Changes to the software and hardware are inevitable throughout the life cycle to fix discrepancy reports and improve system testing and maturity. As these changes occur it is imperative that a process is documented for incorporating necessary changes for hardware and software into the computer system architecture with minimal impact to the safe operation. (see Configuration Management) A flow chart shall be developed to document the development process steps to be followed for all potential areas of change, and this process shall tie to established development, test, and regression test processes. [1]

Software in many cases is changed to mask a resultant output or hardware problem instead of actually fixing the true problem. In many hardware related cases, a software fix is the most economical and time effective means of correcting the deficiency, but this must be thoroughly analyzed to ensure a safe solution. The effect that the software change has to safety critical function threads must also be identified and analyzed. Plan to analyze the change for impact to rate changes, system transients, mechanization flow, hardware and interface compatibility, software modules, and other associated effects. [1]

As with the hardware selection process, the hardware change process should utilize mature, reliable components. It is not recommended that state-of-the-art design be pushed. Performance requirements for the system must not be compromised. Once developed, the changed hardware shall be treated as a new development, and as such, fully re-qualified at the system, platform, and software (operating system and application software) levels. The impact of Diminishing Manufacturing Sources (DMS) must also be considered when re-developing the hardware. The process shall also determine the regression testing process for the areas changed. [1]

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Updated: 7/19/2017

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