验证及确认

求闻百科，共笔求闻

验证及确认（Verification and validation）两者是独立的过程，若两者一起使用，可以用来检查产品、服务或系统满足需求和规格并且符合其原来预期的目的[1]。这些是品质管理系统（例如ISO 9000）的关键组件。有时会在“验证及确认”前面加上“独立”（independent）一词，表示验证及确认是由公正的第三方执行的。“独立验证及确认”可以简称为“IV&V”。

在实务上，在质量管理方面，验证及确认的定义可以不一致。有时甚至可以交换使用[2][3][4]。

电气电子工程师学会（IEEE）采用的标准PMBOK指南中在第 4 版中的定义如下 [5]：

  • “确认（Validation）：保证产品、服务或系统满足客户和其他已识别的利益相关者的需求。它通常涉及外部客户的接受度和适应性。与验证形成对比。”
  • “验证（Verification）：评估产品、服务或系统是否符合规定、需求、规格或其他附加条件。多半是组织内部的流程。与确认形成对比。”

简介

验证（Verification）的目的是要确认产品、服务或系统（或其中的一部分，或是多个形成的组合）是否符合一系列的设计规范[6][7]。在开发阶段的验证包括对产品、服务或系统（或其中的一部分）的专门测试，可能是针对样品测试，也可能是用模拟的方式测试。再针对测试结果进行分析或检查。在开发阶段后的验证是定期性进行的测试，确认当时的产品、服务或系统符合原始的设计需求、规格及法规要求[7][8]。验证是确认产品、服务或系统符合在法规、规格，或是其他在开发初期提出的条件。验证可以在开发阶段进行、批量进行，也可以在量产时进行。验证多半是内部流程。

确认（Validation）的目的是要确认产品、服务或系统（或其中的一部分，或是多个形成的组合）是否符合使用者的操作需求[7][9]。针对新的开发流程或是验证流程，确认程序是针这两个流程建模，用模拟方式来预测是否有错误或是不足之处，可能会造成产品、服务或系统的开发或是验证出现失效或是不完整的情形。一组的确认需求（由客户定义）、规格以及法规就可以作为评估产品、服务或系统（或其中的一部分，或是多个形成的组合）的开发流程或是验证流程是否有效时的基准。另外也可能会有确认过程中的变更、开发流程或是验证流程的变更是否仍可以让产品、服务或系统（或其中的一部分，或是多个形成的组合）符合原始的设计需求、规格以及法规。确认流程有助于让开发流程或是验证流程符合相关规定[来源请求]。确认流程可以建立高度准确的证据，确保产品、服务或系统符合原始的需求。这常常和终端客户或其他产品利益相关者的接受程度及适用性有关。确认多半是外部流程。

可以将确认描述为这个问句“你做的是正确的事吗？”（Are you building the right thing?）[10]，而验证则是“你有把事情做正确吗？”（Are you building it right?）[10]。“做正确的事？”是回归到客户的需要，而“把事情做正确”则是检查系统是否有正确的实现规格中的内容。有些情形下，需要在判定是否相容的正式程序或是协定上有明文列出的需求。

有可能一个产品通过验证（符合规格），但无法通过确认（不符合客户需求）。例如产品是依规格所建立，但规格没有充份说明客户的需求。

活动

机械及设备的验证一般会包括设计验证（design qualification、DQ）、安装验证（installation qualification、IQ）、操作验证（operational qualification、OQ）及性能验证（performance qualification、PQ）。设计验证可以由制造商或是客户来进行，透过审核及测试来确认设备符合书面的采购规格。若机械及设备的相关文件是由制造商提供的，后面的三个验证需要由熟悉工业法规的用户，完整的进行验证。不然，IQ, OQ及PQ的程序就是确认相关的任务。常见的例子是针对一些没有制造商文件（或文件已遗失）的老旧设备，或是一些DIY的组件（例如车辆配件、电脑等），若是可以，使用者需设法找到制造商的文件。DQ、IQ、OQ及PQ程序的样本多半都可以在网路上找到，而机械及设备的DIY验证资料可能可以透过制造商的训练课程教材及指南中取得，或是已发行的指导书。这类DIY的作法也适用于软体验证、电脑操作系统的验证，以及生产程序的验证。活动的最后一步，也是最重要也最关键的步骤，是产生机械及设备的验证报告，并且归档，若是有相关法规强制要求的话，此报告是之后审核的依据。

