生產(chǎn)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(chǎn)之前或在產(chǎn)前會(huì)上，查看產(chǎn)品測(cè)試要求和測(cè)試結(jié)果?會(huì)議記錄中是否記錄了相關(guān)內(nèi)容?

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

　　核對(duì)工廠的產(chǎn)前會(huì)議記錄中是否有討論產(chǎn)品測(cè)試要求和產(chǎn)前測(cè)試結(jié)果的記錄。

　　生產(chǎn)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(chǎn)之前或在產(chǎn)前會(huì)上，查看、鑒別并記錄產(chǎn)品的關(guān)鍵質(zhì)量要求?

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

　　核對(duì)工廠的產(chǎn)前會(huì)議記錄中是否有確認(rèn)產(chǎn)品的關(guān)鍵質(zhì)量要求的記錄。

　　生產(chǎn)控制Are Pre-production meeting notes/issues communicated to theappropriate personnel?

　　工廠是否將產(chǎn)前會(huì)中發(fā)現(xiàn)的問(wèn)題及會(huì)議記錄傳達(dá)到相關(guān)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(shí)工廠是否有程序文件要求將產(chǎn)前會(huì)的會(huì)議記錄，相關(guān)解決方案及時(shí)傳達(dá)到相關(guān)人員。

　　生產(chǎn)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(guān)記錄,要求工廠的質(zhì)檢人員對(duì)大貨首件產(chǎn)品與客戶(hù)的確認(rèn)樣和工藝單進(jìn)行對(duì)照確認(rèn)?

　　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(duì)工廠的程序文件及首件樣檢驗(yàn)記錄，證明工廠的質(zhì)檢人員對(duì)生產(chǎn)線(xiàn)上產(chǎn)出的第一件大貨樣與客戶(hù)的確認(rèn)樣和工藝單進(jìn)行了比對(duì)確認(rèn)。

　　大貨首件樣檢驗(yàn)記錄必須包括確認(rèn)尺寸、結(jié)構(gòu)、做工以及整改方案(如適用)。

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

　　工廠的成品是否儲(chǔ)放在一個(gè)被管控的區(qū)域以避免盜竊、丟失, 破損、變質(zhì)?

　　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(shí)工廠的所有成品是否保存在一個(gè)安全的，普通工人不能接觸的區(qū)域。該區(qū)域密閉條件良好，必需有授權(quán)的員工監(jiān)管。貨物應(yīng)該放置在托盤(pán)上或貨架上。

　　生產(chǎn)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(biāo)識(shí)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(duì)工廠的原材料和零部件是否有清晰的標(biāo)識(shí),以確保產(chǎn)品的可追溯性。包括：包裝材料，生產(chǎn)助劑，中間產(chǎn)品/半成品，產(chǎn)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(gòu)的產(chǎn)品。

　　舉例：根據(jù)清晰的標(biāo)識(shí)追溯鈕扣的供應(yīng)商，螺絲釘?shù)墓��?yīng)商 Production ControlIs traceability available from source of raw material and componentsthru finished product?

　　工廠的可追溯性系統(tǒng)是否貫穿從原材料和零部件的采購(gòu)到成品出運(yùn)?

　　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(jī)抽取一個(gè)正在生產(chǎn)的產(chǎn)品,請(qǐng)工廠對(duì)其內(nèi)部的追溯系統(tǒng)加以解釋?zhuān)�證明根據(jù)原材料/零部件的標(biāo)識(shí)，生產(chǎn)批次，可以追溯到成品的完成時(shí)間，出運(yùn)批次等。

　　生產(chǎn)控制Does the factory test the traceability system to ensure it works?

　　工廠是否有內(nèi)部測(cè)試,以鑒別自己的追溯系統(tǒng)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(duì)工廠的定期測(cè)試追溯系統(tǒng)的記錄。工廠要提供報(bào)告或會(huì)議記錄來(lái)證明工廠的追溯系統(tǒng)工作正常。

　　生產(chǎn)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(dāng)?shù)臉?biāo)識(shí)，用以識(shí)別生產(chǎn)批次和作為追溯問(wèn)題的依據(jù)?

