【正文】 esign with a similar proven designC. 通過測試或演示。By tests or demonstrationsD. 對設計階段的文件在發(fā)放前進行評審. Reviewing the Design Stage Documents before release 設計和開發(fā)確認Design and development validation應根據(jù)策劃階段已擬定的計劃對設計和開發(fā)進行確認以確保最終產(chǎn)品能滿足所規(guī)定的應用及使用要求,若切實可行, 設計和開發(fā)確認需在產(chǎn)品交付或?qū)嵤┣巴瓿? 應保存設計和開發(fā)確認的結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. 設計和開發(fā)變更的控制 Control of design and development changes設計和開發(fā)變更必須加以識別并保存記錄,設計更改在實施前必須經(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.應保存設計和開發(fā)變更的評審結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、實施和改進《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。 ensure purchased products conforms to specified purchase requirementsb. 確保對供方及采購的產(chǎn)品控制的類型和程度將取決于采購的產(chǎn)品對隨后的產(chǎn)品實現(xiàn)或最終產(chǎn)品的影響。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)品的能力評價和選擇供方。 evaluate and select suppliers based on their ability to supply product in accordance with our pany’s requirementsd. 制定選擇、評價和重新評價供方的準則。determine criteria for selecting, assessing and reassessing suppliers, and e. 保留評價結果及評價所引發(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》應規(guī)定采購信息, 以表述擬采購的產(chǎn)品, 適當時包括:Purchasing Procedure shall define purchasing information in order to describe the product to be purchased, including where appropriate A. 產(chǎn)品、程序、過程和設備批準的要求。 requirements for approval of product, procedures, processes and equipment B. 人員資格的要求。requirements for qualification of personnel, and C. 質(zhì)量管理體系的要求。 quality management system requirements 在與供方溝通之前, 采購人員必須確保規(guī)定的采購要求是充分與適宜的. The purchasers shall ensure the adequacy of specified purchase requirements prior to their munication to the supplier 采購產(chǎn)品的驗證:Verification of purchased product 公司建立、實施和改進《進料質(zhì)量控制程序》, 以規(guī)定:Ining Quality Control Procedure shall be established, implemented and improved to stipulate A. 并實施檢驗或其他必要的活動, 以確保采購的產(chǎn)品滿足規(guī)定的采購要求。and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements B. 當本公司或本公司的顧客擬在供方的現(xiàn)場實施驗證時, 采購人員將在采購信息中對擬驗證的安排和產(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、實施和改進《生產(chǎn)管理程序》, 以確保本公司策劃并在受控條件下進行生產(chǎn). 適用時, 受控條件應該包括: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。the availability of information that describes the characteristics of the productB. 獲得作業(yè)指導書。the availability of work instructions, as necessary C. 使用適宜的設備。the use of suitable equipment D. 獲得和使用監(jiān)視和測量裝置。the availability and use of monitoring and measuring devices E. 實施監(jiān)視和測量。the implementation of monitoring and measurement, and F. 放行、交付和交付后活動的實施. the implementation of release, delivery and postdelivery activities 生產(chǎn)過程的確認Validation of processes for productionA. 當生產(chǎn)過程的輸出不能由后續(xù)的監(jiān)視或測量加以驗證時, .We shall validate any processes for production where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies bee apparent only after the product is in use.B. 確認應證實這些過程實現(xiàn)所策劃的結果的能力。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, 適用時包括:We shall establish arrangements for these processes including, as applicable a. 為過程的評審和批準所規(guī)定的準則。 defined criteria for review and approval of the process b. 設備的認可和人員資格的鑒定。approval of equipment and qualification of personnel c. 使用特定的方法和程序。use of specific methods and procedures d. 記錄的要求。requirements for records, and e. 再確認. revalidation 標識和可追溯性Identification and traceability 建立、實施和改進《產(chǎn)品標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. 適當時, 本公司將在產(chǎn)品實現(xiàn)的全過程中使用適宜的方法識別產(chǎn)品。identify the product by suitable means throughout product realization if appropriateB. 針對監(jiān)視和測量要求識別產(chǎn)品的狀態(tài)。identify the products status with respect to monitoring and measurement requirements C. 在有可追溯性要求的場合, 本公司應控制并記錄產(chǎn)品的唯一性標識.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), 技術狀態(tài)管理非保持標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 顧客財產(chǎn)Customer property A. 應愛護在本公司控制下或本公司使用的顧客財產(chǎn)。We shall exercise care with customer property while it is under our control or being used by us B. 應識別、驗證、保護供其使用或構成產(chǎn)品一部分的顧客財產(chǎn)。We shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product C. 當顧客財產(chǎn)發(fā)生丟失、損壞或發(fā)現(xiàn)不適用的情況時