2019年可口可樂公司GMP審核檢查表精品

1、YesDivNo34556)67889本模塊作為審核指南，完成模塊中內(nèi)審的考核以確定被審公司是否符合可樂要求1) Questio nn aire:1. Are pers onnel practices impleme nted as required?人員習(xí)慣符合要求嗎2. Does the pla nt follow the desig n requireme nts for pers onnelfacilities? 廠房設(shè)計(jì)符合人員設(shè)備要求嗎3. Are appropriate programs in place for the hiri ng of pers onn el? 對雇用人員

2、有沒有相關(guān)的程序。4. Is the access to the facility con trolled?進(jìn)入設(shè)備區(qū)受控嗎5. Is the pla nt protected aga inst con tam in ati on from outside?廠房的設(shè)備能防范來自外界的污染嗎6. Is the in terior of the pla nt protected aga inst specificcon tam in ati on?廠房內(nèi)部是無保護(hù)特殊的污染嗎7. Is con tact air (compressed air u sed for blowi ng, filli n

3、g, CIP, plia nt with requireme nts? 接觸的空氣符合要求(用于吹瓶、灌注和CIP等壓縮空氣)8. Is the quality lab accord ing to GMP sta ndards?質(zhì)量實(shí)驗(yàn)室符合GMP標(biāo)準(zhǔn)嗎9. Is the disposal and destruct ion of trademarked materials han dled accord ingto the requireme nts? 是根據(jù)相關(guān)要求處理和破壞有商標(biāo)的材料。10. Is the pla nt only using approved con tac

4、t materials?所用一級包裝材料是經(jīng)認(rèn)可的嗎11. Is an adequate housekeeping program developed and implemented? 制定和實(shí)施了廠房管理程序嗎12. Is an adequate Pest Control program implemented? 實(shí)施了蟲害控制嗎。2) Refere nee Stan dards List:Beverage Operati onsMan ualBO-RQ-Good Manu facturi ngBO-RQ-Con trol & Distr. of Non-con formi ng20

5、0Practices905Trademarked Materials & ProductsBO-RQ-BO-RQ-225Pers onal Practices940SecurityBO-RQ-BO-RQ-950Pest Con trol910Purchas ingTCCQS updates are captured till December 15th, 20053) Specificati ons and Requireme nts Summary：Specificati ons / Requireme ntsPers onnel Practices1Are pers onnel p

6、ractices impleme nted as required?人員習(xí)慣符合要求嗎Especially at the glass lin es, the use of safety apparel is importa nt and man datory.特別是玻璃線人員使用安全服是非常重 要的并是強(qiáng)制性的BO-RQ-225* Apply health standards:使用健康標(biāo)準(zhǔn)：- Employees wear effective hair restra ints in all process ing areas (beard or moustache restra ints ar

7、e also recomme nded)-在加工區(qū)員工須戴有效的防洛發(fā)帽，(胡 子也要求去除)- Open wounds and infectious disease policies in place (not to work in raw material han dli ng, process ing areas, primary package han dli ng)-有對暴露的傷口和傳染病的規(guī)定嗎(不在 原料處理區(qū)、工藝區(qū)、初級材料包裝區(qū)工 作。- Meet all applicable health regulati ons-符合所有健康法規(guī)。 In clude a docume

8、nted hygie ne programin cludi ng:文件化衛(wèi)生程序包括：-Wash-Hands” policies-wash withgermicidal soap and water, ri nse fully with water and dry (before starti ng to work in process ing area and after each abse nee from the area)-洗手措施：-使用具有殺菌功效的肥皂， 充分沖洗并干燥(在進(jìn)入工作區(qū)之前，和 每次離開工作區(qū)以后)- No use of fingernail varnish or

9、lacquer (uni ess gloves are worn). Fingern ails are short and clea n (in process ing areas)-不能留長指甲，不許涂指甲油，保持指甲 清潔。- Food or drinks only in designated areas.-食品和飲料在指定區(qū)域- No drink coolers or food-vending machi nes in process ing areas-工乙區(qū)不能有飲水機(jī)和食品售買機(jī)- No alcohol or drugs allowed in the pla nt.-在廠內(nèi)不能有酒

