API不符合項(xiàng)整改結(jié)果英文

1、API不符合項(xiàng)整改安排表編號(hào)對(duì)應(yīng)的標(biāo)準(zhǔn)條款不符合原因分析糾正及糾正措施由誰采取?提供什么證據(jù)？完成日期責(zé)任人1-第8文檔API標(biāo)準(zhǔn)第九版5.7.1.5條款體系不符合主要不符合：在生產(chǎn)工藝鍛造，熱處理，無損傷檢驗(yàn)等特殊工藝按照要求應(yīng)被驗(yàn)證其有效。無證據(jù)顯示上述工藝被確認(rèn)為有效。原因分析：The special process in the company quality system had been identified and controlled, but validation about the interval not been implemented according to API

2、 Q1 5.7.1.5. 證據(jù)：Correction：1 The tehnical department finished defining process validation control procedureby June,6.more detail see attachment . 2 By June,12 , the HR department organized and implemented training on the document for related staff (see attachment 2.For special process operators ,the

3、 job qualification and certification implemented respectively(see attachment .3 During June,20June,30, the technical department implemented the validation process and reported.(see attachmentEvidence ：Attachment 1: all process validation control procedure；Attachment 2 :training record；Attachment 3-1

4、:HT operator and forging operator qualification；Attachment 3-2: UT,MT checking report and certification；Attachment 4:NDE operator qualification；Attachment 5 validation report for special process；Attachment 6 forging process ；Attachment 7 :HT process Attachment 8 :UT,MT process regulation； Attachment

5、 9 special process re-validation report（PT,UT,MT）Attachment10 Correction contentCorrection action：From July,1 to July 28,2015 improving actions was implemented hosted by top manager and organized by management deputy which focus on improving in production process validtion ,including identifiction a

6、nd planning ,verification for special process and interactions between the processes. As well as revising the manual . quality management manual will be completed translation by ealy August and uploaded to API website.0郝永平2-第6文檔API第九版5.4.2bAPI-6A款4.2.3.1; 表 6, 7, 9; 4.6; 10.1.2.2輕度不符合：1 輸入未包括在API產(chǎn)品規(guī)

7、范要求中2 設(shè)計(jì)輸出未符合設(shè)計(jì)輸入要求3 完成該設(shè)計(jì)的個(gè)人同時(shí)審核了最終設(shè)計(jì)4 設(shè)計(jì)變動(dòng)未按照計(jì)劃完成不符合證據(jù)：在設(shè)計(jì)和包裝環(huán)節(jié)：法蘭6B, BL, RTJ, 4 1/16”, 5000psi, L, 60K, PSL 4;法蘭, 6B, WN, RTJ, 4 1/16”, 5000psi, L, 60K, PSL 4;1 無證據(jù)顯示該設(shè)計(jì)輸入注明了材料等級(jí)2 審核圖#1， # 2后，其化學(xué)合成及機(jī)械性能 按照ASME A694, F60 要求，卻并未符合API 6A 中標(biāo)6,7,9所規(guī)定條款3 執(zhí)行設(shè)計(jì)審查的任海瑞先生同時(shí)也進(jìn)行了設(shè)計(jì)輸出的工作4 未存在設(shè)計(jì)包的成品，故也缺少尺寸檢驗(yàn)記錄和

8、最終審核檢驗(yàn)記錄原因分析：1 Design and development personals did not realize and identify the API Q1 documents and specifications completely.2 design and development division personals did not have clear job responsibility and not have define the plan stage clearly.3 The process of design and development did not

9、 be supervised strictly by the managing personals. Corection：1 To address the material type of the product in the design package and adress applicable API requirements. Chemical composition requirements meet the 6,7,9 clause of API.2 Revise the design package , make the drawings and design input mee

10、t requirements of design output .3 Add product demension inspection records and final inspection records into the design package.4 Arrange Mr Ren Hairui be resposible for design output and Mr Fu Guangming be resposible for design audit.Evidence ：Attachment1 design document in which material grade an

11、d designer addressed ; Attachment 2 API drawing revision Attachment 3 training recordCorrection action：1 Conduct training for related personnals and make them know about the API Q1 . 1 2 Make design division realize their responsibilities and plan stage respectively. 2 The regulations for project de

12、sign process can be consider to be defined as well as its follow-up and check. Or define managers responsibilities for plan, supervising and examination. .0任海瑞3-第3文檔API標(biāo)準(zhǔn)第九版4.4.3條款A(yù)PI-6A條款 2輕度不符合：文件未被認(rèn)證外部原文件未控制（不符合證據(jù)：1 API-6A 材料使用技術(shù)規(guī)范spec.# CJY/ GC- 7.3- 3- 2015- 1, rev. B/ 0;未列入程序文件清單中 was not list

