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FDA医疗器械质量体系手册 第二章 质量体系

(2011-01-18 09:11:21)
标签:

杂谈

2. Quality Systems质量体系

 

INTRODUCTION介绍
QUALITY SYSTEM PRACTICES质量体系实践
     Design Controls 设计控制
     Component Selection 元件选择
     Labeling Content 标签控制
     Process Quality 工艺流程控制
     Management Responsibility 管理责任
     Formal and Documented Quality System 正式并且成文的质量体系
     Approval of Product 产品批准
     Quality Acceptance Activities 质量验收活动
     Quality System Audits 质量体系审核
     Employee Training 员工培训
QUALITY SYSTEM MAINTENANCE 质量体系维护
MEDICAL DEVICE REPORTING 医疗器械报告


INTRODUCTION 介绍

The Quality System (QS) regulation requires that each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured (820.5 and 820.20). The GMP requirements are harmonized with the International Organization for Standards (ISO) 9001:1994 and ISO DIS 13485. The quality system should be an integrated effort -- a total systems approach, to satisfy the particular safety and performance needs of a specific manufacturer, product, and user-market. The quality assurance (QA) activities do not simply consist of inspection and testing spot solutions or "fire-fighting," no matter what the product is or how small the manufacturer. In all cases, quality should be considered at the earliest stages in every significant area that has an effect on the quality, safety, and effectiveness of the device. These areas include product development, design verification and validation, component and/or supplier selection, documentation, development of labeling, design transfer, process development and validation, pilot production, routine manufacturing, test/inspection, device history record evaluation, distribution, service or repair, and complaints. Complaints and, of course, favorable comments constitute customer feedback that may result in improvements in the device, labeling, packaging or quality system.

质量体系法规要求每个制造商建立和保持一套对特定医疗器械设计或生产相适应的质量体系。GMP要求是和ISO9001及ISO13485相协调的。质量体系应该是一个完整的工作--一种系统的方法来满足特定制造商,产品及用户市场对于安全及性能的特别要求。不管是什么产品或者制造商有多小,质量保证活动并不是仅仅由检验测试点的方法或者救火方式组成的。在所有的情况中,质量应该在所有对于质量,安全,以及器械有效性有影响的重要领域首先予以考虑。这些领域包括产品开发,设计验证及确认,元件及供应商选择,文档,标签开发,设计转交,工艺开发及验证,试生产,日常生产,测试检验,器械历史记录评估,分销,保养或维修,以及投诉。投诉当然也包括赞扬组成客户反馈,这些可以导致器械,标志,包装及质量体系的改进。

 

Most important of all is management commitment. Management and employees should have the correct attitude if their quality system program is to be effective. Quality consciousness should be developed in every employee. Each person should be made aware of the importance of his or her individual contributions in the overall effort to achieve an acceptable level of quality.

如果想管理者和雇员想要让他们的质量体系有效,最重要的是管理者承诺。应该让每一个员工建立质量意识。每个人应该知晓他们的对于让质量达到可接受水平的整体工作中所发挥的个体贡献的重要性。

 

After a quality system is in place and checked, it should not be allowed to stagnate -- it should continue to be dynamic. The system remains dynamic through continuous feedback, "big-picture" monitoring by system audits, management review, and corrective and preventive action. Sufficient personnel with necessary education, background, and experience should be in all departments to ensure that quality system activities are properly and adequately performed.

当质量体系一旦建立并运作,则不能停滞,它应该持续地保持动态。体系通过连续的反馈来保持动态,宏观地通过体系审核,管理评审以及改正及预防措施来监控。每个部门要有足够的,受过必要教育,有必要背景及经验的人员来确保质量体系活动正确和适当地执行。

 

The result is an organization that is operating in a known state-of-control for the device design, process design, manufacturing processes, and records. A properly functioning quality system results in increased safety and effectiveness of the device, reduced liability exposure, reduced regulatory exposure, increased customer satisfaction, less scrap, lower costs, much less confusion, higher employee morale, and, as a result, higher profits.

其结果是一个组织能够以所谓“受控状态”运行其医疗器械设计,工艺设计,生产流程及记录。一个正常运行的质量体系可以使医疗器械的安全及有效性得以提高,降低赔偿,降低法规曝光,提高客户满意度,减少报废,降低成本,减少混淆,提升员工士气,并且,作为最终结果,提高利润。

 

There are several QA systems in common use, including quality control, good manufacturing practices, product design assurance, the ISO 9000 series of international QA standards, and total quality assurance. Quality control is a minimal system which emphasizes test and inspection. The QS regulation is a government mandated QA system for medical device manufacturers. It emphasizes device, labeling, packaging and process design and all aspects of production: facilities, equipment, design development, design and production documentation, correct design transfer, production control, production records and feedback. Total quality assurance is a system which emphasizes that: all employees and suppliers are responsible for their activities; design requirements are established and met; process requirements are established and met; all production activities are controlled; finished product specifications are met; and feedback results in appropriate corrections.

