出厂验收测试FAT

Supplier 制造商 嘉华通软 工厂测试方案 Factory Acceptance Test Protocol 文件编号 Doc.Ref 设备型号 Equipment JW5301

监管码赋码系统工厂测试方案

颁发部门/Issuing Department: 生效日期/Effective Date:

质量保证部 Quality Assurance Department 年/Year 月/Month 日/Day

日期 Date 单位 Company 部门 姓名 Name 签字 Signature 起草人 Issued by 起草人 Issued by 审核人 Department Reviewed by 审核人 Reviewed by 审核人 Reviewed by 审核人 Reviewed by 批准人 Approved by 批准人 Approved by 涉及部门/Involves Department:

□ 质量保证部/Quality Assurance Department □ 工程管理部/Engineering Management Department □ 人力资源部/Human Resource Department □ 外事企发部/Business Development Department and Development □ 研 究 开发 部 /Research Department □ 疫苗一室/ Vaccine Office One □ 疫苗三室/Vaccine Office Three □ 包装室/Packing Office □ 质量控制部/Quality Control Department □ 物 料 管 理 部 /Materials Management Department □ 销售部/Sales Department □ 行政管理部/Administration Department □ 生 产 管 理 部 /Production Management Department □ 疫苗二室/Vaccine Office Two □ 分装室/Filling Office □ 其他 Other 制造商 Supplier 工厂测试方案 嘉华通软 Factory Acceptance Test Protocol 文件编号 Doc.Ref 设备型号 Equipment JW5301

目录 Contents

设备信息............................................................................................................................................................. Equipment information ....................................................................................................................................... 厂家方案编制及审核......................................................................................................................................... Preparation and review of manufacturer scheme ................................................................................................ 客户批准............................................................................................................................................................. Customer approval .............................................................................................................................................. 目录.....................................................................................................................................................................

Contents ..............................................................................................................................................................

Ⅰ Purpose..........................................................................................................................................................

1.0 验证计划.............................................................................................................................................. 1.0 Verification plan ....................................................................................................................................

1.1 测试目的.............................................................................................................................................. 1.1 Purpose of test....................................................................................................................................... 1.2 客户批准............................................................................................................................................... 1.2 Customer approval ................................................................................................................................ 1.3 执行...................................................................................................................................................... 1.3 Implementation ..................................................................................................................................... 1.4 验收标准.............................................................................................................................................. 1.4 Acceptance standards ............................................................................................................................

1.5 FAT 结果............................................................................................................................................... 1.5 FAT Result............................................................................................................................................. 1.6 缩写....................................................................................................................................................... 1.6 Abbreviation.......................................................................................................................................... 二、 确认内容................................................................................................................................................... II. Content of confirmation.................................................................................................................................. (Ⅰ) 文件检查.................................................................................................................................................... (Ⅰ) Document inspection ................................................................................................................................... （二）配置检查................................................................................................................................................. （Ⅱ）Configuration inspection .........................................................................................................................

2.1 安装确认............................................................................................................................................... 2.2 线体设备列表....................................................................................................................................... 2.3 硬件调试环境的确认......................................................................................................................... （三） 安装检查............................................................................................................................................. (Ⅲ) Installation inspection................................................................................................................................ （四）运行测试............................................................................................................................................... (Ⅳ) Operation test............................................................................................................................................. 4.1、目的..................................................................................................................................................

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制造商 Supplier

嘉华通软

工厂测试方案 文件编号

Doc.Ref

4.1. Purpose ............................................................................................................................. 12

4.2、质量标准 ......................................................................................................................... 12

4.2. Quality standard ................................................................................................................. 12

4.3、确认内容 ......................................................................................................................... 12

4.3 Content of confirmation ........................................................................................................ 12

三、结论 ........................................................................................................................................ 15

Ⅲ Conclusion ................................................................................................................................. 15

3.1 本报告的目的..................................................................................................................... 15

3.1 The purpose of this report ..................................................................................................... 15

3.2 偏差(见附件偏差汇总表格) ................................................................................................. 15

3.2 Deviations (see deviation summary form in appendix) .............................................................. 15

3.3 结果分析及评价 ................................................................................................................. 15

3.3 Result analysis and evaluation ............................................................................................... 15

3.4 最终批准............................................................................................................................ 16

3.4 Final Approval .................................................................................................................... 16

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Factory Acceptance Test Protocol 设备型号 Equipment

JW5301 制造商 Supplier 工厂测试方案 嘉华通软

Factory Acceptance Test Protocol 文件编号 Doc.Ref 设备型号 Equipment JW5301 一、 目的

Ⅰ Purpose

1.0 验证计划 1.0 Verification plan 1.0.1 嘉华通软：

负责软硬件的安装调试，培训，使用监督和后期维护。在安装前完成设备的安装验证，完成后配合客 户对软件产品进行安全验证。 1.1 测试目的 1.1 Purpose of test 根据厂家要求新进设备应进行设备验证，验证确认后安装、运行、性能确认合格各功能能够达到使用 要求后方可投入使用。 1.2 客户批准 1.2 Customer approval 进行 FAT 之前，FAT 文件应首先获得客户的批准。否则不得进行工厂验收测试。 1.3 执行 1.3 Implementation

测试人员须首先阅读完毕 FAT 部分，然后执行，根据实际测试情况如实填写本文件的测试项目。最后 填写本文件的报告。

1.3.1 良好测试规范

1.3.1 Good test specifications

在进行 FAT 测试和进行审批时应当使用黑色笔进行记录。（符合存档要求）

对支持本测试的文件进行修改时应使用红色笔。

不可使用任何可以遮盖原始文字的修改方式。

如测试发现偏差，应该通过偏差报告来记录和追溯偏差情况。

偏差报告包含问题，并由供应商提出解决方案并整改，整改完毕经过客户认可后关闭偏差。

特殊情况未能关闭的偏差必须双方确认，并在 SAT 时关闭。

测试报告中没有填写的地方应该清楚的标明“N/A”（不适用）。

支持本测试的文件请签名并写上日后附在本文件后作为附件。 完成本测试后，填写测试报告之前应当检查文档是否正确和完整。

1.3.2 如何填写测试报告 1.3.2 How to fill in test report 结果

Result

□ 符合要求 □ 否

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