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1、FDA医疗器械质量体系手册 第三章 设计控制3. Design Controls3 设 计 控 制INTRODUCTION引言 Coverage覆 盖 范 围QUALITY SYSTEM质 量 体 系 Personnel Training人员 培 训DESIGN AND DEVELOPMENT PLANNING设 计 和 开 发 计 划 Interface沟 通 Structure of Plans计 划 的 结 构DESIGN INPUT设 计 输 入 Input Checklists输 入 检 查 表DESIGN REVIEW设 计 评 审 Combination Devices载 药 器
2、 械 Preparation For Reviews评 审 准 备 Why Design Reviews设 计 评 审 的 原 因 Types Of Design Review Meetings设 计 审 核 会 议 的 类 型 Design Review Requirements设 计 评 审 要 求 End Of Initial Design初 步 设 计 的 结 束DESIGN OUTPUT设 计 输出 Documenting Design Output设 计 输 出 的 记 录 成 文 Acceptance Criteria确 认 条 件 Design Output Approval设
3、 计 输 出 审 批DESIGN VERIFICATION AND VALIDATION设 计 确 认 和 验 证 Design Evaluation versus Specifications根 据 规 格 进 行 设 计 评 估 Software Validation软件 验 证 Labeling Verification标 识 确 认DESIGN TRANSFER设 计 转 移DESIGN CHANGES设 计 变 更DESIGN HISTORY FILE设 计 历 史 文 件EXHIBITS示 例 Design Input Requirements Procedure设 计 输 入 规
4、 定 程 序 INTRODUCTION引 言The Safe Medical Devices Act of 1990 added design validation requirements to the GMP requirements in section 520(f) of The Act. Section 820.30 of the Quality System (QS) regulation lists the design control requirements that manufacturers should satisfy to be in compliance. This
5、 chapter describes design controls and provides guidance to assist manufacturers in complying with design control requirements.Design Control Guidance for Medical Device Manufacturers is another document that may assist manufacturers in understanding the intent of the design control requirements. Th
6、is manual interprets the language of the QS regulation and explains the underlying concepts in practical terms. Do It By Design: An Introduction to Human Factors in Medical Devices is a document that contains background information about human factors as a discipline, describes and illustrates devic
7、e problems and discusses human factors principles and methods as a part of the design control system. Both of these manuals are possible resources for manufacturers who are either developing or improving their design control system. These manuals are also available through DSMA. 一九九零年的安全医疗器械法案在法案的 5
8、20（f）部分的 GMP 规定中加入了设计验 证规定。质量体系规章的 820.30 部分列举了生产商为合规须遵守的设计控制规定。本章阐 述设计控制，并且为协助生产商遵守设计控制要求提供向导。 “医疗器械生产商设计控制指南”是另外一份帮助生产商了解设计控制要求主旨的文件。这本手册用通俗的语言表达质量体系规章的内容并解释内涵概念。“通过设计完成任务：医疗器械中的人为因素介绍”是一个包含了把人为因素作为学科的背景信息的文件，该文件对器械问题进行描述并解释并探讨作为设计控制系统一部分的人为因素的原理和方法。对正在编制或改善设计控制系统的生产商来说，两本手册都是可能的资源。这些手册还可以从 DSMA 处
9、获得。 Coverage覆 盖 范 围The design controls section 820.30 of the QS regulation applies to the design of products, and processes and changes to existing designs and processes. Changes to existing designs should be made in accordance with design control requirement even if the original design was not subj
10、ect to these requirements. Design controls are not retroactive to completed portions of ongoing design programs.Each manufacturer of any class III or class II device, and class I devices automated with computer software and those listed below shall establish and maintain procedures to control the de
11、sign of the device in order to make certain that specified design requirements are met. Manufacturers of other Class I devices should develop and document their devices under their own design control system because the documentation is needed to help meet the device master record requirements in 820
