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口罩本体制造机验证报告
报告编号：YJ/VR-020-A
使用部门：生产二车间
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验证报告审批表
以下是各部门负责人签字，代表本文件已审核并批准实施 部门
姓名 职能 签名 日期 目 录
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1. 验证概述 ····································································································································· 4 2. 验证目的 ····································································································································· 4 3. 验证范围 ····································································································································· 4 4. 验证小组成员及职责 ················································································································ 4 5. 验证进度计划 ····························································································································· 5 6. 验证依据 ····································································································································· 5 7. 验证 ············································································································································· 5 8. 偏差及变更控制······················································································································· 18 9. 结果评价及建议······················································································································· 18 10. 再验证周期 ······························································································································· 18
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1.验证概述 1.1设备描述
口罩本体制造机主要用于**公司生产各种规格的口罩，该设备从原材料入料到成品的完成均为一条线作业，性能稳定，操作简单，包装成品美观，质量良好，符合医用口罩的制作质量要求。 1.2设备主要技术参数 电源：220V/50HZ 功率：5.0KW 产能：120pcs/min 机器尺寸：2400*700*1400 2.验证目的
为证明口罩本体制造机满足生产操作要求以及运行的稳定性，确保生产的产品符合生产产品质量要求，即对口罩本体制造机进行安装确认（IQ）、运行确认（OQ）、性能确认（PQ）。 3.验证范围
本方案适用于**公司生产二车间口罩本体制造机的安装、运行和性能确认。 4.验证小组成员及职责 姓 名 部 门 设备部 生产车间 QC QA QA经理 职 责 验证方案及报告的起草和相关数据的整理。 验证方案及报告的审核；为验证的实施提供支持。 验证方案及报告的审核；提供相关项目的检测数据。 验证方案及报告的审核,验证期间各部门之间的协调。 组织验证活动的进行，负责批准验证方案及报告。 4.1验证相关部门职责 4.1.1设备部
4.1.1.1起草验证方案、报告；
4.1.1.2负责口罩本体制造机的安装、运行和性能确认； 4.1.1.3提供设备相关技术资料；
4.1.1.4组织安装、调试并作好记录，收集、归纳并评估调试结果； 4.1.1.6建立设备档案； 4.1.2 品质部
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4.1.2.1现场监督保证整个操作过程按照验证方案实施；
4.1.2.2负责验证方案和报告的审核，及操作过程中对验证文件修订的审核工作； 4.1.2.3负责批准验证方案和报告；验证方案及验证报告的归档工作 4.1.3生产车间
4.1.3.1负责验证方案和报告的审核
4.1.3.2负责协调验证的各项工作，保证本方案规定的项目能够顺利实施； 5.验证进度计划
验证从2012年5月开始，至性能确认结束。 6.验证依据
6.1《医疗器械生产质量管理规范》 6.2《验证管理规程》 YJ/SMP-QA-018 6.3 口罩本体制造机使用说明书
6.4 YJ/SOP-PR-032《无纺布口罩制片机操作规程》 7.验证
7.1设备基本情况
设备厂家：新盛机械有限公司
设备名称：口罩本体制造机 使用部门：生产二车间 7.2验证判断标准
7.2.1安装确认判断标准：设备应具备的技术资料应齐全归档，设备安装符合实际设计要求。
7.2.2运行确认判断标准：安装确认后，空机运转检测设备各部件应性能完好，操作各控制器应灵活有效，并能完全达到规定的技术指标和使用要求。
7.2.3性能确认判断标准：设备投入使用后，设备运行、生产质量等能满足生产工艺要求。 7.3 验证内容 7.3.1安装确认
7.3.1.1设备的使用说明书、合格证等技术资料齐全归档。
7.3.1.2设备安装周围应有足够的活动空间，便于操作，地面应坚固、平整等。 7.3.1.3环境安装要求，即洁净度等级要求。
7.3.1.4检查与设备有关的所有仪器仪表，应显示正常有效。
7.3.1.5与产品直接接触部位的材质应为不锈钢材质，且不会对产品造成污染，符合生产
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口罩本体制造机验证报告