有一些通用的质量体系,包括质量控制,GMP,产品设计保障,ISO9000系列国际QA标准,以及全面质量保障。质量控制是一个最小的质量体系,强调测试和检验。质量体系法规是政府对医疗器械制造商提出的强制要求。它强调医疗器械,标志,包装和工艺设计已及生产的各个方面,包括设备,仪器,设计开发,设计及生产文档,正确的设计交接,生产控制,生产记录及反馈。全面质量保障体系则强调所有员工及供应商对其活动负责,建立和达到设计需求,建立和达到工艺要求,所有生产活动受控,达到产成品规格指标,以及通过反馈进行适当的修正。

 

Product design assurance is a QA system which assures that customer needs are determined, and that product design requirements are established and met. The ISO 9000 series of QA standards ranges from basic quality control to very significant design and production systems.

产品设计保障是确保明确客户需求,建立和达到产品设计需求的质量保障体系。ISO9000系列质量保障标准的范围则涵盖从基本的质量控制到非常重要的设计生产系统。

 

ISO 9001 is the most comprehensive because it covers design, production, servicing and corrective/preventive activities. The FDA GMP requirements are slightly more extensive because they include extensive coverage of labeling, and complaint handling.

ISO9001是最全面的,因为它涵盖设计,生产,维护以及纠正防止措施。而FDA的GMP则相比更加广泛些,应为它还概括标志及投诉处理。

 

An ideal system for quality assurance is discussed in order to explain the concept of a system. An ideal QA system is composed of an organization that executes a QA program according to documented policy and specifications in order to achieve stated objectives as shown in Figure 2.1.

这里讨论一个理想的质保体系以便于解释体系的概念。一个理想的质保体系是由一个按照成文的政策及规范执行质保计划组织,其目的是达到所述目标,如图2.1。

 

FDA医疗器械质量体系手册 <wbr>第二章 <wbr>质量体系

Figure 2.1 Elements of a Quality System
图2.1 质量体系的元素

The written policies and objectives are set by management and are influenced by outside factors such as customer requirements, standards, and regulations. For example, the customer requirements and needs and resulting device specifications should be known to be correct, as these are based on market research, technical and medical considerations, consensus standards, review of existing devices, environmental and compatibility considerations, and design review. The objectives are to produce safe and effective devices at a profit. Ideally, the quality system includes everyone in the company as everyone is fully committed to the quality system program. In addition, however, quality assurance departments such as design QA and production QA are established to help achieve specific objectives. Tasks to be performed to meet these objectives are described in procedures and other documents.

管理者应根据诸如客户要求,标准及法规等外部因素的影响制定书面的政策和目标。例如,客户需求或要求以及据此产生的医疗器械规格的正确性应该被明确,应为这些是基于市场调研,技术及医疗方面的考虑,统计标准,对现有器械的回顾,环境及兼容性考虑,以及设计回顾。目的是生产有利可图的,并且是安全有效的医疗器械。理想地,质量体系涵盖公司中的所有人员,应为每个人对于质量体系计划是需要完全尽责的。然而此外,也要建立质保部门,诸如设计QA和生产QA来帮助达到特定目标。达到这些目标所要执行的任务是在程序文件或其他文件中所阐述的。
 

Documentation for a quality system is composed of: product-specific technical documentation such as engineering drawings, component purchase specifications, procedures for manufacturing processes and testing; labels, etc.; and general quality system documentation, such as standard operating procedures (SOP's) for employee training, audits, etc., that are applicable for all products. All activities and product quality are monitored; and any deviations from device and process specifications and company policies are fed back into the system where the deviations are corrected. Likewise, complaint and service information are processed and fed back for appropriate corrections. If the required activities including the feedback are performed, the quality system is self correcting and, thus, the manufacturer is operating in a state-of-control. FDA requires manufacturers of medical devices to operate in a state-of-control.

质量体系文档是由:由诸如工程图纸,元器件采购规格,工艺流程及测试步骤所特定的产品,标志等;和诸如对员工培训及审计的标准操作程序(SOP)以及对所有产品都适合的通用质量体系文件组成。所有活动及产品质量都受监控。所有背离产品或工艺规格指标及公司质量政策的偏差都反馈回体系,并对偏差进行修正。同样地,客户投诉及维修信息受处理并反馈以得到适当的纠正。如果所需的活动包括反馈都在施行,质量体系则是自我修正的并且制造商从而是运作与受控状态。 FDA要求医疗器械制造商是在受控状态下运行。

QUALITY SYSTEM PRACTICES质量体系实践

An adequate and properly implemented quality system such as the one required by the QS regulation or ISO 9001, because of its broad scope, has a high likelihood of preventing the design, manufacture, and shipment of defective products. Basic quality controls such as inspection and testing, are important parts of a quality system because they provide information that should be fed back into the program where action can be taken to correct root causes of quality problems. Identifying and solving quality problems is a core requirement of the QS regulation. This approach is in contrast to merely applying superficial corrections by pass/fail quality-control inspection including rework of finished product or in-process assemblies.

