q9質(zhì)量風(fēng)險(xiǎn)管理中英文對(duì)照-資料下載頁(yè)

　　

【正文】 ntrol 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. Risk control might focus on the following questions: ? Is the risk above an acceptable level? ? What can be done to reduce or eliminate risks? ? What is the appropriate balance among benefits, risks 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)？ Contains Nonbinding Remendations and resources? ? Are new risks introduced as a result of the identified risks being controlled? Risk reduction focuses on processes for mitigation or avoidance of quality risk when it exceeds a 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)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 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 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)管理手段，也不能完全清除。在這種情形下，應(yīng)確認(rèn)使用了合適的風(fēng)險(xiǎn)管理策略，且風(fēng)險(xiǎn)已被降至特定水平（可接受水平）。這個(gè)可接受水平由很多參數(shù)和各例具體情況來(lái)確定。 Contains Nonbinding Remendations many parameters and should be decided on a casebycase basis. Risk Communication 風(fēng)險(xiǎn)溝通 Risk munication is the sharing of information about risk and risk management between the decision makers and others. Parties can municate at any stage of the risk management process (see Fig. 1: dashed arrows). The output/result of the quality risk management process should be appropriately municated and documented (see Fig. 1: solid arrows). Communications might include those among interested parties。 ., 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(fēng)險(xiǎn)溝通：決策者和其他人就風(fēng)險(xiǎn)和風(fēng)險(xiǎn)管理方面的信息進(jìn)行溝通、交流，各利益集團(tuán)間的交流在風(fēng)險(xiǎn)管理的任意階段都可以進(jìn)行 （見(jiàn)圖 1 虛線部分）。質(zhì)量風(fēng)險(xiǎn)管理過(guò)程的產(chǎn)出和結(jié)果應(yīng)得到合理溝通并存檔。（見(jiàn)圖 1 實(shí)線部分）各利益團(tuán)體間（如監(jiān)管者同企業(yè)之間，企業(yè)和患者之間，公司、企業(yè)、監(jiān)管機(jī)構(gòu)內(nèi)部），就質(zhì)量風(fēng)險(xiǎn)的存在、性質(zhì)、形式、可能性、嚴(yán)重程度、可接受度、控制、處理、可檢測(cè)度及其他方面的信息進(jìn)行交流。不需要就每個(gè)風(fēng)險(xiǎn)承擔(dān)都進(jìn)行風(fēng)險(xiǎn)交流。企業(yè)和監(jiān)管機(jī)構(gòu)之間關(guān)于質(zhì)量風(fēng)險(xiǎn)管理方面的溝通交流可以通過(guò)規(guī)則、指導(dǎo)中給定的渠道來(lái)實(shí)現(xiàn)。 Risk Review 風(fēng)險(xiǎn) 回顧 Risk management should be an ongoing part of the quality management process. A mechanism to review or monitor events should be implemented. 風(fēng)險(xiǎn)管理伴隨著質(zhì)量管理過(guò)程的全程，應(yīng)當(dāng)引入審查和監(jiān)控機(jī)制。 在審查風(fēng)險(xiǎn)管理過(guò)程的結(jié)果時(shí)要將新的知識(shí)