XXXX01風(fēng)險(xiǎn)分析及方法簡(jiǎn)述

1、.：.；風(fēng)險(xiǎn)分析及方法簡(jiǎn)述中英文1 Basic Risk Management Facilitation Methods 根本的風(fēng)險(xiǎn)管理的便利方法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(jiǎn)單的通常運(yùn)用的方法，進(jìn)展風(fēng)險(xiǎn)管理和制定決策： Flowcharts/流程圖 Check Sheets/檢查清單 Process Mapping/過(guò)程圖 Cause

2、and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram)/因果圖或者叫魚(yú)骨圖2 Failure Mode Effects Analysis (FMEA) 失效方式與效果分析2.1 Describe/描畫(huà)FMEA (see IEC 60812) provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance.

3、Once failure modes are established, risk 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 summarizi

4、ng the important modes of failure, factors causing these failures and the likely effects of these failures. FMEA提供了工藝潛在失效方式的評(píng)價(jià)和對(duì)產(chǎn)品性能或結(jié)果的潛在影響。一旦將建立了失效方式，風(fēng)險(xiǎn)的降低可被用來(lái)消除、囊括、降低或控制潛在的失效活動(dòng)。FMEA依賴于對(duì)產(chǎn)品和工藝的了解。FMEA將復(fù)雜的工藝系統(tǒng)地分解為簡(jiǎn)單的步驟。FMEA對(duì)重要的失效方式、引起失效的要素以及失效能夠帶來(lái)的后果進(jìn)展匯總的有力工具。2.2 Potential Areas of Use(s) 運(yùn)用的潛在區(qū)域FME

5、A can be used to prioritize risks and monitor the effectiveness of risk control activities. FMEA可用來(lái)安排風(fēng)險(xiǎn)的優(yōu)先順序，監(jiān)控風(fēng)險(xiǎn)控制活動(dòng)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 wit

6、hin the system that render it vulnerable. 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)備，也可用于分析某一消費(fèi)操作及其對(duì)產(chǎn)品或工藝的影響。它可識(shí)別系統(tǒng)內(nèi)的元素/操作的弱點(diǎn)。FMEA的結(jié)果可被作為設(shè)計(jì)或深化分析或指點(diǎn)資源配置的根據(jù)。3 Failure Mode, Effects and Criticality Analysis (FMECA) 失效方

7、式、效果與關(guān)鍵程度的分析3.1 Describe/描畫(huà)FMEA might 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

8、 such an analysis to be performed, the product or process specifications should be established. FMECA can identify places where additional preventive actions might be appropriate to minimize risks. FMEA可以延伸到結(jié)果嚴(yán)重程度的調(diào)查、發(fā)生的概率和可檢測(cè)性，開(kāi)展為FMECA。為執(zhí)行這樣的分析，應(yīng)建立產(chǎn)品或工藝的質(zhì)量規(guī)范。FMECA可以鑒定何時(shí)采用預(yù)防措施可以將風(fēng)險(xiǎn)家最小化。3.2 Potential

9、 Areas of Use(s) 運(yùn)用的潛在區(qū)域FMECA application 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

10、rank the modes on a relative risk basis.制藥企業(yè)的FMECA應(yīng)最大的利用與消費(fèi)工藝相聯(lián)絡(luò)的失效和風(fēng)險(xiǎn)，但是不局限于這一運(yùn)用。FMECA的結(jié)果是每一風(fēng)險(xiǎn)方式的相對(duì)的風(fēng)險(xiǎn)“中心，用來(lái)分級(jí)相對(duì)風(fēng)險(xiǎn)根據(jù)。4 Fault Tree Analysis (FTA) 失誤樹(shù)分析4.1 Describe/描畫(huà)The FTA tool (see IEC 61025) is an approach that assumes failure of the functionality of a product or process. This tool evaluates sys

11、tem (or sub-system) failures one at 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.