一个按诸如QS法规或ISO9001要求恰当并正确实施的质量体系,由于其范围的宽泛,具有防止设计,生产和运输有缺陷的产品的高度相似性。作为基本的质量控制的测试和检验是质量体系的重要部分,应为其提供了需要反馈回程序的信息,以采取纠正质量问题根本原因的行动。确认和解决质量问题是QS法规的核心需求。这样的方法和仅仅用通过/不通过的质量控制检验以及对产成品或半成品进行返工这样的肤浅的纠正是相对的。

Feedback is necessary to verify the adequacy of the design, manufacturing processes, and the controls used. It also helps trigger corrective action to solve root causes of quality problems rather than just performing rework.

反馈是验证设计,制造工艺及所用的控制的适当性所必须的。这也有助于触发解决质量问题的根本原因的纠正行动而不是仅仅采取返工措施。

Design Controls设计控制

Each manufacturer is required by regulation to establish and maintain design control procedures for any class III or class II device, and a selected group of class I devices. The class I devices subject to design controls are devices automated with computer software and the following specific devices:

法规要求每个制造商为III类或II类以及部分所选择的I类医疗器械建立和维护设计控制流程。受制与设计控制的I类医疗器械是由计算机软件进行自动化的器械及以下指定器械:

SECTION分类 DEVICE器械
868.6810 Catheter, Tracheobronchial Suction导尿管,支气管吸管
878.4460 Glove, Surgeon's外科手术手套
880.6760 Restraint, Protective保护性限制器
892.5650 System, Applicator, Radionuclide, Manual放射性系统,辅料及手册
892.5740 Source, Radionuclide Teletherapy放射性远距离疗法的放射源

Because the intrinsic quality level of devices and processes is established during the design phase, the quality system program should include this phase if the program is to assure overall quality, meet customer requirements, meet company quality claims, and comply with the intent of the FD&C Act. The terms "product assurance" and "design QA" are often used to identify the quality system activities related to product design. The QS regulation uses the term "design controls." A product assurance system or design QA system combined with a production QA system constitutes a total quality system.

因为医疗器械内在质量水平和工艺是在设计阶段就决定的,为了确保整体质量满足客户要求,满足公司质量申明,以及顺从FD&C法规的意图,质量体系项目要包括这个设计阶段。术语“产品保障”及“设计质量保障”经常用于区别与产品设计相关的质量体系活动。QS法规采用“设计控制”的术语。产品保障体系或设计质量保障体系与生产质量保障体系合起来形成全面质量体系。

Quality system, production, regulatory, and other appropriate personnel should participate in the review, evaluation, and documentation of the components, device, and process design. It is from data established during this preproduction phase that all other activities derive such as, purchasing, processing, and testing. Development and validation data are also useful in cases of regulatory or product liability actions to show that the design and manufacturing processes were well conceived and properly validated, reviewed, and documented.

质量体系,生产,法规及其他适当的人员应参加对元器件,装置及工艺设计文档的评审及评估。这些文档是从这个衍生出采购,工艺及测试等其他活动的生产前阶段所制定的数据。开发及验证数据对于涉及法规或产品赔偿义务活动以表明设计和生产流程是构思良好并正确验证,评估和成文是有帮助的。

 

Total quality systems extend from customer requirements through development and production to customer use and feedback. Thus total quality systems encompass the medical device law and regulations, particularly the QS regulation. The FD&C Act, and its implementing regulations such as those for Labeling, Premarket Notification, Investigational Device Exemptions (IDE), Premarket Approval (PMA), and GMP requirements impact the quality of devices at various times during the design product life-cycle. The IDE, PMA, 510(k), labeling and QS regulation with their preproduction and production requirements constitute a total quality system. For example, Section 501(c) of the Act states that a product is adulterated if it does not have a quality equal to the quality stated or implied by the product labeling. Analysis of device recall problem data by FDA has shown that such problems are divided almost equally between design and production. Thus, a production quality assurance program is not sufficient to produce safe and effective devices -- design shall also be covered. A design quality assurance system is required by the QS regulation.

Two other reasons for having a total quality system are 21 CFR Part 803, Medical Device Reporting (MDR), and product liability. MDR requires manufacturers of medical devices to report to FDA certain adverse events that they receive from any source. Product liability actions are often the result of poor design, labeling, and manufacturing. Reporting and liability exposure are reduced by using a total quality system.

