Carry out a risk analysis
Analyze process risks

As seen in the previous step, the risks of failure relate to the five components of activity control: materials, means, methods, environment and manpower.

The approach is similar to FMECA (see Understanding FMECA [FIC 1290] ): if we think in terms of process finality, we are interested in the deliverable (output data) provided by the process. This output is naturally intended for an organization's customer, a company supplier or another QMS process.

A process output thus becomes an input for its external (an interested...