Vendor Factory Evaluation Mandatory and Production Sector Details

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

　　工廠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.

　　核實工廠是否有至少一份書面程序文件，其上規(guī)定相關的操作流程文件和業(yè)務文件是受控的。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.

　　核實工廠的受控文件的總表，其上應該列明了工廠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.

　　核對工廠的文件時（例如：質檢流程，產品生產指導，標準操作程序文件，等等），先隨機選擇若干個要抽查的文件名稱，然后在巡視車間時，根據受控 文件總表或者工廠使用的其它跟蹤文件，來對比抽查的文件是否使用了最新的被授權的版本。工廠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?

　　工廠是否有避免使用過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核對工廠的文件控制程序，是否描述了如何將過期文件移除，避免錯誤使用的程序。工廠提供相應的正在使用的文件加以證實。

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

　　工廠內部的文件能夠被所有相關員工隨時便利地獲取嗎？

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

　　通過面談和觀察來證實相關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?

　　工廠是否有程序文件規(guī)定了質量記錄如何存放，保管，存檔期限和如何銷毀？

　　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.

　　核對工廠的程序文件，了解工廠如何保存質量記錄。程序文件應規(guī)定，自生產結束后，相關的質量記錄必須被保存至少5年。工廠出具相關的文件存檔來證實文件的存檔期達到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(guī)定執(zhí)行。

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

　　工廠的質檢部門是否隸屬于生產部門？

　　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.

　　核對工廠的組織架構圖，如果質檢部門隸屬于總經?或總裁，選擇YES，如果質檢部門隸屬于生產部，選擇NO。

　　如果沒有組織架構圖，當面咨詢工廠的質檢人員。

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

　　工廠的每個生產班次都有質檢部門人員同時工作嗎？

　　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.

　　隨機核對工廠的打卡記錄加以佐證。如果沒有打卡記錄。當面咨詢質檢管理人員。每一個生產班次都必須有質檢人員。

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

　　工廠是否有可衡量的質量目標并收集實際的執(zhí)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.

　　隨機核對工廠的質量目標及執(zhí)行結果。文件、記錄必須包括每種產品的質量目標和通過率。記錄完整的文件應可以隨時提供以便于查閱。

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

　　工廠是否舉行持續(xù)的、生產部門一同參加的質量控制會議，是否有會議記錄？

　　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.

　　核實工廠是否至少每周舉行一次質量會議，以便討論生產中的問題,，產品疵點等。會議記錄必須包括生產中遇到的問題和整改措施。生產經理或生產主管應該出席質量會議。在質量會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?

　　工廠的持續(xù)質量會議記錄，是否顯示工廠的產品質量水平是可以衡量的、并且得到了持續(xù)性的改進？

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

　　核對工廠的質量會議記錄，相關數據，同管理層面談。核實質量方面是否有可衡量的持續(xù)改進。

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

　　每天或每周質量目標和實際質量執(zhí)行結果是否張貼在生產現場？

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

　　在車間巡視的時候，核實工廠的質量目標和實際質檢結果是否在生產車間明示。

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

　　工廠是否有庫存管理系統(tǒng)來控制和記錄進出物料（存放地點，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.

　　核對工廠的庫存管理文件和記錄，核實所有進出物料是否被庫存管理系統(tǒng)有效監(jiān)控。核對存放地，物料類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，被認可的產品、物料和服務類別，被核可的供貨商所提供產品，應符合安全、法律法規(guī)及質量的要求？

　　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.

　　核對工廠的供貨商審核程序文件是否包含：

　　—確認工廠有供應商審核程序。

　　—被核可的供貨商生產的產品清單，這些產品、物料符合安全、法律法規(guī)及質量的要求。

　　如果工廠不生產最終成品，不需要這個程序。

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

　　工廠的供應商審核程序是否包括清晰的評審指標及產品達標的相關績效標準？

　　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.

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

　　如果工廠不生產最終成品，不需要這個程序。

　　Supplier Management   Are supplier approval records kept? 工廠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結束后，至少保存了5年。

　　如果工廠不生產最終成品，不需要這個程序。

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

　　工廠是否根據確定的評審條件及績效標準來評判供應商？

　　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.

　　核對工廠的供貨商審核記錄，證實工廠是否按照既定的評審條件及績效標準來評估供應商。

　　如果工廠不生產最終成品，不需要這個程序。