12、.181 and marketing submission requirements. Thus, manufacturers of exempt Class I devices are encouraged to use 820.30, Design Controls, as guidance.QS 规章 820.30 部分设计控制适用于产品设计以及对现有设计和工艺进行的加工和改变。即使原有设计不需遵守设计控制要求，对这些设计做出的更改仍需遵守设计控制要求规定。设计控制对持续性的设计程序中已经完成的部分不具备追溯效力.任何二类、三类器械的生产商、计算机软件控制的自动化一类器械厂商以及以下列出
13、的一类器械的生产商必须建立并保持一套控制器械设计的程序以确保规定的设计要求得到满足。其他一类器械的生产商应该根据他们自身的设计控制系统开发器械并做记录，因为企业需要这些文件帮助他们遵守 820.181 器械主记录要求以及市场申报规定。因此，鼓励豁免的一类 器械生产商把820.30， 设计控制作为指南使用。 Classification Section Class I Devices Subject to Design Controls Listed in Paragraph 820.30(a)(2) 868.6810 Catheter, Tracheobronchial Suction 878
14、.4460 Glove, Surgeons 880.6760 Restraint, Protective 892.5650 System, Applicator, Radionuclide, Manual 892.5740 Source, Radionuclide Teletherapy All Sect. Devices automated with computer software 分类章节 868.6810 878.4460 880.6760 892.5650 892.5740 所有章节 须遵守列在第 820.30（a）(2) 段中设计控制的一类器械导管，气管支气管抽吸器外科手术手套约
15、束、防护系统、高频电极（applicator），放射性核素、手动远程治疗放射性核素源计算机软件控制的自动化器械 The design requirements for the device are primarily specified by the manufacturer; however, FDA has a few design requirements in the 21 CFR Part 801 labeling regulations and in Parts 1000-1050 which cover radiological and electronic products.
16、A few of the FDA design requirements are in standards. For example, some parameters for medical gloves are in standards by the American Society for Testing and Materials (ASTM). (That is, medical gloves are required to meet these standards in order to be substantially equivalent to gloves already in
17、 commercial distribution.)设计规定主要由生产者自己制定，但是 FDA 在联邦规章典籍 21 CFR 801 部分 标识 规则 以及 1000-1050 部分中有一些设计规定，主要针对影像学和电子产品。FDA 所要求的规格有一些是英制单位。例如，美国材料试验协会（ASTM）制定的医用手套的一些参数是英制的。（也就是说，医用手套必须符合这些标准以便最大限度地符合已经进入商业销售的手套标准） QUALITY SYSTEM 质 量 体 系Each manufacturer is required to establish and maintain a quality syst
18、em that is appropriate for the specific medical device(s) designed or manufactured 820.5 and 820.1(a)(3), and that meets the requirements of Part 820. Therefore, the details of design control systems will vary depending on the complexity of the product or process being designed. However, all non-exe
19、mpt manufacturers including very small manufacturers and manufacturers that design less complex devices or processes are expected to define, document and implement design control procedures and other quality system procedures as called for in the regulation. One of these, a sample design input proce
20、dure, is exhibited at the end of this chapter.每个生产商都必须建立并维护一套适用于其设计或制造的特定的医疗器械的质量体系 820.5 个 820.1（a）(3),该质量体系需遵守 820 部分的要求。因此，设计控制系统的具体内容会根据正在设计的产品或工艺的复杂程度而有所不同。但是，所有未得到豁免的器械生产商，包括非常小的生产商和设计相对简单的器械或工艺的生产商都需要明确，记录成文并执行设计控制程序以及其他的规章需求的质量体系程序。本章结尾例举了其中之一，即设计输入程序样本。 Manufacturers may establish one desig
21、n control procedure to cover the various design control sections in 820.30; or, they may use one or more procedures for each topic. Multiple procedures may be easier to develop, update and implement. Medium to large manufacturers may have several additional procedures to support their main design co
22、ntrol procedures. Design control procedures may be part of the quality system records (QSR) noted in section 820.186.生产商可以制定一套设计控制程序来包括 820.30 部分中的不同的设计控制，或者可以为每个主题使用一个或多个程序。多重程序可能更容易编制、更新和执行。中大型生产商可能有好几个附加程序来支持主设计控制程序。设计控制程序可以作为 820.186 部分所注明的质 量体系记录（QSR）的一部分。Personnel Training 员工培训Personnel traini
23、ng in 820.25 is one of the quality system requirements, which applies to employees that perform any activity covered by the QS regulation including all design activities.Manufacturers are required to establish procedures for identifying training needs and making certain that all personnel are traine
