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CNAS软件评测实验室如何建立人员监督程序

CNAS官方文件中要求,实验室应关注对人员能力的监督模式,确定可以独立承担实验室活动人员,以及需要在指导和监督下工作的人员。所以,cnas软件测试中心新员工、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,各部门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,各检验检测部门应依据风险分析、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。

 

现场观察作为一种非常有效的监督控制方式,有需要时应确保每一位检验人员在一个认可周期内至少安排一次现场观察。所有的监督结果应作为识别培训需求的一种方式。

 

 

在人员首次从事某检测、校准岗位工作时,应安排监督。除此之外,新的检测、校准项目开展工作时;新设备或设备修复后投入使用时或无法进行期间核查的设备在使用时;重要的检测、校准任务时,如仲裁检测、验货检验、质量鉴定;新标准、新规范、新方法或标准、规范、方法发生变更后首次投入应用时;检测、校准方法发生偏离时;检测、校准数据出珊临界值时;顾客有投诉或满意度调查表明检测、校准过程存在缺陷需改进时;被检测、校准样品或参数的操作难度较大时;现场检测或校准时都应该进行人员能力监督。

 

监督内容主要有: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、设施和环境条件控制的符合性、样品抽取、制备及处置的符合性、试剂或消耗性材料制备的符合性、测量不确定度评定的符合性、记录和数据处理的符合性、实验室安全、环保要求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。

 

软件测评实验室应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。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。

 

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。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。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。

 

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