Document Control Is there a procedure in place that defines how documentation iscontrolled?

　　工廠(chǎng)是否有如何控制內部文件的程序？

　　The factory must have at least one written procedure that describes the process and activities theyperform to assure documentation is controlled. These controls may include, but not limited torevision control, authorizing & approving, control of obsolete documents, retention periods, wheredocuments are located, etc.

　　核實(shí)工廠(chǎng)是否有至少一份書(shū)面程序文件，其上規定相關(guān)的操作流程文件和業(yè)務(wù)文件是受控的。這些控制程序包括但不僅限于：文件的更新，授權和確認，過(guò)期文件的控制，存放保管年限，存放位置。

　　Document Control Is there a "Master List" of controlled documents? 工廠(chǎng)是否有受控文件的總表？

　　The document control system is to provide a means of knowing what documents the factory has andtheir latest revision level. The factory must have a master list or some other means of controllingtheir documentation.

　　核實(shí)工廠(chǎng)的受控文件的總表，其上應該列明了工廠(chǎng)有哪些受控文件和受控文件的最新版本。

　　Document Control Are documents in use the current version and are they authorizedand dated?

　　工廠(chǎng)正在使用的文件是最新版本及被授權的版本嗎？

　　During the document review (Examples: QA procedures, Production work instructions, SOP's, etc.)and during the factory floor walk thru, select or identify a sampling of documents and then comparetheir revision level with the master list or whatever means the factory is using to track theirdocuments. The majority of the documents sampled are to have the same revision as indicated bythe document control system and they are to have evidence of authorization such as a signature anda date of issuance.

　　核對工廠(chǎng)的文件時(shí)（例如：質(zhì)檢流程，產(chǎn)品生產(chǎn)指導，標準操作程序文件，等等），先隨機選擇若干個(gè)要抽查的文件名稱(chēng)，然后在巡視車(chē)間時(shí)，根據受控 文件總表或者工廠(chǎng)使用的其它跟蹤文件，來(lái)對比抽查的文件是否使用了最新的被授權的版本。工廠(chǎng)的內部文件應顯示這些文件在發(fā)放前是被授權的，如簽名，發(fā)放日 期等授權證據。

　　Document Control Is there a procedure in place to ensure obsolete documentation isremoved from use?

　　工廠(chǎng)是否有避免使用過(guò)期或廢棄文件的程序？

　　Review and ensure the document control procedure or procedures include a description of theprocess the factory uses to remove obsolete documentation from use. Look for evidence that it is核對工廠(chǎng)的文件控制程序，是否描述了如何將過(guò)期文件移除，避免錯誤使用的程序。工廠(chǎng)提供相應的正在使用的文件加以證實(shí)。

　　Document Control  Is the documentation readily accessible by all relevant staff at alltimes?

　　工廠(chǎng)內部的文件能夠被所有相關(guān)員工隨時(shí)便利地獲取嗎？

　　Interview and observe to confirm factory workers have reasonable access to the documents neededto do their jobs.

　　通過(guò)面談和觀(guān)察來(lái)證實(shí)相關(guān)員工能合理地獲取他們工作需要的文件。

　　Document Control  Is there a written procedure that defines how quality records arestored, protected, and disposed of as well as a defined retentionperiod?

　　工廠(chǎng)是否有程序文件規定了質(zhì)量記錄如何存放，保管，存檔期限和如何銷(xiāo)毀？

　　Review documented procedure on how the factory maintains quality records. The Procedure mustindicate the retention period is at minimum 5 years after production has ended. Record review mustvalidate records have been maintained for a minimum of 5 years after production has ended; ormaintained since the creation of the Document Retention Procedure.

　　核對工廠(chǎng)的程序文件，了解工廠(chǎng)如何保存質(zhì)量記錄。程序文件應規定，自生產(chǎn)結束后，相關(guān)的質(zhì)量記錄必須被保存至少5年。工廠(chǎng)出具相關(guān)的文件存檔來(lái)證實(shí)文件的存檔期達到5年；或者自新的存檔期限生效后，文件保存至今，雖少于5年，但將按照規定執行。

　　Quality Management  Does the QA (Quality Assurance) or QC (Quality Control)department operate separately from the Production department?

