1.0 Factory Facilities and Environment工廠基礎(chǔ)設(shè)施和生產(chǎn)環(huán)境

1.0.1 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas?

在生產(chǎn)，修理，加工，檢驗(yàn)，包裝及裝載的區(qū)域是否有足夠的照明？

1.0.2 The facility maintains clean and organized production, finishing and packing areas.

工廠是否保持清潔,在生產(chǎn)，加工和包裝區(qū)域是否有秩序?

1.0.3 Facility has separate inspection area with inspection table and proper ventilation.

工廠是否有單獨(dú)的檢驗(yàn)區(qū)與檢驗(yàn)臺(tái)并且通風(fēng)良好?

1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)

工廠是否有害蟲/霉菌和濕度的控制程序文件? 是否有經(jīng)常巡查(公司內(nèi)部或第三方檢查)?

1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit.

在審核其間有沒有發(fā)現(xiàn)窗戶破損及房頂漏水可能導(dǎo)致產(chǎn)品污染。

1.0.6 (Critical) Factory implements strict sharp tools control procedure to prevent scissors, knives, blades, broken glasses, and needles to be mixed with product.

(嚴(yán)重) 工廠是否實(shí)行嚴(yán)格的利器控制程序，以防止剪刀、小刀、刀片、碎玻璃及針等混入產(chǎn)品中。

1.1 Machine Calibration and Maintenance機(jī)器設(shè)備校準(zhǔn)和維護(hù)

1.1.1 Factory has documented system and procedure for scheduled equipment cleaning and repairs.

工廠是否有書面的文件系統(tǒng)和程序計(jì)劃安排設(shè)備的清潔及維修。

1.1.2 Factory machines and equipments appear to be clean and in good running condition.

工廠的機(jī)器和設(shè)備是否清潔及運(yùn)行良好。

1.1.3 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule.

機(jī)器、設(shè)備和工具是否有最近的維護(hù)/校準(zhǔn)日期及計(jì)劃日期的標(biāo)識(shí)。

1.1.4 Machines, equipments and tools that need to be repaired are properly labeled to avoid accidental use.

需要維修機(jī)器、設(shè)備和工具是否有維修標(biāo)識(shí)以避免意外使用。

1.1.5 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves.

工廠是否有適當(dāng)，整潔的存儲(chǔ)區(qū)域儲(chǔ)存關(guān)鍵模具(比如:注射模具), 并且放在有標(biāo)識(shí)的架子上。

1.1.6 Factory has proper documentation and updated inventory of machines, tools, spare parts, and equipments.

工廠有適當(dāng)?shù)臋C(jī)器、工具、零部件和設(shè)備的庫(kù)存文件，并保持更新。

1.1.7 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines.

工廠是否擁有一定技術(shù)水平的保養(yǎng)團(tuán)隊(duì)和設(shè)備可以執(zhí)行必要的機(jī)器維修和校準(zhǔn)的工作。

 

2.0 Quality Management System質(zhì)量管理控制體系

2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures.

工廠是否建立起符合他們產(chǎn)品和生產(chǎn)流程的質(zhì)量管理控制體系。

2.0.2 Workers & Supervisors are familiar to these quality policies and objectives.

工人與主管是否熟悉這些品質(zhì)政策和目標(biāo)。

2.0.3 Factory has documented customer complaint system and documented recall program. 工廠是否建立了顧客投訴體系及產(chǎn)品召回程序。

2.0.4 (Critical) Factory QC team is independent from Production division.

(嚴(yán)重) 工廠QC團(tuán)隊(duì)是否獨(dú)立于生產(chǎn)部門。

2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)

是否有書面記錄顯示生產(chǎn)管理和QC團(tuán)隊(duì)共同討論、解決質(zhì)量問題及其他相關(guān)的問題.

2.0.6 Factory has systems and procedures in place to control the risk of physical, chemical, and biological contamination that may damage the product and personnel as well.

工廠是否有系統(tǒng)和程序去控制那些可能會(huì)影響產(chǎn)品或?qū)θ嗽斐蓚Φ奈锢?、化學(xué)和微生物污染風(fēng)險(xiǎn)。

2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments, and tools.

工廠是否進(jìn)行風(fēng)險(xiǎn)評(píng)估，以識(shí)別化學(xué)品、原材料、工藝設(shè)備和工具中帶來的危害。

2.0.8 Is factory accredited with any international, national or customer quality standards association (e.g. ISO 9001, etc.)?

工廠是否取得了國(guó)際的, 國(guó)家的或客戶的質(zhì)量標(biāo)準(zhǔn)組織認(rèn)證證書(例如: ISO 9001證書, 等.)?

 

3.0 Incoming Materials Control來料過程控制

3.0.1 Has the factory taken adequate measures to assure raw materials conformance to required specifications before use?

工廠是否檢測(cè)原物料以確認(rèn)是否與要求的明細(xì)規(guī)格一致?

