【正文】 We shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product C. 當(dāng)顧客財(cái)產(chǎn)發(fā)生丟失、損壞或發(fā)現(xiàn)不適用的情況時(shí)。identify the products status with respect to monitoring and measurement requirements C. 在有可追溯性要求的場合, 本公司應(yīng)控制并記錄產(chǎn)品的唯一性標(biāo)識.control and record the unique identification of the product if traceability is a requirement 注: 在本公司所屬的行業(yè), 技術(shù)狀態(tài)管理非保持標(biāo)識和可追溯性的一種方法NOTE: in our pany’s industry sector, configuration management is not a means by which identification and traceability are maintained 顧客財(cái)產(chǎn)Customer property A. 應(yīng)愛護(hù)在本公司控制下或本公司使用的顧客財(cái)產(chǎn)。requirements for records, and e. 再確認(rèn). revalidation 標(biāo)識和可追溯性Identification and traceability 建立、實(shí)施和改進(jìn)《產(chǎn)品標(biāo)識和可追溯性管理程序》, 以便:Product Identification and Traceability Management Procedure shall be established, implemented and improved to A. 適當(dāng)時(shí), 本公司將在產(chǎn)品實(shí)現(xiàn)的全過程中使用適宜的方法識別產(chǎn)品。approval of equipment and qualification of personnel c. 使用特定的方法和程序。Validation shall demonstrate the ability of these processes to achieve planned results C. 本公司將對這些過程作出安排, 適用時(shí)包括:We shall establish arrangements for these processes including, as applicable a. 為過程的評審和批準(zhǔn)所規(guī)定的準(zhǔn)則。the availability and use of monitoring and measuring devices E. 實(shí)施監(jiān)視和測量。the availability of work instructions, as necessary C. 使用適宜的設(shè)備。and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements B. 當(dāng)本公司或本公司的顧客擬在供方的現(xiàn)場實(shí)施驗(yàn)證時(shí), 采購人員將在采購信息中對擬驗(yàn)證的安排和產(chǎn)品放行的方法作出規(guī)定. where we or our customer intends to perform verification at the supplier’s premises, purchasers shall state the intended verification arrangements and method of product release in the purchasing information 生產(chǎn)Production 生產(chǎn)控制Control of production建立、實(shí)施和改進(jìn)《生產(chǎn)管理程序》, 以確保本公司策劃并在受控條件下進(jìn)行生產(chǎn). 適用時(shí), 受控條件應(yīng)該包括:Production Management Procedure shall be established, implemented and improved to plan and carry out production under controlled conditions. Controlled conditions shall include, as applicable A. 獲得表述產(chǎn)品特征的信息。requirements for qualification of personnel, and C. 質(zhì)量管理體系的要求。determine criteria for selecting, assessing and reassessing suppliers, and e. 保留評價(jià)結(jié)果及評價(jià)所引發(fā)的任何必要措施的記錄.maintain the records of the results of evaluations and any necessary actions arising from the evaluation 采購信息Purchasing information 《采購程序》應(yīng)規(guī)定采購信息, 以表述擬采購的產(chǎn)品, 適當(dāng)時(shí)包括:Purchasing Procedure shall define purchasing information in order to describe the product to be purchased, including where appropriate A. 產(chǎn)品、程序、過程和設(shè)備批準(zhǔn)的要求。ensure that the type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product c. 依據(jù)供方按照本公司的要求提供產(chǎn)品的能力評價(jià)和選擇供方。By tests or demonstrationsD. 對設(shè)計(jì)階段的文件在發(fā)放前進(jìn)行評審. Reviewing the Design Stage Documents before release 設(shè)計(jì)和開發(fā)確認(rèn)Design and development validation應(yīng)根據(jù)策劃階段已擬定的計(jì)劃對設(shè)計(jì)和開發(fā)進(jìn)行確認(rèn)以確保最終產(chǎn)品能滿足所規(guī)定的應(yīng)用及使用要求,若切實(shí)可行, 設(shè)計(jì)和開發(fā)確認(rèn)需在產(chǎn)品交付或?qū)嵤┣巴瓿? 應(yīng)保存設(shè)計(jì)和開發(fā)確認(rèn)的結(jié)果及必要措施的記錄.Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be pleted prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained. 設(shè)計(jì)和開發(fā)變更的控制 Control of design and development changes設(shè)計(jì)和開發(fā)變更必須加以識別并保存記錄,設(shè)計(jì)更改在實(shí)施前必須經(jīng)過評審、.Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.應(yīng)保存設(shè)計(jì)和開發(fā)變更的評審結(jié)果及必要措施的記錄.Records of the results of the review of changes and any necessary actions shall be maintained. 采購Purchasing 采購過程Purchasing process 公司建立、實(shí)施和改進(jìn)《采購程序》Purchasing Procedure shall be established, carried out and improved to a. 以確保采購的產(chǎn)品符合規(guī)定的采購要求。 Performing alternate calculationsB. 與以往相類似設(shè)計(jì)進(jìn)行比較。 provide appropriate information for purchasing , production and for service provision,C. 包含或提及產(chǎn)品接受標(biāo)準(zhǔn)。 where applicable, information derived from previous similar designs, andD. 設(shè)計(jì)和開發(fā)的其它重要要求. other requirements essential for design and development. , 明確且不相互抵觸.These inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other. 設(shè)計(jì)和開發(fā)輸出 Design and development outputs 設(shè)計(jì)和開發(fā)輸出必須以表格的形式提供以便能對應(yīng)設(shè)計(jì)和開發(fā)輸入進(jìn)行驗(yàn)證,此外在分發(fā)前必須獲得批準(zhǔn). The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. 設(shè)計(jì)和開發(fā)輸出須Design and development outputs shallA. 滿足設(shè)計(jì)和開發(fā)輸入的要求。 Functional, performance and appearance requirements,B. 適用的法律及法規(guī)要求。 the review, verification and validation that are appropriate to each design and development stage, andC. 設(shè)計(jì)和開發(fā)的職責(zé)與權(quán)限。 enquiries, contracts or order handling, including amendments, and C. 顧客反饋, 包括顧客投訴. customer feedback, including customer plaints 設(shè)計(jì)和開發(fā)Design and development 本公司建立、實(shí)施和改進(jìn)《新產(chǎn)品設(shè)計(jì)與開發(fā)程序》以確保產(chǎn)品的固有品質(zhì)、效力、安全性及顧客滿意度.New Product Design and Development Procedure shall be established, carried out and improved to ensure the inherent quality, effectiveness, safety and customer satisfaction of the product. 設(shè)計(jì)和開發(fā)策劃 Design and Development Planning 在設(shè)計(jì)和開發(fā)策劃期間,本公司需確定 During the design and development planning, our pany shall determine:A. 設(shè)計(jì)各開發(fā)所需的過程和階段。Where the customer provides no documented statement of requirement, the sales personnel shall request the customer to provide the document. 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