chapter  2
44 Pages

Variations on the Theme—Considerations for Mission-Critical Equipment and Medical Devices

There are markets and products that require rigorous and well-defined development processes. Examples include industrial equipment, cars, trucks, tractors, military equipment, avionics, spacecraft, and medical devices. These types of products are called mission-critical equipment or, sometimes, safety-critical equipment. Mission-critical means that the system or equipment must operate in a

satisfactory fashion that is necessary for a larger overall operation. Should the equipment either fail or operate in an inappropriate manner, it compromises the overall operation or mission. An instrument on a spacecraft is an example of mission-critical equipment; its failure would seriously impair the space mission. Safety-critical is very similar to mission-critical. The one distinction is that

it affects human life. Should the equipment either fail or operate in an inappropriate manner, it puts human life and limb at risk. This chapter will suggest some general processes used in design and

development for mission-critical and safety-critical systems. It will highlight variations in the processes outlined in Chapter 1; these processes include standards, regulations, certification, documentation, development phases, plans, procedures, reviews, configuration control, archiving, and traceability.

2.1.1 What, Why, Who, When, Where, and How