PLC / HMI IOQ - 测试什么？

Today’s post is on initial control system Installation and Operational Qualification (IOQ) of a simple system consisting of an Human/Machine Interface (HMI), Programmable Logic Controller (PLC), and any number of end devices (valves, pumps, sensors, etc.). The question is what should be tested?

今天的主题是一个由人机界面 (HMI)、可编程逻辑控制器 (PLC) 和任意数量的终端设备(阀门、泵、传感器等)组成的简单系统的安装和运行确认 (IOQ)。现在的问题是应该测试什么？

here is the tests that could be expected.

这里列出被期望的测试。让我们开始吧!

Installation Qualification

安装确认

IQ can be its own protocol or combined with OQ in an IOQ for cases without a ton of complexity. IQ is supposed to verify the installation of hardware, software, and any peripherals. You also want to check what documentation is available/applicable here. IQ tests may include:

IQ 可以是独立的方案，对于复杂性程度不高的系统，也可以与OQ 结合形成IOQ。IQ 应该确认硬件、软件和任何外围设备的安装。还需要检查哪些文件可用/适用。IQ测试可能包括:

• Documentation Verification (e.g. SOPs, EREC/ESIG assessment, operating/maintenance manuals, panel and electrical drawings, etc.)

  文件确认(例如 SOP、EREC/ESIG 评估、操作/维护手册、面板和电气图纸等)

• Hardware Verification: verify the make and model of major components at a minimum

  硬件确认：至少确认主要组件的型号

• Software Verification: verify/record software versions.

  软件确认：确认/记录软件版本。

• Configuration Verification: verify any hardware and/or software configuration. This could be two tests, one for hardware, one for software.

  配置确认：确认任何硬件和/或软件配置。这可能是两个测试，一个用于硬件,一个用于软件。

• Loop Check Verification: verify loop checks are performed.

  循环检查确认：确认循环检查是否执行。

• Alarm Configuration Verification

  报警配置确认

• Any other critical installation items

  任何其他关键安装项目

Operational Qualification

运行确认

OQ is the meat of your control qualification. Here you want to test critical functions, that hopefully you have identified earlier (see herefor one approach). OQ may test:

OQ 是控制系统确认的主要内容。在这里，关键功能需要进行测试，希望你尽早确定(请参阅此处的一种方法)。OQ 将测试：

• Interlock Verification including e-stops. A lot of interlocks are safety/business related, but they’re often included in OQ due to how critical they are.

  联锁确认，包括电子站。许多联锁与安全/业务相关，但由于它们的重要性，它们通常包含在 OQ 中。

• Functional Alarm Verification – be sure to include data loss/communication alarms

  功能报警确认 – 确保包括数据丢失/通信警报

• HMI Navigation and Layout Verification

  HMI 导航和布局确认

• Restart/Recovery Verification

  重启/恢复确认

• Sequence of Operations Verification

  操作序列确认

公众号

GMP办公室

• 专业的GMP合规性研究组织

• 国内外（FDA、EMA、MHRA、CFDA、WHO、PIC/S等）GMP法规解读；

• 国内外制药行业GMP监管动态；

• GMP技术指南（ISPE、PDA、ISO、ASTM等）分享