CGMP文件 風(fēng)險(xiǎn)分析格式SOP

1、文件題目Document Title風(fēng)險(xiǎn)分析的格式SOPSOP - Format of risk analysis文件編號(hào)Document Code文件版本號(hào)Version Code00 文件種類(lèi)Category of Document管理標(biāo)準(zhǔn)Management standard發(fā)放部門(mén)Department of IssueQA人員 Person 類(lèi)別 Category姓名/職位Name /Position簽名Signature日期Date編寫(xiě)人Compiled by審核人Checked by批準(zhǔn)人Approved by文件分發(fā)部門(mén)/編號(hào)：（ ）Department of document

2、distributed/Code:序號(hào)Serial No.部門(mén)名稱Department Name份數(shù)Copies負(fù)責(zé)人Manager1”2”3”4”5”6”7”8”文件變更歷史：History of document changing:版本號(hào)Version Code變更日期Changing Date變更內(nèi)容摘要Abstract of Changing Contents002011建立文件 File foundation1 目的 Aim規(guī)范風(fēng)險(xiǎn)分析的格式, 和公司內(nèi)部根據(jù)FMEA（失敗模式影響分析）方法實(shí)施風(fēng)險(xiǎn)分析的方法，最終降低產(chǎn)品的質(zhì)量風(fēng)險(xiǎn)。To standardize the format

3、 of risk analysis and methods to carry out risk analysis according to FMEA (Failed Mode Effects Analysis) in internal enterprise, finally to reduce the quality risk of product.2 范圍 Scope在進(jìn)行工藝驗(yàn)證，設(shè)備確認(rèn)時(shí)（包括生產(chǎn)工藝驗(yàn)證、滅菌工藝驗(yàn)證、水制備工藝驗(yàn)證等）時(shí)，應(yīng)根據(jù)FMEA方法對(duì)驗(yàn)證的過(guò)程進(jìn)行風(fēng)險(xiǎn)分析；在進(jìn)行重大變更時(shí)或引入新的程序時(shí)，應(yīng)根據(jù)需要進(jìn)行風(fēng)險(xiǎn)分析。During process validat

4、ion and equipment qualification (including production process validation, sterilisation process validation and water preparation validation , etc.),its necessary to do risk analysis to validation process on the basis of FMEA；When carrying through important change or inducting new process, use risk a

5、nalysis when needed.3 職責(zé) Responsibility3.1 QA部負(fù)責(zé)建立和更新本SOPQA Department takes responsibility on establishing and updating this SOP.3.2 各部門(mén)負(fù)責(zé)相應(yīng)范圍內(nèi)的風(fēng)險(xiǎn)分析。Every department take charge of risk analysis in corresponding areas.3.3 確認(rèn)/驗(yàn)證委員會(huì)負(fù)責(zé)監(jiān)督驗(yàn)證/確認(rèn)時(shí)本程序的有效實(shí)施。詳細(xì)內(nèi)容請(qǐng)見(jiàn)“確認(rèn)/驗(yàn)證委員會(huì)工作描述”（編碼： ）。Qualification and valid

6、ation committee sees to implement this process efficiently when supervising validation and qualification .Detailed content can be referred in “Position-related job description - Qualification / Validation committee” (Code: ).4 內(nèi)容 Content本SOP的內(nèi)容以FMEA記錄表的形式來(lái)實(shí)施。Contents of this SOP are implemented in t

7、he form of FMEA record tables.本SOP的內(nèi)容需通過(guò)確認(rèn)/驗(yàn)證委員會(huì)或變更控制委員會(huì)通過(guò)會(huì)議討論來(lái)進(jìn)行實(shí)施.在討論會(huì)上，必須至少有一位生產(chǎn)技術(shù)部成員，一位質(zhì)量保證部成員和一位設(shè)備部成員參加。This SOP should be implemented after the discussion in the meetings of qualification and validation committee or changing control committee, and there should be a member of production technol

8、ogy department, a member of quality assurance department and a member of equipment department present at least.4.1 錯(cuò)誤/關(guān)鍵參數(shù)的收集 Collection of wrong and key parameters 需要對(duì)所有過(guò)程或系統(tǒng)的所有操作/功能參數(shù)進(jìn)行測(cè)定，并將各操作項(xiàng)目/功能清楚的列在FMEA記錄單中。確認(rèn)/驗(yàn)證委員會(huì)或變更控制委員會(huì)的所有在場(chǎng)成員都必須參與此項(xiàng)工作。錯(cuò)誤/關(guān)鍵參數(shù)收集的基礎(chǔ)是：可以導(dǎo)致失敗的關(guān)鍵參數(shù)或關(guān)鍵步驟的確認(rèn)。對(duì)于每個(gè)確認(rèn)的參數(shù)/過(guò)程（在FMEA記

