Border Between Commissioning and Qualification

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hello everyone,

I have a bit of a disagreement with my supervisor about the definition and content of the Qualification vs Commissioning.
I’m writing the IQ/OQ protocols for the revamping of a pure steam generator (new PLC, HMI, electrical panel). The supplier provides very thorough IQ/QO protocol and I’m basically going to use those tests as attachments for my in-house protocol’s test sheets.

The disagreement is about which tests I should use from the supplier’s protocol. My supervisor wants me to ignore several IQ tests that he considers as “commissioning activities” and not part of the Qualification’s scope: electrical components verification (against electrical diagram), electrical wiring (10% sampling), electrical panel dimensions, hydraulic components verification (against PID), etc.
He justifies this by saying these tests do not have any direct impact on the system/product and any issue will be detected during OQ testing. “As long as the critical functions of the equipment were checked, we comply”.
I’ve always performed those tests as part of the IQ in the previous companies I worked for. I also think thorough IQ testing is necessary to avoid other issues down the line, during OQ testing. it’s about doing things in the right order to avoid having to fix things during testing.

I found this other topic that is related to this subject: Commissioning vs. Installation Qualification - What is the difference?
The definition of the Installation Qualification is quite simple: Documented verification that a system is installed per written and pre-approved specifications.
So it’s not only about the criticality regarding the equipment and product, right?

It probably looks like I’m answering my own question here.
I guess I mostly want to know who’s right. Your input is much appreciated.
Thanks.

1 Like
2

There is no right answer here. A review of the ISPE guide on commissioning and qualification show there is overlap of commissioning and qualification. I personally feel as though a lot of things are tested in redundancy and just adds hours to the project, without adding value. Remember the FDA is going to a risked-based-approach and is very open about it. I tend to lean toward your supervisor. If the function is tested, do you really need to check the wiring? I’ve had clients check the same thing multiple times (connectivity, naming, programming, white box verification, code review), when a single calibration check would answer all their questions. The tendancy in validation is to check everything, but the FDA does NOT ask for it - they ask for a risked based approach to everything. A good validation person knows what is critical and what isn’t - and will always remember that validation is to ensure product quality and process reliability.

3 Likes
3

I agree with you Jared. In the late 1990’s there was a total overkill approach to validation. One of my co-workers failed an IQ because the wires were not numbered at both ends to verify that they were properly installed. The common approach that I have observed is a cause and effect in validations. Basically, if there is a sensor that identifies when a critical circuit is open and sends a message to a PLC, the test is to verify that when the critical circuit is opened, the HMI provides the message that the circuit is open (i.e., autoclave door is not properly closed).

1 Like