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CNAS软测实验室方法确认程序如何设计

正确的检测方法是获得有效的、可靠的和可重现的检验/检测结果的重要前提,也是测试质量体系建设中的重要组成部分。软件测试实验室在申请CNAS之前,都需要制定方法确认程序或方法确认作业指导书,来规范和指导检测工作,遵照国家有关标准制定符合实际业务的检测规程,选择符合预期用途的检测方法,使整个检测过程有据可依,有章可循。本文我们就一起来看一下,软件检测实验室如何设计方法确认程序。

 

首先我们先一起看一下CNAS官方的要求。

 

实验室应组织本领域专家对非标方法进行技术评审。技术评审可包含但不限于以下内容:

a) 被测试软件类型的描述应包括名称、版本信息、开发语言等;

b) 能够测试的软件质量特性或测试类别、测试目的和测试能力范围;

c) 陪测设备设施软件及其性能要求;

d) 方法应有需要的软件硬件环境、测试数据及其他约束条件。

 

软件测试方法确认应尽可能全面,包括对被测试软件的各种质量子特性的测试顺序、测试约束及测试输入的组合并进行测试方法的验证。

 

实验室需要对非标准方法、实验室开发的方法、超出预定范围使用的标准方法、或其他修改的标准方法进行确认。确认应尽可能全面,以满足预期用途或应用领域的需要。

                    

确认可包括检测或校准物品的抽样、处置和运输程序。可用以下一种或多种技术进行方法确认:

a) 使用参考标准或标准物质进行校准或评估偏倚和精密度;

b)对影响结果的因素进行系统性评审;

c)通过改变受控参数(如培养箱温度、加样体积等)来检验方法的稳健度,;

d)与其他已确认的方法进行结果比对;

e)实验室间比对;

f) 根据对方法原理的理解以及抽样或检测方法的实践经验,评定结果的测量不确定度。

 

当修改已确认过的方法时,应确定这些修改的影响,当发现影响原有的确认时,需要重新进行方法确认。

          

当按预期用途评估被确认方法的性能特性时,应确保与客户需求相关,并符合规定要求。方法性能特性可包括但不限于:测量范围、准确度、结果的测量不确定度、检出限、定量限、方法的选择性、线性、重复性或复现性、抵御外部影响的稳健度或抵御来自样品或测试物基体干扰的交互灵敏度以及偏倚。

实验室需要保存以下方法确认记录:

a) 使用的确认程序

b) 要求的详细说明

c) 方法性能特性的确定

d) 获得的结果

e) 方法有效性声明,并详述与预期用途的适宜性

 

接下来我们一起看一下软件检测实验室方法确认程序的需要包含哪些方面。

软件测试实验室

首先我们重点来看一下人员职责部分大家可以根据自己的实际情况进行参考。技术负责人与部门负责人负责检测方法的制定、确认,及有关国家标准的跟踪;部门负责人负责编写指导检测工作的作业指导书;检测人员有责任严格依据检验/检测规程及有关的程序文件和作业指导书开

展检测。

 

接下来我们再重点看一下方法的确认。技术负责人应组织相关部门对标准方法、非标准方法、实验室设计(制定)的方法、超出其预定范围使用的标准方法、扩充和修改过的标准方法进行确认,以证实该方法适用于预期的用途,且实验室能正确使用该方法。确认须尽可能全面,以满足预定用途或应用领域的需要。任何方法的确认都应考虑以下方面:检验/检测方法、人员、设备、环境、溯源、抽样与样品准备及检验/检测作业指导书或操作规程的准备情况等。

 

对于软件测试,软件测试方法确认应尽可能全面,包括对被测试软件的各种质量子特性的测试顺序、测试约束及测试输入的组合并进行测试方法的验证。对新开展项目按《新开展项目评审管理程序》的要求,使用《新开展项目申请表》、《新开展项目评审表》进行评审确认。

 

应记录所获得的结果、使用的确认程序以及该方法是否适合预期用途的声明。使用标准方法之外的方法须书面征得委托方同意,以使出具的报告能被委托方所接受。执行委托检验/检测之外类型的项目检验/检测时,按法定管理机构要求的标准、规范项目进行检验/检测,委托检验/检测之外的检验/检测类型包括:

A. 产品质量监督检查,

B. 比对检验,

C. 认证产品监督检验,

E. 仲裁检验,

F. 其它法定强制检验/检测。

 

按预期用途进行评价所确认的方法得到的值的范围和准确度,应与法定管理机构要求/客户的需求紧密相关。这些值诸如:结果的不确定度、检出限、方法的选择性、线性、重复性限和/或复现性限、抵御外来影响的稳健度和/或抵御来自样品(或检验/检测物)基体干扰的交互灵敏度。

 

通过以下四种方式对检验/检测方法进行确认:

a) 使用参考标准或标准物质进行校准或评估偏倚和精密度;

b)对影响结果的因素进行系统性评审;

c)通过改变控制检验方法的稳健度,如培养箱温度、加样体积等;

d)与其他已确认的方法进行结果比对;

e)实验室间比对;

f) 根据对方法原理的理解以及抽样或检测方法的实践经验,评定结果的测量不确定度。

 

最后对结果的可接受性进行评审并作出结论,评审须由技术负责人与部门负责人主持。前三种方式参见《检测结果质量控制程序》。对影响结果的因素作系统性审批时,填写《技术评审记录》。

 

当对已确认的非标准方法作某些改动时,需将这些改动的影响制订成文件,适当时需重新进行确认。

对于标准变化的情况应作如下处置:

1) 如果标准只是代号变更,其检验方法、技术指标或参数没有变化的,只需要将标准名称和代号用文字说明统一汇总后报资质认定部门办理标准变更手续。

2) 如果不仅年号变更,其检验方法、技术指标或参数也随之提高,实验室必须新配备相应的仪器设备才能满足标准要求,属于检验性质发生变化,应按新开展项目申请扩项评审,接受资质认定部门的评审。

与检验/检测方法相关的程序文件或作业指导书等文件的建立、修改、审批、发放等过程须遵循《文件控制程序》的要求。

 

以上就是我们为大家整理的软件测试实验室测试质量体系建设中的方法确认程序的内容,如需参考资料可评论留言或私信我交流。

 

(谢绝转载)