药业公司胶囊充填机FAT设备功能测试报告.doc

imazibo dr z 02 03 customer revision 1 0 用户名 天士力帝益药业公司 版本 1 0 天士力帝益药业公司 ima zanasi 85 e 胶囊充填机 fat 设备功能测试报告 machine model 机器型号 zanasi 85e serial n 系列号 pd1118 ima reproduction of this document by any means in whole or in part is prohibited without the authorization of ima s p a 未经伊马公司授权 禁止私自拷贝该文件 全部或一部分 functional test specificationspage 2 of 53 pd1118 rev 1 0 table of modifications revision modification request no modified bydatedescription of modification functional test specificationspage 3 of 53 pd1118 rev 1 0 index 索引索引 1 introduction 导言 5 2 glossary术语表 5 3 description and test plan测试操作描述及测试表 6 3 1 tested areas测试范围 6 3 2 untested activities非测试范围 9 3 3 test format测试格式 9 3 4 test passing criterion测试通过标准 10 3 5 logging test results测试结果录入 10 3 6 steps to take if a test fails测试失败时采取的措施 10 3 7 general warnings for carrying out the test测试时的一般注意事项 11 3 8 special warnings for carrying out the tests测试时的特别注意事项 11 4 documents and test equipment功能测试时所需文件及检测设备 12 5 test procedure测试步骤 13 5 1 main switch主开关 13 5 1 1main switch tes主开关功能测试 13 5 2 control panel控制面板功能测试 14 5 2 1language selection操作界面语言选择 14 5 2 2pushbuttons test machine start machine stop机器按钮功能测试 机器的 起动及停止 15 5 3 capsule product feeding device胶囊 药品 供给装置功能测试 16 5 3 1 capsule feeding device胶囊供给装置功能测试 5 3 1 1capsule feeding activation胶囊供给装置激活 16 5 3 1 2capsule minimum level胶囊最小料位 17 5 3 1 3sorting unopened capsules未打开胶囊分选 18 5 3 1 4capsule check enabling空胶囊在位检测装置 19 5 3 2mixer搅拌装置 19 5 3 2 1microdosing and intelligent hopper微计量及智能粉剂供给装置 21 5 3 2 2mixer 1 time搅拌器 1 时间设定 23 5 3 2 3mixer 2 time搅拌器 2 时间设定 25 5 3 2 4powder mixer 2 intelligent hopper 2 号粉剂搅拌器参数设定测试 智能粉 剂供给装置 27 5 3 2 5no powder 2 intelligent hopper 2 号位缺粉测试 28 5 3 2 6sucked tank 1 and slug release 11 号位吸力槽及打击器 29 5 3 2 7sucked tank 2 and slug release 22 号位吸力槽及打击器 30 5 3 3enabling the units机器类型设置 31 5 4 machine safety devices机器安全保护装置 33 5 4 1handwheel手轮 33 5 4 2jog max run time点动最长时间 34 5 4 3thermal relays热继电器 35 5 4 3 1overload cutouts vacuum pump aspirator 过载断路器 真空泵及吸尘器 35 5 4 4 phase sensors check machine and capsule opening 相位传感器检测 机器及胶囊打开 37 5 4 5slug detachment phase sensor check打击器的传感器时序检测 38 5 4 5 1slug detachment 1 and slug detachment 2 phase sensor check1 号位及 2 号位打击器的传感器时序检测 38 functional test specificationspage 4 of 53 pd1118 rev 1 0 5 4 6compressed air check压缩空气检测 39 5 4 7machine inverter failure机器变频器故障检测 40 5 4 8machine motor brake电机刹车 41 5 4 9intelligent hopper inverter failure智能粉剂供给装置变频器故障检测 42 5 4 10 plc batteryplc电池 43 5 4 11 maximum speed机器最高速运转检测 44 5 5 operator safety devices操作者安全保护装置 45 5 5 1emergency buttons急停按钮 45 5 5 2safety guards open安全护罩打开 46 5 6 machine parameters机器参数 47 5 6 1machine type机器类型 47 5 6 2capsules hour speed每小时胶囊数量 48 5 6 3machine life in hours机器运行时间 49 5 6 4machine running hours minutes机器运行小时 分钟 50 5 6 5number of produced capsules已充填胶囊的数量 51 6 notes注释 53 7 enclosures结束 53 functional test specificationspage 5 of 53 pd1118 rev 1 0 1 introduction 导言导言 this document sets out the functional test specifications of ima industria macchine automatiche s p a for the zanasi plus 85 e machine serial number pd1118 developed for customer wbs technical specifications reference wbs code 这是 zanasi plus 85 e 系列号是 pd1118 胶囊充填机的功能测试文件 以此满足客户的需求 the purpose of this document is to describe the tests to be carried out as evidence that the machine operates correctly in compliance with the functional specifications 照此文件的描述进行功能测试 测试结果与文件要求一致 证明机器运转正常 this document was issued in conformity with the following standard operating procedures sop and work instructions w i of ima s p a 文件发行遵照伊马公司 