机械及设备的验证也和其所在的场所有关，特别是一些对振动敏感，需要调整平衡或是校正的设备，这类设备若进行了位置的移动，需要再重新验证。若一些消耗品（例如滤网）需更换，或是已使用一定的期间，可能需要进行完整的验证[11][12]。若有进行零件更换，和其他设备耦合使用、安装新的应用软体或是重新调整电脑，影响到预设定资料时（例如BIOS、注册表、GUID磁盘分割表、动态链接资料库、或是INI文件等），也需要再重新验证。这些情形下，不论零件/设备/软体是否是原厂的，其规格以及重新调整的提案也应该附在验证报告中。Torres和Hyman曾讨论过在实务上，非原厂零件的适用性，并且提供了指南，让用户可以选择适当的替代品，并且可以避免负面影响[13]。若是因为法规要求，需要使用原厂的零件/设备/软体，就不能针对非原厂的零件进行重新验证，而且该资产不符合法规要求，需要回收。

若机械及设备的验证是由第三方的标准公证组织，例如针对特殊领域的国际标准化组织标准认证公司，此程序则称为认证（certification）[14][15]。

确认的分类

确认工作一般可以分为以下几类：

  • 前瞻性确认：在新的产品发布之前进行的确认，目的是确认所关注的特性可以正常运作，并且符合安全标准[16][17]。可以用在法规、指南以及提案[18][19][20]、方法[21]、原理／假说／模型[22][23]、产品以及服务[24][25]。
  • 回顾性确认：针对已在使用、发布或是正式生产的事物的确认。确认会针对书面规范或是预定决定的期望，依照其历史资讯或事件的文件或记录来进行。若有短少关键的资料，就无法进行完整的确认，可能只会进行局部的确认[16][26][27]。若在以下情形时，需要进行回顾性确认：
    • 没有前瞻性确认的资料，之前的确认方式不适当，或是有造假。
    • 法规或是标准的变化，影响到已经发布给大众或是市场上的产品相容性。
    • 重新使用一些已不用的事物。
以下是一些可以进行回顾性确认的例子：
  • 完全确认
  • 局部确认：常用在时间受限时的研究以及先期计划。会测试最重要以及最明显的效应。若以分析化学的观点，这些效应是选择性、准确度、可重复性、线性以及其范围。
  • 交叉确认
  • 再确认／定位或是定期确认，针对已被淘汰、修复、和其他设备整合或是耦合的设备，更换过位置的设备，或是针对设备定期进行的确认。这类的例子有驾照的定期重新考核、重新认证过期或是有更动位置的分析天平、其至是专业人士的定期资格考核[33][34]。再确认也会发生在活动中出现变化的情形下，例如科学研究或是临床试验要进入下一个阶段。这些变化可能包括
    • 样本母群体（sample matrices）[35][36]
    • 生产规模[37][38]
    • 种群特点及数量[39][40]
    • 规格外（out-of-specification、OOS）检测，可能是因为测试试剂、玻璃片的污染，仪器设备的老化，或是相关资产的折旧[41][42]
在GLP认证的实验室中，常常依照欧洲药典或国际药典的专著来进行验证或再确认，以满足不同国家的需求，也有可能只考虑单一国家的需求，以美国药典或英国药典为准[43]。这些实验室也需要进行方法的确认[44]。
  • 并行确认：在服务、制造或工程进行中同时进行的确认，以下是一些例子
    • 化学检定的双重样品分析。
    • 针对痕量不纯物质，检测极限或量化极限的边际值时，进行的三重样品分析。
    • 由熟练的技术员针对单一样品分析，进行多次的在线系统适用性测试。

