产品设计控制流程说明.docx

产品设计控制流程说明Design Controls设计控制About Design ControlsDesign Controls are a major component of a comprehensive quality system that covers the entire life cycle of the device. Design controls apply to new product development and changes. Design controls are part of a continuous, ongoing effort to design and develop a quality device/product that meets customer needs.关于设计控制 设计控制是关乎设备整个生命周期的综合质量体系的关键因素， 它适用于 新产品研发和变动。为设计和研发满足客户需要的质量设备/产品，需要在设计控制方面做出持续努力。Design Controls in PCPDesign Controls begin with the management approval of design inputs at Gate 1.The requirements for Design Controls are met through the deliverables in the Product Development Plan (PDP). Deliverables and processes used may vary based on the product design, development location and local quality system. All reviewed and approved deliverables and related records associated with Design Controls comprise the Design History File for each product. PCP的设计控制 管理层批准Gate 1阶段的设计输入之后，PCP的设计控制开始。产品研发计划（PDP）的产品列表规定了设计控制的要求。根据产品设计，研发地点和当地质量系统的不同，采用的产出列表和流程可能不尽相同。所有与设计控制相关并且通过审查获得批准的产品列表和相关记录都包括各个产品的设计历史文件。 Design and Development PlanningPlans are developed that define product design and development activities, in order to ensure that the design processes are appropriately controlled, and that the device requirements, safety and quality objectives are met. The organizational and technical interfaces having input to the project are identified in the product development plan. Cross-functional team members are named and plans / processes for communications between the appropriate groups are defined. Design and development planning is started in phase 0 with a preliminary version of the Product Development Plan (PDP). This document is updated throughout the project life cycle.设计和研发计划 为了保证恰当的控制设计流程，满足设备要求以及安全和质量目标，需制定计划以规定产品设计和研发活动。产品研发计划确定了组织和技术的接口对项目的输入，指定了多功能小组成员并规定了适当小组之间的交流计划/流程。phase 0 开始设计和研发计划并制定最初版本的产品研发计划（PDP）。整个项目生命周期内都需对文档进行更新。Requirements: Define design and development activities and deliverables. Define responsibilities and processes for implementation of organizational and technical interfaces between groups and disciplines. Plans should be reviewed, updated, and approved as the design and development evolves.要求 规定设计和研发活动以及产出列表。 规定在小组和内部员工之间实施组织和技术接口责任和流程。 随着设计和研发活动的进展，应该审查、更新和批准计划。Design InputDesign inputs are based on customer requirements, technical capability, safety and applicable statutory and regulatory requirements. Quality records ensure that design requirements are adequate, complete, and properly documented. For changes to existing products or services, the completed product development plan or Engineering Change Order (ECO) documentation shall refer to completed product documentation. Design input is captured and is documented in the System Requirements Specification Allocation, the Product-Customer Requirements Document, Product Serviceability Requirements Document and the Product Requirements Specification. 设计输入基于客户需求、技术能力、安全性和适用性法律法规要求。质量记录保证设计要求充分、完整并且被正确记录。如果需对现有文件或服务做出改动，已完成的产品研发计划或设计变动命令（ECO）文件应参考完成的产品文件。在系统要求规格配置、产品-客户 要求文件、产品适用性要求文件和产品要求规格中获取并且记录设计输入。Requirements: Design / Peer Reviews provide a mechanism for identifying incomplete/ambiguous/conflicting design requirements. Design requirements should address intended use and the needs of the user and patient including human factors/hazards and risk associated with intended use of the product. Design inputs should be periodically reviewed, updated, and approved with the signature of those approving the input. 要求 设计/同伴审查提供了一种鉴别不完整/模糊/冲突的设计要求的机制 设计要求应处理预期用途以及用户和病人的需求，包括人为因素/不可预测因素以及与产品预期用途相关的风险。 应定期对设计输入审查、更新并签名批准。Design OutputQuality records ensure the design is complete and adequate. The documentation enables an evaluation of a product against its design inputs. For changes to existing products or services, the completed product development plan or Engineering Change Order (ECO) documentation shall refer to the appropriate product documentation. Design output is created primarily in phase 2 and 3 and consists of documentation necessary to detail the design for manufacturability and serviceability.设计输出 质量记录保证设计完整和充足。文件允许评估产品相对于设计输入的情况。如果需对现有文件或服务做出改动，已完成的产品研发计划或设计变动命令（ECO）文件应参考完成的产品文件。主要在phase 2 and 3创建设计输出，并包括必要的文件以详细说明设计的可生产性和适用性。Requirements: Acceptance criteria should be established prior to validation and verification of the product. Design output is the completed product in its entirety; e.g., product, testing, labeling, as appropriate. Design outputs should identify those parameters that are essential to the proper functioning of the device. Design outputs should be periodically reviewed, updated, and approved with the signature of those approving the output. 