FAT工厂现场验收测试文件资料瓶装线之理瓶机

1、 FAT 瓶装生产线 草案 THIS PROTOCOL IS VALID FOR GmbH,China MANUFACTURER : HM Pharmachine Swiss Name of the Machine Sl. No. Model A HM BP-BU200 自动理Automatic Bottle Unscrambler 瓶机B 空气喷射器Air Injector HM BP-EC24 C Electronic Counting Machine 电子数粒机HM BP-DS120 D 双头柱干Desiccant Inserting Machine 燥剂塞入机HM BP-CM120A

2、E 星盘式锁盖机Capping Machine HM BP-AS140 F 铝箔封口机Induction Sealing Machine Page 1 of 23 A.0 AUTOMATIC BOTTLE UNSCRAMBLER 自动理瓶机 A.1.0 MACHINE IDENTIFICATION 机器识别 Name of the Machine 名称：ROTARY UNSCRAMLER 旋转理瓶机 型号Type Serial No.序列号 制造Manufactured: Customer: 用户 订购号Order no.: Application:应用 Bottle unscrambling

3、 理瓶 Software 软件PLC A.2.0 TCHNICAL DESCRIPTION 技术说明 Bottles Ranges 瓶子范围 Output rate 产量 Dim 理瓶机尺Unscrambler 寸 Hopper Capacity (lt.) 漏斗容量（L） Power Source & Cons. 电源&条件 Air Pr. & Consumption 空气压力&消耗 A.3.0 SERVICE POINTS 服务点 Service Points are present and have clear and readable tags. 服务点全显示并有清楚和可读的标签 Se

4、rvice Point 服务点& Readable Tag Clear available (Y/N) 清楚和可读的标签（有/ Described in Manual (Y/N) 说明书中描述（有/无） Page 2 of 23 无） Power Supply 电源 Main Air supply 主气源 Control Desk 控制台 评注COMMENTS: - - - - 急停开关按钮安全检查A.4.0 Emergency Stop Button safety Check Objective:目标 To confirm the correct operation of the emerg

5、ency stop button. 确认急停开关按钮的正确操作 Methodology:方法 Apply power to the machine and connect all necessary fittings. Start the machine and then push the emergency stop button fitted to the machine on control desk. 将机器接上电源，接上所有必须的装置，启动机器然后按下在控制台上安装在机器上的急停开关按钮 Acceptance Criteria: 接受标准 When the emergency sto

6、p button is operated it must cease operation but display is On. The system can only be restarted manually by releasing the emergency stop button by pressing the reset button. 当急停开关按钮启动，机器必须停止运转但是显示开启。系统只有通过手动放开急停开关按钮按下复原按钮才能重启 Results:结果 Page 3 of 23 Acceptance Criteria Met 接受标准满足: ! YES 是 ! No 否 Co

7、mments:评注 - - - - - - A.5.0 Door safety Guard Check: 门安全防护检查 Objective:目标 To conform the correct operation of the guard switch fitted to the machine. 确认机器上的防护开关的正确操作 Methodology: 方 法 Apply power to the machine and connect all necessary fittings. Open each door in turn. Close all the doors and reset

8、the machine at the control panel. 将机器接上电源，接上所有必需的装置。依次打开每一个门。关闭所有门然后在控制台重设机器 Acceptance Criteria: 接受标准 Page 4 of 23 When any door is opened, all moving parts on the system must cease operation. The system can only be restarted manually at the control panel after pressing start button. 当任一门打开，系统上所有运动

9、部分都必须停止运行。系统只有通过手动按下控制面扳上启动按钮才能重启。 Results:结果 Acceptance Criteria Met 接受标准满足 : ! YES 是 ! No 否 Comments:评注 - - - - - - - A.6.0 Power failure Test: 电源故障测试 Objective:目标 To confirm the machine is able to stable the memory in case of intermittent power failure. 确认万一出现间发电源故障，机器能够保持存贮稳定 Methodology:方法 Page

10、 5 of 23 Start the machine setting required parameters. Observe the display. Shut off power source and after a few seconds restart the machine. Observe the display. Check the set parameters and performance data. 设置需要参数启动机器。观察显示。关闭电源然后过几秒后重启机器。观察显示。核对设置参数和运行（性能）参数。 Acceptance Criteria: 接受标准 Machine w

11、ill display the set parameters with performance data. 机器显示的设置参数与运行（性能）参数一致 Results:结果 Acceptance Criteria Met 接受标准满足 : ! YES 是 ! No 否 Comments:评注 - - - - - - - A.7.0 M/C Output rate check.机器产量检查 Objective: 目 标 To conform that rotary unscrambler machine operates satisfactory when bottle unscrambling.