9、錄單上的參數(shù)處給出），應(yīng)詳細(xì)評(píng)估其可能帶來(lái)的潛在的失敗的影響（在FMEA記錄單上的潛在風(fēng)險(xiǎn)處給出）。Its necessary to mensurate all operation and function parameters in all process or system, and list every operation item and function on FMEA record tables .All present members of qualification and validation committee or change control committee mus

10、t take part in this task. The basis of collecting wrong and key parameters is that its qualification of key parameters or key process which may lead to failure. Every confirmed parameter or process (placed at Parameter on the record tables) should be given detailed evaluation on influence brought by

11、 possible and potential failure (given at Potential Risk on FMEA record tables).4.2 潛在失敗影響的確定 Confirmation of influence caused by potential failure可能通過(guò)確定合理的失敗原因來(lái)改善對(duì)失敗所造成的影響的描述和評(píng)估。在確定潛在失敗所造成的影響和失敗原因時(shí)，要特別考慮對(duì)產(chǎn)品質(zhì)量造成的影響。It is posible to improve the describtion and evaluation to the effect caused by failu

12、re through confirming reasonable failure reason. When making sure the fluence of potential failure and failure causes, please pay particular attention to fluence on product quality.4.3 潛在失敗/關(guān)鍵參數(shù)的評(píng)估 Evaluation on potential failure and key parameters根據(jù)FMEA方法，在風(fēng)險(xiǎn)評(píng)估過(guò)程中，要對(duì)下面三個(gè)因素進(jìn)行評(píng)估：- 風(fēng)險(xiǎn)的發(fā)生頻率可通過(guò)“失敗的頻率”要素

13、（F）來(lái)確定。-“失敗的嚴(yán)重性”必須由確認(rèn)/驗(yàn)證委員會(huì)或變更控制委員會(huì)來(lái)評(píng)估，它也是風(fēng)險(xiǎn)評(píng)估的一個(gè)要素。- 還要通過(guò)評(píng)估“察覺(jué)失敗的可能性”這一要素對(duì)風(fēng)險(xiǎn)進(jìn)行評(píng)估。According to FMEA, in the process of risk evaluation, three factors below should be evaluated:-Risk occurrence can be confirmed by failure frequency element (represented by F)-Failure graveness should be evaluated by q

14、ualification and validation committee or change control committee, and its also one element of risk evaluation. -Risk should be evaluated from the element -possibility of aware failure.以各要素的值為1-5來(lái)表示。F值為1，表示發(fā)生失敗的頻率最小，F(xiàn)值為5，表示發(fā)生失敗的頻率最大。同理，G=1，表示嚴(yán)重性最小，G=5，表示嚴(yán)重性最大。依此類(lèi)推。在必要的情況下，委員會(huì)可對(duì)所有的風(fēng)險(xiǎn)因素分別確定其評(píng)估數(shù)值。為了避免委

15、員會(huì)成員的意見(jiàn)不統(tǒng)一，建議還是事先確定評(píng)估等級(jí)標(biāo)準(zhǔn)，以便于風(fēng)險(xiǎn)的評(píng)估。范例格式如下表所述：Value of each element is from1 to 5.If F value is 1, it means that failure occurrence is smallest;if its 5,it presents the highest possibility to fail.In the same way,G=1 says that the least graveness ,while G=5 stands for the most importance.The rest can

16、 be deduced from this.The committee may ascertain all risk elements value separately.With the purpose of avoiding disunit ideas,its suggested that to fix evaluating grade standards to facilitate risk evaluation.Format example shows as the table below:風(fēng)險(xiǎn)分析參數(shù)：失敗的頻率 （F）Risk analysis parameter: failure

17、frequency (F)評(píng)估 evaluation標(biāo)準(zhǔn)standard1非常低Extremely low2低Low3中等Medium4高High5非常高Extremely high風(fēng)險(xiǎn)分析參數(shù)：失敗的嚴(yán)重性 （G）Risk analysis parameter: failure graveness (G)評(píng)估evaluation標(biāo)準(zhǔn)standard1非常低：失敗不影響產(chǎn)品的質(zhì)量Extremely low: Failure has no influence to product quality.2低：失敗不影響產(chǎn)品的質(zhì)量或以間接的方式對(duì)產(chǎn)品質(zhì)量有非常小的影響Low: Failure has n

