When working on process automation or any process equipment for pharmaceutical, food and beverage or other products that are for human consumption, it is very important to know what you can and cannot legally change. That is why automation projects in these markets are often very precisely planned and executed, and must be very well documented at every stage. Because iAUTOMATION has a lot of experience in these markets, and in applying the GMP/GAMP principles, we thought we would explain how all of this works. The best way to do this is to highlight the iAUTOMATION project approach when doing a project that requires GMP/GAMP to be considered.
The iAUTOMATION project approach – The design stage
Because it is common to work with 2 project management implementations in the automation market, iAUTOMATION creates a project plan that includes the stages of both PRINCE2 and the GAMP standards. These standards describe the general project flow (PRINCE2) and the technical documentation content (GAMP). Therefore iAUTOMATION will structure the work package in PRINCE2 with the content of GAMP. The design stage is split in 3 design documents for each work package.
The first design document that is made by the project team is a document to create common understanding. This document is the Functional Design Specification or FDS, this document contains the customer’s requirements, and describes the implementation understanding of all of the user requirements by item number. The item number is important because it is also specified in the next two documents, therefore it is a traceability system to verify the all the customers requirements are implemented.
The following two documents after the FDS are the technical design documents. These two documents are the Hardware design specification or HDS and the Software design specification or SDS. The HDS contains all the hardware that is necessary to build the functionality described in the FDS. Whereas the SDS is the document that describes all the software that is needed to run the functionality described in the FDS. These documents are technical documents and so contain a lot of detail and settings. The HDS and SDS are the 2 documents that go to the engineering team for implementation, and so they will have to be detailed enough so the engineering team can start configuration and programming directly from those documents.
In the engineering stage, a couple of engineering tasks are done. These engineering tasks a different for each project, but a typical project will see the following engineering tasks:
Typically these stages will contain an internal testing procedure by the engineer, and only when the engineer is convinced his work is done and up to iAUTOMATION standard, the engineer will release his work for customer testing.
When the engineering stage is done, and all the engineers have successfully tested their work, iAUTOMATION will setup a test with the customer. This test is setup so that the customer can see the solution, and possibly change small things that they would like to see resolved before the system is shipped to site. In this test iAUTOMATION will typically test the system against the HDS and SDS, this test is called the FAT or Factory acceptance test.
After this testing stage, the system is shipped to site and construction and site configuration is started. This implementation is also internally tested and when the engineers finished their testing, the SAT will start. The SAT or Site Acceptance Test is a test to verify the system as it is installed onsite. In many cases the SAT is done with the customer as a final test that will lead to the acceptance by the customer. However in cases where the GAMP standard requires validation, extra steps are required.
Because some project require a full validation of the system, iAUTOMATION will do a full GAMP validation run with documentation in those projects. For the customer, this often mean they will require iAUTOMATION to do an IQ (Installation Qualification) test, in which iAUTOMATION qualifies the system, and provides the customers project team with witnessed test documentation with proof attached for each test. This documentation is then reviewed by the customer’s project team, and will result in the scheduling of an OQ.
This OQ or Operational Qualification is lead by iAUTOMATION and is witnessed by a representative of the customer. The OQ will consist of 2 parts, the first part being a review and testing of the IQ. During the review and testing of the IQ the customer will mostly randomly test the signed off IQ document to ensure the IQ was done correctly. The second part of the OQ will be a defined number of production runs in which the system must perform within certain specifications. When this is completed, the system is validated and ready for use by the customer.
When the system has gone through an OQ, and is validated, the system must remain in that configuration for production. When a change needs to be made, a change request must be created by the customer and submitted to iAUTOMATION. Obviously iAUTOMATION will help the customers project team to write a change request when it comes to technical details, and investigation possible solutions. When is Change request is made, the GAMP V model will guide the technical implementation off the change.
When the change is tested and ready for implementation onsite, the question always is how to install the changes onsite without having to stop production for days? This can be done by creating some switches and redundant system, so the implementation can be done unconnected, and when testing needs te be done, a switch can be switched and the system can be tested. Therefore it makes sense to use virtual PC’s to create a virtual copy of the PC systems, that can be switched on while testing, and switches off when production needs to resume.
iAUTOMATION is een automatiseringsspecialist die zich richt op industriële automatisering, ICT en de koppelingen tussen deze twee werkvelden. Met vele jaren ervaring in de industriële automatisering en ICT wereld is iAUTOMATION een volwassen partner waar u wat aan heeft.
iAUTOMATION verzorgt complete projecten voor de industriële automatiseringswereld met een specialiteit in PCS 7 consultancy en engineering. Maar ook andere systemen zijn bij ons bekend en kunnen door iAUTOMATION geïmplementeerd worden.
Met kennis van virtualisatie, netwerken, domeinen en ICT beheer is iAUTOMATION ook een zeer geschikte partner voor al uw ICT vragen en projecten. Wij zullen u altijd met veel enthousiasme en kennis bijstaan in uw projecten, en proberen onze klant te ontzorgen door pro actief en positief uw project aan te pakken.