24、d to adequately perform their assigned responsibilities. 820.25 部分员工培训是质量体系的规定之一，该规定适用于执行 QS 规章所包含的所有活动的员工，包括所有的设计活动。制造商必须制定一套程序，以便确定培训需求，确保所有员工受训以能够完成所承担的任务。 Design personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. In particular, p
25、ersonnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.必需让设计人员意识到他们承担工作的不合理表现所可能导致的器械缺陷。尤其是进行确认和验证活动的人员必须意识到作为其工作职能的一部分，他们应明白可能遇到的缺陷和故障。 Most technical employees need various degrees of training, as
26、 appropriate, in the medical device regulations, safety, labeling, human factors, verification, validation, design review techniques, etc.合适时，大多数技术类员工都需要不同程度的培训，培训的方面包括医疗器械规章、安全、标识、人为因素、确认、验证、设计评审技术等。 DESIGN AND DEVELOPMENT PLANNING设 计 和 开 发 计 划Developing a new device and introducing it into product
27、ion are very complex tasks. For many new devices and associated manufacturing processes that use software, these tasks are further complicated because of the importance of software, and the possibility of subtle software errors. Without thorough planning, program control, and design reviews, these t
28、asks are virtually impossible to accomplish without errors or leaving important aspects undone. The planning exercise and execution of the plans are complex because of the many areas and activities that should be covered. Some of the key activities are:开发新器械并将之引入生产是非常复杂的任务。对许多新的器械和相关的使用软件的工艺来说，这些任务变
29、得更加复杂，因为软件很重要且可能会出现微小误差。如果没有全面的计划、程序控制和设计评审，那么能够在不犯错或者重要的方面没有遗漏的情况下完成这些任务几乎是不可能的。由于应包含的方面和活动较多，计划活动和计划的执行很复杂。一些关键活动包括：determining and meeting the user/patients requirements;确定并满足用户/病人的需求 meeting regulations and standards;符合规则和标准 developing specifications for the device;为器械制定规则 developing, selecting
30、and evaluating components and suppliers;开发零件和供应商并对之进行选择和评估 developing and approving labels and user instructions;开发并批准标识和用户说明书 developing packaging;开发包装 developing specifications for manufacturing processes;制定生产工艺的规格 verifying safety and performance of prototype and final devices;确定原型和成品的安全性和性能 veri
31、fying compatibility with the environment and other devices;确定产品与环境和其他器械的兼容性 developing manufacturing facilities and utilities;开发生产设施和设备 developing and validating manufacturing processes;开发并验证生产工艺 training employees;培训员工 documenting the details of the device design and processes; and,记录器械设计和工艺的具体内容 i
32、f applicable, developing a service program.如果合适，编制服务计划 To support thorough planning, the QS regulation requires each manufacturer to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.为配合全面的计划，QS 规章要求每个生产商建立并保留计划
33、，该计划描述或参考设计开发活动并为执行明确责任。The plans should be consistent with the remainder of the design controls. For example, the design controls section of the quality system requires a design history file (DHF) 820.30(j) that contains or references the records necessary to demonstrate that the design was develop
34、ed in accordance with the:计划应该与设计控制的其余部分一致。比如，质量体系的设计控制部分规定设计历史文件（DHF）820.30(i)包含或引用必要的记录, 以表明所开发的设计符合： 1. approved design plan, and1. 已批准的设计计划2. regulatory requirements2. 法规要求。 Thus, the design control plans should agree with, and require meeting, the quality system design control requirements. One
35、 of the first elements in each design plan should be how you plan to meet each of the design control requirements for the specific design you plan to develop; that is, the design plans should support all of the required design control activities. Such plans may reference the quality system procedure