全面质量体系将范围扩展至客户使用及反馈。因而全面质量包含医疗器械法律法规,特别是QS法规。FD&C法案以其实施的法规,包括标志,市场前通知,调研性器械法规豁免(IDE),市场前批准(PMA),以及GMP在所设计产品生命周期各个时期影响着其质量。IDE,PMA,510(k),标志及QS法规中关于生产前及生产时的要求构成全面质量体系。例如如法案501(c)节所述的如果产品未达到产品标志所述的或提示的质量,则被认为是次品。FDA通过对召回产品的问题数据分析发现,类似的问题由设计和生产所产生的几乎一样多。因而,生产质量的质量保障程序对于医疗器械的安全和有效是不够的,设计也应包括在内。设计质量保障体系是QS体系所要求的。采用全面质量体系的另两个原因是21CFR803部分,医疗器械报告(MDR ),以及产品义务。MDR要求医疗器械制造商向FDA报告其从任何来源收到的某些不利事件。产品(赔偿或召回)义务活动通常是有不良设计,标志和制造所导致的。报告和(赔偿或召回)义务暴露可通过全面质量体系减少。
 

Intrinsic or desired quality is established by the design specifications for the product, its components, and the manufacturing processes. Complying with the QS regulation assures that the manufacturing processes can consistently achieve desired levels of quality and that the finished device meets its device master record specifications. This result is a significant quality step. However, if the device as designed is of poor quality, the GMP production controls will only assure that a poor quality device is manufactured. Thus, the QS regulation requires an overall quality system program, which embraces evaluation of customer needs; product design; verification and validation; labeling development and control; all manufacturing and control activities; and customer feedback.

内在的或所期望的质量是由产品设计的实际规格,其元器件和制造工艺流程决定的。顺应QS法规确保制造流程可以持续达到期望的质量水平,并使医疗器械达到其设计主文件规格要求。这个结果是重要的质量台阶。然而,如果医疗器械的设计质量的不良,GMP的生产控制只能保证制造不良质量的医疗器械。因而,QS法规要求一个全面的质量体系程序,包括评价客户需求,产品设计,验证和确认;标志的开发和控制;所有的制造和控制活动;以及客户反馈。

Component Selection元器件选择

Component and raw material specifications developed during the design phase should be well conceived and adequate for their intended purpose. New components or components for an unusual application need to be verified (qualified) for the intended use. In some cases, where large quantities of components or raw materials are involved, the specifications should include valid and well understood methods of sampling and acceptance. These specification and sampling/acceptance plans should also be accessible and acceptable to suppliers. The specifications are device master record (DMR) spec document or the specifications appear in a DMR drawing or procedure.

在开发阶段制定的元件和原材料规格应多加考虑以适用于其使用目的。新元件或者非通常使用的元件应针对其使用目的进行验证。有时候,如果用量比较大,规格书应包括有效的并且明了的抽样和验收方法。这些规格和抽样验收计划书应该提供给供应商并为其接受。这些规格书属于设计主记录(DMR)规格文件或者是在DMR图档或流程中出现的规格文件。

 

Manufacturers shall establish and maintain procedures to ensure their purchased and otherwise received products and services conform to their specified requirements. The manufacturers shall then assess their suppliers, contractors, and consultants based on their ability to meet the established specifications. When possible, an agreement shall be established to include that the suppliers, contractors, and consultants will notify the manufacturer of any changes in the product or service that may affect the quality of a finished device.

医疗器械制造商应建立并维护流程以确保其所采购或者接收的产品或服务满足其规格要求。医疗器械制造商然后根据其满足所制定规格的能力评价其供应商,合同承包商及顾问。如果可能,应制定协议使供应商,合同承包商及顾问在任何变更其产品或服务有可能影响最终的(医疗器械)产品质量时通知医疗器械制造商。

Labeling Content标志内容

The regulations in 21 CFR Part 801, Labeling; Part 809, In Vitro Diagnostic Products for Human Use; and Part 812, Investigational Device Exemptions, are intended to control the content of labeling. Likewise, 21 CFR Part 807, Premarket Notification; and Part 814, Premarket Approval and 820.30, Design Controls, help control the content of labeling by design and premarket submissions. The intent of these regulations and the FD&C Act is for manufacturers to have a labeling control program such that their labeling always complies with the regulations and meets the needs of the users. By a formal process under a total quality system during the design phase, clear and concise printed and/or software labeling are written and reviewed; and the ink substrate and attachment methods for printed labeling are developed. Such labeling is designed to meet customer and regulatory requirements. Thereafter, the procurement, use of the correct label, and the correct attachment of labels is assured under a manufacturer's quality system elements for these activities.

