FCCA Quality System Audit Outline
FCCA質(zhì)量體系審核綱要
(Quality System part質(zhì)量體系部分)
4.0 Process and Production Control過程和生產(chǎn)控制
4.0.1 Does factory have work area only for Product Development? 工廠是否有產(chǎn)品開發(fā)工作區(qū)？
4.0.2 Does factory PD study and apply product safety features, evaluates patterns, moulds and samples during product design and development? 在產(chǎn)品設(shè)計(jì)和開發(fā)工廠產(chǎn)品開發(fā)的研究與應(yīng)用是否有產(chǎn)品安全功能、評(píng)估模式、模具和樣品？
4.0.3 Does Product development includes packaging design and tests that conforms to industry standard (ISTA) 產(chǎn)品開發(fā)包括包裝設(shè)計(jì)和測(cè)試以確保符合行業(yè)標(biāo)準(zhǔn)(ISTA)。
4.0.4 Does factory PD perform assembly time-study on product and develop easy ways to use for consumer benefit? 工廠產(chǎn)品開發(fā)在產(chǎn)品執(zhí)行組裝時(shí)間研究，產(chǎn)品開發(fā)和簡(jiǎn)便的方法使用的消費(fèi)者受益呢？
4.0.5 Factory has documented Production procedures at each stage of operation. 工廠有每一個(gè)階段的運(yùn)作生產(chǎn)程序文件。
4.0.6 Factory has documented Quality procedures at each stage of operation. 工廠有每一個(gè)階段的運(yùn)作質(zhì)量程序文件。
4.0.7 Does factory conduct Pre-production meeting prior to start of production?工廠是否實(shí)施進(jìn)行生產(chǎn)前的預(yù)產(chǎn)會(huì)議？
4.0.8 Are production and quality supervisors present during Pre-production meeting?目前在預(yù)產(chǎn)會(huì)議有生產(chǎn)和質(zhì)量主管？
4.0.9 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting? (重要)是至關(guān)重要的質(zhì)量和安全檢查、審查，確定，并采取行動(dòng)加以改進(jìn)記錄在預(yù)產(chǎn)會(huì)議？
4.0.10 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“試運(yùn)行”，檢討對(duì)產(chǎn)品質(zhì)量的規(guī)格表和文件在糾正行動(dòng)之前生產(chǎn)？
4.0.11 Is quality of item acceptable on current production? (Check 3 or 4 completed products from production floor). 質(zhì)量是可以接受的項(xiàng)目就目前的生產(chǎn)呢？(從生產(chǎn)區(qū)檢查3或4個(gè)成品)。
4.0.12 Was in house lab-testing performed on current production? (Request for test copies)內(nèi)部實(shí)驗(yàn)室測(cè)試是否實(shí)施當(dāng)前生產(chǎn)測(cè)試？(要求測(cè)試的副本)
4.0.13 Does factory QC compare first piece samples with approval sample and specification sheet? 工廠QC是否比較首件樣品抽樣檢驗(yàn)和批準(zhǔn)的規(guī)格表？
4.0.14 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、參考樣品和為工人提供適當(dāng)?shù)淖鳂I(yè)指導(dǎo)書？
4.0.15 Does factory use defective/ reject samples to demonstrate examples of common defects?
工廠使用有缺陷的/不合格樣品是否普遍例子？
4.0.16 (Critical) Does Quality Control have authority to stop production if quality of products did not meet specification? (重要)如果產(chǎn)品質(zhì)量不符合規(guī)格質(zhì)量控制是否有權(quán)停止生產(chǎn)？
4.0.17 In-line inspections (IPQC) are performed by QC at every operation process. 在巡檢(IPQC)所執(zhí)行品管在每一個(gè)操作過程。
4.0.18 Does factory use statistical process control (SPC for quality)?工廠使用統(tǒng)計(jì)過程控制?(質(zhì)量統(tǒng)計(jì)分析)
4.0.19 Factory QC inspects per standard AQL or as per industry standards.工廠品管檢驗(yàn)按照標(biāo)準(zhǔn)AQL或按照工業(yè)標(biāo)準(zhǔn).