36、s for design controls in order to reduce the amount of writing and to assure agreement.因此，设计控制计划应该也必须符合质量体系的设计控制规定。每个设计计划的首要元素之一是对于你所计划开发的特定器械来说，你打算如何让产品符合设计控制的每条要求；也就是说，设计计划应该支持所有必需的设计控制活动。这些计划有关设计控制的部分可以参考质量体系程序有关设计程序的部分，以便减少书写量并确保前后一致。 Interface沟 通Design And Development Planning section 820.30(b)
37、 states:The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.If a specific design requires support by contractors such as developing molds, performing a special verification test, clinical tri
38、als, etc., then such activities should be included or referenced in the plan and proactively implemented in order to meet the interface and general quality system requirements. Of course, the interface and general requirements also apply to needed interaction with manufacturing, marketing, quality a
39、ssurance, servicing or other internal functions.设计和开发计划 820.30(b)部分规定： “计划必须识别并描述不同组或活动之间的沟通，这些组或活动可以为设计和开发流程提供 信息” 如果特定的设计需要分包商的支持，比如开发模具、进行特殊确认测试、临床试用等，那么这些活动应该被包括在计划中，并且得到积极执行以便能够符合沟通和质量体系总体要求。当然，沟通和总体要求还适用于与生产、市场营销、QA、服务或其他内部部门有关的必需的交互活动。 Proactive interface is a important aspect of concurrent e
40、ngineering. Concurrent engineering is the process of concurrently, to the maximum feasible extent, developing the product and the manufacturing processes. This valuable technique for reducing problems, cost reduction and time saving cannot work without proactive interface between all involved partie
41、s throughout all stages of the development and initial production program.主动的沟通是并行工程的重要方面。并行工程是在最大的可行范围内，同时开发产品和制造工艺过程。如果在开发和最初生产计划的各个阶段没有相关方面之间的积极沟通，那么这个能减少问题发生，降低成本以及节约时间的有价值的技术并不会收到效果。 Structure of Plans计 划 的 结 构Each design control plan should be broad and complete rather than detailed and comple
42、te. The plan should include all major activities and assignments such as responsibility for developing and verifying the power supplies rather than detailing responsibility for selecting the power cords, fuseholders and transformers. Broad plans are:每个设计控制计划都应该宽泛全面而不是详细完整。这些计划应该包括所有的主要活动和任务，比如开发并确认电
43、力供应的责任，而不是详细地规定选择电缆、熔丝座和变压器的责任。宽泛计划的特点： easier to follow;更易于执行 contain less errors;差错更少 have better agreement with the actual activities; and与实际活动更为一致 will require less updating than detailed plans.与详细计划相比，所需的更新更少 Over the years, several manufacturers have failed to follow this advice and opted for
44、writing detailed design control procedures. They reported being unable to finish writing the over-detailed procedures and were unable to implement them.多年来，数家生产企业都没能遵守此建议，他们选择了编制详细的设计控制程序。他们报告说无法完成编写过于详细的程序，以及无法执行程序。 Regardless of the effort in developing plans, they usually need updating as the dev
45、elopment activities dictate. Thus, the QS regulation requires in 820.30(a) that the plans shall be reviewed, updated, and approved as the design and development evolves. The details of updating are left to the manufacturer; however, the design review meetings are a good time and place to consider, d
46、iscuss and review changes that may need to be made in the design development plan.尽管在制定计划时已经花费了许多努力，但是出于开发活动的需要，这些计划仍然需要更新。因此，QS 规章在 820.30(a)部分要求随着设计和开发的进步，需要定期对这些计划进行审查、更新和批准。更新的具体内容取决于制造商；但是，设计评审会议是考虑、讨论和审查设计发展计划阶段需要做出的修改的最佳时机和场合。 DESIGN INPUT设 计 输 入Design input means the physical and performance
47、 requirements of a device that are used as a basis for device design 820.3(f). 设计输入是指被用作设计基础的器械的物理和性能要求。820.30(f) 820.30(c)Section 820.30(c) Design Input, requires that each manufacturer shall establish and maintain procedures to make certain that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. Also, a design requirement in 820.130 requires that each manufacturer shall make certain
