Tag Archives: IOQ

PLC/HMI IOQ – What to Test?


Hello good people of the world! 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?

Obviously there’s a ton of guidance out there (see e.g.: GAMP) that will have a lot more detail than this post. The purpose here is to list at a high level the tests that could be expected. So let’s get started!

Installation Qualification
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:

  • Documentation Verification (e.g. SOPs, EREC/ESIG assessment, operating/maintenance manuals, panel and electrical drawings, etc.)
  • Hardware Verification: verify the make and model of major components at a minimum
  • Software Verification: verify/record software versions. You’ve got to know what you’ll be OQ’ing!
  • Configuration Verification: verify any hardware and/or software configuration. This could be two tests, one for hardware, one for software.
  • Loop Check Verification: verify loop checks are performed.
  • Alarm Configuration Verification: ideally alarms a setup in such a way that you don’t have to functionality test them all!
  • Any other critical installation items

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

  • 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.
  • Functional Alarm Verification – be sure to include data loss/communication alarms
  • HMI Navigation and Layout Verification
  • Restart/Recovery Verification
  • Sequence of Operations Verification

What kinds of testing are you sure to cover in your control system IOQ protocols? Comment below.

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Staying in Control: Alerts and Alarms


Hello good people of the world! If you work with a mix of process equipment and supervisory control or monitoring systems, you know the importance of alerts and alarms, but most companies do not take the necessary steps to ensure their alerts and alarms are well configured and meaningful. One of the enemies is so-called “nuisance-alarms,” but just as important is knowing that you have enough alerting/alarming so that critical events are not missed and appropriate actions are taken before harm is done.

And by the  way, alerts and alarms are something the FDA has historically shown to care about (e.g.  FDA had observation at Teva Irvine for lack of validation on alerts and alarms). So what considerations are at play?

What should alert/alarm? If you’ve clearly defined your Critical Process Parameters (CPPs) and know what your Critical Quality Attributes (CQAs) are, you know already what needs alerts/alarms: all CPPs.

What should the alert/alarm limits be? This part is tricky: you need limits that provide operators with sufficient information without becoming a nuisance. All too often I see the situation where alarm banners are flashing but no one is paying attention because “there’s always alarms” or whatever.

What action should occur based on alert/alarm conditions? This is another place I often see improvements needed: every alert and alarm should have a documented action associated with it, typically in the SOP, that operators are trained on. If there is no documented action required for an alert/alarm, why do you have it?

What do you find critical in configuring alerts/alarms and introducing them into a manufacturing process?

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10 Easy Steps – Deleting a Point from a Qualified Building Management System (BMS)

Siemens APOGEE

Hello, good people of the world! This post covers the procedure for deleting a point from a qualified Building Management System (BMS), specifically the Siemens APOGEE® BMS. A template for your use is here: Deleting a BMS Point TEMPLATE.

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