12、 确认当进行理瓶时旋转理瓶机运行令人满意。 Methodology:方法 Adjust the machine accordingly with the format place on the M/C. Place bottle on the infeed conveyor. Push START. Page 6 of 23 根据机器上的形式地点调整机器，将瓶子放在进料传送器上，按下开始。 Acceptance Criteria: 接受标准 The through speed will be -bottle/hour. The machine performs with an error ra

13、te less than - % 整个速度为-瓶子/小时，机器运行误差率少于 - % Results:结果 Acceptance Criteria Met 接受标准满足 : ! YES 是 ! No 否 Comments:评注- - - - - - A.8.0 Air Pressure check 气压检查 Objective: 目 标 To confirm that machine can not be operated with insufficient air pressure. 确认气压不足时，不能操作机器 Methodology: 方 法 Turn off the power and

14、 disconnect the air supply or reduce the pressure manually. Turn on the power. Activate the functions of the machine. 关闭电源，断开气体供应或手动减少压力。打开电源，启动机器 Acceptance Criteria: 接受标准 The machine generates signal at low/not available air pressure. 机器在低/无气体压力时产生信号 Page 7 of 23 Results: 结 果 Acceptance Criteria M

15、et接受标准满:!YES!No Comments: 评 注 - - - - - A.9.0 Machines Maximum Speed Check with Bottles: 有瓶时机器最大速度检查 Objective:目标 To confirm that machine operate satisfactory during maximum speed. 确认在机器以最大速度运转时机器运转令人满意 Methodology:方法 Adjust the machine accordingly with necessary fittings and utilities. Run the mach

16、ine. 根据必需的装置和设施，调整机器。运行机器 Acceptance Criteria: 接受标准 i) Machine will be operated at - ii) Machine will not be vibrated during operation. iii) Machine will not produce abnormal sound. iv) Output must be error free. v) 机器以-运行 vi) 机器在运行中不会震动（摇摆） vii) 机器不会产生异声 viii) 产量必须完全无误差 Results: 结 果 Page 8 of 23 Sl

17、. No 序号 Description 描述 Oper. Time/Bottles /瓶 运行，时间Remarks 备注 01 Container #01 #01箱 02 Container #02 #02箱 03 Container #03 #03箱 04 Container #04 #04箱 05 Container #05 #05箱 Acceptance Criteria Met： 接受标准满足 : ! YES 是 ! No 否 Comments: 评 注- - - - A.10.0 : PLC 输入/INPUT/OUTPUT PLC TES T 输出测试 Objective: To v

18、erify that I/O points specified conform to the manufacturers specifications. 目标：证实指明的输入/输出点符合生产商的说明 测试设备：无 Test equipment: None 程序 Procedure: 1. Obtain a copy of the I/O points list and attach it to this page. 取得一张输入/输出点清单，将它附在该页上 2. Exercise the critical I/O points and randomly exercise some of the

19、 others. 演练关键输入/输出点，随意演练一些其他点 Page 9 of 23 3. Mark with a “” each I/O point that has been verified. 在已证实的每个输入/输出点标上一个“” 4. At the end of the page person collecting data must sign and write the date. 在页末，收集数据人必须签名和署上日期 5. Anything that not meet customer specification must be detailed in section 5.0 E

20、xceptional Conditions. 任何没有符合用户说明必须分部分详细说明 5.0 异常条件 接受标准 Acceptance Criteria: ? I/O points exercised conform to the manufacturers specifications. 输入/输出点演练符合生产商的说明 A.11.0 CONTROLS AND INDICATORS TEST 控制和指示器测试 Objective: To confirm that the controls and indicators function as specified by the manufact

21、urer. 目标：确认生产商指明的控制和指示器功能 Test equipment: None 测试设备：无 Procedure:程序 1. Follow the Instructions listed on the attached tables demonstrate or simulate the intended function. 遵照列入展示或模仿预期功能的附件表格中的指示 2. Record the result of the observed response on Controls and Indicators Data Sheet. 记录对控制和指示器数据单观察反馈的结果 P