sop 及 wi 的文件要求 w i9 9 functional test specifications sw quality man 功能测试说明 w i4 4 standards applicable to quality system implementation documentation 该文件标 准遵照 质量系统执行文件 标准 w i4 6 coding applicable to quality system implementation and acceptance tests 该文 件编码遵照 质量系统执行及验收测验 标准 w i4 5 management applicable to quality system implementation documents 该文件事后 管理遵照 质量系统执行文件 标准 sop7 5 9 tests checks and final acceptance tests on machines and production lines 对机器和生产线进行测试 检查及最后验收测试 2 glossary术语表术语表 electrical safety devices 电器安全装置 hardware protecting devices magnetothermal circuit breakers proximity switches etc 电器硬件保护装置 热磁断路器 接近开关等 inclusion 包括 product machine and size datum able to enable or disable the activity functioning through the user s interface 药品 机器 模具更换件 通过操作界对机器进行动作 jog点动 machine run mode the manual jog mode is envisaged for maintenance and or size change operations 机器运转模式 维修及模具更换时用 operator interface 操作界面 machine operator communication software program implemented on pc and or via the operator terminal 人机可通过 pc 机或操作终端进行信息交流 production 机器运作 group of functions associated with monitoring final product quality control 生产是集各种监测装置于一体 最后成品质量控制的多个功能相连的过程 safety devices 安全装置 operator commands and protection devices such as stop buttons 操作控制及保护装置 size changeover 模具更换 function for managing the replacement and or adjustment mode of the components based on the processed size 基于既定型号的模具更换和调整的功能 functional test specificationspage 6 of 53 pd1118 rev 1 0 3 description and test plan测试操作描述及测试表测试操作描述及测试表 the following sub sections describe the structure of the test plan that has been set up for the zanasi plus 85 e machine and in particular the machine s activity groupings to be functionally tested and within such groupings any particular activities not subjected to functional testing and relative motivations for those particular activities not subjected to functional testing the check actions applied in any case are synthetically described each test is logged with an identification code of its own moreover if a test fails the steps to take are described 以下测试表里描述的是对 zanasi plus 85 e 胶囊充填机进行功能测试的说明 尤其是对机器的某些功 能组进行测试 在这些功能测试组里 若对一些功能没有相应的测试说明 测试人员要记录下来 并测 试其功能 3 1 tested areas测试范围测试范围 specific machine activity areas are functionally tested 对该机器的特殊功能进行测试 for this reason the functional test is represented by a number of tests as a whole which in turn are grouped according to the activity to be examined in particular the definition of the grouping can be singled out by the third and fourth character in the test identification code the machine activities that are subjected to functional testing and the corresponding test identification code typologies are listed below 基于这个原因 功能测试总体上是由多个依次测试的内容编组而成 这些编组可以通过测试代码的第三 个和第四个字母进行区分 对机器进行功能测试的内容及代码如下表所示 activities subjected to functional test 功能测试对象功能测试对象 test identification code typology 测试识别代码类型测试识别代码类型 production机器运作cfpr machine inclusions 机器所配置的的元器件 cfim size changeover 模具更换 cfcf safety devices 安全继电器 cfsi electrical safety devices 电器安全装置 cfel functional test specificationspage 7 of 53 pd1118 rev 1 0 test plan功能测试表 the check list of the test plan relative to the zanasi plus 85 e serial number pd1100 is shown below 下表所示为 zanasi plus 85 e 系列号为 胶囊充填机功能测试核对表 the functional test of the zanasi plus 85 e machine is carried out following the set order of the tests listed in this table 按下表中所示顺序对机器进行功能测试 test execution premises test name 测试名称测试名称 test code 测试代码测试代码 ima fat customer sat main switch test主电源开关cfel01 language selection语言选择cfim01 pushbuttons test machine start machine stop按钮测试 机器启动及停机按钮 cfim02 capsule feeding