)進(jìn)行控制時(shí)是否會(huì)引入新的風(fēng)險(xiǎn)？風(fēng)險(xiǎn)抑低：此過(guò)程著力于減輕或避免超過(guò)一定水平（可接受水平）的質(zhì)量風(fēng)險(xiǎn)，包括為減輕危害嚴(yán)重性和發(fā)生 可能性而采取的一系列措施，還包括一些致力于改善 危險(xiǎn)及質(zhì)量風(fēng)險(xiǎn)可檢測(cè)性的程序。風(fēng)險(xiǎn)抑低過(guò)程可能 會(huì)給系統(tǒng)帶入新的風(fēng)險(xiǎn)，其他業(yè)已存在的風(fēng)險(xiǎn)的嚴(yán)重 程度也可能增加。因此，完成風(fēng)險(xiǎn)抑低程序后，有必used as part of a risk control strategy. Th

55、e implementation of risk reduction measures can introduce new risks into the system or in crease the sig nifica nee of other exist ing risks. Hence, it might be appropriate to revisit the risk assessme nt to ide ntify and evaluate any possible cha nge in risk after implementing a risk reduction proc

56、ess.要再重復(fù)一下質(zhì)量評(píng)估過(guò)程，來(lái)識(shí)別和評(píng)價(jià)風(fēng)險(xiǎn)系統(tǒng) 的可能變化。Risk acceptanee is a decision to accept risk. Risk風(fēng)險(xiǎn)接受：就是接受風(fēng)險(xiǎn)的決定。它可能為接受殘留accepta nee can be a formal decisi on to accept the residual風(fēng)險(xiǎn)的正式?jīng)Q定，也可以是忽略剩余風(fēng)險(xiǎn)的消極決risk or it can be a passive decision in which residual risks定。有些類型的風(fēng)險(xiǎn)，即使用最好的質(zhì)量風(fēng)險(xiǎn)管理手are not specified. For some types of harms, eve n the best段，也不能完全清除。在這種情形下，應(yīng)確認(rèn)使用了quality risk management practices might not entirely合適的風(fēng)險(xiǎn)管理策略，且風(fēng)險(xiǎn)已被降至特定水平（可接elim in ate risk. In these circumsta nces, it might be agreed受水平）。這個(gè)可接受水平由很多參數(shù)和各例具體情況that an appropriate quality risk management strategy has來(lái)確定。been applied and that qu