　　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(jī)抽取工廠的幾件不同的成品并核對(duì)：

　　A 兒童產(chǎn)品的產(chǎn)品自身和零售包裝上要有追溯標(biāo)識(shí)。

　　B 其他的產(chǎn)品在零售包裝上有追溯標(biāo)識(shí)。

　　如果工廠不生產(chǎn)最終成品，不需要這個(gè)程序。

　　生產(chǎn)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(biāo)準(zhǔn)操作程序文件明確規(guī)定了，因?yàn)楫a(chǎn)品的原材料、零部件、設(shè)計(jì)、生產(chǎn)程序等方面需要改變從而影響到產(chǎn)品的安全性、合法性以及質(zhì)量要求時(shí)，工廠必須得到客戶(hù)的確認(rèn)方能生產(chǎn)?

　　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(duì)工廠的程序文件證明當(dāng)產(chǎn)品的原材料、零部件、設(shè)計(jì)、生產(chǎn)程序等方面需要改變從而影響到產(chǎn)品的安全性、合法性以及質(zhì)量要求時(shí)，工廠必須得到客戶(hù)的確認(rèn)方能生產(chǎn)。

　　生產(chǎn)測(cè)試計(jì)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(dú)立于Target質(zhì)量要求之外的生產(chǎn)質(zhì)量控制計(jì)劃(Production Test Plan)?其上列明關(guān)鍵質(zhì)量控制計(jì)劃和相應(yīng)的測(cè)試要求。

　　Ask for documentation that confirms the existence of a PTP.

　　核對(duì)工廠的生產(chǎn)質(zhì)量控制計(jì)劃，來(lái)確定工廠有自己內(nèi)部完全獨(dú)立于Target質(zhì)量要求之外的質(zhì)量控制程序。其上列明關(guān)鍵質(zhì)量控制計(jì)劃和相應(yīng)的測(cè)試要求。

　　生產(chǎn)測(cè)試計(jì)劃Does the PTP meet Target minimum requirements?

　　工廠的生產(chǎn)質(zhì)量控制流程是否符合Target質(zhì)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(duì)工廠的生產(chǎn)質(zhì)量控制流程,其上至少包含以下內(nèi)容：

　　1. 測(cè)試、檢驗(yàn)和生產(chǎn)質(zhì)量控制的類(lèi)型。

　　2. 測(cè)試、檢驗(yàn)和生產(chǎn)質(zhì)量控制的頻率。

　　3. 測(cè)試、檢驗(yàn)和生產(chǎn)質(zhì)量控制的標(biāo)準(zhǔn)。

　　生產(chǎn)測(cè)試計(jì)劃Is the PTP appropriate for the product and processes involved?

　　工廠的生產(chǎn)質(zhì)量控制流程是否適用于工廠正在生產(chǎn)的產(chǎn)品和生產(chǎn)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(duì)工廠的生產(chǎn)質(zhì)量控制流程是否全面詳細(xì)而無(wú)任何缺失。綜合考慮產(chǎn)品的類(lèi)型，危險(xiǎn)等級(jí)，現(xiàn)場(chǎng)環(huán)境，生產(chǎn)能力，生產(chǎn)過(guò)程控制和實(shí)施質(zhì)量系統(tǒng)的完成情況。

　　生產(chǎn)測(cè)試計(jì)劃Are there records to support the PTP is being executed asdocumented?

　　工廠是否有相關(guān)的記錄來(lái)證實(shí)工廠在日常生產(chǎn)中非常有效的執(zhí)行生產(chǎn)質(zhì)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(duì)工廠的相關(guān)測(cè)試報(bào)告、檢驗(yàn)報(bào)告的結(jié)果和生產(chǎn)控制記錄以證明生產(chǎn)質(zhì)量控制流程是按照既定的頻率，類(lèi)型,標(biāo)準(zhǔn)有效執(zhí)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(duì)不合格的材料，產(chǎn)品進(jìn)行管控?包括鑒別、存放和銷(xiāo)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(duì)工廠是否有標(biāo)準(zhǔn)操作程序文件，該文件說(shuō)明了不合格產(chǎn)品如何進(jìn)行鑒別、隔離、銷(xiāo)毀以及防止其混入正常生產(chǎn)區(qū)域。

　　工廠是否有對(duì)于不合格產(chǎn)品應(yīng)作出書(shū)面結(jié)論的程序，要求重做、返修、廢棄以及“照常使用”等。書(shū)面結(jié)論還要有最終評(píng)判，說(shuō)明不合格產(chǎn)品是否需要補(bǔ)做、額外測(cè)試、檢驗(yàn)等。所有的處理決定均應(yīng)由被授權(quán)的質(zhì)檢人員作出。