12、). FTA relies on the experts process understanding to identify causal factors. 失誤樹(shù)分析是假定產(chǎn)品或工藝性能的失效的方法。這些工具評(píng)價(jià)系統(tǒng)失效，但是可以結(jié)合失效的多種緣由。在樹(shù)的每一個(gè)程度內(nèi)，應(yīng)描畫(huà)失效方式的結(jié)合。FTA依賴于專家的工藝了解去鑒別原因。4.2 Potential Areas of Use(s) 潛在區(qū)域的運(yùn)用FTA can be used to establish the pathway to the root cause of the failure. FTA can be used to inv

13、estigate complaints or deviations in 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 multi

14、ple factors affect a given issue. The output of an FTA includes a visual representation of failure modes. It is useful both for risk assessment and in developing monitoring programs. FTA可用于建立失效原因的途徑。FTA可用于調(diào)查贊揚(yáng)或偏向，以便全面了解它們的原因，確保預(yù)定的改良能全面處理爭(zhēng)議，并且不會(huì)導(dǎo)致其他的爭(zhēng)議例如：處理完一個(gè)問(wèn)題但是引起了其他的問(wèn)題。失誤樹(shù)分析是評(píng)價(jià)多種要素怎樣影響爭(zhēng)議的有效的工具。失誤樹(shù)

15、分析的結(jié)果包括失效方式的可見(jiàn)的代表。這對(duì)風(fēng)險(xiǎn)評(píng)價(jià)和開(kāi)展監(jiān)控系統(tǒng)是有用的。5 Hazard Analysis and Critical Control Points (HACCP) 危害分析和關(guān)鍵控制點(diǎn)5.1 Describe/描畫(huà)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 ap

16、proach that applies technical and 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)質(zhì)量量、可靠性和平安見(jiàn)WHO技術(shù)報(bào)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(yùn)用技術(shù)和科學(xué)的原那么去分析、評(píng)價(jià)、預(yù)防和控制由藥品的設(shè)計(jì)、研發(fā)、消

17、費(fèi)、風(fēng)險(xiǎn)和運(yùn)用引起的風(fēng)險(xiǎn)或危害的后果。HACCP consists of the following seven steps: HACCP包括以下七個(gè)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(guò)程每一步驟的預(yù)防性措施(2) determine the critical control points; 決議關(guān)鍵控制點(diǎn)(3) establish critical limits; 設(shè)立關(guān)鍵限制(4) establish a syste

18、m to monitor the critical control points; 設(shè)定監(jiān)測(cè)關(guān)鍵控制點(diǎn)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)鍵控制不受控時(shí)的采取的整改措施(6) establish system to verify that the HACCP system is working effectively; 設(shè)立證明HACCP有效任

19、務(wù)的系統(tǒng)(7) establish a record-keeping system. 設(shè)定記錄堅(jiān)持的系統(tǒng)5.2 Potential Areas of Use(s) 運(yùn)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

20、is sufficiently comprehensive to 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(lái)證明和控制與物理、化學(xué)和生物危害包括微生物的污染

21、有關(guān)的風(fēng)險(xiǎn)。當(dāng)有全面的產(chǎn)品和工藝了解支持關(guān)鍵控制點(diǎn)的識(shí)別時(shí)，HACCP是最有用的工具。HACCP分析的結(jié)果是風(fēng)險(xiǎn)管理的信息，它便于消費(fèi)工藝和其他生命周期階段的關(guān)鍵控制點(diǎn)。6 Hazard Operability Analysis (HAZOP) 危害與可操作性/運(yùn)轉(zhuǎn)分析6.1 Describe/描畫(huà)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 sys

22、tematic brainstorming technique 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 us

23、es a team of people with expertise covering the design of the process or product and its application. HAZOP基于這樣的實(shí)際假定設(shè)計(jì)和操作的偏向引來(lái)了風(fēng)險(xiǎn)事件。這是系統(tǒng)的鑒定危害的頭腦風(fēng)暴技巧，就是所謂的“指點(diǎn)詞。 “指點(diǎn)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，協(xié)助 鑒定正常運(yùn)用或設(shè)計(jì)用途的潛在偏向。通常是利用涵蓋工藝或產(chǎn)品的設(shè)計(jì)和其利用的專家人員。PHA-Pro軟件引見(jiàn)與下載PHA-Prowiki軟件/wiki是目前世界上銷(xiāo)量第一的分析軟件，集合了HAZOP,HACCP