13、ed in Document master list# Jan. 1, 20152 API-6A ED 20，工廠對(duì)應(yīng)的附件3未找到3 以下為參照的目前有效的外部技術(shù)規(guī)范清單ASTM A370- 2012a (實(shí)際為 2011, ASTM A388- 2011; ASTM E709- 2008;）1 For API 6A spec，it is not updated in the document .2 In the technical document list, not update the reference specification in time cause identificat

14、ion of the related specification not so clearly.Correction：1 Add the API 6A spe into the document list.2 Purchase the amendment of API 6A ED20.3 Examine and update or buy the updated related specification.Evidence： Attachemnt1 procedure document content; Attachment2 Cover picture of API 6A 20th ED;A

15、ttachemnt 3 applicable standard listCorection action：1 Provide training to related personnals and found method of updating specficaiton on the website.2 Designate MS Hao Weiqin be responsible for related specifications follow-up , updating or acquisition in external technical document list.0任海瑞楊向東4-

16、第7文檔API標(biāo)準(zhǔn)第九版5.6.1.1B條款A(yù)PI-6A條款 9.2輕度不符合：無證據(jù)表明供方產(chǎn)品符合API6A標(biāo)準(zhǔn)第9.2部分的技術(shù)要求，意味著管家營(yíng)公司不具備供應(yīng)該產(chǎn)品的供貨能力。（標(biāo)準(zhǔn)要求：船運(yùn)前，設(shè)備或零件金屬表面保護(hù)層在環(huán)境溫度50度以內(nèi)不應(yīng)發(fā)生流掛。）原因分析： Did not evaluate and control the requirements of 9.2 in API 6A to verify the surface painting sagging in 50°C.Correction： 1 Require that the package division

17、 to implement stablity assessemnt of the painting sagging test below 50°C. Observe the result ,if sagging coming up, then need change material or techniccal process to meet the requirements. If the no sagging coming up ,then the result shall be written into the working instructions2 According t

18、o the test practice, painting is capable of nosagging coming up in 50°C . please see the following pictures in attachment. Evidence: Attachment1:Test practice; Attachment2 :Assessing result pictureCorrection action:Strictly implement the operations by the working instructions.0張水開楊向東-第2文檔API標(biāo)準(zhǔn)第

19、九版4.4.2條款輕度不符合：審核設(shè)備程序時(shí)，無證據(jù)顯示應(yīng)用了以下要求1 第5.7.1.2 技術(shù)要求2 第5.8 部分關(guān)于計(jì)算機(jī)軟件及MME 部分第6.2.2.1 關(guān)于內(nèi)部審核應(yīng)在12個(gè)月之內(nèi)進(jìn)行（描述：此技術(shù)規(guī)范中并沒有對(duì)所有程序進(jìn)行了文字記錄及歸檔。）原因分析： 1. The company did not organize enough training to make related API requirements be comprehended.2. 5.7.1.2 For 5.7.1.2 clauses The company didnt completely retain do

20、cument procedure and describe the product service control.3. For 5.8 clauseDidnt validate the initial software requirements .4 For 6.2.2 clause internal audit The document did not define internal audit should be reviewed every 12 months clearly.5 Actually, internal audit had been implemented 2 times

21、 in last 12 months, but the related records was not retained enough.Correction：1 Revise the document by the quality department, and make the requirements in it.(see part of the document in attachmetnt2 Provide related test and software assessment by the testing center as well as assessment result. 3

22、 Settlle two iternal records completely .Evidence: see Traing exam and records in attachment1, calibration records in attachment 2 , MME certification i attachment 3.Correction action：The HR department organize and implement the trainings about API 6A spe. and API Q1 , made the exam for staff to mak

23、e them understand and implement API requirements into practice.0王澤峰-第11文檔API標(biāo)準(zhǔn)第九版5.7.3條款A(yù)PI-6A條款7.4.2.3.14; 7.4.2.4.5; 8.1.1; 8.1.2輕度不符合：并未按照制造單位，客戶及應(yīng)用產(chǎn)品規(guī)范的要求對(duì)產(chǎn)品進(jìn)行跟蹤記錄及身份認(rèn)證。7.4.2.3 設(shè)備的各零件或單個(gè)設(shè)備均應(yīng)攜帶帶有相應(yīng)跟蹤記錄 標(biāo)記或獨(dú)立代碼。8.1.1 所做標(biāo)記均應(yīng)應(yīng)按表39中規(guī)定位于設(shè)備外表面。8.1.2 印記應(yīng)使用低強(qiáng)度，按照點(diǎn)狀，摩擦印記或V形形狀。7.4.2.4.5 PSL4 及PSL3的跟蹤記錄印記應(yīng)清

