【正文】 ashed 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（見圖1 虛線部分）。質(zhì)量風(fēng)險(xiǎn)管理過程的產(chǎn)出和結(jié)果應(yīng)得到合理溝通并存檔。（見圖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規(guī)則、指導(dǎo)中給定的渠道來實(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. The output/results of the risk management process should be reviewed to take into account new knowledge and experience. Once a quality risk management process has been initiated, that process should continue to be utilized for events that might impact the original quality risk management decision, whether these events are planned (., results of product review, inspections, audits, change control) or unplanned (., root cause from failure investigations, recall). The frequency of any review should be based upon the level of risk. Risk review might include reconsideration of risk acceptance decisions (section ). 風(fēng)險(xiǎn)管理伴隨著質(zhì)量管理過程的全程，應(yīng)當(dāng)引入審查和監(jiān)控機(jī)制。在審查風(fēng)險(xiǎn)管理過程的結(jié)果時(shí)要將新的知識和經(jīng)驗(yàn)納入考慮范圍。一旦一個(gè)質(zhì)量風(fēng)險(xiǎn)管理過程開始啟動，它便用于管理那些可能會影響最初質(zhì)量風(fēng)險(xiǎn)管理決策的事件，不管這些事件是計(jì)劃中的（產(chǎn)品回顧結(jié)果，自檢、審計(jì)和變更控制管理）還是計(jì)劃外的（如失敗調(diào)查的根由，召回）。任何回顧的進(jìn)行頻率都應(yīng)基于風(fēng)險(xiǎn)水平，風(fēng)險(xiǎn)回顧還可能包括對風(fēng)險(xiǎn)接受決定的再審議。5. RISK MANAGEMENT METHODOLOGY 5. 質(zhì)量管理方法學(xué)Quality risk management supports a scientific and practical approach to decisionmaking. It provides documented, transparent and reproducible methods to acplish steps of the quality risk management process based on current knowledge about assessing the probability, severity and sometimes detectability of the risk. Traditionally, risks to quality have been assessed and managed in a variety of informal ways (empirical and/ or internal procedures) based on, for example, pilation of observations, trends and other information. Such approaches continue to provide useful information that might support topics such as handling of plaints, quality defects, deviations and allocation of resources. Additionally, the pharmaceutical industry and regulators can assess and manage risk using recognized risk management tools and/ or internal procedures (., standard operating procedures). Below is a nonexhaustive list of some of these tools (further details in Annex 1 and chapter 8): ?Basic risk management facilitation methods (flowcharts, check sheets etc.)。 ? Failure Mode Effects Analysis (FMEA)。 ? Failure Mode, Effects and Criticality Analysis (FMECA)。 ? Fault Tree Analysis (FTA)。 ? Hazard Analysis and Critical Control Points (HACCP)。 ? Hazard Operability Analysis (HAZOP)。 ? Preliminary Hazard Analysis (PHA)。 ? Risk ranking and filtering。 ? Supporting statistical tools. It might be appropriate to adapt these tools for use in specific areas pertaining to drug substance and drug (medicinal) product quality. Quality risk management methods and the supporting statistical tools can be used in bination (., Probabilistic Risk Assessment). Combined use provides flexibility that can facilitate the application of quality risk management principles. The degree of rigor and formality of quality risk management should reflect available knowledge and be mensurate with the plexity and/ or criticality of the issue to be addressed. 質(zhì)量風(fēng)險(xiǎn)管理中的決策過程用到了一種科學(xué)而實(shí)用的方法，它根據(jù)現(xiàn)有的關(guān)于估計(jì)風(fēng)險(xiǎn)可能性、嚴(yán)重程度和可檢測性方面的知識，提供一些已形成文件的、透明的和可再生的方法，來完成質(zhì)量風(fēng)險(xiǎn)管理各步驟。質(zhì)量風(fēng)險(xiǎn)傳統(tǒng)上是用一系列非正規(guī)方法來進(jìn)行評估和控制的，這些方法基于觀測報(bào)告，風(fēng)險(xiǎn)趨勢以及一些其它信息，在處理投訴，質(zhì)量缺陷，偏差和資源配置方面仍能提供有用的資料。同樣，藥品廠家和管理者也可用已承認(rèn)的工具和內(nèi)部程序來進(jìn)行評估和控制，以下就是這樣一些工具（Annex 1 and section VIII中更有詳敘）：基本風(fēng)險(xiǎn)管理簡易方法（流程圖，對賬單等）失敗模式影響分析失敗模式，影響，和重要性分析(FMECA)錯(cuò)誤樹形分析 (FTA)危害分析和關(guān)鍵監(jiān)控點(diǎn)(HACCP)危害可操作性分析(HAZOP)危害預(yù)分析(PHA)風(fēng)險(xiǎn)排序及濾除 輔助統(tǒng)計(jì)工具將以上方法加以適當(dāng)改進(jìn)，就可用于藥物、藥品質(zhì)量相關(guān)的