24、,LOPA,FMEA,FTA,ETA,WHATIF等等各種分析引導(dǎo)。經(jīng)過(guò)導(dǎo)航引導(dǎo)分析。發(fā)的這個(gè)PDF文件希望對(duì)大家有所協(xié)助 。里面有簡(jiǎn)單的操作闡明。風(fēng)險(xiǎn)管理在藥品消費(fèi)中的運(yùn)用摘要 簡(jiǎn)要引見(jiàn)了國(guó)內(nèi)藥品消費(fèi)企業(yè)運(yùn)用風(fēng)險(xiǎn)管理現(xiàn)狀,描畫(huà)了對(duì)風(fēng)險(xiǎn)管理的了解,概述了風(fēng)險(xiǎn)管理的幾個(gè)運(yùn)用工具,重點(diǎn)論述了風(fēng)險(xiǎn)分析常用的失敗方式與影響分析(FMEA)方法。 關(guān)鍵詞 風(fēng)險(xiǎn)管理;失敗方式與影響分析;風(fēng)險(xiǎn)優(yōu)先數(shù) 中圖分類號(hào)R951 文獻(xiàn)標(biāo)識(shí)碼B 文章編號(hào)1673-7210(2021)12(b)-089-02 21世紀(jì)以來(lái),美國(guó)食品藥品監(jiān)視管理局等藥政管理部門(mén)相繼提出了以風(fēng)險(xiǎn)管理為根底的藥質(zhì)量量管理概念。ICH Q9(風(fēng)

25、險(xiǎn)管理)的發(fā)布正式確定了風(fēng)險(xiǎn)管理的概念,為企業(yè)進(jìn)展風(fēng)險(xiǎn)管理提供了根據(jù)及指點(diǎn)。在原料藥、制劑、生物制品和生物技術(shù)產(chǎn)品的整個(gè)產(chǎn)品生命周期內(nèi),質(zhì)量風(fēng)險(xiǎn)管理可以運(yùn)用于藥物質(zhì)量的一切方面,包括研發(fā)、消費(fèi)、發(fā)放和檢查及遞交評(píng)審過(guò)程。作為國(guó)內(nèi)藥品消費(fèi)企業(yè),要順應(yīng)法規(guī)的新變化,對(duì)消費(fèi)過(guò)程中的藥質(zhì)量量風(fēng)險(xiǎn)進(jìn)展管理。文中經(jīng)過(guò)對(duì)風(fēng)險(xiǎn)概念的了解、風(fēng)險(xiǎn)管理的常用工具以及如何運(yùn)用等幾個(gè)方面的問(wèn)題進(jìn)展討論,以期為藥品消費(fèi)企業(yè)的消費(fèi)過(guò)程質(zhì)量風(fēng)險(xiǎn)管理提供參考。1 國(guó)內(nèi)藥品消費(fèi)企業(yè)運(yùn)用風(fēng)險(xiǎn)管理現(xiàn)狀隨著中國(guó)企業(yè)國(guó)際化和中國(guó)市場(chǎng)全球化程度的不斷提高,風(fēng)險(xiǎn)管理正日益成為中國(guó)企業(yè)所面臨的重要課題,特別是2006年國(guó)資委發(fā)布等相關(guān)文件以來(lái)

26、,中國(guó)企業(yè)曾經(jīng)全面步入了“風(fēng)險(xiǎn)管理年。然而,前不久由甫瀚公司委托獨(dú)立第三方進(jìn)展的一項(xiàng)名為“中國(guó)大陸風(fēng)險(xiǎn)氣壓計(jì)的調(diào)查結(jié)果卻顯示,國(guó)內(nèi)企業(yè)風(fēng)險(xiǎn)管理現(xiàn)狀不容樂(lè)觀,無(wú)論是在風(fēng)險(xiǎn)接受才干還是風(fēng)險(xiǎn)管理才干上都處于較低程度。 在這項(xiàng)調(diào)查中,只需9%的內(nèi)地上市公司高管表示,其公司在識(shí)別和管理一切潛在艱苦風(fēng)險(xiǎn)方面進(jìn)展得“非常有效。這一比例遠(yuǎn)遠(yuǎn)低于美國(guó)(53%)、英國(guó)(37%)以及中國(guó)香港(22%)等大多數(shù)國(guó)家和地域的程度,這清楚地闡明中國(guó)內(nèi)地企業(yè)在風(fēng)險(xiǎn)管理方面與世界的差距。報(bào)告得出的結(jié)論顯示,內(nèi)地大型上市公司雖然在資產(chǎn)規(guī)模、盈利才干、市場(chǎng)占有率方面生長(zhǎng)迅速,但在風(fēng)險(xiǎn)管理才干上表現(xiàn)欠佳,高程度、系統(tǒng)性風(fēng)險(xiǎn)管理架構(gòu)

