ECA CCS指南-附件1：差距评估实例（非详尽无遗）.docx

《ECA CCS指南-附件1：差距评估实例（非详尽无遗）.docx》由会员分享，可在线阅读，更多相关《ECA CCS指南-附件1：差距评估实例（非详尽无遗）.docx（6页珍藏版）》请在第一文库网上搜索。

1、 *ECA* FoundationFostering仔。MP，VDF reuiatiAttachment 1: Example of a gap assessment (non-exhaustive)附件 1：差距评估实例(非详尽无遗)Key AreasKey ElementsDetailed CCS ElementsAnnex 1 revl2 draftreferenceIdentified potential gaps (or documentation improvement need)versus Annex 1 draft expectationsKey supporting Sit

2、e Strategies,Rationales, Risk assessmentsInclude Reference, title and ifpossible hyperlink to theKey Site ProceduresInclude Reference, title and hyperlink to thedocumentFacilities, equipment. Utilitiesand Infrastructure Design,Qualification/ Maintenance andControlFcilit05Facilities DesignPdcility de

3、sign requirements plant lavout air filtration, materialof construction, clea na bility, dirlodcdesign logical 3ndchrcxiologicjl activitiesflorn)4.1, 4.2, 4.3. 4.5, 4.6,474.8. 4.94.10. 4.11, 4.12, 4.13z4.176.66.214.1 expldin how controb and monitoring are identifically justified and capable ofevduoti

4、nq the stole of environmen tai condmoos for deoncooms, airlocks andposs-throughs usedfor motefioland equipment tramfet ”4.3 Barrier，should be considered in the CCS.* Any alternative approaches to the use ofRABS and holoton should be justified Drvcloptbr current material transfer and airlocks section

5、s using wording of 4.10,4.11,4.12. 4.13To be filled out accordinglyTo bcfilled out accordinglyHVAC system design requirements (Air Fdtration/HFPA Filters,Pressure cascades. Temperature, RH, locations air inlets &outlets, ducts cleanability, ?ir exchanges rates, alarms settingsand controls.14 13,4.14

6、, 4.124 16435Dcwlop an adequdte Miction to cover 4.16 Setpointt and the critkotityofpfeiiuredifferentials should be documented within the CCS* / Witrre alarm delays are set,these should be aaessed and justified within the CCS”To beflHedout accordinglyTo be filled ou toccordlnQlyArea Classification /

7、Gradecascading4 1,4 4,4 12,4.13,4.203.14Nogap identifiedPhywcai segregation of activities (dedicated facility/drea. ueofdoted systems,other conUinmentlyitemi,)/Barriers4.2, 43,4.44.18,4.19,4.20. 4.21, 4.22,4.238.10, 8.14, 8.1S, 2.164.3 Use of barriers should be considered in the CCS : any dlternjtiv

8、e approaches to theuse ofRABS or isolators should be justifiedTo beflHedout accordinglyTo be filled ou toccordlnQlyLacdli2ed Unidirectional Air Flow dppliction/protectkn, dustcontrol systems42 4.254.6No gap identifiedClassification & Qualification ofFacilities/BarriersQualification Program and contr

9、ol (AFPT, Air velocity . 4.15,4 21,4 26.4.27.4.28.4.2% 430,4 31. 4.32.4.33.4.344 30& 4 33 develop the current section to pxplain how current strategy fulfills therequirement for the sampling locationsand their positioning during classification ”cnttcaf proccng locations should be based on o document

10、ed risks awsment andknowledge of thG process and operation and dun ng qualification the number ofsampling facations s houldbe based on a doc umen ted risk assessment, including theresults of the classification, air visualization and knowledge of the process andoperationsTo be filled out accordinglyT

11、o bcfilled out accordinglyFacility Cleaning and DisinfectionGean mg Programs (agents select on. frequency, materials )/Practices4.22. 4.36. 4.37No gap identifiedTo be filled out accordinglyTo be fiifedoutoccordinQlySamti/ntion agents vnlidation (including verification ngnm%tlcxulflora)424. 4.37,4.38

12、No gap identifiedTo beflHedout accordinglyTo be filled ou toccordlnQlyPost ControlPest control Program / ag location mapsIdentified as additional rUkbeyond Annex 1 requirementsNo gap identifiedTo be filled out accordinglyTo bfiUed out accordinglyMaintenanceProgram for facilities (includi ng Fit and

13、Finish program)S3 5 6No gap identifiedTo be filled out accordinglyTo bfiUed out accordinglyPeriodic HF PAfi Iters integrity testing4 34No gap identifiedTo ba filled out accordinglyTo befitted outaccardingfyMintendnce prxticc for product protection5.6Nogp identifiedTo be fitted out accordinglyTo be f

14、illed out accordinglyReturn to service after mnmtcnnnccS.6. S.7No gap identifiedTo be fitted out accordinglyTo be filled out accordingly *ECA* Foundation仔MP/qDP agLatio人，Waste M3naementWaste flowand segregationNo gap identifiedTo be filled out accordinglyTo be fitted out acardingtyB2:Hl 7关健领域关健要素详细的

15、CCS要素附件1版本12参考草案确定的潜在差距（成文件改进鬲求）与附件草案1的期相比关健支持现场策略、理由、风险评估包括参考文献、标题,如果可能的话,包括超接关键现场程序包括参考文献、标题和文件的超链接设地、设备、公用系统设缶和茶咄设it的设计、签定、健护和控制设造反笳设计次能设il要束（工厂布时、空气过浊、建筑M科可消沽性、气用设计、避辅和时间活动流-4.1.4.2.43.4.5.4.6.4.7.4.E.4.94.10.4.11,4.12.4.13.4.17.6.66.2!11解林南川和外测如何“有再的泡好并德婚泞例勿丹籽依设德找移的洁净N .气用和通溢的林堆品件状状T一照码粉应在CCS中加以号也,锲用R:HS和隰亮揭的任何替代方法都应科学论证使用41。411%12.4.13的措辞郭力