生產控制Are product test requirements and results reviewed prior toproduction or at the pre-production meeting and is this documentedin the meeting notes?

　　工廠是否在大貨生產之前或在產前會上，查看產品測試要求和測試結果？會議記錄中是否記錄了相關內容？

　　Verify meeting notes document discussion of product test requirements and results.

　　核對工廠的產前會議記錄中是否有討論產品測試要求和產前測試結果的記錄。

　　生產控制Are key product and quality requirements reviewed, identified anddocumented prior to production or at the pre-production meeting?

　　工廠是否在大貨生產之前或在產前會上，查看、鑒別并記錄產品的關鍵質量要求？

　　Verify key product and quality requirements have been identified through review of pre-productionmeeting notes.

　　核對工廠的產前會議記錄中是否有確認產品的關鍵質量要求的記錄。

　　生產控制Are Pre-production meeting notes/issues communicated to theappropriate personnel?

　　工廠是否將產前會中發現的問題及會議記錄傳達到相關的管理人員？

　　Validate factory has a process to communicate the output or action plan of the pre-productionmeeting including action items including accountability and timing.

　　核實工廠是否有程序文件要求將產前會的會議記錄，相關解決方案及時傳達到相關人員。

　　生產控制Does a documented process and records exist for the factory tocompare first production units to client approval sample andspecifications?

　　工廠是否有程序文件和相關記錄,要求工廠的質檢人員對大貨首件產品與客戶的確認樣和工藝單進行對照確認？

　　Verify that there is a process where QC/Production compares the first production units off the lineagainst the clients approval sample and specifications. Required documentation must includeverification of measurements, construction, workmanship and if applicable corrective action plan.

　　核對工廠的程序文件及首件樣檢驗記錄，證明工廠的質檢人員對生產線上產出的第一件大貨樣與客戶的確認樣和工藝單進行了比對確認。

　　大貨首件樣檢驗記錄必須包括確認尺寸、結構、做工以及整改方案（如適用）。

　　生產控制Are finished goods stored in a controlled area to avoid theft, loss,damage, deterioration?

　　工廠的成品是否儲放在一個被管控的區域以避免盜竊、丟失, 破損、變質？

　　Verify all finished must be in an area that is secure and not accessible by general factory population.

　　This area must have a secure perimeter and a roof. There must be assigned personnel to monitorthis room. The goods must be on pallets or shelving.

　　核實工廠的所有成品是否保存在一個安全的，普通工人不能接觸的區域。該區域密閉條件良好，必需有授權的員工監管。貨物應該放置在托盤上或貨架上。

　　生產控制Is the identification of raw materials and components adequate toensure traceability ?

　　工廠的原材料和零配件是否有清晰的標識足以確保它們的可追溯性？

　　Verify raw materials and components can be identified to ensure traceability. This includes:

　　packaging, processing aids, intermediate/semi-processed products, part-used materials, finishedproducts and materials pending investigation. This includes materials sourced from more than onesupplier. An example would be tracing a button to its supplier; or a screw to its supplier, etc.

　　核對工廠的原材料和零部件是否有清晰的標識,以確保產品的可追溯性。包括：包裝材料，生產助劑，中間產品/半成品，產品部件原料，成品，待檢原料。這些物料包括從不同原料供貨商采購的產品。

　　舉例：根據清晰的標識追溯鈕扣的供應商，螺絲釘的供應商 Production ControlIs traceability available from source of raw material and componentsthru finished product?

　　工廠的可追溯性系統是否貫穿從原材料和零部件的采購到成品出運？

　　Select a sample of different finished goods and have the factory explain & demonstrate the lot/batchidentification of the raw materials & components used to manufacture these finished goods.

　　在工廠隨機抽取一個正在生產的產品,請工廠對其內部的追溯系統加以解釋，證明根據原材料/零部件的標識，生產批次，可以追溯到成品的完成時間，出運批次等。

　　生產控制Does the factory test the traceability system to ensure it works?

　　工廠是否有內部測試,以鑒別自己的追溯系統的有效性？

　　Verify the factory periodically confirms that their traceability system is working. Ask the factory toprovide records in the form of reports or meeting minutes that would support the factory is ensuringthe effectiveness of the traceability system.

　　核對工廠的定期測試追溯系統的記錄。工廠要提供報告或會議記錄來證明工廠的追溯系統工作正常。

　　生產控制Are final products suitably marked on packaging and/or product toallow identification and traceability?