18、o influence or influent indirectly to product quality 3中等：失敗對(duì)產(chǎn)品質(zhì)量有非常小的影響或只是間接影響。產(chǎn)品質(zhì)量的下降在某種程度上不影響產(chǎn)品放行。Medium: Failure has a fraction of influences or just indirect ones. Quality decline doesnt affect releasing products.4高：失敗直接影響產(chǎn)品質(zhì)量。產(chǎn)品的質(zhì)量下降會(huì)影響產(chǎn)品放行。High:Failure affects product quality directly. Qualit

19、y decline has impact on product release.5非常高：對(duì)法規(guī)或指導(dǎo)中涉及的方面應(yīng)進(jìn)行評(píng)估，以達(dá)到所要求的標(biāo)準(zhǔn)。Extremely high: Its needed to evaluate the aspects involved in regulations or guidance to expected standard.風(fēng)險(xiǎn)因數(shù)： 察覺(jué)失敗的可能性 （P）Risk factor: possibility of aware failure (P)評(píng)估evaluation標(biāo)準(zhǔn)standard5非常低：失敗不可能被察覺(jué)，沒(méi)有定期的檢查，沒(méi)有文件規(guī)定要進(jìn)行符合性

20、研究。Extremely low: Failure cant be perceived, without regular check and documentation to do compliance research. 4低：基本的過(guò)程控制檢查，失敗不易于察覺(jué)。設(shè)備和儀器的技術(shù)性檢查僅僅是偶爾進(jìn)行。Low: It needs basic process control check and its not prone to failure. Just occasionally technical check on equipment and instruments.3中等：定期進(jìn)行過(guò)程控制檢

21、查或不連續(xù)的監(jiān)測(cè)，失敗易于察覺(jué)。Medium: It needs regular process control check or incontinuous monitoring and failure can be perceived.2高：采取不同的方法進(jìn)行監(jiān)測(cè)，如工藝參數(shù)的監(jiān)測(cè)，有很大可能確定在后續(xù)的生產(chǎn)過(guò)程中發(fā)生的失敗。High: It takes various monitoring methods, such as: monitoring on process parameters; it is more likely to confirm failure in the follo

22、wing product process.1非常高：100% 的監(jiān)測(cè)，并可確定在后續(xù)的生產(chǎn)過(guò)程中發(fā)生的明顯失敗。Extremely high: It needs fully monitoring and can confirm obvious failure in the following product process.重要說(shuō)明：請(qǐng)注意，在此表格中，評(píng)估等級(jí)是從“5”到“1”。Important note: please notice that evaluating grade is from 5 to 1.4.4 風(fēng)險(xiǎn)追蹤 Risk Pursue通過(guò)因素的等級(jí)評(píng)估和三個(gè)要素的乘積數(shù)，可以

23、確定某一個(gè)影響因素的風(fēng)險(xiǎn)評(píng)估值。因此，如果出現(xiàn)下列情況，就必須進(jìn)行風(fēng)險(xiǎn)追蹤：- 三個(gè)要素的乘積數(shù)大于“24”- 三個(gè)被評(píng)估的要素中，有一項(xiàng)大于或等于“4”。關(guān)于風(fēng)險(xiǎn)追蹤，至少應(yīng)考慮該項(xiàng)風(fēng)險(xiǎn)參數(shù)是否是與質(zhì)量相關(guān)的。如果有必要進(jìn)行風(fēng)險(xiǎn)追蹤，應(yīng)提出解決的措施或更進(jìn)一步的調(diào)查研究的內(nèi)容，以消除可能發(fā)生的失敗并實(shí)施下一步的研究。A risk evaluating value can be obtained from factor grade evaluation and products of three elements.Therefore, risk pursue must be carried t

24、hrough if the following cases happen:-The product of three elements is greater than 24;-One of the three evaluated elements is greater than or equal to 4.Concerning on risk pursue, it should be taken into consideration that whether the risk parameter is related to quality or not. If risk Pursue is n

25、ecessary, advance solving measures or make further to survey researching contents to get rid of contingent failure and go on next research.4.5 總結(jié) conclusion風(fēng)險(xiǎn)分析以表格的形式加入在各相應(yīng)的驗(yàn)證文件中，作為文件內(nèi)容的一部分。范例格式如下所示，Risk analysis is added to corresponding validation document in the form of tables as a part of the do