　　工廠(chǎng)的質(zhì)檢部門(mén)是否隸屬于生產(chǎn)部門(mén)？

　　Review an Organizational Chart to see where the QA or QC Department reports. If they report toGeneral Manager, President, etc. score a YES. If they report to anybody in the ProductionDepartment, score is a NO. If organizational chart is not available, interview factory QA/QCleadership.

　　核對工廠(chǎng)的組織架構圖，如果質(zhì)檢部門(mén)隸屬于總經(jīng)?或總裁，選擇YES，如果質(zhì)檢部門(mén)隸屬于生產(chǎn)部，選擇NO。

　　如果沒(méi)有組織架構圖，當面咨詢(xún)工廠(chǎng)的質(zhì)檢人員。

　　Quality Management   Does the quality department have coverage during all shifts?

　　工廠(chǎng)的每個(gè)生產(chǎn)班次都有質(zhì)檢部門(mén)人員同時(shí)工作嗎？

　　Review random documentation of shift schedules. If shift schedule is not available, interviewfactory QA/QC leadership. For every production shift, there must be QC coverage.

　　隨機核對工廠(chǎng)的打卡記錄加以佐證。如果沒(méi)有打卡記錄。當面咨詢(xún)質(zhì)檢管理人員。每一個(gè)生產(chǎn)班次都必須有質(zhì)檢人員。

　　Quality Management  Are measureable quality goals identified and actual performanceresults collected?

　　工廠(chǎng)是否有可衡量的質(zhì)量目標并收集實(shí)際的執行結果？

　　Review random documentation of quality goals performance results. Documentation must includegoals and pass rate per product category. Must be available and complete.

　　隨機核對工廠(chǎng)的質(zhì)量目標及執行結果。文件、記錄必須包括每種產(chǎn)品的質(zhì)量目標和通過(guò)率。記錄完整的文件應可以隨時(shí)提供以便于查閱。

　　Quality Management  Are documented, ongoing Quality Control (QC) meetings held at thefactory in which Production is represented?

　　工廠(chǎng)是否舉行持續的、生產(chǎn)部門(mén)一同參加的質(zhì)量控制會(huì )議，是否有會(huì )議記錄？

　　The factory must have, at a minimum, weekly QC meetings to discuss production issues, defectissues, etc. Documentation must include production issues and corrective action taken. Aproduction manager or supervisor is to attend the QC Meetings. Must see evidence of the above inthe documented meeting notes.

　　核實(shí)工廠(chǎng)是否至少每周舉行一次質(zhì)量會(huì )議，以便討論生產(chǎn)中的問(wèn)題,，產(chǎn)品疵點(diǎn)等。會(huì )議記錄必須包括生產(chǎn)中遇到的問(wèn)題和整改措施。生產(chǎn)經(jīng)理或生產(chǎn)主管應該出席質(zhì)量會(huì )議。在質(zhì)量會(huì )議記錄中必須顯示上述內容及出席人員名單。

　　Quality Management  Do the ongoing QC meetings demonstrate measureable, continuousimprovement?

　　工廠(chǎng)的持續質(zhì)量會(huì )議記錄，是否顯示工廠(chǎng)的產(chǎn)品質(zhì)量水平是可以衡量的、并且得到了持續性的改進(jìn)？

　　Validate by reviewing records, data collection, and interviewing leadership. Verify there ismeasureable continuous improvement.

　　核對工廠(chǎng)的質(zhì)量會(huì )議記錄，相關(guān)數據，同管理層面談。核實(shí)質(zhì)量方面是否有可衡量的持續改進(jìn)。

　　Quality Management   Are daily or weekly quality goals and actual performance resultsposted on the factory floor?

　　每天或每周質(zhì)量目標和實(shí)際質(zhì)量執行結果是否張貼在生產(chǎn)現場(chǎng)？

　　While walking the production floor, look for posted quality goals and performance results.

