Qualification Plan

The engineering firm will be responsible for identifying key supplier documents required for validation (IQ and OQ) and also specifications and ranges for equipment. The validation services will develop protocols for executing each component (IQ and OQ). Performance qualifications are performed after completion of OQ. The engineer or contractor will typically not be involved in PQ. Our experience has been that the producer will perform PQ on the new process. 

The IQ protocols are designed to verify that the installation has been completed as specified. As an example, an IQ protocol for a vacuum pump will ensure that the right pump was installed, as specified. The entire nameplate data will be recorded, documenting all necessary engineering information such as size, type, and purpose. All electrical and instrumentation contacts will be tested and verified. 

The OQ protocols will test all critical parameters for the equipment. It will test all control devices, calibrate critical instruments, and test major vessels under operating conditions (pressure and vacuum). 

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The manufacturer often creates an instrument qualification plan and provides installation, operational, and performance qualifications to be executed in the customer s laboratory. The company using the equipment must determine if the manufacturer supplied instrument qualifications is comprehensive enough to be sure that the equipment is installed, operating, and performing correctly. If they feel it is not, they may choose to perform more tests themselves. 

If a validation plan is available, the hardware installation qualification should be addressed in this plan. If there is no validation plan, the hardware installation plan may be addressed either in a standalone document or as part of the installation qualification protocol. The hardware installation qualification plan identifies the activities to be completed and the responsible parties involved. 

Vendor Qualification Plan/ Certification User Requirements Functional Specifications ... 

VMP is a high-level document which establishes an umbrella validation plan for the entire project, and is used as guidance by the project team for resource and technical planning (also referred to as master qualification plan). 

Each product should be evaluated to determine whether it should be nugrated to the platform. This evaluation should also consider future products and designs. The evaluation has two key parts associated with it. First, a business case needs to be developed to detemune what are the specific expected benefits in terms of cost, interval, capacity improvements vs. the cost of implementation of the platform. Second, there needs to be an assessment to establish the technical feasibility of manufacturing the product using the platform. The technical feasibility must be done from both the design and process viewpoints. This will require that both process and design characterization have been completed. Once both benefits and technical feasibility have been demonstrated, specific experimental and qualification plans can be developed and implemented to nugrate products onto the platform. 

In addition to the tests the detailed technology qualification plan would typically include technical... 

Because of the short time scheduled for the qualification the empty chamber temperature distribution study was combined with the empty chamber temperature penetration study. These studies differ only in the usage of biological indicator (BI), an Fq (accumulated lethality during the SIP hold period) calculation, and the number of thermocouples. By using the same amount of Bis as thermocouples, the studies could be performed together. A separate performance qualification was established as unnecessary. This approach was documented in the qualification plan. 

Li-ion battery suppliers are proposing different designs at the cell and battery levels. Even if all batteries must comply with the same mission specifications, S-P or P-S topologies (Figure 14.4), mechanical interfaces, qualification plans and battery managements can be slightly different. 

The following paragraphs will present cell designs, life tests, battery design and management, qualification plans, models and flight heritage for each of the main suppliers of Li-ion batteries for satellite applications. 

If the battery powers a satellite or other spacecraft rather than a space rocket, then the qualification needs to consider the space environments (such as radiation and exposure to prolonged vacuum) as well as the cell usage. It is at this point that the longevity of the battery often becomes a driving factor. The use of COTS cells makes it viable to test much larger quantities of cells to fully understand the performance of a cell under these various conditions and indeed a standard small-cell qualification process will use in excess of 2000 cells. Some of the key areas of assessment include qualification plans as described in Section 3.2. 

Over the huge amount of tests performed, the essential part of the cell qualification plans has been life testing under conditions as close as possible to those of typical space applications in GEO and LEO. Most of the long-term life tests, mainly on VES140, have been carried out in the European space battery test centre even if the users (satellite manufacturers) have conducted their own tests. These have been running continuously for more than 12 years [11]. 

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