27、的普遍缺失曾經(jīng)成為制約中國(guó)企業(yè)勝利走向國(guó)際市場(chǎng)的一大要素。對(duì)于正加快國(guó)際化步伐的中國(guó)企業(yè)而言,提高風(fēng)險(xiǎn)管理程度已成為加強(qiáng)國(guó)際競(jìng)爭(zhēng)力的當(dāng)務(wù)之急。 2 風(fēng)險(xiǎn)管理的正確了解 通常,風(fēng)險(xiǎn)被了解定義為危害出現(xiàn)的能夠性和危害嚴(yán)重性的結(jié)合。風(fēng)險(xiǎn)分析即是用以評(píng)價(jià)和區(qū)分設(shè)備或工藝功能關(guān)鍵參數(shù)的方法。 風(fēng)險(xiǎn)管理的程序?yàn)?風(fēng)險(xiǎn)評(píng)價(jià),風(fēng)險(xiǎn)控制,風(fēng)險(xiǎn)交流。詳細(xì)見(jiàn)表1。 風(fēng)險(xiǎn)評(píng)價(jià)所得結(jié)果是對(duì)風(fēng)險(xiǎn)的定量估計(jì),如從0到1(0到 100%),或是對(duì)風(fēng)險(xiǎn)范圍的定性描畫(huà),比如“高,“中或“低。 風(fēng)險(xiǎn)控制的目的在于將風(fēng)險(xiǎn)降低到一個(gè)可接受程度。 風(fēng)險(xiǎn)交流是在決策者及其他有關(guān)方進(jìn)展風(fēng)險(xiǎn)及其管理方面信息的交換和共享。 3 風(fēng)險(xiǎn)管理的工具

28、風(fēng)險(xiǎn)管理的工具共有以下幾種:失敗方式與影響分析(FMEA );失敗方式、影響和關(guān)鍵點(diǎn)分析( FMECA );失敗(缺點(diǎn))樹(shù)狀分析法( FTA );危害源分析與關(guān)鍵控制點(diǎn)(HACCP);危險(xiǎn)可操作性分析(HAZOP) ;初步危害源分析(PHA) ;風(fēng)險(xiǎn)評(píng)級(jí)和過(guò)濾;支持性統(tǒng)計(jì)學(xué)分析工具。 其中,FMEA是由美國(guó)航天局在阿波羅工程中被開(kāi)發(fā)的,是一種用來(lái)確定潛在失效方式及其緣由的分析方法。詳細(xì)來(lái)說(shuō),經(jīng)過(guò)實(shí)行FMEA,可在產(chǎn)品設(shè)計(jì)或消費(fèi)工藝真正實(shí)現(xiàn)之前發(fā)現(xiàn)產(chǎn)品的弱點(diǎn)。FMEA是一種提供了定量評(píng)價(jià)缺點(diǎn)及其潛在隱患的預(yù)防性方法,以為是最普通適用方式的風(fēng)險(xiǎn)分析,詳細(xì)如下:發(fā)生幾率(probability of

29、 occurrence,O);失敗的嚴(yán)重程度(severity of the failure,S);檢測(cè)概率(probability of detection,D)。 對(duì)于定量進(jìn)展的風(fēng)險(xiǎn)評(píng)價(jià),三個(gè)要素的“發(fā)生能夠性(O)、“缺陷的嚴(yán)重性(S) 和“檢測(cè)概率(D)通常賦值為110。這些數(shù)值相乘,其結(jié)果是風(fēng)險(xiǎn)優(yōu)先數(shù)(RPN)。RPN=OSD。 該風(fēng)險(xiǎn)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(xiǎn)措施的前提下需求決議RPN值,這就要提出風(fēng)險(xiǎn)分析。當(dāng)再次進(jìn)展評(píng)價(jià)時(shí),這些措施應(yīng)該產(chǎn)生效果,RPN要低于限制值(執(zhí)行措施后)。它也可以在詳細(xì)的運(yùn)