activation胶囊自动供给功能检测cfim03nana capsule minimum level胶囊最小料位cfim04 sorting unopened capsules未打开胶囊分选cfim07 capsule check enabling胶囊在位检测cfim08nana microdosing and intelligent hopper微计量及智能供粉cfim10nana mixer 1 time一号工位搅拌器时间设定cfim11 mixer 2 time二号工位搅拌器时间设定cfim12 powder mixer 2 intelligent hopper 二号搅拌器 智能供粉 cfim17nana no powder 2 intelligent hopper 缺粉检测 智能供粉 cfim22nana sucked tank 1 and slug release 1一号工位吸力槽及打击器 功能测试 cfim27nana sucked tank 2 and slug release 2二号工位吸力槽及打击器 功能测试 cfim28nana enabling the units机器配置单元cfim50 handwheel手轮cfcf01 jog max run time点动最长时间检测cfcf02 overload cutouts vacuum pump aspirator 真空泵吸尘器 过载断路功能检测 cfsi01 phase sensors check machine and capsule opening 机器 相位停机及胶囊打开传感器功能检测 cfsi08nana slug detachment 1 and slug detachment 2 phase sensor check一号及二号工位打击器的传感器检测 cfsi14 compressed air check压缩空气检测cfsi18 machine inverter failure机器变频器故障检测cfsi20 machine motor brake电机刹车cfsi21 intelligent hopper inverter failure 智能供粉电机变频器故障检测 cfsi22nana plc batteryplc电池 cfsi25 maximum speed机器最高速cfsi26 emergency buttons急停按钮cfsi60 safety guards open安全护罩打开cfsi61 machine type机器型号cfpr01 functional test specificationspage 8 of 53 pd1118 rev 1 0 test name 测试名称测试名称 test code 测试代码测试代码 test execution premises ima fat customer sat capsules hour speed每小时所充填胶囊数cfpr02 machine life in hours机器运行时间cfpr03 machine running hours minutes机器运行时间小时 分钟cfpr04 number of produced capsules已充填胶囊总数cfpr05 functional test specificationspage 9 of 53 pd1118 rev 1 0 3 2untested activities不需要进行的功能测试不需要进行的功能测试 none 3 3test format功能测试格式功能测试格式 the formal structure of the functional test includes the following points 正式的功能测试结构 test identification code refer to section 3 1 功能测试识别代码 参阅 3 1 部分 functional specifications reference section s of the functional specifications in which the functionality to be tested is described 关于此项功能的详细说明参考 参阅文件对此项功能有详细的描述 purpose of test synthetic description of the functional evidence that one wants to obtain by means of the test 测试目的 对此项功能进行检测并期望要得到的结果 initial conditions preliminary conditions to be met for the test to be carried out correctly 进行功能测试前的初始条件 正确的进行功能测试所需的预备条件 test description expected results ta operations to be carried out ac result that must be reached 测试描述 期望结果 ta 测试描述 ac 期望结果 steps to take after the test operations to be carried out at the end of the test in general restoring operations or steps to be taken to face the successive test 测试完成后的操作 当一项功能测试完成后 一般是初始化机器状态 进行下一项功能测试 functional test specificationspage 10 of 53 pd1118 rev 1 0 3 4 test passing criterion功能测试通过标准功能测试通过标准 each coded functional test is to be considered passed if each expected ac result is attained overall the functional test is to be considered positive if the machine has passed each coded test 如果功能测试项目达到所期望的结果 ac 则说明此项功能测试通过 进而说 每个编码的功能测试 项目都通过则该机器通过功能测试 3 5logging test results测试结果记录测试结果记录 the test results must be formalized in the following manner 测试结果必须符合以下格式 form frm7 5 6 survey of the testing results must be compiled for every coded test performed 每个测试项目都要记录在测试结果调查表 frm7 5 6 上 the test result sheet must eventually be compiled for every coded test performed upon customer s request and or if during the execution of the test one or more attachments are produced 记录测试项目的测试结果记录单最后必须整理汇编 经客户要求 在测试时每个测试附件表都要求 整理出来以备参阅 if the test is passed write y in the form frm7 5 6 survey of the testing results 如果测试通过 在 frm7 5 6 测试结果调查表 相应表格处填写 y if the test is failed write n in the form frm7 5 6 survey of the testing results 如果测试失败 在 frm7 5 6 测试结果调查表 相应表格处填写 n should an installation test be performed within a final acceptance test of one of the following types preliminary test without customer preliminary