MANAGEMENT SYSTEM ASSESSMENT - PRE ASSESSMENT AUDIT  伊萊克斯質(zhì)量管理體系評價-預評價審核

PRE-ASSESSMENT AUDIT - SECTION QUESTIONNAIRE 伊萊克斯驗廠評估前審計 - 部門調(diào)查問卷

1、 MANAGEMENT 伊萊克斯質(zhì)量評估問卷 - 管理

1.1 Does the supplier organisation hold a current ISO9001 or equivalent certification (e.g. ISO/TS16949) from an accredited certification body for the scope of product/services to be supplied?
工廠是否有認證機構頒發(fā)的ISO9001證書？

1.2 Have quality objectives (both internal and external) been established and agreed using feedback from customers and other available information?
是否有建立的質(zhì)量目標（包括內(nèi)部的和外部的），是否同意使用來自客戶、內(nèi)部及其他可用信息的反饋資料？

1.3 Have objectives been analyzed and are actions being taken if the targets are not achieved? Internal targets and consequent activities have to be considered, too.     質(zhì)量目標是否進行過分析，目標未達到是否采  取相應措施？內(nèi)部目標和結果分析也需要考慮？

1.4 Is there a system to measure quality costs that monitor internal failures, external failures, prevention, and appraisal?
是否有測量質(zhì)量損失（監(jiān)控內(nèi)部損失、外部損失、預防和評價）的系統(tǒng)？

1.5 Have specific improvement projects been identified and are they managed with appropriate measurables and verified for effectiveness?
詳細的改進方案是否進行了鑒定？方案是否考慮了有效性、適當性、可測量性及可證實性？

1.6 Is there a system established to investigate the causes of non-conformance (internal and external, i.e. customer complaints and returned parts analysis) and are appropriate corrective actions developed to eliminate them?
是否建立系統(tǒng)來調(diào)查不合格品原因（內(nèi)部和外部，如顧客投訴和召回部件分析），是否有適當?shù)恼拇胧﹣硐@些原因？

1.7 Is the effectiveness of corrective action verified in a proper way (including targets, trends, PDCA method etc) in order to prevent recurrences?
是否運用恰當?shù)姆绞剑ò繕?、趨勢、PDCA方法等）來驗證整改措施的有效性以便預防錯誤重復發(fā)生？

1.8 Has a system been established to identify training needs and conduct training of all personnel performing activities affecting quality?
是否建立系統(tǒng)來確定培訓需求和進行全員培訓來執(zhí)行影響質(zhì)量的措施？

1.9 Are management reviews performed at defined intervals with active participation of senior management?
管理評審是否在明確的時間間隔內(nèi)進行并且有高級管理層的積極參與？

2、 QUALITY PLANNING Electrolux驗廠 - 質(zhì)量策劃

2.1 "Is there a new product introduction process in place which addresses the following?
- Review of customer requirements;
- Involvement/interfaces with customers and suppliers;
- Feasibility studies;
- Tooling planning;
- FMEA’s;
- Identification/control of critical characteristics;
- Measurement Systems Analysis;
- Control Plans and Flow Charts;
- Sample identification and submission;
- Evaluation of process capability and use of appropriate statistical methods;
- Evaluation of products over intended lifetime;
- Management of changes in the above." "新產(chǎn)品采用過程中是否有以下的品質(zhì)計劃？
1）客戶要求評審；
2）與客戶和供應商共同參與/介入；
3）可行性研究；
4）工裝計劃；
5）FMEA；
6）關鍵特性的鑒定/控制；
7）測量系統(tǒng)分析；
8）控制計劃和流程圖；
9）抽樣鑒定和提交；
10)工序能力評估、合適的統(tǒng)計方法的使用；
11）超過預定使用壽命產(chǎn)品的評估；
12）以上內(nèi)容的變更管理。"

2.2 Can the supplier organization demonstrate capability to undertake Risk Assessment / Failure Mode and Effect Analysis (FMEA)?
工廠能否證明其從事風險評估/失效模式及原因分析（FMEA）的能力？

2.3 Can the supplier organization demonstrate that they are able to perform statistical process capability studies and utilise statistical process control methods? 工廠能否證明其能夠進行統(tǒng)計工序能力研究和使用統(tǒng)計過程控制方法？

2.4 Is there an effective system for approval/ validation of parts and where necessary, processes both internal and external prior to commencement of production at the supplier organization’s facility?
在零部件提交批準/確認時或必要時在生產(chǎn)開始前的內(nèi)外部工序、模具、機器和設備，工廠是否有有效的系統(tǒng)？

3、 Purchasing 伊萊克斯質(zhì)量驗廠 - 采購

3.1 Is there an effective system for ongoing monitoring of supplier performance capability and is QS Management a requirement?
針對進行中的供應商績效能力的監(jiān)控是否有有效系統(tǒng)，且是否要求質(zhì)量標準（QS）管理？

3.2 Is there an effective system ensuring corrective actions are established on the basis of "suppliers’ classification and performance" results?
是否有有效的系統(tǒng)來確保糾正措施是建立在“供應商分類和績效”結果的基礎上？

3.3 Is there a defined process for sample submission from suppliers and for sample evaluation?
對供應商的樣品提交和樣品評估是否有明確的過程？

3.4 Are suppliers required to notify the organization of any changes made to supplied products? Relevant engineering changes must be formally communicated to and responded by suppliers.
是否要求供應商在供應產(chǎn)品發(fā)生任何變更時通知工廠？供應商必須正式地傳達和反映相關的設計變更。

4、 CONTROL OF PRODUCTION, MONITORING & MAINTENANCE Electrolux驗廠 - 生產(chǎn)、監(jiān)控和維護的控制