10、和藥。- Smoking only allowed in designatedareas-在指定區(qū)域抽煙* Apply safety standards:應(yīng)用安全標(biāo)準(zhǔn)：- All loose jewelry removed in the pla nt-不許戴松散型項(xiàng)鏈- Suitable enclosed footwear in use (no san dals)-使用專用鞋具。(不用拖鞋)- Protective apparel where needed(safety glasses, ear plus, gloves, safety shoes, helmet,)-在必要區(qū)使用專用衣著。-

11、 Secure uniform pockets to keep loose object from falli ng-使用專用服裝以防松散物體掉落- Meet all local safety regulations符合地方法規(guī)* Apply dress and personal appearaneecodes:人員穿著與外表要求：- Provide several sets of a standard uni forms laun dered regularly(uni forms light colored and of material that is easy to clean and

12、 able to withsta nd in dustrial use)-提供幾套標(biāo)準(zhǔn)的洗衣設(shè)備(統(tǒng)一用淺色經(jīng) 磨易洗的布料)- Appropriate uni forms for tour guides-參觀人員用專門服飾- Define a dress code for people who don' t wear un iforms (office or sales staff)-規(guī)疋勿需統(tǒng)一著裝人員規(guī)疋(辦公至或銷 售人員)* Pers onnel is in formed (tra in ed) aboutthe requireme nts whe n hired在人員入用之

13、前要進(jìn)行相關(guān)要求的知會2Does the pla nt follow the desig n requireme nts for pers onnel facilities?廠房設(shè)計(jì)符合人員設(shè)備要求嗎If these two con diti ons are not met, hot water should be provided in all wash bas ins:BO-RQ-200* Hand wash statio ns provided in (n ear) all process ing areas在加工區(qū)域要有洗手池* Soap, disposable han d-towel

14、s or hotair dryers, covered trash receptacles, hot water provided如果以條件不能滿足時(shí)則要提供熱水洗 手- supplied water n everfalls below 20° C-所供應(yīng)水不低于20 ° C- process ing equipme nt is not rin sed or washed in this si nk-工藝設(shè)備不用在水槽清洗皂液、一次性紙巾或烘手機(jī)，有蓋的垃圾 簍，要有熱水* Toilet facilities not to open directly into proces

15、s ing areas and equipped with self clos ing devices.洗手間的開口不要直接對于加工區(qū)域且要配 備自動關(guān)門* Toilets are clean and well ventilated洗手間要清潔通風(fēng)* Hot and cold potable water provided in all toilets所有洗手間要冷熱兩用水* Soap, disposable han d-towels or hotair dryers, covered trash receptacles available in toilets.皂液、一次性紙巾或烘手機(jī)，有蓋的

16、垃圾 簍，要有熱水* All joi nts are sealed and coved to ease clea ning所有連接處和密封處、封蓋處易清潔* Slope floor to floor drains, out water traps to drains地面斜坡要斜于排水溝，外面的水流向于排 水溝* Hand wash sig ns in all toilets 所有洗手間要有洗手標(biāo)識3Are appropriate programs in place for the hiri ng of pers onn el?對雇用人員有沒有相關(guān)的程序。BO-RQ-940* Procedure

17、s for hiring personnel (both con tract and perma nent) are impleme nted and in clude:*實(shí)施人沒雇用程序(合同式臨時(shí)式)包括以 下條款：- Corporate and Divisio n HR requireme nts-公司人力要求- Records of previous employme nt-以前員工的記錄-Character refere nces-個(gè)性參考* Temporary or con tract pers onnel can only work in sen sitive areas un

18、der direct supervisi on (prese nee) of a full time employee在專職員工的督下，臨時(shí)工或合同工才可以在 敏感區(qū)域工作Gen eral4Is the access to the facility con trolled?進(jìn)入設(shè)備區(qū)受控嗎BO-RQ-940* Program implemented and includes procedures for:程序?qū)嵤┎ㄒ韵虏襟E：- Buildi ng and premises security-建筑物和安全第一- Han dli ng con fide ntial in formatio n

19、/ products-處理機(jī)密信息和產(chǎn)品- Admitta nee to facilities-設(shè)備使用權(quán)- Access to vehicles-機(jī)車通道Personnel received familiarizationtrai ning人員接受過精心培訓(xùn)5Is the pla nt protected aga inst con tam in ati on from outside?廠房的設(shè)備能防范來自外界的污 染嗎BO-RQ-200* Pave roads and park ing areas, and Ian dscape grounds to limit dust通道和停放區(qū)，裝飾區(qū)

