Conceptual design

   Conceptual Design

  The conceptual design stage is used, where necessary, to generate various alternatives for evaluation in response to the demands of the final User Requirements Sheet and the Requirement Specifications for individual systems. The project team selects the concepts to be taken forward into the functional design stage.

   Functional Design

  The functional design stage generates the key design documents, which are used as a framework for the detailed design process. These documents include:

• Site plans
• Floor plans
• Process and Material flow diagrams
• Air flow diagrams and HVAC schedules
• Electrical one-line diagrams

  A sequence of operations is prepared for each system. It provides a detailed description of:

• System Start-Up
• Normal operation and cleaning (as applicable)
• Process monitoring
• Data acquisition and Archive
• Alarm conditions and response
• Shut-Down

  A desired sequence of operations provides the basis for the system design; however, the sequence of operations will be updated to reflect the nature of the completed system(s). It is this final version of the sequence of operations that is used during procedure writing, commissioning, qualification, and system maintenance. The design review at this stage should assess the facility and systems for expected performance or behavior, under both planned and emergency situations. System start-up, commissioning, and qualification activities should be considered to ensure that associated requirements, such as whether the design accommodates commissioning by e.g., providing test points, are evaluated and met.

  Appropriate representatives from Engineering, Operations, Validation, Maintenance, Safety, and for “Direct Impact” systems, Quality Assurance, should review the relevant design documents based on the appropriate System Impact Assessment.