24、晰可辨。不符合證據(jù)：表39中6A 關(guān)于要求注明的標(biāo)記并沒有注明使用了API中的哪些具體條款，PSL4產(chǎn)品的無獨(dú)立代碼標(biāo)記故不符合API6A中7.4.2.3所述條款。無位置標(biāo)記故不符合API6A中低8.1.2和8.1.1中所列條款要求。2觀察產(chǎn)品認(rèn)證卡及切割位置后，發(fā)現(xiàn)并未注明爐號(hào)。材料的應(yīng)用信息為：批次 ：w04-49,20件 ，Q235,280*280原因分析： 未能充分理解、轉(zhuǎn)換和實(shí)施API-6A 39表標(biāo)識(shí)要求和位置中相關(guān)規(guī)定，標(biāo)識(shí)中未注明獨(dú)立代碼。未能按7.4.2.3.14;要求做到每一單一料塊都有唯一性標(biāo)識(shí)；1 Didnt understand and implement the r

25、equirements in table 9 of API 6A. as well as not have the unique mark for each billet according to 7.4.2.3.14.2 For each cut billet, there was not clear heat no. in it.3 the finished product marking process not meet the requirements of API-6A 8.1.1; 8.1.2 as well as marking not indicate PLS grade.糾正

26、： 1. Revise product marking and traciblity control process to define the unique marking from the material blanking to each billet as well as the heat no. And implement from July,15.2（如PSL3或PSL4）the marking method should meet the requirements of API-6A 8.1.1; 8.1.2 as well as the requirements for pro

27、duct grade(PLS 3,or PLS 4 and have been implemented from July,15糾正措施：Provide the training for related satff about the requirements in API-6A7.4.2.3.14/7.4.2.4.5/8.1.1/8.1.2 and make it into production and practice.2. Define the special auditor and make him resposible for check and review.Evidence se

28、e training records and marking lable in billet in attachment .證據(jù)：Evidence please see attachment （Attachemnt 1 billet marking and heat no. Mark ，Attachment2 training records ,Attachment 3 special auditor post and review records）.0譚宏偉-第12文檔API標(biāo)準(zhǔn)第九版5.8條款A(yù)PI-6A條款 7.2.1體系不符合主要不符合：未對(duì)測(cè)試，監(jiān)督等要求或所用設(shè)備提供“符合要求”的

29、證據(jù)要求：7.2.1 要求：為符合國際標(biāo)準(zhǔn)的要求，所用檢測(cè)設(shè)備及相關(guān)材料生產(chǎn)商在與國國家規(guī)范一致的同時(shí)均應(yīng)進(jìn)行認(rèn)證，控制并進(jìn)行精確計(jì)算。不符合證據(jù)： 無證據(jù)顯示對(duì)MME做出了具體明確的要求無證據(jù)顯示拉伸測(cè)試設(shè)備w20-239 ，及所用計(jì)算機(jī)軟件在使用之前進(jìn)行了確認(rèn)無證據(jù)顯示光照強(qiáng)度顯示器可用于設(shè)備審查MME清單上熱控制MME部分，內(nèi)部校調(diào)間隔應(yīng)為6個(gè)月，實(shí)際記錄上為12個(gè)月審查熱偶6，校調(diào)證書，顯示最近計(jì)算的日期為2014年3月10日和2015年3月9日。無證據(jù)顯示v形槽口角度公差符合ASTM A 370條款。原因分析：1 For WE-239 and MME soft ware，alread

30、y be tested by testing center of Jinxi Machining Company and got the qualification result: the machine mainly be used for test in GB/T228.1-2010、ISO6892-1-2009.But because of the requirements in API 6A 20th for testing machine and related software not be comprehended completely so cause testing mach

31、ine calibrating information not be collected completely.2 calibrating regulations for tools and testing machine not meet the requirements of related specification in APISSMEASTM.糾正：1 Implementing the validation process to hydraulic tesing machine .2 Purchase the ASTM and meet the notch projector req