法规21CFR第801部分,标志;第809部分,人用体外诊断产品;以及第812部分,调研性器械豁免,都力图控制标志的内容。类似的,21CFR第807部分,入市前通告,以及第814部分,入市前批准和820.30,设计控制有助于通过设计及入市前送审来控制标志内容。这些法规以及FD&C法案的目的是使制造商有一个标志控制程序
这样其标志可以始终符合法规并满足用户的需求。通过全面质量体系中设计阶段的正式流程,简单明了的印刷或软件标志要作成文档并经过评审;要开发印刷基材及黏贴方法。这样的标志在设计上是满足法规和用户需求的。因而,采购,正确的使用标志以及正确的黏贴标志这些活动是通过制造商质量体系的要素来保障的。

Process Quality工艺质量

Manufacturing methods and processes to be used should be developed, equipment selected, and processes and methods qualified. For all significant processes such as welding, molding, lyophilizing, sterilizing, and packaging/sealing where the output cannot be fully verified, the qualification should include a full validation of the processes. The output may not be fully verified for economic, technical, or practical reasons and thus validation is needed. Production specifications and methods employed in manufacturing should result in standard in-process and finished products without excessive sorting or reprocessing. Inspection and test methods should be developed that will adequately monitor product characteristics to make certain these are within the acceptable specifications. These methods should be developed, evaluated, validated where necessary, and documented during the product and process development phase. The methods should be implemented at the beginning of routine production.

应开发要用到的制造方法和工艺,选择设备,并验证工艺和方法。对所有重要的工艺例如焊接,成型,冻干,灭菌和包装、封装,这些工艺的结果不能完全验证,那么检验就应该验证其工艺。由于成本,技术或可行性原因不能完全验证结果的就需要确认。产品规格及用于生产的方法应该是标准化作业而不应通过多余的筛选或返工来得到成品。要制定检验测试方法来监测产品的特性以确保其在可接受的指标内。如果需要,这些方法应该经过制定,评价并验证,并在生产工艺开发阶段形成文档。这些方法应在日常生产开始时实施。

 

Any adverse effects the manufacturing processes, manufacturing materials, or equipment may have on device safety and performance should be identified. Where necessary, procedures have to be developed, implemented, and monitored to control these characteristics. Quality system personnel should participate in the timely (i.e., early) development of special controls, test or inspection methods, or training programs needed to insure product quality. Acceptance methods should be developed for accurate measurement of outgoing product quality.

要区分出任何生产流程,生产物料及设备中可能导致医疗器械安全及性能的反作用。如果需要,应制定和实施流程监控这些特性。质量体系人员应及时(例如早期)参与制定特殊控制,测试或检验方法,或者确保产品质量所需要的培训程序。要制定验收方法,以精密测量出产产品的质量。

 
Management Responsibility管理者责任

As set forth by the QS regulation (820.20), one of the most important responsibilities of management when developing a quality system is to establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. This means each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. The QS regulation also requires that each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the GMP requirements. To meet these regulatory requirements, manufacturers are required to provide adequate resources, including the assignment of trained personnel for management, performance of work, and assessment activities, including internal quality audits.

作为QS法规(820.20)的前提,在建立一个质量体系时管理者的一个最重要职责就是建立其政策和目标,以及对质量的承诺。管理者的行政职责是确保质量政策在公司各个层面被理解,贯彻,和维护。其意义是各个制造商应该建立正确的责任和权威,及所有管理,实行并评价影响质量的工作成果的人员的相互关系,并为执行这些工作提供必要的独立性和权威。QS法规也要求每个制造商要建立和维护一个适当的组织架构以确保医疗器械的按照GMP要求来设计生产。要满足这些法规要求,需要制造商提供合适的资源,包括指派受过训练的人员来管理,执行和评价活动,包括内部质量审核。

Management with executive responsibility shall appoint a member of management who will have authority over and responsibility for:

 

行政职责的管理者要指定有授权及责任的管理人员来:

  • Ensuring that quality system requirements are effectively established and effectively maintained; and
  • 确保质量体系按要求有效建立,维护并且
  • Reporting the performance of the quality system to management with executive responsibility for review.
  • 向行政管理职责的管理者报告质量体系绩效以供评价

Thus, the QS regulation requires that management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the regulatory requirements and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

因而,QS法规要求有行政职责的管理者在确定的时间间隔以足够的频率根据所定的步骤来回顾质量体系的适用性和有效性,以确保质量体系满足法规要求及制造商所建立的质量政策和目标。质量体系回顾的日期和结果应做成文档保存。

 

The quality assurance personnel should be able to identify system problems, to recommend and provide solutions, and to verify implementation of the solutions. Other personnel may also identify and solve quality problems. The quality system should support such activities by all personnel. Feedback from quality assessment activities is necessary to verify the adequacy of the manufacturing process and the controls used. It also helps trigger corrective action to solve root causes of quality problems rather than just performing rework.

品质保障人员应该能确定体系问题,建议和提供解决方案,并且验证实施的解决方案。其他人员也可以发现和解决质量问题。质量体系应该对这样的所有人员提供支持。从质量评估活动得到的反馈是验证所用的制造流程及控制合适与否所必要。这也有助于触发纠正行动来解决根本的质量问题而不是仅仅是施行返工。

Typically, a quality system identifies problems with device quality through review of verification and validation data, inspection/test data, analysis of device history and service records, failure analysis, analysis of complaints, and review of other objective data. In this regard, reduction in productivity is often an indicator of quality problems. Low morale and confusion are indicators of inadequate procedures, and/or training and poor management. Also, measurement of scrap and rework is an effective method of detecting quality problems and reducing costs. These are examples of sources that provide feedback to the quality system.