3.0.2 Proper first in-first out (FIFO) system on materials are practiced.

工廠是否實(shí)施物料先進(jìn)先出(FIFO)體系。

3.0.3 Factory has procedures (instructions, guidelines, and documented records) for quality inspection on incoming raw materials, accessories, and components.

工廠是否有進(jìn)倉(cāng)原物料、配件和部件的質(zhì)量檢驗(yàn)程序, 作業(yè)指導(dǎo)書, 及記錄文件。

3.0.4 Is needed testing equipment available, and maintained in good condition?

所需的來料測(cè)試儀器是否配備及保持在一個(gè)良好的狀態(tài)?

3.0.5 Are raw materials properly labeled, stored, and traceable?

所有的原物料是否有合適的標(biāo)識(shí), 儲(chǔ)存及可溯性？

3.0.6 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications.

工廠是否有文件程序和參考樣品以確保來料符合規(guī)格。

3.0.7 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items.

(嚴(yán)重) 工廠是否建立起適當(dāng)?shù)奈锪峡刂企w系, 以隔離不合格的原材料及避免意外污染?

3.0.8 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement.

工廠是否分離良品與不良材料，并標(biāo)識(shí)所需更換的不良材料。

3.0.9 Facility’s storage areas have sufficient lighting, well ventilated and clean surrounding. 廠房的存儲(chǔ)區(qū)域是否有足夠的照明、通風(fēng)和清潔。

3.0.10 Materials, components, and accessories are properly stacked and identified with tags / labels and off the floor.

材料、部件和配件是否妥善堆放并有標(biāo)牌/標(biāo)簽,且與地板隔離。

3.0.11 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination.

(嚴(yán)重) 化學(xué)品和保養(yǎng)的物質(zhì)是否妥善標(biāo)識(shí)和儲(chǔ)存，以防止污染的風(fēng)險(xiǎn)。

3.0.12 Does factory have a documented supplier selection and approval process?

工廠是否有書面的供應(yīng)商的的選用和認(rèn)可流程?

3.0.13 Does factory track, evaluate and document material’s supplier reliability (performance)?

工廠是否跟蹤及評(píng)估物料供應(yīng)商的可信度(表現(xiàn))并記錄在案?

3.0.14 Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability?

工廠是否建立起書面的對(duì)分包商的品質(zhì)控制流程文件? 是否有評(píng)估及監(jiān)督分包商的品質(zhì)表現(xiàn)及信賴度?

 

4.0 Process and Production Control工序和生產(chǎn)控制

4.0.1 Does factory PD study and apply product safety features, evaluates patterns, moulds, and samples during product design and development?

產(chǎn)品設(shè)計(jì)和開發(fā)部門是否在產(chǎn)品設(shè)計(jì)及開發(fā)過程中研究與應(yīng)用產(chǎn)品安全特性,評(píng)估樣式、模具和樣品？

4.0.2 Factory has documented Quality procedures (QP) at each stage of operation.

工廠是否在每一個(gè)生產(chǎn)操作階段都有質(zhì)量程序文件。

4.0.3 Does factory conduct Pre-production meeting prior to start of production?

工廠在生產(chǎn)前是否進(jìn)行產(chǎn)前會(huì)議？

4.0.4 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting?

(嚴(yán)重) 在產(chǎn)前會(huì)議中有沒有審查及確認(rèn)嚴(yán)重的質(zhì)量問題和安全問題并記錄采取的改進(jìn)行動(dòng)？

4.0.5 Does factory conduct “pilot-run”, review product quality against specification sheet and document results with corrective actions prior to production?

工廠是否進(jìn)行“試生產(chǎn)”，根據(jù)產(chǎn)品規(guī)格明細(xì)檢討產(chǎn)品質(zhì)量, 并記錄在生產(chǎn)前的糾正行動(dòng)？

4.0.6 Was in house lab-testing performed on current production? (Request for test copies)

當(dāng)前生產(chǎn)有沒有實(shí)施內(nèi)部實(shí)驗(yàn)室測(cè)試？(要求測(cè)試記錄副本)

4.0.7 Does factory QC compare first piece samples with approval sample and specification sheet?

工廠QC是否根據(jù)客戶簽樣和產(chǎn)品規(guī)格表來制定首件樣品？

4.0.8 Are there adequate approved samples, first piece samples, reference samples, and work instructions to provide workers with proper guidelines?

是否有足夠的核準(zhǔn)樣品、首件樣品、參考樣品和作業(yè)指導(dǎo)書提供給工人做適當(dāng)?shù)闹敢?/span>

4.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification?

(嚴(yán)重) QC是否被授權(quán)當(dāng)產(chǎn)品質(zhì)量不符合規(guī)格時(shí)是否有權(quán)停止生產(chǎn)？

4.0.10 In-line inspections (IPQC) are performed by QC at every operation process.

在每一個(gè)操作過程是否由QC 執(zhí)行巡檢(IPQC)。

4.0.11 Is quality of item acceptable on current production? (Check 8 finished products taken from factory final inspected goods and check for major defects on the item.)

