Purpose of the Tool
This RAPAT tool has been created to support the development, qualification, and certification of products and technologies. It is not intended to provide a fully comprehensive project management system, but rather facilitates a risk-based approach to management of commercial and technical risks, together with identification and collation of appropriate assurance evidence, through the product development process. It is intended to be used to help demonstrate the extent to which a product or technology will meet the user requirements, including any regulatory requirements. The tool can also support applications for funding and investment.
Use of the Tool
RAPAT has been designed as a practical, easy to use Excel-based tool, deployed through Microsoft 365, with the ability to function in both a desktop and web-based SharePoint environment via a Windows or IOS operating system. RAPAT provides clear and simple guidance, to support any equipment supplier, including those inexperienced in risk management, technology qualification, and/or certification.
The overall structure of the RAPAT Framework can be seen in the 'Navigation' worksheet which will appear when the tool is first opened. The center of the Navigation sheet provides a view of the Current Status of technology development and assurance with progress through the supporting sheets indictaed by the 8 blocks around the circle. Starting with the "Commercial" worksheet, users are recommended to work clockwise through the different worksheets: from "Requirements", "Technical Risks (FMECA)", "Responsible Innovation" (coming soon), "Planning", "Design & Manufacture" (coming soon), "Testing & Analysis", to "Assurance & certification" (coming soon). These key worksheets record the information and data considered necessary and sufficient to support qualification and certification of the device or technology. Selecting one of the grey boxes on the Navigation sheet will open the relevant worksheet. The progress status of each individual worksheet is shown below the grey box, and in the individual worksheet dashboards.
The lower sections of the Navigation worksheet provide supporting worksheets intended to supplement the top-level worksheets as needed.
The RAPAT tool is intended to be a "living document" which can be continuously revisited and updated as the product design and maturity evolves. Although information can be added at any time into any section of any worksheet, there is a natural progression through the worksheets from commercial and requirements through to testing and analysis, and the eventual assurance and certification of the technology. The intent is that the completion of all actions identified within the RAPAT tool will provide sufficient documented evidence and references to supporting information for product / technology acceptance by the identified end-user.
Where to Start
When a RAPAT Framework is first generated, it will open on the "Navigation" worksheet. Other worksheets can be opened when needed by clicking on the relevant link on the "Navigation" worksheet.
For any product or new technology, it is important to identify the markets and potential users upfront, and before using the tool, to enable the relevant requirements, including any regulatory codes and standards to be identified and the risks to be understood. It can also be helpful to use the supporting Market Needs Assessment and Competitor Analysis worksheets at this stage.
The "Commercial" and "Requirements" worksheets would normally then be started, followed by the "Planning" and detailed "Technial Risk (FMECA)" assessment worksheet. A TRL assessment may also be required. Further detail is likely to be added to all these worksheets as more information becomes known about the device/equipment, including both the design details and the intended application. The "Design and Manufacture", "Testing and Analysis", and "Assurance and Certification” worksheets would then follow later.
Help Sheets
A help sheet is provided for each worksheet which should be accessed either by clicking on the 
button at the top right of the worksheet, or the 'Help' button on the RAPAT® for Excel 365 ribbon. These help sheets should be read in advance of completing the worksheet to maximise value from the RAPAT Tool. For worksheets which incorporate tables to be populated e.g. the task table on the "Planning" worksheet, the second row of the table provides brief guidance on the expected content for each column.
RAPAT® for Excel 365 Ribbon
The RAPAT Tool provides and Excel Ribbon (toolbar) at the top of the Excel window, which can be selected by clicking on the "RAPAT" label (see image below). The ribbon is used to generate a new RAPAT workbook, restart / update an existing workbook, and access the taskpane and helpsheets.
Format of the Worksheets
Each RAPAT worksheet is laid out in a similar format, with worksheet headings provided in blue cells and subheadings in mid-grey cells.
The grey cells with white borders are intended to be populated with content relevant to the device / equipment being developed.
All cells that are automatically populated based on the input provided in the grey cells are locked to prevent inadvertant over-writing of content.
Many of the worksheets, including the eight key worksheets, and some supporting worksheets include a status indicator at the top of the worksheet / section, which is manually updated using a drop-down list. This information is also automatically provided in the "Navigation" worksheet which provides a high-level overview of project progress. Where appropriate, the worksheets also include an automated dashboard, summarising progress against key content on the worksheet.
Within the worksheets there are several tables and forms to record information. Should additional rows be required, they can be incorporated (or deleted) via the RAPAT functions included in the context menu accessed through the mouse right-click. These RAPAT functions have been included to simplify the process and automatically copy all relevant formatting, formulae, and data valdiation to the new rows. If the add row function is used part way through a table, a single row is added immediately below the selected row. If the add row function is used at the bottom of the table, the user has the option to identify the number of rows to be added at the bottom of the table. The delete row functionality can be accessed at the same location, in the right-click context menu. This will delete the number of rows which are currently selected in the table, to a minimum of one remaining row.
Opening and Saving Files
When RAPAT is first opened, there is an option to start a new blank RAPAT workbook by selecting "Generate RAPAT" in the RAPAT® for Excel 365 ribbon. A previously saved workbook can be re-initialised by selecting "Update RAPAT". This button will restart all RAPAT functionality, and will also automatically apply any updates which have happened since the workbook was last opened. The RAPAT workbook can be saved using the standard Excel save functions via the desktop or web-based Excel app.
Additional Support
Although the RAPAT tool is intended for use by those with limited expertise, very inexperienced individuals or organisations may still require additional help and support. Astrimar can support users requiring further help in either applying the tool or in undertaking subsequent activities to generate the required assurance evidence. Please contact Astrimar at software@astrimar.com.