通常,一个质量体系通过对验证确认数据,检验数据的回顾,分析器械历史及维修记录,失效分析,客户投诉分析,对其他目标数据的分析来鉴别医疗器械质量问题,在这一点上,减产通常是质量问题的指示。士气低迷,混淆是不当步骤以及或者是培训及管理不善的指示,同时,对报废或者返工品的测量是检查质量问题,降低费用的有效方法。这些是为质量体系提供反馈来源的范例。

 

In conclusion, each manufacturer is required to establish a quality plan which defines the quality practices, resources, and activities relevant to the devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met [820.20(d)]. Each manufacturer shall establish quality system procedures and instructions. To facilitate the understanding, use, review, and updating of the quality system, an outline of the structure of the documentation used in the quality system shall be established where appropriate [820.20(e)].

总而言之,要求每个制造商建立质量计划来确定质量实践,资源,以及与医疗器械设计和生产相关的活动。制造商要明确如何满足质量需求(820.20(d))。每个制造商要确立质量体系步骤和指令。为便于理解,使用,回顾及更新质量体系,要正确建立质量体系所使用的文档结构的纲要(820.20(e))。

Formal and Documented Quality System正式的质量体系文档

The QS regulation requires that each manufacturer prepare and implement quality system procedures adequate to assure that a formally established and documented quality system is implemented The system should include not only formal documentation, but also an obvious commitment to quality from top management. There should be manifest indications that management recognizes the need for a quality system in order to assure quality products. In many manufacturers, this commitment is accomplished through means such as: a management policy; assignment of responsibilities and authorities; and general statements and actions such as employee training that define goals of the quality system. This policy is supported by a number of more detailed quality system documents such as verification methods, sampling procedures, inspection/test procedures, product audits, and records indicating that measurement and monitoring of quality has occurred. The number of documents needed depends on the size and complexity of the operation and the characteristics of the product. The QS regulation requires the manufacturer to maintain various records such as:

QS法规要求每个制造商准备和采取适当的质量体系步骤以确保正式建立的文档化的质量体系得以实施。体系应不仅包括正式文档,也要有来自最高管理层的对质量的清晰承诺。管理者应该有为确保产品质量对质量体系认同的明确表示。在很多制造商那里,这些承诺是通过诸如:(质量)管理政策,授予责任和权威,以及诸如在员工培训时明确质量体系目标的申明或行动来达成。这样的(质量)政策是由数个更为详细的质量体系文档,例如验证方法,取样过程,检查检验步骤,产品审核,反映发生质量测量和检测的记录来支撑的。所需的文档数量取决于产品操作及特性的大小和复杂性。QS法规要求制造商保留各种记录,诸如: 

  • design history files,设计历史文件,
  • device master records,器械主记录,
  • device history records,器械历史记录,
  • maintenance schedules and records,维护保养日程及记录,
  • complaint files and failed device/component files,投诉及失效器械/零件的记录
  • audit reports,审计报告
  • distribution records, and分销记录,及
  • personnel training records.人员培训记录

Most of these records are discussed in more detail in later chapters. In each case, the records should be appropriate for the device and the operation involved. Any changes to device master records should be made by a formal procedure and be formally approved.

很多这些记录将在后面的章节更详细地讨论。在每种情况下,这些记录应该与有关的器械与操作相适应。任何对器械主记录的更改应该通过正式流程来达成并正式批准。

 

Among other records, the device master record contains manufacturing procedures and standard operating procedures (SOP's). Some manufacturers tend to write an excessive number of general SOP's. Manufacturers should not generate and use procedures that are not needed. Also, standard operating procedures tend to not match actual operations because the operations gradually change as the company grows or as products are added without amending the procedures. Such procedures may require operations that have no benefit, or require excessive collection of data, or collection of data that is never used. Thus, manufacturers need to occasionally flow chart and analyze their operations to determine, among other things, if the existing procedures are inadequate, correct, or excessive. Flow-charting is a tool that directs a detailed audit of an operation. Flow-charting to analyze operations is an excellent method for improving operations and the associated quality system activities. At the end of Chapter 10, Purchasing and Acceptance Activities, an example of a flow-chart is contained in PA­1004, Procedure for Receiving and Inspection of Material, integral page 4 of 9.