22、age 10 of 23 3. At the end of the testing, ensure all switches are returned to their normal position. 测试末尾，确保所有的开关都返回到正常位置 接受标准 Acceptance Criteria: 1. All controls and indicators must function according to the manufacturers specifications. 所有的控制和指示器必须按照生产商的说明运行 A.12.0 PRODUCT CONTACT MATERIAL CHECK

23、 产品接触材料检查 Objective: All of product contact parts should be checked if there is no problem product quality under the condition of User requirement. 目标：所有产品接触部分都应进行检查，在用户要求的条件下，是否无产品质量问题 Method: Check the list for the product contact parts and the parts. Check the certificate for the written list 方法：

24、检查产品接触部分和部分清单。检查书面清单证书 Acceptance Criteria: product contact parts material should be accord with the material of construction certificate (MOC). 接受标准：产品接触部分材料应该符合结构证书材料（材质证明） Inspection item 测试项目 Material 材料Surface finished 表面抛光Certificate number 证书号Acceptable 可接受的 Y 是 N 否 Page 11 of 23 A.13.0 SPARE

25、 PARTS , TOOL BOX AND DOCUMENTATION 备件，工具箱和文件 Objective: To verify that the spare parts and the documentation are ready to be delivered with the machine. 目标：证实备件和文件已准备好同机器一起出运 Test equipment: None 测试设备：无 Procedure:程序 1. Attach to this page the spare parts list appropriate for the machine. 附上的该页备件清单适

26、合该机器 2. Check that all elements listed on the table attached table are ready to be delivered with the machine 检查所有列在附表上的元件已准备好同机器一起出运 3. Anything that not meet customer specification must be detailed in section 5.0 任何不符合用户说明的必须在 5.0 部分中详细说明 4. Exceptional Conditions. Spare parts and documentation ar

27、e ready to be delivered with the machine. 异常条件，备件和文件已准备好同机器一起出运 接受标准 Acceptance Criteria: 13.A.0 Spare Parts:备件 No 序 号Item 项目 Specification 规格 Qty 数量Manufac turer 生产商 Accepta ble 可接受 的 N Y 是 否 Page 12 of 23 13.B.0 Document Review: 文件检查 Documentation requirements:需求文件 The following documentation, wri

28、tten in English is required. 以下文件，需要英文版本 Documents 文件 Available (Yes/No) 可接受的（是/ 否） Comments 评注 Checked by 核对 Installation Qualification (IQ) 安装确认(IQ) Operational Qualification (OQ) (OQ)操作确认 Mechanical Layout Drawings 机械布局图 Electrical Schematic & Wiring Diagram 配线图&电气原理图 Pneumatic Schematic Diagram

29、气动原理图 Hydraulic with Air Diagram 气，液压图 Oil Lubrication 润滑油 Maintenance Manual 维护手册 Operation Manual 操作手册 Spare Parts Manual 备件手册 Recommended Spare Parts for Two Years 推荐 年备件2 Standard operating procedure (SOP) Page 13 of 23 标准操作程序 PLC Ladder Diagram PLC 梯形图 Preventive Maintenance Schedule 定期检修计划表 In

30、struction for Change-over 转换指导书 Instruction for Cleaning 清洁指导书 Documentation of Sound Level 声音标准文件 Instruction for Fault Finding & Rectification 纠正指导书故障探测& Comments:评注 工具箱13.C.0 Tool Box: No 序 号Item 项目 Specification 规格 Qty 数量Manufacture r 生产商 可接受的Acceptable Y 是 N 否 Page 14 of 23 Comments:评注 - - A.14

31、.0 Supplementary /Change parts lists 辅助物/更换部分清单 Description of Items 项目描述 Qty 数量Available (Y/N) 可接受的 （是/否） Container #01 箱#01 箱Container #02 #02 Container #03 箱#03 Container #04 #04箱 Container #05 箱#05 Page 15 of 23 A.15.0 Check list some Adjustable systems. 检查清单 一些可调系统 Objective:目标 To clarify the f

32、ollowing system. 详细说明以下系统 Sl. No. 序列 号Description 描述 Test Result/s Acceptable/not acceptable (Y/N) 测试结果/可接受/ 不可接受（是/否）Remarks 备注 01 Switch on-off random & Vertical-horizontal conveyor 随意转换开关&纵向-横向输送 02 Vertical stepping conveyor Belt capacity test 纵向分级传输带产量测试 03 Unscrambler speed adjustment by inver