現(xiàn)行生產(chǎn)的產(chǎn)品質(zhì)量是否可以接受? (檢查8個(gè)已檢驗(yàn)的完成品是否有主要缺陷)

4.0.12 Factory QC inspects per standard AQL or as per industry standards.

工廠QC檢驗(yàn)是否按照AQL抽樣檢驗(yàn)標(biāo)準(zhǔn)或按照工業(yè)標(biāo)準(zhǔn).

4.0.13 Factory performs 100% functionality check on final products?

工廠對(duì)最終產(chǎn)品有沒有實(shí)施100%功能性檢查?

4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)

工廠是否使用糾正措施和根本原因分析方法？(請(qǐng)?zhí)峁├?

4.0.15 Does factory have guidelines in place to ensure packaging is correct for product?

工廠是否有工作指引以確保產(chǎn)品包裝是正確的？

4.0.16 Does packing area have enough space to perform packing functions properly? Is it clean and organized?

包裝區(qū)是否有足夠的空間用來履行包裝職能？是否清潔和有秩序？

4.0.17 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather. 包裝紙箱是否儲(chǔ)存在封閉區(qū)域內(nèi), 沒有暴露于陽(yáng)光和潮濕天氣。

4.0.18 Does factory track and document on-time ship performance?

工廠是否有跟蹤和記錄準(zhǔn)時(shí)出貨的表現(xiàn)？

 

5.0 In-House Lab-Testing內(nèi)部實(shí)驗(yàn)室測(cè)試審核

5.0.1 Does factory perform in-house lab testing and are facilities appropriately equipped? (Please refer to the FCCA attachment for in-house lab testing requirements.)

工廠是否執(zhí)行內(nèi)部實(shí)驗(yàn)室測(cè)試和配備適當(dāng)設(shè)施(請(qǐng)參考FCCA 內(nèi)部實(shí)驗(yàn)室測(cè)試要求的附頁(yè))？

5.0.2 All gauges and test equipments have valid calibrations.

所有量規(guī)和測(cè)試設(shè)備是否有效校準(zhǔn)。

5.0.3 Testing manuals of various industry standards are available as reference.

是否有各種行業(yè)標(biāo)準(zhǔn)測(cè)試手冊(cè)作為參考。

5.0.4 In-house Lab Technicians are properly trained to perform testing functions.

內(nèi)部實(shí)驗(yàn)室的技術(shù)人員有沒有受過適當(dāng)訓(xùn)練來執(zhí)行測(cè)試工作。

 

6.0 Final inspection最終檢驗(yàn)

6.0.1 Does factory have procedure and working instruction for final QC?

工廠有沒有最終檢驗(yàn)程序, 最終檢驗(yàn)QC有沒有工作指導(dǎo)書？

6.0.2 Factory QC conducts final inspection per standard AQL or as per industry standards.

工廠QC 有沒有根據(jù)AQL抽樣檢驗(yàn)標(biāo)準(zhǔn)或行業(yè)標(biāo)準(zhǔn)來實(shí)施最終檢驗(yàn)。

6.0.3 An approved sample or reference sample with packing list and shipping marks are available as reference for factory QC.

最終檢驗(yàn)QC有沒有客戶簽樣或參考樣品, 包裝清單以及出貨嘜頭作參考.

6.0.4 Are there formal written final inspection reports? Are they properly filed and traceable to review quality of products?

有沒有正式的最終檢驗(yàn)報(bào)告? 這些報(bào)告是否歸檔及可追蹤產(chǎn)品質(zhì)量?

6.0.5 Does factory final QC perform internal mechanical tests to ensure the safety of product?

工廠最終檢驗(yàn)QC有沒有做一些機(jī)械測(cè)試以確保產(chǎn)品的安全性?

6.0.6 Where appropriate, are inspection and testing equipment used by the inspector in good condition and calibrated?

檢驗(yàn)及測(cè)試的儀器設(shè)備是否使用良好且有校正?

6.0.7 (Critical) Failed inspections are properly corrected prior to final inspection by customer.

(嚴(yán)重) 退貨的產(chǎn)品在客戶最終檢驗(yàn)前有沒有得到適當(dāng)糾正。

6.0.8 Factory does not ship goods unless subjected to release procedures from customer.

工廠有沒有程序控制只有當(dāng)客戶同意的情況下才能出貨。

 

7.0 People Resources and Training人力資源招聘和培訓(xùn)

7.0.1 (Critical) Factory conducts, documents, maintains on-job training for all personnel, or conducts pre-hire testing of skilled workers prior to hiring.

(重要) 工廠有沒有實(shí)施、記錄、保持對(duì)所有人員進(jìn)行崗位培訓(xùn), 對(duì)技術(shù)工人在聘用前進(jìn)行測(cè)試。

7.0.2 2. Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QC and Lab Test Technician.

工廠有沒有對(duì)電氣/機(jī)械工程師、技師、檢驗(yàn)員和實(shí)驗(yàn)室測(cè)試技術(shù)員實(shí)施技術(shù)培訓(xùn)，并保持記錄。

7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained.

是否有保存所有人員的培訓(xùn)記錄和個(gè)人表現(xiàn)記錄。、