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莱阳市传江油脂调味有限公司化验室管理手册（第二版）编号：CJ/HY-I-2-2012分发号：批准：王传江受控状态：2014-3-1发布2014-3-1实施地址：中国山东烟台莱阳市柏林庄工业园邮编：265200电话/传真:0535-72602873369708传江公司化验室管理手册CJ/HY-I-2-20121/29目录1、发布令···················································································································22、化验室简介·············································································································33、化验室质量方针声明·································································································44、组织······················································································································55、文件控制················································································································66、记录的控制·············································································································87、人员······················································································································98、设施与环境条件······································································································109、检测方法···············································································································1210、设备····················································································································1311、检测样品的处理·····································································································1512、结果报告··············································································································1613、保证公正性、公平性程序························································································1714、样品管理程序········································································································1815、设施和环境控制程序·······························································································1916、化验室废弃物处理程序···························································································2017、无菌间使用管理要求·······························································································2118、化验室检测计划·····································································································22附录：微生物内部控制标准·····································································································24仪器设备一览表···········································································································25化验室平面图··············································································································26人员培训计划··············································································································27水质微生物检测取样计划·······························································································28水质余氯取样计划········································································································29传江公司化验室管理手册CJ/HY-I-2-20122/29发布令为了保证实验室工作质量，确保检验结果的公正性，准确性和科学性，使实验室按国际通用标准运行，依据ISO/IEC17025:2005《检测和校准实验室能力的通用要求》，并结合本化验室的工作实际，编制了质量手册等质量体系文件。它们是化验室工作质量管理和质量改进的保证，是进行质量审核，复审和评审的依据，是全体人员的工作指南。经审定，本手册符合实验室质量体系实际情况，现予批准发布，自二零一四年三月一日起实施。全体人员必须严格遵守并认真执行。经理：2014年3月1日传江公司化验室管理手册CJ/HY-I-2-20123/29化验室质量方针声明质量方针：以事实为依据，以求真为准则，保证检测结果准确率100％。本化验室本着实事求是的态度，认真对待产品检测活动，对待检测步骤和结果严肃认真，所有的工作都将积极致力于检测结果的准确和及时，保证产品质量。质量目标：4.1确保主要原材料合格率100%。4.2及时准确地为各部门、各车间提供化验数据，保证产品理化指标合格率100%。4.3各车间工作环境卫生理化指标合格率100%。4.4保证产品出厂前漏检率为0，出厂产品理化指标合格率100%。管理目标：1、按照《检测和/或校准实验室能力的通用要求》的要求建立管理体系，并严格按照体系的要求进行运作，保证管理的科学和有序。2、本化验室的所有人员都得认真学习本手册，保证管理体系的有效运行。3、持续改进。本化验室积极致力于对管理体系和技术手段的改进。质量方针支持依据：1、职业规范实验室全体人员在工作中严格遵守如下职业规范：1.1科学的工作态度以科学的态度对待工作，真实反映检测数据。质量管理和关键岗位人员要按照实验室质量体系文件进行质量控制；检测人员要按照规定的标准、方法进行检测，并如实记录检测结果。1.2公正的职业道德所有人员必须要站在第三方的公正立场上，客观、公正的出具检测报告，自觉维护实验室的公正地位和信誉。1.3专业的技术水平实验室管理人员要掌握与本实验室范围相适应的法律法规相关知识和信息，检测人员必须达到本化验室检测范围相适应的技术水平。实验室所有人员都接受相应的培训和教育，并达到相应要求。传江公司化验室管理手册CJ/HY-I-2-20124/29化验室简介本化验室是莱阳市传江油脂调味有限公司下设单位，成立于2006年10月，于2007年11月正式投入使用，面积30平方米，主要检测加工产品的微生物、理化检测项目，为工厂的微生物、理化管理水平开展监测工作。人员情况：本实验室现有检测人员2名，其中大专1名，中专1名，受过专业岗前培训，有较长时间实践经验，能够胜任目前的检测工作。设备状况：本化验室现有电热恒温培养箱、灭菌锅、水浴锅、均质器、分析天平、电光分析天平、比色计、恒温干燥箱等检测设备。检测能力：本化验室现在可以开展的检测项目有：微生物：菌落总数、大肠菌群、大肠杆菌、沙门氏菌、金黄色葡萄球菌理化：水分、酸价、过氧化值、余氯传江公司化验室管理手册CJ/HY-I-2-20125/29组织1目的阐明实验室的法律地位、公正立场、诚信度要求、活动准则；确立组织结构；规定从事影响检测质量的管理、执行或验证工作的人员的责任。2适用范围适用于所有影响检测质量的区域和从事影响检测质量的管理、执行或验证工作的人。3职责3.1公司经理负责组织机构的设置、职能的分配和资源的配置，任命关键岗位的人员。3.2化验员在各自的职责范围内具体执行相关职能。4要求4.1组织机构图（见附件一）4.2职责与权限化验室负责人全权负责本化验室的日常事务，其它各化验人员各司其职。4.3防止不恰当干扰对于任何削弱化验室技术能力、公正性以及对结果作出独立判断信心和工作品德的活动，以保证检测数据的公正性。附件一：组织机构图公司经理化验室负责人化验员化验员传江公司化验室管理手册CJ/HY-I-2-20126/29文件控制1目的对与管理体系有关的文件进行控制，确保各相关场所均能得到和使用文件的有效版本。2适用范围适用于化验室管理体系文件的编制、审批、发放、修改和管理等各个环节，包括外来文件的控制。3职责化验室负责人负责组织《质量手册》编制及审核，批准质量记录格式和批准检验方法细则，以及技术标准，外来与法规的控制。4要求4.1文件编制a、《管理手册》的编制应符合相关法律法规的要求；b、其他文件的编制应与《管理手册》相协调，不得与本《管理手册》的要求相抵触；c、文件的文字表达应简明、准确、易懂，所有的符号、代号应符合有关规范，编制格式应统一。4.2文件编号a、管理体系文件以编号作为唯一性标识。b、化验室体系文件的编号方法：公司代号+实验室代号+文件级别号+版本号+发布年度，如CJ/HY-I-2-2012文件级别号：I代表管理手册，II代表程序文件，III代表作业指导书版本号：用A、B、C依次类推4.3文件审批A、《管理手册》由化验室负责人审核，经公司经理批准；B、检验方法细则、仪器操作规程等作业指导书由化验室负