除了其他记录外,器械主记录还要包含生产流程及标准作业程序(SOP)。有些厂商倾向于写很多通用的SOP文件。制造商不要制作和使用不需要的步骤(文件)。此外,标准作业程序的趋势是与实际操作不相符合,因为当公司成长或产品增加作业步骤渐渐地变化而程序未予修订。这样的步骤会要求无益的操作,或过多的收集数据或收集无用的数据,因此,制造商需要经常对其流程制图或分析,除此之外,要确定现存的步骤是否不适用,(不)正确或者多余。流程制图是导向详细审核一个流程的工具。流程制图来分析作业是改进流程及相关质量体系活动的卓越方法。在第10章,采购和验收活动的结尾处,在后续的PA1004就是第4/9页的接收和检验流程中举了一个流程图例子,

Approval of Product产品批准

The quality system includes procedures for assuring that all products such as components, packaging, labeling, manufacturing materials, and finished devices have been approved for use; and that contracted items and services are suitable [820.50, 820.80]. Likewise, the quality system shall assure that rejected items are identified and properly disposed [820.90]. Additionally, the quality system shall assure that production records are reviewed before the product is distributed [820.80(d)]. These records are part of the device history record. Device history records shall be reviewed to verify that the operations represented have been properly conducted and that the records are complete.

质量体系包括确保所有产品诸如元器件,包装,标志,原材料,以及成品都经过批准使用的步骤。这同样也适用于合同承包项目及服务[820.50, 820.80]。类似地,质量体系要确保拒收的物料被识别和妥善处理[820.90]。此外,质量体系要确保生产记录在销售前得到评审。这些记录是器械历史记录的一部分,而器械历史记录应被回顾以确定所表现的操作是否正确执行,记录是否完整。

Quality Acceptance Activities质量验收活动

The quality system shall determine that all tests and inspections are performed correctly (see 820.80, 820.181, and 820.20). Some of the methods used to accomplish this are adequate test and inspection procedures, training of test personnel, quality system audits, review of quality system records, and product audits. However, simply instituting a quality system and checking that it is conducted correctly is not enough to satisfy the QS regulation. The regulation also requires that the quality system be appropriate and adequate for the purpose. This determination should be done during final product development, pilot production, and, of course, whenever product and/or processes are modified. In cases where conformance to specifications cannot be adequately measured by in-process or finished product testing and inspection, the system should include validation of processes.

质量体系应确定所有的测试和检验是正确执行的(见 820.80, 820.181, 和 820.20)。达成这点的部分方法是正确适当的测试检验步骤,受过培训的测试人员,质量体系审核,评审质量体系记录,以及产品审核。然而,对质量体系及检查的简单的直觉以及正确执行检查并不足以满足QS法规的要求,法规也要求质量体系对于目的是适当的和合适的。这个结论要在产品开发的最后阶段,试生产,并且当然也包括产品或工艺流程的改变时得出。当最终产品的指标符合不能适当地在流程内或终测时检测,体系也要包括工艺过程验证。

Quality System Audits质量体系审核

The QS regulation requires (820.20) that each manufacturer shall prepare and implement quality system procedures adequate to assure that a formally established and documented quality system program is performed. Many activities are required to fulfill this requirement. As management performs their assigned routine duties, they should be aware of the obvious aspects of the quality system. However, to make sure that all aspects, obvious, hidden or subtle, of the required program exist and are operating correctly, the QS regulation requires planned and periodic audits (820.22) of the quality system. Management with executive responsibility reviews audit reports as part of their review of the suitability and effectiveness of the quality system.

QS法规(820.20)要求每个制造商准备和采取适当的质量体系步骤以确保正式建立的文档化的质量体系得以实施。要满足这个要求,需要采取许多行动。作为管理者贯彻其赋予的日常职责,他们应该知晓质量体系的显著方面。然而,为确保所需项目所存在的其他各方面,无论是显著的还是隐含的,或者变通的都得以正确执行,QS发钱要求有计划的定时的审计质量体系(820.22)。管理者有行政责任来回顾审计报告,回顾质量体系的适用性和有效性。

Employee Training员工培训

QS regulation requires quality awareness training for manufacturing and quality system personnel [820.25(b)]. Personnel involved in quality system activities shall be properly trained, both by education and experience. No matter how effective quality system and production systems are as concepts, people still play the major role in producing a quality product. Lack of training -- as reflected in instances of negligence, poor operating techniques, or inability of employees to discharge their functions properly -- can lead to defective products and, sometimes, to regulatory or liability problems. Management should be diligent in looking for factors that indicate a need for employee training.

QS法规要求对生产和质量体系人员进行质量意识培训。参与质量体系活动的人员应接受正确的培训,既包括教育也包括经验。不管质量体系和生产系统在理论上多有效,人员还是在生产高质量产品中扮演主要角色。缺乏培训,正如在疏忽事件所反映的,缺乏操作技巧,或雇员在正确履行其职能上所表现出的无能,都导致产品缺陷并且有时会导致法律或责任问题。管理者应该勤力寻找员工培训需求的指示。

A quality system should include an ongoing formal program for training and motivating all personnel. All employees should be made aware that product quality is not solely the responsibility of management. Quality is the responsibility of every employee -- any employee can potentially generate a quality problem through negligence. It is extremely important to understand the following points with respect to typical quality-related functions.