　　工廠是否在成品或者零售包裝上有適當的標識，用以識別生產批次和作為追溯問題的依據？

　　Select a sample of different finished goods and verify:

　　A. Children's products have traceability labeling on packaging and product.

　　B. All other products have traceability on packaging.

　　Not Applicable will apply only if factory does not produce finished goods.

　　隨機抽取工廠的幾件不同的成品并核對：

　　A 兒童產品的產品自身和零售包裝上要有追溯標識。

　　B 其他的產品在零售包裝上有追溯標識。

　　如果工廠不生產最終成品，不需要這個程序。

　　生產控制Is there an SOP that requires customer approval when changingmaterials, components, design, or manufacturing processes that mayaffect meeting safety, regulatory and quality requirements of theproduct?

　　工廠是否有標準操作程序文件明確規定了，因為產品的原材料、零部件、設計、生產程序等方面需要改變從而影響到產品的安全性、合法性以及質量要求時，工廠必須得到客戶的確認方能生產?

　　Verify the factory's written procedures for notifying customers and obtaining approval when thefactory is changing materials, components, design or manufacturing processes that could affectsafety, regulatory and quality requirements of the finished goods.

　　核對工廠的程序文件證明當產品的原材料、零部件、設計、生產程序等方面需要改變從而影響到產品的安全性、合法性以及質量要求時，工廠必須得到客戶的確認方能生產。

　　生產測試計劃Does the factory have a documented Production Test Plan(s) (PTP)independent of Target's requirements?

　　工廠是否有完全獨立于Target質量要求之外的生產質量控制計劃(Production Test Plan)？其上列明關鍵質量控制計劃和相應的測試要求。

　　Ask for documentation that confirms the existence of a PTP.

　　核對工廠的生產質量控制計劃，來確定工廠有自己內部完全獨立于Target質量要求之外的質量控制程序。其上列明關鍵質量控制計劃和相應的測試要求。

　　生產測試計劃Does the PTP meet Target minimum requirements?

　　工廠的生產質量控制流程是否符合Target質量控制的最低要求？

　　Verify the PTP documentation includes the following elements of testing, inspection andmanufacturing controls:

　　1. Type2. Frequency3. Criteria核對工廠的生產質量控制流程,其上至少包含以下內容：

　　1. 測試、檢驗和生產質量控制的類型。

　　2. 測試、檢驗和生產質量控制的頻率。

　　3. 測試、檢驗和生產質量控制的標準。

　　生產測試計劃Is the PTP appropriate for the product and processes involved?

　　工廠的生產質量控制流程是否適用于工廠正在生產的產品和生產流程？

　　Is the factory's PTP appropriate when taking into consideration the product type, product risk level,site conditions, manufacturing capabilities and manufacturing controls and level of Quality Systemsimplementation.

　　核對工廠的生產質量控制流程是否全面詳細而無任何缺失。綜合考慮產品的類型，危險等級，現場環境，生產能力，生產過程控制和實施質量系統的完成情況。

　　生產測試計劃Are there records to support the PTP is being executed asdocumented?

　　工廠是否有相關的記錄來證實工廠在日常生產中非常有效的執行生產質量控制流程？

　　Review test reports, inspection results and manufacturing control records to verify the PTP is beingexecuted as written with regard to frequency, type of, criteria used, etc.

　　核對工廠的相關測試報告、檢驗報告的結果和生產控制記錄以證明生產質量控制流程是按照既定的頻率，類型,標準有效執行的。

　　控制約定的材料Does the factory have effective documented procedures for thecontrol of non-conforming materials and products includingidentification, segregation and dispositioning?

　　工廠是否有行之有效的程序文件對不合格的材料，產品進行管控？包括鑒別、存放和銷毀？

　　Verify the factory has a written SOP which describes how non-conforming material is identified,segregated or kept from getting placed back in with normal production. Also, there is to be adisposition process where a documented decision is made to rework or repair, scrap or discard, use"As Is", etc. along with decisions to recertify or not, test, inspect, etc. The disposition is to identifythe person who authorized the actions.

　　核對工廠是否有標準操作程序文件，該文件說明了不合格產品如何進行鑒別、隔離、銷毀以及防止其混入正常生產區域。

　　工廠是否有對于不合格產品應作出書面結論的程序，要求重做、返修、廢棄以及“照常使用”等。書面結論還要有最終評判，說明不合格產品是否需要補做、額外測試、檢驗等。所有的處理決定均應由被授權的質檢人員作出。