　　在車(chē)間巡視的時(shí)候，核實(shí)工廠(chǎng)的質(zhì)量目標和實(shí)際質(zhì)檢結果是否在生產(chǎn)車(chē)間明示。

　　Supplier Management  Is there an inventory control system with incoming/outgoingmaterials monitored and documented (location, quantity, etc)?

　　工廠(chǎng)是否有庫存管理系統來(lái)控制和記錄進(jìn)出物料（存放地點(diǎn)，數量，）Review documentation to verify that all incoming / outgoing materials are monitored by aninventory control system. Verify location, material type and quantity matches inventory records.

　　核對工廠(chǎng)的庫存管理文件和記錄，核實(shí)所有進(jìn)出物料是否被庫存管理系統有效監控。核對存放地，物料類(lèi)型和數量與庫存記錄是否匹配。

　　Supplier Management  Does the factory have a documented supplier approval procedure,including a list of approved suppliers for products, materials andservices impacting product safety, legality, or quality?

　　工廠(chǎng)是否有供應商審核程序，包括被核可的供貨商清單，被認可的產(chǎn)品、物料和服務(wù)類(lèi)別，被核可的供貨商所提供產(chǎn)品，應符合安全、法律法規及質(zhì)量的要求？

　　Review documentation to ensure the site has:

　　- A documented supplier approval procedure- A list of approved suppliers for products, materials and services impacting product safety, legalityor qualityNot Applicable will apply if factory does not manufacture a finished product.

　　核對工廠(chǎng)的供貨商審核程序文件是否包含：

　　—確認工廠(chǎng)有供應商審核程序。

　　—被核可的供貨商生產(chǎn)的產(chǎn)品清單，這些產(chǎn)品、物料符合安全、法律法規及質(zhì)量的要求。

　　如果工廠(chǎng)不生產(chǎn)最終成品，不需要這個(gè)程序。

　　Supplier Management   Does the supplier approval procedure include clear criteria forongoing assessment and the standards of performance required?

　　工廠(chǎng)的供應商審核程序是否包括清晰的評審指標及產(chǎn)品達標的相關(guān)績(jì)效標準？

　　Procedures shall be established which include clear criteria for ongoing assessment and thestandards of performance required. Ongoing assessment may take the form of monitoringperformance through one or more of the following: in house checks; certificates of analysis;certificate of conformity; supplier audits; traceability checks, etc.

　　Not Applicable will apply if factory does not manufacture a finished product.

　　核實(shí)工廠(chǎng)的供貨商評審程序，是否清楚地包含了持續的評估和所需績(jì)效標準。持續評估可以采用表格通過(guò)內部檢查，認證分析，法規認證，供應商評估，可追溯性檢查等等的形式。

　　如果工廠(chǎng)不生產(chǎn)最終成品，不需要這個(gè)程序。

　　Supplier Management   Are supplier approval records kept? 工廠(chǎng)是否保存供應商審核記錄？

　　Supplier approval records must be retained for a minimum of 5 years after production has ended.

　　Not Applicable will apply if factory does not manufacture a finished product.

　　核對供應商審核記錄是否在生產(chǎn)結束后，至少保存了5年。

　　如果工廠(chǎng)不生產(chǎn)最終成品，不需要這個(gè)程序。

　　Supplier Management    Does the factory review the performance of suppliers against adefined criteria?

　　工廠(chǎng)是否根據確定的評審條件及績(jì)效標準來(lái)評判供應商？

　　The factory is to have defined criteria for reviewing suppliers. There are to be records of thesuppliers being reviewed against this criteria.

　　Not Applicable will apply if factory does not manufacture a finished product.

　　核對工廠(chǎng)的供貨商審核記錄，證實(shí)工廠(chǎng)是否按照既定的評審條件及績(jì)效標準來(lái)評估供應商。

　　如果工廠(chǎng)不生產(chǎn)最終成品，不需要這個(gè)程序。