32、uiements in that spe.3 Buy the illumination intensive indicator and implememt the calibration, usage ,record and control process.4 Revise the regulationscalibration process for tools and testing machineas well as MME requirements, and define the calibrating inerval is 6 monthes.document 糾正措施：Invite

33、third party to make agreemnt to check the themocouple by Sep,8 and make records.Evidence see attachment （Attachment 1 personnal certification ; Attachment2 adjusting certification for testing machine ;Attachment3 adjusting certification for testing machine ; Attachment4 MME certification Attachment5

34、 tension test records ; Attachment6 illumination intensive indicator ; Attachment7 illuimination test working instructions ; Attachment8 illumination checking regulation ; Attachment9 agreement for measurements and tools calibrationaAttachment 10 impact test picture.0王志忠王澤峰-第10文檔API標(biāo)準(zhǔn)第九版5.條款A(yù)PI-6A條款

35、5.2.2b，5.4.4.3輕度不符合：產(chǎn)品策劃過程未注明相關(guān)要求。無證據(jù)顯示API 6A 第5.2.2部分所規(guī)定之熔化試驗(yàn)在設(shè)備中有所注明。5.2.2b 對(duì)PSL2 到PSL4 ，所有要求應(yīng)等同于PSL1，及其之后的附加項(xiàng)允許熔化試驗(yàn)5.4.4.3 aa 淬火淬火開始，水溫或淬火介質(zhì)的溫度不應(yīng)超過40度。完全淬火后，淬浴后的溫度不應(yīng)超過50度不符合證據(jù)據(jù)： 1 審查熱處理卡card# GJY/ GC/ GY/ RCL/ A694 F60,之后發(fā)現(xiàn)上面顯示熱處理溫度不應(yīng)超過80度，此項(xiàng)未符合API6A標(biāo)準(zhǔn)中第5.4.4.3a 部分條款2 無證據(jù)顯示API 6A 第5.2.2部分所規(guī)定之熔化試驗(yàn)

36、在設(shè)備中有所注明。原因分析：1 In the heat treatment card # GJY/ GC/ GY/ RCL/ A694 F60, it was not clarified clearly for the process,etc.2 In the design package, the detailed melting method was not provided for forgings.糾正：1 In heat treatment card, about the quench temperature ,add new details for quenchng start t

37、emperature should be 40 in the document, and more details please see attachment 1.2 Add melting method of steel in design package .more details please see attachment 23 Use cycling water assisting equipment in actual operation to ensure temperature control requirements in API 6A 5.4.4.3a and more de

38、tails see attachment 3. 糾正措施：1 provide concrete heat treatment document in the process and make the records and make it not occurs in the future. Evidence see Attachment .0王 晉牛飛龍-第5文檔API標(biāo)準(zhǔn)第九版5.1.3a條款發(fā)貨前，應(yīng)進(jìn)行審核以確保符合相關(guān)要求并進(jìn)行產(chǎn)品身份認(rèn)證及文件記錄。輕度不符合：并未規(guī)定了適用性要求；發(fā)貨之前，并未進(jìn)行相關(guān)審核。不符合證據(jù)：審核后發(fā)現(xiàn)以下合同中規(guī)定的關(guān)于不同尺寸法蘭合同號(hào)t# 7503

39、771090, 發(fā)貨期.: 2014,9月15日;合同號(hào)t# PO76774, 2015年2月16日 合同號(hào)# 20141106, 發(fā)貨日期 2014年11月6日合同號(hào)t# Z13XYCNJ10191 無證據(jù)顯示PSL 級(jí)別的適用要求2 無證據(jù)顯示合同簽署之前進(jìn)行了相關(guān)的合同審核。原因分析：1 Did not identify PSL requirements in API 6A.2 No specified auditor for checking before manufacturing. 3 For contract review records, there are not so st

40、andard to verify .and did not define the applicable PSL requirements.糾正：1 Add contract review record to meet the requirements and address the actual review date. And PSL grade in the record.2 Send the contract review record to the working processes.3 Add the traceable supplement for t# 7503771090 ,

41、t# PO76774, # 20141106, t# Z13XYCNJ1019 ,to verify that meet the requirements of PSL.糾正措施：1 Set the special auditor post.2 Define the resposibilty of the auditor.3 To implement the review before delivery and make the records .Evidence :Attachment 1 special auditor postAttachment 2 review record befo