4.0.20 Factory performs 100% functionality check on final products?工廠最終產(chǎn)品實(shí)施100%功能性確認(rèn)?
4.0.21 Does factory use corrective actions and root cause analysis methods? (Please provide examples)工廠是否使用的糾正措施和根本原因分析方法呢？(請(qǐng)?zhí)峁├?/span>)
4.0.22 Does factory have guidelines in place to ensure packaging is correct for product? 工廠是否有指南以適當(dāng)確保包裝是正確的產(chǎn)品？
4.0.23 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？它是清潔和有組織的？
4.0.24 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather. 包裝紙箱都儲(chǔ)存在封閉區(qū)域內(nèi)沒有暴露于陽光和潮濕天氣。
4.0.25 Does factory track and document on-time ship performance?工廠是否有跟蹤和文件準(zhǔn)時(shí)出貨職能？
4.1 Suppliers and Sub-contractors供應(yīng)商和分包商
4.1.1 Does factory have a documented supplier selection and approval process?工廠是否有供應(yīng)商選擇和批準(zhǔn)過程文件?
4.1.2 Does factory track, evaluate and document material’s supplier reliability (performance)?工廠是否跟蹤、評(píng)價(jià)和文件物料供應(yīng)商的可靠性(效能) ？
4.1.3 Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability? 工廠是否有建立質(zhì)量記錄的程序和工廠評(píng)估、監(jiān)測(cè)分包商的質(zhì)量性能和可靠性呢？
5.0 In-House Lab-Testing內(nèi)部實(shí)驗(yàn)室-測(cè)試
5.0.1 Does factory perform in-house lab testing and are facilities appropriately equipped? 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？
5.0.2 All gauges and test equipments have valid calibrations.所有量規(guī)和測(cè)試設(shè)備有效校準(zhǔn)。
5.0.3 Testing manuals of various industry standards are available as reference.各種行業(yè)標(biāo)準(zhǔn)測(cè)試手冊(cè)是可作為參考。
5.0.4 In-house Lab Technicians are properly trained to perform testing functions. 在內(nèi)部實(shí)驗(yàn)室的技術(shù)人員受過適當(dāng)訓(xùn)練的執(zhí)行測(cè)試功能。
6.0 Final inspection最終檢驗(yàn)
6.0.1 Does factory QC performs final inspection and documents it?工廠QC是否執(zhí)行最終檢驗(yàn)和文件？
6.0.2 An approved sample or reference sample with packing list and shipping marks are available as reference for factory QC. 已核準(zhǔn)的樣品或參考樣品與包裝清單和嘜頭，可作為工廠品管參考的。
6.0.3 (Critical) Failed inspections are properly corrected prior to final inspection by customer.
(重要的)失效檢驗(yàn)得到適當(dāng)糾正在客戶最終檢驗(yàn)。
6.0.4 Factory does not ship goods unless subjected to release procedures from customer.
工廠不出貨的貨物除非從客戶獲得豁免的程序。
7.0 People Resources and Training人力資源和培訓(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)工廠進(jìn)行、文件、保持對(duì)在職培訓(xùn)的所有人員或進(jìn)行崗前技能培訓(xùn)。
7.0.2 Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QA Auditor and Lab Test Technician. 工廠進(jìn)行和文件的技術(shù)培訓(xùn)計(jì)劃電動(dòng)/機(jī)械工程師，機(jī)械師，質(zhì)量保證審計(jì)員和實(shí)驗(yàn)室測(cè)試技術(shù)員。
7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained. 記錄學(xué)員及所有工作人員定期與相應(yīng)的業(yè)績(jī)記錄，保存和維修保養(yǎng)。
Factory Quality System工廠的質(zhì)量體系
1.0 Factory Facilities and Environment工廠設(shè)施和環(huán)境
1.0.1 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas? 足夠的照明上：生產(chǎn)，返工，加工，檢驗(yàn)，包裝及裝載的區(qū)域？
1.0.2 The facility maintains clean and organized production, finishing and packing areas.
工廠保持清潔和有組織的生產(chǎn)，加工和包裝領(lǐng)域。
1.0.3 Facility has separate inspection area with inspection table and proper ventilation.
工廠有單獨(dú)的檢驗(yàn)區(qū)與檢驗(yàn)臺(tái)并且適當(dāng)?shù)耐L(fēng)設(shè)備。
1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)
工廠已記錄害蟲/霉菌和濕度的控制程序，其中包括經(jīng)常巡查。(在公司內(nèi)部或第三方)
1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit. 沒有打破窗戶或屋頂漏水，可能導(dǎo)致產(chǎn)品污染的觀察審核期間。
1.0.6 Factory has metal detecting unit. (Scoring will not apply (N/A) if factory does not need this machine.) 工廠有金屬檢測(cè)單位。
1.0.7 (Critical) Factory implements strict sharp tools control procedure to prevent scissors, knives, blades, broken glasses and needles to be mixed with product.