20、不能塵埃* Grade roads, yards and park ing areas to help drain age等級公路、院落和停放區(qū)以助排水* Surround the plant' s outside wallswith an area that has no grass or dirt not to harbor in sects etc (typicallyuse pebbled rocks, con crete, asphalt)工廠周圍無草區(qū)或泥土不能滋生昆蟲(一般 用鵝卵石、瀝青、水泥)* Seal all ope nings around pipes, doo

21、rs, windows, and ventilation ductwork that go through outside walls.密封所有由墻 面與外界連通的管道、門窗 和通風(fēng)管。* Scree n all win dow, vent and fan ope ning所有窗戶、通風(fēng)口、風(fēng)扇口要有濾網(wǎng)* Pallet repair area not located in the pla nt托板修理區(qū)不能在廠內(nèi)* Entran ces are closed or have air- curta ins an d/or quick ope ning doors入口處關(guān)著或是有空氣簾或是快開啟

22、門* In sect killers and vermin preve nti on devices are in stalled n ear the entran ces滅蠅燈和防蟲害裝置放在入口附近6Is the in terior of the pla nt protected aga inst specific con tam in atio n?廠房內(nèi)部是無保護(hù)特殊的污染嗎BO-RQ-200* Dedicated area for trash and waste with proper drain age and sealed surface floor垃圾和廢物處理區(qū)要有適當(dāng)?shù)呐潘?/p>

23、措施和密 封的表面板 Lights are covered where applicable光線充足 Explosive proof light ing in side sugar silos*在糖silos內(nèi)要有防爆燈 No use of mercury-c ontaining lamps / equipme nt不使用汞燈7Is con tact air (compressed air used for blowi ng, filli ng, CIP, etc.)complia nt with requireme nts?接觸的空氣符合要求(用于吹瓶、灌注 和CIP等壓縮空氣)BO-RQ-

24、200* Air compressors with appropriate traps, filters and dryers*空壓機(jī)要有適當(dāng)?shù)倪^濾器和干燥器* On ly food grade steam is used (potable water, approved boiler additives, activated carb on filter in stalled)僅用食品級的蒸氣(飲用水、認(rèn)可的鍋爐添 加劑，安裝活性碳過濾器。)8Is the quality lab according to GMP sta ndards?質(zhì)量實(shí)驗(yàn)室符合GMP標(biāo)準(zhǔn)嗎BO-RQ-200* Slop

25、e all wall ledges to ease clea ning所有墻壁設(shè)計(jì)易于清潔* Floors, walls, ceili ngs and doors from smooth, non-porous materials地面、墻、天花板和門都要用光滑防水材料* Use only coun ter tops built from smooth, non-porous material that resists stai ns*僅用光滑、防水不銹材料制成* Place water traps in all floor drains所有的水要都能進(jìn)地面地溝* Place scree n t

26、raps where n ecessary必要地方安裝過濾器* Self-clos ing devices on doors, in stall all doors an d win dows to fit tightly aga inst their frames所有的都是自動門，窗要與框緊密吻合* Lab is easy clea nable and clea n. Adequate draining is provided化驗(yàn)室要易清潔，要有足夠的排水設(shè)施* All fume hoods to be ven ted outsidethe pla nt; away from air in

27、lets所有的濃煙都被抽出廠外并遠(yuǎn)離氣體入口* Adequate ven tilati on system in use (typically 10 cha nges per hour)要足夠的排氣系統(tǒng)(一般1小時(shí)10次)* Supply eno ugh potable hot and cold water to acid/base resista nt sinks提供足夠冷熱水使酸堿下沉。* Provide distilled or dei oni zed water , if commercial source is not available使用蒸餾水或去離子水，如沒有商業(yè)化水源* Pi

28、pe treated water to the lab if possible如果可能，自來水要接入化驗(yàn)室* Electrical power through multiple lines電源要多線路* Separate storage facilities for chemicals化學(xué)品分開貯存設(shè)備* Con trolled access cab inet for toxic chemicals有毒化學(xué)品柜使用受控* Adequate storage facilities for rete ntio n samples要有足夠的留樣設(shè)施* Microbio. room ven tilati

