Two weeks ago I visited a factory in Italy, where we’ve done this acceptance tests for our new Automatic Tube Filling and Sealing Machine.
Along with the acceptance tests, also IQ/OQ was performed.
Now the machine has been transported to our factory in Poland.
The question is: should I repeat IQ/OQ tests when the filling machine is installed on our site?
Typically , IQ/OQ tests are repeated when they are location dependent…i.e. utilities. You can leverage testing performed at the factory as long as you can demonstrate that nothing changed after you left and during transit. Oh, and that you planned for leveraging in your validation plan.
yes, IQ/OQ shall be repeated to prove that there is no daamage / or change in basic operating function of equipment.
It depends on how you set up to do the IQ/OQ at your suppliers.
We have a system where we as a company will always do Factory Acceptance Testing (FAT) at our suppliers site. This is a commercial requirement - we will not pay the main sum of money until the FAT is done and satisfactory. So the commercial pressure is on to ensure that FAT is done thoroughly.
As a result, we set up a FAT protocol, which looks suspiciously like a combined IQ/OQ protocol, and get it approved by both the commercial guys, and everyone who would normally approve an IQ or OQ.
The FAT is executed, documented, and results compared to the pre-determined acceptance criteria. A report is written - approved by commercial and everyone who would approve an IQ or OQ report.
The equipment is shipped to site, the supplier is paid the majority of the contract.
The FAT document is then reviewed to determine which tests will be repeated in IQ or OQ on site, and which will not. Tests will not be repeated if they would get the same results on our site as they did at the suppliers. If they could (or would) get a different result at our site - becuase of transit damage, different utility supplies etc, they are repeated.
We have found that doing it this way has 2 benefits.
Firstly the FAT is very thorough. It covers more than just a validation (IQ or OQ) would so it’s a great document to use - and provided that the normal validation approvers approve it, it can be used in validation - our procedures are written to allow it. The beneift of adding the validation approvers means that pre-determined acceptance criteria are present. This allows everyone conducting or seeing the FAT to know exactly when a test has passed. This takes quite a lot of pressure off the people there on our behalf.
Secondly, it’s surprising how many tests don’t need repeating - so our IQ and OQ become much faster, yet are properly documented and approved.
Hope that helps!
Hi, typically we perform a FAT (Factory Acceptance Test) at the supplier’s site before shipping to ensure all is ok. Some of the tests performed might be some of the final OQ and PQ tests being pulled forward, this depends of the available functionality of the machine at the supplier’s site (not all utilities required might be avalable). We then have the supplier commission the machine once on site and then perform our IQ,OQ and PQ.
In my opinion you can not fulfill al the requirements of the Installation Qualification by performing it at the manufacturer’s site, you need to assign ID’s, check docs received, check available utilities, book into PPM and Calibration programs etc.
If it were the case manufacturers would be able to sell/issue already qualified equipment to customers.
Just my thoughts
I agree with Michael. IQ is Installation Qualification, and until the equipment / instrument is installed at the customer site, it cannot be initiated and performed. If the IQ is not done, the equipment / instrument is not ready for OQ. Hence, OQ cannot be initiated.
So maybe my proposal is suitable:
To prepare joint of SAT/IQ/OQ/PQ protocol and execute it in our site (Site Acceptance Test).
Anyway if PQ would be joint with SAT, there must be a number of components bought before shipping to perform some PQ exercises.
What do You think?
I have never relied on FATs too much. Previously at my old job, I was part of a few FATs as an Observer, and the companies were big outfits, and boy oh boy did they really do things on the “lean”.
Get the Fat Done so it’s suitable and acceptable to your contract needs.
Then, do your IQ/OQ/PQ on site. The FAT can serve as a pretty good foundation to build your I/O/PQ on .
As a regulator, I don’t look at FAT’s, I’m gonna be looking at your in house testing.
I think that it should be do again,because you go to The Italy,is only do the FAT,you come back you company and after the machine has transported to you campany,you will begin to write the protocol for the validation(IQ/OQ/PQ),after approval,start to do the validation,and then is validation report.
Thank you all for a good advice
The full IQ/OQ (also PQ) was performed after installing the machine in our factory. If I knew Italian, I’m sure I’d recognise some dirty words after telling the Italian guy that we won’t pay for the machine until we make sure it runs perfectly