test with customer acceptance test the supervisors must sign the aforesaid forms as prescribed by sop7 5 9 tests checks and final acceptance tests on machines and production lines 对机器进行以下最后验收测试时包括对机器进行安装测试 这些验收测试文件包括 客户不在场的情 况下对机器进行初测试 客户在场的情况下对机器进行初测试 验收测试 验收监督人必须 在以上文件中签字并按文件 sop7 5 9 对机器及生产线进行测试 检查及最后的验收测试 所描述 的要求做 the forms to utilize are provided along with this document 以上表格同这份文件一起提供给相关人员 in case during the test a sheet will be printed out this one will be signed dated referred to the test number and paged 把测试表打印出来 相关人员签字 录入日期 测试号并标明页数 3 6 steps to take if a test fails如果测试失败时 如果测试失败时 in this case ima refers to that which is prescribed in sop7 5 9 tests checks and final acceptance tests on machines and production lines 在此情况下 按文件 sop7 5 9 对机器及生产线进行测试 检查及最后的验收测试 所描述的要求 做 functional test specificationspage 11 of 53 pd1118 rev 1 0 3 7 general warnings for carrying out the test进行测试时一般注意事项 进行测试时一般注意事项 with regard to tests that need to be carried out when the following safety guards are opened the reduction of safety levels must be considered 进行相关测试时以下的安全保护装置会失效 保护等级会降低 测试者必须注意 machine electrical equipment housing box doors 电器柜门 machine guards 机器护罩 successive tests are referred to zanasi plus 85 e 之后测试参考 zanasi plus 85 e 文件 3 8 special warnings for carrying out the tests进行测试时特别注意事项 进行测试时特别注意事项 the operation indicated as start the machine involves a series of special operations see basic machine functional specifications doc ref pd1100sf001 chap 1 3 unless a pre starting sequence is implicitly suggested 在做功能测试时按测试文件起动机器 之前需要对机器进行一系列的预操作 参阅文件 basic machine functional specifications doc ref pd1100sf001 chap 1 3 除非文件对机器预起动已有相关的说明 functional test specificationspage 12 of 53 pd1118 rev 1 0 4 documents and test equipment测试所需文件及测试设备测试所需文件及测试设备 documents文件 functional specifications doc ref pd1100sf 功能说明书 forms for logging test results frm7 5 6 frm7 5 8 test result sheet测试结果记录表 frm7 5 6 frm7 5 8 test result sheet electric technical documents of the zanasi plus 85 e serial no pd1100 doc ref epd1100 zanasi plus 85 e 电气文件 instructions manual of the zanasi plus 85 e serial no pd1100 doc ref pd1100m22 zanasi plus 85 e 操作说明手册 inverter instructions manual sj200 sj200 变频器操作说明手册 any previous and or subsequent revisions made to the document should be managed separately from this document 对这些文件的新旧版本应有所区分 instruments测试设备 workshop equipment 设备 supplied guard keys安全门钥匙 sample product unit with preset weight characteristics取样单元 reference balance所需用的天平 5 test procedure测试步骤测试步骤 5 1 main switch主电源开关主电源开关 5 1 1 main switch test主电源开关功能测试主电源开关功能测试 test identification code 测试代码 cfel01 functional specifications reference pd1100sf001 1 2 2 4 相关功能说明参考 pd1100sf001 1 2 2 4 purpose of test 测试目的 the purpose of this test is to check that when the qs0 main switch located on the panel is deactivated off the machine and the auxiliary units connected to it are electrically cut off and that when the qs0 main switch located on the panel is activated on the board is powered 检测电气护罩板上的主电源开关 qso 动作时 机器及其辅件能否正确的通电和断电 initial conditions 初始状态 the qs0 main switch located on the panel must be deactivated off 电气护罩板上的主电源开关 qso 位于 off 档 test description expected results 测试描述 正确结果 ta1press the machine run pushbutton sb1 twice located on the control panel to start the pumps aspirator 启动真空泵吸尘器按钮 sb1 位于控制面板上 ac1the pumps aspirator do not start 真空泵吸尘器不动作 ta2activate the qs0 main switch located on the panel qs0 位于 on 档 functional test specificationspage 13 of 53 pd1118 rev 1 0 ac2the dc voltage presence green led hd1 turns on the ha1 audible alarm cuts in the display is enabled and a message corresponding