Implementation Phase

Phase Two of Design & Implementation

There are two potential routes that may be followed in the Implementation Phase. The first is when the Implementation Proposal meets the client’s need. That is IP matches the client’s URS. The second route arises when the ePAT device and it’s implementation, does not meet the client’s URS.

When Client URS matches the Implementation Proposal (URS = IP)

The client may use the Implementation Proposal, presented in the Feasibility Phase, as a basis for their own User Requirement Specification or URS. When URS matches the Implementation Proposal, then the Functional Design Specification that is generated as a result is taken from Expo’s archive of standard FDS documents. Also, when a standard ePAT system meets the specification in the client’s URS, the benefits of a faster implementation, full risk assessment documentation, and user manuals for both hardware and software being all off the shelf, are realized. In addition, there is a much greater history of implementation of the ePAT device in question; in turn knowledge of the robustness of the device and therefore the accompanying risk assessment documentation will be much more comprehensive.

When Client URS does not match the Implementation Proposal (URS ≠ IP)

If the implementation requires a new technology or configuration of technology that does not match a standard ePAT device, the following procedure is initiated.

User Requirement Specification ⇒ Prototype ⇒ Risk Assessment ⇒ Robustness Testing ⇒ Functional Design Specification

The measurement technology having been identified by the client’s own internal Applications Feasibility Study or by an AFS undertaken by Expo personnel, or a combination thereof, then the client's User Requirement Specification (URS) is reviewed and a prototype device is built and tested against the URS. The URS from the client may or may not contain areas where particular attention must be paid to the robustness of the device. A full specification test against the URS and Risk Assessment and robustness of the prototype device is performed. It is this Risk Assessment protocol that assists in refining the URS into a finalized FDS. A Functional Design Specification is presented to the client. It is this agreed FDS against which the final and agreed ePAT system is designed, manufactured and subsequently supported.

Risk Assessment

All risks identified and contained within a Risk Assessment Document are evaluated and prioritized and Mitigation and Response Plans are discussed, tested and finally documented as part of the final ePAT product for a specific Unit Operation.

In all cases, the results of this phase of development and testing will be documented and become part of the project file. It is not expected that all risks will be eliminated. A series of Robustness Experiments are performed for those risks identified. The resulting Robustness Documents are

A selection of these documents, pertaining to the ePAT601 Blend Monitoring measurement device, as an example, is accessible in the left hand column. For a full list of Expo Technologies' Risk Assessment Documents including those listed in the left column, please Contact Expo.

This iterative process continues until a final ePAT standard product, with full robustness assessment, IQ/OQ documentation, User Manual, etc., is complete. The measurement device can then be made available for Application and Implementation Feasibility Studies as part of the ePAT Feasibility Phase within Expo Technologies' project management approach.

Functional Design Specification ⇒ Manufacture ⇒ Factory Acceptance Test

Once the ePAT standard product has met all parameters within the Functional Design Specification, it is ready for manufacturing

As part of the ePAT prototyping process a Factory Acceptance Test is developed from knowledge of key robustness criteria. The Factory Acceptance Test or FAT is a rigorous pre-shipment test. The objective of the Factory Acceptance Test (FAT) is to describe how to test the ePAT measurement device for real-time measurement for a specific Unit Operation and to verify the proper operation of all hardware components and supporting technology. These tests will be performed at the factory prior to delivery and installation. Factory Acceptance Test involves testing the major hardware and software component functions and application. The satisfactory operation of the system will be verified by executing tests described in the Factory Acceptance Test document. The completed acceptance tests document that the system and related software operate as required. We encourage the client to attend the FAT procedure at one of our Technology Centers in Columbia, MD or Thames Ditton, England.

Factory Acceptance Test ⇒ Shipment ⇒ Implementation

The device is then shipped to the client and, as part of the installation, either a Site Acceptance Test (SAT) or a more comprehensive Installation Qualification / Operational Qualification (IQ/OQ) procedure is performed. All documentation is provided by Expo Technologies. Once the device is implemented, Expo Technologies and the Client sign off this part of the process and enter the maintenance or Sustainability Phase.