质量体系应该包括一个持续的正式项目来培训和激励所有人员。所有人员应该知晓产品质量不仅仅是管理者责任,质量是每个雇员的职责,--任何人都有可能由于忽视而产生质量问题。明白以下几点关于典型的质量相关功能是至关重要的

  • Top management sets the quality attitude for the company.最高管理层建立公司的质量态度
  • Research and development has primary responsibility for designing quality into the device.研发部门对产品的设计质量负有最基本的责任
  • Technical services or an equivalent functional group has primary responsibility for documenting the design.技术服务或相当的职能部门负有设计文档的基本责任。
  • Manufacturing, process or "scale-up" engineering has primary responsibility for designing quality into the manufacturing processes.制造,工艺或量产工程部门负有制造流程设计质量的基本责任。
  • Manufacturing personnel have primary responsibility for producing devices that have the maximum level of quality that can be achieved based on the product and process designs.制造人员对基于产品设计和工艺设计基础上生产能达到的最高质量产品负有基本责任。
  • Quality system personnel have primary responsibility for the program's management, status reports, audits, problem identification, data analysis, etc., as described in the QS regulation and in this manual.质量体系人员对质量程序管理,状态报告,审计,问题确认数据分析,等等,如在QS法规和本手册所描述的那样负有基本责任。

A medical device manufacturer should NEVER try to operate on the basis that only the quality system organization has primary and direct responsibility for the quality of the products. To do so means that quality problems will not be solved in a timely manner because attention is directed toward the wrong organization. In reality, it is part of the responsibility of the quality system to see that attention is directed toward the correct department if a quality problem arises.

医疗器械制造商永远不要尝试将将质量体系的运作基于由质量体系部门承担基本的和直接的产品质量责任。如果那样做,意味着质量问题不能以及时的方式解决,因为那样会将注意力引向一个错误的组织。在现实中,质量体系的一部分责任就是在产生质量问题时将注意力引向正确部门

Where necessary, employees should be certified to perform certain manufacturing or quality system procedures. Records of training and/or certification shall be maintained. Personnel performing quality system functions should:

如果需要,员工应该经过认证来承担某个制造步骤或者质量体系步骤。受训的记录或者证明应该保留。执行质量体系职能的人员要:

  • have sufficient, well-defined responsibilities and authority;接受足够的,明确定义职责和授权
  • be afforded the organizational freedom to identify and evaluate quality problems;有组织提供的自由度来识别和评估质量问题。
  • be able to formulate, obtain, and recommend possible solutions for quality system problems; and,能够简明阐述,获得和建议可能的质量体系问题的解决方案;
  • verify implementation of solutions to quality problems.验证质量问题解决方案的实施

QUALITY SYSTEM MAINTENANCE 质量体系的维护

After the quality system is operational, personnel should continue to look for problem areas or factors that can have an impact on product quality. Many factors that can have an impact on product quality include:

质量体系开始运作后,质量人员要继续寻找可能影响产品质量的问题区域或因素,可能影响产品质量的许多因素包括:

 

  • changes in, or absence of, personnel; 变动或缺少人员
  • uncomfortable working conditions (e.g., breakdowns in air conditioning); 不舒适的工作环境(例如,空调损坏)
  • increases in workload or production rates;增加工作负担或产量
  • introduction of new production or inspection equipment;引入新生产或检验设备
  • changes in company incentive techniques (e.g., placing hourly employees on piecework can cause deterioration of product quality); and公司奖励机制的变更(例如,引入计件制的小时工可引发产品质量劣化)
  • changes in sources for purchased components and materials, as well as changes in components, devices, or process techniques.变更采购元器件和原材料的货源,或者是变更元件,器具及工艺技术。

As noted, quality system audits and flow-charting of operations are excellent methods for determining the detailed status of the system. Correcting problems or responding to conditions identified by audits, operational analyses, and customer feedback data can result in quality system improvements.

一个标记的质量体系审计及操作的流程制图都是确定系统详细状态的优越方法。纠正问题或对审计所鉴别的状况的反应操作分析,及客户反馈数据都可改善质量体系

MEDICAL DEVICE REPORTING医疗器械报告

FDA has promulgated regulations [803] for manufacturers, distributors, and initial distributor(s) requiring them to establish and maintain reports, including the Medical Device Reporting (MDR) reports for serious injuries, death, or certain other adverse incidents. If a manufacturer has a quality system as required by the QS regulation, the frequency of MDR reporting should be minimized.

FDA有制造商,分销商及经销商公告法规[803],要求其建立和维护报告(体系),包括医疗器械报告(MDR),报告严重受伤,死亡及某些不利事件。如果制造商有符合QS法规的质量体系,MDR报告的频率会是最少的。

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