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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
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 职能 签名 日期
目 录
1. 验证概述 ·································································································4
2. 验证目的 ·································································································4
3. 验证围 ····································································································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
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 职 责
设备部 验证方案及报告的起草和相关数据的整理。
生产车间 验证方案及报告的审核；为验证的实施提供支持。
QC 验证方案及报告的审核；提供相关项目的检测数据。
Q
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