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人员能力监督与人员监控的区别,如何具体实施?(附模板)

人员是软件测试实验室测试体系建设中的重要环节,也是实验室质量管理体系中的重要要素,在CNAS-CL01:2018《检测和校准实验室能力认可准则》中对人员监督模式和人员能力监控有着明确的要求:

6.2.5 实验室应有以下活动的程序,并保存相关记录:

a) 确定能力要求;

b) 人员选择;

c) 人员培训;

d) 人员监督;

e) 人员授权;

f) 人员能力监控。

人员监督强调“新”,初始能力。人员培训合格后,尚不能独立操作,应在监督人员的监督下工作,是针对人员授权前的监督。人员能力监控强调“授权在岗”,持续能力。人员独立上岗后,实验室还应选择适当的方式对其工作进行监控,并保留相应记录,以确认其能力能够持续保持。

软件测试实验室监督员通常是其他岗位兼职的,一般占专业技术岗位人员数量的10%。人员监督是一项技术性工作,监督员应由了解检测目的,熟悉检测的方法、程序,懂得结果评价的人员来担当,就专业知识而言,要求其高于一般检测、核查人员。

软件检测实验室的人员监督主要是针对在培人员,新进人员、换岗人员等。新员工、新授权之前和新项目运行时,应对人员进行“初始能力”的监督 ,监督的方法可以采用口试、笔试、演示、现场见证、全程监控、样品考核、结果评估、实验室内比对、能力验证和实验室间比对结果、现场监督实际操作过程、核查记录等等。

可根据业务性质选择适用的监督方法,同时应保留相关监督记录并进行评价。 为确认人员持续已被确认能力的情况,应依据风险分析、 技术复杂性、方法稳定性、人员经验、等确认监控方案,可采用但不限于现场见 证、调阅记录、审核/批准报告、内部质控、外部比对/能力验证等质控结果实施人员能力的监控。

实验室监督的重点是人员的技术能力,对监督人员应有资格要求,由熟悉各项检测/校准方法、程序、目的和结果评价的人员的担任,监督的重点是检测/校准的现场和操作过程,关键环节,主要的步骤以及重要的检测/校准任务;制定监督计划,明确对象、内容、时间、地点、确定监督的过程和方法。

监督员应做好监督记录,记录应有规定的格式,并对检测全过程进行描述;并对监督的结果做出评价,并由相关负责人确认。软件测试实验室要形成管理有序的监督机制。

监督的内容包括:人员资格及资格保持的有效性、文件及方法执行的有效性、设备操作的符合性及熟练程度、环境条件设置是否合理、方法选择是否得当、测量不确定度评定的符合性、记录和数据处理的符合性、以及处理突发事件的应变能力等。结果监督的内容主要为数据、结果是否准确、可靠以及结果报告的出具情况等。

如果检验活动的风险程度和复杂性是明显的,或者以往监督活动的结果是明显的,或者发生相关的技术、规范或立法的变化,则应考虑更高的频次。监督记录要作为人员档案的一部分,行业政委应及时将监督记录提交人资归档保管。

人员监督流程:

(1)编制相关程序性文件,明确人员监督的职责分工、人员监督工作的流程和要求、人员监督中不符合工作的处理及改进的机会。

(2)制订年度人员监督计划。计划应包括监督的方式、项目、频次、要求等。

(3)质量管理部门组织编制监督记录表。对监督内容进行文件化,监督内容覆盖上年度管理体系运行中的薄弱环节;设置对检测活动进行评价,以及对不符合检测工作提出处理意见等栏目。

(4)监督员按计划实施监督,并详细记录活动的内容;对发现的不符合和潜在不符合项按照程序文件要求,及时处理和反馈。

(5)质量管理部门对监督结果加以收集、汇总、分析、报告、评价,并作为管理评审的意见输入相关文件。

软件测试实验室

所有对检测结果有效性有影响的岗位人员均需监督和监控,不仅限于检测人员,包括合同评审人员、样品管理员、授权签字人等。对于授权签字人的监控,可通过统计签发报告出错率。如果实验室有两位或以上同领域的授权签字人,则可任命为监督员,授权签字人之间相互查阅对方批准的报告和记录、相互提问等方式进行能力监控。如果实验室只有一位授权签字人,可在外部评审时,通过评审员对授权签字人的考核,作为能力监控。

人员监督报告是管理评审的输入,可作为人员能力持续评价和制定人员培训计划及后续监督计划的依据,软件测试实验室一定要将该部分重视起来,如需相关模版资料可私信我或在评论区交流讨论。