33、ter 理瓶机速度通过变换器调整 04 adjustment speed Conveyor with motor 电机调整传输速度 A.16.0 ALARMS AND INTERLOCKS TES T 警报和互锁测试 Objective: To verify that the alarms and interlocks function as specified by the manufacturer. 目标：验证警报和互锁功能符合生产商的规定 Test Equipment: None 测试设备：无Page 16 of 23 Procedure:程序 1. Obtain a copy of t

34、he alarms and interlocks and attach it to this page. 取得一张警报和互锁清单然后附到该页上 ”. Induce a malfunction for each alarm and interlock listed and mark it with “2. ”.“引导产生列出的每个警报和互锁故障，然后标上 3. At the end of the page person collecting data must sign and write the date. 在页末，收集数据人必须签名和署上日期 4. Anything that not mee

35、t customer specification must be detailed in section5.0 Exceptional Conditions. 任何不符合用户说明的必须在 5.0 部分中详细说明 Acceptance Criteria:接受标准 ? All alarms and interlocks must function according to the manufacturers specifications. 所有警报和互锁必须根据生产商的说明运行 Page 17 of 23 A.17.0 PLC OPERATORS INTERFACE TES T PLC 操作员界面

36、测试 Objective: To verify that the Operators Screens perform as intended according to design specification. 目标：验证操作员屏幕按照预期的设计说明运行 Test Equipment: None 测试机器：无 Procedure: 程序 1. Obtain a copy of the Operators Screens and attach it to this page. 取得一张操作员屏幕然后附到该页上 2. The intent of this procedure is to test

37、all the signals shown on each screen of the operators panel to verify they perform their intended operation. 程序内容是测试所有的显示在操作员面板的信号来验证它们按照预期运行 3. The machine should be fully operational to testing of the operators screens. 机器应该被完全操作来测试操作员屏幕。 4. The executor shall not make any program changes during t

38、his test. 执行者不应在测试中更改程序 5. The executor shall push the respective buttons or control keys to cause the screens to changes as designed. 执行者应分别按下按钮或控制键使屏幕按照设计作出更改 6. The test should be started in the “Initial” screen. 测试应该在“初始”屏幕中开始 7. Test each screen and mark it with “ ”. 测试每个屏幕然后标上“”. 8. At the end

39、 of the page person collecting data must sign and write the date. 在页末，收集数据人必须签名和署上日期 9. Anything that not meet customer specification must be detailed in section 5.0 Exceptional Conditions. 任何不符合用户说明的必须在 5.0 部分中详细说明 Acceptance Criteria: 接受标准 ? The operator screens move to other screens when the corr

40、ect key is entered and return to the correct location when the correct input is entered. The operator screen meets the functional specifications and performs as designed. 当按下正确的按键，操作员屏幕移动到其他屏幕；当输入正确的输入，屏幕返回到正确的位置。 操作员屏幕符合功能说明，按照设计运行。 Page 18 of 23 A.18.0 PLC PASSWORD TEST PLC 口令测试 Objective: To veri

41、fy that the PLC is protected to non authorized changes in machine configuration parameters. 目标：验证 PLC 被保护，无认可的机器配置参数更改 Test Equipment: None 测试设备：无 Procedure: 程序 1. Try to make changes in the machine configuration parameters using an incorrect password. One attempt will be made. 设法使用不正确的口令更改机器配置参数，进行

42、一次尝试 2. Try to make changes in the machine configuration parameters using a correct password. One attempt will be made. 设法使用正确的口令更改机器配置参数，进行一次尝试 Acceptance Criteria: 接受标准 ? The PLC only allows access to machine configuration parameters using the correct password. PLC 仅仅准许用正确口令进入机器配置参数（更改） PLC PASSWO

43、RD TEST (cont.) PLC A. 口令测试（内容） EXPECTE D RESULT OCCURS EXPECTED PASSWORD #ACTION 产生期望结 RESULT果 口令操作 期望结果(YES / NO) (是 /否) PLC does not allow access to machine Use and incorrect password and try to make configuration changes in the machine configuration parameters parameters PLC 不准许进入机器 使用不正确的口令设法更改机器配置参数 配置参数Page 19 of 23 Use an