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干货丨实验室仪器设备改如何管理?赶紧收藏!

   2018-06-25 食品实验室服务公众号265
核心提示:portant; word-wrap: break-word !important;">一.实验室仪器设备的风险portant; word-wrap: break-word !important; line-heigh
 portant; word-wrap: break-word !important;">一.实验室仪器设备的风险

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 14px;">

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 16px;">1.相互有影响的仪器设备放置在一起,相互干扰,数据不准;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">2.仪器设备长期不校准/检定,准确性无保障;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">3.仪器设备不做期间核査,性能不撑控;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">4.仪器设备无状态标识或标识混乱,容易错用;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">5.仪器设备无安全保护装备,对操作员有安全风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">6.气瓶没有分类贮存,无固定和防漏设施,有爆燃隐患;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">7.仪器设备气路交叉杂乱,有火灾安全隐患;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">8.仪器设备使用无记录,出現异常无法追溯;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">9.仪器设备档案信息不全,对维护造成困扰;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">10.仪器设备无强排风装置,对操作人员有伤害。

 

 

portant; word-wrap: break-word !important;">二.实验室环境控制存在风险

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 14px;">

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">1.操作间与仪器间无温湿度仪,实验环境条件不清楚;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">2.无“三废”收集处理装置,对环境造成威胁;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">3.房间墙壁脱落,地面粗糙不,杂物乱放,台面凌乱,环境感官不佳,有粉尘污染实验的危险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">4.实验室无强制通风设备,无防火、防水、防腐和急救设施,有人身安全感风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">5.废旧和长期停用设备未清出检测现场,有误用风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">6.检测工作时无环境条件记录,检测结果无法复现;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">7.微生物学实验室物流与人流未分开,一更、二更和三更不规范,有交叉污染风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">8.致病性微生物实验室无生物安全装置,对操作人员有病菌感染风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">9.相互有影的工作空间没有有效隔离,影响检测结果准确性;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">10.办公室、检测室、仪器室混用,相互交叉污染,存在安全隐患和结果准确性风险。

 

portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">三.实验室标准和标准物质存在风险

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 14px;">

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">1.标准无受控编号,标准变更后无法全部追溯变更,有错用废旧标准的风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">2.标准长时间无查新,标准废替新发不掌握,有错用废旧标准的风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">3.废旧标准无收回或无加盖“作废”章,有误用可能;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">4.现行有效标准没有购买正式板本,有文本错误的可能;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">5.新标准无宣贯记录,无法保证所有相关人员准确掌握;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">6.新标准启用无审批程序和记录,技术负责人责任不到位;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">7.标准物质与其它试剂混存,有交叉污染的风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">8.标准物质无期间核查记录,标准质量不掌控,对检测结果有影响;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">9.标准物质无法定证书,标准质量不保证,有结果失真风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">10.用容量瓶贮存标准物质,有测量准确性下降的风险。

portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">四.实验室化学药品及耗材存在问题

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 14px;">

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">1.没有合格供应商名录,耗品质量无保障;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">2.剧毒药品未实现双人双锁和使用跟踪监督制度,有剧毒药品外泄风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">3.易制毒药品未实现双人双锁,有易制毒药品外泄风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">4.试剂药品无领用登陆记录,试剂药品管理不到位;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">5.试剂贮存与操作间同室,对检验员健康有害;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">6.试剂瓶标识信息不足,试剂过期失效不掌控;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">7.标准试剂配制时未在恒温恒湿条件下进行,量具热涨冷缩,标准溶液无法配准;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">8.批量采购或用量大试剂未再检验验证,试剂不合格会造成巨大损失;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">9.耗材质量无风险分析评估,耗材质量不合格会造成巨大损失;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">10.试剂没分类贮存,有交叉污染风险,试剂室或试剂柜无强排设施,对操作员健康有害。

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 14px;"> 

portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">五.实验室样品管理存在十大问题

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 14px;">

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">1.样品编号混乱,无统一唯一性编号,易混淆;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">2.收样时无进样品状态描述和风险评价,出现结果异常无法追溯;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">3.样品没有流转卡,样品责任不明确;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">4.样品无待检、在检、己检和留样状态标识,有漏检和重检的可能;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">5.样品和留样无分类贮存和监控,存在交叉污染和霉变风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">6.检毕样品回收和处置不规范,技术负责人责任不到位;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">7.样品室与办公室混用,有安全风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">8.样品处理室与检测室混用,有交叉污染风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">9.样品贮存无环境监控记录,有样品损毁风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">10.样品采集过程中代表性不强,抽样记录不祥,影响检测结果。

 

portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">六.实验室人员管理存在十大问题

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 14px;">

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">1.关键岗位人员无任命文件,职权不明确;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">2.检验项目无人员上岗证,能力不确认;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">3.各类人员岗位交叉,岗位职责不明确;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">4.关键人员无监督计划或记录,监控不到位;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">5.技术和管理人员无培训计划或记录,技能不能持续提高;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">6.人员技术档案与人事档案混淆,对准则理解不准确;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">7.授权鉴字人职称和学历达不到要求,不能担任该职;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">8.技术负责人职称学历达不到要求,不能担任该职;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">9.检测人员无大型设备操作证,对设备和结果度不利;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">10.人员的所学专业与从事专业跨度太大,必须继续教育和考核。

portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">七.实验室检测报告中存在十大问题

portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋体; font-size: 14px;">

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">1.报告信息量不足,不符合《准则》要求;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">2.报告结论不正确,授权签字人责任不到位;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">3.报告数据与原始记录不一致,报告审核人责任不到位;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">4.报告无三级审批签字,报告管理混乱;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">5.报告格式多变,不严肃谨慎;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">6.报告中加盖的“检验检测专用章”不符合《准则》要求,必须更换;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">7.报告无骑缝章,有报告调换内页的风险;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">8.报告或原始记录有不规范的涂改,由作假的可能;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">9.分不清检验报告、检测报告、鉴定报告的区别;

portant; word-wrap: break-word !important; font-family: 宋体; text-indent: 32px; font-size: 16px;">10.报告的发送程序执行不严,有涉密风险。



 
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