要求 应在确认和验证产品之前创建验收标准。 设计输出是完成的完整产品，如产品、测试、标签，视情况而定。 设计输出应该确定对设计的正常运作至关重要的参数。 应定期对设计输入审查、更新并签名批准。Design ReviewFormal documented reviews of design plans, inputs and outputs shall be planned and conducted in order to evaluate the adequacy of the design requirements, to ensure that the design meets these requirements, and to identify problems. Design reviews ensure verification and validation of design input to design output and at a minimum must be conducted to review the design, the Test Verification Plan and readiness for Design Transfer in accordance with the Design Review process.设计审查 为了评估设计要求的充足性，保证设计满足要求和发现问题，应当计划和实施对设计计划、输入和输出的正式有记录的审查。设计审查保证从设计输入到设计输出的 验证和确认，至少应该根据设计审查流程审查设计、测试验证计划和准备设计传输。Requirements: Design Review participants should include representatives of all concerned functions. Design Review participants shall include individuals not directly associated, e.g., independent, with the part/ module/ subsystem being reviewed as appropriate. Design Review participants should include specialists, as needed. 要求 设计审查人员应包括所有相关功能的代表。 设计审查人员应包括不直接相关的个人，如独立个人，视情况而定审查零件/模块/子系统。 如果需要，设计审查人员应包括专家。Design VerificationDesign verification is the execution of the procedures to confirm that the design outputs satisfy the design inputs. The Traceability Matrix facilitates Design Verification by tracing product requirements to design inputs and tracing test cases and test results to product requirements. 设计验证 设计验证是指实施一定步骤保证设计输出满足设计输入。通过追溯产品要求到设计输入以及追溯测试实例和测试结果到产品要求，基体的可追溯性可促进设计验证。Requirements: Design verification documentation includes both the methods of verification and the criteria for acceptance, which are approved prior to performing design verification. The results of the design verification and test data derived from evaluation tests are documented in a controlled location. 要求 设计验证文件包括验证的方法和验收标准，方法和标准在实施设计验证之前已经获得批准。 由评估测试衍生出的设计验证结果和测试数据记录在控制位置上。Design Validation(Mindy: by user)Design validation ensures that the product conforms to defined user needs and intended uses. This may take the form of clinical evaluations, trade trials, human factors studies, literature searches of validated design options, or testing under conditions that replicate actual usage as close as feasible for the product involved. This is accomplished via execution of the external product evaluation plan and product quality testing. 设计确认 设计批准保证产品满足特定的用户需求和预期用途。这可能有多种形式，包括临床评估、trade trials, 人为因素研究，已确认设计选择的文献查找或者在尽可能接近产品实际使用的条件下进行测试。通过外部产品评估计划和产品质量测试实现设计确认。 Requirements: Design validation shall be performed under defined operating conditions. Include any consumables expected to be used with the device and the operation of the device in a networked environment if the device is intended for such uses. Design validation should ensure that the device conforms to defined users needs and intended use. Design validation shall include software and hardware validation. Design validation documentation shall include the design, method, dates, and the individuals performing the validation. 要求 设计确认应当在规定的操作条件下实施。 包括任何预期与设备一起使用的消耗品和联网的环境中设计的操作，如果设备有此类预期用途。 设计确认应当 保证设备符合特定用户需求和预期用途。 设计确认应包括软件和硬件确认。 设计确认文件应包括设计、方法、日期和实施确认得到人员。Design TransferDesign transfer assures that the design requirements are correctly translated into production specifications. Readiness to affect design transfer (also referred to as manufacturing readiness and process validation/certification) is accomplished via the Design/Peer Review process and completed in phase 3. 设计传输 设计传输保证设计要求能够正确传输到产品规格中。通过设计/同伴审查流程完成影响影响设计传输的准备工作（也指的生产准备和流程确认/证明），在phase 3完成此项工作。Requirements: Design Transfer documentation must show traceability of design requirements to production specifications. 要求 设计传输文件必须显示设计要求到产品规格的可追溯性。Design ChangesDesign changes are controlled throughout the entire product life cycle. Design change control is exercised from the point when the design is released for evaluation, testing, or integration. The review, approval, verification, validation, documentation and release of Design changes are performed in accordance with the local quality system.设计变动 在整个产品生命周期中全程控制设计变动。设计变动控制落实到点，发行设计进行评估、测试或整合。根据当地质量体系进行设计的审查、批准、验证、确认、文件记录和发行设计变动。 Requirements: Design change documentation shall include validation or verification methodology and results. Design change documentation shall be reviewed and approved by all affected disciplines. 要求 设计变动文件应包括批准或验证的方法和结果。 设计变动文件应由所有受到影响的人员审查和批准。Device Master Record and Design History FilesAll documentation pertaining to the specification, design, verification, validation, testing and design changes is filed in the Design History File. Documents pertaining to the finished device including device specifica