Tag Archives: Validation

PLC/HMI IOQ – What to Test?

PLC

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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Validation Project Plans

develop-project-plan-1200x480

Hello good people of the world! Today’s post is about Validation Project Plans, which is a specific type of project plan for projects in the pharmaceutical, biotechnology, and medical device regulated industries. This post covers Validation Project Plans for pharmaceutical/biotechnology industries in particular.

Often I’ve see Validation Project Plans contain a lot of fluff but little meat, making them of less value to the project team. A good project plan clearly documents the following, at a minimum:

  1. What facilities, systems, and equipment are in scope of the plan
  2. What are the expected activities and deliverables
  3. Who is responsible for what
  4. What is the validation approach and rationale for that approach
  5. What happens after the validation scope covered in the plan is completed (i.e. ongoing requirements)

Note I do not include project cost or schedule in a project plan, because these are often changing rapidly and should be maintained in a less controlled, more flexible manner, e.g. with scheduling software for a schedule.

The plan itself should be controlled (i.e. approved and revision controlled) as soon as possible in the project but early enough so that scope will not change (too much).

Additional things to think about when drafting your plan:

  1.  Commissioning versus Qualification versus Validation. If your project has multiple phases (and any decent-sized project should), be sure to clearly state responsibilities and deliverables at each stage.
  2. Include references to regulations, industry guidance, and site procedures that govern your plan. Make it clear to everyone who reads the plan what framework you are working inside.
  3. The purpose and scope of the document should be clear and up front.
  4. Get buy-in from all functional groups by having them approve the document.
  5. Like all controlled documents, the plan should have version/revision history.
  6. Use tables to clearly present information.

I put together a quick template here:

Validation Project Plan Template MWV

What do you feel is necessary in a Validation Project Plan? Comment below.

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Basic Components of a Test Form

Hello good people of the world! Today’s post is a short one on what are the basic components of a test form. In Validation, you’re going to record a lot of data, and you want this data to be well organized and easily understood. Here are the basic components I think every test form should have:

  1. Numbering! Each step should have a unique number so that it is easily identifiable and easy to reference elsewhere.
  2. A Title! What is this test all about? A short description should be provide.
  3. Purpose! What is the purpose of the test? Make it clear.
  4. Verification Steps! Clearly define what steps need to be performed.
  5. Expected Results! Clearly define what the expected results are. Does every step need an expected result? Every step can have one, so include it.
  6. Actual Results! This is where the actual data is collected. The actual results can be recorded exactly as the expected results are stated to avoid any confusion.
  7. Pass/Fail! Did the step pass or fail? This will quickly tell you. Also a good place to reference any comments.
  8. Initials/Date! In order for the data to be attributable, initial/date uniquely identifying the test executer must be included for each step.

What basic components do you include on your test forms? Comment below.

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What NOT to Re-qualify

autoclave
Hello good people of the world! Today’s post is on what NOT to include in requalification/revalidation. I was recently on a site that had a five (5) year requalification requirement for sterilizers per a site SOP, which sounds reasonable (continuous monitoring would be better). But then I noted they included in their requalification requirements a re-execution of the entire initial controls system IOQ! The requalification included verification of:

  • Hardware/software installation
  • E-stop, guarding, and door interlocks
  • Restart and recovery
  • Recipe management
  • Temperature, pressure, and time control
  • Communication
  • Security

And it was expected that this would be done every five years! It just so happened that in 2014 they paid a contractor to do the work, who sadly did not help the site out by letting them know the wastefulness of such an endeavor. This is an egregious example of resource misuse and not understanding the expectations of a validation program/taking a risk-based approach. The point of requalification/revalidation is to look for drift in processes, not blindly repeat testing already performed.

What misunderstanding-of-validation-expectation horror stories do you have? Comment below.

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WHO’s Draft Guidelines on Validation May 2016

Hello good people of the world! On May 15, 2016, the World Health Organization released its draft Guidelines on Validation. It is available on the WHO website for download here.

This post covers my review of the guidance. Continue reading WHO’s Draft Guidelines on Validation May 2016

Considerations in SaaS Validation

SaaS Qualification

Hello good people of the world! Today’s post is about qualifying Software as a Service (SaaS), also known as “cloud-based” or “hosted” software. Simply, SaaS is any computer system in which any server is not hosted by the system owner. Here are some key considerations in qualifying SaaS computer systems:

Continue reading Considerations in SaaS Validation

False Positives in Statistical Process Control

false positive

Hello good people of the world! This post is about Statistical Process Control (SPC), and what false positives, or type I errors, mean for SPC results.

A false positive or type I error may be simply described as an error where a correlation is believed to be seen, although it does not actually exist. In statistics, this is called falsely rejecting the null hypothesis. Details can be found, for instance, on Wikipedia.

Continue reading False Positives in Statistical Process Control