4.1 Do procedures (or control plans)/work instructions specify requirements for operation, inspection, testing, gauging, production start-up approval (including appointed responsible) as well as product, process and tooling changes, with recorded results? Availability of necessary procedures/work instructions at the work station is mandatory.
程序（或控制計劃）/作業(yè)指導書對操作、檢驗、測試、測量、生產(chǎn)啟動批準（包括指定的責任人）是否規(guī)定了要求，同樣生產(chǎn)、過程、模具變更是否有記錄結果？工作站上的必要程序/作業(yè)指導書強制要求其可實用性。

4.2 Are special processes identified and subjected to planned complementary activities to ensure that products shall meet product specifications?
特殊工序是否被鑒定和承受計劃的補充措施，來確保產(chǎn)品符合產(chǎn)品規(guī)格？

4.3 Are statistical methods, SPC, implemented? Process capability index Cpk ≥1.33 where applied to relevant parameters.
是否實施了統(tǒng)計方法和統(tǒng)計過程控制（SPC）？應用于相關參數(shù)的工序能力指數(shù)Cpk≥1.33。

4.4 Are inspections and tests performed at defined stages with clear indication of inspection/test status?
檢驗和測試是否在明確階段根據(jù)檢驗/測試狀態(tài)的清晰指示執(zhí)行？

4.5 Has an effective system been implemented for handling, storage, packaging, delivery and preservation of the product?
在產(chǎn)品搬運、儲存、包裝、交付和保存過程是否實施了有效系統(tǒng)？

4.6 Is the cleanness of the work environment in general well tailored and well organized to ensure that products comply with requirements and are not contaminated or otherwise affected?
工作環(huán)境的清潔通常是否被很好地組織和整理來確保產(chǎn)品遵守要求且沒有受到污染或其他影響？

4.7 Are written procedures used to monitor the product quality (including special process parameters) from incoming, through the in process controls, to the final statistical product audit of ready to ship products?
是否使用書面程序來監(jiān)督產(chǎn)品質(zhì)量（包括特殊工藝參數(shù)）從通過過程質(zhì)量控制的來料到最終的統(tǒng)計產(chǎn)品準備審核再到運輸產(chǎn)品？

4.8 Is there a planned maintenance system for all equipment including a maintenance schedule, defined criteria, frequencies and assigned responsibilities and records?
對所有的設備是否有計劃維護系統(tǒng)包括維護計劃、明確的標準、頻率、指定的職責和記錄？

4.9 Is there a system to manage key manufacturing equipment spare parts including their identification and availability?
是否有一個系統(tǒng)來管理關鍵制造設備的備用配件包括它們的標識和有效性？

5、 CALIBRATION, IDENTIFICATION, TRACEABILITY & DOCUMENTATION 伊萊克斯質(zhì)量驗廠 - 校準、標識、可追溯性和文件

5.1 Is there a system in place which ensures that appropriate measuring and test equipment is properly calibrated at periodic intervals with traceability to national/ international standards and the performance of MSA (Measurement Systems Analysis) studies?
是否有合適的系統(tǒng)來確保測量和測試設備在一定周期間隔內(nèi)很好地被校準，可追溯到國家/國際標準和測量系統(tǒng)分析（MSA）研究成果？

5.2 Are materials, products and constituent components, and are homogeneous batches kept separated identified at all stages of production including incoming and final warehousing?
物料、產(chǎn)品、組成部件、同種批次是否在生產(chǎn)所有階段包括來料倉庫和成品倉庫進行隔離識別？

5.3 Has provision been made for a recorded and maintained traceability system of product to source and through all the relevant process parameters?
記錄和維護的生產(chǎn) 追溯系統(tǒng)是否制定了相應規(guī)定來追溯來源和通過所有相關的過程參數(shù)？

5.4 Does the system for document control, by means of a master list, include review, approval, issue dating and distribution of documents and procedures? This must include control of relevant computer software, masters, and customer drawings?
借助于總清單的文件控制系統(tǒng)是否包括文件和程序的評審、批準、簽發(fā)日期、分發(fā)？必須包括對相關計算機軟件、持有者和客戶圖紙的控制。

5.5 Has an effective system been implemented to handle engineering and process changes to ensure that they have been properly approved and implemented?
是否實施 有效系統(tǒng)來處理設計和過程變更以確保這些變更得到正確的認可和實施？

6、 DESIGN CONTROL 伊萊克斯驗廠 - 設計控制

6.1 Is there a system established and maintained to identify, control and verify design inputs and outputs, targets, development stages, review, verification and validation?
是否有建立和維護一個系統(tǒng)來識別，控制和驗證設計的投入和產(chǎn)出，目標，開發(fā)階段，評審，驗證和確認？

6.2 Is there a system clearly defining when the design review, engineering changes included, is conducted, the frequency and at which stages?
是否有一個系統(tǒng)明確界定時，包括設計評審，工程變更，傳導，頻率以及哪些階段？

6.3 Are the safety, regulatory, customer, and validation requirements clearly defined and the relevant responsible authorities appointed and competent?
是安全，法規(guī)，客戶和驗證的要求明確規(guī)定和任命能勝任的主管部門？

6.4 Does it exist a system for validation and acceptance plan of the design? This must include reliability and testing plans.
是否存在一個系統(tǒng)的驗證和驗收設計計劃？這必須包括可靠性和測試計劃。

6.5 Are all records of project inputs and outputs targets, safety / regulatory / statutory / customer included, design validation and relevant competent authorities’ approvals maintained, traceable and retrievable for the required time?
是否項目的輸入和輸出記錄指標，安全/管理/法律/客戶包括，設計驗證和有關主管部門的認同維護，規(guī)定時間內(nèi)的所有記錄可追溯和檢索？