30、用領(lǐng)域進(jìn)展 (如計(jì)算機(jī)系統(tǒng)的風(fēng)險(xiǎn)分析)。因此對(duì)于風(fēng)險(xiǎn)分析,FMEA是一個(gè)非常靈敏的方法。 發(fā)生幾率(O):事件發(fā)生的頻率,要記錄特定的失效緣由和機(jī)制,多長(zhǎng)時(shí)間發(fā)生一次以及發(fā)生的幾率。失敗發(fā)生越頻繁,風(fēng)險(xiǎn)越高,假設(shè)為10,那么表示幾乎一定要發(fā)生,會(huì)時(shí)常發(fā)生,發(fā)生概率為1代表幾乎不會(huì)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 further

31、 reading you must HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_coverDate=12%2F05%2F2021&_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=d045a79313

32、4cf0d394ce12d30d4065e2 purchase this article.J.F. van Leeuwen HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc02

33、0df7a86d2819c4c5f8877a505f l aff1#aff1 a, HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc020df7a86d2819c4c5f887

34、7a505f l aff3#aff3 c, M.J. Nauta HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc020df7a86d2819c4c5f8877a505f l

35、aff2#aff2 b, HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc020df7a86d2819c4c5f8877a505f l aff4#aff4 d, D. de K

36、aste HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc020df7a86d2819c4c5f8877a505f l aff1#aff1 a, Y.M.C.F. Odeker

37、ken-Rombouts HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc020df7a86d2819c4c5f8877a505f l aff1#aff1 a, M.T. Ol

38、denhof HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc020df7a86d2819c4c5f8877a505f l aff1#aff1 a, M.J. Vredenbr

39、egt HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc020df7a86d2819c4c5f8877a505f l aff1#aff1 a, , and D.M. Baren

40、ds HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1174781113&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=41cc020df7a86d2819c4c5f8877a505f l aff1#aff1 aaNational Institute

41、 for Public Health and the Environment, RIVM, Centre for Quality of Chemical-Pharmaceutical Products, Bilthoven, The NetherlandsbNational Institute for Public Health and the Environment, RIVM, Laboratory for Zoonoses and Environmental Microbiology, Bilthoven, The NetherlandscCurrent affiliation: Med

42、icines Evaluation Board, CBG, The Hague, The NetherlandsdCurrent affiliation: National Food Institute, Danish Technical University (DTU), Sborg, DenmarkReceived 6 April 2021; accepted 28 June 2021. Available online 7 July 2021. AbstractWe subjected a Near-Infrared (NIR) analytical procedure used for

43、 screening drugs on authenticity to a Failure Mode and Effects Analysis (FMEA), including technical risks as well as risks related to human failure. An FMEA team broke down the NIR analytical method into process steps and identified possible failure modes for each step. Each failure mode was ranked

44、on estimated frequency of occurrence (O), probability that the failure would remain undetected later in the process (D) and severity (S), each on a scale of 110. Human errors turned out to be the most common cause of failure modes. Failure risks were calculated by Risk Priority Numbers (RPNs)=ODS. F

45、ailure modes with the highest RPN scores were subjected to corrective actions and the FMEA was repeated, showing reductions in RPN scores and resulting in improvement indices up to 5.0. We recommend risk analysis as an addition to the usual analytical validation, as the FMEA enabled us to detect pre

46、viously unidentified risks.Keywords: Near-Infrared spectroscopy; Analytical validation; FMEA; Risk analysis; Human factorArticle Outline1. HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_coverDate=12%2F05%2F2021&_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=d045a793134cf0d394ce12d30d4065e2 l secx1 Introduction 2. HYPERLINK sciencedirect/science?_ob=ArticleURL&_udi=B6TGX-4WPJ61J-4&_user=10&_cov