(重要)工廠實(shí)行嚴(yán)格的尖銳工具控制程序，以防止剪刀、刀、刀片、碎玻璃和針頭，以混合的產(chǎn)品。
1.0.8 Factory has back-up power supply available. “Generator” 工廠有后備電力供應(yīng)。“發(fā)電機(jī)”
1.1 Machine Calibration and Maintenance機(jī)器校準(zhǔn)和維護(hù)
1.1.1 Factory machines and equipments are appropriate to produce Wal-Mart products. 工廠的機(jī)器和設(shè)備是適合的生產(chǎn)沃爾瑪?shù)漠a(chǎn)品。
1.1.2 Factory has documented system and procedure for scheduled equipment cleaning and repairs. 工廠有文件體系和程序，預(yù)定設(shè)備清洗和維修。
1.1.3 Factory machines and equipments appear to be clean and in good running condition.
工廠的機(jī)器和設(shè)備顯示是清潔和良好的運(yùn)行狀態(tài)。
1.1.4 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule. 機(jī)器、設(shè)備和工具有適當(dāng)?shù)臉?biāo)識(shí)最后維修/校準(zhǔn)日期及進(jìn)度表。
1.1.5 Machines, equipments and tools that needs to be repaired are properly labeled to avoid accidental use. 機(jī)器、設(shè)備和工具需要維修時(shí)有標(biāo)識(shí)以避免意外使用。
1.1.6 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves. 工廠有適當(dāng)?shù)?，清潔的和有組織的存儲(chǔ)區(qū)域的關(guān)鍵模具(即注射模)與標(biāo)識(shí)的貨架上。
1.1.7 Factory has proper documentation and updated inventory of machines, tools, spare parts and equipments. 工廠有適當(dāng)?shù)奈募透聨?kù)存機(jī)器、工具、零部件和設(shè)備。
1.1.8 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines. 工廠維修團(tuán)隊(duì)與合適的技術(shù)水平和設(shè)備，以履行必要的維修和校準(zhǔn)的機(jī)器上。
2.0 Quality Management System質(zhì)量管理體系
2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures. 工廠建立適合產(chǎn)品和程序質(zhì)量管理體系。
2.0.2 Workers & Supervisors are familiar to these quality policies and objectives. 工人與主管所熟悉的這些質(zhì)量的政策和目標(biāo)。
2.0.3 Factory has documented customer complaint system and documented recall program. 工廠已記錄了顧客投訴體系，并記錄召回計(jì)劃。
2.0.4 (Critical) Factory QC team is independent from Production division. (重要)工廠QC團(tuán)隊(duì)是獨(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) 生產(chǎn)管理和QC團(tuán)隊(duì)討論和共同努力在解決質(zhì)量問題/關(guān)注的問題。（記錄）
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. 工廠有制度和程序能控制物理、化學(xué)和生物污染風(fēng)險(xiǎn)，可能會(huì)損害產(chǎn)品和人員。
2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments and tools. 工廠進(jìn)行風(fēng)險(xiǎn)評(píng)估，以識(shí)別危險(xiǎn)化學(xué)品、原材料、工藝設(shè)備和工具。
3.0 Incoming Materials Control進(jìn)料控制
3.0.1 Proper first in-first out (FIFO) system on materials are practiced.物料實(shí)施先進(jìn)先出(FIFO)體系。
3.0.2 Factory has procedures for quality inspection on incoming raw materials, accessories and components. 工廠有對(duì)進(jìn)倉(cāng)原物料、配件和部件質(zhì)量檢驗(yàn)的程序。
3.0.3 Incoming and outgoing material quantities are monitored and documented. 進(jìn)料和出貨的物料的數(shù)量進(jìn)行監(jiān)測(cè)和記錄。
3.2.4 Factory has specifications for purchased materials. 工廠有采購(gòu)物料規(guī)范。
3.2.5 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications. 工廠有文件程序和參考樣品以確保進(jìn)倉(cāng)原料符合規(guī)格。
3.2.6 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items. (重要)工廠已適當(dāng)?shù)膶?duì)物料隔離體系，不合格的項(xiàng)目隔離以避免意外污染，
3.2.7 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement. 工廠適當(dāng)隔離良品(不良品)，并確定不良品(拒絕)更換。
3.2.8 Facility’s storage areas have sufficient lighting, well ventilated and clean surrounding. 廠房的存儲(chǔ)區(qū)域周圍有足夠的照明、通風(fēng)和清潔。
3.0.9 Materials, components and accessories are properly stacked and identified with tags / labels and off the floor. 材料、部件和配件的妥善堆放并有標(biāo)記/標(biāo)簽并與地板隔離。
3.0.10 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination. (重要)化學(xué)品和維修的物質(zhì)妥善標(biāo)識(shí)和儲(chǔ)存，以防止污染的風(fēng)險(xiǎn)。
3.0.11 Color relevant materials such as fabrics, genuine leather and synthetic PU/ PVC, trims and accessories are sorted by lot numbers. 顏色有關(guān)的材料如布料、真皮及合成聚氨酯/聚氯乙烯、裝飾及配件按批號(hào)儲(chǔ)存。