26、cument. Format example shows below: 項(xiàng)目Item潛在的風(fēng)險(xiǎn) / 錯(cuò)誤Potential Risk/ Errors失敗的頻率Frequency of Failure (F)失敗的嚴(yán)重性Gravity of Failure (G)察覺(jué)失敗的可能性Probability to detect Failure (P)風(fēng)險(xiǎn)評(píng)估Evaluation of Risk(FGP)風(fēng)險(xiǎn)的追蹤*Pursue of Risk*項(xiàng)目1Item 1項(xiàng)目2Item 2項(xiàng)目3Item 34.6 風(fēng)險(xiǎn)接受評(píng)價(jià) Risk accept evaluation應(yīng)在采取措施后再進(jìn)行風(fēng)險(xiǎn)分析，以確定風(fēng)險(xiǎn)

27、已降低至可接受水平內(nèi)(即三個(gè)要素的乘積數(shù)小于或等于“24”).同時(shí)應(yīng)對(duì)相關(guān)的本來(lái)在可接受水平內(nèi)的風(fēng)險(xiǎn)再進(jìn)行一次風(fēng)險(xiǎn)分析,以確定風(fēng)險(xiǎn)未有增加，仍然在可接受水平內(nèi).若依然有風(fēng)險(xiǎn)項(xiàng)目超出控制范圍,則應(yīng)重點(diǎn)對(duì)該風(fēng)險(xiǎn)進(jìn)行分析,提出新的改進(jìn)控制措施.直至該風(fēng)險(xiǎn)降低到可接受水平. 風(fēng)險(xiǎn)評(píng)估的格式如下所示:Conduct risk analysis after pursue measures to ensure risk has been declined to an acceptable level (that product of the three element is less than or equ

28、al to 24). At the same time, conduct one more risk analysis on related and essentially acceptable risk to make sure that risk doesnt increase and stay acceptable. If there still are risk items out of controllable range, focus on analysis on this risk and put forward new improving control measure unt

29、il it falls to an acceptable level. The format of risk evaluation is as following: 項(xiàng)目Item潛在的風(fēng)險(xiǎn) / 錯(cuò)誤Potential Risk/ Errors風(fēng)險(xiǎn)的追蹤Pursue of Risk失敗的頻率Frequency of Failure (F)失敗的嚴(yán)重性Gravity of Failure (G)察覺(jué)失敗的可能性Probability to detect Failure (P)風(fēng)險(xiǎn)評(píng)估Evaluation of Risk(FGP)風(fēng)險(xiǎn)接受評(píng)價(jià)Risk accept evaluation項(xiàng)目1Item

30、 1項(xiàng)目2Item 2項(xiàng)目3Item 35 風(fēng)險(xiǎn)分析的記錄 Risk analysis record一般來(lái)說(shuō)，風(fēng)險(xiǎn)分析的進(jìn)行通常和計(jì)劃的改進(jìn)措施合并在一起，因此不必要另外編寫(xiě)一份風(fēng)險(xiǎn)分析文件，只需要在相關(guān)文件中附加風(fēng)險(xiǎn)分析的記錄。如在工藝驗(yàn)證主方案中，風(fēng)險(xiǎn)分析記錄需要按照附錄1 中“FEMA 記錄表”來(lái)設(shè)計(jì)。Generally speaking, risk analysis usually combines with arranged improving measures. So theres no need to compile another risk analysis document

31、but additional risk analysis records in related documents. For example, risk analysis record should be designed according to FEMA record table in appendix 1 in process validation main protocol.6 變更控制程序 Change control process如果本程序需要變更或進(jìn)行特別的修改，必須按變更控制程序來(lái)實(shí)行并進(jìn)行記錄。具體操作，請(qǐng)參考變更控制SOP（編碼： 7）。If this process n

32、eeds change or special modification, follow change control process and make records. Specific operation see “SOP - Change control procedure (code: ).7 風(fēng)險(xiǎn)分析流程圖 Flow-chart of risk analysis確認(rèn)/驗(yàn)證委員會(huì)或變更控制委員會(huì)會(huì)議Qualification/validation committee or change control Meetings 公司FMEA方法的應(yīng)用Application of corporation FMEA method 錯(cuò)誤/關(guān)鍵參數(shù)來(lái)源的收集Collection of wrong/key parameter sources潛在失敗效果的鑒定Identification of potential failure effect根據(jù)FMEA方法評(píng)估潛在失敗的影響Evaluate potential failure influence basing on FMEA method失敗的頻率 （F）failure frequency (F)失敗的嚴(yán)重性（G）failure graveness (G)察覺(jué)失敗的可能（P）possibility of aware failu