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System Requirements are development from the User Needs (sometimes called Market Requirements, etc. ). The idea is to make specific statements but about the abstract or general Needs of the user. For medical device, a User Need might be to be able to process all samples in one shift. A system requirement would be a Translation of that need into more concrete technical or quantitative statements , like 1200 samples must be processed in one 10 hour hospital shift by one operator.
Systems that are more complicated than one module, will be designed, requirements decomposed and assigned and verified across the multiple modules, assemblies and interfaces of the System. Thus there will be Requirements made at multiple levels moving through the “V” shaped product development process.
The cascade of the requirements into these lower level subassemblies, modules, circuit cards, and components is (should be) a methodical process that makes it rather easy to cascade requirements from the top to bottom of the V. However, teams not being guided by a Lead System Engineer may cause this process to fragment and end up with separately development requirements that at some point cause conflicts and make a clear system integration problematic.
Following a Methodical means to develop the requirements makes the faster to develop, more consistent and easier to verify. This promotes clear communication across the team. But again, when all parts of the team start designing without clear requirements, it’s not log till the inconsistencies start appearing.
System Requirements are development from the User Needs (sometimes called Market Requirements, etc. ). The idea is to make specific statements but about the abstract or general Needs of the user. For medical device, a User Need might be to be able to process all samples in one shift. A system requirement would be a Translation of that need into more concrete technical or quantitative statements , like 1200 samples must be processed in one 10 hour hospital shift by one operator.
Systems that are more complicated than one module, will be designed, requirements decomposed and assigned and verified across the multiple modules, assemblies and interfaces of the System. Thus there will be Requirements made at multiple levels moving through the “V” shaped product development process.
The cascade of the requirements into these lower level subassemblies, modules, circuit cards, and components is (should be) a methodical process that makes it rather easy to cascade requirements from the top to bottom of the V. However, teams not being guided by a Lead System Engineer may cause this process to fragment and end up with separately development requirements that at some point cause conflicts and make a clear system integration problematic.
Following a Methodical means to develop the requirements makes the faster to develop, more consistent and easier to verify. This promotes clear communication across the team. But again, when all parts of the team start designing without clear requirements, it’s not log till the inconsistencies start appearing.