ABSTRACT
The next stage is to develop a detailed project plan, typically summarised in the form of a Gantt chart, which will establish the time schedule of the project, including the vital milestones, such as design approval and factory acceptance test (FAT): a sort of predelivery inspection. This, in many ways, becomes the key document, as it is the yardstick by which progress may be judged. Whilst it may change as the project moves on, this project plan should be established at an early stage and then monitored closely throughout the period of the project. Each Gantt chart will, of course, be tailored to its individual project, but typical stages in the chart might be as follows:
• URS approval • General design • Detail design • Design approval (DQ) • Fabrication • Parts procurement • Assembly • Test • Predelivery inspection and FAT • Packing and shipment • Assembly and installation • Site Acceptance Tests (SAT) and IQ • Commissioning • OQ • Preproduction work (PQ)
The concept of qualification documents was introduced at the start of Chapter 5; these are the design, installation, operational, and performance qualifications that may be defined briefly as follows:
IQ — installation qualification The IQ document is often written by the isolator supply company, following detailed discussions with the client, though it may be written by the users or by outside validation contractors. The IQ simply lays out how and where the isolator will be installed.