29、 on through 0,5 卩 filter (or laminar flow hood) 微生物室的通風(fēng)過濾器要是0,5卩9Is the disposal and destruct ion of trademarked materials han died accord ing to the requireme nts?是根據(jù)相關(guān)要求處理和破壞有商標(biāo)的材 料This questi ons refers to all destructio n of trade-marked materials such as: empty packages, labels, filled packages

30、,這個(gè)冋題參考商標(biāo)材料的報(bào)廢.This questi on is on ly valid duri ng type 1 audits, since for type 2, 3 and 4 audits, this is covered by the System Eleme nt“ Material andProduct In tegrity ”.這問題在1型審核中可以認(rèn)為是合理的BO-RQ-905* Program impleme nted and follows Divisio n requireme nts實(shí)施程序并符合要求* Substa ndard or obsolete packa

31、ges and filled products are destroyed不合格包裝材料與成品破壞掉* Writte n records of the types & amounts of (filled) packages destroyed書面記錄被破壞包裝的類型與數(shù)量* If done by 3 rd party, writte n certificate of destruct ion available如果上述行為由第三方來做，則要其有破壞 證明* Destructio n of Concen trate, Beverage Bases and Juices n eed ap

32、proval from Concen trate Pla nt Chemist and Divisio n但對于2, 3和4審核時(shí)系要素含蓋了： 材料與產(chǎn)品的完整性QA Man ager and must be wit nessed byCompa ny pers onnel主劑、濃縮液和果汁的報(bào)廢須得到濃縮液廠 化學(xué)家QA經(jīng)理的批準(zhǔn)，并且公司要有證人 在廠10Is the pla nt only using approved con tact materials?所用一級包裝材料是經(jīng)認(rèn)可的嗎BO-RQ-910* Curre nt list of Divisi on approved con

33、tact materials available on site最新版的認(rèn)可的一級包材清單。 Equipme nt purchase con tracts specify approved materials設(shè)備采購合同指定認(rèn)可的材料Housekeep ing:11Is an adequate housekeep ing program developed and impleme nted?制定和實(shí)施了廠房管理程序嗎Adequate housekeep ing program(as a Quality System) in cludes: 足夠的的倉庫清潔程序：- Procedures for

34、 clea ning / keep ing tidy-清潔、保持程序- System for in specti on on housekeep ing effective ness-清潔效果監(jiān)控機(jī)制- Metrics on housekeep ing effective ness-清潔效果的測量Light sources with a wide distributi on spa n are measured at 4-10 points and average is used as result.對于跨度較大的輕源產(chǎn)品測試4-10點(diǎn)并 取平均值BO-RQ-200* Develop and

35、implement housekeeping procedures to in clude:制定并實(shí)施室內(nèi)管理程序，并包括：- Procedures for each area of thefacility-程序涵蓋設(shè)備每個(gè)區(qū)域-Freque ncies- 頻率- Approved clea ning age nts,in clud ing their concen trati on,-所認(rèn)可的清潔劑，包括濃度- method of applicati on andspecificatio ns-所應(yīng)用的方法和標(biāo)準(zhǔn)* In stall eno ugh light ing throughout

36、the pla nt to ease clea ning and process ing activities安裝足夠的燈源以便于清潔和生產(chǎn)- Make sure light ning meet local regulatio ns for worker safety-確保燈光符合地方員工安全法規(guī)的要 求- Measure light in te nsity at the worki ng surface from which the task is performed (300 lux in shipp in g, recei ving and storage -300-800 lux in

37、 the syrup andfilli ng rooms 750 to 1000 luxin the lab)-在工作臺面上測試光強(qiáng)結(jié)果如下： (裝運(yùn)(300 lux，在糖房接收與貯 存 300-800 lux，在化驗(yàn)室 750 to1000 lux- Con sult with Illu min ati onEngineer or Lighting Architect to en sure appropriate level in each area.-咨詢相關(guān)照明工程師或燈具設(shè)計(jì)師以 確保每個(gè)區(qū)域光線適合Pest Con trol:12Is an adequate Pest Con trol program impleme nted?實(shí)施了蟲害控制嗎Pers onnel may be internal whe n toxic chemicals are used; however they must be externally licensed to han dle pest co