Factory Acceptance Testing: not a simple business19/01/2016 - Kin Chun Cheung, Project Manager Pharmaceutical Engineering at Quality by Design
Early November 2015, I set off for a ten day trip to Scandinavia. Main purpose of the trip? Checking on a completed filling and packaging machine for ointment. I visited the machine builder who has been designing and constructing this machine for our client for over a year now. The most important objective of my visit was to inspect if the machine was ready to leave the factory and be sent to our client, determined by a so called Factory Acceptance Test (FAT).
A walking encyclopaedia
It was not the first time I visited the filling and packaging machine and the factory in Scandinavia. As a project manager Pharmaceutical Engineering I am responsible for everything that is happening around the machine. In this kind of project my job starts at the design phase, when I act as a walking encyclopaedia for all the technical questions of the vendors design department and our operations department. During the design and construction of the machine, I am a consultant and supervisor. I make sure everyone knows his role, knows how to communicate with each other and how the machine works. And when it is time to validate the machine, it is my job to decide who is testing which part of the machine using what kind of protocols. Because of my involvement right from the start of the project I am aware of all the ins and outs of the machine, saving time in developing tests. In order to save time in this project the philosophy of a risk-based approach was chosen. This means that the test performed during FAT was accurately documented, with the goal to take advantage of these tests in the validation phase. So by testing the machine in the factory and documenting this process in a correct way, we save time. Of course all organizations involved need thorough preparation to be able to cope with this way of working.
However, four weeks before my planned departure to Scandinavia we encountered some problems. The vendor’s protocol was not ready and only a standard FAT protocol was available. We immediately saw that this protocol was not sufficient to meet the requirements that where set to use these tests as official validation tests. In other words, the FAT was about to have a bad start.
The value of Factory Acceptance Testing
What you should know about Factory Acceptance Testing is that it is an extremely important part of a project. When conducting a FAT, the vendor demonstrates that the design and manufacturing of a system or machine meets the contract specifications of the client. This is a real milestone: the system is changing hands, from the vendor to the client. That is why it is important to make sure a machine or system runs a thorough FAT, preferably with a successful outcome. Besides, for the vendor it is crucial because usually a successful FAT triggers a substantial financial payment to the vendor. Not a single company accepts the shipping of a machine or system without completing a successful FAT. Therefore, taking off to Scandinavia knowing that the FAT of the filling and packaging machine could not start successfully, was not an option.
We gave the vendor two weeks time before we took over. Because neither the vendor nor somebody within the organisation of our client could provide us with a good protocol, I decided – as a consultant of QbD – to rewrite the whole protocol itself in the remaining two weeks. This resulted in an accurate and complete protocol, just in time for my departure to the Nordics. It was a challenge, but we were still on schedule.
It is all about safety and quality
Unfortunately in the end it turned out the machine did not comply with the FAT we conducted, due to various issues. However, by rewriting the protocol we set a baseline to which the system must comply to produce reliably for our client. Rushing through a FAT is never a good idea. In some cases, companies want to ship equipment as soon as possible to receive their payment. By the time the machine or system is installed, each observed non conformity requires flexibility, a lot of resources and extra costs to effectively resolve the problems. The filling and packaging machine for example was planned to be shipped to the other side of the world just one month after the FAT. By testing the machine formally, extensively and with an adequate protocol, we saved our client from experiencing quality issues after shipping. This year I will travel to Scandinavia again, to hopefully conduct a successful FAT. Because in the end, safety and quality is what it is all about. To be continued…