确认的项目

确认工作中最常需要确认的项目可能包括以下几项：

  • 此方式密集的作业需求以及其消耗的时间[49][需要解释]
  • 会受到不同标准中对于词语定义的不同所限制。
为了解决这种问题，有些监管机构或是方法会建议何时应该要进行特定系统的系统适用性测试。

产业标准

这些词语广泛的用在不同的产业及组织中。针对不同的产品、法规以及产业，也可能会有不同的意义以及需求。以下是一些例子：

主条目：软体验证及确认

相关条目

参考资料

  1. ↑ Global Harmonization Task Force - Quality Management Systems - Process Validation Guidance (GHTF/SG3/N99-10:2004 (Edition 2) page 3
  2. ↑ Ad Sparrius. Everything You Thought You Knew about Validation and Verification is Probably Dodgy (PDF). 12th INCOSE SA Systems Engineering Conference. 2016 [2018-04-30]. There are some authors who apparently regard these two terms as synonymous, others who seem to be only vaguely aware of the differences. Some even appear to believe that V&V is one word! ... There is such a fundamental difference between these models that the term validation has many years ago been selected to be different from the term verification. Nevertheless, it is debatable whether the distinction between validation and verification should be continued. 
  3. ↑ James D. McCaffrey. Validation vs. Verification. 2006-04-28 [2018-04-30]. Two terms that sometimes confuse software test engineers are "validation" and "verification". ... Obviously the two IEEE definitions are so close to each other it’s hard to determine the difference. 
  4. ↑ Difference between Verification and Validation. Software Testing Class. [2018-04-30]. In interviews most of the interviewers are asking questions on “What is Difference between Verification and Validation?” Lots of people use verification and validation interchangeably but both have different meanings. 
  5. ↑ IEEE. IEEE Guide--Adoption of the Project Management Institute (PMI®) Standard A Guide to the Project Management Body of Knowledge (PMBOK® Guide)--Fourth Edition: 452. [2017-03-28]. doi:10.1109/IEEESTD.2011.5937011 (不活跃 2019-07-11). 
  6. ↑ "Systems and software engineering - Vocabulary," ISO/IEC/IEEE std 24765:2010(E), 2010. | verification 5. ...product, service, or system complies with a regulation, requirement, specification, or imposed condition.
  7. ↑ 7.0 7.1 7.2 IEEE 1012-2004, IEEE: 9, 2004 
  8. ↑ "Systems and software engineering - Vocabulary," ISO/IEC/IEEE std 24765:2010(E), 2010. | verification 6. ...comply with requirements (e.g., for correctness, completeness, consistency, and accuracy) for all life cycle activities during each life cycle process (acquisition, supply, development, operation, and maintenance)
  9. ↑ "Systems and software engineering - Vocabulary," ISO/IEC/IEEE std 24765:2010(E), 2010. | validation (especially 1. & 2.)
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  70. ↑ Haboudane, Driss; et al. Hyperspectral vegetation indices and novel algorithms for predicting green LAI of crop canopies: Modeling and validation in the context of precision agriculture. Accreditation and Quality Assurance (爱思唯尔). 2004, 90 (3): 337–352. Bibcode:2004RSEnv..90..337H. doi:10.1016/j.rse.2003.12.013. 
  71. ↑ Thorp, Kelly; et al. Using cross-validation to evaluate ceres-maize yield simulations within a decision support system for precision agriculture. [2008-03-20]. 
  72. ↑ Randolph, Susan; et al. Monitoring the Realization of the Right to Food: Adaptation and Validation of the U.S. Department of Agriculture Food Insecurity Module to Rural Senegal. [2008-03-20]. 
  73. ↑ Pruitt, Kirk; Ryan Paul Chamberlain. Method and system for authenticating appraisal reports. 

延伸阅读

  • Majcen, N.; Taylor, P. Practical examples on traceability, measurement uncertainty and validation in chemistry 1. European Union. 2010: 217. ISBN 978-92-79-12021-3. 

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