to the machine s state is displayed 直流电压指示 灯发光二极管 hd1 变亮 同时报警 显示器显示此时机器的状态 ta3press the machine run pushbutton sb1 on the control panel only once or press the function key f1 located on the control panel operator terminal 按下 sb1 或者按位于控制面板上的 f1 键键 ac3the green led associated to the key f1 light turns on and the pumps aspirator starts 绿色发光二集管及 f1 键变亮 同时真空泵吸尘器启动 steps to take after the test 测试完毕后操作 press and hold down the machine stop pushbutton sb2 for at least 5 seconds on the control panel to disable the pumps aspirator 按下 sb2 持续 5 秒钟关闭真空泵吸尘器 functional test specificationspage 14 of 53 pd1118 rev 1 0 5 2control panel控制面板控制面板 5 2 1language selection语言选择语言选择 test identification code cfim01 测试代码 cfim01 functional specifications reference pd1100sf 3 1 8 3 相关功能说明参考 pd1100sf 3 1 8 3 purpose of test 测试目的 the purpose of this test is to check the working efficiency of page 13 by which the desired language may be selected 测试第 13 页的语言选取功能 能否正确的对目的语言进行选取 initial conditions 初始状态 the qs0 main switch located on the panel must be activated on the machine must be stopped the dosing unit dosers must not be installed on the machine qs0 主电源开关处于 on 档 此时机器处于停机状态 机器不要安装计量针组件 test description expected results 测试描述 正确结果 ta1press the function key f12 located on the control panel operator terminal using the dw and up keys scroll to page 13 language selection 激活控制面板上的操作终端上的 f12 按钮 通过使用 dw 及 up 按钮选取到第 13 页 语言选取一 栏 ac1page 13 is displayed in which the language to be used may be selected 操作终端显示第 13 页 可以选择目的语言 ta2press the enter key 按下 enter 键 ac2the blinking cursor will appear on the first value n 光标指针闪烁出现在第一种语言上 ta3type in 5 press the enter key 输入 5 并键入 enter ac3the entered value is not accepted 输入值系统不接受 ta4type in the value consistent with the language to be selected press enter twice consecutively 输入目的语言的代表数值 连续按 enter 键两次 ac4the entered value is accepted 系统接受输入值 steps to take after the test 测试完毕后操作 reset normal machine operating conditions 把机器恢复到测试前的初始状态 functional test specificationspage 15 of 53 pd1118 rev 1 0 5 2 2pushbuttons test machine start machine stop按钮功能测试 机器启动 停止按钮功能测试 机器启动 停止 test identification code 测试代码 cfim02 functional specifications reference pd1100sf001 2 2 1 3 1 相关功能说明参考 pd1100sf001 2 2 1 3 1 purpose of test 测试目的 the purpose of this test is to check the proper operation of the pushbuttons machine start machine stop 测试机器启动及停止按钮动作是否正确 initial conditions 初始状态 the qs0 main switch located on the panel must be activated on qs0 主电源开关处于 on 档 the machine must be stopped 机器处于停机状态 the dosing unit dosers must not be installed on the machine 机器不要安装计量针组件 test description expected results 测试描述 正确结果 ta1press the machine run pushbutton sb1 on the control panel if the machine is starting for the first time press the machine run pushbutton sb1 three times 激活控制面板上的机器启动按钮 sb1 如果是首次开机 需连续按 sb1 三次 ac1the green lamp hl1 turns on the machine starts running 绿色指示灯 hl1 变亮 机器开始运转 ta2press the machine stop pushbutton sb2 located on the control panel 激活控制面板上的机器停机按钮 sb2 ac2the machine stops and alarm message 010 operator stop is displayed the green lamp hl1 turns off 机器停机 并显示报警信号 010 operator stop ta3press and hold down the machine stop pushbutton sb2 for at least 5 seconds on the control panel to disable the pumps aspirator or press the function key f1 located on the control panel operator terminal 按下 sb2 持续 5 秒钟 或按 f1 键关闭真空泵吸尘器 ac3the pumps aspirator stops 真空泵吸尘机停机 ta4press the machine run pushbutton sb1 on the control panel only once 激活控制面板上的按钮 sb1 只需按一下 ac4the pumps aspirator starts 真空泵吸尘器运转 ta5as per ta3 操作 ta3 步骤 ac5the pumps aspirator stops alarm message 012 pump suction