42、re delivery.0譚宏偉劉鳳瑞-第9文檔API標(biāo)準(zhǔn)第九版A5b3條款輕度不符合：未按照API 中規(guī)定使用交織字母印記標(biāo)記于適用產(chǎn)品的規(guī)定位置上。標(biāo)識(shí)程序文件內(nèi)未確定API 標(biāo)志的具體適用位置。原因分析：沒有API中規(guī)定的交織字母。以前打字用的是組合字母。Did not define the API monogram location in the procedure # GJY/ GB- 9.0- 01- 09, rev. F/ 0 clearly. And will order and buy new API monogram.Correction :1 Define API mon

43、ogram usage and location in marking control document # GJY/ GB- 9.0- 01- 09, rev. F/ 1 clearly.2 Use monogram in the product according to control documents.Correction action：購買API交織字母，并使用。To define new API marking letter and usage according to revised document. Please see the picture of API monogram

44、.Evidence :see attachment.( Attachment1 API monogram location in the product；Attachment 2 marking control document ；Attachment 3 PSL mark in the product.0張水開-第1文檔API標(biāo)準(zhǔn)第九版4.4.1b條款輕度不符合：質(zhì)量說明書并未包括質(zhì)量管理體系之間的順序及互動(dòng)說明。不符合證據(jù)：審核QM# GJY/ GA- 2014, rev. F/ 0;， 無證據(jù)顯示對(duì)管理文件及相關(guān)記錄使用的控制，及對(duì)風(fēng)險(xiǎn)管理，MOC均未進(jìn)行注明。原因分析： 1.未能充分準(zhǔn)

45、確理解API4.4.1b 的全部要求；以致所編制的惡QEOA管理手冊(cè)未充分闡明質(zhì)量管理體系之間的順序及互動(dòng)說明。The requirements of API Q1 4.4.1b not been comprehended completely so cause the system interaction not been described in QEOA management manual clearly.Correction ： 1 revise the QEOA management manuual ,and add some items about the MOC ,communi

46、cation part and process validation and interaction discription .2 add some items to the principle .3 adjust the structure of the mannual and make more clear between the items.Correction action：Organize training for related staff make the revised mannual better comprehended.Evidence please see attach

47、ment (Attachment 1Quality mannual revision recordAttachment 2 Quality mannual revisionAttachment 3 Training record for API Q 1.0付光明-第4文檔API標(biāo)準(zhǔn)第九版7.5.1.3B條款輕度不符合：未規(guī)定記錄按照API要求保留至少5年。不符合證據(jù)：質(zhì)量記錄單2014年3月27日上顯示的用戶滿意度調(diào)查單，熱處理檢驗(yàn)卡，熱處理流轉(zhuǎn)，內(nèi)部審核報(bào)告，MR報(bào)告，文件派發(fā)記錄，均被要求保留3年。原因分析：1 Because different documents had differe

48、nt retain time ，not unify the retention period for all the document .2 In control process records4.5, defined the duration is at least 7 years while our company only obsolete the documents 8 years ago . Now we kept the documents built from 2008 completely.3For actual obsolete process please see cont

49、rol process records4.6.3Corection ： revise the document ,and define the retained pereiod for all the document is at leasst 7 years.Correction action ：Send the revised document to all the sections of the company and according to the requirements of GJY/GB-4.2-02 4.5 :quality records should be sent to

50、 quality department within one month of produciton finished .證據(jù)： Evidence please see attachment 1 Special auditor post ；attachment 2 Auditor reivew record ；Attachment 3 Document in 2008.0劉鳳瑞各位：鑒于我公司在此次API審核中存在問題多，程度重的嚴(yán)峻局面，急需高標(biāo)準(zhǔn)、迅速完成整改，否則可能面臨難以預(yù)料的重要后果。為此：我針對(duì)審核員開出的不符合條款，編制了這份API不符合項(xiàng)整改安排表，限于時(shí)間和水平，我只在表中

51、提示了證據(jù)要求。在原因分析，糾正，糾正措施欄未及給出合適提示；關(guān)于表格的格式是否符合也不完全肯定。特要求各位重視此事，共同努力予以整改。涉及各相關(guān)部門的，見此表必須無條件配合，不得推諉，不得降低要求。公司領(lǐng)導(dǎo)將參加督促驗(yàn)證。關(guān)于要求提供英文版的問題，在判斷中文版基本符合的情況下，公司統(tǒng)一組織翻譯。各位只需做出中文版即可。 楊向東2015年6月12日星期五Correction And Correction Actions ContentFinding number for Audit ID 60719DescriptionResponsible person for correctionCompletion dateImplementation dateNo 1Quality manual had not included a description of the sequence and interaction between all the processes of the quality management system;Hao YongpingJune 23-28 ,